Endovascular medical devices and associated devices, systems, and methods

Abstract

Endovascular treatment devices are disclosed herein. According to some embodiments, the present technology includes a drive handle configured to be operatively coupled to a handle of a treatment catheter. The drive handle can comprise a receiving portion configured to receive the handle of the treatment catheter and an actuator movable by a user between a first position farther from the receiving portion and a second position closer to the receiving portion. The drive handle can further comprise a slider coupled to the actuator and the receiving portion and configured to move axially relative to the receiving portion. When the handle of the treatment catheter is received by the receiving portion, movement of the actuator between the first and second positions causes the slider to move axially, thereby causing the treatment catheter to move axially and / or rotationally within the receiving portion.

Description

ENDO VASCULAR MEDICAL DEVICES AND ASSOCIATED DEVICES, SYSTEMS,AND METHODSCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 489,714, filed March 10, 2023, which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present technology relates generally to endovascular treatment systems and associated devices and methods.BACKGROUND

[0003] Deep vein thrombosis (DVT) is a condition comprising a blood clot in a deep vein, usually a leg vein though they can also occur in arm veins. Symptoms include pain, swelling, tenderness, and / or discoloration in the affected limb. If untreated, it can lead to worsening of symptoms and complications such as post-thrombotic syndrome with symptoms of chronic pain, swelling, and skin discoloration, or pulmonary embolism (PE), a very serious and life-threatening condition. Pharmacologic treatments include blood-thinning medications or thrombolytic drugs. More recently, percutaneous catheters have been developed for the more rapid removal of clot to remove the blockage and prevent PE. These include catheters which can deliver thrombolytic agents to the site of the clot, in some cases in combination with aspiration and / or the disruption of the clot into smaller pieces. Other catheters mechanically capture and remove clot without thrombolytic agents, thereby reducing the bleeding risk incurred by these drugs. An early example of this is the Fogarty Balloon Thrombectomy catheter. More recent examples include the ClotTriever® (Inari Medical, Irvine, CA) and the ReVene® Thrombectomy Catheter (Vetex Medical, Galway, Ireland).

[0004] Unfortunately, many of these therapies have limited success for partial or full blockages caused by chronic thrombus (i.e., a thrombus over one or two months old). As the clot remains in the limb over a period of months, the initial thrombus transforms acutely into a fibrin structure, and chronically can become a collagen structure which is tougher and more firmly adhered to the wall. Chronic thrombus may take the form of fibrous trabeculae or membranes stretching into and across the vein lumen (also known as venous synechiae).Further, the thrombus becomes more firmly attached to the wall. Catheter-based thrombolysis or thrombectomy devices have a lower success rate in removing these blockages. Venous synechiae may also prevent optimal treatment of venous obstruction by balloon angioplasty or stenting, as the fibrous structures prevent permanent stretching of the vessel wall. There is a need for an improved endovascular thrombectomy device which is able to successfully remove chronic thrombus.SUMMARY

