阅读说明：本技术 用于治疗具有血栓的患者的系统 (System for treating a patient having a thrombus ) 是由 大卫·M·卢克 布拉德利·S·卡伯特 于 2016-09-03 设计创作，主要内容包括：一种用于治疗具有血栓的患者的系统,包括：抽吸导管,其具有远端、近端、以及在其之间延伸并耦接到真空源的抽吸腔；细长件,其具有远端和近端,并穿过抽吸导管的抽吸腔就位；操作装置,其包括由用户的手支撑的壳体,壳体具有远端和近端；接合件,通过壳体承载,具有锁定模式和解锁模式,在锁定模式中,接合件与细长件锁定,在解锁模式中,接合件不与细长件锁定；电机,设置在壳体内,构造为使接合件运动,使得当接合件处于其锁定模式时,接合件的旋转运动转换为细长件的运动；激活件,其由壳体承载,使得当壳体由用户的手支撑时激活件可由用户的手的一部分操作。本发明能方便地移动和跟踪体内血栓,有效地进行治疗操作。(A system for treating a patient having a thrombus, comprising: an aspiration catheter having a distal end, a proximal end, and an aspiration lumen extending therebetween and coupled to a vacuum source; an elongate member having a distal end and a proximal end and positioned through the aspiration lumen of the aspiration catheter; an operating device comprising a housing supported by a hand of a user, the housing having a distal end and a proximal end; an engaging member carried by the housing and having a locked mode in which the engaging member is locked with the elongated member and an unlocked mode in which the engaging member is unlocked from the elongated member; a motor disposed within the housing and configured to move the engagement member such that when the engagement member is in its locked mode, rotational movement of the engagement member is translated into movement of the elongate member; an activation member carried by the housing such that the activation member is operable by a portion of the user's hand when the housing is supported by the user's hand. The invention can conveniently move and track thrombus in vivo and effectively carry out treatment operation.)

1. A system for treating a patient having a thrombus, comprising:

an aspiration catheter having a distal end for placement into a blood vessel, a proximal end, and an aspiration lumen having an open distal end and extending between the distal end of the aspiration catheter and the proximal end of the aspiration catheter, the aspiration lumen configured to be coupled to a vacuum source;

an elongate member having a distal end and a proximal end, the distal end of the elongate member having a distal straight portion such that the elongate member is configured to be inserted through an aspiration lumen of the aspiration catheter such that the distal end of the elongate member extends from the aspiration catheter into a thrombus located in the blood vessel;

an operating device, the operating device comprising:

a housing configured to be supported by a hand of a user, the housing having a distal end and a proximal end;

an engaging member carried by the housing having a locked mode in which the engaging member is locked with the elongated member and an unlocked mode in which the engaging member is not locked with the elongated member;

a motor disposed within the housing and configured to move the engagement member such that rotational movement of the engagement member is translated into movement of the elongated member when the engagement member is in its locked mode; and

an activation member carried by the housing such that the activation member is operable by at least a portion of a user's hand when the housing is supported by the user's hand.

2. The system of claim 1, wherein the motor is configured to rotate the engagement member.

3. The system of claim 1, wherein the motor is configured to rotate the engagement member clockwise and configured to rotate the engagement member counterclockwise.

4. The system of claim 1, wherein the motor is configured to move the engagement member in a cyclical longitudinal motion.

5. The system of any one of claims 1 to 4, wherein the distal end of the elongate member has a ball or football shaped portion.

6. The system of any one of claims 1 to 4, wherein the elongate member comprises a lead.

7. The system of any one of claims 1 to 4, wherein the elongate member includes a curved portion configured to remain within the suction lumen of the suction catheter while the distal end of the elongate member extends from the suction lumen and the elongate member is moved by the motor.

8. The system of any one of claims 1 to 4, wherein the distal end of the elongated member comprises a distal straight portion.

9. The system of claim 8, wherein the distal end of the elongated member includes a curved portion directly adjacent the distal straight portion and configured to be positionable outside the aspiration lumen of the aspiration catheter.

10. The system of any one of claims 1 to 4, wherein the aspiration catheter further comprises:

a supply lumen having a wall and a distal end and configured to be coupled to a fluid source; and

an orifice at or near a distal end of the supply lumen, wherein the supply lumen is in fluid communication with an interior of the aspiration lumen.

Technical Field

The present application relates to the technical field of medical devices, in particular to a system for treating patients with thrombi.

Background

Leads and other elongate medical devices are configured to be positioned in conduits and lumens of the body. These devices may be manually operated to move or track the device through tortuous, obstructed, or constricted passages. Such operations are often challenging and require skill and experience. Sometimes, it is not possible to successfully move or track the device to the desired target location within the body.

Disclosure of Invention

In one embodiment of the present disclosure, a system for treating a patient having a thrombus comprises: an aspiration catheter having a distal end for placement into a blood vessel, a proximal end, and an aspiration lumen having an open distal end and extending between the distal end of the aspiration catheter and the proximal end of the aspiration catheter, the aspiration lumen configured to be coupled to a vacuum source; an elongate member having a distal end and a proximal end, the distal end of the elongate member having a distal straight portion such that the elongate member is configured to be inserted through an aspiration lumen of an aspiration catheter such that the distal end of the elongate member extends from the aspiration catheter into a thrombus located in the blood vessel; an operating device, the operating device comprising: a housing configured to be supported by a hand of a user, the housing having a distal end and a proximal end; an engaging member carried by the housing and having a locked mode in which the engaging member is locked with the elongated member and an unlocked mode in which the engaging member is unlocked from the elongated member; a motor disposed within the housing and configured to move the engagement member such that, when the engagement member is in its locked mode, rotational movement of the engagement member is translated into movement of the elongate member; and an activation member carried by the housing such that the activation member is operable by at least a portion of a user's hand when the housing is supported by the user's hand.

Drawings

Fig. 1 illustrates a view of a lead manipulation device for use on a patient according to one embodiment of the present disclosure.

Fig. 2A shows a top view of the lead manipulation device of fig. 1.

Fig. 2B shows a side view of the wire handling device of fig. 1.

Fig. 3 shows an open top view of the lead manipulation device of fig. 1.

Fig. 4 shows a bottom open view of the lead manipulation device of fig. 1.

Fig. 5 shows a cross-sectional view of the drum of the wire handling device of fig. 1.

Fig. 6 illustrates a side view of a lead manipulation device according to one embodiment of the present disclosure.

Fig. 7 illustrates a side view of the lead manipulation device of fig. 6 with a trigger depressed according to one embodiment of the present disclosure.

Fig. 8 illustrates a side view of a lead manipulation device according to one embodiment of the present disclosure.

Fig. 9 shows a side view of the wire handling device of fig. 8.

Fig. 10 illustrates a perspective view of a lead manipulation device according to one embodiment of the present disclosure.

Fig. 11 shows a side cross-sectional view of the lead manipulation device of fig. 10.

Fig. 12 shows a side cross-sectional view of the lead manipulation device of fig. 10.

Fig. 13 shows a perspective open view of the lead manipulation device of fig. 10.

Fig. 14 shows a perspective open view of the lead manipulation device of fig. 10.

Fig. 15 shows a perspective open view of the lead manipulation device of fig. 10.

Fig. 16 shows a side open view of a lead manipulation device according to one embodiment of the present disclosure.

Fig. 17 shows a side open view of the lead manipulation device of fig. 16.

Fig. 18 shows a side view of a lead manipulation device according to one embodiment of the present disclosure.

Fig. 19 shows a side open view of a lead manipulation device according to one embodiment of the present disclosure.

Fig. 20 shows a side open view of the lead manipulation device of fig. 19.

Fig. 21 shows a side open view of a lead manipulation device according to one embodiment of the present disclosure.

Fig. 22 shows a side open view of the lead manipulation device of fig. 21.

Fig. 23 illustrates a view of one embodiment of a lead manipulation device for use on a patient according to one embodiment of the present disclosure.

Fig. 24 depicts a schematic block diagram of a lead manipulation device according to one embodiment of the present disclosure.

Fig. 25 depicts a vertical cross-sectional view of a lead manipulation device according to one embodiment of the present disclosure.

Fig. 26 depicts a portion of an activator used in the lead manipulation device of fig. 25.

Fig. 27 depicts a perspective view of a hub portion of a chuck that transmits axial motive force to a lead when using the lead manipulation device of fig. 25.

Fig. 28 depicts a block diagram of a controller for a lead wire handling device according to one embodiment of the present disclosure.

Fig. 29 depicts a vertical cross-sectional view of an alternative embodiment of a lead wire manipulation device.

Fig. 30 depicts a partial perspective view of a portion of a lead drive assembly for the lead manipulation device of fig. 29.

Fig. 31 depicts a cross-sectional view of a portion of a housing for the lead wire manipulation device of fig. 29.

Fig. 32 depicts a vertical cross-sectional view of the wire handling device of fig. 29 with an activator engaged to apply an axial motive force to the wire in accordance with one embodiment of the present disclosure.

