Intravascular medical devices and related devices, systems, and methods

Abstract

An intravascular treatment device is disclosed herein. According to several embodiments, the technology includes a drive handle configured to be operationally coupled to a handle of a treatment catheter. The drive handle may comprise a receiving portion configured to receive the handle of the treatment catheter, and an actuator movable by a user between a first position further from the receiving portion and a second position closer to the receiving portion. The drive handle may 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, the movement of the actuator between the first and second positions causes the slider to move axially, thereby moving the treatment catheter axially and / or rotationally within the receiving portion.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of priority of U.S. Provisional Application No. 63 / 489,714, filed Mar. 10, 2023, which is incorporated herein by reference in its entirety.

[0002] This technology generally relates to intravascular treatment systems and associated devices and methods.

Background Art

[0003] Deep vein thrombosis (DVT) is a condition that includes a blood clot in a deep vein, usually occurring in the leg veins but also potentially in the arm veins. Symptoms include pain, swelling, tenderness, and / or discoloration in the affected limb. If untreated, this can lead to post - thrombotic syndrome with symptoms of chronic pain, swelling, and skin discoloration, or the worsening and complications of symptoms such as pulmonary embolism (PE), a very severe and life - threatening condition. Pharmacological treatments include anticoagulant drug therapy or thrombolytics. More recently, percutaneous catheters for more rapid removal of blood clots have been developed to remove obstructions and prevent PE. These include, in some cases, catheters that can deliver thrombolytic agents to the site of the blood clot in combination with aspiration and / or fragmentation of the blood clot into smaller pieces. Other catheters mechanically capture and remove blood clots without thrombolytics, thereby reducing the bleeding risks posed by these drugs. An early example of this is the Fogarty balloon embolectomy catheter. More recent examples include the ClotTriever® (Inari Medical, Irvine, CA) and ReVene® thrombus removal catheters (Vetex Medical, Galway, Ireland).

[0004] Unfortunately, many of these therapies have limited success against partial or complete occlusions caused by chronic thrombosis (i.e., thrombi lasting for a period of one or two months). When thrombi remain in the limbs for several months at a time, the initial thrombus can acutely deform into a fibrin structure and chronically become a collagenous structure that is more rigid and adheres more tightly to the wall. Chronic thrombi can take the form of fibrous trabeculae or membranes (also known as venous adhesions) that are within and extend across the venous lumen. Furthermore, the thrombus becomes more tightly adhered to the wall. Catheter-based thrombolytic or thrombectomy devices have a lower success rate in removing these occlusions. Venous adhesions can also hinder optimal treatment of venous occlusion with balloon angioplasty or stent placement because the fibrous structure prevents permanent extension of the vessel wall. There is a need for improved intravascular thrombectomy devices that can successfully remove chronic thrombi. [Overview of the project] [Means for solving the problem]

