System for assisting in the delivery of a mechanical endovascular treatment device

Abstract

The invention is entitled "Systems for assisting delivery of mechanical endovascular therapeutic devices." The invention discloses a system for assisting delivery of mechanical endovascular therapeutic devices, wherein the system includes a first auxiliary device having a first linear sliding mechanism. The linear sliding mechanism includes a first non-slidable segment, a first slidable segment that is linearly displaceable relative to the first non-slidable segment, and a first tensioning device connected to the first slidable segment for movement therewith; the first tensioning device is convertible between an unsecured state and a secured state. A first securing hub is fixedly attached to the first non-slidable segment, wherein the first securing hub is convertible between an unsecured state and a secured state. The system can also include a second auxiliary device. The auxiliary devices provide enhanced control over movement of a delivery wire and / or a guide catheter.

Description

TECHNICAL FIELD

[0001] The present invention relates to systems for assisting in the delivery (e.g., deployment, recapture) of mechanical endovascular therapeutic devices (e.g., braided flow diverters). In particular, the present invention relates to systems for assisting in the delivery of mechanical endovascular therapeutic devices that are capable of providing additional force during navigation through tortuous vessels and / or providing enhanced control over the precise positioning of the device at a target site in the vessel.

[0002] Related Art

[0003] In the treatment of aneurysms, a plurality of ancillary devices (e.g., guide catheters, microcatheters, and delivery wires) are used to advance a mechanical endovascular therapeutic device (e.g., a braided flow diverter and other self-expanding stent devices) endovascularly through the body to a target location. Once the microcatheter and mechanical endovascular therapeutic device have been positioned at the target site within the vessel, the self-expanding stent is deployed (withdrawn) to an expanded state, thereby diverting blood flow away from the aneurysm. The deployment of such self-expanding mechanical endovascular devices requires significant dexterity and coordinated, complex “push-pull” hand manipulation by the interventionalist using both hands simultaneously, which is not natural, comfortable, or ergonomic. In essence, such hand manipulation for deploying a self-expanding mechanical endovascular therapeutic device requires the interventionalist to push the delivery wire with one hand while holding the hub of the delivery microcatheter with the other hand and simultaneously pulling the microcatheter back (i.e., withdrawing) from the self-expanding mechanical endovascular device, thereby allowing the self-expanding mechanical endovascular device to automatically expand / enlarge at the target site into physical contact with the inner wall of the vessel. In addition to the complex independent movements of both hands simultaneously, relatively high force can be required to counteract the friction experienced during deployment and then recapture the shunt when advancing through tortuous passageways. In the case of challenging anatomy, an assistant can be required to assist the interventionalist. Even if the interventionalist is able to deploy and / or recapture the self-expanding mechanical endovascular device alone, precision control with any accuracy is difficult due to such complex, unnatural hand manipulation.

[0004] Accordingly, it would be desirable to develop a system for assisting in the delivery (e.g., deployment and / or recapture) of mechanical endovascular therapeutic devices that allows for such complex movements in a more ergonomic, natural manner while providing enhanced control and imparting additional force when necessary. SUMMARY

[0005] One aspect of the present invention relates to a system for assisting in the delivery (e.g., deployment and / or recapture) of mechanical endovascular therapeutic devices that allows for complex movements in a more ergonomic, natural manner while providing enhanced control and imparting additional force when necessary.

[0006] Another aspect of the present invention relates to a system for assisting in the delivery of a mechanical endovascular therapeutic device, wherein the system includes a first auxiliary device having a first linear slide mechanism. The linear slide mechanism includes: a first non-slidable segment; a first slidable segment that is linearly displaceable relative to the first non-slidable segment; and a first tensioning device connected to the first slidable segment for movement therewith; the first tensioning device is convertible between an unsecured state and a secured state. A first securing hub is fixedly attached to the first non-slidable segment, wherein the first securing hub is convertible between an unsecured state and a secured state.

[0007] Yet another aspect of the present invention relates to a system for assisting in the delivery of a mechanical endovascular therapeutic device, wherein the system is configured such that the first tensioning device receives and secures therein a delivery wire, and the first securing hub receives and secures therein a microcatheter. Controlled linear movement of the delivery wire can be achieved using the first linear slide mechanism while the microcatheter is held in place when both the first tensioning device and the first securing hub are in the secured state.

[0008] Still another aspect of the present invention relates to a system for assisting in the delivery of a mechanical endovascular therapeutic device, wherein the system is configured such that the first tensioning device receives and secures therein a microcatheter, and the first securing hub receives and secures therein a guide catheter. Controlled linear movement of the microcatheter can be achieved using the first linear slide mechanism while the guide catheter is held in place when both the first tensioning device and the first securing hub are in the secured state.

[0009] Another aspect of the present invention relates to a system for assisting in the delivery of a mechanical endovascular therapeutic device, wherein the system is configured such that the first linear slide mechanism includes an extension shaft extending from one end of the first non-slidable segment, and the first slidable segment is telescopically slidable along at least a portion of the extension shaft.