Fig. 33 depicts a partial vertical cross-sectional view of another embodiment of a wire management device for imparting axial motive force to a wire.

Fig. 34 illustrates an intravascular suction catheter used with a lead moved by a lead manipulation device according to one embodiment of the present disclosure.

Fig. 35 illustrates an intravascular suction catheter used with a lead moved by a lead manipulation device according to another embodiment of the present disclosure.

Fig. 36 illustrates an intravascular suction catheter used with a lead moved by a lead manipulation device according to another embodiment of the present disclosure.

Figure 37 illustrates a plan view of a system for treating a patient having a thrombus according to one embodiment of the present disclosure.

Figure 38 illustrates a plan view of a system for treating a patient having a thrombus according to one embodiment of the present disclosure.

Detailed Description

Embodiments of the present disclosure include systems and methods for operating one or more medical devices. The medical device may comprise an elongate medical device including, but not limited to: guidewires, maceration devices, such as maceration devices with expanding elements (e.g., baskets), cutting devices, atherectomy devices, and a variety of different catheter shafts, including solid and hollow catheter shafts. Conventional manual methods of operation of a lead typically include applying torque to the lead to assist in its passage through a tortuous, occluded or stenotic duct or vessel. A user can sometimes rotate the lead between fingers (e.g., gloved fingers) to create torque that helps manipulate the lead through challenging anatomical structures. This technique is sometimes called "helicopter hoisting", implying rotating blades of a helicopter. This technique is difficult to achieve because the small diameter of the wire typically makes it difficult to grasp. In addition, it may be difficult to apply the necessary frictional force to the surface of the lead to cause it to rotate, as the lead is typically coated with a lubricious coating. For similar reasons, it may be difficult to apply longitudinal forces on the lead by manual operation, including front and rear longitudinal forces intended to apply an oscillating motion on the lead.

Fig. 1 illustrates one embodiment of a wire management device 100, advancing the wire management device 100 over a wire 102. As seen in this figure, a lead 102 is introduced into a blood vessel (e.g., femoral artery) of a patient. Sliding the operator 100 over the lead 102 and selectively locking the operator 100 to the lead 102. When advancing the lead 102 into the patient, the user operates the operation device 100 to appropriately rotate or vibrate the lead 102.

For example, when the distal end of the lead 102 reaches an angled or curved region of a blood vessel, the user activates the operation device 100 to rotate the lead 102 (i.e., in a counterclockwise direction indicated by arrow 103), thereby causing the distal end of the lead 102 to more simply advance through the angled or curved region. In another example, the distal end of the lead 102 reaches an obstacle (e.g., a thrombus), but cannot simply pass through. The user then activates the lead manipulation device 100 to vibrate it (e.g., by rapidly passing between a clockwise direction and a counterclockwise direction), thereby causing the distal end of the lead 102 to pass over an obstruction. In another example, the device 100 may include a plurality of preprogrammed rotation patterns (e.g., 180 degrees clockwise rotation followed by 180 degrees counterclockwise rotation; 90 degrees clockwise rotation followed by 90 degrees counterclockwise rotation; or 30 degrees clockwise rotation followed by 180 degrees counterclockwise rotation) appropriate for different vessel configurations.

Fig. 2A and 2B show external views of the lead manipulation device 100. The lead manipulation device 100 may also include a microprocessor and memory connected to the motor and buttons 108 for storing and executing preprogrammed modes of rotation. As seen in these figures, the lead 102 passes through the channel along the length of the lead manipulation device 100. Preferably, the lead operating device 100 includes a locking assembly in the form of a lead lockout switch 106 that allows a user to selectively lock the lead operating device 100 to the lead 102. In this regard, the lead manipulation device 100 may be movable relative to the lead 102 in the unlocked state and may move the lead 102 (rotationally and/or longitudinally) in the locked state.

The lead wire operating device 100 also preferably includes a power indicator light 104 (e.g., an LED) that indicates whether the device 100 is powered and a rotation button 108 that causes the lead wire 102 to rotate. By pressing button 108, the user activates device 100. Optionally, the device 100 may include a button, switch, or similar mechanism to toggle the device 100 between rotating in a clockwise direction or rotating in a counterclockwise direction. Alternatively, the button 108 may include a variety of activation techniques for determining clockwise or counterclockwise rotation (e.g., slide forward or backward, multi-button press, etc.).

Preferably, the outer container or housing 110 is composed of a lightweight material, such as plastic, and has an ergonomic shape that at least partially fits the user's hand. In this regard, the user may comfortably operate the lead manipulation device 100 during a surgical procedure.

Referring to fig. 3 and 4, internal views of the wire handling device 100 within the outer housing 110 are shown according to one embodiment of the present disclosure. The wire 102 is engaged by the apparatus 100 with an elongated roller 120 (also seen in the cross-sectional view of fig. 5). Preferably, the apparatus 100 includes at least three rollers, however, any number of rollers 120 is possible (e.g., 1-5 rollers). When the button 108 is pressed, the roller 120 rotates, thereby rotating the wire 102. Preferably, the lockout switch 106 raises or lowers one or more rollers 120 relative to the wire 102 to lock the wire 102 with the device 100 when the rollers 120 are pressed against the wire 102 and to unlock the wire 102 from the device 100 when the roller(s) 120 are moved away from the wire 102.

One or more rollers 120 are preferably driven by a motor 116 that is powered by the battery 114 (or alternatively, by alternating current such as an electrical outlet). The motor 116 is connected to the drum(s) 120 through a cam 119, and the cam 119 is constituted by a first link 118 connected to the motor 116 and a second link 112 connected to the drum(s) 120. In this regard, activation of the motor 116 drives the cam 119 and ultimately the rotation of the one or more rollers 120.

Fig. 6 and 7 illustrate another embodiment of a manually operated device 130 according to the present disclosure. The device 130 is generally similar to the device 100 described previously, except that the rotation at the drum 120 and thus the wire 102 is driven by the handle 126. For example, depressing the handle 126 may rotate the lead 102 in a clockwise direction (arrow 122), and releasing the handle 126 may rotate the lead 102 in a counterclockwise direction (arrow 123). In addition, a switch 124 is included to change the type of rotation caused by the handle 126. For example, the switch 124 may change the gear ratio, thereby changing the amount of rotation caused by pressing the handle. In another example, the switch 124 may change the direction of rotation caused by pressing the handle 126. By manually activating the handle 126 by the user, the internal drive component does not require the motor 116 to drive rotation of the lead 102.

Fig. 8 and 9 illustrate another embodiment of a manual wire-handling device 132, which is generally similar to the devices 100 and 130 described previously. However, the device 132 includes a selectively lockable thumb roller 134 on the distal end of the device 132. The thumb roller 134 includes a locked mode, as shown in fig. 8, in which the roller 134 is engaged with the wire 102, allowing the user to roll the roller 134 and thus the wire 102. The thumb roller 134 also includes an unlocked mode, as shown in fig. 9, in which the roller 134 is pulled distally from the housing 136, exposing the space 138 and disengaging the roller 134 from the lead 102. Thus, in the unlocked mode, the device 132 may be moved along the length of the lead 102.

Fig. 10-15 illustrate another embodiment of a lead manipulation device 140 according to one embodiment of the present disclosure. The device 140 is substantially similar to the device 100 described previously. For example, the device 140 includes a hand-held (e.g., configured to be held within a hand of a user), ergonomic housing 142, and operational buttons 144. As best seen in fig. 11 and 12, the device 140 further includes a motor 152 powered by the battery 154 and a lead channel 158 configured to pass the lead 102.

Preferably, the device 140 includes a locking assembly in the form of a locking hub 146 (similar to the device 132) that allows a user to selectively lock the lead 102 with the device 140. The locking hub 146 allows free movement of the lead 102 when positioned adjacent the housing 142 (fig. 11), and locks the lead 102 when the locking hub is pulled away from the housing 142 (fig. 12). Locking hub 146 includes an interior cavity with a top surface angled downward toward housing 142. Within the lumen is a locking wedge 150 that is located within a window 149 of the tube 148 that exposes the lead 102. In the unlocked position of fig. 11, the locking boss 146 restrains the locking wedge 150, but does not press down on the locking wedge 150, thereby allowing the lead 102 to slide under the locking pin 150. In the locked position of fig. 12, the angled inner surface of the locking hub 146 forces the locking pin downward against the lead 102, preventing the lead from moving relative to the device 140. A perspective view of the locking pin 150 can also be seen in fig. 15.

As seen in fig. 11-15, the motor 152 includes a worm 155 that engages a first gear segment 156B of a shaft 156. The worm 156A of the shaft 158 engages the gear arrangement 148A on the outer surface of the tube 148. In this regard, when the motor 152 is activated, it ultimately rotates the roller assembly or tube 148. Thus, the locking hub 146 must be in the slid out locked position to cause the lead 102 to rotate.

