Minimal invasive procedure controller

Abstract

An interface-device and method for operating a material removal instrument for removal of material from a body passage of a treated subject. The interface device comprises a housing, two or more slider elements each connectable to either a wire or a tube of the material removal instrument and configured for sliding motion inside the housing, and an actuation mechanism configured to move the one or more sliders inside the housing in a predefined sequence determined by a procedure to be thereby carried out.

Description

[0001] MINIMAL INVASIVE PROCEDURE CONTROLLER

[0002] TECHNOLOGICAL FIELD

[0003] The present invention is generally in the field of catheter intervention devices useful for clot removal, and more specifically relates to a device for interfacing and operating a minimal invasive treatment and / or diagnostic instrument.

[0004] BACKGROUND

[0005] A blood clot, also known as a thrombus, can interrupt and even block blood flow to critical tissues and organs in the body, that can be limb or life-threatening. Common places for blood clots to occur in are the legs, arms, intestines, brain, lungs and heart. Some blood clots only require treatment with medicine like anticoagulants or thrombolytic s. There are however cases when intervention is required to remove blood clots from a treated subject.

[0006] There are various surgical or interventional treatments to remove blood clots in an artery or vein to help restore blood flow through a blood vessel. One such common treatment is catheter-based thrombectomy in which a catheter is inserted into an incision (e.g., at the groin, arm or neck), and advanced therefrom through the vascular system to the blood clot (treatment site). Then, a clot removal device (e.g., a stent retriever, suction balloon) is introduced to capture the blood clot and bring it inside the catheter to remove it from the blood vessel completely. However, there are significant challenges associated with designing clot removal devices that can deliver high levels of protection.

[0007] Most of the solutions used nowadays rely heavily on extra hand manipulation by the practitioner to precisely, safely, and reliably arrange and position the clot removal devices within the vasculature, without rupturing the blood vessel walls, while preventing particles / fractures of the clot to enter the flow of blood in the vasculature. In turn, success and safety rely heavily on practitioner's manual accuracy during delivery, typically under relatively poor non-invasive visualization supervision. Such approaches therefore unnecessarily increased risk of injury to the patient.

[0008] The manual operation of elements of clot removal devices (e.g., wires, balloons, tubes) can thus turn to be unsafe due to lack of control and exertion of too much pressure on the blood vessel. Accordingly, there remains a need for new devices to controllably, safely and effectively remove an obstructing clot from within blood vessels. GENERAL DESCRIPTION

[0009] There is a need in the art for interfacing equipment usable for accurate and easy manipulation of catheter intervention devices and other minimal invasive procedure tools, for simplifying and alleviating the operations thereby carried out. The present application provides a device for interfacing to components (e.g., tubes, wires, balloons, stents, or similar elements) of a body material removal assembly, and for guiding and aiding procedures thereby carried out, and substantially eliminating confusion and errors that may occur therewith.

[0010] In a broad aspect there is provided an interface-device comprising attachment and manipulation means for interfacing to components (e.g., tubes, wires, balloons, stents, etc.) of treatment (e.g., material removal) instrumentation, and designed to facilitate and accurately guide operations of a minimally invasive procedure therewith. The interfacedevice can be electrically connectable to a control device (also referred to herein as remote-control apparatus or device) configured to easily operate the interface-device for effectively and precisely (and remotely, if so needed) performing the treatment procedures, e.g., by simply pressing one or more buttons of the control device.

[0011] For example, is some embodiments the interface-device is configured to guide and simplify a clot removal procedure by interfacing to proximal extremities of tube and wires of a material removal assembly introduced into a blood vessel of a treated subject through a guiding catheter (also referred to as guiding tube). The interface-device can be connected to the proximal extremities of the delivery tube (e.g., microcatheter) and of the wire(s) of the material removal assembly, after their distal extremities are introduced into the treatment site through the guiding catheter e.g., and in case of a clot removal procedure, also after the delivery tube is distally passed across the clot material to be thereby removed.

[0012] Once connected to the delivery tube and wire(s), the operator / practitioner can use the interface-device (and / or its control apparatus) to conduct a clot removal procedure by successively performing all stages thereof e.g., utilizing a single press-button (though in possible embodiments at least two press-buttons are provided in the control device). In some embodiments, the clot removal procedure is initiated by discharge of a material removal assembly, which components are connected to distal extremities of one or more wires, through a distal opening of the delivery tube and into a treatment site. A distal capturing element of the material removal assembly is discharged from the delivery tube downstream to the clot, in a stretched and collapsed delivery state thereof. Optionally, but in some embodiments preferably, a proximal capturing element of the material removal assembly is also discharged into the treatment site, upstream to the clot e.g., for capturing fractures / fragments of the clot and preventing their drift into the blood stream.

[0013] By using the control apparatus, the interface-device can then precisely manipulate at least one of the wires of the material removal assembly to change the distal capturing element from its stretched and collapsed-delivery state into its deployed-operational state, for capturing the clot thereby. Upon assuming its operational deployed state, the distal capturing element can be retracted proximally for engaging and capturing the clot therewithin. The delivery tube and capture element(s) of the material removal assembly can be then retracted proximally into the guiding tube, and removed from the body of the treated subject with the clot thereby captured.

[0014] In some embodiments, the distal capturing element is at least partially received within the proximal capturing element, to thereby encapsulate the clot there between. Thereafter, in such embodiments, the delivery tube and the clot capturing elements, with the clot captured therebetween, can be spontaneously retracted into the guiding catheter for removal from the body of the treated subject.

[0015] In some embodiments, the control device comprises forward and backwards control buttons. This way, in each stage of the clot removal procedure, the operator can use the buttons of the control device to proceed to the next stage of the clot removal procedure, by pressing the forward control button, or to return to one or more of the previous stages (in a reverse- sequence), by pressing the backward control button.

[0016] For this purpose, the interface-device utilizes an actuation mechanism configured for controlling operation of the material removal assembly. More specifically, the actuation mechanism is configured to control sliding motion of an arrangement of sliders of the interface-device being connectable to the delivery tube and to the wires of the material removal assembly. In some embodiments, the arrangement of sliders of the control device includes a discharge- slider connectable to the delivery tube, a deployment slider connected to a proximal extremity of a deployment-wire connected by its distal extremity to a distal portion of the distal capture element, and a capture- slider connectable to a proximal extremity of a capture-wire connected by its distal extremity to a proximal portion of the distal capture element. In some embodiments the distal capture element comprises a deformable ring element at a proximal opening thereof, and the distal extremity of the capture-wire is connected to the deformable ring element of the distal capture element. Optionally, and in some embodiments preferably, the deployment-slider is slidable over a sliding surface of the capture- slider.

[0017] In some embodiments, the interface device includes a static anchor- member for anchoring at least one wire of the material removal assembly thereto. The anchor-member is connectable in some embodiments to a proximal extremity of an optional anchoringwire connected to the optional proximal capture element.

[0018] In some embodiments, the actuation mechanism comprises a gear arrangement coupled to a cam-plate thereof and configured for successively moving the sliders inside the interface device. In forward direction, the slider actuation starts in moving the discharge- slider, followed by movement of the deployment- slider, and completed in movement of the capture-slider. The actuation mechanism, and its gear arrangement and cam-plate, are configured to permit successively reversing the order of motion of the sliders during the procedure, if so needed. The gear arrangement can be operatively coupled to an actuator (e.g., electric motor) which can be electrically controlled to drive the gear arrangement.

[0019] In some embodiments, the gear arrangement includes an input-gearwheel (e.g., a compound-gearwheel), an invert-gearwheel, two output-gearwheels (e.g., at least one of which may be a compound-gearwheel), which are all rotatably coupled to a gear-plate. The input-gearwheel is operatively coupled to the actuator via a rotatable shaft which rotatably drives the input-gearwheel, rotatably coupled to the gear-plate e.g., via a pivot projecting from gear-plate. The input- gearwheel engages a rack-gear of the cam-plate for transferring rotary motion of the input-gearwheel into (reciprocal) axial movement of the cam-plate. The output-gearwheels are configured to be selectively engageable with either a discharge rack-gear of the of the discharge-slider or a deployment rack-gear of the deployment- slider, for selectively transferring rotary motion of the gearwheels into axial sliding motion of the discharge and deployment sliders.

