Steerable aspiration handle

Abstract

Disclosed embodiments describe thrombectomy catheter systems, including a steerable handle at a proximal end of an elongate shaft of such system, for providing control (e.g., control of aspiration and / or pressurized fluid jet actuation) to the system, as well as steering of the distal end of the elongate shaft, e.g., through a wire puller configuration.

Description

STEERABLE ASPIRATION HANDLECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of United States Patent Application Serial No. 63 / 778,045 filed on March 26, 2025, and entitled "STEERABLE ASPIRATION HANDLE," which application is expressly incorporated herein by reference in its entirety.BACKGROUND1. The Field of the Invention

[0002] The present disclosure relates to handles for use with a thrombectomy catheter, e.g., used in removal of clots in blood vessels, where such thrombectomy catheter may employ a combination of aspiration through a catheter and an internal high-pressure jet (e.g., saline jet) within the catheter to macerate clot tissue during aspiration. In more detail, embodiments of the invention relate to handles for such devices, e.g., for controlling actuation of aspiration and the high-pressure fluid jet, while allowing a practitioner to steer the distal end of the elongate shaft of such thrombectomy catheter, by manipulating the handle located at the proximal end of the elongate shaft.2. The Relevant Technology

[0003] Several devices and systems already exist to aid in the removal of thrombotic material. These include simple aspiration tube type devices using vacuum syringes to extract thrombus into the syringe, simple flush-and-aspirate devices, more complex devices with rotating components that pull in, macerate and transport thrombotic material away from the distal tip using a mechanical auger, and systems that use very high pressure saline to macerate the thrombus and create a venturi effect to flush the macerated material away.

[0004] All of the devices described above have limitations as a result of individual design characteristics. Accordingly, there is an ongoing need for improved systems and devices within the field.BRIEF SUMMARY OF THE INVENTION

[0005] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an indication of the scope of the claimed subject matter.Page 1 Docket No 22935 56A - 16097WOO1

[0006] An embodiment of the present disclosure relates to a handle for a steerable thrombectomy catheter system for aspirating thrombus. Such a handle may include a handle body and a vacuum switch ring at a distal end of the body, the vacuum switch ring being configured to selectively actuate aspiration and / or pressurized fluid jet flow at a distal end of a thrombectomy catheter of the system. Rotation of the vacuum switch ring may be configured to provide steering of the distal end of the elongate shaft of the thrombectomy catheter system (e.g., turning to the right or left). Such may be achieved through a mechanism employing one or more wires and wire pullers.

[0007] Another embodiment is directed to a steerable thrombectomy catheter system for aspirating thrombus, the system comprising an elongate shaft configured for placement within a blood vessel of a subject, an aspiration lumen extending along the elongate shaft, at least one supply lumen extending along the elongate shaft, wherein the at least one supply lumen includes an orifice configured to allow a pressurized fluid jet to flow into the aspiration lumen; and a pressurized fluid source in communication with the at least one supply lumen to provide the pressurized fluid to the supply lumen. The system also includes a handle for steering at least a distal end of the elongate shaft and for controlling aspiration and / or pressurized fluid jet flow at the distal end of the elongate shaft. The handle may be located at a proximal end of the elongate shaft, and may include a handle body and a vacuum switch ring at a distal end of the handle body, where the vacuum switch ring is configured to selectively actuate aspiration and / or pressurized fluid jet flow at the distal end of elongate shaft.

[0008] In any of the described embodiments, the vacuum switch ring may be configured to slide axially to selectively actuate aspiration and / or pressurized fluid jet flow at the distal end of the thrombectomy catheter.

[0009] In any of the described embodiments, the vacuum switch ring may be configured to slide axially a distance within a range of about 1 mm to about 5 mm, or about 2 mm to about 3 mm.

[0010] In any of the described embodiments, the vacuum switch ring may be biased distally.

[0011] In any of the described embodiments, the vacuum switch ring may be spring loaded.Page 2 Docket No 22935 56A - 16097WOO1

[0012] In any of the described embodiments, the vacuum switch ring may be biased distally, and configured to actuate aspiration and / or pressurized fluid jet flow at the distal end of the thrombectomy catheter upon a user sliding the vacuum switch ring proximally.

[0013] In any of the described embodiments, the vacuum switch ring may be configured to actuate aspiration and / or pressurized fluid jet flow when slid proximally, where the system maintains the aspiration and / or pressurized fluid jet flow until the vacuum switch ring is slid proximally a second time.

[0014] In any of the described embodiments, the vacuum switch ring may include one or more external ribs for improved grip to better facilitate the user grasping the collar of the vacuum switch ring, and rotating such collar clockwise or counterclockwise, to steer the distal end of the elongate shaft (e.g., where the shaft encounters thrombus material, and the high-pressure fluid jet is delivered).

[0015] In any of the described embodiments, the handle may include a selectively illuminated distal tip for indicating operational status of the system (e.g., whether the distal end of the elongate shaft is in contact with thrombus clot material, is in contact with the vessel wall, or is in a free bloodstream).

[0016] In any of the described embodiments, the handle may include a haptic vibrator motor for indicating operational status of the system. For example, different haptic feedback may be provided, depending on the status of the system (e.g., in contact with thrombus clot material, in contact with the vessel wall, or in a free bloodstream).

[0017] In any of the described embodiments, the vacuum switch ring may include a collar, wherein rotation of the collar of the vacuum switch ring steers the distal end of the elongate shaft through a wire puller mechanism.

