Thrombectomy Devices

Abstract

The present invention discloses medical devices and methods of using medical devices. An example method of forming an expandable thrombectomy device includes arranging a scraping member along a mandrel, the scraping member including a proximal region, a distal region, and an intermediate region positioned between the proximal region and the distal region. The method also includes constraining the proximal region of the scraping member, constraining the distal region of the scraping member, and heat setting the scraping member.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 355,365, filed on June 24, 2022, and is related to U.S. Provisional Patent Application No. 63 / 151,054, entitled “Thrombectomy Tools and Devices,” filed on February 18, 2021, and U.S. Provisional Patent Application No. 63 / 249,561, entitled “Thrombectomy Tools and Devices,” filed on September 28, 2021, each of which is incorporated herein by reference in its entirety. Background Art

[0002] Removing material from a vessel or chamber is often useful. For example, removing tissue, such as a blood clot, from within the vascular system can improve the patient's condition and quality of life. Removal of clots may be beneficial or even necessary to improve the patient's outcome. For example, in the peripheral vascular system, intervention and surgery can reduce the need for amputation by 80%. The ultimate goal of any technology used to treat these conditions is to quickly, safely and cost-effectively remove the blockage and restore patency.

[0003] Devices for mechanically removing material, including thrombotic material, from a lumen of a blood vessel may include a device for removing material from a body lumen, such as an inverted tube (e.g., a thrombectomy device) for removing a clot from a blood vessel, which is disclosed and described in each of U.S. Patent Nos. 10,271,864, 10,835,234, 10,561,431, 10,842,513, and 11,253,291. These devices do an excellent job of removing material from a blood vessel, but in some cases may present challenges in removing large amounts of material that may require multiple attempts to remove, and / or in removing softer clotted material that may be difficult to hold. In some cases, it may be difficult to completely remove the clotted material from the blood vessel wall.

[0004] Therefore, there is a need for devices, including thrombectomy devices, that can remove tissue, and particularly large and / or soft material, from a body cavity.Described herein are apparatus (devices, systems, and kits) and methods of use thereof that can address the needs and problems discussed above. Summary of the invention

[0005] The present invention provides designs, materials, manufacturing methods and use alternatives for medical devices. An example method of forming an expandable thrombectomy device includes arranging a scraping member along a mandrel, the scraping member including a proximal region, a distal region and an intermediate region positioned between the proximal region and the distal region. The method also includes constraining the proximal region of the scraping member, constraining the distal region of the scraping member and heat setting the scraping member.

[0006] Alternatively or additionally to any of the above embodiments, constraining the proximal region of the scraping member further comprises constraining the proximal region of the scraping member with a first constraining wire.

[0007] Alternatively or additionally to any of the above embodiments, constraining the distal region of the scraping member further comprises constraining the distal region of the scraping member with a second constraining wire.

[0008] Alternatively or additionally to any of the above embodiments, it also includes removing the first restraining wire before heat setting the scraping member.

[0009] Alternatively or additionally to any of the above embodiments, it also includes removing the second restraining wire before heat setting the scraping member.

[0010] Alternatively or additionally to any of the above embodiments, wherein the scraper further includes an intermediate region positioned between the proximal region and the distal region.

[0011] Alternatively or additionally to any of the above embodiments, wherein heat setting the scraping member defines an expansion point in the intermediate region.

[0012] Alternatively or additionally to any of the above embodiments, wherein during heat setting the scraping member, the intermediate region is free of the first and second restraining wires.

[0013] Alternatively or additionally to any of the above embodiments, wherein the first constraining wire is configured to maintain a proximal region of the scraping member at the first diameter during heat setting the scraping member.

[0014] Alternatively or additionally to any of the above embodiments, wherein the second constraining wire is configured to maintain the distal end region of the scraping member at the second diameter during heat setting the scraping member.

[0015] Alternatively or additionally to any of the above embodiments, wherein the intermediate region comprises a third diameter during heat setting the scraping member, and wherein the third diameter is greater than the constrained first diameter and the constrained second diameter.

[0016] Alternatively or additionally to any of the above embodiments, wherein the first restraining wire, the second restraining wire, or both the first restraining wire and the second restraining wire are copper.

[0017] Another method of forming an expandable thrombectomy device includes arranging a plurality of braided wires along a mandrel, the plurality of braided wires including a proximal region, a distal region, and an intermediate region positioned between the proximal region and the distal region. The method also includes constraining the proximal region of the plurality of braided wires, constraining the distal region of the plurality of braided wires, and heat setting the plurality of wires.

[0018] Alternatively or additionally to any of the above embodiments, wherein constraining the proximal region of the plurality of braided wires further comprises constraining the proximal region of the plurality of braided wires with a first constraining wire.

[0019] Alternatively or additionally to any of the above embodiments, wherein constraining the distal region of the plurality of braided wires further comprises constraining the distal region of the plurality of braided wires with a second constraining wire.

[0020] Alternatively or additionally to any of the above embodiments, further comprising removing the first restraining wire and the second restraining wire prior to heat setting the plurality of braided wires.

[0021] Alternatively or additionally to any of the above embodiments, wherein heat setting the plurality of braided wires defines an expansion point in the intermediate region.

[0022] Alternatively or additionally to any of the above embodiments, wherein the first restraining wire, the second restraining wire, or both the first restraining wire and the second restraining wire are copper.

[0023] An example scraper device includes a handle and an outer shaft, the outer shaft having a proximal region, a distal region, and a cavity extending therein that is coupled to the handle. The scraper device also includes an inner shaft extending through the cavity of the outer shaft, the inner shaft having a proximal region and a distal region, wherein the proximal region is coupled to the handle; and an expandable scraping member, the expandable scraping member having a proximal region attached to the proximal region of the outer shaft, a distal region attached to the distal region of the inner shaft, and an intermediate region positioned between the distal region and the proximal region. In addition, the scraping member is configured to switch between an unexpanded configuration and an expanded configuration, wherein the intermediate region defines an expansion point of the scraping member.

[0024] Alternatively or additionally to any of the above embodiments, wherein the expandable scraping member is formed from a plurality of heat set wires.

[0025] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] A better understanding of the features and advantages of the methods and apparatus described herein will be obtained by reference to the following detailed description and accompanying drawings which set forth illustrative examples, in which:

[0027] Figure 1 One example of a method of using an expandable scraper and / or backstop as described herein is schematically illustrated.

[0028] Figure 2 An example of a system including an expandable scraper device and an inversion tube apparatus as described herein is shown.

[0029] FIG. 3A to FIG. 3D An example of an expandable scraper device as described herein is shown.

[0030] FIG. 4A to FIG. 4D An example of an expandable scraper device as described herein is shown.

[0031] FIG. 5A to FIG. 5C An example of an expandable scraper device as described herein is shown.

[0032] Figure 6 A diagrammatic representation of an example of an expandable scraper device as described herein is shown.

[0033] Figure 7 is an example of an expandable scraper device as described herein.

[0034] Figure 8 is an example of an expandable scraper device as described herein.

[0035] 9A to 9C Another example of an expandable scraper device as described herein is shown.

[0036] FIG. 10A to FIG. 10B One example of an expandable backstop device as described herein is shown.

[0037] FIG. 11A to FIG. 11B An example of an expandable backstop device as described herein is shown.

[0038] FIG. 12A to FIG. 12B An example of an expandable backstop device as described herein is shown.

[0039] FIG. 13A to FIG. 13B An example of an expandable backstop device as described herein is shown.

[0040] Fig.14 An example of a braided material that can be used to form the distal expansion (scraper) region of an expandable scraper (or backstop) as described herein is shown. Fig.14 In the case of braided fabrics, the braid is made from a combination of flat and round wires.

[0041] Fig.15An example of a braided material that can be used to form the distal expansion (scraper) region of an expandable scraper (or backstop) as described herein is shown. Fig.15 In knitwear, the braid is made from a combination of flat and round wires and a knitted sleeve, which can provide texture to the surface.

[0042] Fig.16 Another example of a region that may be used as a distal expansion (scraper) region of an expandable scraper device as described herein is shown.

[0043] 17A to 17C Various concepts are shown that may be used for a distal expansion region of an expandable scraper device as described herein.

[0044] FIG. 18A to FIG. 18B An example of an inverted thrombectomy device including an integrated expandable backstop / scraper is shown.

[0045] 19A to 19D One example of an expandable scraper device as described herein is shown. Fig.19A A side perspective view is shown. Fig.19B Shows Fig.19A View of the proximal handle of the expandable scraper device. Fig.19C Shows Fig.19A region of the elongated shaft of the expandable scraper device. Fig.19D Shown in Fig.19A An expandable basket at the distal end of the expandable scraper device.

[0046] FIG. 20A to FIG. 20C An enlarged view of one example of an expandable basket of an expandable scraper device is shown. Fig. 20A The basket is shown in a collapsed (unexpanded) configuration. Fig. 20B The basket is shown in an expanded configuration. Fig. 20C The distal region of the expandable scraper device is shown.

[0047] Fig.21A and Fig.21B An example of a basket region of an expandable scraper device is shown.

[0048] Fig.22A A side view is shown and Fig. 22B An end view of one example of a basket of an expandable scraper device is shown, wherein the basket is configured to deform to expand off-axis relative to a longitudinal axis of the expandable scraper device.

[0049] FIG. 23A to FIG. 23F Shows something like FIG. 22A to FIG. 22B An example of an expandable basket is shown in .

[0050] FIG. 24A to FIG. 24EShown are details of one example of a proximal handle of an expandable scraper device as described herein. Fig.24A A perspective view of the handle is shown. Fig. 24B Shows to Fig.24A A partially transparent view in the handle of the . Fig.24C Shows FIG. 24A to FIG. 24B An enlarged view of the ratchet lock portion of the handle. Fig.24D Shows Fig.24A Magnified view of the proximal region of the handle. Fig.24E Shown is an enlarged view of the controls that control the expansion / contraction of the expandable scraper assembly.

[0051] FIG. 25A to FIG. 25C One example of expansion of a basket of an expandable scraper device as described herein is shown.

[0052] FIG. 26A to FIG. 26C An example of the collapse of a basket of an expandable scraper device as described herein is shown.

[0053] FIG. 27A to FIG. 27C The use of one or more protrusions on the shaft in conjunction with an engagement area on the handle of the expandable scraper device to shorten the elongated shaft of the expandable scraper device is shown. Fig.27A A perspective view of the handle is shown. Fig.27B An enlarged side view of the junction area is shown. Fig.27C The use of a junction region to shorten (by forming a ring) the elongated shaft of an expandable scraper device is shown.

[0054] FIG. 28A to FIG. 28C An access method for the devices described herein is shown.

[0055] FIG. 29A to FIG. 29E Methods of delivering the devices described herein to a target area of ​​the vasculature are shown.