[0020] Optionally, and in some embodiments preferably, the discharge and deployment rack-gears are located at opposite sides of the gear-plate, which is configured for rotational motion with respect to a rotation axis e.g., defined by the rotatable shaft of the actuator. Accordingly, in some embodiments, the gear-plate is rotatable to toggle motion transfer by the discharge rack-gear of the discharge-slider or by the and deployment rackgear of the deployment-slider, such that in operation the gear-plate rotates interchangeably to alternately transfer motion either to the discharge rack-gear or to the deployment rack-gear. In particular, the gear-plate is rotatable between two operative positions, in each operative position one of the output-gearwheels of the gear-plate, respectively engages and transfer motion either to the discharge-slider or to the deployment- slider, while the other one of the output-gearwheels is disengaged from its respective slider, which in some embodiments is maintained locked and immobilized in its location.

[0021] In some embodiments, the actuation mechanism comprises a locking-lever moveably mounted to the gear-plate. The locking-lever has rack-gear-stoppers at apposite extremities thereof for engagement with the rack-gears of the discharge- slider and of the deployment- slider. The locking-lever is configured for axial / reciprocal movements either towards the rack-gear of the discharge- slider or towards the rack-gear of the deploymentslider, such that upon engagement of one of its stoppers with the rack-gear of the discharge- slider its other stopper becomes disengaged from the rack-gear of the deployment- slider, and vice versa i.e. upon engagement one of its stoppers with the rackgear of the deployment- slider its other stopper becomes disengaged from the rack-gear of the discharge- slider. This way, the locking-lever can lock and immobilize either the discharge- slider or the deployment- slider.

[0022] In some embodiments, the gear-plate and the locking-lever move in opposite directions, such that when gearwheels of the gear-plate transfer motion to one component of the actuation mechanism the locking-lever immobilizes another component thereof. This way, when the discharge- slider is moved by a respective output-gearwheel of the gear-plate, the deployment- slider is locked by the locking-lever, and vice versa i.e., when the deployment- slider is moved by a respective output-gearwheel of the gear-plate, the discharge- slider is locked by the locking-lever.

[0023] Optionally, and in some embodiments preferably, the cam-plate and the gear-plate take the form of a cam-follower arrangement configured for converting axial linear motion of the cam-plate, into selective rotational motion of the gear-plate about an axis e.g., the axis of the actuator's rotatable shaft. For this purpose, the cam-plate comprises an elongated camming-channel / groove inscribed / etched on its bottom surface facing the gear-plate, and the gear-plate is configured with a pin-follower e.g., on an apex thereof, projecting upwardly therefrom for engagement in the elongated camming-channel / groove of the cam-plate. The elongated camming-channel / groove of the cam-plate can have an alternating configuration for alternatingly toggling the gear-plate between its motion transfer states. This way, during operation, the axial position of the cam-plate inside the interface device can selectively set angular position of the gear-plate.

[0024] The pin-follower passes in some embodiments through an orifice of the lockinglever and extends into the camming-channel of the cam-plate for engagement therewith, such that the angular motion of the gear-plate simultaneously affects axial motion of the locking-lever. In operation, the pin-follower traces a path of the camming-channel, as the cam-plate axially slides thereover, thereby imparting motion of the cam-plate to selective reciprocal angular motion of the gear-plate for toggling the engagement of the outputgearwheels of the gear arrangement with either the rack-gear of the discharge- slider or the rack-gear of the deployment-slider, and simultaneously oppositely toggling the engagement of the locking-lever with either the rack-gear of the deployment-slider or the rack-gear of the discharge-slider.

[0025] In some embodiments, the camming-channel has several sections defining an alternating configuration of the camming-channel, for alternatingly shifting the pinfollower of the gear-plate between two operational state: (i) proximal or distal movement of the discharge- slider by setting the angular position of the gear-plate such that one of its gearwheels engage the rack-gear of the discharge-slider, and simultaneously setting the axial position of the locking-lever to engage and immobilize by one of its stoppers the rack-gear of the deployment- slider; and (ii) proximal or distal movement of the deployment- slider by setting the angular position of the gear-plate such that its gearwheels engage the rack-gear of the deployment- slider, and setting the locking-lever to engage and immobilize by its other stopper the rack-gear of the discharge-slider. This way, each section of the camming-channel can set a desired motion transfer scheme of a respective stage / step of the clot removal procedure.

[0026] In some embodiments, the interface-device comprises a locking-member movably situated in an annular pass-through opening formed in a sliding- surface of the captureslider. The locking-member is configured for: (i) locking and immobilizing the captureslider to a base element of the interface-device, while permitting movement of the deployment- slider; and (ii) releasing the locking of the capture-slider to the base element while locking the deployment-slider to the capture-slider, to thereby permit the deployment and capture sliders to slide together inside the interface-device, when locked one to the other. In one aspect there is provided an interface-device for an material removal (e.g., in vivo) procedure instrument, the device comprising a housing, two or more slider elements, each connectable to either a wire or a tube of said material removal instrument, and configured for sliding motion inside the housing, and an actuation mechanism configured to move the one or more slider elements inside the housing in a predefined sequence determined by a procedure to be thereby carried out. The device comprises in some embodiments a gear-mechanism mounted on a gear-plate configured to alternatingly deliver motion from an actuator to one of the two or more slider elements.

[0027] A gear-mechanism mounted on a gear-plate of the interface-device can be used to alternatingly deliver motion from an actuator to one of the two or more slider elements. The device can comprise a stopper-element configured to selectively lock and immobilize one of the two or more slider elements. Optionally, the device comprises a cam-plate configured to alternately move the gear-plate and the stopper-element so as to lock and immobilize one the two or more slider elements while motion is delivered to another one of the two or more slider elements. The device may comprise two output gearwheels each being couplable to a respective rack gear of two of the two or more slider elements.

[0028] One of the two or more slider elements is connectable in possible embodiments to a delivery tube of the material removal instrument for discharge of one or more material capture elements of the material removal instrument therefrom. At least another one of the two or more slider elements can be connectable to a wire of the material removal instrument for manipulating at least one of the one or more material capture elements of the instrument. The device can comprise two slider elements connectable to respective two wires of the material removal instrument for respectively coupling to and manipulating a distal extremity and a proximal opening of one of the material capture elements. The slider element coupled to the distal extremity of the material capture element can be configured for sliding motion in a recess formed in the slider element coupled to the proximal opening of the material capture element.

[0029] In possible applications the device comprises a locking mechanism configured to either lock the slider element coupled to the proximal opening of the material capture element to the housing, or to lock the slider element coupled the distal extremity of the material capture element to the slider element coupled to the proximal opening of the material capture element. The device comprises in possible embodiments a locking -member held in an opening formed in the slider element coupled to the proximal opening of the material capture element. The locking-member can be configured to be received in a retentioncavity formed in a base portion of the housing for locking the slider element thereto. The device can comprise a locking-channel in the slider element coupled to the distal extremity of the material capture element. The locking-channel can be configured for allowing movement of the slider element over the locking -member in the recess of the slider element coupled to the proximal opening of the material capture element. A releasecavity can be provided at one end of the locking-channel for allowing movement of the locking-member out of the retention-cavity formed in the base portion of the housing, and thereby release a locking of the slider element coupled to the proximal opening of the material capture element to the base portion of the housing, and lock the two slider elements one to the other. A sliding-channel extending from the retention-cavity along a length of the base portion of the housing can be provided for allowing movement of the two slider elements inside the housing while locked one to the other by the lockingmember, while some portion of the locking-member is situated in the sliding-channel.

[0030] The device can be coupleable to a remote-control device configured to remotely operate the actuation mechanism e.g., by a user / surgeon. The remote-control device comprises in some embodiments two or more pushbuttons configured to cause either forward or backword sequence of stages / states of the material removal procedure. The remote-control device can be operated by the pushbuttons and / or by an application running on a remote computer device.

[0031] The device can have an infusion port and a tube coupled thereto and configured to maintain positive pressure conditions inside a delivery-tube of the material removal instrument.

[0032] In another aspect there is provided a method for removal of material from a body lumen. The method comprising introducing a guiding catheter to a treatment site in the body lumen, introducing a delivery tube comprising a material removal instrument into the treatment site via the guiding tube, passing a distal portion of the delivery tube across the material to be removed, activating an interface-device coupled to the material removal instrument and configured for discharging the material removal instrument out of the delivery tube, deploying one or more material capture elements of the material removal instrument, and capturing the material at least partially in the one or more material capture elements.