[0018] In any of the described embodiments, the collar may include left hand internal threads and right hand internal threads, the left hand internal threads and right hand internal threads being operatively coupled to wire pullers within the handle that are oppositely threaded relative to one another, so that the wire pullers move in opposite axial directions when the collar is rotated, the wire pullers being operatively connected to the distal end of the elongate shaft (e.g., through one or more wires), so as to steer the distal end of the elongate shaft upon rotation of the collar.

[0019] In any of the described embodiments, the collar may be restrained axially by a snap ring and / or a thrust ring.Page 3 Docket No 22935 56A - 16097WOO1

[0020] In any of the described embodiments, the handle may further comprise at least one printed circuit board.

[0021] In any of the described embodiments, the at least one printed circuit board may include a pressure transducer in operative communication with a vacuum port of the handle, for measuring pressure within the aspiration lumen.

[0022] In any of the described embodiments, the pressure transducer within the handle may be configured to measure pressure within the aspiration lumen, to determine whether the distal end of the elongate shaft is in contact with thrombus, is in contact with a vessel wall, or is in a free bloodstream.

[0023] In any of the described embodiments, the distal tip of the handle (or other handle portion) may be selectively illuminated in a specified color, and / or a haptic vibrator motor in the handle may be actuated, depending on whether the distal end of the elongate shaft is in contact with thrombus, is in contact with a vessel wall, or is in a free bloodstream, to indicate an operational status of the system to a user.

[0024] In any of the described embodiments, the vacuum switch ring may selectively contact an operation switch of the at least one printed circuit board to actuate aspiration through the aspiration lumen, when the vacuum switch ring is slid proximally.

[0025] In any of the described embodiments, the handle may include teeth for securing an electrical cable that provides power to the handle.

[0026] In any of the described embodiments, the components of the handle may snap together, rather than using screws to hold the components together.

[0027] In any of the described embodiments, the at least one supply lumen may include more than one orifice, so as to deliver a plurality of pressurized fluid jets into the aspiration lumen.

[0028] Additional features and advantages of exemplary embodiments of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of such exemplary embodiments. The features and advantages of such embodiments may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features will become more fully apparent from the following description and appended claims or may be learned by the practice of such exemplary embodiments as set forth hereinafter.Page 4 Docket No 22935 56A - 16097WOO1BRIEF DESCRIPTION OF THE DRAWINGS

[0029] A description of various aspects and features of the invention will be rendered by reference to various representative embodiments thereof illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope.

[0030] Figure 1 is a perspective view of an exemplary aspiration catheter according to an embodiment of the present disclosure.

[0031] Figure 2 is a sectional view of an exemplary aspiration catheter according to an embodiment of the present disclosure.

[0032] Figure 3 illustrates an exemplary aspiration catheter within a body lumen aspirating thrombus according to an embodiment of the present disclosure.

[0033] Figure 4 is a sectional view of an exemplary aspiration catheter with two supply lumens according to an embodiment of the present disclosure.

[0034] Figure 5A is a perspective view of an exemplary handle including a vacuum switch ring in a distal position according to an embodiment of the present disclosure.

[0035] Figure 5B is a perspective view of an exemplary handle including a vacuum switch ring in a proximal position according to an embodiment of the present disclosure.

[0036] Figure 6A is a cut away view of an exemplary handle including a vacuum switch ring in a distal position according to an embodiment of the present disclosure.

[0037] Figure 6B is a cut away view of an exemplary handle including a vacuum switch ring in a proximal position according to an embodiment of the present disclosure

[0038] Figure 7 is a bottom view of an exemplary handle according to an embodiment of the present disclosure.

[0039] Figure 8 is a top cut-away view of an exemplary handle according to an embodiment of the present disclosure.

[0040] Figure 9 is a cross-sectional view of an exemplary handle according to an embodiment of the present disclosure.

[0041] Figure 10 is a close-up magnified view of an exemplary handle including a distal printed circuit board according to an embodiment of the present disclosure.

[0042] Figure 11 is an assembled view of an exemplary steering subassembly according to an embodiment of the present disclosure.Page 5 Docket No 22935 56A - 16097WOO1

[0043] Figure 12 is an exploded view of an exemplary steering subassembly according to an embodiment of the present disclosure.

[0044] Figure 13 is another exploded view of an exemplary steering subassembly according to an embodiment of the present disclosure.

[0045] Figure 14 is a perspective view of a barrel component of an exemplary steering subassembly according to an embodiment of the present disclosure.

[0046] Figure 15 is a perspective assembled view of two barrel components of an exemplary steering subassembly according to an embodiment of the present disclosure.

[0047] Figure 16A is a close-up magnified view of a vacuum port of an exemplary handle showing a y-connector according to an embodiment of the present disclosure.

[0048] Figure 16B is a close-up magnified view of a vacuum port of an exemplary handle not showing a y-connector according to an embodiment of the present disclosure.

[0049] Figure 17 is a cross-sectional perspective view of an interface between an exemplary steering subassembly and a handle body according to an embodiment of the present disclosure.DETAILED DESCRIPTION

[0050] One or more specific embodiments of the present disclosure will be described below. In an effort to provide a concise description of these embodiments, some features of an actual embodiment may be described in the specification. It should be appreciated that in the development of any such actual embodiment, as in any engineering or design project, numerous embodiment-specific decisions will be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one embodiment to another. It should further be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.