As with all of the motorized embodiments described in this specification, the device 140 may also include a microprocessor and memory for storing and executing different rotation sequences (i.e., direction and speed of rotation).

Fig. 16 and 17 illustrate a lead manipulation device 170 according to yet another embodiment according to the present disclosure. The device 170 is generally similar to the previously described embodiments, including a housing 184 having an activation button 176 coupled to a battery 186, and a motor 178. The gear 180 of the motor 178 is engaged with the gear 182, and the gear 182 is also engaged with the gear segment 181 on the wedge tube 174.

The hub 172 includes an internal angled passage that increases in diameter in the distal direction. The wedge tube 174 is partially located within the hub 172. In the unlocked position of fig. 16, the angled channel of the hub 172 complements the distally expanded shape of the wedge tube 174, thereby preventing the wedge tube 172 from pinching or providing force on the lead wire 102, and thereby allowing the lead wire 102 to slide and rotate relative to the device 170. In the locked position of fig. 17, the hub 172 is moved distally from the housing 184 such that the smaller diameter internal passage of the hub 172 wedges or clips onto the expanded distal end of the wedge tube 174. Thus, the wedge 174 (preferably comprised of a compressible, semi-compressible, or deformable material) closes around the lead 102, maintaining the position of the lead 102 relative to the device 170, and further allowing rotation of the lead 102.

Fig. 18-20 illustrate another embodiment of an apparatus 190 according to the present disclosure. The device 190 is substantially similar to the previously described devices. However, the device 190 includes a locking assembly in the form of a lead lock that is activated by depressing the trigger 196. In this regard, the user may rotate the hub 192 clockwise or counterclockwise to rotate the lead 102 accordingly.

The device 190 is generally similar to the previously described embodiments, including a motor 210 powered by a battery 208, a gear 214 coupled to an output gear 212 of the motor 210 and to the gear portion 200B of the wedge tube 200, and a housing 194 containing these components. The motor 210 is controlled by the rocker switch 192 connected to the first circuit board 202, which sends the position of the rocker switch 192 to the second circuit board 206. The second circuit board 206 includes a microprocessor and memory for executing a plurality of rotation programs. These rotation programs instruct the motor 210 to perform a predetermined rotational motion, for example, in a single direction, increase the rotational speed exponentially, rotate rapidly to cause a vibration or a series of predetermined rotational motions. Thus, more complex movements may be performed by the user.

The device 190 is locked to the lead 102 when the user releases the trigger 196 (see fig. 19), and unlocks the lead 102 when the user depresses the trigger 196. The trigger 196 moves the outer tubing 198, which is biased in a distal direction by a spring 204. The inner channel of the outer tubing 198 increases in diameter in the distal direction, forming an inverted conical shape. An inner wedge tube 200 is located within the channel of the outer tubing 198 and includes a wedge 200A that increases in size in the distal direction of the device 190. The lead 102 is located within the channel of the wedge 200.

When the trigger 196 is released, as shown in fig. 19, the outer tubing 198 is moved distally by the spring 204 such that the smaller diameter region of the inner channel of the outer tubing 198 presses against the wedge 200A of the wedge tube 200. The wedge 200 is then compressed around the lead 102, locking the lead 102 in place relative to the device 190. When the trigger 196 is depressed, as shown in fig. 20, a portion of the trigger 196 urges the outer tubing 198 in a proximal direction, against the bias of the spring 204. The angled portion of the inner channel of the outer tubing 198 moves away from the wedge 200a, allowing the inner channel of the wedge tube 200 to release the lead 102. Thus, a user may selectively lock onto the lead 102 and rotate the lead 102 (via the roller assembly, including the wedge tube 200) by releasing the trigger 196 and depressing the activation button 192.

Fig. 21 and 22 illustrate another embodiment of a lead manipulation device 220 according to the present disclosure. The device 220 is substantially similar to the previously described embodiments. Including a battery 234 and an activation button 228 that power a motor 236, the motor 236 drives the wedge 224 (via a gear 240 connected to the gear region 224B and an output gear 238).

The device 220 further includes a locking mechanism assembly that locks the lateral position of the lead 102. As shown in fig. 21, when the user releases the trigger 232, the device remains in the locked position, allowing the user to rotate the lead 102. As shown in fig. 22, when the user depresses the trigger 232, the device remains in the unlocked position, allowing the user to slide the device 220 along the lead 102 and prevent the lead from rotating.

In the locked position, trigger 232 holds outer tube 222 in the proximal position, proximally biased by spring 226. The outer tube includes an inner passage of generally decreasing diameter in the distal direction. The inner surface of the outer tube 222 presses against the wedge 224A of the wedge tube 224, causing the wedge tube 224 to press against the lead wire 102 and lock onto the lead wire 102.

In the unlocked position, trigger 232 pushes outer tube 222 distally, against the bias of spring 226. The surface of the inner channel of the outer tube 222 moves away from the wedge 224A, releasing the wedge tube 224 from the lead 102.

The systems and methods disclosed herein further include a wire handling device for selectively transferring motive force (rotational and/or axial/longitudinal (linear) motion) to the wire. In use, such a lead manipulation device is selectively locked to a lead and activated to transmit motive force to maneuver the lead to a desired location during an intravascular procedure. The motive force applied to the lead is optionally rotational or axial to facilitate moving the lead through the vessel and/or penetrating the occlusion.

Fig. 23 illustrates a view of a lead manipulation device 2100 for use on a patient 2110 according to one embodiment of the present disclosure. In one embodiment, lead manipulation device 2100 is a handheld device capable of fitting into the palm of a user's hand and being manipulated using one hand. In one embodiment, the lead manipulation device 2100 is advanced over the lead 2102, i.e., the lead 2102 passes through a channel longitudinally oriented in the device 2100. During an endovascular procedure, a lead 2102 is introduced into a blood vessel 2106 (e.g., a femoral artery) of a patient 2110. The lead manipulation device 2100 is selectively locked to the lead 2102. When advancing the lead into the patient, the user operates the operating device 2100 to transfer motive force (rotational and/or axial motion) to the lead 2102, as appropriate.

For example, when the distal end 2108 of the lead 2102 reaches an angled, curved, stenotic, or occluded region of the blood vessel 2106, the user locks the operating device 2100 to the lead and transmits rotational motive force to the lead 2102 (e.g., in a counterclockwise direction indicated by arrow 2104), thereby causing the distal end 2108 of the lead 2102 to more easily advance through the angled, curved, stenotic, or occluded region of the blood vessel 2106. Once advanced past the region, the device 2100 is unlocked from the lead and the lead may be advanced further through the vessel. In another example, the distal end 2108 of the lead 2102 reaches an obstacle (e.g., a thrombus, including, but not limited to, a thromboembolism), but cannot pass through the obstacle. The user then locks the lead manipulation device 2100 to the lead 2102 and imparts a vibratory motion (e.g., rapid oscillation between clockwise and counterclockwise rotation). This movement causes distal end 2108 of lead 2102 to pass over the obstruction. In another example, when the distal end 2108 of the lead 2102 reaches an obstruction, the user locks the lead manipulation device 2100 to the lead 2102 and imparts an axial motion (e.g., a linear motion of the lead 2102) to create a jackhammer effect. In another embodiment, a user can lock device 2100 to lead 2102 while imparting rotational and axial motion to lead 2102. In another embodiment of the present disclosure, a series of predefined lead operations (i.e., modes) may be generated using a computer program for controlling motion as described in detail below. Various motivational modes to be selectively used in various surgical situations may be selected from memory and applied to the lead.

Fig. 24 depicts a schematic block diagram of one embodiment of a lead manipulation device 2100. The lead manipulation device 2100 defines an axial longitudinal channel 2204, and during use, the lead 2102 is passed through the axial longitudinal channel 2204. The lead manipulation device 2100 includes a housing 2200, an activator 2206, and a chuck 2202. Chuck 2202 includes a wire locking mechanism 2208. In use, the chuck 2202 is locked to the lead 2102 using the locking mechanism 2208. Once locked, the activator selectively transmits motive force (rotational and/or axial motion) to the lead 2102.

Fig. 25 depicts a vertical cross-sectional view of one embodiment of a lead manipulation device 2100. In this embodiment, the activator 2206 of fig. 24 is divided into a rotary activator 2206A and an axial activator 2206B such that the device can selectively do the following for the lead: no motive force, rotational motive force, or both rotational and axial motive forces are applied.

The device 2100 includes a housing 2200 that is generally formed as halves that are glued, bonded, threaded, or otherwise secured to one another to form a housing. A groove 350 is defined within the housing 2200, retaining the sleeves 302A and 302B in the groove 350. The sleeves 302A and 302B support the shaft 300 on its outer surface 310. The shaft 300 defines a channel 2204 extending axially through the shaft 300. When in use, lead 2102 is passed through channel 2204.