[0033] The introducing of the delivery tube can be carried out manually or by a surgery robotic system. The discharging of the material removal instrument out of the delivery tube can locate a capture element of the material removal instrument downstream from the material to be removed.

[0034] The method comprises in some embodiments coupling (e.g., via wired and / or wireless signal / data communication) a remote operator device to the interface-device for remotely activating the interface-device. The activating of the interface-device can be carried out via an application running on a computer device. The activating of the interface-device can be carried out over one or more data / communication networks.

[0035] The method can comprise manually or robotically removing the material removal instrument form the body lumen via the guiding catheter. The method can comprise maintaining positive pressure conditions inside a delivery-tube of the material removal instrument to prevent backflow of body fluids therethrough.

[0036] In yet another aspect there is provided a remote-control device couplable to an interface-device configured to operate a (e.g., minimal invasive) surgical device for successively carrying our steps of a surgical procedure. The interface-device is connected to proximal extremities of tube(s) and / or wire(s) of the surgical device and comprise a mechanism for manipulating the tube(s) and / or wire(s) of the surgical device and successively carrying out steps of the surgical procedure.

[0037] The remote-control device comprises in some embodiments forward and backwards control buttons, such that in each stage of the surgical procedure, the operator can use the buttons of the remote-control device to proceed to the next step of the procedure, by pressing the forward control button, or to return to one or more of the previous steps (in a reverse-sequence), by pressing the backward control button. The remote-control device can be coupled to the interface-device over electrical wires and / or wirelessly. The remote-control device can be activated by a remote operator e.g., via an application running on a remote computer device. In some embodiments the surgical device is a material removal instrument / device as disclosed herein. The interface-device can be also implemented as disclosed herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

[0039] Fig. 1 schematically illustrates a clot removal procedure according to some possible embodiments;

[0040] Fig. 2A to 2C schematically illustrate an interface-device configured for controlling and guiding an in vivo material removal procedure according to some possible embodiments, wherein Fig. 2A shows a cross-sectional view of the interface-device, Fig. 2B shows a perspective view of the interface-device, and Fig. 2C shows a remote-control device configured for operating the interface-device of Figs. 2A and 2B;

[0041] Figs. 3A to 31, schematically illustrate different views of the interface-device according to possible embodiments, wherein Figs. 3A and 3B show bottom and top perspective views of an actuation mechanism of the interface-device, respectively, Figs. 3C and 3D respectively show sectional and top views of a base element of the interfacedevice, Fig. 3E shows a bottom exploded view showing a top cover element of the interface-device and some elements thereof, Fig. 3F shows a top perspective view of the actuation mechanism, Fig. 3G shows a bottom view of the a cam follower arrangement of the actuation mechanism, Fig. 3H shows an arrangement of the gearwheels on the gearplate, and Fig. 31 shows an exploded view of the sliders and the gearwheel arrangement with the locking lever;

[0042] Figs. 4A to 4E schematically illustrate operational states of the interface-device according to possible embodiments; and

[0043] Figs. 5A and 5B schematically illustrate material removal procedures carried out with the remote control according to possible embodiments, wherein Fig. 5A illustrates carrying out the material removal procedure by a remote or nearby operator, and Fig. 5B is a flowchart demonstrating procedural steps for remote or nearby operator operation.

[0044] DETAILED DESCRIPTION OF EMBODIMENTS

[0045] One or more specific and / or alternative embodiments of the present disclosure will be described below with reference to the drawings, which are to be considered in all aspects as illustrative only and not restrictive in any manner. It shall be apparent to one skilled in the art that these embodiments may be practiced without such specific details. In an effort to provide a concise description of these embodiments, not all features or details of an actual implementation are described at length in the specification. Elements illustrated in the drawings are not necessarily to scale, or in correct proportional relationships, which are not critical. Emphasis instead being placed upon clearly illustrating the principles of the invention such that persons skilled in the art will be able to make and use the disclosed embodiments once they understand their features. This invention may be provided in other specific forms and embodiments without departing from the essential characteristics described herein.

[0046] The present application discloses an interface-device for interfacing and guiding operation of a minimally invasive e.g., in vivo procedure. The interface-device can be operated by a remote-control apparatus electrically connectable thereto. The interfacedevice is configured to connect to tube and wires of a minimal invasive procedure instrument and allow the operator to carry out the procedure's steps in a precise, orderly and simplified manner, eliminating the requirement to directly and manually manipulate the different components of the instrument under the relatively poor non-invasive visualization conditions typically available in such procedures.

[0047] The interface-device is configured to permit precise manipulation of components of the procedure instrument within a predefined range and up to a maximally acceptable state suitable for properly guiding the procedure throughout its different steps in correct and orderly manner. The interface-device disclosed herein thus significantly reduces the risks of confusing between the elements of the instrument, and of excessive manipulation of any of the elements of the instrument, thereby improving procedure's safety and efficiency.

[0048] In some embodiments the interface-device is configured for interfacing and guiding a clot removal procedure instrument / device, utilizing one or more sliders for manipulating a delivery tube of the material removal device, and / or one or more wires thereof. The interface-device is configured to connect to the delivery tube and to wires of the clot removal instrument after their distal extremities are introduced into a treatment site through a guiding tube (e.g., guiding catheter), and distally passed across a clot located therein.

[0049] The one or more sliders can be then used to proximally retract the delivery tube relative to the extremities of the wires, to thereby discharge capture element(s) of the material removal device e.g., in a stretched and collapsed state thereof, downstream to (z.e., distally away from) the clot. The one or more sliders can be then used to change the capture element(s) into a deployed state for thereby capturing the clot e.g., by proximal retraction. The wires, delivery tube, and the capture element(s) can be then removed from the body of the treated subject through the guiding tube with the captured clot, by proximally pulling the interface-device until all elements of the material removal instrument are retracted outwardly.

[0050] For an overview of several example features, process stages, and principles of the invention, the instrumentation examples illustrated schematically and diagrammatically in the figures are intended for clot removal procedures. These clot removal instruments are shown as one example implementation that demonstrates a number of features, processes, and principles used to interface and guide clot removal procedures, but they are also useful for other applications and can be made in different variations. Therefore, this description will proceed with reference to the shown examples, but with the understanding that the invention recited in the claims below can also be implemented in myriad other ways, once the principles are understood from the descriptions, explanations, and drawings herein. All such variations, as well as any other modifications apparent to one of ordinary skill in the art and useful in minimally invasive applications may be suitably employed, and are intended to fall within the scope of this disclosure.

[0051] Reference is made to Fig. 1 illustrating successive stages of a clot removal procedure by way of a flow-chart, and a corresponding schematic illustration of each step of the flow-chart. Generally, the procedure is carried out by deploying / releasing one or more components of a material removal device 10 in a pre-defined sequence / successive stages (steps si to s7). If so required, the procedure can include returning to one or more of the previously conducted stages / states (steps s6’ to si’) of the procedure carried out using the material removal device 10.

[0052] The material removal device 10 comprises one or more capture elements e.g., elongated basket / sleeve elements. A primary (distal) capture element 12 having a deformable ring element 13 at a proximal opening thereof is used in some embodiments to receive and capture clot material deposited inside a body passage, such as a blood vessel. In possible embodiments, a secondary (proximal) capture element 14 is also provided in the material removal device 10 for capturing fragments of the clot material and preventing migration thereof in the blood stream of the treated subject. In this non- limiting example, two capture elements 12,14 are provided in the material removal device 10 e.g., having sleeve-shaped net / basket configuration. It is noted that the term "proximal" is used herein to denote the direction closer to the operator (practitioner), and the term "distal" is used herein to denote the direction closer to, or further away from, the treatment site wherein the clot is located.

[0053] The distal capture element 12 and the optional proximal capture element 13 are configured to be delivered in a compactly crimped state inside the delivery tube 15, such as a micro-catheter, into a body lumen 19 (e.g., of a blood vessel) comprising occluding / blocking material (e.g., clot) 17. The capture elements 12 and 13 are released inside the body lumen 19 in a pre-defined sequence of successive stages and deployed outside the delivery tube 15 to restore their normally opened / deployed state thereinside, for capturing occluding / blockage material deposited inside the body lumen and removal thereof from the body of the treated subject. The material removal device 10 can be associated with a transport / delivery system which includes a guiding tube / catheter 18 placed in the vasculature of the treated subject and configured for delivering the material removal device 10 to the target site in its compactly crimped state.