[0005] The subject technology is illustrated, for example, according to various aspects described below, including with reference to FIGS. 1 A-9. Various examples of aspects of the subject technology are described as numbered examples (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology.1. A device, comprising: a handle for use in combination with an endovascular medical device that allows for selectable attachment or detachment of the handle from the medical device.2. The device of Example 1, wherein the handle is configured to facilitate motorized motion control of the medical device.3. The device of Example 1 or Example 2, wherein the handle facilitates hand- actuated, mechanized motion control of an endovascular device.4. The device of any one of Examples 1 to 3, wherein the handle imparts rotational, translational, vibrational, oscillatory, or reciprocating motion to a medical device.5. The device of any one of Examples 1 to 4, wherein the handle is configured to permanently attach to the medical device.6. The device of any one of Examples 1 to 5, wherein the handle is configured to be detachably coupled to the medical device.7. The device of any one of Examples 1 to 6, wherein the handle is configured to impart energy from a mechanical, thermal, radiofrequency (RF), or microwave source to the medical device.8. A drive handle configured to be operatively coupled to a handle of a treatment catheter, the drive handle comprising: a receiving portion configured to receive the handle of the treatment catheter therein; an actuator movable by a user between a first position farther from the receiving portion and a second position closer to the receiving portion; and a slider coupled to the actuator and the receiving portion and configured to move axially relative to the receiving portion, wherein, when the handle of the treatment catheter is received by the receiving portion, movement of the actuator between the first and second positions causes the slider to move axially, thereby causing the treatment catheter to move axially within the receiving portion.9. The drive handle of Example 8, wherein, when the handle of the treatment catheter is received by the receiving portion, movement of the actuator between the first and second positions causes the slider to move axially, thereby causing the treatment catheter to rotate.10. A drive handle configured to be operatively coupled to a handle of a treatment catheter, the drive handle comprising: a receiving portion configured to receive the handle of the treatment catheter therein; an actuator movable by a user between a first position farther from the receiving portion and a second position closer to the receiving portion; and a slider coupled to the actuator and the receiving portion and configured to move axially relative to the receiving portion, wherein, when the handle of the treatment catheter is received by the receiving portion, movement of the actuator between the first and second positions causes the slider to move axially, thereby causing the treatment catheter to rotate within the receiving portion.11. The drive handle of any of Examples 8 to 10, wherein the slider is coupled to the receiving portion via a linkage that extends away from the slider and through a slot within the receiving portion, and wherein the linkage is configured to slide within the slot.12. The drive handle of Example 11, wherein the linkage is a first linkage, the slot is a first slot, and wherein the slider is coupled to the actuator via a second linkage that extends away from the slider and through a second slot defined by the actuator, and wherein the second linkage is configured to slide within the second slot.13. The drive handle of Example 12, wherein the second slot is disposed at a non- 90-degree angle relative to the first slot.14. A drive handle configured to be operatively coupled to a handle of a treatment catheter, the drive handle comprising: a receiving portion configured to receive the handle of the treatment catheter therein; an actuator rotatable by a user between a first position farther from the receiving portion and a second position closer to the receiving portion; and a mechanical linkage between the actuator and the receiving portion, the mechanical linkage configured to translate rotational motion of the actuator into axial movement of the handle when the handle is received within the treatment catheter.15. The drive handle of any one of Examples 8 to 14, wherein the actuator comprises a lever.16. The drive handle of any one of Examples 8 to 15, wherein the actuator is biased towards the first position such that in the absence of a counteracting force, the actuator remains in the first position.17. The drive handle of any one of Examples 8 to 16, wherein the receiving portion defines a helical groove configured to receive a protrusion of the handle when the handle is received within the receiving portion.18. The drive handle of any one of Examples 8 to 17, wherein the receiving portion includes a cradle on which the handle is configured to be positioned when operatively coupled to the drive handle and a door configured to extend over the handle and be detachably coupled to the cradle to secure the handle within the receiving portion.19. The drive handle of any one of Examples 8 to 18, further comprising a motor configured to impart vibratory or oscillatory motion to the treatment catheter when the treatment catheter is coupled to the drive handle.20. The drive handle of any one of Examples 8 to 19, further comprising a power source and / or wherein the drive handle is configured to be electrically coupled to a power source.21. A method for operating a drive handle, comprising: positioning a handle of a treatment catheter within a receiving portion of the drive handle; and rotating an actuator of the drive handle from a first position farther from the receiving portion to a second position closer to the receiving portion, thereby causing translation of the treatment catheter relative to the drive handle.22. A method for operating a drive handle, comprising: positioning a handle of a treatment catheter within a receiving portion of the drive handle; and rotating an actuator of the drive handle from a first position farther from the receiving portion to a second position closer to the receiving portion, thereby causing rotation of the treatment catheter relative to the drive handle.23. A method for operating a drive handle, comprising: positioning a handle of a treatment catheter within a receiving portion of the drive handle; and rotating an actuator of the drive handle from a first position farther from the receiving portion to a second position closer to the receiving portion, thereby causing rotation and translation of the treatment catheter relative to the drive handle.24. The method of any one of Examples 21 to 23, wherein the actuator is a lever.25. The method of any one of Examples 21 to 24, wherein the drive handle further comprises a slider coupled to the receiving portion and the actuator, and wherein rotation of the actuator causes translation of the slider.26. The method of any one of Examples 21 to 25, wherein positioning the handle of the treatment catheter within the receiving portion of the drive handle includes positioning the handle within a cavity of the receiving portion.27. The method of Example 26, wherein the cavity is defined by a cradle and the method further comprises rotating a door of the receiving portion over a top surface of the handle and detachably coupling the door to the cradle, thereby securing the handle to the drive handle.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure.[00071 FIG. 1 A shows a treatment system in accordance with several embodiments of the present technology.

[0008] FIG. IB shows the treatment system of FIG. 1A with the capture device delivered through the cutting device in accordance with several embodiments of the present technology.

[0009] FIGS. 2 A and 2B are side and perspective cross-sectional views of a handle of a cutting device in accordance with several embodiments of the present technology.

[0010] FIG. 3 A is a perspective view of a drive handle configured in accordance with the present technology, shown receiving a handle of a cutting device and in a partially closed / partially open configuration with the actuator in a first position.

[0011] FIG. 3B is a perspective view of the drive handle of FIG. 3A in an open configuration and with the actuator in a first position.

[0012] FIG. 3C is a perspective view of the drive handle of FIG. 3A in a partially closed / partially open configuration and with the actuator in a second position.

[0013] FIG. 4A is a cross-sectional side view of the drive handle shown in FIGS. 3A- 3C, shown with the actuator in a first position.

[0014] FIG. 4B is a cross-sectional side view of the drive handle shown in FIGS. 3A- 3C, shown with the actuator in a second position.

[0015] FIG. 5 is a cross-sectional perspective view of the drive handle shown in FIGS. 3A-3C, shown with the actuator in a first position.

[0016] FIG. 6 is a top perspective view of the drive handle shown in FIGS. 3A-3C.

[0017] FIG. 7 shows a proximal portion of a treatment device configured in accordance with several embodiments of the present technology.

[0018] FIG. 8 shows a drive handle configured in accordance with several embodiments of the present technology.

[0019] FIG. 9 shows the proximal portion of the treatment device of FIG. 7 received within the drive handle of FIG. 8 in accordance with several embodiments of the present technology.DETAILED DESCRIPTION

[0020] The present technology relates to endovascular treatment systems and associated devices and methods. Some embodiments of the present technology, for example, are directed to a selectively attachable handle (or “drive handle”) configured to interface with an endovascular treatment device for the purpose of providing enhanced motion control, application of force, or delivery of energy. The drive handle is configured to supplement an otherwise independently functioning treatment device by interfacing with existing nonmechanized handle components and enable the treatment device to be used in either a mechanized or non-mechanized configuration. The drive handle may be designed to replicate the same motion produced with hand manipulation or to provide a mechanical advantage for optimized force, speed, or precision motion control beyond the capabilities of the nonmechanized catheter. The drive handles of the present technology can be particularly well- suited for use with mechanical thrombectomy devices for treating DVT or post thrombotic syndrome (PTS), although other endovascular applications are possible. Specific details of several embodiments of the technology are described below with reference to FIGS. 1 A-9.I. Treatment Systems and Associated Devices and Methods

[0021] FIG. 1 A schematically depicts a treatment system 10 (also referred to herein as “the system 10”) configured in accordance with the present technology. The treatment system 100 is configured to access a body lumen (such as a vein or artery) and modify, capture, and / or remove obstructive material from the body lumen at a treatment site. As used herein, “obstruction” or “obstructive material” can comprise, for example, clot material, atherosclerotic plaque, and / or other flow-obstructing structures, including those derivative of clot material, such as fibrotic clot material, venous synechiae, fibrinous structures, collagenous structures, fibrous trabeculae, and / or others. As shown in FIG. 1 A, the system 10 can comprise a cutting device 105 and a capture device 107, each configured to access the treatment site. In other embodiments, the system 10 comprises only the cutting device 105 or only the capture device 107.