Rotary activator 2206A includes a shaft 300, a motor 328, a drive assembly 326, a controller 330, and a control switch 332. The drive assembly 326 couples the rotational motion of the motor 328 to the shaft 300 using a plurality of gears, as further described below with respect to fig. 26. In one embodiment of the present disclosure, the controller 330 is simply one or more batteries coupled to the motor 328 via a control switch 332. In this embodiment, the control switch 332 may simply apply voltage from the one or more batteries to the motor 328 to cause the motor 328 to rotate. In its simplest form, the control switch 332 is a simple Single Pole Single Throw (SPST) momentary contact switch. In other embodiments, the controller 330 includes a programmable microcontroller as described below with respect to fig. 28. In other embodiments, the switch 332 may apply a voltage to cause the motor 328 to selectively rotate clockwise or counterclockwise. The control switch 332 is typically mounted so as to be exposed to the exterior of the housing 2200 and to be conveniently operated by one hand of the user (e.g., a thumb-activated button or a slide switch).

The shaft 300 is coupled to the chuck 2202. In one embodiment, chuck 2202 includes coupler 304, hub 324, and wedge 314. The coupler 304 and the shaft 300 have splined mating surfaces 342 that are used to couple rotational movement of the shaft 300 to the chuck 2202 while allowing the coupler 304 to move in an axial direction. With hub 324 threaded onto coupler 304 at surface 312. The wedge 314 is positioned in a window 352 defined by the coupler 304. The hub 324 retains the wedge 314 within the window 352. In the disengaged (unlocked) position, the hub 324 transmits no pressure to the wedge 314, allowing the lead 2102 to slide freely under the wedge 314 and through the channel 2204. To lock (engage) the wire into the locking mechanism 2208, the hub 324 is rotated relative to the coupler 304 such that the angled surface 316 of the hub 324 interacts with the top surface 308 of the wedge 314. As the hub 324 is moved relative to the coupler 304 via the mating threaded surface 312, the wedge 314 is forced against the lead 2102. Thus, the wire 2102 is captured between the wedge 314 and the coupler 304, thereby locking the wire 2102 in the chuck 2202. Once locked, any motion (e.g., rotational and/or longitudinal) of the chuck 2202 is transferred to the lead 2102 as a motive force.

Other embodiments of the present disclosure use other forms of chucks. In a broad sense, any mechanism that can be used to selectively lock the wire to the motive force source can be used. Other forms of chuck having multiple jaws or compression slotted cylinders are applicable.

The coupler 304 includes a spring seat 354 that supports a first end of the spring 306. The second end of the spring 306 rests against a flange 322 extending from the inner surface of the housing 2200. Spring 306 is one embodiment of a resilient member that biases coupler 304 inwardly toward shaft 300. The coupler 304 further includes a flange 320 that extends radially from an outer surface of the coupler 304. The flange 320 is positioned along the coupler 304 to limit the amount of axial motion that can be transferred to the chuck 2202. Flange 320 abuts housing flange 322. As such, spring 306 biases coupler 304 to maintain contact between flange 320 and flange 322.

To transmit axial (longitudinal) motion to the chuck 2202, the bottom surface 356 of the hub 324 is dimpled. The bottom surface 356 interacts with a protrusion 336 extending from an outer surface of the housing 2200 proximate the bottom surface 356 of the hub 324. Depending on the position of the hub 324 relative to the coupler 304, the spring 306 ensures that the protrusion 336 interacts with the dimpled bottom surface 356. Upon locking the chuck 2202 to the lead 2102 and transferring rotation to the chuck 2202, the lead 2102 moves in an axial direction as indicated by arrow 358. To release the axial motive force, the hub 324 is rotated along the threads 312 relative to the coupler 304 to disengage the extension 336 from the bottom surface 356. In this manner, the locking mechanism 2208 retains the lead 2102 such that rotational motion of the shaft 300 is transferred to the lead 2102 without transferring axial motion. In this embodiment, the axial motion activator 2206B includes a hub 324, a spring 306, a coupler 304, and a housing 2200.

Fig. 26 depicts a cross-sectional view of the drive assembly 326 of the rotary activator 2206A taken along line 26-26 of fig. 25 according to one embodiment of the present disclosure. The drive assembly 326 includes a motor gear 400, an intermediate gear 402, and a shaft gear 404. The motor 328 of fig. 25 is coupled to the motor gear 400 to transfer rotational motion to the motor gear 400. In one embodiment, the shaft gear 404 is formed as an integral part of this surface of the shaft 300 of FIG. 25. The intermediate gear 402 is designed to provide a gear ratio between the motor gear 400 and the shaft gear 404. The diameter and number of teeth of each gear are considered a design choice that will define the speed of rotational movement and the oscillating speed of axial movement of wire 2102.

In other embodiments, the motor 328 of FIG. 25 may be coupled to the shaft via other forms of drive assemblies, such as a direct drive, a worm gear, and so forth. Specific motor and drive assembly characteristics are considered design choices to develop specific lead speeds and torques. In some embodiments, the drive assembly may be adjustable to facilitate generating a particular speed and torque profile or adjustment. One form of adjustment may be facilitated by the use of a stepper motor that is controlled by a pulse width modulated signal generated by a controller, as discussed below.

An alternative embodiment for transmitting the rotary motive force in alternative directions uses a gear train comprising two larger diameter spur gears mounted on a common shaft that is constantly driven in one direction by an electric motor. Each of these two spur gears has a segment of its teeth removed, approximately more than 1/2 of its total number. The removed tooth segments are positioned such that only one or the other of two additional smaller spur gears will be driven at a time, each spur gear being positioned to be driven by one of the common shaft gears. One of the two smaller spur gears is then used at a time to drive the gears on the shaft, but positioning an additional gear between only one of the drive gears and the shaft gear results in a reversal of the direction of rotation of the shaft when the set drives the shaft gear.

If only forward and reverse directions are required (no near constant rotational speed in either direction), then another embodiment has spur gears on the shaft driven by a pivoting 1/4 pie plate. The toothed curved segment opposite the pivot on the end edge will be configured with the correct pitch radius to engage the shaft spur gear. This pivoting gear segment plate will have a slot in its surface extending upwardly from its pivot axis in which the eccentrically mounted pin and disk are free to slide up and down. When the motor turns this disk in a constant direction, it will cause the pivot plate to rock back and forth so that its gear segments drive the spur gear in one direction and then in the opposite direction.

Fig. 27 depicts a perspective view of a hub 324 according to one embodiment of the present disclosure. Hub 324 includes a surface 356 having a plurality of dimples (dimples) 504 and spaces 502 between dimples 504. Hub 324 further includes a threaded inner surface 312. The threaded inner surface 312 is adapted to interact with a threaded outer surface of the coupler 304 to adjust the position of the hub relative to the coupler 304 and the wedge 314. Dimples 504 and spaces 502 between dimples 504 are adapted to interact with protrusions 336 to transfer axial motion to chuck 2202. The spacing of the dimples and the speed of the motor control the rate of oscillation of the axial motion. Also, the depth of dimple 504 relative to space 502 on surface 356 controls the travel distance of the axial motion.

Fig. 28 depicts a block diagram of a controller 330 according to one embodiment of the present disclosure. The controller 330 includes a microcontroller 600, auxiliary circuitry 602, memory 604, and a power supply 606. Microcontroller 600 may be one or more of many commercially available microcontrollers, microprocessors, Application Specific Integrated Circuits (ASICs), and the like. The support circuits 602 include well-known circuits that facilitate operation of the microcontroller 600, including, but not limited to, clock circuits, cache, power supplies, input/output circuits, indicators, sensors, and the like. In one embodiment, power source 606 includes one or more batteries. In other embodiments, power supply 606 may include an ac-to-dc converter to allow the lead wire handling device to be plugged into a wall socket. In other embodiments, the power supply 606 may include one or more batteries, and the charging circuitry for the batteries may be inductively coupled to the base charger.

Memory 604 may be any form of memory device for storing digital instructions and data for microcontroller 600. In one embodiment, the memory 604 is a random access memory or read only memory that includes control code 608 (e.g., computer readable instructions) for controlling the activator 2206 to impart motion to the lead 2102. The program that microcontroller 600 uses to control activator 2206 is typically controlled by control switch 332 and/or another input device.

In one embodiment of the present disclosure, the motor 328 is a stepper motor that is controlled using, for example, a pulse width modulated signal generated by the controller 330 to impart a particular torque and/or speed profile to the motor 328. In some embodiments, a predefined program may be generated and selected by operation of the switch 332 to enable a user to overcome a particular type of obstruction within the path of the lead. For example, if the surgeon encounters a particular type of thrombus, a particular procedure defining the motion of the lead to overcome the obstruction may be selected and performed. Various procedures can be generated by empirical studies of lead use in endovascular surgery. To select a particular movement pattern, the switch may be a slide switch having a plurality of selectable positions, where each position corresponds to a different movement pattern.