[0054] The material removal device 10 can be implemented by any of the embodiments described and illustrated in international patent publication Nos. WO 2023 / 021511 and / or WO 2018 / 134801 of the same applicant hereof, the disclosure of which is incorporated herein by reference.

[0055] The clot removal procedure is carried out after advancing (step si) the guiding tube 18 into the blood circulation system of the treated subject towards a treatment site where the clot 17 is located, to position the guiding catheter 18 in a certain vicinity to the clot material 17, for delivery of the clot removal device 10 to the treatment site. Once the guiding tube 18 is properly positioned in the vicinity to the clot material 17, a delivery tube 15 is passed through and out of the guiding-catheter 18 into the treatment site towards the clot material 17.

[0056] The delivery tube 15 can be advanced into the treatment site over a guidewire (not shown) passed through the guiding tube 18 and passed across the clot material 17, such that a distal end portion thereof is placed downstream to the clot material 17. The guidewire can be then removed, and the clot removal device 10 is advanced in its undeployed state, such that its proximal and distal capture elements 14 and 12, and the manipulation ring element 13, are compactly crimped / stretched therewithin. The clot removal device 10 is passed through the delivery tube 15 to locate the distal capture element 12 downstream to the clot material 17 z.e., adjacent to the distal end of the delivery tube 15. If the material removal device 10 includes the optional proximal capture element 14, then it is preferably located inside the delivery tube 15 upstream to the clot material 17, as demonstrated in Figs. 1 and 2A.

[0057] Once the delivery tube 15 is properly positioned with respect to the clot 17, the delivery tube 15 is retracted backwardly z.e., in a proximal direction towards the guiding tube 18, and the distal capture element 12 is unsheathed (step s2) in its inoperable, at least partially stretched / collapsed state, out of the delivery tube 15 downstream of the clot material 17. As shown, in this state the manipulation ring element 13 is at least partially closed and / or tilted with respect to an axis of the of the delivery tube 15. In some embodiments, the distal capture element 12 can be sheathed and retrieved back (step s2’) into the delivery tube 15 by advancing the delivery tube 15 forwardly z.e., in a distal direction away from the guiding tube 18. The distal capture element 12 can be then once again unsheathed (step s2), if so needed (by carrying step si). This may be required, for example, if the distal capture element 12 is deployed in an undesired location with respect to the clot 17.

[0058] The distal capture element 12 can be then distally deployed (step s3) to assume its normally opened / deployed operable state e.g., in which the manipulation ring element 13 is substantially perpendicular to an axis of the delivery tube 15. The distal capture element 12 can be then collapsed / stretched (step s3’) back to its inoperable at least partially stretched / collapsed state, and then again distally deployed once again (step s3), if so needed.

[0059] Once the distal capture element 12 is distally deployed it can be locked in its operational state (step s4). The distal capture element 12 can be then returned to its unlocked state (step s4’ ), and thereafter locked again in its operational state (step s4) once again, if so needed.

[0060] Next, the delivery tube 15 is further retracted backwardly towards the guiding tube 18, and the optional proximal capture element 14 is ejected / deployed in a second unsheathing retraction step (s5) to assume its normally opened / deployed state in a location upstream to the clot 17, such that the clot 17 is located between the optional proximal capture element 14 and the distal capture element 12. In some embodiments, the optional proximal capture element 14 can be sheathed and retrieved back (step s5’) into the delivery tube 15 by advancing the delivery tube 15 forwardly i.e., in a distal direction away from the guiding tube 18. The optional proximal capture element 14 can be then once again unsheathed (step s5), if so needed.

[0061] The distal capture element 12 is then retracted backwardly towards the optional proximal capture element 14 to receive and capture the clot 17 thereinside. Optionally, at least a portion of the distal capture element 12 is received within the optional proximal capture element 14, so as to form a capsule securing / encapsulating (step s6) the clot 17 therewithin. In other possible embodiments, the distal capture element 12 can be moved distally to decapsulate (step s6’) the clot 17, and then once again proximally to reencapsulate (step s6) the clot 17, if so needed. In the final stage of the procedure, the capture element(s) with the clot 17 encapsulated therewithin can be retracted proximally into the guiding catheter 18 and removed (step s7) from the body of the treated subject.

[0062] Reference is made to Figs 2A to 2C illustrating an interface-device 100 according to possible embodiments. The interface-device 100 is configured for controllably operating the material removal device 10 for carrying out the clot removal procedure shown in Fig. 1. In some embodiments, the interface-device 100 is configured for controllably operating the material removal device 10 by successively (in a pre-defined sequence) performing the clot removal stages (steps si to s7 of Fig. 1), while also allowing, at each stage / step, carrying out one or more reverse-sequences for returning the procedure to one or more of the previous / preceding stages / states (steps s6’ to s2’of Fig. 1).

[0063] As shown in Figs. 2A and 2B, the interface-device 100 has an elongated housing lOOh having a top cover lOv and a base element 10b couplable to each other and defining an internal space / cavity lOy of the housing lOOh. As seen in Fig. 2A, the interface-device 100 includes an arrangement of slider elements (collectively referred to herein as “sliders”) including a discharge- slider 15s, a deployment-slider 12s and a capture- slider 13s located inside the housing lOOh. The sliders 15s, 12s, and 13s, are configured for sliding (forward and backwards) motion within the cavity lOy of the elongated housing lOOh, to thereby manipulate the delivery tube 15, the distal capture element 12, and / or the ring element 13, respectively, inside the body lumen 19. In particular, in some embodiments, the discharge-slider 15s and the capture- slider 13s are adapted to slide on inner surfaces of the base element 10b, and the capture- slider 13s is adapted to slide in a sliding recess (12v in Fig. 31) of the capture- slider 13s to manipulate the delivery tube 15, the distal capture element 12, and the ring element 13, respectively, inside the body lumen 19.

[0064] To this end, the discharge-slider 15s is couplable to a proximal end portion of the delivery tube 15 distally extending from the housing 10 via an opening 15d formed in the housing lOOh. The deployment- slider 12s and the capture- slider 13s are connectable to proximal end portions of manipulation wires passing through the delivery tube 15 into the housing lOOh of the interface-device 100 e.g., deployment-wire 12w connected to a distal portion of the distal capture element 12, and / or capture- wire 13w connected to a proximal portion of the distal capture element 12 e.g., to the ring element 13 at the opening of the distal capture element 12. In some embodiments, the interface-device 100 also includes a stationary anchor-member 14s e.g., located at a proximal edge of the housing and connectable to a proximal end portion of an immobilizing-wire 14w, which is coupled by its distal end portion to the optional proximal capture element 14.

[0065] The interface-device 100 includes an actuation mechanism 11 connected to an actuator (e.g., electric engine) 20 via a rotatable shaft 20x. The rotatable shaft 20x is configured for transmission of rotary motion from the actuator 20 to the actuation mechanism 11. The actuation mechanism 11 is configured to manipulate the sliders 15s, 12s, and 13s, in a pre-defined sequence, so as to carry out the clot removal stages in a forward- sequence (steps si to s7 of Fig. 1), while allowing to return to one or more previous stages of the procedure (backward-sequence steps s6’ to s2’ of Fig. 1), if so required.

[0066] The actuator 20 is operatively connected to a circuitry 10c configured to operate the actuator 20 (i) in a first operational mode in which it rotates the shaft 20x in a first direction (e.g., clockwise) thereby causing the actuation mechanism 11 to manipulate the sliders 15s, 12s, and 13s, for carrying out one or more of the material removal stages in the forward- sequence (steps si to s7 in Fig. 1), or (ii) a second operational mode in which it rotates the shaft 20x in a second, opposite, direction (e.g., anti-clockwise), thereby causing the actuation mechanism 11 to manipulate the sliders 15s, 12s, and 13s, for carrying out one or more of the material removal stages in the backward-sequence i.e., to reversely move one or more of the sliders 15s, 12s, and 13s, so as to return to one or more of the previous stages of the clot removal stages (steps s6’ to s2’ in Fig. 1).