[0005] overview The subject art is illustrated according to various aspects described below, including, for example, with reference to Figure 1A-9. Various embodiments of aspects of the subject art are described for convenience as numbered embodiments (1, 2, 3, etc.). These are provided as embodiments and do not limit the subject art. 1. A device, and the device is A device for use in combination with an intravascular medical device, comprising a handle that allows for the selective attachment or detachment of the handle from the medical device. 2. The device according to Example 1, wherein the handle is configured to facilitate electric motion control of a medical device. 3. The handle facilitates manually operated mechanized motion control of the intravascular device, as described in Example 1 or Example 2. 4. The handle provides rotational, translational, vibrational, oscillating, or reciprocating motion to the medical device, as described in any one of Examples 1-3. 5. The device according to any one of Examples 1-4, wherein the handle is configured to be permanently attached to the medical device. 6. The device according to any one of Examples 1-5, wherein the handle is configured to be detachably coupled to the medical device. 7. The device according to any one of Examples 1-6, wherein the handle is configured to impart energy to the medical device from a mechanical, thermal, radio frequency (RF), or microwave source. 8. A drive handle configured to be operationally coupled to the handle of a treatment catheter, wherein the drive handle is It includes a receiving section configured to receive the handle of the treatment catheter, An actuator that can be moved by the user between a first position further from the receiving part and a second position closer to the receiving part, A slider is coupled to an actuator and a receiving part and configured to move axially relative to the receiving part. Equipped with, When the handle of the treatment catheter is received by the receiving part, the movement of the actuator between a first position and a second position causes the slider to move axially, thereby causing the treatment catheter to move axially within the receiving part, the drive handle. 9. The drive handle according to Embodiment 8, wherein when the handle of the treatment catheter is received by the receiving part, the movement of the actuator between the first position and the second position causes the slider to move axially, thereby rotating the treatment catheter. 10. A drive handle configured to be operationally coupled to the handle of a treatment catheter, wherein the drive handle is It includes a receiving section configured to receive the handle of the treatment catheter, An actuator that can be moved by the user between a first position further from the receiving part and a second position closer to the receiving part, A slider is coupled to an actuator and a receiving part and configured to move axially relative to the receiving part. Equipped with, When the handle of the treatment catheter is received by the receiving part, the movement of the actuator between the first position and the second position causes the slider to move axially, thereby rotating the treatment catheter within the receiving part, which is the drive handle. 11. A drive handle according to any of Examples 8-10, wherein the slider is connected to the receiving portion via a link mechanism that extends away from the slider and through a slot in the receiving portion, and the link mechanism is configured to slide within the slot. 12. A drive handle according to Embodiment 11, wherein the link mechanism is a first link mechanism, the slot is a first slot, and the slider is coupled to the actuator via a second link mechanism that extends away from the slider and through a second slot defined by the actuator, the second link mechanism being configured to slide within the second slot. 13. The drive handle according to Embodiment 12, wherein the second slot is positioned at an angle other than 90 degrees to the first slot. 14. A drive handle configured to be operationally coupled to the handle of a treatment catheter, wherein the drive handle is It includes a receiving section configured to receive the handle of the treatment catheter, An actuator that can be rotated by the user between a first position further from the receiving part and a second position closer to the receiving part, A mechanical link mechanism between an actuator and a receiving part, wherein the link mechanism is configured to convert the rotational motion of the actuator into the axial movement of the handle when the handle is received in the treatment catheter. A drive handle equipped with a drive handle. 15. The actuator is a drive handle as described in any one of Embodiments 8-14, comprising a lever. 16. A drive handle according to any one of Embodiments 8-15, wherein the actuator is biased toward a first position such that the actuator remains in a first position when there is no reaction force. 17. A drive handle according to any one of Examples 8-16, wherein the receiving portion defines a spiral groove configured to receive a protruding portion of the handle when the handle is received within the receiving portion. 18. A drive handle according to any one of Embodiments 8-17, wherein the receiving portion includes a cradle configured such that the handle is positioned thereon when operably coupled to the drive handle, and a door extending over the handle and removably coupled to the cradle, and configured to secure the handle within the receiving portion. 19. A drive handle according to any one of Examples 8-18, further comprising a motor configured to impart vibration or oscillation motion to a therapeutic catheter when the therapeutic catheter is coupled to the drive handle. 20. A drive handle according to any one of Examples 8-19, further comprising a power supply and / or the drive handle being configured to be electrically coupled to the power supply. 21. A method for operating a drive handle, the method being: Position the handle of the treatment catheter within the receiving portion of the drive handle, The actuator of the drive handle is rotated from a first position further from the receiving part to a second position closer to the receiving part, thereby causing translation of the treatment catheter relative to the drive handle. Methods that include... 22. A method for operating a drive handle, the method being: Position the handle of the treatment catheter within the receiving portion of the drive handle, The actuator of the drive handle is rotated from a first position further from the receiving part to a second position closer to the receiving part, thereby causing rotation of the treatment catheter relative to the drive handle. Methods that include... 23. A method for operating a drive handle, the method being: Positioning the handle of the treatment catheter within the receiving portion of the drive handle, rotating the 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, and A method comprising: 24. The method according to any one of embodiments 21-23, wherein the actuator is a lever. 25. The method according to any one of embodiments 21-24, wherein the drive handle further comprises a slider coupled to the receiving portion and the actuator, and rotation of the actuator causes translation of the slider. 26. The method according to any one of embodiments 21-25, wherein positioning the handle of the treatment catheter within the receiving portion of the drive handle comprises positioning the handle within the cavity of the receiving portion. 27. The method according to embodiment 26, wherein the cavity is defined by a cradle, and the method further comprises rotating a door of the receiving portion across an upper surface of the handle and removably 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 more deeply understood by referring to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure.

[0007] [Figure 1A] FIG. 1A shows a treatment system according to some embodiments of the present technology.

[0008] [Figure 1B] FIG. 1B shows the treatment system of FIG. 1A in which a capture device is delivered through a cutting device according to some embodiments of the present technology.

[0009] [Figure 2]Figures 2A and 2B are side and perspective cross-sectional views of the handle of a cutting device according to some embodiments of the present technology.

[0010] [Figure 3A] Figure 3A is a perspective view of a drive handle configured according to the present technology, shown in a partially closed / partially open configuration that receives the handle of the cutting device and where the actuator is in a first position.

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

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

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

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

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

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

[0017] [Figure 7]Figure 7 shows the proximal portion of a therapeutic device configured according to several embodiments of the present technology.

[0018] [Figure 8] Figure 8 shows a drive handle configured according to several embodiments of the present technology.

[0019] [Figure 9] Figure 9 shows the proximal portion of the therapeutic device of Figure 7, which is received within the drive handle of Figure 8, according to some embodiments of the present technology. [Modes for carrying out the invention]

[0020] Detailed explanation This technology relates to intravascular therapeutic systems and associated devices and methods. Some embodiments of this technology relate to selectively attachable handles (or “drive handles”) configured to work in conjunction with intravascular therapeutic devices for the purpose of providing enhanced motor control, force application, or energy delivery. The drive handles complement therapeutic devices that function separately and independently by working in conjunction with existing non-mechanized handle components, enabling the therapeutic devices to be used in either mechanized or non-mechanized configurations. The drive handles may be designed to replicate the same motion produced using manual operation, or to provide mechanical advantages for optimized force, velocity, or precision motor control that exceed the capabilities of non-mechanized catheters. The drive handles of this technology may be particularly suitable for use in conjunction with mechanical thrombectomy devices for treating DVT or post-thrombotic syndrome (PTS), but other intravascular applications are also possible. Specific details of some embodiments of this technology are described below with reference to Figure 1A-9. I. Treatment systems and associated devices and methods

