System for assisting delivery of mechanical endovascular treatment devices - Patent Application 20070122999

Abstract

To provide a system to assist delivery of a mechanical intravascular treatment device.SOLUTION: The system includes a first assist device having a first linear sliding mechanism. The linear sliding mechanism includes: a first non-slidable section; a first slidable section linearly displaceable relative to the first non-slidable section; and a first tension device connected to the first slidable section to move together, the first tension device being transitionable between an unsecured state and a secured state. A first securing hub is fixedly attached to the first non-slidable section, where the first securing hub is transitionable between an unsecured state and a secured state. The system may also include a second assist device. The assist devices provide enhanced control of movement of a delivery wire and / or guide catheter.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] The present invention relates to a system for assisting the delivery (e.g., deployment, recapture) of a mechanical endovascular treatment device (e.g., a braided flow diverter). Specifically, the present invention relates to a system for assisting the delivery of a mechanical endovascular treatment device that can provide additional force during navigation through tortuous vessels and / or can provide enhanced control for precise positioning of the device at a target site within a vessel. [Background technology]

[0002] Mechanical endovascular treatment devices, such as braided flow diverters and other self-expanding stent devices, are advanced intravascularly through the body to a target location using multiple assist devices (e.g., a guide catheter, a microcatheter, and a delivery wire) in the treatment of aneurysms. Once the microcatheter and mechanical endovascular treatment device are positioned intravascularly at the target site, the self-expanding stent is deployed (removed) to an expanded state that diverts blood flow from the aneurysm. Deploying such self-expanding mechanical vascular devices requires significant dexterity and a coordinated, complex "push-pull" hand maneuver by the interventional physician using both hands simultaneously, which is not natural, comfortable, or ergonomic. Essentially, such hand maneuvers for deploying a self-expanding mechanical endovascular treatment device require the interventional physician to push the delivery wire while holding the hub of the delivery microcatheter with one hand and simultaneously pull back (i.e., remove) the microcatheter from the self-expanding mechanical endovascular treatment device with the other hand, allowing it to automatically expand / expand at the target site and make physical contact with the inner wall of the blood vessel. In addition to coordinating complex, independent movements of both hands simultaneously, relatively large forces may be required to overcome friction experienced when deploying and subsequently recapturing the flow diverter as it navigates through tortuous paths. In difficult anatomical structures, an assistant may be required to assist the interventionalist. Even if the interventionalist alone is capable of deploying and / or recapturing a self-expanding mechanical vascular device, such complex, unnatural hand manipulations make it difficult to achieve precise control with any degree of accuracy. Summary of the Invention [Problem to be solved by the invention]

[0003] It is therefore desirable to develop a system to assist in the delivery (e.g., deployment and / or recapture) of mechanical endovascular treatment devices that provides enhanced control and allows for such complex movements in a more ergonomic, natural manner while applying additional force as needed. [Means for solving the problem]

[0004] One aspect of the present invention is directed to a system that assists in the delivery (e.g., deployment and / or recapture) of mechanical endovascular treatment devices, allowing for complex movements, if desired, in a more ergonomic and natural manner.

[0005] Another aspect of the invention relates to a system for assisting delivery of a mechanical endovascular treatment device, the system including a first assist device having a first linear sliding mechanism. The linear sliding mechanism includes a first non-slidable section, a first slidable section linearly displaceable relative to the first non-slidable section, and a first tensioning device connected to and moving with the first slidable section, the first tensioning device being movable between an unlocked state and a locked state. A first locking hub is fixedly attached to the first non-slidable section, the first locking hub being movable between an unlocked state and a locked state.

[0006] Yet another aspect of the present invention is directed to a system for assisting the delivery of a mechanical endovascular treatment device, the system being configured such that a first tensioning device receives and secures a delivery wire therein, while a first fixation hub receives and secures a microcatheter therein, and when the first tensioning device and the first fixation hub are both in a fixed state, controlled linear movement of the delivery wire can be achieved using a first linear slide mechanism while maintaining the microcatheter in place.

[0007] Yet another aspect of the invention relates to a system for assisting delivery of a mechanical endovascular treatment device, the system including a first tensioning device configured to receive and secure a microcatheter therein, while a first fixation hub configured to receive and secure a guide catheter therein, and when the first tensioning device and the first fixation hub are both in a fixed state, controlled linear movement of the microcatheter can be achieved using a first linear slide mechanism while maintaining the guide catheter in place.

[0008] Yet another aspect of the present invention is directed to a system for assisting in the delivery of a mechanical intravascular treatment device, the system including a first linear sliding mechanism including an extension shaft extending from one end of a first non-slidable section, the first slidable section configured to be telescopically slidable along at least a portion of the extension shaft.

[0009] Another aspect of the invention relates to a system for assisting delivery of a mechanical endovascular treatment device configured such that a first non-slidable section is a first frame having parallel sides and curved opposing ends, the first slidable section is linearly displaceable along a portion of one of the sides of the first frame, and the first slidable section includes a first slider tab connected to a tensioning device via a first connecting arm.

[0010] A further aspect of the present invention is directed to a system for assisting delivery of a mechanical endovascular treatment device, the system further configured to include a second assist device having a second linear slide mechanism, the linear slide mechanism including a second non-slidable section and a second slidable section linearly displaceable relative to the second non-slidable section, and a second tensioning device connected to the second slidable section for movement therewith, the second tensioning device being transitional between an unlocked state and a locked state; a second locking hub fixedly attached to the second non-slidable section, the second locking hub being transitional between an unlocked state and a locked state;

[0011] A still further aspect of the present invention relates to a system for assisting in the delivery of a mechanical intravascular treatment device, wherein the first tensioning device is configured to receive and secure a delivery wire therein, while the first fixation hub is configured to receive and secure a microcatheter therein. When the first tensioning device and the first fixation hub are both in a fixed state, controlled linear movement of the delivery wire can be achieved using a first linear slide mechanism while maintaining the microcatheter in place. The system is further configured to receive and secure a guide catheter therein, while the second tensioning device is configured to receive and secure the microcatheter therein. When the second tensioning device and the second fixation hub are both in a fixed state, controlled linear movement of the microcatheter can be achieved using a second linear slide mechanism while maintaining the guide catheter in place.