[0022] The cutting device 105 has a proximal portion 105a configured to be positioned extracorporeally during the procedure, a distal portion 105b configured to be positioned at the treatment site within the body lumen, a handle 200 at the proximal portion 105a, and a cutting assembly 110 at the distal portion 100b. The device 100 further includes an outer shaft 102 extending from a proximal portion 102a at or within the handle 200 to a distal portion 102b at the cutting assembly 110, and an inner shaft 103 extending from a proximal portion 103a at or proximal of the handle 200 to a distal portion 103b at the cutting assembly 110. The cutting device 105 can be configured to be delivered over a guidewire 106 (see FIG. IB), for example through a lumen defined by the inner shaft 103.

[0023] The cutting assembly 110 can comprise one or more cutting elements configured to cut through obstructive material in the vessel lumen, thereby separating and / or releasing obstructive material from the vessel wall, a non-native structure positioned within the vessel (such as a failed stent), and / or from other obstructive material. In the example shown in FIG. 1, the cutting assembly 110 comprises a cutting element 116 comprising a helical ribbon having a proximal end 116a fixed to the outer shaft 102 and a distal end 116b fixed to the inner shaft 103. The outer and inner shafts 102, 103 are rotated relative to one another to radially expand and collapse the helical ribbon 116 relative to a longitudinal axis of the cutting device 105. During expansion and collapse, the proximal and distal ends 116a, 116b of the cutting element 116 do not move relative to one another. While a helical ribbon cutting element 116 is shown in FIGS. 1A and IB, the handles and drive handles of the present technology can be used with cutting devices 105 having other cutting elements and / or cutting assemblies. Forexample, additional description of the cutting assembly 110, as well as additional cutting assemblies (also referred to as “cutting portions”) can be found in, for example, U.S. Patent Application No. 18 / 120,361, filed March 10, 2023, which is disclosed by reference herein in its entirety.

[0024] Referring still to FIG. 1A, the capture device 107 has a proximal portion 107a configured to be positioned extracorporeally during the procedure, a distal portion 107b configured to be positioned at the treatment site within the body lumen, and a capture assembly 112 at the distal portion 107b. The capture device 107 further includes a shaft 104 extending from a proximal portion 104a at an extracorporeal location to a distal portion 104b at or distal of the capture assembly 112. The capture device 107 can be configured to be delivered over a guidewire 106 (see FIG. IB), for example through a lumen defined by the shaft 104.

[0025] The capture assembly 112 can comprise one or more expandable mesh structures configured to engage, trap, or otherwise become enmeshed with obstructive material at the treatment site before, during, or after engagement by the cutting assembly 112. In some embodiments, for example as shown in FIG. 1A, the capture assembly 112 can comprise a mesh bag 118 having proximal and distal end portions 118a, 118b coupled to the shaft 104. The mesh bag 118 can have a closed distal region and an opening at the proximal region. The proximal end portion 118a may be axially fixed to the shaft 104 or may be free to slide along the shaft 104. Likewise, the proximal end portion 118a may be rotationally fixed to the shaft 104 or may be free to rotate about the shaft 104. The distal end portion 118b may be axially fixed to the shaft 104 or may be free to slide along the shaft 104. Likewise, the distal end portion 118b may be rotationally fixed to the shaft 104 or may be free to rotate about the shaft 104. In some examples, the proximal end portion 118a is rotationally and axially fixed relative to the shaft 104 while the distal end portion 118b is free to rotate and translate relative to the shaft 104. In other embodiments, the proximal end portion 118a can be axially fixed along the shaft 104 (for example, via two stop elements on either side of the hub at the proximal end portion 118a) but free to rotate, while the distal end portion 118b is free to rotate and translate relative to the shaft 104. Allowing the distal end portion 118b to rotate about and translate along the shaft 104 can be beneficial for allowing foreshortening of the mesh bag during deployment. In some embodiments, the capture assembly 107 may be configured to be delivered through a sheath (not shown). Allowing rotation of the proximal and distal end portions 118a, 118b can beneficially allow the shaft 104 to be rotated (for example, to engage the obstructive material with the nosecone 124) without also rotating the mesh bag 118, whichcan remain relatively rotationally fixed, along with the sheath. Forcing the mesh bag 118 to rotate with the shaft 103 while the sheath remains stationary can cause the mesh bag 118 to get twisted within the sheath, which can make deployment of the mesh bag 108 more difficult.

[0026] When the cutting device 105 is coupled to the capture device 107 (see FIG. IB), the mesh bag 118 can be distal of the cutting assembly 110 such that obstructive material separated from the treatment site by the cutting assembly 110 can be collected by the mesh bag 118, either by pulling the mesh bag 118 proximally during the procedure or by merit of the mesh bag 118 being downstream from the cutting assembly 110. Additional description of the capture assembly 112, as well as additional capture assemblies (also referred to as “capture portions”) can be found in, for example, U.S. Patent Application No. 18 / 120,361, filed March 10, 2023, as well as U.S. Provisional Application No. 63 / 622,799, filed January 19, 2024, both of which are disclosed by reference herein in their entireties.