[0010] Another aspect of the present invention relates to a system for assisting in the delivery of a mechanical endovascular therapeutic device, wherein the system is configured such that the first non-slidable segment is a first frame having parallel sides and curved opposite ends. The first slidable segment is linearly displaceable along a portion of one of the sides of the first frame; wherein the first slidable segment includes a first slider tab connected to the tensioning device via a first connecting arm.

[0011] Another aspect of the present invention relates to a system for assisting in the delivery of a mechanical endovascular therapeutic device, wherein the system is configured to further comprise a second auxiliary device having a second linear sliding mechanism. The second linear sliding mechanism comprises: a second non-slidable segment; a second slidable segment linearly displaceable relative to the second non-slidable segment; and a second tensioning device connected to the second slidable segment for movement therewith; the second tensioning device being convertible between an unsecured state and a secured state. A second securing hub is fixedly attached to the second non-slidable segment; the second securing hub being convertible between an unsecured state and a secured state.

[0012] While another aspect of the present invention relates to a system for assisting in the delivery of a mechanical endovascular therapeutic device, wherein the system is configured such that the first tensioning device receives and secures therein a delivery wire, while the first securing hub receives and secures therein a microcatheter. Controlled linear movement of the delivery wire can be achieved using the first linear sliding mechanism while the microcatheter is held in place when both the first tensioning device and the first securing hub are in the secured state. The system is further configured such that the second tensioning device receives and secures therein the microcatheter, while the second securing hub receives and secures therein a guide catheter. Controlled linear movement of the microcatheter can be achieved using the second linear sliding mechanism while the guide catheter is held in place when both the second tensioning device and the second securing hub are in the secured state.

[0013] Yet another aspect of the present invention relates to a system for assisting in the delivery of a mechanical endovascular therapeutic device, wherein the system is configured such that the second non-slidable segment is a second frame having parallel sides and curved opposite ends. The second slidable segment is linearly displaceable along a portion of one of the sides of the second frame; wherein the second slidable segment comprises a second slider tab connected to the second tensioning device by a second connecting arm.

[0014] Yet another aspect of the present invention relates to a method of using a system to assist in the delivery of a mechanical endovascular therapeutic device, wherein the system comprises a first auxiliary device having a first linear sliding mechanism. The first linear sliding mechanism comprises: a first non-slidable segment; a first slidable segment linearly displaceable relative to the first non-slidable segment; and a first tensioning device connected to the first slidable segment for movement therewith; the first tensioning device being convertible between an unsecured state and a secured state. A first securing hub is fixedly attached to the first non-slidable segment, wherein the first securing hub is convertible between an unsecured state and a secured state. During use of the system, a delivery wire is advanced through a lumen of a microcatheter until a mechanical endovascular therapeutic device disposed at a distal end of the delivery wire emerges from a distal end of the microcatheter; wherein such advancement is achieved using only the first linear sliding mechanism without the need to grasp any portion of the delivery wire.

[0015] Another aspect of the present invention relates to a method for using a system to assist in the delivery of a mechanical endovascular therapeutic device, wherein the first tensioning device receives and secures therein a delivery wire, while the first securing hub receives and secures therein a microcatheter. When both the first tensioning device and the first securing hub are in a secured state, a controlled movement of the delivery wire can be achieved using the first linear sliding mechanism, while the microcatheter is held in place.

[0016] Yet another aspect of the present invention relates to a method for using a system to assist in the delivery of a mechanical endovascular therapeutic device, wherein the first tensioning device receives and secures therein a microcatheter, while the first securing hub receives and secures therein a guide catheter. When both the first tensioning device and the first securing hub are in a secured state, a controlled movement of the microcatheter can be achieved using the first linear sliding mechanism, while the guide catheter is held in place.

[0017] Yet another aspect of the present invention relates to a method for using a system to assist in the delivery of a mechanical endovascular therapeutic device, wherein the first linear sliding mechanism comprises an extension shaft extending from one end of the first non-slidable segment, and the first slidable segment is slidable along at least a portion of the extension shaft.

[0018] Yet another aspect of the present invention relates to a method for using a system to assist in the delivery of a mechanical endovascular therapeutic device, wherein the first non-slidable segment is a first frame having parallel sides and curved opposite ends. The first slidable segment is linearly displaceable along a portion of one of the sides of the first frame; wherein the first slidable segment comprises a first slider tab connected to the tensioning device via a first connecting arm.

[0019] Another aspect of the present invention relates to a method for using a system to assist in the delivery of a mechanical endovascular therapeutic device, wherein the system further comprises a second auxiliary device having a second linear sliding mechanism. The second linear sliding mechanism comprises: a second non-slidable segment; a second slidable segment linearly displaceable relative to the second non-slidable segment; a second tensioning device connected to the second slidable segment for movement therewith, the second tensioning device being convertible between an unsecured state and a secured state. The system further comprises a second securing hub secured in place relative to the second non-slidable segment; the second securing hub being convertible between an unsecured state and a secured state. The method of using the system entails, simultaneously with the advancing step, withdrawing the mechanical endovascular therapeutic device from the distal end of the microcatheter using only the second linear sliding mechanism, without the need to grasp any portion of the microcatheter.