[0012] Yet another aspect of the invention is directed to a system for assisting in the delivery of a mechanical endovascular treatment device, the system being configured such that the second non-slidable section is a second frame having parallel sides and curved opposing ends, the second slidable section is linearly displaceable along a portion of one of the sides of the second frame, and the second slidable section includes a second slider tab connected to a second tensioning device via a second connecting arm.

[0013] Yet another aspect of the present invention is directed to a method of using a system for assisting the delivery of a mechanical endovascular treatment device, the system including a first assist device having a first linear sliding mechanism. The first linear sliding mechanism includes a first non-slidable section, a first slidable section linearly displaceable relative to the first non-slidable section, and a first tensioning device connected to and moving with the first slidable section, the first tensioning device being movable between an unlocked state and a locked state. A first locking hub is fixedly attached to the first non-slidable section, the first locking hub being movable between an unlocked state and a locked state. During use of the system, a delivery wire is advanced through a lumen of a microcatheter until a mechanical vascular treatment device disposed at a distal end of the delivery wire emerges from the distal end of the microcatheter, such advancement being achieved using only the first linear sliding mechanism without grasping any portion of the delivery wire.

[0014] Another aspect of the invention relates to a method of using a system for assisting delivery of a mechanical endovascular treatment device, where a first tensioning device receives and secures a delivery wire therein, while a first fixation hub receives and secures a microcatheter therein, and when the first tensioning device and the first fixation hub are both in a fixed state, controlled movement of the delivery wire while maintaining the microcatheter in place can be achieved using a first linear slide mechanism.

[0015] Yet another aspect of the invention is directed to a method of using a system for assisting delivery of a mechanical endovascular treatment device, wherein a first tensioning device receives and secures a microcatheter therein, while a first fixation hub receives and secures a guide catheter therein. When the first tensioning device and the first fixation hub are both in a fixed state, controlled movement of the microcatheter can be achieved using a first linear slide mechanism while maintaining the guide catheter in place.

[0016] Yet another aspect of the present invention relates to a method of using a system for assisting delivery of a mechanical endovascular treatment device, wherein a first linear sliding mechanism includes an extension shaft extending from one end of a first non-slidable section, and the first slidable section is slidable along at least a portion of the extension shaft.

[0017] Another aspect of the invention is directed to a method of using a system for assisting delivery of a mechanical endovascular treatment device, wherein a first non-slidable section is a first frame having parallel sides and curved opposing ends, the first slidable section is linearly displaceable along a portion of one of the sides of the first frame, and the first slidable section includes a first slider tab connected to a tensioning device via a first connecting arm.

[0018] Yet another aspect of the present invention relates to a method of using a system for assisting the delivery of a mechanical endovascular treatment device, the system further including a second assist device having a second linear sliding mechanism. The second linear sliding mechanism includes a second non-slidable section, a second slidable section linearly displaceable relative to the second non-slidable section, and a second tensioning device connected to and moving with the second slidable section, the second tensioning device being movable between an unlocked state and a locked state. The system further includes a second fixation hub fixed in position with the position of the second non-slidable section, the second fixation hub being movable between an unlocked state and a locked state. A method of using the system involves simultaneously advancing and removing the mechanical endovascular treatment device from the distal end of the microcatheter using only the second linear sliding mechanism without grasping any portion of the microcatheter.

[0019] Another aspect of the invention is directed to a method of using a system for assisting delivery of a mechanical intravascular treatment device, wherein a first tensioning device receives and secures a delivery wire therein, while a first fixation hub receives and secures a microcatheter therein. When the first tensioning device and the first fixation hub are both in a fixed state, controlled linear movement of the delivery wire can be achieved using a first linear slide mechanism while maintaining the microcatheter in place. A second tensioning device receives and secures the microcatheter therein, while a second fixation hub receives and secures a guide catheter therein. When the second tensioning device and the second fixation hub are both in a fixed state, controlled linear movement of the microcatheter can be achieved using a second linear slide mechanism while maintaining the guide catheter in place.

[0020] Yet another aspect of the present invention is directed to a method of using a system for assisting delivery of a mechanical endovascular treatment device, wherein the second non-slidable section is a second frame having parallel sides and curved opposing ends, the second slidable section is linearly displaceable along a portion of one of the sides of the second frame, and the second slidable section includes a second slider tab connected to a second tensioning device via a second connecting arm.

[0021] Yet another aspect of the present invention is directed to a method of using a system for assisting in the delivery of a mechanical endovascular treatment device, wherein a first linear slide mechanism associated with the advancing step and a second linear slide mechanism associated with the removing step are performed by moving in respective directions toward each other to deploy the mechanical endovascular treatment device.