[0067] Optionally, and in some embodiments preferably, the interface-device 100 includes a locking-member 26 configured to secure the capture-slider 13s to the base element 10b before unsheathing of the capture elements (e.g., during step si of Fig. 1), and thereafter (e.g., during step s2 to s7 of Fig. 1) to secure the deployment-slider 12s to the capture- slider 13s, thereby attaching the deployment-slider 12s to the capture- slider 13s and causing them to slide together inside the housing lOOh. More specifically, the locking-member 26 is displaceable / moveable between (i) a first position in which it locks the capture-slider 13s to the base element 10b and (ii) a second position in which it locks the deployment-slider 12s to the capture- slider 13s and unlocks the capture-slider 13s from the base element 10b. In this non-limiting example, the locking -member 26 has a spherical shape.

[0068] In some embodiments, initially, the discharge- slider 15s is moved proximally / backward within the cavity lOy of the housing lOOh for pulling the microcatheter 15 proximally, thereby unsheathing the distal capture element 12 compactly crimped / stretched therewithin (steps s2 in Fig. 1). If required, the discharge- slider 15s can be displaced distally (to its initial position) to push the delivery tube 15, thereby sheathing back the distal capture element 12 into the delivery tube 15 (steps s2’ in Fig. 1).

[0069] Next, the deployment-slider 12s is moved proximally / backward while the captureslider 13s is locked / anchored to the base element 10b by the locking-member 26 and held stationary in place. Consequently, the distal capture element 12 is distally deployed (step s3 of Fig. 1). More specifically, when the distal capture element 12 is unsheathed from the delivery tube 15 it is in an inoperable at least partially closed / collapsed state e.g. , with its ring element 13 tilted. As the deployment-slider 12s is being pulled proximally / backward, the deployment- wire 12w attached to the deployment- slider 12s proximally pulls the distal end of the capture element 12. Consequently, the distal end of the deployment-wire 12w is pulled towards the distal end of the capture-wire 13w, which is connected to the ring element 13 of the distal capture element 12. This way, the distal capture element 12 is changed into an unstretched and deployed operational state e.g., wherein the manipulation ring element 13 restores a substantially open e.g., perpendicular orientation, thereof with respect to the axis of the delivery tube 15, and the proximal opening of the distal capture element 12 is then fully opened.

[0070] Upon deployment of the distal capture element 12, the deployment- slider 12s is located in a location which enables unlocking of the capture- slider 13s from the base element 10b. If required, distal / forward movement of the deployment- slider 12s at this stage will lock the capture-slider 13s back to the base element 10b and distally push the distal end of the deployment-wire 12w, thereby causing distal collapse of the distal capture element 12 (step s3’ of Fig. 1), by stretching the distal capture element 12 back to its elongated flattened state.

[0071] In some embodiments, after the optional proximal capture element 12 is deployed in its operational state, the discharge- slider 15s is retracted further proximally / backwards for pulling of the delivery tube 15 and thereby unsheathing the optional proximal capture element 14.

[0072] Next, the distal capture element 12 is moved proximally backwards by pulling proximally / backwards the deployment- slider 12s with the capture- slider 13s locked to it by the locking-member 26. This way, the deployment-wire 12w and the capture- wire 13w consequently move together proximally, thereby moving the distal capture element 12 e.g., with its ring element 13, in their operational states, proximally / backwards for encapsulation of the clot 17 (steps s6 of Fig. 1).

[0073] In some embodiments, the interface-device 100 has an infusion port lOp fluidly coupled to the delivery tube 15 for application of weak fluid pressure conditions through the delivery tube 15 for preventing backflow of body fluids (e.g., blood) thereinto. Optionally, the infusion port lOp is used for introducing antithrombotic substance(s) and / or a medicament through the delivery tube 15 into the treatment site.

[0074] As shown in Figs. 2B and 2C, the interface-device 100 is provided in some embodiments with electrical input port lOe configured for electrical connection of the interface-device 100 to a remote-control device 22 (e.g., via wires or wireless communication dongle). In this non-limiting example, the remote-control device 22 has two pushbuttons: (i) a forward pushbutton lOd to operate the interface device 100 to perform the clot removal stages in the forward- sequence (i.e., steps sl-s7 in Fig. 1), and (ii) a backward pushbutton lOu for returning to one or more of the previous stages by performing one or more of the backward-sequence steps (steps s2’ to s6’ in Fig. 1).

[0075] Optionally, but is some embodiments preferably, the remote-control device 22 is configured to be remotely and wirelessly operated to enable a remote practitioner / surgeon to carry out the material removal procedure with the material removal tool device 10 and the interface-device 100 connected to it, without being physically present in the surgery room (e.g., as shown in Figs. 5A and 5B). Reference is made to Figs. 3A to 31, illustrating different views of the remotely operated device 100. As shown, the actuation mechanism 11 includes a gearwheel arrangement 27a operatively coupled to / actuated by the actuator 20 via the rotatable shaft 20x (seen in Fig. 3B and 3F). The gearwheel arrangement 27a is configured for reciprocally moving (z.e., backward, and forward) a cam-plate 23, the discharge- slider 15s, and the deployment-slider 12s, within the cavity (lOy in Fig. 2A) of the housing lOOh. In some embodiments, the gearwheel arrangement 27a is configured for moving the discharge- slider 15s and the deployment-slider 12s alternately (z.e., move one while the other is stopped and vice versa) as will be described in detail further below.

[0076] As seen in Fig. 3A, in some embodiments the interface-device 100 comprises a tube (illustrated by dashed lines) 14f connecting between the infusion port lOp and the delivery tube 15 for maintaining positive pressure conditions inside the delivery-tube 15 to prevent backflow of body fluids therethrough. In these embodiments a pass-through bore (not shown) is provided in the deployment- slider 12s and / or the capture- slider 13s for passing the tube 14f therethrough, and for the deployment-slider 12s to freely slide thereover. The deployment-slider 12s and / or the anchor-member 14s is provided in some embodiments with a wire locking mechanism (not shown) for connecting the respective wire thereto in place, sealed for liquid leakage.

[0077] As better seen in Figs. 3G to 31, in some embodiments, the gear / -wheel arrangement 27a has four (4) gears-wheels including an input(driver)-compound- gearwheel 23g, an invert-gearwheel 27g, an output-gearwheel 15g, and an output- compound-gearwheel 12g, rotatably coupled to a gear-plate 27. The input-compound- gearwheel 23g is rotatably coupled to the gear-plate 27 via a pivot (27p in 4A to 4E), and operatively coupled to the actuator 20 via the rotatable shaft 20x, which transmits torque from the actuator 20 to the input-compound-gearwheel 23g.

[0078] The input-compound-gearwheel 23g comprises a main-gearwheel 3m (seen in Fig. 3H) that meshes / engages with the invert-gearwheel 27g and with the outputgearwheel 15g. As best seen in Fig. 3F, the input-compound-gearwheel 23g also comprises an auxiliary gearwheel 3a that meshes / engages with a rack gear 23r of the cam-plate 23. The invert-gearwheel 27g is configured to inverse the rotary motion thereby transferred to the output-compound-gearwheel 12g, to thereby cause the output gearwheels 12g and 15g to rotate in opposite angular directions, for thereby moving the slider-arms 12a, 15a in the same axial direction for a certain rotary motion direction of the actuator 20.

[0079] The output-compound-gearwheel 12g comprises a main-gearwheel 2m that engages with the invert-gearwheel, and an auxiliary-gearwheel 2a that engages with a rack gear 12r extending from the deployment-slider 12s. As also seen in Figs. 3H and 31, the output-gearwheel 15g engages with the main gearwheel 3m of the input-compound- gearwheel 23g, and also with the rack-gear 15r extending from the discharge- slider 15s for sliding motion thereof.

[0080] As also shown in Figs. 3H and 31, in some embodiments, the discharge-slider 15s has a slider-arm 15a projecting therefrom, on which the rack-gear 15r of the dischargeslider 15s is formed. In some embodiments, the rack-gear 15r of the discharge- slider 15s is sized to define a predetermined range of allowable movements range of the dischargeslider 15s within the cavity (lOy).

[0081] In some embodiments, the deployment-slider 12s has a slider-arm 12a projecting therefrom e.g., substantially parallel to the slider-arm 15a of the discharge-slider 15s. The slider-arm 12a is formed with the rack-gear 12r extending along at least a portion thereof. The slider-arm 12a is configured for engagement, by its rack gear 12r, with the output compound wheel 12g for movement of the deployment- slider 12s. In some embodiments, the rack-gear 12r is sized to define a predetermined range of allowable movements range for the deployment- slider 12s within the cavity lOy.