[0056] FIG. 30A to FIG. 30C An example of an inverted tube (e.g., thrombectomy) device that can be used to remove material from a blood vessel is shown. Fig. 30A , the assembled device is shown in a side view showing the flip support catheter and the flexible outer tube. Fig. 30B The blood vessels proximal to the clot are shown Fig. 30A Flip tube equipment. Fig. 30C The invention shows the use of a flexible tube on the outside of the inverted support catheter by pulling it proximally so that it rolls over the distal end of the inverted support catheter and enters the inverted support catheter, thereby dragging the clot with it. Fig. 30A A device that removes a clot from a blood vessel; the device can be advanced distally.

[0057] Figure 31 to Figure 33A method of forming an example expandable basket is shown.

[0058] Figure 34 to Figure 35 A method of forming another example expandable shaving device is shown. DETAILED DESCRIPTION

[0059] The methods and apparatus described herein may also relate to the removal of clotted material, and in particular to scraping devices to assist in the removal of clotted material from within the vessel wall. The apparatus and methods described herein may be used with any device for removing clotted material, including suction (e.g., suction catheters) and inversion tube devices for removing material from the body.

[0060] Any of the features, components, and techniques described herein may be used alone or in any combination.

[0061] For example, an expandable scraper is described herein that can help remove material (e.g., clot material) from the cavity so that the material can be captured for removal, for example, by any appropriate clot removal / capture device or technology. In particular, these devices can be used with suction (e.g., suction catheter) and / or with flip thrombectomy equipment. For example, any of these methods and devices can include leading the expandable scraper to the distal side into the clot or a portion of the clot (or just distal to it), and expanding the expandable scraper, and pulling it proximally to remove or remove the clot material from the vessel wall so that the clot material can be captured and removed. These steps can be repeated using the device described herein.

[0062] For example, before or during the use of the suction tube and / or the use of the inverted thrombectomy device, the vessel wall can be scraped with an expandable scraper and / or fixed in place with an expandable check. In some examples, the scraper and / or check can be integrated into the inverted thrombectomy device and / or method. For example, the expandable scraper and / or check can help aggregate clot material so that the inverted thrombectomy device can capture it. The expandable scraper and / or check can cause material, including thrombotic material, to detach or move out of the wall of the blood vessel.

[0063] Generally, a method of using a scraper can include positioning an expandable scraper in a compressed, undeployed configuration in an appropriate location in a blood vessel, preferably proximal to the clotted material to be removed (e.g., distal to the clotted material, where distal refers to further away from the direction of insertion and proximal refers to toward the direction of insertion). Figure 1An example of a method of using a scraper and a flip thrombectomy device is shown. In some cases, before inserting the expandable scraper 103, it may be necessary to optionally insert a guide wire (or guide catheter) into the blood vessel to be treated, and into or to the distal end of the clot material. Alternatively, the expandable scraper itself can act as a guide wire or guide catheter. The expandable scraper can include a distal expansion (scraping) region and a proximal elongated body (e.g., a wire, a catheter, etc.). The expandable scraper can be inserted in a compressed (undeployed) form, for example, into a blood vessel in the body through a sheath hub, so that the distal end of the expandable scraper enters the clot 105 or is distal to the clot 105. In some examples, a flip thrombectomy device (including a flip support catheter with a flexible tube, as described above) can be inserted above the slender body of the expandable scraper, so that the distal end of the flip support catheter is adjacent to the proximal end of the clot, wherein the clot material is between the distal expansion (scraping) region of the expandable scraper and the distal end of the flip support catheter 107.

[0064] The distal expansion (scraping) region of the expandable scraper can expand into or behind the clot 109, for example, by releasing the self-expanding distal expansion (scraping) region or by actively expanding the distal expansion (scraping) region, for example, by pulling an actuator (e.g., a pullwire, tendon, drive expansion member, etc.) 109. In examples where the expandable scraper is used with an inverted thrombectomy device, the distal expansion (scraping) region can expand prior to and / or during delivery of the inverted thrombectomy device.

[0065] Then, the expanded distal expansion area can be pulled proximally within the blood vessel so that the clot material is removed from the wall of the blood vessel 111. In some examples, the clot material can be removed by actuating the flip thrombectomy device, for example, by pulling the puller proximally to flip and roll the flexible tube into the flip support catheter, as described above. In some examples, the flip thrombectomy device can be actuated simultaneously with the expandable scraper. For example, the proximal end of the puller and the expandable scraper can move simultaneously (and can be connected together); the distal end of the flip support catheter can also be pushed distally at the same time. Alternatively, the distal end of the flip support catheter can be kept in place and the expandable scraper can be pulled proximally to drive the clot material into the actuated flip thrombectomy device. Alternatively or additionally, the clot material can be removed by suction. Therefore, the expandable scraper can scrape the blood vessel wall. In some examples, the expandable scraper can be collapsed again (e.g., by proximally actuating, e.g., pulling the actuator) and can be advanced distally again into or beyond additional clot material, thereby repeating the process. The inverted thrombectomy device can be removed and reloaded or reset over the expandable scraper, as described above, and then repositioned on the expandable scraper. In some examples, the expandable basket forming the scraper can be shaped in a collapsed configuration, and a force can be applied to expand the basket, as described herein; this can enable resetting and repeating the process.

[0066] In some examples, the expandable device can be an expandable backstop, rather than an expandable scraper, configured as a backstop that prevents the clot from moving away from the distal end of the inverted thrombectomy device when the clot is advanced. In this example, the expandable backstop can remain in a relatively static position relative to the blood vessel when the inverted thrombectomy device is advanced distally.

[0067] In some examples, the expandable device can operate as both an expandable backstop and an expandable scraper. For convenience, the same device may be referred to herein as an expandable scraper.

[0068] Before, during or after use with the inverted thrombectomy device, the expandable scraper (or expandable backstop) can be removed from the blood vessel. For example, the expandable scraper can be collapsed from the expanded deployment configuration back to the compressed (undeployed) configuration and repositioned or removed from the blood vessel, as mentioned above.

[0069] Figure 2 An example of a system including both an inverted thrombectomy device and an expandable scraper as described herein is shown. Figure 2, the inverted thrombectomy device 201 is shown deployed within a blood vessel proximate to a clot 230. The expandable scraper 220 is shown deployed through the inverted thrombectomy device and into the clot, and expanded within the clot, as described above. The inverted thrombectomy device generally includes any of the features discussed above, including an inverted support catheter, a flexible (e.g., knitted) tube 228 inverted at the distal end 229 of the inverted support catheter, and a puller 213. The expandable scraper 230 is deployed through the inverted thrombectomy device (e.g., through the flexible tube and the inverted support catheter) and includes a distal expansion (scraping) region ("distal expansion region") 232. The inverted thrombectomy device and the expandable scraper can be deployed through a sheath hub 233.

[0070] FIG. 3A to FIG. 3D , FIG. 4A to FIG. 4D , FIG. 5A to FIG. 5C , Figure 6 , Figure 7 , Figure 8 , 9A to 9C , Fig.16 17 both show examples of expandable scrapers as described herein. Features of any of these devices may be recombined with each other and / or with one or more of the inverted thrombectomy devices described herein.

[0071] For example, FIG. 3A to FIG. 3B An example of an expandable scraper (which may also be an expandable backstop) is shown. In this example, the expandable scraper includes a distal expansion (scraping) region 306 formed of a knitted, woven or braided material, which is attached to a wire (or catheter) 310 at the distal end and to a proximal catheter 308 slidably positioned on the wire (or catheter) at the proximal end. Figure 3B As shown in FIG, the device can be removed from the proximal catheter by pushing the proximal catheter distally. Figure 3A The collapsed delivery configuration shown in is deployed so that the distal expansion (shaving) region expands. The distal expansion (shaving) region can be preset (biased) to expand or be in a collapsed configuration. Figure 3C Actuation of the distal dilation (shaving) region from the proximal region is shown. The proximal catheter may have an OD of less than 0.38". The device may be actuated by pushing the inner (wire) or pulling the outer proximal catheter to dilate the distal dilation (shaving) region.

[0072] In some examples, the expandable scraper can be locked in an expanded and / or collapsed configuration. For example, Figure 3DAn example of a locking mechanism for an expandable scraper is shown, wherein the scraper is biased (e.g., by shape setting) to be in an unexpanded configuration. As shown, the inner wire can be pulled relative to the proximal catheter to expand and can be held in an expanded configuration (with the distal expansion region expanded) by engaging the locking protrusion 312 into a matching fastener 313 on the catheter.

[0073] For example, in operation, the expandable scraper can be delivered to the area of ​​the clot and passed through the clot and through the sheath hub in a collapsed configuration. In some examples, the inverted thrombectomy device can be introduced over the expandable scraper. Before, during, or after introducing the inverted thrombectomy device over the expandable scraper, the expandable scraper can be deployed, for example, by pulling a wire, such as Figure 3D As described in.

[0074] FIG. 4A to FIG. 4D Another example is shown in which the distal expansion (shaving) region is configured to exhibit a funnel shape. Figure 4A The device is shown in an undeployed configuration, collapsed for insertion into the body. The distal end of the distal expansion (shaving) region is distally attached to a drawwire (e.g., a 0.018" drawwire) 408, and the distal expansion (shaving) region 410 is formed of a heat-set braid or braided material having a smaller collapsed diameter. The proximal end of the distal expansion (shaving) region is inverted and coupled to a catheter 412 (e.g., a catheter having an outer diameter of 0.038"). Figure 4B Shows Figure 4A The funnel shape is formed by pulling the inner wire 408 proximally relative to the outer catheter 412. Figure 4D is shown as fully deployed. Figure 4C Proximal actuation is shown. FIG. 5A to FIG. 5B Shows something like FIG. 4A to FIG. 4D Another example is shown in . Figure 5A The device is shown in a collapsed configuration, and Figure 5B and Figure 5C The expanded configuration is shown, with the scraper flipped back on itself. The proximal end (coupled to catheter 412) is within the inverted basket. The basket can be deployed by pushing the proximal end distally relative to the distal end or by pulling the distal end proximally relative to the proximal end.

[0075] Figure 6 An example of an expandable scraper having multiple (e.g., 2, 3, 4, 5, etc.) collapsible funnels forming a distal expansion (scraping) region is schematically shown. Figure 6 In the figure, three funnel regions are formed, which are similar to FIG. 4A to FIG. 4D and FIG. 5A to FIG. 5C As shown in . Figure 7 and Figure 8 An example of a double infundibulum distal expansion (shaving) region is shown.

[0076] 9A to 9C An example of an expandable scraper having three distal expansion regions 901, 902, 903 is shown. These regions can expand to achieve a more aggressive or less aggressive scraping based on the direction in which they expand. For example, Fig. 9B Expansion is shown wherein the distal expansion member is recessed away from the proximal direction (in some examples, away from inverting the thrombectomy device), for example, by pulling the draw wire of the device proximally and pinning the proximal catheter. Conversely, Fig. 9C One example is shown in which the distal expansion member is recessed in a proximal direction (in some examples, toward inverting the thrombectomy device), for example, by pulling the catheter and pinning wire of the device proximally.