[0022] A further aspect of the present invention relates to a method of using a system for assisting delivery of a mechanical endovascular treatment device, wherein a first linear slide mechanism associated with the advancing step and a second linear slide mechanism associated with the detaching step are performed by moving in opposite directions to each other to recapture the mechanical endovascular treatment device within the microcatheter. [Brief explanation of the drawings]

[0023] These and other features of the present invention will become more readily apparent from the following detailed description and drawings which illustrate the invention, and in which like reference numerals refer to like elements throughout the several views. [Figure 1A] 1 shows a schematic diagram of an assist device according to a first embodiment of a system of the present invention for assisting the delivery of a mechanical endovascular treatment device, the assist device being a linear sliding mechanism connected to the proximal end of a microcatheter, wherein a delivery wire is advanced through the lumen of said microcatheter using only the linear sliding mechanism. [Figure 1B] 1A shows the right and left hands of an interventionalist during deployment of a mechanical endovascular treatment device. The right hand controls the advancement ("pushing") of the delivery wire with the mechanical endovascular treatment device located at its distal end, using only the linear sliding mechanism of the assist device of FIG. 1A, without direct physical contact with the delivery wire itself. [Figure 1C] FIG. 1B is a longitudinal cross-sectional view of the assist device of FIG. 1A, depicting the linear slide mechanism in a fully extended position. [Figure 1D] 1C and 1E are longitudinal cross-sectional views of the assist device of FIG. 1A, with the linear slide mechanism depicted in a position approximately midway between the fully extended position of FIG. 1C and the fully retracted position of FIG. 1E. [Figure 1E] FIG. 1B is a longitudinal cross-sectional view of the assist device of FIG. 1A, with the linear slide mechanism depicted in a fully retracted position. [Figure 2A]A first assist device of an assist stem according to a second embodiment of the present invention assembled to a first rotating hemostatic valve for controlled advancement ("pushing") of a delivery wire having a mechanical endovascular treatment device disposed at its distal end, using a first linear slide mechanism while maintaining a microcatheter in place. [Figure 2B] FIG. 2 is a second assist device of an assist system according to a second embodiment of the present invention assembled to a second rotating hemostatic valve for controlled removal ("pullback") of the distal end of the microcatheter, exposing a mechanical endovascular treatment device while maintaining the guide catheter in place. [Figure 2C] 2C is an exemplary schematic assembly of a first assist device and a second assist device, along with the respective rotating hemostatic valves of FIGS. 2A and 2B, for an exemplary assist system according to a second embodiment of the present invention. [Figure 2D] 2C illustrates insertion of the proximal end of the guide catheter through the guide catheter receiving channel of the second assist device of FIG. 2B. [Figure 2E] Figure 2B shows the proximal end of the inserted guide catheter being secured within the guide catheter securing hub of the second rotating hemostatic valve associated with the second assist device (while the second linear slide mechanism of the second assist device is fully retracted ("pushed") toward the guide catheter receiving passage). [Figure 2F] Depicted is loosening a microcatheter tensioning device associated with a second assist device to allow insertion of a distal end of a microcatheter therein, positioning the microcatheter at a target site within a blood vessel, and tightening the microcatheter tensioning device of the second assist device to secure the microcatheter in place. [Figure 2G]Figure 2A depicts the proximal end of the microcatheter being attached to the microcatheter fixation hub of the first assist device (while the first linear slide mechanism is fully extended ("pulled out") to the maximum distance between the microcatheter fixation hub and the delivery wire tensioning device), securing the microcatheter therein. [Figure 2H] Depicted is loosening the delivery wire tensioning device of the first assist device to allow insertion of a delivery wire therein with a mechanical endovascular treatment device disposed at its distal end, positioning the mechanical endovascular treatment device at the target site, and tightening the delivery wire tensioning device to secure the delivery wire in place. [Figure 2I] 1 depicts the bimanual use of an assembled first and second assist device, along with respective first and second rotary hemostatic valves, according to a second embodiment of the assist system of the present invention, where the left hand operates the second linear slide mechanism of the second assist device to remove ("pull back") the distal end of the microcatheter from the mechanical endovascular treatment device, while the right hand operates the first linear slide mechanism of the first assist device to advance ("push") the delivery wire of the mechanical endovascular treatment device located at its distal end. [Figure 3] FIG. 10 shows the use of assembled first and second assist devices with both hands, according to a third exemplary embodiment of an assist device of the present invention, which uses a rotary dial (e.g., thumbwheel) to impart linear motion: the left hand operates the second linear slide mechanism of the second assist device to remove the microcatheter, while the right hand operates the first linear slide mechanism of the first assist device to simultaneously push the delivery wire with the mechanical endovascular treatment device at its distal end. DETAILED DESCRIPTION OF THE INVENTION

[0024] The terms "distal" or "proximal" are used in the following description with reference to a location or direction relative to the treating physician or medical interventionist. "Distal" or "distally" refers to a location that is far from or away from the physician or interventionist and a location that is closest to or toward the target site being treated within the blood vessel. "Proximal" or "proximally" or "proximate" refers to a location that is close to or toward the physician or interventionist and far from or away from the target site being treated within the blood vessel. The terms "occlusion," "clot," or "blockage" are used interchangeably.

[0025] The present invention is directed to a device for assisting the delivery (e.g., deployment and / or recapture) of a mechanical endovascular treatment device (e.g., an automatic, self-expanding stent) using a guide catheter, a microcatheter, and a delivery wire (e.g., a pusher wire) and other possible assist devices. A variety of mechanical configurations can be used to generate the linear motion generated by the linear slide mechanism used with the first assist device and / or the second assist device of the assist system of the present invention and are not limited by the exemplary configurations shown and described. Other configurations of the linear slide mechanism are contemplated and are within the intended scope of the present invention.