[0027] The cutting device 105 can optionally include a nosecone 122 at its distal end portion 105b, distal of the cutting assembly 110, that is configured to facilitate engagement and / or penetration of obstructive material. Additionally or alternatively, the cutting device 107 can optionally include a nosecone 124 at its distal end portion 107, distal of the capture assembly 112, that is configured to facilitate engagement and / or penetration of obstructive material. The nosecones 122, 124 can be any of the nosecones described in PCT Application No. [TBD - Attorney Docket No. IVN.004WO], titled INTERVENTIONAL SYSTEMS AND ASSOCIATED DEVICES AND METHODS, filed herewith and incorporated herein by reference in its entirety.

[0028] FIG. IB shows the treatment system 10 arranged such that the cutting device 105 has been delivered over the shaft 104 of the capture device 107. As such, the shaft 104 of the capture device 107 is positioned through the lumen of the inner shaft 103 of the cutting device 105, which is positioned over a guidewire 106. The shaft 104 can extend proximally through the handle 200 of the cutting device 105 until exiting the proximal end of the handle 200. In some cases, the handle 200 can include a luer lock 207 coupled to a proximal end of the handle 200, and the shaft 104 can extend through the luer lock 207.

[0029] The handle 200 can be configured to enable controlled rotation of the outer and inner shafts 102, 103 of the cutting device 105 relative to one another to expand and collapse the helical cutting element 116. FIGS. 2A and 2B show side cross-sectional and perspective views, respectively, of the handle 200. With reference to FIGS. 1 A, IB, 2A, and 2B, the handle200 can comprise a proximal housing 202 and a distal housing 204 movably coupled to the proximal housing 202. The inner shaft 103 can be operatively coupled to the proximal housing 202 and the outer shaft 102 can be operatively coupled to the distal housing 204. The proximal housing 202 is configured to be rotated relative to the distal housing 204 to cause rotation of the inner shaft 103 relative to the outer shaft 102 to selectively expand and collapse the helical cutting element 116. As detailed below, the handle 200 may optionally include one or more features to prevent unintended actuation (rotation) of the inner shaft 102 and / or one or more features that indicate to the user an amount of radial expansion of the cutting element 116.[0030| The distal housing 204 may be configured to be coupled to the proximal end portion 102a of the outer shaft 102, either directly or via a coupler 206, such that the outer shaft 102 is not movable axially or rotationally relative to the distal housing 204. The handle 200 may further include a lumen 208 having a proximal end portion 208a at or near the proximal end of the proximal housing 202 and a distal end portion 208b within the distal housing 204, proximal of and aligned with the location at which the distal housing 204 connects to the outer shaft 102. The handle 200 can further include a tube 210 positioned within and extending through the lumen 208 such that tube 210 spans the proximal and distal housings 202, 204.

[0031] The tube 210 defines a lumen extending therethrough, and the lumen is configured to receive the inner shaft 103 therein. When the cutting device 105 is assembled, a proximal length of the inner shaft 103 extends proximally beyond the proximal end of the outer shaft 102 (fixed within the distal housing 204) and into the tube 210, then within the tube 210 the inner shaft 103 extends proximally through the distal housing 204 and into the proximal housing 202. The inner shaft 103 may terminate proximally within the handle 200 or may extend proximally from the handle 200. The inner shaft 103 may be axially fixed relative to the tube 210 such that axial movement of the tube 210 causes a corresponding axial movement of the inner shaft 103, and rotational movement of the tube 210 causes a corresponding rotational movement of the inner shaft 103. For example, all or a portion of the length of the inner shaft 103 within the tube 210 can be bonded to an inner surface of the tube 210.

[0032] A distal end region 210b of the tube 210 can be longitudinally constrained by a receiving element 212 that is formed by or operatively coupled to the distal housing 204. The receiving element 212 prevents axial movement of the tube 210 relative to the distal housing 204 but allows rotation of the tube 210 relative to the distal housing 204. As such, the receiving element 212 prevents axial movement of the inner shaft 103 (fixed to the tube 210) relative tothe outer shaft 102 (fixed to the distal housing 204) while allowing rotation of the inner shaft 103 relative to the outer shaft 102.

[0033] A proximal end region 210a of the tube 210 can be operatively coupled to the proximal housing 202 such that the tube 210 and proximal housing 202 are rotationally coupled but axially decoupled (e.g., rotation of the proximal housing 202 causes rotation of the tube 210 while the proximal housing 202 is free to translate independently of the tube 210). In some examples, the proximal housing 202 defines a channel 214 through which the lumen 208 and the tube 210 extend, and the handle 200 includes a slider 216 fixed to an outer surface of the tube 210 and slidably received within the channel 214. The slider 216 can engage the proximal housing 202 (directly or indirectly) such that the slider 216 and proximal housing 202 are rotationally fixed but free to move axially relative to one another. As but one example, the slider 216 can have a hexagonal (or other non-circular) cross-sectional shape and the channel 214 can have a complementary hexagonal shape (or any shape complementary to that of the slider 216) that rotatably locks the slider 216 within the proximal housing 202. Other coupling means are possible. In use, rotation of the proximal housing 202 relative to the distal housing 204 causes rotation of the inner shaft 103 (via slider 216 and tube 210) relative to the outer shaft 102 as the outer shaft 102 remains fixed within the distal housing 204 (via the coupler 206).