[0077] Fig.16 Another example of a structure (having a basket-like morphology) that can be used as a distal flared (scraper) region of a scraper as described herein is shown. 17A to 17C Various features of the scraper that can be included as a distal expansion (scraper) region are shown, including being longitudinally divided into two ( Fig.17A ) or three ( Fig. 17B ) part or area and / or torsion ( Fig. 17C ) of a tube (e.g., a cylinder).

[0078] FIG. 10A to FIG. 10B , FIG. 11A to FIG. 11B , FIG. 12A to FIG. 12B and FIG. 13A to FIG. 13B Examples of expandable backstops as described herein are shown. Features of any of these expandable backstop devices may be recombined with each other, with any features of an expandable scraper, and / or with one or more of the inverted thrombectomy devices described herein.

[0079] Fig. 10A An example of an expandable backstop is shown, which includes two pairs of three legs that can be controllably expanded outward, such as in Fig. 10B . The outwardly expanding legs can be formed by a laser cut hypotube. The distal expansion region can be actuated by pulling a drawwire within the hypotube. In some examples, the device is configured to return to a collapsed configuration when tension is released from the drawwire.

[0080] Fig.11A and Fig. 11B Another example of an expandable backstop is shown, each comprising three adjacent regions of three expandable "legs." When maximally expanded, the expanded diameter may be approximately 14 mm. Fig. 11BThe expandable check valve is shown in an undeployed configuration. Thin struts (legs 113, 113', 113") (e.g., approximately 0.019") can be arranged in a spiral with three sections cut into a tube (e.g., 0.0374" OD with a 0.00595" wall and 0.0255" inner diameter). The dimensions are shown as examples only, and other dimensions (e.g., + / - 5%, 10%, 25%, 50%, 70%, 100%, etc. of the dimensions shown) may also be used. Fig. 11B , the second section including the support 113' is rotated 40 degrees counterclockwise relative to the first section including the support 113, and the third section including the support 113" is rotated 80 degrees counterclockwise relative to the first section including the support 113.

[0081] FIG. 12A to FIG. 12B Shown as FIG. 11A to FIG. 11B 11 shows the expanded configuration, while FIG. 12 shows the distal expansion (scraper) region of the expandable backstop similar to that shown in FIG. 12, but with wider (e.g., about 0.038") helical struts 123, 123', 123" in three total sections (tube OD of .0374" with 0.00595" wall, 0.0255" ID). Fig. 11B The collapsed (unexpanded) configuration is shown. FIG. 12A to FIG. 12B Examples are shown only, and other dimensions (e.g., + / - 5%, 10%, 25%, 50%, 70%, 100%, etc. of the dimensions shown) may also be used. Fig. 12B , the second section including the support 123' is rotated 40 degrees counterclockwise relative to the first section including the support 123, and the third section including the support 123" is rotated 80 degrees counterclockwise relative to the first section including the support 123.

[0082] FIG. 13A to FIG. 13B The distal expansion (scraper) region of an expandable backstop is shown having wide helical struts (e.g., legs) (approximately 0.038"), non-offset struts 133, 133', 133", 133'", 4 segments total (tube OD is .0374" with 0.00595" walls, 0.0255" ID). Fig. 13B shows that in the unexpanded form Fig.13A In any of these examples, the distal expansion (scraper) region can be preset to an expanded or collapsed configuration. FIG. 13A to FIG. 13BExamples are shown only, and other dimensions (e.g., + / - 5%, 10%, 25%, 50%, 70%, 100%, etc. of the dimensions shown) may also be used. In FIG. 13 , the second segment including strut 133' is rotated 30 degrees counterclockwise relative to the first segment including strut 133, the third segment including strut 133" is rotated 60 degrees counterclockwise relative to the first segment including strut 133, and the fourth segment including strut 133' is rotated 90 degrees relative to the first segment including strut 133.

[0083] FIG. 18A to FIG. 18B An example of a reversing thrombectomy device is shown that includes an integrated expandable backstop / scraper 1803 (in this example, shown integrated into the inversion support catheter proximal to the distal region). The inversion tube 1802 can slide over the scraper 1803 as the inversion tube is pulled into the device. The features of any of the expandable scrapers and / or expandable backstops described herein can be recombined with each other and / or with one or more of the inversion thrombectomy devices described herein.

[0084] For example, in Fig.18A In the invention, the inverted support catheter of the inverted thrombectomy device includes an expandable scraper / backstop region that can be integrated with the device and can help remove clotted material from the wall of or around the vessel lumen, such as Fig.18B The flexible tube can be pulled over the distal end and into the device as shown. Fig.18A and Fig.18B In the example of the embodiment of the present invention, both the distal funnel region and the more proximal distal expansion (scraper) region can be collapsed in the delivery configuration and can be expanded once the device is positioned near the clot. The device can be advanced distally while the puller is pulled proximally, and thus the flexible tube is pulled over the end of the inverted support catheter and into the cavity of the inverted support catheter. In this example, the funnel and the more proximal expansion scraper / backstop region can be controllably expanded when deployed, or collapsed when the device is removed from the vessel.

[0085] Typically, the expandable scraper device described herein can be configured as a braided expandable scraper device configured to remove clotted material from within a blood vessel without damaging the wall of the blood vessel, including the intima and / or the intima and media. Typically, the expandable portion can be an expandable basket formed from a plurality of braided filaments or fibers. The materials and arrangement forming the basket can be specifically configured to optimize scraping and removal of clotted material while preventing the device from becoming stuck within the blood vessel, and while also preventing damage to the blood vessel wall during operation.

[0086] For example, a woven basket forming an expandable region may form pores (spaces between the woven wires or fibers). The pore size of the basket and the pulling stiffness of the basket may be within a functional range that allows it to operate without getting stuck and without damaging the vessel wall; outside these ranges, the expandable scraper device may otherwise get stuck and / or may damage the vessel.

[0087] FIG. 19A to FIG. 19D An example of an expandable scraper device 1900 is shown. In this case, the device includes an elongated shaft 1903 extending from a distal end to a proximal end of the device. The elongated shaft includes an inner elongated member 1927 ( Fig.19D 1925) is slidably disposed within the outer elongated member 1925. The entire elongated shaft is flexible so that it can be navigated through tortuous blood vessels in the body. The total length of the device can be, for example, between 30 cm and 200 cm (e.g., between 50 cm and 180 cm, between 100 cm and 150 cm, etc.). For example, in Fig.19A The length of the device shown in is about 134cm ± 5cm, and has an effective length of about 115cm ± 5cm. The length of the elongated shaft can be, for example, between 20cm and 180cm (or longer), such as, between 40cm and 180cm, between 50cm and 150cm, etc. In some cases, the shaft can have, for example, an inner diameter between 0.5mm (+ / -0.025mm) and 1.5mm (+ / -0.025mm), such as about 1.0mm. The outer diameter can be, for example, between about 2.2mm and about 3.0mm (e.g., between about 2.5mm and about 2.85mm) + / -0.025mm.

[0088] The elongated shaft may be formed from any suitable material, including in particular polymeric materials such as styrene block copolymers (e.g., ), functionalized thermoplastic olefins, thermoplastic elastomer alloys, thermoplastic polyurethanes (e.g., ), polyamide-based thermoplastic elastomers (e.g., ), polyester-based thermoplastic elastomers (e.g., ), ionomer thermoplastic elastomers (e.g. ) and any combination thereof.

[0089] Fig.19A The expandable woven basket device of also includes an expandable woven basket 1907 at the proximal end of the device. In this example, the expandable woven basket ("basket") is coupled to the distal region of the outer elongated member at a first end and to the distal region of the inner elongated member at a second end (e.g., distal end). Fig.19D, which shows a basket in a collapsed (unexpanded) configuration. Generally, the expandable woven basket can be formed from a wire or filament. It is beneficial to use a wire or filament having a diameter of about 0.15 mm or more (e.g., 0.18 mm or more, 0.20 mm or more, etc.). Wires / filaments of this size can provide a basket with a surface texture that, when woven as described herein, can remove plaque material without damaging the vessel wall. In any of these devices, the basket can also include a marker, such as a radiopaque (RO) marker 1931, which is shown at a distal region of the basket.

[0090] The expandable woven basket device may also include a handle 1909, which is Fig.19B The handle is coupled to the elongated member at the proximal end and may include one or more controls 1911, 1913 for operating the expandable basket, for example, expanding / contracting the expandable basket, and / or locking the expandable basket in a particular expanded position. Fig.19B The controls shown in the include a slide 1311 that can extend or retract the inner elongated member 1927 relative to the outer elongated member to expand or contract the basket. The controls are configured to slide the inner elongated member relative to the outer elongated member to expand the expandable woven basket from an unexpanded configuration. The handle also includes a lock control 1913, shown as a button, that releases a ratchet lock to allow the slide to move, or, when released, locks the slide (and thereby the expansion of the basket) in place. Fig.19B , the handle includes a grip area 1915 that is configured to be gripped by a user, such as a doctor, nurse, technician, etc.

[0091] FIG. 19A to FIG. 19D The device shown in FIG. 1 also includes a plurality of protrusions 1941, Fig.19C One of these is shown in more detail in FIG. In this example, the projections are annular rings (or ferrules). Three projections 1941, 1941', 1941" are shown. These projections are configured to engage with a lock on a handle 1943 that can receive the projections and can be releasably locked to the projections when pulled distally to form a loop of the elongated shaft and reduce the effective length of the elongated shaft. This is described below with reference to FIG. 27A to FIG. 27B Described in more detail.

[0092] Fig. 20A and Fig. 20B Shown with FIG. 19A to FIG. 19D An example of a distal end of a device similar to that shown in , includes a basket 2007, an inner elongate member 2027, and an outer elongate member 2025. The basket in this example is formed from a plurality of wires that are loosely woven together. Fig. 20A The basket is shown in a collapsed, fully unexpanded configuration. Fig. 20BBasket 2007 is shown in a fully deployed, expanded configuration. In this example, the braided wire is a nitinol wire configured to expand outward to a maximum expanded diameter of, for example, between 10 mm and 40 mm (e.g., 20 mm, 30 mm, etc.). The basket region can have an unexpanded length of between 3 and 14 cm, such as, for example, 5 cm (+ / - 0.2 cm), 7 cm (+ / - 0.2 cm), etc.

[0093] like Fig. 20B As shown in , the basket can be expanded by pulling the distal end of the basket (wire) proximally 2050 relative to the proximal end of the basket, causing the basket to expand outward. Alternatively, in some examples, the basket can be expanded outward by driving the proximal end distally. The basket can be partially or fully expanded. In some examples, the basket can be locked in one or more (or any / continuous) intermediate positions.

[0094] exist Fig. 20C , the distal region of the device is shown, which shows the attachment of the distal end of the basket to the inner elongated member. Fig. 20C In one of these expandable scraper devices, the device may include a lumen through which a guidewire or other elongated member may pass, such as through the lumen of the inner elongated member 2027.