[0026] The assist system of the present invention can include (i) a single assist device to assist in the controlled movement of the microcatheter for removal ("pullback"); (ii) a single assist device to assist in the controlled advancement ("pushing") of a delivery wire having a mechanical endovascular treatment device disposed at its distal end; or (iii) both assist devices used simultaneously by the interventional physician, one operated by each hand. As an illustrative example, FIGS. 1A-1E show an assist system according to a first embodiment of the present invention, including only a single or first assist device for assisting in the delivery of a mechanical endovascular treatment device. Meanwhile, exemplary FIGS. 2A-2I show an assist system according to a second embodiment of the present invention, including two assist devices (one associated with each hand) used simultaneously. One assist device controls the movement during removal of the distal end of the microcatheter from the mechanical endovascular treatment device (i.e., the "pullback" operation), while a separate assist device assists in the independent delivery (i.e., the "pushing" operation) of a delivery wire having a mechanical endovascular treatment device disposed at its distal end. 3 shows a third embodiment of the assist system of the present invention, which uses two assist devices simultaneously, such that linear movement is achieved via a rotary dial (e.g., thumbwheel). The assist system of the present invention may be configured as only a single assist device to assist in the delivery / control of a single device (e.g., "pulling back" a microcatheter or "pushing" a delivery wire), or as two assist devices operated simultaneously, although it is contemplated and within the intended scope of the present invention that each assist device may be used to assist in the independent operation of the controlled movement of a device.

[0027] 1A is a side view of a first embodiment of an assist system of the present invention consisting of only a single assist device 100 for assisting the delivery, deployment, and / or recapture of a mechanical vascular treatment device, such as an automatic, self-expanding stent. Starting at the proximal end (i.e., furthest from the target vascular site to be treated (e.g., an aneurysm)) and advancing distally toward the opposite distal end (i.e., closest to the target vascular site to be treated), the assist device 100 preferably includes a linear slide mechanism 115 connected directly to the proximal end of a microcatheter 101 via a fixed hub 114 (e.g., either a fixed or rotating male connector). The microcatheter 101 includes a microcatheter hub 101b fixed to or assembled with a microcatheter shaft 101a. A fluid or irrigation port 116a and an associated fixed female connector luer 116b may be provided for dispensing fluids (e.g., saline) therethrough. Fluid leakage is prevented by multiple seals, namely: (i) a ring seal (e.g., O-ring) 111 positioned radially between the extension shaft 115b and the slide 115c, and (ii) a compression seal 105a positioned at the axial interface between the slide 115c and the delivery wire tensioning device 105.

[0028] Specifically, linear slide mechanism 115 includes delivery wire tensioning device 105 (e.g., a rotary valve) and slidable section 115c, telescopically slidable along extension shaft 115b, fixedly attached to non-sliding portion 115a, which in turn serves as a stop element for limiting or restricting the movement of slidable section 115c. Delivery wire tensioning device 105 is transitionable, preferably by rotation, between an unlocked / released / open / relaxed state and a locked / secured / closed / tensioned state about delivery wire or pusher wire 103. While in the unlocked / released / open / relaxed state, delivery wire or pusher wire 103 can be freely inserted, slid, or advanced through the axial opening / lumen of delivery wire tensioning device 105. While in the locked / secured / closed / tensioned state, delivery wire tensioning device 105 is fixed about delivery wire 103, preventing the two components from displacing relative to one another. The proximal end of the slidable section 115c is fixedly connected / anchored to the distal end of the delivery wire tensioning device 105 so that the two components move linearly together along the extension shaft 115b.

[0029] In a preferred embodiment, initially (in the absence or absence of any externally applied mechanical force applied in the distal direction), the slidable section 115c is in its fully extended position or state (i.e., maximum linear displacement D1 between the non-slidable section 115a and the slidable section 115c, and minimum length L1 of the delivery wire 103 not detached from the microcatheter 101). The non-slidable section 115a acts as a bumper or stop element to limit or restrict the linear displacement of the slidable section 115c in the distal direction.

[0030] During delivery (e.g., deployment or recapture) of the mechanical endovascular treatment device 110, the inventive assist device 100 of FIG. 1A is used to "push" or advance the delivery wire 103 through the lumen of the microcatheter 101, thereby eliminating the need to grasp the delivery wire itself (i.e., without direct finger manipulation of the delivery wire 103 itself). In operation of a first embodiment of the inventive assist device 100, the microcatheter 101 and the mechanical endovascular treatment device 110 disposed within its lumen are properly positioned at the target treatment site using the delivery wire 103. Once properly positioned at the target treatment site, the delivery wire tensioning device 105 secured thereto is moved (e.g., via rotation) to a fixed / closed / clamped / locked state about the delivery wire 103 while the slidable section 115c is in a fully extended state (i.e., maximum linear displacement D1 between the non-slidable section 115a and the slidable section 115c, and minimum length L1 of the delivery wire 103 detached from the microcatheter 101), as shown in FIG. 1C. As the slidable section 115c linearly displaces distally along the extension shaft 115b, the delivery wire 103 secured within the delivery wire tensioning device 105 advances accordingly (as shown in FIGS. 1D and 1E, which show displacements to approximately an intermediate position and a fully compressed / retracted position, respectively). In the fully compressed / retracted position shown in FIG. 1E, a minimum linear displacement D3 exists between the non-slidable section 115a and the slidable section 115c, and a maximum length L3 of the delivery wire 103 is removed from the microcatheter 101.

[0031] 1B, the mechanical endovascular treatment device 110 is deployed using a single assist device according to this first embodiment of the assist system of the present invention. With one hand (e.g., the left hand), the interventionalist removes ("pulls back") the distal end of the mechanical endovascular treatment device 110 by directly manipulating the microcatheter 101 proximally (i.e., toward the first assist device 100), as indicated by the right-pointing arrow. Simultaneously, with the other hand (e.g., the right hand), the interventionalist grasps the slidable section 115c between the little finger and palm, while displacing the slidable section 115c distally (as indicated by the arrow) toward the non-slidable section 115a (held between the thumb and index finger), thereby advancing ("pushes") the mechanical vascular treatment device 110 distally from the distal end of the microcatheter 101 with the delivery wire 103. This combined movement of both hands detaches the distal end of the microcatheter 101 from the distal end of the delivery wire 103 and simultaneously pushes a self-expanding mechanical intravascular treatment device located on the distal end of the delivery wire 103 out of the distal end of the microcatheter 101, causing the mechanical intravascular treatment device to automatically deploy (automatically self-expand to an enlarged diameter) at the target site within the blood vessel. Use of the assist device 100 of the present invention eliminates the need for the interventional physician to directly grasp or hold the delivery wire 103 itself and provides precise control of movement and maximizing force required during navigation of tortuous paths.