Fig. 29 depicts a vertical cross-sectional view of a lead manipulation device 650 according to an alternative embodiment of the present disclosure. In this embodiment, the use of axial movement is selected by operation of the mechanical switch 702. As with the previous embodiment, this embodiment selectively performs the following operations on the leads: the motive power is not transmitted, the rotary motive power is transmitted, or the rotary motive power and the axial motive power are transmitted. The device 650 includes a rotary activator 2206A as described above with respect to fig. 25. In this embodiment, the coupler 700 includes a spring seat 750, a dimple flange 710, and a switch stop 752. The slidable switch 702 includes an extension 704 that interacts with a switch base 752. The switch seat 752 and spring seat 750 define a space 706 that captures the switch extension 704. Operation of the switch 702 causes the coupler 700 to move axially along a surface that mates with the shaft 300. The spring 708 is positioned between the spring seat 750 and the housing flange 322. The spring 708 biases the coupler 700 inward toward the shaft 300. A dimple flange 710 extends radially from the coupler 700. One surface of the dimple flange 710 abuts the housing flange 322 to limit the distance the coupler 700 moves in the axial direction. The dimple flange 710 has a surface that aligns with the dimple surface 712 of the housing 2200. When the lead 2102 is locked to the chuck 2202 and the rotation activator 2206A is activated, the lead 2102 rotates without any axial movement. As described further below with respect to fig. 32, when switch 702 is moved forward to cause the micro-concave surface of flange 710 to engage micro-concave surface 712, the axial motive force of lead 2102 is transferred to lead 2102.

Fig. 30 depicts a partial perspective view of a coupler 700 according to one embodiment of the present disclosure. The coupler 700 has holes 806, allowing the leads 2102 to pass through the holes 806. Dimple flange 710 includes a radially extending flange 802 having a plurality of dimples 800 formed in surface 801. In one embodiment, dimples 800 are formed as a series of wedges. In other embodiments, to cause axial movement of the chuck when rotating the coupler 700, the surface 801 of the flange 802 is altered so that interaction with a corresponding surface can cause axial movement of the coupler 700.

Fig. 31 depicts a cross-sectional view of the housing 2200 taken along line 31-31 in fig. 29. In one embodiment, surface 712 includes corresponding protrusions shaped to interact with dimples 800 in surface 801 of coupler 700. In another embodiment, surface 712 may include a wedge 900 that is complementary to surface 801 of coupler 700. The shape of wedge 900 defines, in part, the distance traveled, the acceleration rate of wire 2102, and the oscillating velocity of wire 2102.

Fig. 32 depicts an embodiment of the lead manipulation device 650 of fig. 29 in which the dimple flange 710 has engaged the protrusion surface 712. In this manner, switch 702 has moved coupler 700 forward to facilitate engagement of surfaces 710 and 712. When chuck 2202 is locked to lead 2102 and the rotation activator is activated, lead 2102 rotates as indicated by arrow 1002 and oscillates axially as represented by arrow 1000.

Fig. 33 depicts a vertical cross-sectional view of a portion of a lead manipulation device 1100. The device 1100 includes an axial activator 2206B, which can be selectively used 2206B without imparting rotational motion to the lead. Thus, with this embodiment, the apparatus 1100 selectively performs the following operations on the leads: the motive power is not transmitted, the rotary motive power is transmitted, the axial motive power is transmitted, or the axial motive power and the rotary motive power are transmitted.

In one embodiment, device 1100 includes a linear activator 1116 coupled to a shaft 1114 that interacts with a fulcrum 1112. Linear actuator 1116 imparts linear motion to a portion of fulcrum 1112. Fulcrum is mounted on fulcrum 1120 such that fulcrum 1112 rotates about fulcrum 1120 when a linear motive force is applied to fulcrum 1112. A second end of fulcrum 1112 interacts with coupler 1104. As with the previous embodiments, the coupler 1104 has a splined surface that interacts with the shaft 300 to transfer rotational motion to the coupler 1104 as needed. The coupler 1104 includes a spring seat 1108. A spring 1106 is positioned between the housing 1102 and a spring seat 1108 to bias the coupler 1104 toward the shaft 300. Fulcrum 1112 is coupled to spring seat 1108 such that movement of fulcrum 1112 moves coupler 1104 axially. In this manner, the linear activator 1116 transmits axial motion to the coupler 1104 and to the lead 2102, which is locked in the chuck 2202, without any rotational motion.

In one embodiment, the linear activator 1116 may be a solenoid, a piezoelectric actuator, a linear motor, a rotary motor, and a ball screw or rack/pinion, among others. In another embodiment, the axial force may be transferred to the lead using a hammer drill type assembly.

The controller 330 may control the linear activator 1116 in a manner similar to that described as controlling the motor 328 of fig. 25.

Fig. 34 shows the open distal end 3158 of the aspiration lumen 3160 of an aspiration catheter 3000 for aspirating thrombus within a blood vessel 3600. A scraping device 3162 may be formed in the polymer sleeve 3146 of the pumping chamber 3000 to facilitate the removal of debris from the fluid by a vacuum source (e.g.,syringe, vacuum bottle) and injection of a fluid into the distal end of the aspiration lumen 3160, as described below, to assist in the entry of thrombus 3164 (in the direction of arrow 3180) drawn into the aspiration lumen 3160. The scraping means 3162 also minimizes the chance of the open distal end 3158 drawing against the vessel wall 3166. The distal supply tube 3168 of the aspiration catheter 3000 has a closed distal end 3170. For example, it may clog during manufacturing using adhesives, epoxies, hot melt adhesives, or disturbers (e.g., metal or polymer plugs). However, in some embodiments, the suction catheter 3000 may have a blunt or non-angled tip instead of the scraping means 3162. Alternatively, distal supply tube 3168 may be closed by melting a portion of it. Distal supply tube 3168 has a lumen 3176 extending its length and an aperture 3172 formed through its wall 3174 adjacent and proximal to closed distal end 3170. The orifice 3172 may have a diameter of between about 0.0508mm (0.002 inch) and about 0.1016mm (0.004 inch), or a diameter of about 0.0787mm (0.0031 inch). The inner diameter of distal supply tube 3168 may be between about 0.3048mm (0.012 inches) and about 0.4826mm (0.019 inches), or between about 0.3556mm (0.014 inches) and about 0.4318mm (0.017 inches) or about 0.3937mm (0.0155 inches). The lumen 3176 of the distal supply tube 3168 is an extension of the general flow path originating from the fluid source (e.g., saline bag, saline bottle), including an extension conduit (not shown). In some embodiments, lumen 3167 of distal supply tube 3168 may taper, for example, from an inner diameter of about 0.3937mm (0.0155 inches) at the proximal end portion to an inner diameter of about 0.2974mm (0.011 inches) at the distal end portion. In some embodiments, the equivalent of a cone may be achieved by joining different diameter pipes to each other, resulting in a tapered pipe inner diameter. In some embodiments, tapered conduits of different diameters may be combined with one another for a combination of tapering and tapered diameters. An output pressure wave (e.g., of saline injected via a pump) causes a liquid injectate to flow through the flow path, including distal supply tube 3168 (arrow 3182), and fluid jet 3178 to exit orifice 3172 at high velocity. The fluid jet 3178 serves to macerate thrombus 3164 drawn into the aspiration lumen 3160 and may also serve to dilute the thrombus. This maceration and dilution ensures that there is a continuous flow through the aspiration chamber 3160 so that it will not clog. The fluid jet 3178 is configured to be contained within the suction lumen 3160 and not exit into a blood vessel or other body cavity. A lead tube 3132 having a distal end 3136 and a proximal end 3137 and having a distal port 3139 and a proximal port 3141 is secured to the aspiration catheter 3000 by an attachment material 3186. Although lead wire 3132 of fig. 34 is shown having a length that is shorter than the length of aspiration catheter 3000 (sometimes called a rapid exchange catheter), in other embodiments, lead wire 3132 may extend substantially the entire length of aspiration catheter 3000. In some embodiments, aspiration catheter 3000 may have a length between 100cm and 180cm, and lead tube 3132 may have a length of 28cm orA smaller length. In some embodiments, the lead tube 3132 may have a length of 25cm or less. In some embodiments, the lead tube may have a length of 10cm or less. In some embodiments, the lead tube may have a length of 3cm or less. In some embodiments, the lead tube may have a length between about 3cm and about 28 cm. The lead tube 3132 may be located alongside (i.e., to the side of) the suction lumen 3160 or may be located coaxially within the suction lumen 3160. The additional lead 3102 may be used with any aspiration catheter (including, for example, the aspiration catheter 3000) to facilitate movement of aspirated or softened thrombus through a catheter lumen, for example, through the aspiration lumen 3160 of the aspiration catheter 3000. The lead 3102 is secured at its proximal end 3188 (fig. 37) to any embodiment of a lead manipulation device 100, 132, 140, 170, 190, 220, 2100, 650, 1100. The distal end 3143 may include a straight portion 3145 or a curved portion 3147, or a combination of straight portion 3145 and curved portion 3147. The lead 3102 may include a bend 3149 that is not located exactly at the distal end 3143. The curved portions 3147, 3149 may comprise a single arc or multiple arcs, but may generally comprise any non-straight pattern. The one or more arcs may be contained within a plane, or it may be three-dimensional. The flexures 3147, 3149 may include a helical structure, such as a single diameter helical structure or a tapered diameter helical structure. The tapered diameter helix may be tapered such that it increases in diameter as it extends distally, or such that it decreases in diameter as it extends distally. In some cases, a fully straight lead 3102 may be used.