[0034] In some cases, it may be beneficial to provide one or more features for locking the rotational position of the inner shaft 103 relative to the outer shaft 102 in order to maintain a desired cutting element 116 diameter. To this end, the handle 200 may include one or more locking elements configured to rotationally lock the proximal housing 202 relative to the distal housing 204. In some examples, including that shown in FIGS. 2A and 2B, the distal end of the proximal housing 202 includes one or more protrusions 220 configured to be slidably received within matching slots 222 defined by the proximal end of the distal housing 204. The protrusions 220 may be an integral part of / monolithically formed with the proximal housing 202 and / or may be a separate component (such as a pin) fixed to the proximal housing 202 and extending distally therefrom. The protrusions 220 can be spaced apart around a perimeter of the proximal housing 202 and the slots 222 can be spaced apart around a perimeter of the distal housing 204. While the protrusions 220 are received within the slots 222, the proximal and distal housings 202, 204 cannot rotate relative to one another. To rotate the proximal housing 202, the proximal housing 202 can be pulled proximally away from the distal housing 204 such that the protrusions 220 move out of the slots 222. One the proximal housing 202 has beenrotated a desired amount (thereby changing the circumferential positions of the protrusions 220), the proximal housing 202 can be moved back into engagement with the distal housing 204 such that the protrusions 220 slide into new corresponding slots 222 (“new” relative to the slots 222 engaged prior to rotation), thereby re-locking the proximal and distal housings 202, 204. It will be appreciated that the protrusions 220 could alternatively be positioned at the distal housing 204 (extending proximally from the distal housing 204) and the slots 222 within the proximal housing 202.[00351 To bias the proximal housing 202 towards the distal housing 204 (to maintain the handle 200 in a locked position by default), the handle 200 can optionally include a spring 224 disposed within the channel 214 and extending between a proximal end of the slider 216 and a portion of the proximal housing 202 defining the distal end of the channel 214. When the proximal and distal housings 202, 204 are engaging one another in a locked configuration (as shown in FIGS. 2A and 2B), the spring 224 is in an unloaded (extended state). When the proximal housing 202 is pulled proximally away from the distal housing 204, the proximal housing 202 slides proximally over the tube 210 and the slider 216 (which remain stationary relative to the distal housing 204 since the distal end portion 110b of the tube 110 is axially constrained by the receiving element 212), thereby compressing the spring 224 between the slider 216 and the proximal housing 202. When the pulling force on the proximal housing 202 is released, the spring 224 pushes the proximal housing 202 distally, back into engagement with the distal housing 204. It will be appreciated that other temporary rotational locking means can be used.

[0036] According to some embodiments, the handle 200 optionally includes a proximal housing lock 205 (only shown in FIG. 1 A) disposed at the proximal end of the proximal housing 202, between the proximal housing 202 and the luer lock 207. The proximal housing lock 205 can be configured to prevent inadvertent movement of the proximal housing 202 away from the distal housing 204. For example, the proximal housing lock 205 can have a recess at its proximal face that is configured to receive a flange of the luer lock therein when the recess is rotationally aligned with the flange. When the flange and the recess are aligned, the proximal housing lock 204 can move proximally relative to the luer lock 207, thereby allowing proximal movement of the proximal housing 202 away from the distal housing 204. When the flange and the recess are not aligned, the flange of the luer lock 207 prevents proximal movement of the proximal housing lock 205 relative to the luer lock 207, thereby holding the proximalhousing 202 against the distal housing 204. It will be appreciated that other locking mechanisms are possible.[00371 In some embodiments, the proximal and distal housings 202, 204 are not biased towards one another. In these non-biased examples and other biased examples, the proximal housing 202 may be rotated relative to the distal housing 204 without pulling the proximal housing 202 away from the distal housing 204. In such embodiments, the proximal and distal housings 202, 204 may be temporarily secured to one another in a desired rotational position by means other than protrusions and slots, such as a movable latch at the exterior between the proximal and distal housings 202, 204, and others.

[0038] In some examples, the handle 200 may include an optional indicator 230 that indicates to the user the expansion distance of the cutting element 116. The indicator 230 can include a pin 236 configured to travel within a slot 234 (see FIG. 1) in the distal housing 204. An outer surface of the distal housing 204 can include a series of markings 232 (only one labeled in FIG. 1) along the slot 234 that indicate a particular expansion distance. The markings 232 can include a series of tick marks or lines with different lengths (to indicate different expansion distances), letters corresponding to different expansion distances, numbers corresponding to different expansion distances, or any other character, symbol, image, etc. configured to communicate different expansion distances.

[0039] As best shown in FIGS. 2 A and 2D, the pin 236 can be fixed to a nut 238 disposed within the distal housing 204 and comprising a threaded inner surface. The nut 238 can be disposed around a lead screw 240 having a threaded outer surface that engages the threaded inner surface of the nut 238. The lead screw 240 may define a lumen extending therethrough, and the tube 210 can be disposed in the lumen. The tube 210 can be fixed to the lead screw 240 such that rotational movement of the tube 210 causes rotational movement of the lead screw 240, which causes the nut 238 to move axially along the lead screw 240. Axial movement of the nut 238 moves the pin 236 within the slot 234. Accordingly, a user can associate a given rotational movement of the proximal housing 202 or rotational position of the proximal housing 202 with a corresponding change in expansion distance or a certain expansion distance, respectively.II. Drive Handles

[0040] As previously discussed, the treatment devices disclosed herein can be used to disrupt, collect, and / or remove obstructive material from a blood vessel lumen (such as thelumen of a vein in the deep venous system) to restore patency, in addition to other endovascular treatments. The composition and associated mechanical properties of obstructive material such as thrombus are highly variable with rapid change occurring within the initial weeks following onset of the DVT. In its early form, fibrin dominant thrombus develops and becomes progressively more organized and robust as the level of cross-linking increases. Adhesion to the vessel wall is also common during this phase. With additional time, the fibrin-based thrombus undergoes further transition until a collogen dominant post thrombotic material is formed, with further integration into the vessel wall possible. The progression of the DVT through the acute, sub-acute, chronic, and ultimately post thrombotic phases corresponds to increased material toughness and typically requires more aggressive mechanical treatments to successfully debulk the vessel. Further complicating treatment, mixed etiology is common with various types of obstruction present within the same vessel segment.