[0032] The single assist device 100 shown in FIGS. 1A-1E is used to assist the interventionalist with only one hand (e.g., typically performed using the right hand) in “pushing” a self-expanding mechanical endovascular treatment device over a delivery wire and out the distal end of the microcatheter lumen. The manual dexterity required to advance a delivery wire through the microcatheter lumen while maintaining the microcatheter in place (e.g., typically performed with the right hand) is more complex and unnatural than using the other hand to detach the microcatheter from the self-expanding mechanical endovascular treatment device while maintaining a guide catheter in place (e.g., typically performed with the left hand). Alternative embodiments and configurations are contemplated and within the scope of the present invention, including the use of two assist devices, one for each hand. Such an assist system according to the present invention is shown in FIGS. 2A-2I and includes two simultaneously operated assist devices, with each hand of the interventionalist independently operating a corresponding assist device.

[0033] Referring to FIG. 2A , the assist system of the present invention includes a first assist device 250 for use with one hand (e.g., the right hand) to assist in the controlled forward movement (e.g., “pushing”) of a self-expanding mechanical endovascular treatment device from the distal end of a microcatheter using a delivery wire while maintaining the microcatheter in place. The first rotating hemostatic valve or Y-valve includes a microcatheter fixation hub 255, an irrigation or fluid port 265, a primary shaft 285, and a connector 290, all of which are in fluid communication with each other. The first rotating hemostatic valve or Y-valve is assembled to a first frame 275 of the first assist device, which serves as the first, non-slidable section of a first linear sliding mechanism (as shown in FIG. 2I ), for easy grasping by the interventional physician. In the exemplary illustration, the first frame 275 is a closed loop with parallel longitudinal sides and opposing curved ends (resembling links in a chain) that serve as a handle or grip. The microcatheter fixation hub 255 and irrigation port 265 are disposed on the exterior of the first frame 275, while the primary shaft 285 and connector 290 are disposed on the interior of the first frame 275. The proximal end of the first frame 275 has a delivery wire receiving passage (e.g., a loop or eyelet) 280 defined therein, through which a delivery wire can pass freely. At the opposite distal end of the first frame 275, a microcatheter fixation hub 255 disposed on the exterior of the first frame 275 receives and secures a microcatheter therein, preventing linear movement of the microcatheter once the delivery wire is properly positioned at the target site within the blood vessel. The first linear slide mechanism further includes a slidable section 260 (e.g., a slider or actuator tab) slidable along a portion of one of the longitudinal sides of the first frame 275. The sliding movable section 260 is preferably connected to the delivery wire tensioning device 270 via a connecting arm 262 disposed within the first frame 275. The extension shaft 295 is telescopically slidable within an internal channel or passageway of a connector 290 attached to the distal end of the primary shaft 285 opposite the microcatheter fixation hub 255.Delivery wire tensioning device 270 is attached to the proximal end of extension shaft 295 opposite the proximal end of connector 290. The linear displacement of slide (e.g., slider or actuator tab) 260 is limited by the longitudinal length of linkage arm 262. However, other conventional mechanical devices for limiting linear displacement are contemplated, such as stop elements.

[0034] Referring to FIG. 2B, a second assist device 200 assists an interventionalist in removing ("pulling back") the distal end of a microcatheter from a mechanical endovascular treatment device while maintaining a guide catheter in place. The second assist device 200 includes a second linear slide mechanism including a second non-slidable section, i.e., a second frame 230 (similar in configuration to the first frame 275 of the first assist device). The distal end of the second frame 230 has a guide catheter receiving passage (e.g., a U-shaped channel, loop, or eyelet) 235 defined therein sized to allow the guide catheter to pass freely therethrough. Attached to the second frame is a second rotary hemostatic valve or Y-valve. The second rotary hemostatic valve or Y-valve includes a guide catheter fixation hub 220, an irrigation or fluid port 215, a primary shaft 240, and a connector 245, all of which are in fluid communication with each other. In the exemplary configuration shown in FIG. 2B , a guide catheter securement hub 220 disposed inside the second frame 230 receives and secures the guide catheter therein to prevent movement of the guide catheter when the microcatheter is removed. The second frame 230 includes a microcatheter tensioning device 205 on its exterior, which is securable around the outer surface of the microcatheter. The second frame 230 includes a slidable section (e.g., a slider or actuator tab) 210 along a portion of one of its longitudinal sides. A connecting arm 247 attaches the slidable section 210 to the microcatheter tensioning device 205. The connecting arm 247 is preferably disposed outside / outward of the second frame 230 and is preferably curved to substantially match the curved contoured end of the second frame 230. The connector 245 is connected to the guide catheter securement hub 220 via the primary shaft 240. The guide catheter fixation hub 220, the primary shaft 240, the connector 245, the extension shaft 246, and the microcatheter tensioning device 205 each have an internal channel defined therein for fluid communication with one another.The extension shaft 246 is telescopically slidable within an internal channel or passageway of the connector 245 and is connected to the microcatheter tensioning device 205. The linear displacement of the slider or actuator tab 210 is limited by the curved end of the second frame 230. However, other conventional mechanical configurations for limiting linear displacement are contemplated, such as stop components.

[0035] The two assist devices 200, 250 of Figures 2A and 2B and their respective rotating hemostatic valves are shown in Figure 2C, assembled together as an assist system of the present invention according to a second embodiment. The steps performed during preparation of the assist system of Figure 2C are shown in Figures 2D-2I, each of which is described below.