[0021] Figure 1A schematically depicts a treatment system 10 (also referred to herein as "System 10") configured according to the present technology. The treatment system 100 is configured to access a body lumen (such as a vein or artery) and to correct, capture, and / or remove occlusive material from the body lumen at the treatment site. As used herein, "obstruction" or "obstructive material" may include, for example, thrombotic material, atherosclerotic plaque, and / or other flow-inhibiting structures derived from thrombotic material, such as fibrous thrombotic material, venous adhesions, fibrinous structures, collagenous structures, fibrous trabeculae, and / or others. As shown in Figure 1A, System 10 may comprise a cutting device 105 and a capture device 107, each configured to access the treatment site. In other embodiments, 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 outside the body during the procedure, a distal portion 105b configured to be positioned at the treatment site within a body lumen, a handle 200 in the proximal portion 105a, and a cutting assembly 110 in the distal portion 100b. The device 100 further includes an outer shaft 102 extending from the handle 200 or a proximal portion 102a within the handle 200 to the distal portion 102b in the cutting assembly 110, and an inner shaft 103 extending from the handle 200 or a proximal portion 103a to the distal portion 103b in the cutting assembly 110. The cutting device 105 can be configured to be delivered, for example, through a lumen defined by the inner shaft 103 across a guidewire 106 (see Figure 1B).

[0023] The cutting assembly 110 may comprise one or more cutting elements configured to cut occlusive material within a vascular lumen, thereby separating and / or releasing the occlusive material from the vessel wall, non-specific structures located within the vessel (such as a failed stent), and / or other occlusive material. In the embodiment shown in Figure 1, the cutting assembly 110 comprises a cutting element 116 comprising a helical ribbon having a proximal end 116a fixed to an outer shaft 102 and a distal end 116b fixed to an inner shaft 103. The outer and inner shafts 102, 103 rotate relative to each other, causing the helical ribbon 116 to expand and collapse radially relative to the 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 each other. A spiral ribbon cutting element 116 is shown in Figures 1A and 1B, but the handle and drive handle of this technology can be used in conjunction with a cutting device 105 having other cutting elements and / or cutting assemblies. For example, an additional description of a cutting assembly 110 and additional cutting assemblies (also referred to as “cutting portions”) can be found, for example, in U.S. Patent Application No. 18 / 120,361, filed March 10, 2023, which is disclosed herein in its entirety by reference.

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

[0025] The capture assembly 112 may comprise one or more expandable mesh structures configured to engage with, capture, or otherwise entangle with occlusive material at the treatment site before, during, or after engagement by the cutting assembly 112. In some embodiments, for example, as shown in Figure 1A, the capture assembly 112 may comprise a mesh bag 118 having proximal and distal end portions 118a, 118b coupled to the shaft 104. The mesh bag 118 may have a closed distal region and an opening in the proximal region. The proximal end portion 118a may be axially fixed to the shaft 104 or may slide freely along the shaft 104. Similarly, the proximal end portion 118a may be rotationally fixed to the shaft 104 or may rotate freely about the shaft 104. The distal end portion 118b may be axially fixed to the shaft 104 or may slide freely along the shaft 104. Similarly, the distal end portion 118b can be fixed to the shaft 104 in a rotational direction or can rotate freely around the shaft 104. In some embodiments, the proximal end portion 118a is fixed to the shaft 104 in a rotational and axial direction, while the distal end portion 118b rotates and translates freely around the shaft 104. In other embodiments, the proximal end portion 118a is fixed axially along the shaft 104 (for example, via two stop elements on both sides of the hub in the proximal end portion 118a) but can rotate freely, while the distal end portion 118b rotates and translates freely around the shaft 104. Allowing the distal end portion 118b to rotate around the shaft 104 and translate along the shaft 104 can be beneficial to allow shortening 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 the proximal and distal end portions 118a and 118b to rotate is beneficial because it allows the shaft 104 to rotate (for example, to engage the occlusive material with the nose cone 124) without rotating the mesh bag 118, which, together with the sheath, can remain relatively fixed in the rotational direction. Forcing the mesh bag 118 to rotate together with the shaft 103 while the sheath remains stationary can cause the mesh bag 118 to twist within the sheath, which may make the deployment of the mesh bag 108 more difficult.

[0026] When the cutting device 105 is coupled to the capture device 107 (see Figure 1B), the mesh bag 118 can be located distal to the cutting assembly 110, so that occlusive material separated from the treatment site by the cutting assembly 110 can be collected by the mesh bag 118, either by drawing the mesh bag 118 proximal during the procedure or by the merit of the mesh bag 118 being downstream from the cutting assembly 110. Additional descriptions of the capture assembly 112 and additional capture assemblies (also referred to as “capture portions”) can be found, for example, in U.S. Patent Application No. 18 / 120,361 filed March 10, 2023, and U.S. Provisional Application No. 63 / 622,799 filed January 19, 2024, both of which are disclosed herein by reference as a whole.