[0051] One or more embodiments of the present disclosure may generally relate to handles for thrombectomy catheter systems, for use in removing thrombotic material or thrombus using one or more high pressure fluid jets (e.g., saline jets) in combination with an aspiration catheter. Such systems may include an elongate shaft configured for placement within a blood vessel of a subject, an aspiration lumen extending along the elongate shaft, at least one supply lumen extending along the elongate shaft, wherein Page 6 Docket No 22935 56A - 16097WOO1the at least one supply lumen includes an orifice configured to allow a pressurized fluid jet to flow into the aspiration lumen; and a pressurized fluid source in communication with the at least one supply lumen to provide the pressurized fluid to the supply lumen. The system further includes a handle for steering at least a distal end of the elongate shaft and for controlling aspiration and / or pressurized fluid jet flow at the distal end of the elongate shaft, the handle being located at a proximal end of the elongate shaft, the handle including a handle body and a vacuum switch ring at a distal end of the handle body, the vacuum switch ring being configured to selectively actuate aspiration and / or pressurized fluid jet flow at the distal end of elongate shaft.

[0052] Various exemplary thrombectomy catheter systems are disclosed in Applicant's U.S. Patent Application Nos. 18 / 965,087, filed on December 2, 2024; 18 / 965,805, filed on December 2, 2024; 18 / 966,629, filed on December 3, 2024; 18 / 967,093, filed on December 3, 2024; 18 / 968,801, filed on December 4, 2024; 18 / 968,851, filed on December 4, 2024; 18 / 968,880, filed on December 4, 2024; 18 / 968,896, filed on December 4, 2024; 18 / 971,460, filed on December 6, 2024; 18 / 974,256, filed on December 9, 2024; 18 / 976,691, filed on December 11, 2024; 18 / 976,864, filed on December 11, 2024; 18 / 978,264, filed on December 12, 2024; 18 / 978,310, filed on December 12, 2024; 63 / 748,025, filed on January 22, 2025; PCT / US26 / 11122, filed on January 13, 2026; 63 / 748,030, filed on January 22, 2025; PCT / US26 / 11125, filed on January 13, 2026; 63 / 755,039, filed on February 6, 2025; PCT / US26 / 11130, filed January 13, 2026; 63 / 760,921, filed on February 20, 2025; and PCT / US25 / 41131, filed August 7, 2025, each of which is herein incorporated by reference in its entirety.

[0053] Figures 1-4 illustrate an aspiration catheter 102 that can be used with any of the above noted systems for aspirating thrombus. Aspiration catheter 102 includes an aspiration lumen 104 formed by a shaft 106, such as a hypotube, jacketed by a polymer jacket or a polymer jacket is laminated on the hypotube. For instance, a shaft body 108a is illustrated being jacketed by a jacket 108b. A distal end 110 of the aspiration catheter 102 includes a multilayer structure. A portion 108c of the jacket 108b extends distally of a shaft distal end 112 of the shaft 106 to form part of the distal end 110. An outer layer or outer jacket 108d overlaps the jacket 108b, extends towards and overlaps a shaft distal end 112, and forms the aspiration catheter distal end 110 or the distal most end of the aspiration catheter with the distal opening 114. The outer jacket 108d protects a distalPage 7 Docket No 22935 56A - 16097WOO1portion 116 of a supply tube 118 containing a supply lumen 120. While reference is made to a multilayer structure, it will be understood that one or more layers can be omitted or combined together. Additionally, one or more of the layers or shaft body can include braided or other members to increase strength and / or flexibility. Alternatively, the shaft and associated layers can be formed by extruding the shaft or using other structure to form the shaft.

[0054] The shaft 106 can include one or more openings 122 to increase a flexibility of shaft 106 to aid with advancement of the aspiration catheter 102 through the tortuous anatomy of a patient. While reference is made to a "hypotube," it will be understood that other tubular structures can be used for the shaft 106. Additionally, the shaft 106 can be formed from polymers, metals, alloys, braided structures, coiled structures, and combinations or modifications thereof. Furthermore, the jacket 108b and outer jacket 108d can be formed of a variety of polymers and copolymers, plastics, PEBAX, HYTREL, rubber, thermoplastic elastomer, fluorinated ethylene propylene, polytetrafluoroethylene, other elastomer and combinations or modifications thereof.

[0055] The supply lumen 120 may be configured to provide a high pressure fluid injection, such as saline, within the aspiration lumen 104 for macerating a thrombus as it is aspirated, such as illustrated in Figure 3 where the aspiration catheter 102 is disposed within a vessel lumen VL of a vessel V and aspirant A is being drawn into the aspiration lumen 104. The saline injection may occur through orifice 124 near the distal end of the supply lumen 120 if the opening of the supply lumen is plugged with a plug. Aspiration catheter 102 may also include a radiopaque (RO) ring 128 at or nearthe distal end 110 of aspiration catheter 102 for identifying the location of aspiration. The radiopaque ring 128 optionally encircles the aspiration catheter 102. In the illustrated configuration, the RO ring 128 is disposed between the jacket 108b and outer jacket 108d. The RO ring 128 can be formed of or comprise any suitable radiopaque material, such as tantalum, tungsten, platinum / iridium, gold, silver, and combinations or modifications thereof.