[0036] In operation, the proximal end of the guide catheter 201 is received through the guide catheter receiving passage 235 (FIG. 2D) and inserted (while in an unlocked, relaxed state) into the guide catheter securement hub 220 of the second assist device 200 (FIG. 2E), and the second linear slide mechanism is maintained in its fully retracted state (i.e., “pushed” toward the guide catheter receiving passage 235 with minimal linear displacement between the microcatheter tensioning device 205 and the connector 245). A detent, catch, pin, or other mechanical component may be used to maintain the slider 210 in the fully retracted state. As an illustrative example, a catch, pin, or other mechanical detent disposed radially outward on the extension shaft 246 may engage an associated recess or other mating member disposed on the interior surface of the passage of the connector 245. The guide catheter securement hub 220 is then moved (e.g., rotated) from an unlocked / unlocked / relaxed state to a locked / locked / tensioned state, as shown in FIG. 2E, to secure the proximal end of the guide catheter therein.

[0037] The microcatheter tensioning device 205 is loosened or unlocked to allow the microcatheter 202 to freely advance to the desired location within the lumen of the guide catheter 201. For example, in clot retrieval, the distal end of the microcatheter 202 is positioned proximal or at the face of the occlusion. Once the distal end of the microcatheter 202 is in the desired location within the target vessel, the microcatheter tensioning device 205 is moved (e.g., tightened by rotation) to a lock / tension / closed / fixed position that maintains the microcatheter 202 in place, as shown in FIG. 2F.

[0038] 2G, the proximal end of microcatheter 202 is then attached to microcatheter securement hub 255 of first assist device 250. The linear slide mechanism unit of first assist device 250 is displaced to an extended state by moving slider or actuator tab 260 away from second assist device 200 (i.e., toward delivery wire receiving passage 280). In this extended state, a catch, pin, or other mechanical engagement member engages with a recess or other mechanical mating member to hold the first linear slide mechanism of first assist device 250 in its extended state, similar to that described above with respect to second assist device 200.

[0039] 2H, delivery wire tensioning device 270 of first assist device 250 is unlocked / relaxed / released (e.g., by rotating). While undergoing fluoroscopy or other imaging using delivery wire 203, a self-expanding mechanical endovascular treatment device positioned proximate the distal end of delivery wire 203 is advanced distally through the lumen of microcatheter 202 until it is proximate the distal end of the microcatheter. Once the self-expanding mechanical vascular treatment device is properly positioned proximate the distal end of microcatheter 202, delivery wire tensioning device 270 is locked / tensioned / closed / fixed (e.g., rotated) about delivery wire 203.

[0040] At this point, the microcatheter 202 and mechanical endovascular treatment device disposed on the distal end of the delivery wire 203 are properly positioned at the target site within the blood vessel, and (i) controlled removal of the distal end of the microcatheter 202 from the mechanical endovascular treatment device is achieved using the second linear slide mechanism of the second assist device 200, and (ii) controlled advancement of the mechanical endovascular treatment device using the delivery wire 203 is achieved using the first linear slide mechanism of the first assist device. During such controlled movement, the guide catheter 201 is maintained in place via the guide catheter fixation hub 220 of the second assist device 200, and the microcatheter 202 is fixed in place via the microcatheter fixation hub 255 of the first assist device 250.

[0041] 2I, with one hand, the interventional surgeon displaces slider or actuator tab 210 of second assist device 200 proximally toward first assist device 250 (i.e., away from guide catheter 201), thereby removing (“pulling back”) the mechanical endovascular treatment device from the distal end of microcatheter 202. During such removal, the guide catheter is secured in place by guide catheter securement hub 220. Simultaneously, with the other hand, the interventional surgeon displaces (“push”) slider or actuator tab 260 of first assist device 250 distally toward second assist device 200, thereby advancing delivery wire 203 through the lumen of microcatheter 202 until the self-expanding mechanical endovascular treatment device exits the distal end of the microcatheter. No longer radially compressed by the inner wall of the lumen of microcatheter 202, the self-expanding mechanical endovascular treatment device automatically deploys to its expanded state (enlarged diameter).

[0042] Up to this point, operation of the system of the present invention has been described for deployment of a mechanical endovascular treatment. Recapture (re-entry) of the mechanical endovascular treatment device can be achieved by performing the reverse of the above. That is, with the second assist device 200 pulled distally (away from the first assist device 250), the mechanical endovascular treatment device is re-entered by the distal end of the microcatheter, while simultaneously with the right hand, the delivery device (with the mechanical endovascular treatment device) is retracted proximally (away from the second assist device 200) to compress its diameter for receipt within the lumen of the microcatheter.

[0043] 3 shows yet another alternative configuration in which the slider 210 or actuator tab 260 associated with each of the linear slide mechanisms of the first assist device 200 and second assist device 250 of FIG. 2I is replaced with a rotary dial 210' or wheel 260' (e.g., a thumbwheel) in combination with a conventional rack and pinion gear arrangement. Although not shown, it is contemplated that the device for actuating the linear slide mechanism may be replaced with a lever or other linear actuation mechanism.

[0044] While the essential novel features of the present invention as applied to the preferred embodiments thereof have been shown, described, and pointed out above, those skilled in the art will recognize that various omissions, substitutions, and changes in the form and details of the illustrated systems / devices, as well as in their operation, may be made without departing from the spirit and scope of the present invention. For example, all combinations of elements and / or steps that perform substantially the same function in substantially the same way to achieve the same result are expressly intended to be encompassed within the scope of the present invention. Furthermore, the substitution of elements from one described embodiment for another is fully intended and anticipated. It should also be understood that the drawings are not necessarily drawn to scale and are merely conceptual. It is therefore intended to be limited only by the scope of the appended claims.