[0027] The cutting device 105 may optionally include a nose cone 122 configured to facilitate engagement and / or penetration of occluding material at its distal end portion 105b distal to the cutting assembly 110. In addition, or alternatively, the cutting device 107 may optionally include a nose cone 124 configured to facilitate engagement and / or penetration of occluding material at its distal end portion 107 distal to the capture assembly 112. The nose cones 122, 124 may be any of the nose cones described in PCT application No. [Undetermined - Patent Attorney Reference No. IVN.004WO], titled "INTERVENTIONAL SYSTEMS AND ASSOCIATED DEVICES AND METHODS" (filed together with this specification and incorporated herein by reference as a whole).

[0028] Figure 1B shows a treatment system 10 in which the cutting device 105 is arranged to be delivered across the shaft 104 of the capture device 107. Thus, 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 across the guidewire 106. The shaft 104 can extend proximal through the handle 200 of the cutting device 105 until it exits from the proximal end of the handle 200. In some cases, the handle 200 may include a Luer lock 207 coupled to the 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 allow controlled rotation of the outer and inner shafts 102 and 103 of the cutting device 105 relative to each other in order to expand and crush the helical cutting element 116. Figures 2A and 2B show a side section and perspective view of the handle 200, respectively. Referring to Figures 1A, 1B, 2A, and 2B, the handle 200 may comprise a proximal housing 202 and a distal housing 204 movably coupled to the proximal housing 202. The inner shaft 103 can be operably coupled to the proximal housing 202, and the outer shaft 102 can be operably coupled to the distal housing 204. The proximal housing 202 is rotated relative to the distal housing 204, causing the rotation of the inner shaft 103 relative to the outer shaft 102, thereby selectively expanding and crushing the helical cutting element 116. As detailed below, the handle 200 may optionally include one or more features to prevent unintended operation (rotation) of the inner shaft 102, and / or one or more features to indicate to the user the 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 coupling 206, so 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, wherein the distal end portion 208b is located proximal to and aligned with the location where the distal housing 204 connects to the outer shaft 102. The handle 200 may further include a tube 210 positioned within and extending through the lumen 208 so as to straddle the proximal housing and the distal housings 202, 204.

[0031] The tube 210 defines a lumen through which it extends, and the lumen is configured to receive the inner shaft 103. When the cutting device 105 is assembled, the proximal length of the inner shaft 103 extends proximal into the tube 210 beyond the proximal end of the outer shaft 102 (which is fixed in the distal housing 204), and then, within the tube 210, the inner shaft 103 extends proximal through the distal housing 204 and into the proximal housing 202. The inner shaft 103 may terminate proximal in the handle 200 or may extend proximal from the handle 200. The inner shaft 103 may be fixed axially 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 part of the length of the inner shaft 103 inside the pipe 210 can be joined to the inner surface of the pipe 210.

[0032] The distal end region 210b of the tube 210 can be longitudinally constrained by a receiving element 212 formed by or operably 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. In this way, the receiving element 212 prevents axial movement of the inner shaft 103 (fixed to the tube 210) relative to the outer shaft 102 (fixed to the distal housing 204), while allowing rotation of the inner shaft 103 relative to the outer shaft 102.

[0033] The proximal end region 210a of the tube 210 can be operationally coupled to the proximal housing 202 such that the tube 210 and the proximal housing 202 are rotatably coupled but axially discoupled (for example, rotation of the proximal housing 202 causes rotation of the tube 210, while the proximal housing 202 translates freely independently of the tube 210). In some embodiments, 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 the outer surface of the tube 210 and slidably received within the channel 214. The slider 216 can engage with the proximal housing 202 (directly or indirectly) such that the slider 216 and the proximal housing 202 are rotatably coupled but move freely axially relative to each other. In one embodiment, the slider 216 may have a hexagonal (or other non-circular) cross-sectional shape, and the channel 214 may 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 also possible. When in use, rotation of the proximal housing 202 relative to the distal housing 204 causes rotation of the inner shaft 103 (via the 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 coupling 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 the diameter of the desired cutting element 116. For this purpose, the handle 200 may include one or more locking elements configured to lock the proximal housing 202 in the rotational direction relative to the distal housing 204. In some embodiments, including those shown in Figures 2A and 2B, the distal end of the proximal housing 202 includes one or more projections 220 configured to be slidably received in a matching slot 222 defined by the proximal end of the distal housing 204. The projections 220 may be an integral part of the proximal housing 202 / and / or 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 projection 220 can be spaced apart around the outer circumference of the proximal housing 202, and the slot 222 can be spaced apart around the outer circumference of the distal housing 204. While the projection 220 is received in the slot 222, the proximal housing and the distal housings 202, 204 cannot rotate relative to each other. To rotate the proximal housing 202, it can be pulled proximal away from the distal housing 204 so that the projection 220 moves out of the slot 222. Once the proximal housing 202 has been rotated by the desired amount (thus changing the circumferential position of the projection 220), it can be moved back to engagement with the distal housing 204 so that the projection 220 slides into the new ("new" relative to the slot 222 that engages prior to the rotation) corresponding slot 222, thereby re-locking the proximal housing and the distal housings 202, 204. It should be understood that, as an alternative to the protrusion 220, the slot 222 can be positioned within the proximal housing 202, in the distal housing 204 (extending proximal to the distal housing 204).