[0056] In at least one embodiment, the aspiration catheter 102 includes a second supply lumen 130, such as illustrated in Figure 4. The second supply lumen 130 may also be configured to provide a high pressure fluid injection, such as saline, within the aspiration lumen 104 for macerating a thrombus as it is aspirated. The saline injection may occur through a second orifice 126 near the distal end of the supply lumen 120 if the openingPage 8 Docket No 22935 56A - 16097WOO1of the supply lumen is plugged with a plug. When a first supply lumen 120 and a second supply lumen 130 are present, the first orifice 124 and the second orifice 126 may be offset where one orifice (e.g., orifice 126) is proximal to the other orifice (e.g., orifice 124). In other embodiments, the first orifice 124 and the second orifice 126 may be directly across from one another therefore macerating thrombotic material from both sides of the aspiration lumen 104.

[0057] In some situations, one supply lumen (e.g., supply lumen 130) may provide saline while the other supply lumen (e.g., supply lumen 120) supplies a different fluid, such as a drug, coating, contrast media, lubricant, or water. In some instances, both supply lumens may be activated at the same time. In other instances, one supply lumen may initially be activated while the other supply lumen is activated at a later time. Similarly, in some instances, the high pressure fluid may stop flowing through one supply lumen at one point in time and continue to flow through the other supply lumen until a later time. In at least one embodiment, the high pressure fluid stops flowing through both supply lumens at the same time. In at least one embodiment, one or both supply lumens may have a continuous pressure or a pulsatile pressure.

[0058] In some situations, during aspiration, there is a risk of damage to the vessel that might occur because the vessel wall is drawn into the aspiration lumen 104 and comes into contact with the jet of pressurized fluid being injected (e.g., a high pressure saline spray at, for example, about 550 psi (3.79 MPa) or about 650 psi (4.48 MPa)), from supply lumen 120. By way of example, the supply lumen(s) may provide pressurized fluid (e.g., saline at a pressure from about 3 MPa to about 7 MPa). More generally such pressure may range from about 400 psi (2.6 MPa) to about 3,000 psi (20.7 MPa), from about 400 psi (2.6 MPa) to about 2,000 psi (13.8 MPa), or from about 500 psi (3.4 MPa) to about 2,000 psi (13.8 MPa), orfrom about 600 psi (4.1 MPa) to about 1,750 psi (12.1 MPa). Such pressures may be as measured at the proximal end of the supply lumen, or at the distal end e.g., adjacent the orifice. A tissue encroachment prevention assembly can be provided to prevent aspiration catheter 102 from damaging the vessel during aspiration. The tissue encroachment prevention assembly can be selectively added to the distal end 110 of the aspiration catheter 102 or the distal end 110 can be modified or changed to accommodate such a tissue encroachment prevention assembly.Page 9 Docket No 22935 56A - 16097WOO1

[0059] While providing multiple orifices 124, 126 can be achieved using multiple supply lumens as shown, it is also possible to provide multiple orifices associated with just a single supply lumen (e.g., by providing multiple orifices within such supply lumen).

[0060] Figures 5A-17 illustrate exemplary embodiments of a handle, and features thereof, that may be used with the thrombectomy catheter systems and / or devices described herein. The handle 500 may be configured to selectively actuate aspiration, selectively control delivery of a pressurized fluid jet, and / or provide steering control through user manipulation at the proximal end of the thrombectomy catheter system and / or devices. In at least one embodiment, movement of or at the handle 500 may steer a catheter 502 through a vessel of a patient. Additionally or alternatively, the handle 500 may include components that provide an improved manufacturing process by reducing the number of total components relative to known devices as well as providing a simpler construction of the handle 500.

[0061] Figures 5A and 5B show perspective views of an exemplary handle including a vacuum switch ring, with the ring shown in a distal position and a proximal position, respectively, according to at least one embodiment of the present disclosure. Figures 5A and 5B show that the handle 500 may include a handle body 510 that may be formed from any suitable material, for example polymers and copolymers, plastics, PEBAX, HYTREL, rubber, thermoplastic elastomer, fluorinated ethylene propylene, polytetrafluoroethylene, other elastomers and combinations or modifications thereof. The handle 500 may be constructed through any suitable manufacturing technique, for example additive manufacturing and / or injection molding.

[0062] Figures 5A and 5B further illustrate that the handle 500 may include a vacuum switch ring 520 positioned at a distal end of the handle body 510. The vacuum switch ring 520 may be configured to move axially (for example, along axis 3 shown in Figure 5A) relative to the handle body 510 to selectively actuate aspiration. In a distal position, as shown in Figure 5A, the vacuum switch ring 520 may be disengaged from an internal switch (for example, printed circuit board switch 530 shown in Figures 6A and 6B) disposed within the handle body 510 such that aspiration is not activated. When the vacuum switch ring 520 is displaced proximally, as shown in Figure 5B, the vacuum switch ring 520 may engage the internal switch, which may actuate aspiration in the catheter 502. While a proximal position is described as actuating aspiration, it will be appreciatedPage 10 Docket No 22935 56A - 16097WOO1that in another embodiment, a distal position could alternatively be associated with aspiration actuation. Various other alternatives are of course possible.