[0020] Another aspect of the present invention relates to a method of using a system to aid in the delivery of a mechanical endovascular therapeutic device, wherein a first tensioning device receives and secures therein a delivery wire, while a first securing hub receives and secures therein a microcatheter. When both the first tensioning device and the first securing hub are in a secured state, a controlled linear movement of the delivery wire can be achieved using a first linear sliding mechanism, while the microcatheter is held in place. A second tensioning device receives and secures therein the microcatheter, while a second securing hub receives and secures therein a guide catheter. When both the second tensioning device and the second securing hub are in a secured state, a controlled linear movement of the microcatheter can be achieved using a second linear sliding mechanism, while the guide catheter is held in place.

[0021] Yet another aspect of the present invention relates to a method of using a system to aid in the delivery of a mechanical endovascular therapeutic device, wherein the second non-slidable segment is a second frame having parallel sides and curved opposite ends; the second slidable segment is linearly displaceable along a portion of one of the sides of the second frame; wherein the second slidable segment comprises a second slider tab connected to the second tensioning device by a second connecting arm.

[0022] Another aspect of the present invention relates to a method of using a system to aid in the delivery of a mechanical endovascular therapeutic device, wherein the first linear sliding mechanism associated with the advancing step and the second linear sliding mechanism associated with the withdrawing step are performed by moving towards each other in respective directions to deploy the mechanical endovascular therapeutic device.

[0023] An additional aspect of the present invention relates to a method of using a system to aid in the delivery of a mechanical endovascular therapeutic device, wherein the first linear sliding mechanism associated with the advancing step and the second linear sliding mechanism associated with the withdrawing step are performed by moving in opposite directions to each other to recapture the mechanical endovascular therapeutic device within the microcatheter. BRIEF DESCRIPTION OF DRAWINGS

[0024] The above described and other features of the present invention will become more apparent from the following detailed description of the invention when taken in conjunction with the accompanying drawings, in which like reference characters refer to like elements throughout the several views and in which:

[0025] Figure 1A A schematic view of an assisting device according to a first embodiment of the system of the present invention is shown, the assisting device being used to aid in the delivery of a mechanical endovascular therapeutic device; the assisting device is a linear sliding mechanism connected to a proximal end of a microcatheter; wherein only the linear sliding mechanism is used to advance a delivery wire through a lumen of the microcatheter;

[0026] Figure 1B A right hand and a left hand of an interventionalist during deployment of a mechanical endovascular therapeutic device are shown; wherein the right hand only uses Figure 1Alinear slide mechanism of an auxiliary device to control the advancement ("push") of the delivery wire without direct physical contact to the delivery wire itself, wherein the mechanical endovascular therapeutic device is disposed at the distal end of the delivery wire;

[0027] Figure 1C is a longitudinal cross-sectional view of the auxiliary device of Figure 1A , wherein the linear slide mechanism is shown in a fully extended position;

[0028] Figure 1D is a longitudinal cross-sectional view of the auxiliary device of Figure 1A , wherein the linear slide mechanism is shown in a Figure 1C position approximately midway between the fully extended position of Figure 1E and the fully retracted position of

[0029] Figure 1E is a longitudinal cross-sectional view of the auxiliary device of Figure 1A , wherein the linear slide mechanism is shown in a fully retracted position;

[0030] Figure 2A is a first auxiliary device of an auxiliary system according to the second embodiment of the present invention, which is assembled to a first rotary hemostatic valve for controlling the advancement ("push") of a delivery wire having a mechanical endovascular therapeutic device disposed at its distal end using a first linear slide mechanism, while holding a microcatheter in place;

[0031] Figure 2B is a second auxiliary device of an auxiliary system according to the second embodiment of the present invention, which is assembled to a second rotary hemostatic valve for controlling the withdrawal ("pullback") of the distal end of a microcatheter, thereby exposing a mechanical endovascular therapeutic device, while holding a guide catheter in place;

[0032] Figure 2C is an exemplary schematic assembly of the Figure 2A and Figure 2B first and second auxiliary devices of an exemplary auxiliary system according to the second embodiment of the present invention, along with their respective rotary hemostatic valves;

[0033] Figure 2D shows the insertion of the proximal end of a guide catheter through the guide catheter receiving channel of the second auxiliary device of Figure 2B ;

[0034] Figure 2E shows the fixation of the inserted proximal end of the guide catheter in the guide catheter, thereby fixing the hub of the second rotary hemostatic valve associated with the second auxiliary device of Figure 2B , while the second linear slide mechanism of the second auxiliary device is fully retracted ("pushed in") towards the guide catheter receiving channel;

[0035] Figure 2F loosening of the microcatheter tensioning device associated with the second auxiliary device to allow insertion of the distal end of the microcatheter therein; positioning of the microcatheter to the target site within the blood vessel; and tightening of the microcatheter tensioning device of the second auxiliary device to secure the microcatheter in place;

[0036] Figure 2G showing attachment of the proximal end of the microcatheter to the microcatheter fixation hub of the first auxiliary device (while the first linear sliding mechanism fully extends (“pulls out”) the maximum distance between the microcatheter fixation hub and the delivery wire tensioning device), thereby securing the microcatheter therein; Figure 2A