In fig. 34, either the straight portion 3145 of the distal end 3143 or the curved portion 3147 of the distal end 3143 (or a combination of both) may be placed near or within the thrombus 3164 by inserting the lead 3102 through the aspiration lumen 3160 of the aspiration catheter 3000 and then operating the lead manipulation device 100, 132, 140, 170, 190, 220, 2100, 650, 1100 to rotate, longitudinally cycle, or otherwise move the lead 3102. The resulting motion at the distal end 3143 of the lead 3102 serves to help disrupt or macerate the thrombus 3164, and also helps move the partially or fully macerated thrombus 3164 (or a portion thereof) toward the aspiration catheter 3000, and in particular toward the open distal end 3158 of the aspiration lumen 3160 of the aspiration catheter 3000. The bend 3149 within the aspiration lumen 3160 of the aspiration catheter 3000 also serves to facilitate movement of the partially or fully macerated thrombus 3164 (or a portion thereof) through the aspiration lumen 3160 of the aspiration catheter 3000 toward the proximal end of the aspiration lumen 3160. The curved portion 3149 may also be used to help center the lead 3102 within the aspiration lumen 3160 or to stabilize the lead 3102 as the lead 3102 is rotated or moved longitudinally by the lead manipulation devices 100, 132, 140, 170, 190, 220, 2100, 650, 1100. In some cases, the lead 3102 may be slowly pulled proximally during aspiration of the thrombus 3164 such that the bend 3149 helps translate a portion of the thrombus. In some embodiments, the curved portion 3149 may be replaced by a straight portion. For example, the lead may include an outer coil extending along its longitudinal axis, the outer coil including an outer profile that will serve to macerate or translate a portion of the thrombus. The lead manipulation devices 100, 132, 140, 170, 190, 220, 2100, 650, 1100 may be operated such that the lead 3102 is rotated in a direction such that the curved portion 3149 (or straight portion of the helical coil) rotates in a direction that preferably moves a portion of the thrombus proximally in the aspiration lumen to function similar to a propeller or a helical lift water pump. If the aspiration lumen 3160 of the aspiration catheter 3000 becomes occluded by a thrombus or other embolus, the lead manipulation device 100, 132, 140, 170, 190, 220, 2100, 650, 1100 may be attached to the lead 3102 already in place (i.e., through the lead lumen) to guide the catheter, and then the lead manipulation device may be activated to move (rotate, longitudinally translate, etc.) the lead 3102 to help dislodge the thrombus or other embolus so that it may be completely aspirated/emptied and removed from the aspiration lumen 3160 to eliminate the occlusion. The lead 3102 or other elongate medical device may be made of many different biocompatible materials, including, but not limited to, stainless steel or a shape memory alloy, such as nickel titanium alloy (nitinol).

In fig. 34, the aspiration catheter 3000 and the lead 3102 may be inserted (separately or together) through a delivery catheter, such as a coronary guide catheter. Fig. 35 shows the aspiration catheter 3000 and a guidewire 3102, such as a coronary guide catheter, inserted through the delivery catheter 3151, but in this case the guidewire 3102 is in contact with the aspiration catheterRadially adjacent, in the annulus between the interior of the delivery conduit 3151 and the exterior of the aspiration conduit 3000. Thus, the lead 3102 can be moved or manipulated by the lead manipulation device 100, 132, 140, 170, 190, 220, 2100, 650, 1100 such that the distal end 3143 helps to macerate and move the thrombus 3164 not only into the aspiration lumen 3160 of the aspiration catheter 3000, but also into the lumen 3153 of the delivery catheter 3151. The curved portion 3149 (or straight portion) is configured to assist in the movement of the thrombus 3164 (or a portion thereof) through the lumen 3153 of the delivery catheter 3151. In some cases, the lead 3102 may be slowly pulled proximally during aspiration of the thrombus 3164 such that the bend 3149 helps translate a portion of the thrombus 3164. In other embodiments, two leads 3102 and two lead manipulation devices 100, 132, 140, 170, 190, 220, 2100, 650, 1100 may be used in a combination of the methods of fig. 34 and 35. The aspiration catheters described herein may include any standard aspiration catheter having one or more aspiration lumens. Aspiration catheters for use herein may include ACE manufactured by Penumbra, Calif^TMOrA conduit.

The suction catheter and suction system may include those described in U.S. patent application publication No.2015/0282821 to hook et al, published on 8/10/2015.

The suction catheter and suction system may include those described in U.S. patent application publication No.2015/0327875 to hook et al, published 11/19/2015.

Fig. 38 shows a system 4246 for treating thrombus. A system 4246 for treating thrombus includes a delivery catheter 3151 having a lumen 3153, and an aspiration catheter 3000 placed in the lumen 3153. The lead 3102 may be inserted through the lumen 3153 of the delivery catheter 3151, or (as shown in fig. 38) through the lumen of the aspiration catheter 3000, for example, through the aspiration lumen 3160 of the aspiration catheter 3000. The lead 3102 is configured to be operated (rotationally and/or longitudinally) by a lead manipulation device 4231, the lead manipulation device 4231 having a housing 4232 and a handle 4237. The lead manipulation device 4231 may include any of the embodiments described herein, or may include an embodiment of a lead manipulation device such as those disclosed in co-pending U.S. patent application No. 15/235,920 entitled "system and method for manipulating an elongate medical device" filed on 12.8.2016. The delivery catheter 3151 has a proximal end 3192 and a distal end 3190, the proximal end 3192 being coupled to the y-connector 4244 by a luer connection 4248. In some embodiments, the luer connection 4248 may comprise a female luer fitting attached to the proximal end 3192 of the delivery catheter 3151, and a male luer fitting located at the distal end of the y-connector 4244. The hemostasis valve 4250 at the proximal end of the y-connector 4244 is configured to seal around the shaft 4252 of the aspiration catheter 3000, and may comprise a Touhy-Borst, spring-loaded seal, duckbill seal, or other seal. The connector 4254 is attached to the proximal end 4256 of the aspiration catheter 3000. The connector 4254 includes a central bore 4258 in fluid communication with the aspiration lumen 3160 and terminating in a connector 4261 (e.g., a female luer connector). In embodiments where the aspiration catheter 3000 comprises a positive aspiration catheter, the port 4260 is in fluid communication with the lumen 3176 of the distal supply tube 3168 (fig. 34). The port 4260 may thus be configured to be coupled to a source of pressurized fluid 4268 (e.g., saline). Connector 4261 is configured to couple to connector 4263 at the distal end of y-connector 4265. Connector 4263 may comprise a male luer fitting. y-connector 4265 comprises a hemostasis valve 4267(Touhy-Borst, spring-loaded seal, etc.) and a side port 4269. The hemostasis valve 4267 is configured to seal around the lead 3102. Side port 4269 of y-connector 4265 is configured to couple to vacuum source 4266. Side port 4262 of y-connector 4244 may additionally be configured to couple to a vacuum source 4270 and/or may be used to inject a fluid, such as a contrast media.