[0095] In this example, the basket can be formed from multiple wires of a superelastic alloy (e.g., a nickel-titanium alloy such as Nitinol) that is superelastic and can be repeatedly bent without breaking. In some examples, other materials (stainless steel, polymers, etc.) can be used. The basket can be woven into a pattern. For example, FIG. 21A to FIG. 21B An example of a woven basket is shown in an expanded configuration. Fig.21A In FIG. 1 , basket 1507 is woven into a pattern of diamond-shaped holes 1547 each having a hole area. The hole area may change as the device expands or contracts, but is consistent for a particular expanded diameter. For example, in FIG. Fig.21A When the expandable woven basket is expanded to a diameter between 5 and 15 mm, the pore size is between 1.2 and 7.5 mm. 2 between (e.g., may have between 1.2 and 5 mm 2 ); in this example, the basket has a maximum diameter of 20 mm in the expanded configuration.

[0096] exist Fig.21A In the example, the basket is formed of a braided Nitinol material (from 0.2 mm diameter wires). This example includes 32 wires (32 ends) and forms a pattern known as a half-loaded diamond pattern (1 up 1 down 1). The pitch of this basket is 40 per inch. Fig.21BA similar basket is shown, also formed of a braided Nitinol material (0.2 mm diameter wire). In this example, the basket is formed of 48 ends (48 wires) and is braided into a fully loaded regular pattern (1 up 2 down 2) with a pitch of 50 per inch. Fig.21B The basket 1507' shown in FIG. 1 has a maximum opening diameter of 30 mm. When the expandable woven basket is expanded to a diameter between 5 and 15 mm, the aperture 1547' is also between 1.2 and 7.5 mm. 2 between.

[0097] Applicants have discovered that for a given diameter of a wire or filament greater than 0.15 mm (e.g., 0.2 mm or greater, between 0.15 and 0.5 mm, between 0.15 and 0.4 mm, between 0.15 and 0.3 mm, etc.) forming a basket as described herein (e.g., having a maximum outer diameter between 15 and 40 mm), there is an optimal pore area that provides a surface texture sufficient to scrape clots without damaging the intima of the vessel while also preventing entrapment within the vessel. Specifically, when the wire or filament forming the basket has a diameter of 0.15 mm or greater and is woven into a pore area between 1.2 and 7.5 mm when the expandable woven basket is expanded to a diameter between 5 and 15 mm (and having a maximum diameter between 15 and 40 mm in the expanded configuration), the pore area is between 1.2 and 7.5 mm. 2 (or 1.2 and 5mm 2 ) between 0.05 and 0.10, the resulting basket has a sufficiently rough texture to remove clotted material from the vessel wall while preventing entrapment within the vessel. In some examples, the basket can be configured to expand in an off-axis manner, as will be described in more detail below. Surprisingly, the morphology of the basket in an off-axis shape when expanded was found to provide scraping without damaging the vessel wall; without being bound by theory, this may be due, at least in part, to the ability of the wires or filaments forming the basket to move relative to each other and allow the basket to collapse. The off-axis shape was found to limit the pulling force to a maximum scraping force of about 1.5 pounds-force against the wall of the vessel lumen when the basket was expanded in the off-axis shape.

[0098] In operation, the devices described herein can be configured to have a pulling force within a vessel of between 0.18 and 1.5 pounds-force when expanded against the vessel wall with, for example, a radial force between about 0.25 and 0.6 pounds. Outside of these ranges for pore size and for applied pulling force, the basket may get stuck or may damage the vessel. Table 1 shows examples of baskets with various pore size ranges that will not get stuck within a vessel. Table 1

[0099] As mentioned, for larger pore sizes, this may result in larger holes through the basket, while the texture may also be larger, the texture may be too aggressive and may damage the intima, resulting in bleeding and tearing of the vessel wall. Further, if the pores are too large (e.g., greater than about 8 mm), the pores may be too large. 2 ), clotted material may instead enter the basket without adequate scraping. The above range can balance the pore size for a preferred scraping texture (using a wire with a diameter of greater than or equal to about 0.006", e.g., about 0.008") and the ability to pull at a predetermined pulling force without damaging the vessel, which is also described as the stiffness of the basket.

[0100] Generally, the basket must have sufficient stiffness when in the vessel so that it scrapes the vessel wall when expanded, however, it should not be too stiff or it may damage the vessel wall. Therefore, the expandable basket can be configured so that it can expand against the vessel wall with a radial expansion force sufficient to load the vessel wall, and once loaded against the vessel wall within a predetermined radial force range, can apply a force within a predetermined range against the vessel wall when pulled (or pushed) along the vessel. This force applied by pulling (or pushing) the at least partially expanded basket of the expandable scraper device may be referred to herein as a pulling force. The pulling force may be a function of the stiffness of the basket. Generally, an expanded basket having a pulling force between about 0.18 and 0.4 pounds when expanded intraluminally with a radial force (against the lumen wall) between about 0.25 and 0.6 pounds of force against the wall of the vessel lumen may correspond to a specific range within which the device can effectively remove clot material while avoiding damage to the vessel wall. Outside of this tension range (e.g., between about 0.25 and 0.6 lbf, between about 0.18 and 0.4 lbf, or between about 0.2 and 0.35 lbf, or outside of about 0.2 and about 0.33 lbf when the basket is expanded to apply a radial force against the wall), the basket may lock up or may damage the vessel wall if the tension is greater than the upper limit of the range (e.g., greater than 0.4 lbf), and the basket will not effectively scrape clotted material if the tension is less than the lower limit of the range (e.g., less than 0.18 lbf). Without being bound by theory, the configuration in which the basket is expanded off-axis can provide a non-uniform radial force within the lumen of the vessel, which can surprisingly allow for gentler and more effective scraping and removal of clotted material. The non-uniform force applied by the off-axis basket described herein can allow the device to more effectively pass through the vessel.

[0101] Examples of various loading (expansion) forces and pulling forces are provided herein for illustration, however these forces are not intended to be limiting, but are merely examples. For example, a "20 mm basket" (or 20 mm scraper) that may be referred to as a basket having a maximum expansion diameter of about 20 mm may be within the effective range when the vessel wall is loaded with about 0.32 lbf (radial force) and the basket is slid in a 6 mm vessel using about 0.26 lbf (pulling force), or when the vessel wall is loaded with about 0.31 lbf (radial force) and the basket is slid in a 12 mm vessel using about 0.22 lbf (pulling force), or when the vessel wall is loaded with about 0.46 lbf (radial force) and the basket is slid in a 16 mm vessel using about 0.28 lbf (pulling force). Similarly, a 32 mm basket, which may be referred to as a basket having a maximum expanded diameter of about 32 mm, is within the effective range when the vessel wall is loaded with about 0.49 lbf (radial force) and the basket is slid with about 0.24 lbf (tension) in a 16 mm vessel, or when the vessel wall is loaded with about 0.45 lbf (radial force) and the basket is slid with about 0.30 lbf (tension) in a 20 mm vessel, or when the wall is loaded with about 0.49 lbf (radial force) and the basket is slid with about 0.30 lbf (tension) in a 28 mm vessel. As mentioned above, radial forces may be applied unevenly around the basket diameter against the wall of the vessel lumen, particularly in off-axis baskets.

[0102] Thus, any of the expandable scraper devices described herein may be configured such that the expandable basket presents a non-radially symmetrical configuration ("off-axis") such that the central axis of the expandable basket is off-axis. As mentioned, it has been found to be surprisingly effective to configure the basket to present this shape. This may be beneficial because it allows the basket to contact and scrape the wall of the vessel while the elongated shaft (including, in some examples, the inner and outer shafts) may be positioned outside the midline of the vessel with the basket expanded within the vessel. This off-axis configuration may also allow the expandable scraper device to be positioned in series with another device in the vessel; for example, the expandable scraper device may be displaced laterally (proximal to the expandable basket) to provide space for an adjacent device (e.g., suction) in this proximal region within the vessel while still being able to expand and scrape the vessel wall.

[0103] FIG. 20A to FIG. 20C An example of radial symmetry of a scraper is shown. FIG. 20A to FIG. 20C As shown, in some examples, the expandable scraper includes a longitudinal axis (a portion of the elongated shaft) about which the scraper expands outwardly. Alternatively, the longitudinal axis within the basket can be configured to deflect during basket expansion. Therefore, due in part to the flexibility of the longitudinal axis and also due to the morphology and flexibility of the wires forming the basket, the basket can be configured to expand off-axis (deform away from the longitudinal midline). Therefore, in general, the expandable basket can be configured to deform to an off-axis shape in the expanded configuration.

[0104] This is FIG. 22A to FIG. 22B and FIG. 23A to FIG. 23F In Fig.22A , the basket region 2207 of the expandable scraper device is shown as being at least partially expanded. The basket 2207 (shown schematically, with the holes not visible) is expanded, and the longitudinal shaft portion 2223 of the elongated shaft 2203 is shown, which includes a flexible inner elongated member 2227 slidably disposed within a flexible outer elongated member 2225. The longitudinal shaft portion 2222 can be flexible (bendable). As shown in FIG. Fig. 22B As shown in , which shows a distal view of the basket 2207 and elongated shaft 2203, the longitudinal axis is off-axis (away from the midline of the basket), but can also be expanded to contact, and thereby scrape, the walls of the cavity.

[0105] FIG. 23A to FIG. 23F An example of an expanded basket is shown such that the longitudinal axis is radially offset from the midline of the expanded basket. Fig.23A In FIG. 2 , basket 2307 is at least partially expanded within the lumen of a blood vessel having a diameter of about 8 mm. Fig. 23B In the embodiment of the present invention, the basket 2307' is at least partially expanded within the lumen of a blood vessel having a diameter of about 10 mm. Fig.23C In FIG. 2 , basket 2307″ is at least partially expanded within the lumen of a blood vessel having a diameter of about 12 mm. Fig.23D In the examples, basket 2307'" is at least partially expanded within the lumen of a blood vessel having a diameter of approximately 14 mm. In each of these examples, the basket is an expanded woven basket, as shown. The device can be driven (pulled or pushed) within the lumen of the blood vessel to scrape the wall of the blood vessel.

[0106] Thus, an expandable scraper device may include an elongated shaft and an expandable woven basket coupled to the elongated shaft (wherein the elongated shaft extends within the basket), wherein the expandable woven basket is configured to deform in an expanded configuration so that a portion of the elongated member within the expandable woven basket is not concentric with the expandable woven basket, as shown. Any of these expandable scrapers may also include a proximal handle, as described above.

[0107] Thus, any of the devices (e.g., apparatus, systems, etc., which include expandable scraper devices) can be configured as an off-axis scraper. These expandable scraper devices can include a central axis about which the scraper expands in a non-radially uniform manner, such that the basket deflects off-axis during expansion. The device can be configured to perform off-axis expansion by selecting the number, size and / or material properties of the wires (filaments) used, as well as the manner in which the wires / filaments are woven. The flexibility of the central axis and the flexibility of the wires forming the basket, including their relative flexibility, can result in the off-axis morphology described herein. In some examples, the basket can therefore be configured to have a variable pore size. As in FIG. 22A to FIG. 22B and FIG. 23A to FIG. 23F As shown in , the expandable basket can be configured to deform into an off-axis shape in the expanded configuration.