[0035] To bias the proximal housing 202 toward the distal housing 204 (and to maintain the handle 200 in the locked position by default), the handle 200 may optionally include a spring 224 positioned within the channel 214 and extending between the 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 housing and the distal housings 202, 204 are engaged with each other in a locking configuration (as shown in Figures 2A and 2B), the spring 224 is in an unloaded (extended) state. When the proximal housing 202 is pulled proximal away from the distal housing 204, the proximal housing 202 slides proximal across the tube 210 and the slider 216 (the distal end portion 110b of the tube 110 remains stationary relative to the distal housing 204 because it 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, returning to engagement with the distal housing 204. It should be understood that other temporary rotation locking means may also be used.

[0036] According to some embodiments, the handle 200 optionally includes a proximal housing locking portion 205 (shown only in Figure 1A) positioned at the proximal end of the proximal housing 202 between the proximal housing 202 and the Luer locking portion 207. The proximal housing locking portion 205 can be configured to prevent accidental movement of the proximal housing 202 away from the distal housing 204. For example, the proximal housing locking portion 205 may have a recess on its proximal surface, which is configured to receive the flange of the Luer locking portion into it when the recess is aligned with the flange in the rotational direction. When the flange and recess are aligned, the proximal housing locking portion 204 moves proximal to the Luer locking portion 207, thereby allowing proximal movement of the proximal housing 202 away from the distal housing 204. When the flange and recess are not aligned, the flange of the Luer locking portion 207 prevents the proximal housing locking portion 205 from moving proximal to the Luer locking portion 207, thereby holding the proximal housing 202 relative to the distal housing 204. It should be understood that other locking mechanisms are also possible.

[0037] In some embodiments, the proximal and distal housings 202, 204 are not biased toward each other. In these unbiased embodiments and other biased embodiments, the proximal housing 202 can be rotated toward the distal housing 204 without pulling the proximal housing 202 toward the distal housing 204. In such embodiments, the proximal and distal housings 202, 204 can be temporarily fixed toward each other at a desired rotational position by means other than protrusions and slots, such as externally movable latches and the like between the proximal housing 202 and the distal housing 204.

[0038] In some embodiments, the handle 200 may include an optional indicator 230 that shows the user the extension distance of the cutting element 116. The indicator 230 may include a pin 236 configured to move within a slot 234 (see Figure 1) in the distal housing 204. The outer surface of the distal housing 204 may include a series of markings 232 (only one is labeled in Figure 1) along the slot 234 indicating a specific extension distance. The markings 232 may include a series of scales or lines of different lengths (to indicate different extension distances), letters corresponding to different extension distances, numbers corresponding to different extension distances, or any other letter codes, symbols, images, etc., configured to convey different extension distances.

[0039] As shown most in detail in Figures 2A and 2D, the pin 236 can be fixed to a nut 238 located within the distal housing 204 and having a threaded inner surface. The nut 238 can be positioned around a lead screw 240 having a threaded outer surface that engages with the threaded inner surface of the nut 238. The lead screw 240 may define a lumen extending through it, and a tube 210 can be positioned within 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 in turn causes the nut 238 to move axially along the lead screw 240. The axial movement of the nut 238 moves the pin 236 within the slot 234. Thus, the user can associate a given rotational movement of the proximal housing 202 or a rotational position of the proximal housing 202 with a corresponding change in the extension distance or a certain extension distance, respectively. II. Drive Handle

[0040] As discussed above, the therapeutic devices disclosed herein can be used, in addition to other endovascular treatments, to fragment, collect, and / or remove occlusive material from vascular lumens (such as the lumens of veins in the deep venous system) to restore patency. The composition and associated mechanical properties of occlusive material, such as thrombi, fluctuate considerably, with rapid changes occurring within the first few weeks following the onset of DVT. In its initial form, the thrombus, primarily composed of fibrin, progressively becomes more organized and robust as it develops and the level of crosslinking increases. Adhesion to the vascular wall is also common during this stage. With additional time, the fibrin-based thrombus undergoes further transitions until postthrombotic material, primarily composed of collagen, is formed, allowing for further integration into the vascular wall. The progression of DVT through the acute, subacute, chronic, and final thrombotic phases corresponds to increased material toughness and usually requires more aggressive mechanical treatment to successfully debulking the vessels. Further complicating treatment is the common mixed etiology, where various types of occlusions exist within the same vascular segment.

[0041] The variability of material composition, the potential for mixed etiologies, and inaccurate preoperative assessment methods can complicate device selection, given the highly diverse and age-dependent mechanical properties of DVT and PTS. For less developed occlusions, low-irritation removal methods are often preferred to minimize the risk of vascular trauma and can be performed solely through manual catheter manipulation. However, the same treatment may not be effective for more developed chronic DVT or PTS material, or for material that has adhered to or become embedded in the vessel wall. In these cases, stronger force, more complex, or otherwise aggressive device manipulation that is not achievable through standard manual movement may be required.