Aspiration catheter 3000 includes an open distal end 3158, which may include a scraping device 3162. The lead 3102 is shown in fig. 38 as having a distal end 3143, the distal end 3143 including a curved portion 3147 and a straight portion 3145, including only curved portions or only straight portions, although other distal end configurations are also contemplated. The lead 3102 is shown extending through the aspiration lumen 3160 of the aspiration catheter 3000 and proximally through the connector 4254 and through the y-connector 4265. The lead 3102 may be secured at its proximal end 3188 to a rotatable chuck 4207, which is rotatably carried by the lead manipulation device 4231. The chuck 4207 is operable to selectively grip and release (engage and disengage, lock and unlock, etc.) the wire 3102 via a collet or any equivalent device. The lead wire manipulation device 4231 is configured to be supported by a user's hand and includes a handle 4237 having one or more controls 4243. The handle 4237 may extend in a generally perpendicular direction from the axis of the lead 3102 as it extends through the housing 4262, and may be angled toward the distal end 4236 of the housing 4232 (shown in fig. 38) in the reverse pistol grip handle. Alternatively, the grip 4237 may have a standard pistol grip (see fig. 37), and thus may be angled toward the proximal end 4234 of the housing 4232. The controls 4243 are shown in fig. 38 as being carried on a distal-facing surface 4239 of the grip 4237, and in this embodiment may be configured to be operated by one or more fingers of the user's hand, which may include non-thumb fingers. The controller 4243 may include an activation button 4214 configured to energize and de-energize, for example, to power a motor (not shown) configured to rotate and/or longitudinally move the lead 3102. The control knob 4217 may be configured to increase or decrease a rotational speed (e.g., of a motor) or select a plurality of different operating procedures. The operating program may be stored in a memory carried within the lead wire handling device 4231, for example, on a circuit board. The circuit board may include a controller as described with respect to other embodiments herein. A representative operating procedure may include rotating the lead 3102 in a first rotational direction for 8 cycles, and then rotating the lead 3102 in a second, opposite rotational direction for 8 cycles. Another operational procedure may include continuous rotation in a single direction. Another operational procedure may include continuous rotation in one direction while repeatedly translating the lead 3102 distally and proximally (longitudinal cycling). Alternatively, the controls 4243 may be carried on the proximal-facing surface 4238 of the grip 4237 and may be configured to be operated primarily by the thumb of the user's hand. The motor may be connected directly to the chuck 4207, or through other drive elements, including gearing, which may be used to change speed, torque, or direction of rotation. The drive elements may include those described with respect to any of the embodiments disclosed herein. In use, the vacuum source 4266 may be coupled to the side port 4269 of the y-connector 4265, thus drawing in thrombus through the aspiration lumen 3160 of the aspiration catheter 3000. The vacuum source 4266 may comprise a syringe, a vacuum chamber, or a vacuum pump. A syringe with a lockable plunger (e.g., a syringe having a volume between about 20ml and about 30 ml) may be used as the vacuum source. While performing the aspiration procedure, the user may simultaneously or sequentially operate the lead manipulation devices 4231 to rotate and/or longitudinally move the lead 3102 to aid in maceration of the thrombus and/or movement of the thrombus or pieces of thrombus through the aspiration lumen 3160.

Fig. 37 shows a system 5200 for treating a thrombus. A system 5200 for treating thrombi includes a sheath 5202 having a cavity 5204 therethrough, and a microcatheter 5206 placed in the cavity 5204. The lead wire 3102 may be inserted into the cavity 5208 of the microcatheter 5206. The lead 3102 is configured to be operated (rotationally and/or longitudinally) by a lead operating device 5231 having a housing 5232 and a handle 5237. The lead manipulation device 5231 can include any of the embodiments described herein, or can include embodiments of lead manipulation devices such as those disclosed in co-pending U.S. patent application No. 15/235,920 entitled "system and method for manipulating elongate medical devices," filed on 12.8.2016. The housing 5232 has a proximal end 5234 and a distal end 5236, and the handle 5237 extends in a substantially radial direction from the lead axis of the housing 5232. The control 5243 is carried by the proximal-facing surface 5238 and includes an activation button 5214 and a control knob 5217, which may be configured in a similar manner as the activation button 4214 and the control knob 4217 of the lead wire operating device 4231 of fig. 38. The user's hand is configured to grasp the standard pistol grip of the grip 5237 by wrapping around the distally facing surface 5239. A handle 5237 angled toward the proximal end 5234 of the housing 5232 is depicted in fig. 37. The user may operate the controller 5243 using the user's thumb, or a combination of the user's thumb and one non-thumb finger of the user's hand. The chuck 5207 is carried by a wire handler 5231 on a proximal end 5234 side of the housing 5232 and is configured to rotate and/or longitudinally move the wire 3102 in a manner similar to the chuck 4207 of fig. 38. However, the lead 3102 is configured to pass through the housing 5232, and the proximal end 3188 of the lead 3102 is configured to be secured to the chuck 5207. The lead manipulation device 4231 includes a locking element 5210 carried near a distal end 5236 of a housing 5232 that is connectable to a connector 5211, the connector 5211 being coupled to a proximal end 5213 of the microcatheter 5206. The locking element 5210 and the connector 5211 comprise male and female luer locks, or may comprise other types of locking connections that secure the connector 5211 relative to the lead manipulation device 5231. When securing the locking element 5210 and the connector 5211 to one another, relative rotational and/or longitudinal movement between the lead manipulation device 5231 and the connector 5211 is inhibited. The sheath 5202 includes a proximal end 5233 and a distal end 5235, and may include a proximal internal seal 5241, and a side port 5245 with a luer fitting 5247. In use, a user can operate the lead manipulation device 5231 (e.g., by holding the handle 5237 and depressing the activation button 5214) while also pushing or pulling the microcatheter 5206 within the cavity 5204 of the sheath 5202. The thrombus can be macerated by the distal end 3143 of the lead 3102. If desired, thrombus may be aspirated through the cavity 5204 of the sheath 5202 by applying a vacuum to the side port 5245 of the sheath 5202 (e.g., attaching a vacuum source, not shown). The sheath 5202 can also be moved proximally or distally so that the distal end 5235 of the sheath is in proximity to the thrombus or portion of thrombus to be aspirated or blood. If desired, the locking element 5210 of the lead manipulation device 5231 can be detached from the connector 5211 of the microcatheter 5206 and a vacuum source (not shown) can be attached to the connector 5211 to draw thrombus or blood through the lumen 5208 of the microcatheter 5206.

Fig. 36 shows a suction catheter 4000 within a blood vessel 4600 having a vessel wall 4166. The aspiration catheter 4000 has an aspiration lumen 4160 configured to aspirate thrombus 4164 and place a lead 4102 configured to track the aspiration catheter 4000 in the vasculature of the patient. Distal supply tube 4168 with lumen 4176 is configured to inject a pressurized fluid, such as saline. Pressurized fluid is injected through the cavity 4176 and out the orifice 4172 into the suction cavity 4160. The aperture is located at the distal most end of the distal supply tube 4168. The output of pressurized fluid through the orifice 4172 may include a jet 4178. The thrombus 4164 is aspirated into the aspiration lumen 4160. In some embodiments, the jet 4178 macerates the thrombus 4164 as the jet 4178 passes through the thrombus 4164. The lead 4102 can be attached to a lead manipulation device 100, 132, 140, 170, 190, 220, 2100, 650, 1100, 4231, andthe lead manipulation devices 100, 132, 140, 170, 190, 220, 2100, 650, 1100, 4231 are moved by the lead manipulation devices in one or more modes including rotational movement 4180 and/or longitudinal movement 4190. Either or both of these motions can be transmitted on the lead 4102 to, in combination, help macerate the thrombus 4164 and/or help transport the thrombus 4164 from the distal end through the suction lumen 4160 to the proximal end. Rotational movement 4180 may include only clockwise, only counterclockwise, or a combination of clockwise and counterclockwise, such as back-and-forth rotational oscillation as described herein. The longitudinal motion 4190 may be a motion that is directly translated on the lead 4102 by operation of the lead handling device 100, 132, 140, 170, 190, 220, 2100, 650, 1100, 4231, or may be manually applied by a user by moving the lead handling device 100, 132, 140, 170, 190, 220, 2100, 650, 1100, 4231 back and forth (both distally and proximally). In some cases, the lead handling device 100, 132, 140, 170, 190, 220, 2100, 650, 1100, 4231 may be pulled gradually while the lead 4102 is rotated by the lead handling device 100, 132, 140, 170, 190, 220, 2100, 650, 1100, 4231. In some cases, the handle of the lead manipulation device can be moved distally and proximally cyclically while gradually pulling on the lead manipulation device 100, 132, 140, 170, 190, 220, 2100, 650, 1100, 4231 proximally. E.g., 1cm at the distal end, 2cm at the proximal end, etc. In some embodiments, the aspiration catheter 4000 may consist of only a single lumen for aspiration and guidewire placement without any forced injection (i.e., without the distal supply tube 4168). In some embodiments, manipulation of the lead 4102 by the lead manipulation devices 100, 132, 140, 170, 190, 220, 2100, 650, 1100, 4231 may perform similar functions for a "detachment device" as the ACE manufactured by Penumbra corporation of alamida, california, usa^TMOrThe same applies to the suction catheter used together. A "detachment device" is a lead-type device having a ball or football-shaped portion at its distal end extending from and in communication with the aspiration lumenThe distal port pulls the ends relatively to help break apart or macerate the thrombus/clot.

A variety of different elongate medical devices may be rotated, longitudinally moved, or otherwise manipulated by embodiments of the lead manipulation devices 100, 132, 140, 170, 190, 220, 2100, 650, 1100, 4231 described herein, including embodiments of the elongate medical instruments and macerator disclosed in U.S. patent application publication No.2014/0142594 to Fojtik, published 5/22/2014.