[0108] For example, Fig.23E and Fig.23F An example of an expandable scraper device 2300 is shown, comprising: an elongated shaft including a flexible inner elongated member 2327 slidably disposed within a flexible outer elongated member 2325. The inner elongated member can be a shaft, a cannula (e.g., including a cavity, such as a guidewire cavity), a rod, a wire, etc. The outer elongated member can be a cannula and can include a lubricating inner layer. The device also includes an expandable woven basket 2300, which is connected to the distal region of the flexible outer elongated member at a proximal end 2361 and is connected to the distal region of the flexible inner elongated member at a distal end 2363, wherein the expandable woven basket 2300 is configured to deform from an unexpanded state of the wire to an expanded state, so that a portion of the flexible inner elongated member within the expandable woven basket is not concentric with the expandable woven basket, as shown.

[0109] exist Fig.23E and Fig.23F In FIG. 2 , the inner elongate member 2327 is radially offset from the midline of the basket and is shown displaced on one side of the basket. The basket expands outwardly within the vessel lumen (which in this example is molded as a clear polymeric tube).

[0110] The device may also include a proximal handle (not shown). FIG. 23A to FIG. 23F ), but will be referred to below FIG. 24A to FIG. 27C As will be described in more detail below, the handle may include a control configured to slide the flexible inner elongated member relative to the flexible outer elongated member to expand the expandable woven basket. The control on the proximal handle may be a slide coupled to the flexible inner elongated member.

[0111] Generally, the expandable woven basket can be configured to open to an off-axis configuration, as described above and FIG. 23A to FIG. 23F As shown in . In some examples, the device can be formed of a superelastic alloy material (e.g., a nickel titanium alloy material). The basket can be formed of between about 10 and 60 filaments (e.g., between 20 and 60, etc.), and the shape can be set so that the basket is collapsed (unexpanded). Therefore, when the basket area is unconstrained, it can collapse to an unexpanded configuration. For example, the superelastic alloy can be shaped to return to an unexpanded configuration. Any suitable wire can be used, but in particular, the basket can be formed of a wire having a diameter between about 0.15 mm and 0.35 mm.

[0112] The length of the elongated shaft of the device can be, for example, between 50 and 180 cm. The expandable woven basket can have a length between 3 and 10 cm in the unexpanded configuration. The expandable woven basket can be loosely woven so that the expandable woven basket is configured to deform about the long axis. The expandable woven basket can have a diameter of less than 3.3 mm in the unexpanded configuration. For example, the present invention describes an expandable scraper device, which includes: a slender shaft, the slender shaft including a flexible inner slender member slidably disposed within a flexible outer slender member; an expandable woven basket, the expandable woven basket is connected to the distal region of the flexible outer slender member at a proximal end and to the distal region of the flexible inner slender member at a distal end, the expandable woven basket having a length between 3 and 10 cm in an unexpanded state, wherein the expandable woven basket is formed from between 20 and 60 nickel-titanium wires, each having a diameter between 0.15 mm and 0.35 mm, and is configured to deform from an unexpanded state to an expanded state such that a portion of the flexible inner slender member within the expandable woven basket is not concentric with the expandable woven basket, further wherein the expandable woven basket will be shaped to return to the unexpanded state in an unconstrained state; and a proximal handle, the proximal handle including a control, the control being configured to slide the flexible inner slender member relative to the flexible outer slender member to expand the expandable woven basket.

[0113] In use, the expandable scraper device can be used to remove clots. For example, the expandable scraper can be positioned within the lumen of a blood vessel so that the expandable woven basket of the expandable scraper device is positioned distal to or within the clot. The expandable woven basket can then be expanded against the wall of the lumen of the blood vessel so that the inner elongated member slidably disposed within the flexible outer elongated member within the expandable woven basket is positioned within the expandable woven basket, offset from the midline of the expandable woven basket (as shown above). The expandable woven basket can then be pulled proximally to scrape clot material from the wall of the lumen of the blood vessel without damaging the wall of the lumen of the blood vessel.

[0114] For example, methods of removing a clot using any of these devices, such as the off-axis basket described above, are also described herein. Such methods may include positioning an expandable scraper device within the lumen of a blood vessel such that an expandable woven basket of the expandable scraper device is positioned distal to or within the clot; expanding the expandable woven basket against the wall of the lumen of the blood vessel by adjusting a control on a proximal handle of the expandable scraper device such that an inner slender member slidably disposed within a flexible outer elongated member and within the expandable woven basket is positioned within the expandable woven basket, offset from the midline of the expandable woven basket; and pulling the expandable woven basket proximally to scrape clot material from the wall of the lumen of the blood vessel without damaging the wall of the lumen of the blood vessel.

[0115] Pulling can include pulling with a pulling force between about 0.2 and 1.5 pounds. Any of these methods can include applying suction to remove clotted material from the vessel lumen. Any of these devices can be used with a mechanical thrombectomy device. For example, any of these methods can include using an inverted thrombectomy device.

[0116] Positioning the expandable scraper device within the lumen of the blood vessel may include inserting the expandable scraper device adjacent to the inverted thrombectomy device. The scraper may be used as described herein, including pulling it proximally so as to drag and / or remove clotted material from the lumen.

[0117] FIG. 24A to FIG. 24E An example of a handle 2409 as described above is shown. These handles may be used with any of the devices described herein. Generally, the handle 2409 may be configured to be grasped and held with one hand. As described above, the handle may include one or more controls 2411, 2413 for controlling the expansion / collapse of the basket, as mentioned above. Fig.24A In the embodiment, the handle includes a slider control 2411, which can be slid distally or proximally to expand the basket. Fig. 24B As shown in FIG. 24 , the slider can be coupled to an inner elongate member 2461 that is slidably disposed within an outer elongate member 2463. Thus, driving the slider proximally (see arrow 2466) can shorten the basket and expand it. The inner elongate member can include a passageway (lumen) that can pass a guidewire and / or can be used to pass fluid (e.g., for flushing). For example, in Fig.24D , an irrigation luer connector 2471 (or port) is shown in a transparent view as being coupled to the inner elongated member via an irrigation hub and seal 2472. Thus, port 2471 can provide access to the lumen. In some examples, the device can also include a locking feature for locking the expanded state of the basket.

[0118] exist Fig. 24B and 24C , a ratchet lock is shown. In this example, the locking feature is configured as a ratchet lock that includes a toothed surface 2467 into which the lock control 2413 engages to secure the position of the elongated inner member, thereby preventing it from moving proximally or distally to further expand or contract the basket. This Fig.24E24, which shows a lock control that drives the displacement of a pawl or spring element 2479 that engages the teeth of the toothed surface 2467. Thus, pushing the lock control 2413 downward disengages the pawl element 2479 from the teeth 2467, thereby allowing the slide 2411 to be driven proximally or distally to open or close the basket. Once the desired position is reached (which can be based on a sensed force acting on the basket), the lock control can be released, as described in more detail below, thereby allowing the pawl to engage the teeth and lock the position of the basket.

[0119] exist FIG. 25A to FIG. 25C and FIG. 26A to FIG. 26C This operation is shown in FIG. FIG. 25A to FIG. 25C , the basket can be opened by depressing the lock control 2513 to release the pawl 2579 from the teeth 2567 (which is in Fig.25B 2566 to release the lock. Once the pawl (leaf spring 2579) is disengaged, the slide can be driven proximally to open / expand the basket 2507, as shown in FIG. Fig.25C As shown in FIG. 26A to FIG. 26C , the basket can be closed / retracted by depressing the lock control 2613 again to release the pawl (leaf spring) 2679 from the teeth 2667, as shown in FIG. Fig.26B Thus, the slide 2611 can then be slid distally 2666 to drive the inner elongated member distally and collapse the basket 2607, as shown in FIG. Fig.26C as shown in .

[0120] Any of these expandable scraper devices may also include a locking or gathering feature ("gathering") on the handle that can engage with the elongated shaft and, in particular, engage with one or more projections on the shaft to shorten the shaft so that the device can be more easily manipulated by one or two hands, even in the case where the elongated flexible shaft is very long. The projections can be releasably engaged with a gathering piece (also referred to herein as a locking piece or support piece) on the handle so that the effective length of the elongated shaft is shortened. This is particularly useful in FIG. 27A to FIG. 27C Shown in.

[0121] FIG. 27A to FIG. 27C An expandable scraper device is shown, which includes a handle 2709 having one or more protrusions 2741 (e.g., locking rings or collars) on an elongated flexible shaft to adjust the pulled length of the elongated body; the protrusions 2741 are releasably locked to an engagement region 2781 of the proximal handle of the scraper. The engagement region 2781 includes a tapered channel formed on the side of the handle (e.g., in the housing) and is configured so that the elongated shaft 2725 can be inserted into the engagement region channel and pulled distally until the protrusions engage with the clamping region 2782 of the engagement region channel, as shown. Fig.27B and Fig.27C As shown in . In practice, a loop of a long and flexible slender shaft of the device can be formed by sliding the slender shaft into the engagement area until the protrusion engages the clamping area of ​​the engagement area, and the slender flexible shaft can be pulled proximally, for example, to pull the clot material proximally. In some examples, the slender shaft can include more than one (e.g., two, three, four, five, six, etc.) protrusions, which can each engage with the handle at a predetermined position. In some examples, the protrusions can be movably positioned on the shaft, thereby allowing the formation of a loop with variable size. For example, the protrusions can be an elastic material that can roll or slide along the outer surface of the shaft.

[0122] Thus, the expandable scraper device may include an elongated shaft and one or more projections on the elongated shaft, wherein at least one of the one or more projections is positioned in a middle region of the elongated shaft. The device may also include an expandable woven basket and a proximal handle, the proximal handle including a control configured to slide the inner elongated member relative to the outer elongated member to expand the expandable woven basket from an unexpanded configuration; and a lock on the proximal handle configured to receive one of the one or more projections from a proximal direction and releasably lock to the projection when it is pulled distally to form a loop of the elongated shaft and reduce the effective length of the elongated shaft.

[0123] Any of the devices described herein may include a handle and wire management features, as described herein. For example, any of these devices may include one or more projections on the elongated shaft, wherein at least one of the one or more projections is positioned in the middle region of the elongated shaft. Any of these devices may include a lock on the proximal handle, the lock being configured to receive one of the one or more projections from the proximal direction and releasably lock to one of the one or more projections when it is pulled distally to form a loop of the elongated shaft and reduce the effective length of the elongated shaft. For example, the lock may include a tapered channel on the outer surface of the proximal handle. The one or more projections may include a plurality of projections spaced more than 10 cm apart from each other.

[0124] Generally, methods are also described herein to manually adjust the diameter of the basket to maintain the force within a certain range when the basket is pulled. The device is configured to allow this operation by having a button (release) on the handle.