[0063] In any case, the vacuum switch ring 520 may be configured to operate the internal switch. In at least one embodiment, the internal switch may be configured such that aspiration is activated when the vacuum switch ring 520 is moved to the proximal position. In certain embodiments, aspiration may remain active until the vacuum switch ring 520 is moved proximally a second time, which may be referred to as a toggle mode. In other embodiments, aspiration may remain active only while the vacuum switch ring 520 is maintained in the proximal position, which may be referred to as a pull mode. Providing either a toggle mode or a pull mode may allow selection of a desired control scheme. For example, a toggle mode may reduce the need for continuous user force during aspiration, while a pull mode may permit rapid deactivation of aspiration, such as in an emergency situation where potential damage to the patient should be avoided.

[0064] In at least one embodiment, the one or more printed circuit boards 580 may comprise one or more processors and one or more non-transitory computer readable storage media that store instructions that are configured to operate various functions of the handle 500. For example, the toggle mode and the pull mode may be implemented via firmware on the one or more printed circuit boards 580, and a user may be able to select between the two modes using an input to the one or more printed circuit boards 580.

[0065] Figures 5A and 5B also illustrate that the handle body 510 may include a distal tip 512 that may be at least partially translucent or transparent and may be configured to emit light and / or allow the passage of light therethrough. In at least one embodiment, the distal tip 512 may be illuminated by one or more internal light sources (for example, one or more light sources 514 in Figure 10) to indicate an operational status of the handle 500 and / or the associated thrombectomy system. The internal light source may include any suitable illumination device, such as one or more light emitting diodes (LEDs), and may emit light of one or more colors. In certain embodiments, the illumination may be steady, flashing, pulsed, or otherwise varied to convey different operational conditions of the system.

[0066] In at least one embodiment, a haptic vibrator motor 540 (Figure 6A) may be disposed within the handle body 510. The one or more internal light sources and / or thePage 11 Docket No 22935 56A - 16097WOO1haptic vibrator motor 540 may be configured to indicate an operational status of the handle 500. For example, while the vacuum is off, the one or more internal light sources and / or the haptic vibrator motor 540 may be in a deactivated state. When the vacuum switch ring 520 is actuated proximally and engages the internal switch, the one or more internal light sources and / or the haptic vibrator motor 540 may be activated and may indicate that the vacuum is operating.

[0067] In at least one embodiment, the handle 500 may be configured to detect if the catheter 502 is in contact with a clot, a vessel wall, and / or is in a free bloodstream. The one or more internal light sources and / or the haptic vibrator motor 540 may be used to provide any sensed detection to the user of the handle 500, for example by activating when the catheter senses contact with the clot or the vessel wall. In at least one embodiment, the one or more internal light sources may light up a certain color, for example red, when the catheter 502 is in contact with the vessel wall, a different color, for example green, when the catheter 502 is in a free bloodstream, and a still different color, for example blue, when the catheter 502 is in contact with the clot.

[0068] As discussed above, Figure 5A shows the vacuum switch ring 520 in a distal position. In such a position, a thrombectomy catheter device including the handle 500 may provide no aspiration. In at least such a way, the distal position may be considered a default position. Figure 5B shows the vacuum switch ring 520 in the proximal position. In at least one embodiment, a user may slide the vacuum switch ring 520 proximally by pulling on the collar 522 of the vacuum switch ring 520 which may engage the vacuum and begin aspiration.

[0069] In at least one embodiment, the handle 500 may include a steering subassembly 550. The steering subassembly 550 may control the advancement and / or positioning of the catheter 502 within the patient's body, as discussed in further detail in regard to Figure 11.

[0070] Figures 5A and 5B also illustrate that the handle 500 may include one or more icons 516 associated with steering. The icons 516 may include, for example, one or more arrows or other indicia indicating a direction in which the steering subassembly 550 may be moved (e.g., rotated) to effect steering of the catheter 502. In some embodiments, rotation of the steering subassembly 550, for example rotation of the collar 522 of the vacuum switch ring 520, in a direction indicated by the icons 516 may causePage 12 Docket No 22935 56A - 16097WOO1corresponding displacement, deflection, or rotation of a distal portion of the catheter 502 within a patient's body. The inclusion of such icons 516 may facilitate intuitive operation and improve user control during advancement and positioning of the catheter 502.

[0071] Figures 6A and 6B show a cut-away view in which a bottom portion of the handle 500 has been cut-away to better illustrate one example of how the vacuum switch ring 520 may engage a switch of a printed circuit board switch 530. FIGS. 6A and 6B illustrate that the printed circuit board switch may be disposed and housed within the handle 500, for example in a distal portion of the handle 500. Figure 6A shows the vacuum switch ring 520 in the distal position. When in the distal position, the vacuum switch ring 520 may not engage with the printed circuit board switch 530, which may cause no aspiration to occur.

[0072] Figures 6A and 6B show that the vacuum switch ring 520 may be spring loaded distally by a spring 525. In at least one embodiment, the spring 525 may oppose proximal movement of the vacuum switch ring 520 and bias the vacuum switch ring 520 into the distal position. The spring 525 may allow the vacuum switch ring 520 to return to the distal position more quickly and with less effort.

[0073] Figure 6B shows the vacuum switch ring 520 in the proximal position. In at least one embodiment, when the vacuum switch ring 520 engages the printed circuit board switch 530, aspiration may be actuated. A degree of proximal shift of the vacuum switch ring 520 may be sufficient in some at least one embodiment to result in some flex of a contacting flex element of the switch ring, which may also cause aspiration to be actuated.