[0082] The gear-plate 27 is configured for rotational motion about a rotation axis defined by the pivot 27p (shown in Figs. 4A to 4E). Particularly, the gear-plate 27 is rotatable between: (i) a first position / state, in which the output-gearwheel 15g engages with the rack gear 15r, thereby moving the discharge- slider 15s while the output-compound- gearwheel 12g is disengaged from the rack gear 12r of the deployment-slider 12s; and (ii) a second position in which the auxiliary gearwheel 2a of the output-compound- gearwheel 12g engages with the rack gear 12r of the deployment- slider 12s, thereby moving the deployment-slider 12s while the output wheel 15g is disengaged from the rack gear 15r of the discharge- slider 15s. This way, in operation, the gear-plate 27 enables the output gearwheels 15g and 12g to alternatingly engage with the rack gears 15r and 12r of the sliders 15s and 12s, respectively, thereby alternatingly moving the dischargeslider 15s and the deployment- slider 12s. As best seen in Figs. 3G to 31, in some embodiments, the actuation mechanism 11 includes a locking-lever 29 moveably mounted to inner side of the cover element lOv e.g., by support-eyelets 29q. The locking-lever 29 is formed with rack-gear- stoppers 15k and 12k on opposite edges / extremities thereof, adapted for engagement with the rack gears 15r and 12r of the sliders 15s and 12s, respectively. In this non-limiting example, the locking-lever 29 comprises a step-portion 29n configured to locate the rack-gear- stopper 12k slightly elevated with respect to the rack- gear- stopper 15k, for the rack-gear- stopper 12k to properly engage the rack-gear 12r formed on the slider-arm 12a, which is also slightly elevated with respected to the rack-gear 15r formed on the slider-arm 15a.

[0083] The locking lever 29 is configured for moving reciproc ally / axially between the rack-gears 15r and 12r (e.g., substantially perpendicularly to an axis of movement of the actuation plate 23). In some embodiments, the locking-lever 29 is moveable between: (i) a first position, in which the rack-gear-stopper 15k engages with the rack-gear 15r formed on the slider-arm 15a, for thereby locking and immobilizing the discharge- slider 15s, while the rack-gear- stopper 12k is disengaged from the rack-gear 12r formed on the slider-arm 12a of the deployment slider 12s; and (ii) a second position, in which the rack- gear-stopper 12k engages with the rack-gear 12r formed on the slider-arm 12a, for thereby locking and immobilizing the deployment- slider 12s while the rack-gear- stopper 15k is disengaged from the rack-gear 15r of the discharge-slider 15s. This way, in operation, the locking lever 29 can interchangeably lock and immobilize either the discharge- slider 15s or the deployment- slider 12s.

[0084] As seen in Figs. 3F and 3G, in some embodiments, the cam-plate 23 has a (e.g., pass-through) channel 23c having a rack-gear 23r extending along one of its sides. The rack-gear 23r is adapted for engagement / meshing with the auxiliary-gearwheel 3a of the input-compound-gearwheel 23g, for reciprocal movement of the cam-plate 23.

[0085] As best seen in Fig. 3G, in some embodiments, the cam-plate 23 and the gearplate 27 form a cam-follower arrangement / mechanism configured for transforming axial sliding motion of the cam-plate 23 into selective angular motion of the gear-plate 27 about the pivot 27p, and selective reciprocal movement of the locking lever 29. To this end, the cam-plate 23 has an elongated camming channel / groove 23i inscribed / etched on a bottom surface thereof, which faces the gear-plate 27. The gear-plate 27 has a pin follower 27e e.g., located on an apex thereof, and projecting upwardly and passing through a pass- through orifice / bore 29e formed in the locking leaver 29, and extending into the camming channel 23i. This way, the pin follower 27e engages with the inscribed camming channel 23i and traces its path as the cam-plate 23 is axially moved over the pin follower 27e.

[0086] In some embodiments, the camming channel / groove 23i has an alternating form with different regions / sections (cl to c4 in Figs. 4A to 4E) constituting discharge and deployment actuation states of the actuation mechanism 11. Each section / sub-channel (cl to c4 in Figs. 4A to 4E) is configured to cause a respective movement of one or more of the sliders 15s, 12s, and 13s, to thereby perform the one or more of the successive stages (steps s2 to s6 in Fig. 1) of the clot removal procedure, as will be described in detail below with reference to Figs. 4A to 4E.

[0087] In operation, the pin follower 27e moves / rides inside the camming-channel 23i following the alternating geometry of the different sections (cl to c4 in Figs. 4A to 4E) of the camming-channel 23i. Consequently, the pin follower 27e selectively rotates the gear-plate 27 about the pivot 27p on clockwise and counterclockwise directions, and thereby pushes the locking lever 29 in opposite directions. This way, in the discharge actuation state of the gear-plate 27 (e.g., s2 in Fig. 1), the output-gearwheel 15g engages with the rack-gear 15r formed on the slider-arm 15a, and thereby moves the dischargeslider 15s while the rack-gear-stopper 12k engages with the rack-gear 12r formed on the slider-arm 12a, thereby locking and immobilizing the deployment- slider 12s. In the deployment actuation state (e.g., s3 in Fig. 1), the gear-plate 27 is rotated by the pin follower 27e such that the output-compound-gearwheel 12g engages with the rack-gear 12r formed in the slider-arm 12a and thereby moves the deployment- slider 12s, while the rack-gear-stopper 15k engages with the rack-gear 15r formed on the slider-arm 15a, thereby locking and immobilizing the discharge-slider 15s.

[0088] In operation, the gear-plate 27 alternatingly rotates about the pivot 27p to alternatingly engage its output gearwheels 15g and 12g with the respective rack gears 15r and 12r, while simultaneously causing the locking-lever 29 to alternatingly axially move oppositely between the rack-gears 12r and 15r, such that when the rack-gear 15r is engaged with the output-gearwheel 15g the rack-gear 12r is locked by the rack-gear- stopper 12k to immobilize the deployment- slider 12s, and vice versa i.e., when the rackgear 12r is engaged with the auxiliary gearwheel 2a of the compound-output-gearwheel 12g the rack gear 15r is locked by the rack-gear- stopper 15k to immobilize the dischargeslider 15s. As such, movement of the gear-plate 27 in accordance with shape / geometry of the different sections of the cam-channel 23i causes the output wheels 15g and 12g to engage interchangeably with the rack-gears 15r and 12r of the sliders 15s and 12s, respectively.

[0089] As seen in Fig. 3G, the locking-lever 29 can be coupled to the top cover lOv by the support-eyelets 29q, such that they are spaced apart from each other a pre-defined distance to accommodate a width of the cam-plate 23. As such the support-eyelets 29q enable sliding motion of the cam-plate 23 between them. The locking lever 29 can be held by the support-eyelets 29q such that the locking lever 29 is spaced apart from the top cover lOv at a pre-defined distance allowing the cam-plate 23 to move reciprocally (backward and forward) in the space between the locking lever 29 and the top cover lOv.

[0090] As better seen in Figs. 3C and 3D, the base element 10b can be configured to define a sliding recess 12e for the sliding of the deployment- slider 12s therein. The base element 10b can be further configured to define a sliding recess 13e for the sliding of the capture- slider 12s therein. As seen in Fig. 31, the capture- slider 13s is configured to define a sliding-recces 12v for receiving a bottom-projection 12q of the deployment slider 12s for it to slide thereinside. The length of the sliding recess 12e is configured to define a predetermined range of allowable movements for the deployment-slider 12s.

[0091] As better seen in Fig. 3E, the capture-slider 13s comprises in some embodiments a pass-through bore 26h configured for passage of the locking-member 26 therethrough. As seen in Figs. 3C and 3D, the sliding recess 13e comprises a sliding-channel 13h having a retention-cavity 13t at its distal end. The sliding-channel 13h is configured for receiving the locking-member 26 therewithin for locking (to the base element 10b) and immobilizing the capture-slider 13s when the locking-member 26 is at least partially received in the retention-cavity 13t, as demonstrated in Figs. 2A, 4A and 4B. As seen in Fig. 3E, the deployment- slider 12s has a locking-channel 26c formed along portion of a bottom surface thereof, which faces the sliding-recces 12v of the capture- slider 13s, and configured for receiving a portion of the locking-member 26 therewithin.