[0125] Also described herein are methods of removing a clot using the devices described herein. For example, a clot can be removed by positioning an expandable scraper device in an unexpanded configuration within the lumen of a blood vessel such that an expandable woven basket of the expandable scraper device is positioned distal to or within the clot; expanding the expandable woven basket against a wall of the lumen of the blood vessel to an expanded configuration, wherein the expandable woven basket is configured to apply a maximum scraping force of 1.5 pounds-force or less against the wall of the lumen of the blood vessel; and pulling the expandable woven basket proximally while expanding or contracting the expandable woven basket by operating a control on a handle of the expandable scraper device to maintain the pulling force between about 0.2 and 1.5 pounds-force to adjust the pulling force to scrape clot material from the wall of the lumen of the blood vessel without damaging the wall of the lumen of the blood vessel.

[0126] In any of these methods, expanding the expandable woven basket includes expanding the expandable woven basket against a biasing force, the biasing force being configured to return the expandable woven basket to an unexpanded configuration in an unconstrained state. Expanding the expandable woven basket may include expanding the expandable woven basket from a length between 3 and 10 cm in the unexpanded configuration. In some examples, expanding the expandable woven basket includes expanding a braid having between 20 and 60 nickel-titanium wires to an expanded configuration, each of the nickel-titanium wires having a diameter between 0.15 mm and 0.35 mm. For example, expanding the expandable woven basket may include expanding it so that an inner elongated member extending between a distal end of the expandable woven basket and a proximal end of the expandable woven basket is positioned within the expandable woven basket, offset from a midline of the expandable woven basket.

[0127] In some examples, adjusting the tension by operating a control on a handle of the expandable scraper device includes operating a finger slide to manually adjust expansion of the expandable woven basket to maintain the tension between approximately 0.2 and 1.5 pounds-force.

[0128] Adjusting the tension by operating a control on the handle of the expandable scraper device may include operating both a release button and a finger slide to manually adjust the expansion of the expandable woven basket to maintain the tension between about 0.2 and 1.5 pounds of force, as described above. FIG. 26A to FIG. 26C Described in .

[0129] Any of these methods may include repeatedly positioning the expandable scraper device within the lumen of a blood vessel to scrape the same location of the blood vessel by advancing the expandable scraper in a collapsed configuration over a guidewire, expanding the expandable scraper, and pulling the expandable woven basket proximally while adjusting the tension. Thus, the scraper can be repositioned (e.g., using a guidewire) to repeatedly scrape the same area of ​​the blood vessel.

[0130] In general, these methods can be used to adjust the applied pulling force even when the diameter of the vessel lumen changes (narrows or widens) along its length. The methods described herein can also include pulling the expandable woven basket proximally and expanding or contracting the expandable woven basket by operating a control on the handle of the expandable scraper device to maintain the pulling force between about 0.2 and 1.5 pounds-force to scrape clotted material from the wall of the vessel lumen without damaging the wall of the vessel lumen even when the diameter of the vessel wall changes along its length.

[0131] In any of these apparatuses and methods for performing the same, the tension may be adjusted by operating a control on a handle of the expandable scraper device; the control may include releasing a ratchet lock on the handle to expand or contract the expandable woven basket.

[0132] Any of these methods may include providing feedback of the applied pulling force. As mentioned above, these methods of using the device may include applying suction to remove clotted material from the vessel lumen. Pulling the expandable woven basket proximally may include maintaining the pulling force at an approximately constant level.

[0133] Positioning the expandable scraper device within the lumen of the blood vessel may include inserting the expandable scraper device through the catheter, and pulling the expandable woven basket with the clot to the distal tip of the catheter, and aspirating the clot through the catheter.

[0134] For example, a method for removing a clot (e.g., clotted material) may include: positioning an expandable scraper device in an unexpanded configuration within a lumen of a blood vessel such that an expandable woven basket of the expandable scraper device is positioned distal to or within the clot; expanding the expandable woven basket against a wall of the lumen of the blood vessel, wherein the expandable woven basket is configured to apply a maximum scraping force of 1.5 pounds-force or less against the wall of the lumen of the blood vessel, further wherein the expandable woven basket is biased to return to the unexpanded configuration in an unconstrained state, and wherein the expandable woven basket is configured to return to the unconstrain .... The basket has a length between 3 and 10 cm in an unexpanded configuration, wherein the expandable basket is formed of between 20 and 60 nickel-titanium wires each having a diameter between 0.15 mm and 0.35 mm; and pulling the expandable basket proximally while expanding or contracting the expandable basket by operating a control on a handle of the expandable scraper device to maintain the pulling force between about 0.2 and 1.5 pounds-force to adjust the pulling force to scrape clotted material from the wall of the vessel lumen without damaging the wall of the vessel lumen. The expansion may include expanding the expandable basket so that an inner elongated member extending between a distal end of the expandable basket and a proximal end of the expandable basket is positioned within the expandable basket, offset from a midline of the expandable basket.

[0135] A method for removing a clot may include: positioning an expandable scraper device in an unexpanded configuration within a lumen of a blood vessel such that an expandable woven basket of the expandable scraper device is positioned distal to or within the clot; expanding the expandable woven basket against a wall of the lumen of the blood vessel, wherein the expandable woven basket is configured to apply a maximum scraping force of 1.5 pounds-force or less against the wall of the lumen of the blood vessel, further wherein the expandable woven basket is expanded against a biasing force configured to return the expandable woven basket to an unexpanded configuration in an unconstrained state; and pulling the expandable woven basket proximally while expanding or contracting the expandable woven basket by operating controls on a handle of the expandable scraper device to adjust the tension by maintaining the tension between approximately 0.2 and 1.5 pounds-force to scrape clotted material from the wall of the lumen of the blood vessel without damaging the wall of the lumen of the blood vessel, wherein adjusting the tension by operating controls on the handle of the expandable scraper device includes releasing a ratchet lock on the handle and sliding a slide to expand or contract the expandable woven basket.

[0136] In operation, the device can remove a clot by positioning an expandable scraper device in the lumen of a blood vessel so that an expandable woven basket of the expandable scraper device is positioned distal to or within the clot. The method may include forming a loop of a portion of the proximal end of the elongated shaft of the expandable scraper and fixing a protrusion extending from the elongated shaft in a lock formed on the handle of the expandable scraper device so as to shorten the effective length of the expandable scraper device. The expandable woven basket can be expanded against the wall of the blood vessel lumen before or after shortening the elongated shaft by forming the loop, or it can be expanded against the wall after forming the loop. The device (e.g., the expandable woven basket) can then be pulled proximally to scrape clot material from the wall of the blood vessel lumen without damaging the wall of the blood vessel lumen, for example, by pulling the handle.

[0137] In general, the device can operate by adjusting the diameter of the basket during operation (e.g., when the basket is pulled or pushed to scrape clotted material) so as to maintain the pulling force on the basket relatively constant (or within a predetermined range) to prevent snagging and / or damage to the vessel wall. For example, the expansion of the basket can be adjusted manually or automatically. In some examples, the expansion of the basket can be adjusted by manually adjusting the diameter of the basket while the basket is pulled to maintain the force within a certain range. The diameter of the basket can be adjusted, as described above, for example, by acting on a control (e.g., a button) to release a ratchet lock on the handle and then sliding the slide distally or proximally.

[0138] For example, a method for removing a clot may include: positioning an expandable scraper device within the lumen of a blood vessel so that an expandable woven basket of the expandable scraper device is positioned distal to or within the clot; expanding the expandable woven basket against the wall of the blood vessel lumen with a radial force between approximately 0.25 and 0.6 pounds-force against the wall of the blood vessel lumen; and pulling the expandable woven basket proximally while expanding or contracting the expandable woven basket by operating one or more controls on a handle of the expandable scraper device to adjust the pulling force by maintaining the pulling force between approximately 0.18 and 0.4 pounds to scrape clot material from the wall of the blood vessel lumen without damaging the wall of the blood vessel lumen.

[0139] Thus, the pull force (or push force) can be maintained within a target range of between 0.18 and 0.4 lbf (referred to as a "constant force" or a force within this target range) during removal by, for example, reducing or expanding the diameter of the basket. As mentioned, this can be done manually by a user managing one or more controls (e.g., a lock release control and a slider control).

[0140] Any of the methods and devices described herein may include inserting an expandable scraper device into the same vascular region as a clot removal device, such as an aspiration chamber and / or inverting a thrombectomy device, as described above. FIG. 28A to FIG. 28C Different insertion sites into the vascular system are shown with different combinations of techniques for inserting the expandable scraper device and inverting the thrombectomy apparatus.

[0141] For example, Fig.28A A single vessel access (e.g., "single root") is shown, with both an expandable scraper device and an inverted thrombectomy device inserted antegrade from the popliteal region. Fig.28A In the embodiment of the present invention, the inverted thrombectomy device 4502 is inserted through a sheath 4504 (shown as a 14F sheath with suction). The same sheath can be used to insert an expandable scraper device (not shown) separately. Thus, the two devices can be inserted alternately into the target area; suction can be applied after using the expandable scraper device and / or the inverted thrombectomy device can be used.

[0142] Fig.28B An alternative approach is shown in which two separate vascular access areas are used. Fig.28B In one embodiment, one of the devices (e.g., a flip thrombectomy device) is inserted from the femoral position 4510 (retrograde) while a second device (e.g., an expandable scraper device) is inserted from the popliteal region or anterior tibial vein 4512. Alternatively, Fig.28CAnother example of a method in which two entry sites are used is shown; in this example, the popliteal fossa area 4512 is used to insert the flip thrombectomy device 4502 and / or an expandable scraper device, and a second site at the saphenous vein can be used to insert another device (e.g., an expandable scraper device) and / or a balloon 4518, as shown.

[0143] FIG. 29A to FIG. 29E Additional examples of methods of accessing the vascular system using the devices described herein are shown. Fig.29A In the example, the device includes a single introducer sheath (e.g., an 18F introducer sheath) into which the expandable scraper device 4612 can be inserted in parallel with the flip thrombectomy device 4602. In this example, the sheath can be inserted into the popliteal region, as described above in Fig.28A as shown in .

[0144] Fig.29B An alternative entry method is shown for an expandable scraper device 4612 to be inserted in parallel with the inverted thrombectomy device 4602, wherein the expandable scraper device is inserted through the inverted thrombectomy device, as shown. In some examples, this can be done without the use of an introducer sheath (as shown).

[0145] Fig.29C Shows something like Fig.28A Another example of a method of inverting thrombectomy device 4602 and expandable scraper device 4612 is inserted through the same access area (e.g., popliteal region) and through the same sheath 4618. The two devices can be used in alternative ways. For example, the expandable scraper device can be used between passes with the inverted thrombectomy device.

[0146] In any of these methods, a guide wire can be used to guide both devices to the target area for clot removal. During the procedure, the guide wire can remain in place or can be removed.

[0147] Fig.29D and Fig.29E Shows something like Fig.28B and Fig.28C 28D , the expandable scraper device 4612 is inserted from an entry point in the lower popliteal region using a sheath, and the flip thrombectomy device 4602 is inserted from the higher popliteal region using a second sheath. The two devices can be turned to converge on the treatment area, as shown.