[0041] The variability in material composition, potential for mixed etiology, and imprecise methods of pre-operative assessment can complicate device selection given the highly varied and age dependent mechanical properties of DVT and PTS. For less developed obstructions, gentle methods of removal are often preferable to minimize risk of vessel trauma and may be accomplished through manual catheter manipulation alone. The same treatments might however be ineffective against the more developed chronic DVT or PTS materials or that which has become adhered to or incorporated with the vessel wall. In these instances, higher force, more complex, or otherwise aggressive device actuation not achievable through standard hand movements may be required.

[0042] The drive handles of the present technology address the foregoing challenges. The drive handles disclosed herein are selectively attachable to an endovascular medical device (including the treatment devices of the present technology, such as the cutting device 105 and the capture device 107) to facilitate use of the device in either a mechanized or non-mechanized (manual) configuration. The drive handles are configured to impart additional device functionality in the form of enhanced motion control, application force, and / or delivery of energy. In some embodiments, the drive handles disclosed herein may be used in conjunction with a treatment device (including the treatment devices of the present technology) for debulking intralumenal material such as thrombus or collagen-based post thrombotic material from the deep veins of the venous system. Other uses are possible.

[0043] The drive handles of the present technology beneficially provide a the treatment devices herein with the benefits of both the mechanized and non-mechanized configurationsbased on user preference and procedural needs. This may be desirable in various situations including those where pre-procedural assessment and interrogation methods are not fully capable of predicting the extensiveness, severity, or complexity of the disease. In situations such as this, the procedure may be initiated using only the basic, non-mechanized device. Then, if perioperative findings warrant, a selectively attachable drive handle may be used to enhance device functionality for more aggressive treatment without requiring use of a different device. In doing so, the additional expense and complexity associated with the drive handle would only be incurred if needed to successfully complete the procedure.[0044.1 FIGS. 3A, 3B, and 3C are different views of a selectively attachable drive handle 300 configured in accordance with the present technology, shown coupled to the handle 200 of the cutting device 105. The drive handle 300 is configured to interface with nonmechanized components of the handle 200 to replicate and / or supplement one or more device movements typically achieved via manual manipulation. For example, during a typical debulking procedure, the cutting assembly 110 may be advanced partially or completely into the obstructive material and the cutting element 116 may be placed in a partially or fully expanded state. In that expanded state, the user may repeatedly rotate and / or translate the cutting assembly 110 to contact and break apart as much obstructive material within the vessel lumen as possible. The drive handle 300 of the present technology replicates the rotation and translation but with a mechanical advantage that provides a degree of force, speed, and control beyond the capabilities of the cutting device 105 under manual manipulation.(0645] The drive handle 300 can include a receiving portion 302 configured to receive and secure a handle 200 of a cutting device 105 (or any endovascular treatment device) (only the handle 200 is shown in FIGS. 3 A-3C for ease of illustration), an actuator 304 configured to be manipulated by the user to impart a desired motion to one or more portions of the treatment device, a body 306, and one or more means for translating user manipulation of the drive handle 300 to movement of the one or more portions of the treatment device. For example, when coupled to the handle 200 of the cutting device 105, manipulation of the actuator 304 causes the entire cutting assembly 110 to rotate partially or completely about the longitudinal axis of the cutting device 105 while simultaneously translating the cutting assembly 110. Advantageously, the proximal end of the handle 200 remains exposed and manipulatable by the user while the handle 200 is operatively coupled to the drive handle 300. As such, the user maintains the ability to adjust a radial position / degree of expansion of the cutting element 116 while the handle 200 is operatively coupled to the drive handle 300.

[0046] FIGS. 3A and 3B show the handle 200 received within the receiving portion 302 of the drive handle 300 with the actuator 304 in a first position and the handle 200 in a corresponding first axial position. In FIG. 3A, the receiving portion 302 is shown in a partially closed / partially open (unsecured) state, while in FIG. 3B the receiving portion 302 is shown in an open (unsecured). FIG. 3C shows the drive handle 300 in the partially closed / partially open (unsecured state) with the actuator 304 in a second position and the handle 200 in a corresponding second axial position. In use, the receiving portion 302 would be in a closed state (secured) state during operation of the actuator 304 and is shown in a partially open / partially closed state in several of the drawings to better visualize the movement of the handle 200 within the receiving portion 302.

[0047] As shown in FIGS. 3A-3C, the receiving portion 302 can include a cradle 310 configured to receive the handle 200 and a door 312 pivotably coupled to the cradle 310 via one or more hinges 311 (see FIG. 3B). The receiving portion 302 can be positioned in an open configuration (see FIG. 3B) for receipt of the handle 200, after which the door 312 can be rotated over the top of the handle 200 until a coupling element 314 on the door 312 engages a coupling element 316 on the cradle. While the drawings show the coupling element 314 comprising a latch with the coupling element 316 comprising a ridge to engage the latch, other coupling means are possible, such as snaps, slides, screws / threads, pins, magnetic couplers, and others.