[0092] The locking-channel 26c comprises a release-cavity 26i at a distal portion thereof, configured to release the locking and immobilizing of the capture -slider 13s to the base element 10b, and allow sliding motion of the deployment-slider 12s together with the capture- slider 13s, such that a portion of the locking-member 26 slides within the sliding- channel 13h formed in the base element 10b. The locking-cavity 26c is configured for maintaining the locking and immobilizing of the capture- slider 13s to base element 10b, while permitting movement of the deployment- slider 12s in the sliding-recces 12v of the capture- slider 13s.

[0093] As shown in Figs. 3C and 3D, the base element 10b has two side walls lOf and lOi over which the top cover lOv can be mounted. The base element 10b is configured to define a sliding recess 15e for sliding motion of the discharge- slider 15s therein, and a predetermined range of allowable movements for the discharge-slider 15s between its extremities. The sliding recess 13e formed in the base element 10b is adapted to enable sliding motion of the capture-slider 13s therein and defines a predetermined range of allowable movements for the capture-slider 13s between its extremities. Further, the base element 10b defines support surfaces 12f and 15f for supporting portion of a distal support plates 25 thereover.

[0094] As better seen in Figs. 3A, 3B and 3E, in some embodiments, the actuation mechanism 11 includes distal and proximal support plates 25 and 24 spaced-apart from each other and attachable / couplable to the top cover lOv. The distal and proximal support plates 25 and 24 can have a plurality of connection bores 25h and 24h, respectively, for providing coupling (e.g., via screws or bolts) to respective bore 24f located on a bottom surface of the top cover lOv. The distal and proximal support plates 25 and 24 can have sliding surfaces configured for enabling sliding motion of the cam-plate 23 thereover.

[0095] Reference is made to Figs. 4A to 4D, schematically illustrating operational principles of the interface-device 100 according to possible embodiments. Each one of Figs. 4A to 4D shows a longitudinal- sectional view of the interface-device 100, a top view of the cam-plate 23 with the pin follower 27e in the camming channel 23i, and a top view of the actuation mechanism 11. In Fig. 4A, the practitioner operates of the device and initiates the clot removal procedure subsequently to properly locating the guiding tube (18 in Fig. 2A) within the body lumen, i.e., in proximity to the clot (17 in Figs. 1 and 2A). Then a delivery tube (15 in Figs. 1 and 2A) is passed out of the guiding-catheter 18 into the treatment site towards the clot / material 17.

[0096] After the material removal tool device 10 is connected to the interface-device 100, the actuator 20 rotates the input-compound-gearwheel 23g which, in turn, rotates the output-gearwheel 15g engaged with the rack-gear 15r of the discharge- slider 15s. The auxiliary gearwheel 3a of the input-compound-gearwheel 23g engages with the rack-gear 23r thereby slidably moves the cam-plate 23 proximally backwards over the slide surfaces 25c and 24c of the support plates 25 and 24, and over pin follower 27e, such that the pin follower 27e of the gear-plate 27 is moved within section cl of the cam-channel 23i. While the pin follower 27e is situated in section cl, the gear-plate 27 is in its first (initial) state. In this state, the output wheel 15g engages with the rack-gear 15r formed in the slider-arm 15a, while the auxiliary gearwheel 2a of the output-compound-wheel 12g is disengaged from the rack-gear 12r of the slider-arm 12a. In this state, the lockinglever 29 engages the rack-gear 12r of the slider-arm 12a, thereby locking and immobilizing the deployment-slider 12s.

[0097] Rotations of the output wheel 15g when engaged with the rack-gear 15r of the slider arm 15a slidably moves the discharge- slider 15s proximally backward. Consequently, the delivery tube (15 in Fig. 1), which is coupled to the discharge-slider 15s, is retracted in a proximal direction, and the distal capture element (12 in Fig. 1) is unsheathed (step s2 in Fig. 1) in its inoperable / stretched state.

[0098] In Fig. 4B, the discharge- slider 15s is retracted backwards and the lockingmember 26 is located between the locking-channel 26c of the deployment-slider 12s and the retention-cavity 13t formed in the base element 10b. In this state, the capture- slider 13s is locked and immobilized to the base element 10b.

[0099] As the input-compound-gearwheel 23g further moves the cam-plate 23 further moves proximally backwards, the pin follower 27e of the gear-plate 27 is displaced into section c2 of the camming-channel 23i. This causes the gear-plate 27 to rotate about the pivot 27p to the deployment state, while pushing the locking-lever 29 towards the rack gear 15r of the slider-arm 15a. In this state of the gear-plate 27, the auxiliary gearwheel 2a of the output-compound-gearwheel 12g engages with the rack gear 12r of slider-arm 12a, for moving the deployment-slider 12s proximally backwards, while the outputgearwheel 15g is disengaged from the rack-gear 15r of slider-arm 15a. Concurrently, the locking-lever 29 is disengaged from the rack-gear 12r of the slider-arm 12a and is engaged with the rack gear 15r of the slider arm 15a. As a result, the discharge-slider 15s is locked and immobilized in its position while the deployment-slider 12s slides in sliding recess 12v of the capture- slider 13s, which is locked and immobilized to the base element 10b.

[0100] Rotations of auxiliary-gearwheel 2a of the output-compound-gearwheel 12g in this state causes the deployment- slider 12s to pull the distal end of the distal capture element (12 in Fig. 1) by the deployment-wire (12w in Fig. 2A), such that the distal end of the deployment- wire (12w) is pulled proximally towards the distal end of the capture- wire (13w in Fig. 2A). Consequently, the distal capture element (12 is in Fig. 1) is distally deployed (step s3 in Fig. 1) from its at least partially collapsed / stretched state e.g., its ring element (13 in Fig. 1) is changed from a deformed state to an open state to assume its normally opened / deployed operable state in which it is substantially perpendicular to an axis of the delivery tube (15 in Fig. 1).

[0101] In Fig. 4C, the deployment- slider 12s is slid proximally backwards until it abuts the capture- slider 13s and locate the release-cavity 26i above the locking-member 26 resting in the retention-cavity 13t. This unlocks the capture-slider 13s from the base element 10b and permits mutual proximal movement of the deployment- slider 12s and capture- slider 13s together.

[0102] As the input-compound-gearwheel 23g is further rotated the cam-plate 23 is further moved proximally backwards such that the pin follower 27e of the gear-plate 27 is displaced into section c3 of the cam channel 23i. This causes the gear-plate 27 to rotate back to its discharge state while pushing the locking-lever 29 back towards the rack gear 12r of the slider arm 12a, to thereby lock and immobilize the deployment-slider 12s. In this state the output wheel 15g engages with the rack gear 15r of the slider-arm 15a to further move the discharge-slider 15s proximally backwards, while the auxiliary gearwheel 2a of the output-compound-gearwheel 12g is disengaged from the rack gear 12r of the slider-arm 12a.

[0103] This facilitates further retraction backwardly of the delivery tube (15 in Fig. 1) towards the guiding tube (18 in Fig. 1), and the optional proximal capture element (14 in Fig. 1) is thereby discharged in a second unsheathing retraction (step s5 in Fig. 1) to assume its normally opened / deployed state.

[0104] In Fig. 4D, the discharge-slider 15s is maximally retracted such that it is adjacent to the deployment- slider 12s. As the input-compound-gearwheel 23g is further rotated, the cam-plate 23 is further moved proximally backwards, and the pin follower 27e of the gear-plate 27 is displaced into section c4 of the camming channel 23i. This causes the gear-plate 27 to rotate to its deployment state while pushing the locking-lever 29 towards the rack gear 15r of the slider arm 15a. In this state of the gear-plate 27, the auxiliary gearwheel 2a of output-compound-gearwheel 12g engages with the rack gear 12r, thereby moving proximally backwards the deployment-slider 12s together with the capture-slider 13s. This results in movement of the locking -member 26 into the sliding-channel 13h formed in the base element 10b, while remaining in the release-cavity 26i of the deployment- slider 12s, thereby locking the deployment-slider 12s to the capture-slider 13s.

[0105] In Fig. 4E, the deployment- slider 12s and the capture- slider 13s are locked to each other and moved together proximally backwardly. As shown, the locking-member 26 is located between the release-cavity 26i and the slide-channel 13h. This way, the distal capture element (12 in Fig. 1) is retracted backwardly to capture the clot (17), optionally until at least a portion of the distal capture element (12 in Fig. 1) is received within the optional proximal capture element (14 in Fig. 1) to form a capsule securing / encapsulating (step s6 in Fig. 1) the clot (17 in Fig. 1) therewithin.