[0148] exist Fig.29EIn FIG. 4 , the expandable scraper device 4612 is inserted from an entry point in the popliteal (posterior tibial) region, and the inverted thrombectomy device 4602 is inserted from the femoral vein region. The two devices converge on the treatment area, but from different directions, as shown. Tube flipping equipment

[0149] Generally, an inverted tube device (also referred to herein as a "mechanical thrombectomy device" or "inverted thrombectomy device") can be configured to remove material, such as a clot, using a length of inverted tube, such as FIG. 30A to FIG. 30C The devices and methods of use described herein can be used within the vascular system, including the neurovascular system and the peripheral vascular system.

[0150] For example, Fig. 30A A flip thrombectomy device 3000 is shown, such as the examples described in U.S. Patent Application No. 15 / 496,570 and in U.S. Patent No. 9,463,035. The device includes a flip support catheter 3007 and a flexible tube 3003 extending above the outer surface of the flip catheter. The flexible tube can be referred to as a traction tube (or flexible traction tube) and can be attached to a puller 3001 at one end region, which can be a pullwire or a pulltube (e.g., a catheter), for example, at a distal region of the puller. In some examples, the flexible tube can be attached proximal to the distal end of the puller (e.g., between 1 mm and 50 mm from the distal end, between 1 mm and 40 mm, between 1 mm and 30 mm, greater than 5 mm, greater than 10 mm, greater than 20 mm, greater than 30 mm, etc. from the distal end of the puller). As Fig. 30B and Fig. 30C As shown in , pulling the puller proximally causes the flexible tube to flip over the distal opening 3011 of the flip support catheter to capture and remove material (such as clots) in the vascular cavity. In operation, the amount of material that can be captured corresponds to the length of the flexible tube.

[0151] exist Fig. 30B In the figure, the flip-traction mechanical thrombectomy device 3000 is shown to be deployed near a clot 3009. In the deployed configuration, the puller 3001 (shown here as a pulling microcatheter, alternatively the puller may be a wire) is held within an elongated flip support catheter 3007, such that a flexible traction tube 3003 extends from the end of the puller 3001 and expands toward the inner radius of the elongated flip support catheter 3007; at the distal opening 3011 of the elongated flip support catheter, the traction tube flips over and extends proximally over the distal end of the elongated flip support catheter in a flipped configuration. Fig. 30CAs shown in , by pulling the puller proximally, the pulling tube rolls 3013, 3013' and flips over the distal opening of the elongated flip support catheter, thereby pulling the adjacent clot into the elongated flip support catheter as shown.

[0152] Fig. 30A The elongated inversion support catheter is shown as an elongated tube having a distal end having an inner diameter that is the same size as the proximal length of the inversion support catheter. In some examples, the distal end of the inversion support catheter can be funnel-shaped (or configured to expand to a funnel shape, see, e.g., Figure 2 A to Figure 2 B) In FIG. 30A to FIG. 30C In the embodiment, the inverted support catheter 3007 is shown positioned between the traction tube (e.g., flexible tube 3003) and the puller 3001, so that the flexible tube can be pulled proximally by pulling the puller and rolling the flexible tube into the elongated inverted support catheter so that it is inverted. The portion of the flexible tube inverted above the distal end of the elongated inverted support catheter has an outer diameter greater than the outer diameter of the elongated inverted support catheter. The flexible tube can be biased so that it has a relaxed expanded configuration with a diameter greater than the outer diameter (OD) of the elongated inversion support catheter; in addition, the flexible tube can be further configured (e.g., by heat setting, etc.) so that when the flexible tube is inverted and rolled into the elongated inversion support catheter over the distal opening, the outer diameter of the flexible tube within the elongated inversion support catheter has an outer diameter that is about y times (y times) the inner diameter of the elongated inversion support catheter (e.g., where y is greater than 0.1x, 0.5x, 0.6x, 0.7x, 0.75x, 0.8x, 0.9x, 1x, etc. of the inner diameter ID of the elongated inversion support catheter). This combination of an uninverted diameter of the flexible tube that is greater than the OD of the elongated inversion support catheter and an inverted diameter of the flexible tube that is greater than, for example, 0.7x of the ID of the elongated inversion support catheter unexpectedly helps prevent the device from getting stuck when deploying the device and when rolling the flexible tube over the distal opening of the elongated inversion support catheter to capture a clot. The flexible tube may be expandable and may be coupled to a puller, as shown. In some examples, the flexible tube and puller may comprise the same material, but the flexible tube may be more flexible and / or expandable, or may be coupled to an elongated puller (e.g., a push / pull wire or catheter). As mentioned above, the puller may be optional (e.g., the flexible tube itself may be pulled proximally into the inversion support catheter).

[0153] exist Fig. 30CIn the embodiment of the present invention, the clot can be pulled into the elongated inverted support catheter by pulling the flexible tube proximally and flipping the thrombectomy device to the distal end of the elongated inverted support catheter, as shown by arrows 3013, 3013', which represent pulling the inner portion of the flexible tube so that the flexible tube is rolled over the end opening of the catheter and into the distal end of the catheter, and flipping the expandable distal region so that it is pulled into the catheter, as shown by the arrow. The end of the flexible tube outside the catheter can be loose relative to the outer wall of the catheter.

[0154] As described herein, an example method for removing a clot using any of the devices described herein (e.g., the expandable off-axis basket described above) may include: positioning an expandable scraper device (including any of the expandable scraper devices described herein) within the lumen of a blood vessel such that an expandable woven basket of the expandable scraper device is positioned distal to or within the clot; expanding the expandable woven basket against the wall of the blood vessel lumen by adjusting controls on a proximal handle of the expandable scraper device such that an inner slender member slidably disposed within a flexible outer slender member and within the expandable woven basket is positioned within the expandable woven basket offset from the midline of the expandable woven basket; and pulling the expandable woven basket proximally to scrape clot material from the wall of the blood vessel lumen without damaging the wall of the blood vessel lumen.

[0155] Additionally, in some examples, the outer elongated member of the expandable scraper device can be connected to a suction mechanism (e.g., a suction vacuum, etc.) that allows clot material, fluid, etc. to be suctioned through the outer elongated member. For example, after the expandable woven basket is pulled proximally to scrape clot material from the wall of the blood vessel, the clot material can be positioned near the distal end of the outer elongated member, whereby the clot material is then suctioned out substantially through the lumen of the outer elongated member.

[0156] Additionally, the method of removing clotted material may further include deploying an expandable woven basket within the clotted material, waiting for a period of time (e.g., allowing the expandable woven basket to rest within the clotted material for a period of time, thereby allowing the clot to bind / engage the expandable woven basket), and then pulling the expandable woven basket proximally to scrape the clotted material from the wall of the blood vessel. The woven basket may be pulled proximally to a position adjacent to the distal end of the outer sheath (but not into the lumen of the outer sheath). These steps may be performed multiple times to ensure that all clotted material is removed from the blood vessel wall. After determining that the clotted material has been sufficiently cleared from the blood vessel wall (e.g., determined via visualization under fluoroscopy), the expandable woven basket may be pulled into the lumen of the outer sheath, whereby the action of pulling the basket into the lumen of the outer sheath may scrape the clotted material from the expandable basket, thereby depositing the clotted material at the distal end of the outer sheath (e.g., adjacent to the distal opening of the lumen of the outer sheath). Prior to aspiration of the deposited clotted material, the expandable basket may be deployed distal to the clotted material, thereby acting as a distal embolic protection device as the clotted material is aspirated through the outer sheath.

[0157] In the example methods described above, the expandable basket can be initially deployed about 2 cm to 16 cm within the clotted material, or about 3 cm to about 14 cm within the clotted material, or about 4 cm to about 12 cm within the clotted material, or about 5 cm to about 10 cm within the clotted material. In addition, the expandable basket can be allowed to remain within the clotted material for about 10 seconds to about 90 seconds, or about 15 seconds to about 60 seconds, or about 20 seconds to about 50 seconds, or about 25 seconds to about 40 seconds, or about 30 seconds before being pulled proximally toward the outer sheath. Repeating the cycle of deploying the expandable basket within the clotted material, allowing the expandable basket to remain within the clotted material for a period of time (e.g., waiting a period of time to allow the basket to engage with the clotted material) before being pulled proximally toward the outer sheath, then pulling the basket proximally toward the outer sheath to clear the clotted material, can be repeated multiple times (e.g., about 1 to 6 times) before aspirating the clotted material through the outer sheath.

[0158] Figure 31 to Figure 33 A method of forming an example expandable basket 5000 is shown. The expandable basket 5000 can be similar in form and function to other expandable baskets used with the various example scraper devices described herein. For example, the expandable basket 5000 can be similar in form and function to the example baskets described above with respect to FIG. 23E to FIG. 23F The expandable off-axis basket 2127. Figure 31 to Figure 33 A method of constructing an expandable basket 5000 is described, which can then be attached to the inner and outer shafts of a scraper device, whereby the basket 5000 is configured to deform from an unexpanded configuration to an expanded configuration (e.g., such as, but not limited to, FIG. 23E to FIG. 23F The expanded basket pattern shown in ). Figure 31 to Figure 33 The described methods may be used to form any of the example expandable baskets disclosed herein.

[0159] Fig.31 An example first step of forming an expandable woven basket 5000 is shown that can include positioning (e.g., winding, braiding, weaving, etc.) a plurality of wires 5020 along a mandrel 5010. The plurality of wires 5020 used to form the expandable woven basket 5000 can include 20 to 60 nickel-titanium wires, each having a diameter between about 0.15 mm and about 0.35 mm.

[0160] Fig.32 The example second step of forming the expandable woven basket 5000 may include wrapping the distal region 5030a of the plurality of wires 5020 with the copper wire 5050, and may also include wrapping the proximal region 5030b of the plurality of wires 5020 with the copper wire 5050. Fig.32As shown, the intermediate region 5040 of the plurality of filaments 5020 (positioned between the distal region 5030a and the proximal region 5030b) may not be wrapped with copper wire and is therefore free to assume a constrained configuration relative to the distal region 5030a and the proximal region 5030b.

[0161] Additionally, after the copper wire 5050 is wrapped around the distal region 5030a and the proximal region 5030b, the expandable woven basket 5000 can be heat set (e.g., exposed to elevated temperatures for a period of time to impart a particular shape to the basket 5000). It should be appreciated that wrapping the copper wire 5050 around the distal region 5030a and the proximal region 5030b can reduce the overall diameter of the distal region 5030a and the proximal region 5030b relative to the unconstrained middle region prior to heat setting. Thus, heat setting (e.g., exposing the expandable woven basket 5000 to an elevated temperature for a period of time to impart a particular shape to the basket 5000) can reduce the overall diameter of the distal region 5030a and the proximal region 5030b relative to the unconstrained middle region prior to heat setting. Fig.32 ) can generate Fig.33 In other words, after heat setting the woven basket 5000, the woven basket 5000 is shaped as shown. Fig.32 As shown and described in the drawings, the copper wire 5050 can be removed from the distal region 5030a and the proximal region 5030b to achieve the following Fig.33 The woven basket 5000 is shown in its heat set shape. Fig.33 The illustrated heat set basket 5000 may include a distal region 5030a and a proximal region 5030b having an outer diameter Y, and a middle region 5040 having a diameter X. It should be appreciated that the diameter Y of the distal region 5030a and the proximal region 5030b may be smaller than the diameter X of the middle region 1040.