[0048] Together, the door 310 and the cradle 312 enclose the handle 200 along all or a portion of its length. (As previously mentioned, in some embodiments a proximal region of the handle 200 remains exposed to allow the user to manipulate the handle 200 while the handle 200 is coupled to the drive handle 300.) The door 312 prevents the handle 200 from inadvertently disengaging the cradle 310 during use. In some embodiments, the cradle 310 includes one or more engagement elements that engage one or more portions of the handle 200 to further secure the handle 200 to the drive handle 300. In some examples, the door 312 can include a window (either a cutout or a transparent portion) aligned with the indicator 230 of the handle 200 so that the user can view the indicator 230 without having to open the door 312.

[0049] In some embodiments, the receiving portion 302 does not include a door and / or does not enclose the handle 200 when the handle 200 and the drive handle 300 are operatively coupled. Instead, the handle 200 is secured via one or more engagement elements disposed within and / or on the cradle 310. In these and other embodiments, the receiving portion 302 may comprise one or more latches, strips, or other securing elements that are configured toextend over the top of the handle 200 but without covering the majority of the surface area of the handle 200 so that the user may access one or more features of the handle 200 during use.[00501 The actuator 304 can comprise a lever or other structure configured to move relative to the body 306 and / or receiving portion 302. Other means for providing a mechanical advantage and enhance drive handle outputs include gears, cams, hydraulics, and others. In any case, the actuator 304 can have a grip portion configured to be gripped by a user, for example by the curled fingers of the hand while the palm of the hand rests on the door 312. This way, the user can squeeze the drive handle 300 to actuate the actuator. The actuator 304 can have a first, extended position in which one end of the actuator 304 is farthest from the body 306 and a second, retracted position in which the one end of the actuator 304 is closest to the body. The first position of the actuator 304 corresponds to the first position of the slider 322, and the second position of the actuator 304 corresponds to the second position of the slider 322.[00511 The body 306 of the drive handle 300 can be positioned between the actuator 304 and the cradle 310 and can comprise one or more mechanisms for translating movement of the actuator 304 into movement of the handle 200. FIGS. 4A and 4B are side cross-sectional views of the drive handle 300 with the actuator 304 in a first and second position, respectively. FIG. 5 shows a perspective cross-sectional view of the drive handle 300 with the actuator 304 in the first position. With reference to FIGS. 4A, 4B, and 5, the body 306 can include a housing 320, a slider 322 disposed within the housing 320, a first linkage 324 fixed to and extending away from the slider 322 through a slot 300 in the cradle 310, a spring 326 between the slider 322 and the housing 320, and a second linkage 328 fixed to and extending away from the slider 322 through a slot 334 in the housing 320 and a slot 336 in the actuator 304.

[0052] The handle 200 can be placed within the cradle 310 such that the exposed portion of the first linkage 324 sits within a groove 340 on the handle 200. As a result, linear movement of the slider 322 causes linear movement of the handle 200 (and thus linear movement of the entire cutting device 105). As best shown in FIG. 6, the handle 200 can optionally include a pin or other protrusion 342 that, when the handle 200 is received within the cradle 310, sits within a helical slot 344 defined by the cradle 310 and the door 312. When the handle 200 is moved linearly within the receiving portion 302 by the slider 322, the protrusion 342 on the handle 200 travels within the helical slot 344 which causes the handle 200 to rotate within the receiving portion 302. Accordingly, actuation of the actuator 304 causes the handle 200 to rotate and translate within the receiving portion 302.

[0053] Referring again to FIGS. 4A, 4B, and 5, the slider 322 can be slidably mounted on a rail 346 mounted within the housing 320. The spring 326 can also be mounted on the rail 346 and extend between a portion of the housing 320 and the slider 322. The spring 326 is in an unloaded (elongated) state when the actuator 304 and slider 322 are in their respective first positions (FIGS. 4A and 5), and compressed when the actuator 304 and slider 322 are in the respective second position (FIG. 4B). Thus, the spring 326 biases the actuator 304 towards the first position.

[0054] As previously mentioned, the second linkage 328 is fixed to the slider 322 and extends through the slot 334 in the housing 320 of the body 306 and the slot 336 in the actuator 306. The slot 336 in the actuator 336 can be angled relative to the slot 334 in the body housing 320 such that pulling the lever towards the body 306 which simultaneously forces the second linkage 328 to slide along the angled slot 336 in the actuator 304 and the horizontal slot 334 in the body 306, thereby forcing the slider 322 to move linearly towards the second position (in which the lever is closer to the body 306) and compress the spring 326. Release of the actuator 304 and / or lessening of the force on the actuator 304 allows the spring 326 to unload which simultaneously forces the second linkage 328 to slide along the angled slot 336 in the actuator 304 and the horizontal slot 334 in the body 306, thereby forcing the slider 322 to move linearly towards the first position (in which the lever is farther from the body 306).

[0055] The linear and / or rotational distance traveled per squeeze of the drive handle 300, as well as the rotation speed, can be fixed or adjustable via one or more adjustment mechanisms on the drive handle 300. The drive handle 300 may be configured to affect motion of the entire device (as described above) or may be configured to actuate individual device features or subassemblies. In the present example, the drive handle 300 is configured to both rotate and translate the entire cutting assembly 110, including both the inner and outer shaft 103, 102. In other embodiments, the drive handle 300 may be configured to separately control movement of the inner and outer shafts to expand and collapse the cutting element 116.