[0042] The drive handle of this technology addresses the aforementioned problems. The drive handle disclosed herein is selectively attachable to intravascular medical devices (including therapeutic devices of this technology, such as the cutting device 105 and the capture device 107) to facilitate the use of the device in either a mechanized or non-mechanized (manual) configuration. The drive handle is configured to provide additional device functionality in the form of enhanced motor control, applied force, and / or energy delivery. In some embodiments, the drive handle disclosed herein may be used in conjunction with therapeutic devices (including therapeutic devices of this technology) for debulking intraluminal material such as thrombi or collagen-based post-thrombotic material from deep veins of the venous system. Other uses are also possible.

[0043] The drive handle of this technology beneficially provides the therapeutic device herein with the advantages of both mechanized and non-mechanized configurations, based on user preference and procedural needs. This may be desirable in a variety of situations, including those where pre-procedural assessment and response measurement methods cannot fully predict the extent, severity, or complexity of the disease. In such situations, the procedure may be initiated using only basic non-mechanized devices. Then, if intraoperative findings justify it, a selectively attachable drive handle may be used to enhance device functionality for more aggressive treatment without requiring the use of different devices. In doing so, the additional cost and complexity associated with the drive handle will only arise if necessary to successfully complete the procedure.

[0044] Figures 3A, 3B, and 3C are different diagrams of the selectively mountable drive handle 300 configured according to this art, shown coupled to the handle 200 of the cutting device 105. The drive handle 300 works in conjunction with the non-mechanized components of the handle 200 and is configured to replicate and / or complement one or more device movements that are normally achieved through manual operation. For example, during a typical debulking procedure, the cutting assembly 110 may be advanced partially or completely into the occlusive material, and the cutting element 116 may be positioned 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 as much of the occlusive material as possible within the vascular lumen and disintegrate it. The drive handle 300 of this art replicates rotation and translation but comes with mechanical advantages that provide a degree of force, speed, and control that exceeds the capabilities of the cutting device 105 under manual operation.

[0045] The drive handle 300 may include a receiving portion 302 (for ease of illustration, only the handle 200 is shown in Figures 3A-3C) configured to receive and secure the handle 200 of the cutting device 105 (or any intravascular treatment device), an actuator 304 operated by a user and configured to impart a desired movement to one or more parts of the treatment device, a body 306, and one or more means for translating user operation of the drive handle 300 into movement of one or more parts of the treatment device. For example, when coupled to the handle 200 of the cutting device 105, operation of the actuator 304 causes the entire cutting assembly 110 to rotate partially or completely around 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 operable by the user while the handle 200 is operationally coupled to the drive handle 300. In this way, the user maintains the ability to adjust the degree of radial position / expansion of the cutting element 116 while the handle 200 is operationally coupled to the drive handle 300.

[0046] Figures 3A and 3B show the handle 200 being 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 Figure 3A, the receiving portion 302 is shown in a partially closed / partially open (unfixed) state, while in Figure 3B, the receiving portion 302 is shown in an open (unfixed) state. Figure 3C shows the drive handle 300 in a partially closed / partially open (unfixed) state, with the actuator 304 in a second position and the handle 200 in a corresponding second axial position. During use, the receiving portion 302 is closed (fixed) during the operation of the actuator 304, and is shown in a partially open / partially closed state in some of the drawings to better visualize the movement of the handle 200 within the receiving portion 302.

[0047] As shown in Figures 3A-3C, the receiving portion 302 may include a cradle 310 configured to receive the handle 200 and a door 312 pivotally coupled to the cradle 310 via one or more hinges 311 (see Figure 3B). The receiving portion 302 can be positioned in an open configuration (see Figure 3B) for receiving the handle 200, and the door 312 can then be rotated over the top of the handle 200 until a coupling element 314 on the door 312 engages with a coupling element 316 on the cradle. The drawings show a coupling element 314 with a latch, with a coupling element 316 having a protrusion for engaging with the latch, but other coupling means such as snaps, slides, screws / threads, pins, magnetic couplers, and others are also possible.

[0048] Both the door 310 and the cradle 312 enclose the handle 200 along all or part of their length (as mentioned above, in some embodiments, the proximal region of the handle 200 remains exposed to allow the user to operate 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 engaging elements that engage with one or more portions of the handle 200 to further secure the handle 200 to the drive handle 300. In some embodiments, the door 312 may include a window (either a cutout or a transparent portion) on the handle 200 that is aligned with the indicator 230, 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 enclose the handle 200 when the handle 200 and the drive handle 300 are operationally coupled. Instead, the handle 200 is secured via one or more engaging elements located 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 extend over the top of the handle 200 so that a user can access one or more features of the handle 200 during use, but are configured not to cover a large portion of the surface area of ​​the handle 200.

[0050] The actuator 304 may include a lever or other structure configured to move relative to the body 306 and / or the receiving portion 302. Other means for providing mechanical advantages and enhanced drive handle output include gears, cams, hydraulic devices, and the like. In any case, the actuator 304 may have a gripping portion configured to be grasped by the user, for example, by the curled fingers of the hand while the palm is on the door 312. In this way, the user can actuate the actuator by gripping the drive handle 300. The actuator 304 may have a first extended position in which one end of the actuator 304 is further away from the body 306, and a second retracted position in which one end of the actuator 304 is closest to the body. The first position of the actuator 304 corresponds to a first position of the slider 322, and the second position of the actuator 304 corresponds to a second position of the slider 322.