[0162] As discussed herein, the heat set expandable woven basket 5000 can be configured to deform from an unexpanded configuration to an expanded configuration. In some examples, the expandable woven basket 5000 can be configured to deform from an unexpanded configuration to an expanded configuration such that a portion of the inner elongated member extending within the expandable woven basket is not concentric with the expandable woven basket. Specifically, the woven basket 5000 can be designed such that the middle portion (e.g., Fig.33 The larger diameter "bulge" portion of the basket 5000 shown can be pre-set to flex as the basket 5000 expands, thereby forming an expanded portion with a larger diameter relative to the distal region 5030a and the proximal region 5030b. In some examples, the expanded portion of the basket 5000 can be formed such that the inner elongated member within the expandable woven basket is not concentric (e.g., off-axis) relative to the expandable woven basket.

[0163] As described herein, various example expandable baskets described herein can be formed from multiple braided nitinol wires. For example, some example expandable baskets described herein can be formed from 32 wires and can form a pattern referred to as a half-loaded diamond pattern (1 up 1 down 1). In other examples, some example expandable baskets described herein can be formed from 48 wires and can form a pattern referred to as a fully loaded regular pattern (1 up 2 down 2).

[0164] In addition, it should be understood that the ends of the wires of any expandable basket (e.g., the ends of a 32-wire pattern or a 48-wire pattern) can be fixedly attached to the inner member, the outer member, or both the inner member and the outer member at the distal bonding area, the proximal bonding area, or both the distal bonding area and the proximal bonding area of ​​the example scraping device.

[0165] For example, Fig.34 An example scraping device 6000 is shown, which includes an inner shaft 6020 extending through both an example outer shaft 6010 and an example expandable basket 6040. Fig.34 As shown in the detailed view of , each of the wires forming the basket 6040 can include a proximal end positioned along the proximal bonding area of ​​the outer shaft 6010. Fig.34 The detailed view of woven basket 6040 shows that it can include a first wire end 6040a positioned adjacent to a second wire end 6040b. As an example, although Fig.34 The detailed view of FIG. 6040 shows the ends 6040a, 6040b of five wires, but it should be understood that in a basket having 48 wires, there may be ends of 48 wires aligned adjacent to each other along the proximal bonding area. Thus, the ends of the wires of the basket 6040 can contribute to the scraping device 6000 having a proximal waist (the area along the outer shaft 6010 where the ends of the wires are bonded to the outer shaft 6010) having an outer diameter X ( Fig.34 ).

[0166] It should also be appreciated that it may be desirable to minimize the profile of the proximal waist of the scraping device 6000. Minimizing the profile of the proximal waist of the scraping device 6000 may allow the scraping device 6000 to fit through a smaller diameter introducer sheath.

[0167] Fig.35 An example method for reducing the overall profile of the proximal waist of the shaving apparatus 6000 is shown. Fig.35 The detailed view of 6040 shows that some of the ends 6040a of the wires of the woven basket 6040 can be cut (e.g., trimmed) relative to the ends 6040b of the wires of the remaining wires of the woven basket 6040. For example, Fig.35The detailed view shows that the ends 6040a of two wires are trimmed shorter than the ends 6040b of the remaining wires. It should be understood that removing (e.g., trimming) some of the material from the ends of the wires along the proximal waist can reduce the number of wires stacked on each other along the proximal waist. For example, a woven basket comprising 48 wires may have 24 of the ends of the wires removed along the proximal waist, whereby a woven basket comprising 32 wires may have 16 ends of the wires removed along the proximal waist. However, it should be understood that more than half or less than half of the total number of wires used to construct the woven basket may be removed along the proximal waist. Reducing the number of wires stacked on each other (e.g., removing material) can reduce the overall outer diameter of the proximal waist. For example, Fig.35 The detailed view shows the reduced diameter Y of the proximal waist, whereby the outer diameter Y is smaller than Fig.34 The outer diameter X shown in FIG. In addition, it should be understood that this method can be used to reduce the diameter of the distal waist of the scraping device 6000.

[0168] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such summaries are not mutually inconsistent) are considered to be part of the inventive subject matter disclosed herein and can be used to achieve the benefits described herein.

[0169] When a feature or element is referred to as "on" another feature or element in this article, it can be directly on another feature or element, or there can also be intermediate features and / or elements. On the contrary, when a feature or element is referred to as "directly on" another feature or element, there are no intermediate features or elements. It should also be understood that when a feature or element is referred to as "connected", "attached" or "coupled" to another feature or element in this article, it can be directly connected, attached or coupled to other features or elements, or there can be intermediate features or elements. On the contrary, when a feature or element is referred to as "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intermediate features or elements. Although it is described or shown in relation to an example, the features and elements described or shown in this way may also be applicable to other examples. It should also be understood by those skilled in the art that the structure or feature mentioned "adjacent" another feature setting can have a part overlapping or located below an adjacent feature.

[0170] The terms used in this article are only used to describe specific examples and are not intended to limit the present invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to also include plural forms, unless the context clearly indicates otherwise. It should also be understood that when used in this specification, the terms "include" and / or "include" specify the presence of the features, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of the associated listed items and can be abbreviated as " / ".

[0171] For ease of description, spatial relative terms may be used herein, such as, "below", "below", "lower", "above", "upper", etc. to describe the relationship between an element or feature and another element or feature shown in the figure. It should be understood that, in addition to the orientation depicted in the figure, spatial relative terms are intended to include different orientations of the device in use or operation. For example, if the device in the figure flips, the element described as "below" or "below" other elements or features will then be oriented to "above" other elements or features. Therefore, the exemplary term "below" can include two orientations above and below. The device can be oriented in other ways (rotated 90 degrees or adopting other orientations) and the spatial relative descriptors used herein are interpreted accordingly. Similarly, the terms "upward", "downward", "vertical", "horizontal", etc. are only used for explanation in this article unless otherwise specifically indicated.

[0172] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, without departing from the teachings of the present invention, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0173] In this specification and the claims that follow, unless the context requires otherwise, the word "comprises" and variations such as "comprises" and "comprising" refer to various components that can be employed together in methods and articles (e.g., compositions and devices including apparatus and methods). For example, the term "comprising" should be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0174] In general, any of the devices and methods described herein should be understood to be inclusive, but all or a subset of the components and / or steps may alternatively be exclusive, and may be expressed as "consisting of" or alternatively "consisting essentially of" the various components, steps, sub-components or sub-steps.

[0175] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly provided, all numbers can be read as prefixed with the word "about" or "approximately", even if the term does not appear explicitly. When describing size and / or position, the phrase "about" or "approximately" can be used to indicate that the value and / or position described are within the appropriate expected range of the value and / or position. For example, the value of the numerical value can be + / -0.1% of the value (or value range), + / -1% of the value (or value range), + / -2% of the value (or value range), + / -5% of the value (or value range), + / -10% of the value (or value range), etc. Unless otherwise indicated by the context, any numerical value given herein should also be understood to include about or approximately the value. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range described herein is intended to include all sub-ranges contained herein. It should also be understood that when a value is disclosed, "less than or equal to" the value, "greater than or equal to the value," and possible ranges between values ​​are also disclosed, as would be appropriately understood by a skilled artisan. For example, if the value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats, and that the data represents endpoints and starting points, as well as ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, and between 10 and 15 are also disclosed. It should also be understood that every unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0176] Although various illustrative examples are described above, any of a variety of changes may be made to the various examples without departing from the scope of the invention as claimed. For example, in alternative examples, the order in which the various described method steps are performed may generally be changed, and in other alternative examples, one or more method steps may be skipped entirely. Optional features of the various apparatus and system examples may be included in some examples and not included in other examples. Therefore, the above description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0177] The examples and illustrations included herein show the specific examples that can practice this theme by way of illustration and not limitation. As mentioned, other examples can also be utilized and derived so that structural and logical replacement and changes can be made without departing from the scope of the invention. These examples of the subject matter of the present invention can be referred to as or collectively referred to as "inventions" individually herein, which is merely for convenience, and is not intended to voluntarily limit the scope of the present application to any single invention or inventive concept (if in fact more than one is disclosed). Therefore, although specific examples are shown and described herein, any arrangement calculated for achieving the same purpose can be replaced for the specific examples shown. The present invention is intended to cover any and all adaptive changes or modifications of various examples. For those skilled in the art, after reviewing the above description, the combination of the above examples and other examples not specifically described herein will be apparent.

Claims

1. A method of forming an expandable thrombectomy device, the method comprising: a scraping member disposed along the mandrel, the scraping member comprising a proximal region, a distal region, and an intermediate region positioned between the proximal region and the distal region; constraining the proximal region of the scraping member; constraining the distal region of the scraping member; as well as The scraping member is heat-set. 2 . The method of claim 1 , wherein constraining the proximal region of the scraping member further comprises constraining the proximal region of the scraping member with a first constraining wire. 3 . The method of claim 2 , wherein constraining the distal region of the scraping member further comprises constraining the distal region of the scraping member with a second constraining wire.

4. The method of any one of claims 2 to 3, further comprising removing the first restraining wire before heat setting the scraping member.

5. The method of any one of claims 3 to 4, further comprising removing the second constraining wire before heat setting the scraping member.

6. The method according to any one of claims 1 to 5, wherein the scraping member further comprises an intermediate region positioned between the proximal region and the distal region.

7. The method of claim 6, wherein heat setting the scraping member defines an expansion point in the intermediate region.

8. The method according to any one of claims 6 to 7, wherein during heat setting of the scraping member, the intermediate region is free of the first and second restraining wires.

9. The method according to any one of claims 2 to 8, wherein the first constraining wire is configured to maintain the proximal region of the scraping member at a first diameter during heat setting of the scraping member. 10 . The method of claim 24 , wherein the second constraining wire is configured to maintain the distal end region of the scraping member at a second diameter during heat setting of the scraping member.

11. The method of any one of claims 3 to 10, wherein the intermediate region comprises a third diameter during heat setting the scraping member, and wherein the third diameter is larger than the constrained first diameter and the constrained second diameter.

12. The method of any one of claims 3 to 11, wherein the first restraining wire, the second restraining wire, or both the first restraining wire and the second restraining wire are copper.

13. A method of forming an expandable thrombectomy device, the method comprising: Disposing a plurality of braided wires along the mandrel, the plurality of braided wires comprising a proximal region, a distal region, and an intermediate region positioned between the proximal region and the distal region; constraining the proximal region of the plurality of braided wires; constraining the distal region of the plurality of braided wires; as well as The plurality of filaments are heat set. 14 . The method of claim 13 , wherein constraining the proximal region of the plurality of braided wires further comprises constraining the proximal region of the plurality of braided wires with a first constraining wire. 15 . The method of claim 14 , wherein constraining the distal region of the plurality of braided wires further comprises constraining the distal region of the plurality of braided wires with a second constraining wire.

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