In one embodiment, the operation device includes: a housing configured to be supported by a hand of a user, the housing having a distal end and a proximal end; a drive system disposed within the housing and configured to rotate the rotating member; an engagement member coupled to the rotation member and configured to be removably coupled to the elongate medical device to convert rotational movement of the rotation member into rotational movement of the elongate medical device; an activator carried by the housing such that the activator is operable by at least a portion of a user's hand when the housing is supported by the user's hand, and wherein the drive system is configured to apply a combination of motive force components to the engagement member. In some embodiments, the combination of motive force components includes alternating clockwise and counterclockwise motion. In some embodiments, the combination of motive force components includes rotational motion and cyclical longitudinal motion. In some embodiments, the activation member includes a handle coupled to the housing and configured to be operable by a hand of a user. In some embodiments, the handle is configured to mechanically couple to a drive system. In some embodiments, the rotating member comprises a tube having a window. In some embodiments, the operating device further comprises a motor operably coupled to the drive system, wherein the activator is configured to initiate operation of the motor. In some embodiments, the operation device further comprises a gear arrangement coupled to the motor. In some embodiments, the activation member comprises a switch. In some embodiments, the elongate medical device is comprised of at least one of a lead, a basket, an expandable device, a catheter shaft, an infuser, or a cutting device. In some embodiments, the combination of motive force components includes a helical motion. In some embodiments, the combination of motive force components includes a jackhammer motion.

In another embodiment, a method for treating a patient having a thrombus, comprises: providing an operating device comprising: a housing configured to be supported by a hand of a user, the housing having a distal end and a proximal end; a drive system disposed within the housing and configured to rotate the rotating member; an engagement member coupled to the rotation member and configured to be removably coupled to the elongate medical device; an activator carried by the housing such that the activator is operable by at least a portion of a user's hand when the housing is supported by the user's hand, and wherein the drive system is configured to apply a motive force to the engagement member; securing the elongate member to a coupling member, the coupling member having a distal end configured to be introduced into the vasculature of a patient; introducing at least the distal end of the elongate member into a blood vessel adjacent the thrombus; operating the activation member to cause at least some rotation of the rotating member, which in turn causes at least some rotation of the distal end of the elongate member at or near the thrombus; and aspirating at least some of the thrombus through the aspiration catheter. In some embodiments, the motive force comprises a combination of motive force components comprising alternating clockwise and counterclockwise motions. In some embodiments, the combination of motive force components includes rotational motion and cyclical longitudinal motion. In some embodiments, the activation member includes a handle coupled to the housing and configured to be operable by a hand of a user. In some embodiments, the handle is configured to mechanically couple to a drive system. In some embodiments, the rotating member comprises a conduit comprising a window. In some embodiments, the operating device further comprises a motor operably coupled to the drive system, wherein the activator is configured to initiate operation of the motor. In some embodiments, the operation device further comprises a gear arrangement coupled to the motor. In some embodiments, the activation member comprises a switch. In some embodiments, the elongate medical device is comprised of at least one of a lead, a basket, an expandable device, a catheter shaft, an infuser, or a cutting device. In some embodiments, the combination of motive force components includes a helical motion. In some embodiments, the combination of motive force components includes a jackhammer motion. In some embodiments, the elongated member comprises a lead. In some embodiments, the distal end of the elongated member is substantially straight. In some embodiments, the distal end of the elongated member is curved. In some embodiments, at least a portion of the aspiration catheter extends alongside at least a portion of the elongate member within the delivery lumen of the delivery catheter. In some embodiments, at least a portion of the distal end of the elongate member rotates to facilitate movement of thrombus through the delivery lumen of the delivery catheter. In some embodiments, the delivery catheter is a coronary guide catheter. In some embodiments, the elongate member extends within the lumen of the aspiration catheter. In some embodiments, the elongate member extends within the aspiration lumen of the aspiration catheter. In some embodiments, the elongate member is rotatable within the lumen of the aspiration catheter. In some embodiments, at least a portion of the distal end of the elongate member rotates to facilitate movement of thrombus through the lumen of the aspiration catheter. In some embodiments, an aspiration catheter includes a supply lumen having a wall and a closed distal end, and an aspiration lumen configured to be coupled to a vacuum source and having an inner wall surface and an open distal end, the wall of the supply lumen having an orifice in fluid communication with an interior of the aspiration lumen, the orifice located proximal to the open end of the aspiration lumen and proximal to the closed distal end of the supply lumen. In some embodiments, the method further includes providing a tubing set having a first tubing configured to couple the supply lumen of the aspiration conduit to the fluid source, and a pump member connected to the first tubing and configured to be detachably coupled to the drive unit such that movement from the drive unit is translated to the pump member such that the resulting movement of the pump member causes fluid from the fluid source to be injected through the supply lumen of the aspiration conduit and into the aspiration lumen through the orifice. In some embodiments, the pump comprises a piston. In some embodiments, the orifice is configured to produce a spray pattern when pressurized fluid is pumped through the supply chamber such that the spray pattern impinges against an inner wall surface of the suction chamber. In some embodiments, the aspiration catheter comprises: a tubular suction piece having a proximal end, a distal end, and a lumen and configured to at least partially protrude from the lumen of a delivery catheter having a lumen into the vasculature of a subject; an elongate support coupled to the tubular suction piece and extending between the proximal end of the suction catheter and the proximal end of the tubular suction piece; and an annular seal comprising at least one annular seal coupled to the tubular suction piece.

In another embodiment, a method for fragmenting a thrombus or embolus includes: providing a manually operated wire handling device, the wire handling device comprising: a housing having a proximal end, an elongated body, and a distal end; a rotating member disposed within the housing and configured to rotate relative to the housing; a locking assembly operably coupled to the distal end of the rotating member, the locking assembly having a locked mode in which the rotating member is engaged with the lead and an unlocked mode in which the rotating member is disengaged from the lead; a handle coupled to the housing and configured to be operable by one hand of a user; and a drive system operably coupled to the handle, the drive system configured to rotate the rotary member in a first direction relative to the housing upon activation of the handle by one hand of a user, thereby causing the lead to rotate in a first rotational direction when the locking assembly is in the locked mode, wherein the handle is configured to be releasable by the user such that the handle moves in a second direction relative to the housing when released, the second direction being opposite the first direction, wherein the handle is configured to cause rotation of the rotary member in a second rotational direction opposite the first rotational direction when the handle is moved in the second direction, thereby causing the lead to rotate in the second rotational direction, securing the lead to the rotary member via the locking assembly, the lead having a distal end that extends through the lumen of the catheter and into the vasculature of the patient, operating the manually-operated lead operating device to cause at least some degree of rotation of the rotary member, this in turn causes at least some rotation of the lead and aspiration of at least some of the thrombus or embolus through the lumen of the catheter. In some embodiments, the catheter is an aspiration catheter. In some embodiments, the lumen is an aspiration lumen. In some embodiments, the aspiration lumen is also a lead lumen. In some embodiments, the catheter is a guide catheter.

In some embodiments described herein, the chuck is not rotated, but instead is a rotating luer lock (luer lock) connector. For example, the selectable male luer lock connector may be coupled to a medical device (e.g., an elongate medical device, which may include a catheter) to rotate the medical device.

In some embodiments, the medical device to be rotated, axially moved, or moved in any other pattern may include one or more of the following: drills, burr machines, such as burr systems for special craniotomies. In some embodiments, the system may include a safety stop. In some embodiments, the medical device to be rotated, axially moved, or moved in any other pattern may include one or more of the following: a tapered tip device advanced by rotation (e.g., a scraping catheter), a cutting tool for bone manipulation, a gill wire, a hollow trepan (flexible or rigid) for biopsy, a dissection element that slides or finds a channel (and in some cases may be able to expand), a retriever that penetrates a thrombus and then expands once in place expands a stent-like structure, a balloon or other expandable structure that delivers a drug by rubbing the vessel wall via axial motion, rotation, or a combination thereof. It can be appreciated that by connecting to any of the embodiments described herein, various types of medical devices can be operated to perform movements such as rotation (one or more rotational directions) and picking (back and forth). Additionally, the oscillatory action may be used in a coaxial system to move two elements relative to each other to release particles, drugs or other materials. In some embodiments, the medical device to be rotated, axially moved, or moved in any other pattern may include one or more of the following: endoscopic trocar stylets, stylet, needle guide, female cervical fallopian tube penetrator for implantation of an infertile device, ureteral penetrator for kidney stone manipulation, filling system for root canals, FESS (functional endoscopic sinus surgery) or burr surgery device, sinus/nasal access, plastic surgery device for tunneling under layers of dermis, fat, neurosurgical nasal access device, deep brain access device such as pennsylvania university Deep Brain Stimulation (DBS) device. In some embodiments, the medical device to be rotated, axially moved, or moved in any other pattern may include one or more of the following: a hollow, perforated wire drug delivery device that delivers drug while rotating, a drug such as a G2B3 inhibitor that can be delivered to or in a thrombus. In some embodiments, the medical device to be rotated, axially moved, or moved in any other pattern may include one or more of the following: an aneurysm wire/catheter navigation device and a liquid emboli dispensing device.

While the foregoing is directed to embodiments of the present disclosure, other and further embodiments may be devised without departing from the basic scope thereof.