[0106] Referring back to Fig. 2A, in possible embodiments the material removal device 10 is provided operationally ready for insertion inside the delivery tube (e.g., microcatheter) 15, and connected to the interface-device 100 i.e., proximal end portions of the delivery tube 15 and of the wires 12w,13w and optionally 14w, are connected to their respective sliders 12s, 13s and 15s, and optionally to stationary anchor-member 14s, if the optional proximal capture element 14 is used. The material removal device 10 can be accordingly introduced into the treatment site by a practitioner or by a robotic surgical system (55 in Fig. 5A) ready to be operated by the interface-device 100, which can be then operated to carry out a material removal procedure e.g., using the remote-control device 22 (shown in Fig. 2C) with wired electrical connectivity to the electrical input port lOe (shown in Fig. 2B), or wirelessly.

[0107] The practitioner / surgeon carrying out the material removal procedure can thus operate the interface-device 100 without being physically present in the surgery room e.g., from a nearby room to reduce exposure to imaging radiation, from another hospital if there is no nearby experienced practitioner / surgeon to perform the procedure, or even from home or any other location having wired or wireless network connectivity.

[0108] Referring now to Figs. 5A and 5B, a material removal procedure 58 according to possible embodiments may be initiated by introducing (step dl), manually or by a surgery robotic system (e.g., Vasco of Navigantis Inc., Libert of Microbot Medical, or suchlike) 55, the guiding catheter 18 towards the treatment site inside the body of the treated subject 50. The delivery tube 15 can be then introduced (step d2), manually or by a surgery robotic system 55, into the treatment site with the material removal instrument 10 readily located thereinside, such that distal end portion of the delivery tube 15 is passed across the material / clot to be removed to locate the distal capture element (12) downstream thereto.

[0109] Optionally, if a suitable surgeon is not present in the surgery room or healthcare facility 52, communication with a remote operator device (e.g., desktop / laptop computer system, smart device / phone, or suchlike) 57 is established (step d3) over data / signals communication bus lines and / or wirelessly, and one or more communication networks 54, if so needed. The remote-control device 22 can be then connected to the interfacedevice 100 (step d4), and if needed communicated with the remote operator device 57, to carry out the material removal procedure (step d5) using the interface-device 100 electrically coupled to the remote-control device 22, and the material removal instrument 10 connected to the interface-device 100. Upon capturing the body material by the material removal instrument 10, the instrument 10 with the captured body material (17) can be manually or robotically removed (step d6) from the body of the treated subject 50.

[0110] Relative terms such as "lower," "upper," "horizontal," "vertical," "above," "below," "up," "down," "top" and "bottom", as well as derivatives thereof (e.g., "horizontally," "downwardly," "upwardly," etc.), and similar adjectives in relation to orientation of the described elements / components refer to the manner in which the illustrations are positioned on the paper, not as any limitation to the orientations in which these elements / components can be used in actual applications.

[0111] It should also be understood that throughout this disclosure, where a process or method is shown or described, the steps / acts of the method may be performed in any order and / or simultaneously, and / or with other steps / acts not illustrated / described herein, unless it is clear from the context that one step depends on another being performed first. In possible embodiments not all of the illustrated / described steps / acts are required to carry out the method.

[0112] As described hereinabove and shown in the associated figures, the present application provides an interface device for (e.g., in vivo) minimal invasive procedures and related methods. While particular embodiments of the invention have been described, it will be understood, however, that the invention is not limited thereto, since modifications may be made by those skilled in the art, particularly in light of the foregoing teachings. As will be appreciated by the skilled person, the invention can be carried out in a great variety of ways, employing more than one technique from those described above, all without exceeding the scope of the claims.

Claims

CLAIMS:

1. An interface-device for a material removal procedure instrument configured for removal material from a body passage, said interface device comprising: a housing; two or more slider elements each connectable to either a wire or a tube of said material removal instrument and configured for sliding motion inside said housing; and an actuation mechanism configured to move said one or more sliders inside said housing in a predefined sequence determined by a procedure to be thereby carried out.

2. The device of claim 1 comprising a gear-mechanism mounted on a gear-plate configured to alternatingly deliver motion from an actuator to one of said two or more slider elements.

3. The device of claim 2 comprising a stopper-element configured to selectively lock and immobilize one of the two or more slider elements.

4. The device of claim 3 comprising a cam-plate configured to alternately move the gearplate and the stopper-element so as to lock and immobilize one the two or more slider elements while motion is delivered to another one of said two or more slider elements.

5. The device of any one of claims 2 to 4 comprising two output gearwheels each being couplable to a respective rack gear of two of the two or more slider elements.

6. The device of any one of the preceding claims wherein one of the two or more slider elements is connectable to a delivery tube of the material removal instrument for discharge of one or more material capture elements of said material removal instrument therefrom.

7. The device of any one of the preceding claims wherein at least another one of the two or more slider elements is connectable to a wire of the material removal instrument for manipulating at least one of the one or more material capture elements of said material removal instrument.

8. The device of claim 7 comprising two slider elements connectable to respective two wires of the material removal instrument for respectively coupling to and manipulating a distal extremity and a proximal opening of one of the material capture elements.

9. The device of claim 8 wherein the slider element coupled to the distal extremity of the material capture element is configured for sliding motion in a recess formed in the slider element coupled to the proximal opening of the material capture element.

10. The device of claim 8 or 9 comprising a locking mechanism configured to either lock the slider element coupled to the proximal opening of the material capture element to the housing, or lock the slider element coupled to the distal extremity of the material capture element to the slider element coupled to the proximal opening of the material capture element.

11. The device of claim 10 comprising a locking-member held in an opening formed in the slider element coupled to the proximal opening of the material capture element, said lockingmember configured to be received in a retention-cavity formed in a base portion of the housing for locking said slider element thereto.

12. The device of claims 9 and 11 comprising a locking-channel in the slider element coupled to the distal extremity of the material capture element, said locking-channel configured for allowing movement of said slider element over the locking-member in the recess of the slider element coupled to the proximal opening of the material capture element.

13. The device of claim 12 comprising release-cavity at one end of the locking-channel for allowing movement of the locking-member out of the retention-cavity formed in the base portion of the housing, and thereby release a locking of the slider element coupled to the proximal opening of the material capture element to the base portion of the housing and lock the two slider elements one to the other.

14. The device of claim 13 comprising a sliding-channel extending from the retention-cavity along a length of the base portion of the housing for allowing movement of the two slider elements inside the housing while locked one to the other by the locking-member while some portion thereof is situated in said sliding-channel.

15. The device of any one of the preceding claims coupleable to a remote-control device configured to remotely operate the actuation mechanism.

16. The device of claim 15 wherein the remote-control device comprises two or more pushbuttons configured to cause forward or backword sequence of stages / states of the procedure.

17. The device of claim 15 or 16 wherein the remote-control device is operated by the pushbuttons and / or by an application running on a remote computer device.

18. The device of any one of the preceding claims comprising an infusion port and a tube coupled thereto configured to maintain positive pressure conditions inside a delivery-tube of the material removal instrument.

19. A method for removal of material from a body lumen, the method comprising introducing a guiding catheter to a treatment site in said body lumen, introducing a delivery tube comprising a material removal instrument into the treatment site via said guiding tube, passing a distal portion of said delivery tube across the material to be removed, activating an interface-device coupled to said material removal instrument and configured to for discharging said material removal instrument out of said delivery tube, deploying one or more material capture elements of said material removal instrument, and capturing said material at least partially in said one or more material capture elements.

20. The method of claim 19 wherein the introducing of the delivery tube carried out manually or by a surgery robotic system.

21. The method of claim 19 or 20 wherein the discharging of the material removal instrument out of the delivery tube locates a capture element of the material removal instrument downstream from the material to be removed.

22. The method of any one of claims 19 to 21 comprising coupling a remote operator device to the interface-device for remotely activating the interface-device.

23. The method of claim 21 wherein the coupling is via wired and / or wireless signal / data communication.

24. The method of claim 22 or 23 the activating the interface-device is carried out via an application running on a computer device.

25. The method of claim 24 wherein the activating the interface-device is carried out over one or more data / communication networks.

26. The method of any one of claims 19 to 25 comprising manually or robotically removing the material removal instrument form the body lumen via the guiding catheter.

27. The method of any one of claims 19 to 26 comprising maintaining positive pressure conditions inside a delivery-tube of the material removal instrument to prevent backflow of body fluids therethrough.

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