[0056] In some embodiments, the drive handle 300 includes a power source. For example, the drive handle 300 can include a battery and / or or may be configured to be electrically coupled to wall power. The drive handle 300 can further include a motor, and the power source can be configured to be electrically coupled to the motor to impart additional motion to the cutting device 105 (in addition to the motion provided by the mechanical -assist components). As but one of several examples, the drive handle 300 can include a motorconfigured to impart vibratory motion to all or a portion of the cutting device 105. Other examples are possible.[00571 FIG. 7 shows a proximal portion of a treatment device configured in accordance with several embodiments of the present technology. As depicted, the treatment device can include a handle 700 and one or more elongate members 702 coupled to and extending away from the handle 700. The treatment device can comprise any endovascular medical device, such as a mechanical thrombectomy device, an atherectomy device, a crossing device, a cutting device, a capture device, etc. FIG. 8 shows a motorized drive handle 800 configured to be operatively coupled to the treatment device of FIG. 7, and FIG. 9 shows the drive handle 800 operatively coupled to the treatment device. As shown, the drive handle 700 can be configured to selectively attach to a hub and / or handle of an endovascular treatment device. The drive handle 800 can comprise a motor activated by an actuator 804 and configured to provide motion to the treatment device via a drive system. The motion includes rotational motion, oscillatory motion, vibratory motion, linear motion, reciprocating motion, and others. The drive handle 800 can include a power source, or may be configured to be electrically coupled to a power source. The drive handle 800 can further include coupling elements for mounting and / or coupling to one or more portions of the treatment device.

[0058] The drive handle features may vary based on the design of the corresponding device, desired output motion, and power source (e.g., hand actuated, motor driven, or similar). In some embodiments, the drive handle attachment may be temporary or permanent once engaged with the device. According to certain embodiments, the drive handle may be single use only or designed for multiple uses. In some examples, the drive handles disclosed herein may be actuated by hand / finger inputs (e.g., triggers, squeeze levers, or similar). In some embodiments, the drive handle may be used to impart energy to the treatment device from ultrasonic, thermal, radio frequency, microwave, or similar sources. The receiving portion of the handles disclosed herein may be device specific or designed for universal acceptance of multiple device designs or product families.Conclusion

[0059] Although many of the embodiments are described above with respect to systems, devices, and methods for retrieving clot material from a blood vessel lumen, the technology is applicable to other applications and / or other approaches, such as removal and / or modification of other obstructive structures within any body lumen (e.g., crossing catheters,thrombectomy devices, atherectomy devices, etc.). Moreover, other embodiments in addition to those described herein are within the scope of the technology. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described above with reference to FIGS. 1 A-9.[00601 The descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Where the context permits, singular or plural terms may also include the plural or singular term, respectively. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0061] As used herein, the terms “generally,” “substantially,” “about,” and similar terms are used as terms of approximation and not as terms of degree, and are intended to account for the inherent variations in measured or calculated values that would be recognized by those of ordinary skill in the art.

[0062] Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term "comprising" is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and / or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

CLAIMSI / We claim:

1. A drive handle configured to be operatively coupled to a handle of a treatment catheter, the drive handle comprising: a receiving portion configured to receive the handle of the treatment catheter therein; an actuator movable by a user between a first position farther from the receiving portion and a second position closer to the receiving portion; and a slider coupled to the actuator and the receiving portion and configured to move axially relative to the receiving portion, wherein, when the handle of the treatment catheter is received by the receiving portion, movement of the actuator between the first and second positions causes the slider to move axially, thereby causing the treatment catheter to move axially within the receiving portion.

2. The drive handle of Claim 1, wherein, when the handle of the treatment catheter is received by the receiving portion, movement of the actuator between the first and second positions causes the slider to move axially, thereby causing the treatment catheter to rotate.

3. A drive handle configured to be operatively coupled to a handle of a treatment catheter, the drive handle comprising: a receiving portion configured to receive the handle of the treatment catheter therein; an actuator movable by a user between a first position farther from the receiving portion and a second position closer to the receiving portion; and a slider coupled to the actuator and the receiving portion and configured to move axially relative to the receiving portion, wherein, when the handle of the treatment catheter is received by the receiving portion, movement of the actuator between the first and second positions causes the slider to move axially, thereby causing the treatment catheter to rotate within the receiving portion.

4. The drive handle of Claim 1 or Claim 2, wherein the slider is coupled to the receiving portion via a linkage that extends away from the slider and through a slot within the receiving portion, and wherein the linkage is configured to slide within the slot.

5. The drive handle of Claim 4, wherein the linkage is a first linkage, the slot is a first slot, and wherein the slider is coupled to the actuator via a second linkage that extends away from the slider and through a second slot defined by the actuator, and wherein the second linkage is configured to slide within the second slot.

6. The drive handle of Claim 5, wherein the second slot is disposed at a non-90 degree angle relative to the first slot.

7. A drive handle configured to be operatively coupled to a handle of a treatment catheter, the drive handle comprising: a receiving portion configured to receive the handle of the treatment catheter therein; an actuator rotatable by a user between a first position farther from the receiving portion and a second position closer to the receiving portion; and a mechanical linkage between the actuator and the receiving portion, the mechanical linkage configured to translate rotational motion of the actuator into axial movement of the handle when the handle is received within the treatment catheter.

8. The drive handle of any one of Claims 1 to 7, wherein the actuator comprises a lever.

9. The drive handle of any one of Claims 1 to 8, wherein the actuator is biased towards the first position such that in the absence of a counteracting force, the actuator remains in the first position.

10. The drive handle of any one of Claims 1 to 9, wherein the receiving portion defines a helical groove configured to receive a protrusion of the handle when the handle is received within the receiving portion.

11. The drive handle of any one of Claims 1 to 10, wherein the receiving portion includes a cradle on which the handle is configured to be positioned when operatively coupled to the drive handle and a door configured to extend over the handle and be detachably coupled to the cradle to secure the handle within the receiving portion.

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