[0074] In at least one embodiment, the vacuum switch ring 520 may be configured to slide proximally and / or distally a distance in a range from about 1 mm to about 5 mm, about 2 mm to about 4 mm, and / or about 2 mm to about 3 mm. In at least one embodiment, the vacuum switch ring 520 may be configured to slide about 2.5 mm. At least one embodiment of the vacuum switch ring 520 may improve useability of the handle 500 by requiring at least some actuation to operate the vacuum while minimizing the amount necessary to control such operation.

[0075] Figure 7 is a bottom perspective view of an exemplary handle according to an embodiment of the present disclosure. Figure 7 shows that the bottom of the handle 500Page 13 Docket No 22935 56A - 16097WOO1may also include one or more icons 516 that may be disposed proximal to the vacuum switch ring 520. In at least one embodiment, the icons 516 may be disposed on an opposite side from other, matching icons 516 on the top side of the handle 500 (as shown in Figures 5A and 5B). Embodiments that include the one or more icons 516 may provide for greater ease of use of the handle 500. In embodiments that include the one or more icons 516 on both the top and the bottom of the handle 500, a user of the handle 500 may not be required to rotate the handle or user's head to find the one or more icons 516, which may improve user experience.

[0076] Figure 8 is a cut-away top view of an exemplary handle according to an embodiment of the present disclosure. Figure 8 shows that the handle body 510 of the handle 500 may be hollow and may include one or more components. For example, Figure 8 shows that the steering subassembly 550, the catheter 502, a y-connector 570, the vacuum switch ring 520 and one or more printed circuit boards 580 may be disposed at least partially within and / or adjacent to the handle body 510.

[0077] According to at least one embodiment, the catheter 502 may be part of the thrombectomy catheter systems and / or devices described herein. The catheter 502 may thus provide a channel for conveyance of a broken up thrombus and may provide for aspiration of the thrombus.

[0078] Figure 9 is a cross-sectional view of an exemplary handle according to an embodiment of the present disclosure. Figure 9 shows that the handle 500 may include similar components as described above with reference to Figure 8. Figures 8 and 9 illustrate that the handle 500 may include a top portion 501 and a bottom portion 509 (or other 2 portions) that may be configured to snap together and become connected without the use of additional elements such as screws. This may provide for an improved manufacturing process of the handle 500 by reducing the amount of total components necessary to form the handle 500. The top portion 501 and the bottom portion 509 may be mirrored components of one another and / or may be symmetrical. This may allow for a same die to be used when molding the top portion 501 and the bottom portion 509, which may provide a further improved and simplified manufacturing process of the handle 500.

[0079] Figures 8 and 9 also show that the handle 500 may include a snap mount 508 for the catheter 502. In at least one embodiment, the snap mount 508 may lock the catheterPage 14 Docket No 22935 56A - 16097WOO1502 within the handle 500 and may reduce axial or other movement of the catheter 502 within the handle 500. The handle 500 may also include a window at the bottom and / or the top of the handle 500 so that a user may see whether the catheter 502 is properly snapped into the snap mount 508.

[0080] Figure 10 is a close-up magnified view of an exemplary handle including a distal printed circuit board according to an embodiment of the present disclosure. As discussed herein, the handle 500 may include one or more light sources 514 disposed at least partially within the handle body 510. The one or more light sources 514 may include one or more light emitting diodes (LEDs) or other light sources. The LEDs or other light sources may be configured to emit light that indicates an operational status of the handle 500.

[0081] Figure 11 is an assembled view of an exemplary steering subassembly according to an embodiment of the present disclosure. Figure 12 is a partially exploded view of an exemplary steering subassembly according to an embodiment of the present disclosure. Figure 13 is a more fully exploded view of an exemplary steering subassembly according to an embodiment of the present disclosure. Figures 11-13 show that the steering subassembly 550 may include the vacuum switch ring 520. In at least one embodiment, rotation of the collar 522 may provide for steering of the distal end of the catheter 502. The collar 522 may include internal left hand and right hand threads.

[0082] Figures 11-13 also show that the steering subassembly 550 may include one or more wire pullers 552. The one or more wire pullers 552 may be oppositely threaded and may interface with the collar 522 such that the one or more wire pullers 552 move in opposite axial directions when the collar 522 is rotated.

[0083] By way of example and not limitation, rotation of the collar 522 may be less than a full revolution, for example within a range greater than 0 degrees and less than or equal to 360 degrees. In certain embodiments, rotation may be within a range of about 5 degrees to about 300 degrees, about 10 degrees to about 240 degrees, about 15 degrees to about 180 degrees, about 20 degrees to about 150 degrees, or about 30 degrees to about 120 degrees. Such rotation may produce distal tip deflection greater than 0 degrees and less than or equal to 180 degrees. In some embodiments, distal tip deflection of the catheter 502 may be within a range of about 1 degree to about 90 degrees, about 2 degrees to about 70 degrees, about 5 degrees to about 60 degrees, about 10 degrees to about 50 degrees, or about 15 degrees to about 45 degrees. The particular relationshipPage 15 Docket No 22935 56A - 16097WOO1between rotational input and distal deflection may depend on factors such as thread pitch, wire routing geometry, catheter stiffness, and steering wire attachment location and may be substantially linear or non-linear.

[0084] According to at least one embodiment, axial movement of the one or more wire pullers 552 may apply differential tension to one or more steering wires 553 (Figure 13) coupled to the distal portion of the catheter 502, which may cause controlled deflection of the distal end of the catheter 502. In some embodiments, each wire puller 552 may be formed as a molded component, which may simplify manufacture and assembly of the steering subassembly 550.