[0051] The body 306 of the drive handle 300 can be positioned between the actuator 304 and the cradle 310 and may include one or more mechanisms for converting the movement of the actuator 304 into the movement of the handle 200. Figures 4A and 4B are side cross-sectional views of the drive handle 300 with the actuator 304 in a first position and a second position, respectively. Figure 5 shows a perspective cross-sectional view of the drive handle 300 with the actuator 304 in the first position. Referring to Figures 4A, 4B, and 5, the main body 306 may include a housing 320, a slider 322 located within the housing 320, a first link mechanism 324 fixed to the slider 322 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 link mechanism 328 fixed to the slider 322 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 installed in the cradle 310 such that the exposed portion of the first link mechanism 324 fits into the groove 340 on the handle 200. As a result, the linear movement of the slider 322 causes the linear movement of the handle 200 (and thus the linear movement of the entire cutting device 105). As shown in most detail in Figure 6, the handle 200 may optionally include a pin or other projection 342 that fits into a helical slot 344 defined by the cradle 310 and the door 312 when the handle 200 is received in the cradle 310. When the handle 200 is moved linearly by the slider 322 in the receiving portion 302, the projection 342 on the handle 200 moves in the helical slot 344, which causes the handle 200 to rotate in the receiving portion 302. Thus, the operation of the actuator 304 causes the handle 200 to rotate and translate in the receiving portion 302.

[0053] Referring again to Figures 4A, 4B, and 5, the slider 322 can be slidably mounted on a rail 346 which is 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 unloaded (extended) when the actuator 304 and the slider 322 are in their respective first positions (Figures 4A and 5), and is compressed when the actuator 304 and the slider 322 are in their respective second positions (Figure 4B). Thus, the spring 326 biases the actuator 304 toward the first position.

[0054] As mentioned above, the second link mechanism 328 is fixed to the slider 322 and extends through a slot 334 in the housing 320 of the main body 306 and a slot 336 in the actuator 306. The slot 336 in the actuator 336 can be angled relative to the slot 334 in the housing 320, which pulls the lever toward the main body 306 and at the same time forces the second link mechanism 328 to slide along the angled slot 336 in the actuator 304 and the horizontal slot 334 in the main body 306, thereby forcing the slider 322 to move linearly toward a second position (where the lever is closer to the main body 306) and compressing the spring 326. The release of actuator 304 and / or the reduction of force on actuator 304 allows spring 326 to become unloaded, while simultaneously forcing second link mechanism 328 to slide along angled slot 336 in actuator 304 and horizontal slot 334 in body 306, thereby forcing slider 322 to move linearly toward first position (where lever is further away from body 306).

[0055] The linear and / or rotational distance advanced per grip of the drive handle 300, as well as the rotational 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 influence the motion of the entire device (as described above) or to actuate individual device features or subassemblies. In this embodiment, the drive handle 300 is configured to both rotate and translate the entire cutting assembly 110, including both the inner and outer shafts 103, 102. In other embodiments, the drive handle 300 may be configured to independently control the movement of the inner and outer shafts to expand and crush the cutting element 116.

[0056] In some embodiments, the drive handle 300 includes a power supply. For example, the drive handle 300 may include a battery and / or be configured to be electrically coupled to a wall outlet. The drive handle 300 may further include a motor, and the power supply may be electrically coupled to the motor and configured to give the cutting device 105 additional motion (in addition to the motion provided by the mechanical auxiliary components). In just one of several embodiments, the drive handle 300 may include a motor configured to give oscillating motion to all or part of the cutting device 105. Other embodiments are also possible.

[0057] Figure 7 shows a proximal portion of a therapeutic device configured according to several embodiments of the present technology. As depicted, the therapeutic device may include a handle 700 and one or more extension members 702 coupled to the handle 700 and extending away from the handle 700. The therapeutic device may comprise any intravascular medical device such as a mechanical thrombectomy device, atherosclerotic device, transverse device, cutting device, or capture device. Figure 8 shows an electrically driven handle 800 configured to be operationally coupled to the therapeutic device of Figure 7, and Figure 9 shows a drive handle 800 operationally coupled to the therapeutic device. As shown, the drive handle 700 may be configured to be selectively attached to the hub and / or handle of the intravascular therapeutic device. The drive handle 800 may comprise a motor activated by an actuator 804 and configured to provide motion to the therapeutic device via a drive system. Motion may include rotational motion, oscillating motion, vibrating motion, linear motion, reciprocating motion, and others. The drive handle 800 may include a power supply or may be configured to be electrically coupled to a power supply. The drive handle 800 may further include coupling elements for mounting and / or coupling to one or more parts of a therapeutic device.