[0037] Figure 2H showing loosening of the delivery wire tensioning device of the first auxiliary device to allow insertion of the delivery wire therein, with the mechanical endovascular therapeutic device disposed at the distal end of the delivery wire; positioning of the mechanical endovascular therapeutic device at the target site; tightening of the delivery wire tensioning device to secure the delivery wire in place;

[0038] Figure 2I showing dual-handed use of the assembled first and second auxiliary devices of the second embodiment of the auxiliary system according to the present invention along with their respective first and second rotary stopcock valves; i.e., with the left hand withdrawing (“pulling back”) the distal end of the microcatheter from the mechanical endovascular therapeutic device by manipulating the second linear sliding mechanism of the second auxiliary device, while simultaneously with the right hand advancing (“pushing”) the delivery wire by manipulating the first linear sliding mechanism of the first auxiliary device, with the mechanical endovascular therapeutic device disposed at the distal end of the delivery wire; and

[0039] Figure 3 showing dual-handed use of the assembled first and second auxiliary devices of the exemplary third embodiment of the auxiliary system according to the present invention employing rotary dials (e.g., thumbwheels) to impart linear movement; i.e., with the left hand withdrawing the microcatheter by manipulating the second linear sliding mechanism of the second auxiliary device, while simultaneously with the right hand advancing the delivery wire by manipulating the first linear sliding mechanism of the first auxiliary device, with the mechanical endovascular therapeutic device at the distal end of the delivery wire. DETAILED DESCRIPTION

[0040] ​The terms "distal" or "proximal" are used in the following description in relation to position or orientation relative to the treating physician or medical interventionalist. "Distal" or "distally" is a position that is away from or in a direction away from the physician or interventionalist and closest to or in a direction toward the target site to be treated in the vessel. "Proximal" or "proximally" or "proximate" is a position that is close to or in a direction toward the physician or medical interventionalist and away from or in a direction away from the target site to be treated in the vessel. The terms "occlusion," "clot" or "blockage" are used interchangeably.

[0041] The present invention relates to a device that assists during delivery (e.g., deployment and / or recapture) of a mechanical endovascular therapeutic device (e.g., a self-expanding stent) that employs a guide catheter, a microcatheter and a delivery wire (e.g., a push wire) and other possible assisting devices. Various mechanical configurations can be used to produce linear movement that is generated by a linear sliding mechanism used with the first and / or second assisting devices of the assisting system of the present invention and the various mechanical configurations are not limited to the exemplary configurations shown and described. Other configurations of the linear sliding mechanism are conceivable and within the intended scope of the present invention.

[0042] The assisting system of the present invention can include (i) a single assisting device that facilitates controlled movement of withdrawal ("pullback") of the microcatheter, (ii) a single assisting device that facilitates controlled advancement ("pushing") of the delivery wire having the mechanical endovascular therapeutic device disposed at its distal end, or (iii) two assisting devices used simultaneously by the interventionalist, one in each hand. By way of illustrative example, Figures 1A-1E An assisting system according to a first embodiment of the present invention is shown that includes only a single or first assisting device to facilitate delivery of the mechanical endovascular therapeutic device. However, the exemplary Figures 2A-2I An assisting system according to a second embodiment of the present invention is shown that includes two assisting devices employed simultaneously (one in each hand). One assisting device controls movement of the distal end of the microcatheter during withdrawal (i.e., "pullback" operation) from the mechanical endovascular therapeutic device while a separate assisting device facilitates independent delivery (i.e., "pushing" operation) of the delivery wire having the mechanical endovascular therapeutic device disposed at its distal end. Figure 3A third embodiment of the present auxiliary system employing two auxiliary devices simultaneously is shown, wherein linear movement is achieved by rotating a turntable (e.g., a thumbwheel). The present auxiliary system is contemplated and constructed within the intended scope of the present invention as either a single auxiliary device only to facilitate delivery / control of a single device (e.g., “pull back” of a microcatheter or “push” of a delivery wire), or two auxiliary devices operating simultaneously, wherein each auxiliary device is used to assist independent operation of controlled movement of a device.

[0043] Figure 1A A side view of a first embodiment of the present auxiliary system, the auxiliary system includes a single auxiliary device 100 only to facilitate delivery, deployment, and / or recapture of a mechanical vascular therapeutic device (e.g., an automatic self-expanding stent). Proceeding from a proximal end (i.e., furthest from a target vascular site (e.g., an aneurysm) to be treated) and in a distal direction toward an opposite distal end (i.e., closest to the target vascular site to be treated), the auxiliary device 100 preferably includes a linear sliding mechanism 115 that is directly connected to a proximal end of a microcatheter 101 via a fixed hub 114 (e.g., a fixed or rotating male connector). The microcatheter 101 includes a microcatheter hub 101b that is fixed or assembled to a microcatheter shaft 101a. A fluid or flush port 116a and an associated fixed female connector luer hub 116b can be provided for dispensing fluid (e.g., a saline solution) therethrough. Leakage of the fluid is prevented by a plurality of seals, namely: (i) an annular seal (e.g., an O-ring) 111 disposed radially between an extension shaft 115b and a sliding segment 115c; and (ii) a compression seal 105a located at an axial interface between the sliding segment 115c and a delivery wire tensioning device 105.