[0085] In at least one embodiment, the collar 522 may be restrained axially by a snap ring 554 and a thrust ring 555. Such axial restraint may permit rotational movement of the collar 522 while limiting axial displacement, which may maintain proper threaded engagement with the wire pullers 552.

[0086] Figures 11-13 illustrate how the steering assembly 550 may be configured to snap together, rather than requiring the use of screws, for assembly. As shown in Figures Ills, the steering subassembly 550 may include one or more barrel components 558. In at least one embodiment, the one or more barrel components 558 may be designed as a simple A-B molded part. For example, two barrel components 558 may be snapped together (one rotated 180 degrees about axis 3 from the other) in the steering assembly 550. As shown in Figures 11-13, the one or more barrel components 558 may be configured to receive and support the one or more wire pullers 552, and each barrel component 558 may support a single wire puller 552.

[0087] Figures 11-13 also show that the steering subassembly 550 may include a grip 559 that may provide increased grip to a user of the distal end of the handle 500. The grip 559 may improve user experience by providing improved use of the vacuum switch ring 520.

[0088] Figure 14 is a perspective view of a barrel component 558 of an exemplary steering subassembly according to an embodiment of the present disclosure. Figure 15 is a perspective assembled view of two barrel components 558 of an exemplary steering subassembly according to an embodiment of the present disclosure. Figures 14 and 15 illustrate how the one or more barrel components 558 may be configured to snap together with another barrel component 558, which may reduce a production cost of thePage 16 Docket No 22935 56A - 16097WOO1one or more barrel components 558. For example, the barrel component 558 may include one or more teeth 558a and one or more receiving portions 558b that are configured to interface with one another such that the barrel component 558 becomes attached to another barrel component 558.

[0089] Figure 16A is a close-up magnified view of a vacuum port of an exemplary handle showing a y-connector 570 according to an embodiment of the present disclosure. Figure 16B is a close-up magnified view of a vacuum port of an exemplary handle not showing a y-connector according to an embodiment of the present disclosure. As shown in Figures 16A and 16B, a pressure transducer 560 may be provided on the printed circuit board 580. The pressure transducer 560 may be configured to sense pressure within the catheter 502.

[0090] In at least one embodiment, the sensed pressure may be processed to determine an operational status of the handle 500. For example, pressure measurements may be used to indicate whether the distal end of the catheter 502 is in contact with a vessel wall, is engaging clot or thrombus material, or is positioned within a free bloodstream. Based on the determined status, one or more feedback mechanisms may be activated. In some embodiments, one or more light emitting diodes (LEDs) disposed within the handle 500 may be illuminated in a selected manner (e.g., color, intensity, flashing pattern), and / or a vibrational motor for haptic feedback may be actuated. Different visual and / or haptic outputs may correspond to different detected conditions, thereby providing real-time procedural feedback to a user.

[0091] In at least one embodiment, the pressure transducer 560 may detect a pressure drop below a first threshold that may indicate free flow, an increased pressure drop above a second threshold that may indicate engagement by the catheter 502 with a vessel wall, and an intermediate pressure drop that may be in between the first threshold and the second threshold may indicate engagement by the catheter 502 with a blood clot to be cleared.

[0092] Figures 16A and 16B further illustrate that the handle body 510 may define one or more teeth 511 configured to secure an electrical cable to the handle 500. The electrical cable (not shown) may provide power to one or more printed circuit boards 580 and associated electronic components, including, for example, the pressure transducer 560, one or more light sources 514, and / or the haptic vibrator motor 540.Page 17 Docket No 22935 56A - 16097WOO1

[0093] Figures 16A and 16B also illustrate that the handle body 510 may provide an internal space to house a valve. For example, the proximal end of the handle 500 as shown in Figures 16A and 16B may be configured to accommodate a hemostasis valve (e.g., Abbott COPILOT).

[0094] Figure 17 is a cross-sectional perspective view of an interface between an exemplary steering subassembly and a handle body according to an embodiment of the present disclosure. Figure 17 illustrates how the steering subassembly 550 and handle body 510 may define an interface 515 between the steering subassembly 550 and the handle body 510 which may be designed to absorb torsional load that resists separation.

[0095] For example, the interface 515 may include one or more teeth 515a and one or more receiving portions 515b as shown in Figure 17. The one or more teeth may be defined by the steering subassembly 550 and the one or more receiving portions may be defined by the handle body 510.

[0096] The articles "a," "an," and "the" are intended to mean that there are one or more of the elements in the preceding descriptions. The terms "comprising," "including," and "having" are intended to be inclusive and mean that there may be additional elements other than the listed elements. Additionally, it should be understood that references to "one embodiment" or "an embodiment" of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. Numbers, percentages, ratios, or other values stated herein are intended to include that value, and also other values that are "about" or "approximately" the stated value, as would be appreciated by one of ordinary skill in the art encompassed by embodiments of the present disclosure. A stated value should therefore be interpreted broadly enough to encompass values that are at least close enough to the stated value to perform a desired function or achieve a desired result. The stated values include at least the variation to be expected in a suitable manufacturing or production process, and may include values that are within 5%, within 1%, within 0.1%, or within 0.01% of a stated value.