[0045] All issued patents, pending patent applications, publications, articles, books, or other references cited herein are each incorporated herein by reference in their entirety.

[0046] [Embodiment] (1) A system for assisting delivery of a mechanical endovascular treatment device, comprising: a first assist device, the first assist device comprising: a first linear slide mechanism, a first non-slidable section; a first slidable section linearly displaceable relative to the first non-slidable section; a first linear slide mechanism including: a first tensioning device connected to and moving with the first slidable section, the first tensioning device being transitionable between an unlocked state and a locked state; and a first locking hub fixedly attached to the first non-slidable section, the first locking hub being transitionable between an unlocked state and a locked state; Including, the system. (2) The system of embodiment 1, wherein the first tensioning device receives and secures a delivery wire therein while the first fixation hub receives and secures a microcatheter therein, and when the first tensioning device and the first fixation hub are both in the fixed state, controlled linear movement of the delivery wire can be achieved using the first linear slide mechanism while maintaining the microcatheter in place. (3) The system of embodiment 1, wherein the first tensioning device receives and secures a microcatheter therein, the first fixation hub receives and secures a guide catheter therein, and when the first tensioning device and the first fixation hub are both in the fixed state, controlled linear movement of the microcatheter can be achieved using the first linear slide mechanism while maintaining the guide catheter in place. (4) The system of embodiment 1, wherein the first linear sliding mechanism includes an extension shaft extending from one end of the first non-slidable section, and the first slidable section is telescopically slidable along at least a portion of the extension shaft. (5) the first non-slidable section is a first frame having parallel sides and curved opposing ends; the first slidable section is linearly displaceable along a portion of one of the sides of the first frame; the first slidable section includes a first slider tab connected to the first tensioning device via a first connecting arm; A system as described in embodiment 1.

[0047] (6) The method further includes a second support device, wherein the second support device: a second linear slide mechanism, a second non-slidable section; and a second slidable section linearly displaceable relative to the second non-slidable section; and a second tensioning device connected to and moving with the second slidable section, the second tensioning device being transitionable between an unlocked state and a locked state; and a second locking hub fixedly attached to the second non-slidable section, the second locking hub being transitionable between an unlocked state and a locked state; 2. The system of claim 1, comprising: (7) The first tensioning device receives and secures a delivery wire therein while the first fixation hub receives and secures a microcatheter therein, and when the first tensioning device and the first fixation hub are both in the fixed state, controlled linear movement of the delivery wire can be achieved using the first linear slide mechanism while maintaining the microcatheter in place; and the second tensioning device receives and secures the microcatheter therein while the second fixation hub receives and secures a guide catheter therein, and when the second tensioning device and the second fixation hub are both in the fixed state, controlled linear movement of the microcatheter can be achieved using the second linear slide mechanism while maintaining the guide catheter in place. A system as described in embodiment 6. (8) The second non-slidable section is a second frame having parallel sides and curved opposing ends; the second slidable section is linearly displaceable along a portion of one of the sides of the second frame; 7. The system of embodiment 6, wherein the second slidable section includes a second slider tab connected to the second tensioning device via a second connecting arm. (9) A method of using a system for assisting the delivery of a mechanical intravascular treatment device, comprising: the system has a first assist device including a first linear sliding mechanism, the first linear sliding mechanism including a first non-slidable section, a first slidable section linearly displaceable relative to the first non-slidable section, and a first tensioning device connected to the first slidable section and moving therewith, the first tensioning device being movable between an unlocked state and a locked state; the system further includes a first fixed hub fixed in a predetermined position together with a position of the first non-slidable section, the first fixed hub being movable between an unlocked state and a locked state; The method comprises: advancing a delivery wire through a lumen of a microcatheter until the mechanical vascular treatment delivery device disposed at the distal end of the delivery wire emerges from the distal end of the microcatheter, the advancing using only the first linear slide mechanism without grasping any portion of the delivery wire. method. (10) The method of embodiment 9, wherein the first tensioning device receives and secures the delivery wire therein while the first fixation hub receives and secures the microcatheter therein, and when the first tensioning device and the first fixation hub are both in the fixed state, controlled movement of the delivery wire can be achieved using the first linear slide mechanism while maintaining the microcatheter in place.

[0048] (11) The method of embodiment 9, wherein the first tensioning device receives and secures the microcatheter therein, the first fixation hub receives and secures the guide catheter therein, and when the first tensioning device and the first fixation hub are both in the fixed state, controlled movement of the microcatheter can be achieved using the first linear slide mechanism while maintaining the guide catheter in place. (12) The method of embodiment 9, wherein the first linear sliding mechanism includes an extension shaft extending from one end of the first non-slidable section, and the first slidable section is slidable along at least a portion of the extension shaft. (13) The method of embodiment 9, wherein the first non-slidable section is a first frame having parallel sides and curved opposing ends, the first slidable section is linearly displaceable along a portion of one of the sides of the first frame, and the first slidable section includes a first slider tab connected to the first tensioning device via a first connecting arm. (14) The system further includes a second assist device having a second linear sliding mechanism, the second linear sliding mechanism including a second non-slidable section, a second slidable section linearly displaceable relative to the second non-slidable section, and a second tensioning device connected to the second slidable section and moving therewith, the second tensioning device being movable between an unlocked state and a locked state, the system further includes a second fixed hub fixed in a predetermined position together with the position of the second non-slidable section, the second fixed hub being movable between an unlocked state and a locked state, The method comprises: 10. The method of embodiment 9, further comprising, simultaneously with the advancing step, removing the mechanical intravascular treatment device from the distal end of the microcatheter using only the second linear slide mechanism without grasping any portion of the microcatheter. (15) The first tensioning device receives and secures the delivery wire therein, while the first fixation hub receives and secures the microcatheter therein, and when the first tensioning device and the first fixation hub are both in the fixed state, controlled linear movement of the delivery wire can be achieved using the first linear slide mechanism while maintaining the microcatheter in place; the second tensioning device receives and secures the microcatheter therein, and the second fixation hub receives and secures a guide catheter therein, and when the second tensioning device and the second fixation hub are both in the fixed state, controlled linear movement of the microcatheter can be achieved using the second linear slide mechanism while maintaining the guide catheter in place. The method of embodiment 14.