[0044] In particular, the linear sliding mechanism 115 includes a delivery wire tensioning device (e.g., a rotary valve) 105, a slidable segment 115c that is telescopically slidable along an extension shaft 115b that is in turn fixedly mounted to a non-slidable segment 115a that serves as a stop element to limit or define movement of the slidable segment 115c. The delivery wire tensioning device 105 is transitionable between an unlocked / released / opened / loosened state and a locked / fixed / closed / tensioned state preferably by rotation about a delivery wire or push wire 103. When in the unlocked / released / opened / loosened state, the delivery wire or push wire 103 is freely insertable, slidable, or advanceable through an axial opening / lumen of the delivery wire tensioning device 105; when in the locked / fixed / closed / tensioned state, the delivery wire tensioning device 105 is fixed about the delivery wire 103, thereby preventing displacement of the two components relative to one another. A proximal end of the slidable segment 115c is fixedly connected / fixed to a distal end of the delivery wire tensioning device 105 such that the two components are simultaneously linearly moved together along the extension shaft 115b.

[0045] In a preferred embodiment, initially (in the absence of any externally applied mechanical force applied in the distal direction), the slidable segment 115c is in its fully extended position or state (i.e., the maximum linear displacement D1 between the non-slidable segment 115a and the slidable segment 115c; and the minimum length L1 of the delivery line 103 withdrawn from the microcatheter 101), as... Figure 1C As shown. The non-sliding segment 115a acts as a buffer or stop element to limit or restrict the linear displacement of the sliding segment 115c in the distal direction.

[0046] During delivery (e.g., deployment or recapture) of the mechanical endovascular treatment device 110, using Figure 1A The assistive device 100 of the present invention eliminates the need to grasp the delivery line itself by “pushing” or advancing the delivery line 103 through the lumen of the microcatheter 101 (i.e., no direct finger manipulation of the delivery line 103 itself is required). In operation of a first embodiment of the assistive system 100 of the present invention, the delivery line 103 is used to properly position the microcatheter 101 and the mechanical endovascular treatment device 110 disposed in its lumen at the target treatment site. Once properly positioned at the target treatment site, and with the slidable segment 115c in a fully extended state (i.e., the maximum linear displacement D1 between the non-slidable segment 115a and the slidable segment 115c; and the minimum length L1 of the delivery line 103 withdrawn from the microcatheter 101), as Figure 1C As shown, the delivery line tensioning device 105 fixed thereto is rotated (e.g., by rotation) around the delivery line 103 to a fixed / closed / tensioned / locked state. When the sliding segment 115c is linearly displaced in the distal direction along the extension axis 115b, the delivery line 103 fixed within the delivery line tensioning device 105 is advanced along with it (e.g., ...). Figure 1D and Figure 1E As shown, the displacement is illustrated at approximately the midpoint and at the fully compressed / retracted position, respectively. Figure 1E In the fully compressed / retracted position shown, there is a minimum linear displacement D3 between the non-sliding segment 115a and the sliding segment 115c; while the maximum length L3 of the delivery line 103 is withdrawn from the microcatheter 101.

[0047] See Figure 1BThe interventionalist deploys the mechanical endovascular therapeutic device 110 using the single assist device of the first embodiment of the assist system according to the present application. With one hand (e.g., the left hand), the interventionalist withdraws ("pulls back") the distal end of the mechanical endovascular therapeutic device 110 by directly hand-manipulating the microcatheter 101 in the proximal direction (i.e., toward the first assist device 100) as indicated by the rightward arrow. At the same time, with the other hand (e.g., the right hand), the interventionalist displaces the slidable segment 115c in the distal direction (as indicated by the arrow) toward the non-slidable segment 115a (grasped between the thumb and index finger) while grasping the slidable segment 115c between the little finger and the palm, thereby advancing ("pushing") the mechanical endovascular therapeutic device 110 along the delivery wire 103 out of the distal end of the microcatheter 101 in the distal direction. This combined motion of the two hands withdraws the distal end of the microcatheter 101 from the distal end of the delivery wire 103 while simultaneously pushing the self-expanding mechanical endovascular therapeutic device disposed at the distal end of the delivery wire 103 out of the distal end of the microcatheter 101 such that the mechanical endovascular therapeutic device automatically deploys (automatically self-expands to an expanded diameter) at the target site in the blood vessel. The use of the assist device 100 of the present application eliminates the need for the interventionalist to directly grasp or hold the delivery wire 103 itself, thereby providing precise control of movement and the maximum force required during navigation of tortuous pathways.