[0058] The characteristics of the drive handle may vary depending on the design of the corresponding device, the desired output motion, and the power source (e.g., manual operation, motor drive, or similar). In some embodiments, the drive handle mounting may be temporary or permanent once engaged with the device. According to some embodiments, the drive handle may be for single use only or designed for multiple use. In some embodiments, the drive handles disclosed herein may be actuated by hand / finger input (e.g., trigger, grip lever, or similar). In some embodiments, the drive handle may be used to supply energy to a therapeutic device from an ultrasonic, thermal, radio frequency, microwave, or similar source. The receiving portion of the handle disclosed herein may be device-specific or designed for universal acceptance across multiple device designs or product families. conclusion

[0059] While many of the embodiments described above relate to systems, devices, and methods for recovering thrombotic material from vascular lumens, the technology is applicable to other uses and / or other approaches, such as the removal and / or modification of other occlusive structures in any body lumen (e.g., transverse catheters, thrombectomy devices, atherosclerotic devices, etc.). Furthermore, other embodiments in addition to those described herein are also within the scope of the technology. In addition, some other embodiments of the technology may have different configurations, components, or procedures than those described herein. Those skilled in the art will therefore understand that the technology may have other embodiments with additional elements, or that the technology may have other embodiments without some of the features shown and described above with reference to Figure 1A-9.

[0060] The description of embodiments of this technology is not intended to be exhaustive or to limit the technology to any specific form disclosed above. Where the context allows, singular or plural terms may also include plural or singular terms, respectively. Specific embodiments of the technology and examples relating to the technology are described above for illustrative purposes, but as those skilled in the art will recognize, various equivalent modifications are possible within the scope of the technology. For example, while the steps are presented in a given order, alternative embodiments may carry out the 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 approximations, not as terms of degree, and are intended to take into account the inherent variability in measured or calculated values ​​that would be recognized by those skilled in the art.

[0062] Furthermore, unless the word “or” is explicitly limited to referring to a list of two or more items and meaning only a single item that is exclusive from the other items, the use of “or” in such a list shall be interpreted as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. In addition, the term “comprising” is used throughout to mean including at least the listed (single or multiple) features so as not to exclude any more than a number of identical features and / or other features of additional types. Also, while specific embodiments are described herein for illustrative purposes, it should be understood that various modifications can be made without departing from the Art. Furthermore, while advantages associated with certain embodiments of the Art are described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily have to exhibit such advantages in order to fall within the scope of the Art. Accordingly, the Disclosure and the Art associated therewith may encompass other embodiments not expressly shown or described herein.

Claims

1. A drive handle configured to be operationally coupled to the handle of a treatment catheter, wherein the drive handle is It includes a receiving portion configured to receive the handle of the treatment catheter, An actuator that can be moved by the user between a first position further from the receiving portion and a second position closer to the receiving portion, A slider coupled to the actuator and the receiving portion and configured to move axially relative to the receiving portion Equipped with, A drive handle, wherein when the handle of the treatment catheter is received by the receiving portion, the movement of the actuator between the first position and the second position causes the slider to move axially, thereby causing the treatment catheter to move axially within the receiving portion.

2. The drive handle according to claim 1, wherein when the handle of the treatment catheter is received by the receiving portion, the movement of the actuator between the first position and the second position causes the slider to move axially, thereby rotating the treatment catheter.

3. A drive handle configured to be operationally coupled to the handle of a treatment catheter, wherein the drive handle is It includes a receiving portion configured to receive the handle of the treatment catheter, An actuator that can be moved by the user between a first position further from the receiving portion and a second position closer to the receiving portion, A slider coupled to the actuator and the receiving portion and configured to move axially relative to the receiving portion Equipped with, A drive handle, wherein when the handle of the treatment catheter is received by the receiving portion, the movement of the actuator between the first position and the second position causes the slider to move axially, thereby rotating the treatment catheter within the receiving portion.

4. The drive handle according to claim 1 or 2, wherein the slider is connected to the receiving portion via a link mechanism that extends away from the slider and through a slot in the receiving portion, and the link mechanism is configured to slide within the slot.

5. The drive handle according to claim 4, wherein the link mechanism is a first link mechanism, the slot is a first slot, the slider is coupled to the actuator via a second link mechanism extending away from the slider and through a second slot defined by the actuator, and the second link mechanism is configured to slide within the second slot.

6. The drive handle according to claim 5, wherein the second slot is positioned at an angle other than 90 degrees with respect to the first slot.

7. A drive handle configured to be operationally coupled to the handle of a treatment catheter, wherein the drive handle is It includes a receiving portion configured to receive the handle of the treatment catheter, An actuator that can be rotated by the user between a first position further from the receiving portion and a second position closer to the receiving portion, A mechanical link mechanism between the actuator and the receiving portion, wherein the mechanical link mechanism is configured to convert the rotational motion of the actuator into the axial movement of the handle when the handle is received in the treatment catheter. A drive handle equipped with a drive handle.

8. The actuator is a drive handle according to any one of claims 1 to 7, comprising a lever.

9. The drive handle according to any one of claims 1 to 8, wherein the actuator is biased toward the first position such that the actuator remains in the first position when there is no reaction force.

10. The drive handle according to any one of claims 1 to 9, wherein the receiving portion defines a spiral groove configured to receive the protruding portion of the handle when the handle is received within the receiving portion.

11. The drive handle according to any one of claims 1 to 10, wherein the receiving portion includes a cradle configured such that the drive handle is positioned thereon when it is operably coupled to the drive handle, and a door extending over the handle and removably coupled to the cradle, and configured to secure the handle within the receiving portion.

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