[0049] (16) The method of embodiment 14, wherein the second non-slidable section is a second frame having parallel sides and curved opposing ends, the second slidable section is linearly displaceable along a portion of one of the sides of the second frame, and the second slidable section includes a second slider tab connected to the second tensioning device via a second connecting arm. (17) The method of embodiment 14, wherein the first linear slide mechanism associated with the advancing step and the second linear slide mechanism associated with the releasing step are performed by moving in respective directions toward each other to deploy the mechanical intravascular treatment device. (18) The method of embodiment 14, wherein the first linear slide mechanism associated with the advancing step and the second linear slide mechanism associated with the releasing step are performed by moving in opposite directions to each other to recapture the mechanical intravascular treatment device within the microcatheter.

Claims

1. 1. A system for assisting delivery of a mechanical endovascular treatment device, comprising: a first assist device defining a longitudinal axis, the first assist device comprising: a first linear slide mechanism, a first non-slidable section; and a first slidable section linearly displaceable relative to the first non-slidable section; a first tensioning device connected to and moving with the first slidable section, the first tensioning device receiving a delivery wire therein and transitionable between an unlocked state that does not secure the delivery wire and a locked state that secures the delivery wire; and a first fixation hub fixedly attached to the first non-slidable section, the first fixation hub receiving a microcatheter therein and being movable between an unlocked state in which the microcatheter is not secured and a locked state in which the microcatheter is secured; Including, the first non-slidable section is a first frame having parallel sides and curved opposing ends; the first slidable section is linearly displaceable along a portion of one of the sides of the first frame; The system, wherein the first slidable section includes a first slider tab connected to the first tensioning device via a first connecting arm.

2. The system described in claim 1, wherein when the first tensioning device and the first fixation hub are both in the fixed state, controlled linear movement of the delivery wire can be achieved using the first linear slide mechanism while maintaining the microcatheter in a predetermined position.

3. The first linear slide mechanism includes a shaft extending from one of the opposing ends of the first frame; The system of claim 1 , wherein the first fixation hub, the shaft, and the first tensioning device define an inner lumen extending about the longitudinal axis for receiving the delivery wire therein.

4. and a second assist device, the second assist device comprising: a second linear slide mechanism, a second non-slidable section; and a second slidable section linearly displaceable relative to the second non-slidable section; and a second tensioning device connected to and moving with the second slidable section, the second tensioning device being transitionable between an unlocked state and a locked state; and a second locking hub fixedly attached to the second non-slidable section, the second locking hub being transitionable between an unlocked state and a locked state; The system of claim 1 , comprising:

5. When the first tensioning device and the first fixation hub are both in the fixed state, controlled linear movement of the delivery wire can be achieved using the first linear slide mechanism while maintaining the microcatheter in place; the second tensioning device receives and secures the microcatheter therein, while the second fixation hub receives and secures the guide catheter therein, and when the second tensioning device and the second fixation hub are both in the locked state, controlled linear movement of the microcatheter can be achieved using the second linear slide mechanism while maintaining the guide catheter in place. The system of claim 4.

6. the second non-slidable section is a second frame having parallel sides and curved opposing ends; the second slidable section is linearly displaceable along a portion of one of the sides of the second frame; The system of claim 5 , wherein the second slidable section includes a second slider tab connected to the second tensioning device via a second connecting arm.

7. 2. The system of claim 1, wherein the first tensioning device is located proximal to the first slidable section and the first locking hub is located distal to the first non-slidable section.

8. A system for assisting delivery of a mechanical endovascular treatment device, comprising: A first assist device defining a longitudinal axis, the first assist device comprising: a first linear slide mechanism, a first non-slidable section; and a first slidable section linearly displaceable relative to the first non-slidable section; a first tensioning device connected to and moving with the first slidable section, the first tensioning device receiving a delivery wire therein and transitionable between an unlocked state that does not secure the delivery wire and a locked state that secures the delivery wire; and a first fixation hub fixedly attached to the first non-slidable section, the first fixation hub receiving a microcatheter therein and being movable between an unlocked state in which the microcatheter is not secured and a locked state in which the microcatheter is secured; Including, a first assist device, wherein the first linear slide mechanism includes a shaft extending from one end of the first non-slidable section, the first fixation hub, the shaft, and the first tensioning device defining an inner lumen extending about the longitudinal axis for receiving the delivery wire therein; a second assisting device, the second assisting device comprising: a second linear slide mechanism, a second non-slidable section; and a second slidable section linearly displaceable relative to the second non-slidable section; and a second tensioning device connected to and moving with the second slidable section, the second tensioning device receiving the microcatheter therein and movable between an unlocked state that does not secure the microcatheter and a locked state that secures the microcatheter; and a second fixation hub fixedly attached to the second non-slidable section, the second fixation hub receiving a guide catheter therein and being movable between an unlocked state in which the guide catheter is not locked and a locked state in which the guide catheter is locked; and a second assistive device comprising: the second non-slidable section is a second frame having parallel sides and curved opposing ends; the second slidable section is linearly displaceable along a portion of one of the sides of the second frame; the second slidable section includes a second slider tab connected to the second tensioning device via a second connecting arm.

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