[0048] Figures 1A-1E The single assist device 100 shown in FIG. 1 is used only to assist the interventionalist's one hand (e.g., typically performed using the right hand) in "pushing" the self-expanding mechanical endovascular therapeutic device out of the distal end of the microcatheter's lumen via the delivery wire. The manual dexterity required to advance the delivery wire through the microcatheter's lumen while simultaneously holding the microcatheter in place (e.g., typically performed using the right hand) is more complex and unnatural than manipulating the other hand to withdraw the microcatheter from the self-expanding mechanical endovascular therapeutic device while simultaneously holding the guide catheter in place (e.g., typically performed using the left hand). Alternative embodiments and configurations are contemplated and within the scope of the present application in which two assist devices are employed, one assist device for each hand. Such assist systems according to the present application are shown in FIGS. 2 and 3, which include two assist devices operating simultaneously, each hand of the interventionalist independently manipulating a corresponding assist device. Figures 2A-2I

[0049] Referring to FIG. 2, the assist system 200 according to the present application includes two assist devices 100a and 100b, each assist device 100a and 100b being independently manipulated by a corresponding hand of the interventionalist. The interventionalist's left hand manipulates the first assist device 100a to advance the delivery wire 103 out of the distal end of the microcatheter 101 in the distal direction, while the interventionalist's right hand manipulates the second assist device 100b to withdraw the distal end of the microcatheter 101 from the distal end of the delivery wire 103 in the proximal direction. The interventionalist's left hand also manipulates the first assist device 100a to advance the delivery wire 103 out of the distal end of the microcatheter 101 in the distal direction, while the interventionalist's right hand manipulates the second assist device 100b to withdraw the distal end of the microcatheter 101 from the distal end of the delivery wire 103 in the proximal direction. Figure 2A ​The assistive system of the present invention includes a first assistive device 250 for use with one hand (e.g., the right hand) to assist in controlling the propulsive movement (e.g., "push") of the self-dilatating mechanical endovascular treatment device away from the distal end of the microcatheter using a delivery line, while holding the microcatheter in place. A first rotary hemostatic valve or Y-valve includes a microcatheter fixation hub 255, a flushing or fluid port 265, a spindle 285, and a connector 290, all of which are in fluid communication with each other. The first rotary hemostatic valve or Y-valve is assembled to a first frame 275 of the first assistive device, which serves as a first non-slidable segment of a first linear sliding mechanism for easy gripping by the interventional surgeon (e.g., ...). Figure 2I (As shown). In an exemplary embodiment, the first frame 275 is a closed loop (similar to a chain link) having parallel longitudinal sides and opposite curved ends, which serves as a handle or gripper. A microcatheter retaining hub 255 and a flushing port 265 are disposed outside the first frame 275, while a spindle 285 and a connector 290 are disposed inside the first frame 275. The proximal end of the first frame 275 has a delivery line receiving channel (e.g., a collar or eyelet) 280 defined therein, through which the delivery line can freely pass. At the opposite distal end of the first frame 275, the microcatheter retaining hub 255, disposed outside the first frame 275, receives and retains the microcatheter therein to prevent linear movement of the microcatheter once the delivery line is properly positioned at the target site in the blood vessel. The first linear sliding mechanism also includes a slidable segment 260 (e.g., a slider or actuator protrusion) that can slide along a portion of one of the longitudinal sides of the first frame 275. The slidable segment 260 is connected to the delivery line tensioning device 270 via a connecting arm 262 preferably disposed within the first frame 275. An extension shaft 295 is telescopably slidable within an internal passage or channel of a connector 290, which is attached to the distal end of a main shaft 285 opposite to the distal end of the microcatheter retaining hub 255. The delivery line tensioning device 270 is attached to the proximal end of the extension shaft 295 opposite to the proximal end of the connector 290. The linear displacement of the sliding segment (e.g., a slider or actuator protrusion) 260 is limited by the length of the connecting arm 262 in the longitudinal direction; however, other conventional mechanical devices, such as stop elements, are contemplated for limiting linear displacement.

[0050] See Figure 2B, the second auxiliary device 200 helps the interventionalist to withdraw ("pull back") the distal end of the microcatheter from the mechanical intravascular therapeutic device while keeping the guide catheter in place. The second auxiliary device 200 includes a second linear sliding mechanism including a second non-slidable segment, i.e., a second frame 230 (similar in configuration to the first frame 275 of the first auxiliary device). The distal end of the second frame 230 has a guide catheter receiving channel (e.g., a U-shaped channel, a collar, or a bore) 235 defined therein that is sized to allow the guide catheter to pass freely therethrough. A second rotary stopcock or Y-valve is assembled to the second frame. The second rotary stopcock or Y-valve includes a guide catheter fixation hub 220, an irrigation or fluid port 215, a spindle 240, and a connector 245, all of which are in fluid communication with one another. In Figure 2B In the exemplary configuration shown, the guide catheter fixation hub 220 disposed inside the second frame 230 receives and secures the guide catheter therein in place to prevent it from moving as the microcatheter is withdrawn. External to the second frame 230 is a microcatheter tensioning device 205 that is securable about the outer surface of the microcatheter. Slidable along a portion of one of the longitudinal sides of the second frame 230 is a slidable segment (e.g., a slider or actuator tab) 210. A connecting arm 247 attaches the slidable segment 210 to the microcatheter tensioning device 205. The connecting arm 247 is preferably disposed external / outer to the second frame 230 and is preferably curved to substantially conform to the curved profile end of the second frame 230. The connector 245 is connected to the guide catheter fixation hub 220 via the spindle 240. The guide catheter fixation hub 220, the spindle 240, the connector 245, the extension shaft 246, and the microcatheter tensioning device 205 each have an internal passageway defined therein that is in fluid communication with one another. The extension shaft 246 is telescopically slidable within the internal passageway or channel of the connector 245 and is connected to the microcatheter tensioning device 205. 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 a stop member.

[0051] The two auxiliary devices 200, 250 and their respective rotary stopcocks are assembled together as an auxiliary system of the present invention according to a second embodiment Figure 2A and Figure 2B are shown in Figure 2C . The steps taken during the preparation of the auxiliary system of Figures 2D-2I are depicted in Figure 2C . Each of these is described below.

[0052] During operation, the proximal end of the guide catheter 201 is passed through the guide catheter receiving channel 235 Figure 2DThe guide tube fixing hub 220 of the second auxiliary device 200 is received and inserted (when in the unlocked, unfixed, or loose state). Figure 2E In this configuration, the second linear sliding mechanism remains in its fully retracted state (i.e., "pushed" towards the guide tube receiving channel 235 with minimal linear displacement between the microcatheter tensioning device 205 and the connector 245). Stops, fasteners, pins, or other mechanical components may be used to hold the slider 210 in the fully retracted state. By way of illustrative example, a fastener, pin, or other mechanical stop radially outwardly disposed on the extension shaft 246 may engage with an associated recess or other mating component disposed on the inner surface of the channel of the connector 245. The guide tube retaining hub 220 then transitions (e.g., rotates) from an unlocked / unsecured / loosened state to a locked / secured / tensioned state, thereby securing the proximal end of the guide tube therein, as... Figure 2E As shown.

[0053] The microcatheter tensioning device 205 is released or unlocked to allow the microcatheter 202 to freely advance to the desired location within the lumen of the guide tube 201. For example, during clot retrieval, the distal end of the microcatheter 202 is located on the proximal side or face of the blockage. Once the distal end of the microcatheter 202 is at the desired location within the target vessel, the microcatheter tensioning device 205 is switched (e.g., by rotational tightening) to a locked / tensioned / closed / secured position that holds the microcatheter 202 in place, such as... Figure 2F As shown.

[0054] Then, in Figure 2G In this configuration, the proximal end of the microcatheter 202 is attached to the microcatheter retaining hub 255 of the first auxiliary device 250. The linear sliding mechanism unit of the first auxiliary device 250 is displaced in its extended state by moving the slider or actuator protrusion 260 in a direction away from the second auxiliary device 200 (i.e., toward the delivery line receiving channel 280). In this extended state, fasteners, pins, or other mechanical stops engage with recesses or other mechanically mating components to hold the first linear sliding mechanism of the first auxiliary device 250 in its extended state, similar to the situation described above regarding the second auxiliary device 200.

[0055] The delivery line tensioning device 270 of the first auxiliary device 250 unlocks / releases (e.g., by rotation), such as Figure 2HThe self-expanding mechanical endovascular treatment device disposed near the distal end of the delivery wire 203 is advanced in the distal direction through the lumen of the microcatheter 202 (as indicated by the arrow) using the delivery wire 203 while being subjected to fluoroscopy or other imaging until near the distal end of the microcatheter. Once the self-expanding mechanical endovascular treatment device is properly positioned near the distal end of the microcatheter 202, the delivery wire tensioning device 270 locks / tensions / closes / secures (e.g., rotates) around the delivery wire 203.

[0056] At this point, the microcatheter 202 and the mechanical endovascular treatment device disposed at the distal end of the delivery wire 203 are properly positioned at the target site in the blood vessel while (i) controlled withdrawal of the distal end of the microcatheter 202 from the mechanical endovascular treatment device is achieved using the second linear sliding mechanism of the second auxiliary device 200; and (ii) controlled advancement of the mechanical endovascular treatment device using the delivery wire 203 is achieved using the first linear sliding mechanism of the first auxiliary device. During such controlled movements, the guide catheter 201 is held in place via the guide catheter securing hub 220 of the second auxiliary device 200, while the microcatheter 202 is secured in place via the microcatheter securing hub 255 of the first auxiliary device 250.

[0057] Referring to Figure 2I , the interventionalist shifts the slider or actuator tab 210 of the second auxiliary device 200 in the proximal direction (away from the guide catheter 201) with one hand, thereby withdrawing (“pulling back”) the mechanical endovascular treatment device from the distal end of the microcatheter 202. During such withdrawal movements, the guide catheter is secured in place by the guide catheter securing hub 220. At the same time, with the other hand, the interventionalist shifts (“pushes”) the slider or actuator tab 260 of the first auxiliary device 250 in the distal direction toward the second auxiliary device 200, thereby advancing the delivery wire 203 through the lumen of the microcatheter 202 until the self-expanding mechanical endovascular treatment device exits from the distal end of the microcatheter. No longer being radially compressed by the inner wall of the lumen of the microcatheter 202, the self-expanding mechanical endovascular treatment device automatically expands to its expanded state (enlarged diameter).

[0058] Until this point, the operation of the system according to the present application has been described for deployment of a mechanical endovascular treatment. Recapture (re-sheathing) of the mechanical endovascular treatment device can be achieved by performing operations opposite to those described above. That is, with the second auxiliary device 200 pulled in the distal direction (away from the first auxiliary device 250), the mechanical endovascular treatment device is re-sheathed by the distal end of the microcatheter, while the delivery device (together with the mechanical endovascular treatment device) is withdrawn in the proximal direction (away from the second auxiliary device 200) with the right hand, its diameter being compressed to be received within the lumen of the microcatheter.

[0059] Figure 3 For another configuration, respectively with Figure 2I The slider or actuator protrusions 210, 260 associated with the linear sliding mechanism of each of the first and second auxiliary devices 200, 250 are replaced with rotating disks or wheels 210', 260' (e.g., finger wheels) that are coupled with conventional rack and pinion drives. Although not shown, it is also conceivable that the means for actuating the linear sliding mechanism may be replaced by levers or other linear actuation mechanisms.

[0060] Therefore, although the essential novel features of the invention applied to its preferred embodiments have been shown, described, and pointed out, it should be understood that various omissions, substitutions, and changes in form and detail can be made to the illustrated system / apparatus and its operation by those skilled in the art without departing from the spirit and scope of the invention. For example, it is clearly contemplated that all combinations of those elements and / or steps that perform substantially the same function in substantially the same manner to achieve the same result are within the scope of the invention. Substitution of elements from one described embodiment to another is also entirely conceivable and envisionable. It should also be understood that the drawings are not necessarily drawn to scale, but are merely conceptual in nature. Therefore, limitation is intended only as indicated by the scope of the appended claims.

[0061] Each published patent, pending patent application, publication, journal article, book, or other reference cited in this article is incorporated in its entirety by way of citation.

Claims

1. A system to assist in the delivery of a mechanical endovascular therapeutic device, the system comprising: a delivery wire; a first assistance device, the first assistance device comprising: a first linear sliding mechanism, the first linear sliding mechanism comprising: a first non-slidable segment; a first slidable segment, the first slidable segment being linearly displaceable relative to the first non-slidable segment; an extension shaft; a first tensioning device, the first tensioning device being directly connected to the first slidable segment to move with the extension shaft; the first tensioning device being convertible between an unsecured state and a secured state; the first tensioning device receiving and securing the delivery wire therein; and a first securing hub, the first securing hub being fixedly attached to the first non-slidable segment; the first securing hub being convertible between an unsecured state and a secured state; wherein the delivery wire extends through the first non-slidable segment, the extension shaft, the first tensioning device, and the first securing hub; wherein the first non-slidable segment is a first frame having parallel sides and curved opposite ends forming a loop around the extension shaft through which the delivery wire passes; the first slidable segment being linearly displaceable along a portion of one of the sides of the first frame; wherein the first slidable segment comprises a first slider tab connected to the first tensioning device by a first connecting arm.

2. The system of claim 1, wherein, the first tensioning device receiving and securing therein the delivery wire while the first securing hub receives and secures therein a microcatheter; and wherein when both the first tensioning device and the first securing hub are in the secured state, controlled linear movement of the delivery wire can be achieved using the first linear sliding mechanism while the microcatheter is held in place.

3. The system of claim 1, wherein, the first tensioning device receiving and securing therein a microcatheter while the first securing hub receives and secures therein a guide catheter; and wherein when both the first tensioning device and the first securing hub are in the secured state, controlled linear movement of the microcatheter can be achieved using the first linear sliding mechanism while the guide catheter is held in place.

4. The system of claim 1, wherein, the system further comprising: a second assistance device, the second assistance device comprising: a second linear sliding mechanism, the second linear sliding mechanism comprising: a second non-slidable segment; a second slidable segment, the second slidable segment being linearly displaceable relative to the second non-slidable segment; a second tensioning device, the second tensioning device being connected to the second slidable segment to move together; the second tensioning device being convertible between an unsecured state and a secured state; and a second securing hub, the second securing hub being fixedly attached to the second non-slidable segment; the second securing hub being convertible between an unsecured state and a secured state.

5. The system of claim 4, wherein, The first tensioning device receives and secures therein the delivery wire, while the first securing hub receives and secures therein a microcatheter; and wherein when both the first tensioning device and the first securing hub are in the secured state, controlled linear movement of the delivery wire can be achieved using the first linear sliding mechanism, while the microcatheter is held in place; wherein the second tensioning device receives and secures therein the microcatheter, while the second securing hub receives and secures therein a guide catheter; and wherein when both the second tensioning device and the second securing hub are in the secured state, controlled linear movement of the microcatheter can be achieved using the second linear sliding mechanism, while the guide catheter is held in place.

6. The system of claim 4, wherein, The second non-slidable segment is a second frame having parallel sides and curved opposite ends; the second slidable segment is linearly displaceable along a portion of one of the sides of the second frame; wherein the second slidable segment comprises a second slider tab connected to the second tensioning device by a second connecting arm.

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