[0097] A person having ordinary skill in the art should realize in view of the present disclosure that equivalent constructions do not depart from the spirit and scope of the present disclosure, and that various changes, substitutions, and alterations may be made to embodiments disclosed herein without departing from the spirit and scope of thePage 18 Docket No 22935 56A - 16097WOO1present disclosure. Equivalent constructions, including functional "means-plus-function" clauses are intended to cover the structures described herein as performing the recited function, including both structural equivalents that operate in the same manner, and equivalent structures that provide the same function. It is the express intention of the applicant not to invoke means-plus-function or other functional claiming for any claim except for those in which the words 'means for' appear together with an associated function. Each addition, deletion, and modification to the embodiments that falls within the meaning and scope of the claims is to be embraced by the claims.

[0098] The terms "approximately," "about," and "substantially" as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," and "substantially" may refer to an amount that is within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of a stated amount. Further, it should be understood that any directions or reference frames in the preceding description are merely relative directions or movements. For example, any references to "up" and "down" or "above" or "below" are merely descriptive of the relative position or movement of the related elements.

[0099] Some ranges may be disclosed herein. Additional ranges may be defined between any values disclosed herein as being exemplary of a particular parameter. All such ranges are contemplated and within the scope of the present disclosure.

[0100] Following are some further example embodiments of the invention. These are presented only by way of example and are not intended to limit the scope of the invention in any way. Further, any example embodiment can be combined with one or more of the example embodiments.

[0101] Embodiment 1. A handle for a steerable thrombectomy catheter system for aspirating thrombus, the handle comprising:a handle body; anda vacuum switch ring at a distal end of the body, the vacuum switch ring being configured to selectively actuate aspiration and / or pressurized fluid jet flow at a distal end of a thrombectomy catheter of the system.Page 19 Docket No 22935 56A - 16097WOO1

[0102] Embodiment 2. The handle of embodiment 1, wherein the vacuum switch ring is configured to slide axially to selectively actuate aspiration and / or pressurized fluid jet flow at the distal end of the thrombectomy catheter.

[0103] Embodiment 3. The handle of embodiments 1 or 2, wherein the vacuum switch ring is configured to slide axially a distance within a range of about 1 mm to about 5 mm, or about 2 mm to about 3 mm.

[0104] Embodiment 4. The handle of any of the preceding embodiments, wherein the vacuum switch ring is biased distally.

[0105] Embodiment 5. The handle of any of the preceding embodiments, wherein the vacuum switch ring is spring loaded.

[0106] Embodiment 6. The handle of any of the preceding embodiments, wherein the vacuum switch ring is biased distally, and configured to actuate aspiration and / or pressurized fluid jet flow at the distal end of the thrombectomy catheter upon a user sliding the vacuum switch ring proximally.

[0107] Embodiment 7. The handle of any of the preceding embodiments, wherein the vacuum switch ring is configured to actuate aspiration and / or pressurized fluid jet flow when slid proximally, the system maintaining the aspiration and / or pressurized fluid jet flow until the vacuum switch ring is slid proximally a second time.

[0108] Embodiment 8. The handle of any of the preceding embodiments, wherein the vacuum switch ring includes one or more external ribs for improved grip.

[0109] Embodiment 9. A steerable thrombectomy catheter system for aspirating thrombus, the system comprising:an elongate shaft configured for placement within a blood vessel of a subject; an aspiration lumen extending along the elongate shaft;at least one supply lumen extending along the elongate shaft, wherein the at least one supply lumen includes an orifice configured to allow a pressurized fluid jet to flow into the aspiration lumen;a pressurized fluid source in communication with the at least one supply lumen to provide the pressurized fluid to the supply lumen; anda handle for steering at least a distal end of the elongate shaft and for controlling aspiration and / or pressurized fluid jet flow at the distal end of the elongate shaft, the handle being located at a proximal end of the elongate shaft, the handle including aPage 20 Docket No 22935 56A - 16097WOO1handle body and a vacuum switch ring at a distal end of the handle body, the vacuum switch ring being configured to selectively actuate aspiration and / or pressurized fluid jet flow at the distal end of elongate shaft.

[0110] Embodiment 10. The system of embodiment 9, wherein the handle includes a selectively illuminated distal tip for indicating operational status of the system.

[0111] Embodiment 11. The system of embodiments 9 or 10, wherein the handle includes a haptic vibrator motor for indicating operational status of the system.

[0112] Embodiment 12. The system of any of the preceding embodiments, wherein the vacuum switch ring comprises a collar, wherein rotation of the collar of the vacuum switch ring steers the distal end of the elongate shaft through a wire puller mechanism.

[0113] Embodiment 13. The system of embodiment 12, wherein the collar includes left hand internal threads and right hand internal threads, the left hand internal threads and right hand internal threads being operatively coupled to wire pullers within the handle that are oppositely threaded relative to one another, so that the wire pullers move in opposite axial directions when the collar is rotated, the wire pullers being operatively connected to the distal end of the elongate shaft, so as to steer the distal end of the elongate shaft upon rotation of the collar.

[0114] Embodiment 14. The system of embodiments 12 or 13, wherein the collar is restrained axially by a snap ring and / or a thrust ring.

[0115] Embodiment 15. The system of any of the preceding embodiments, wherein the handle further comprises at least one printed circuit board.

[0116] Embodiment 16. The system of embodiment 15, wherein the at least one printed circuit board includes a pressure transducer in operative communication with a vacuum port of the handle, for measuring pressure within the aspiration lumen.

[0117] Embodiment 17. The system of embodiment 16, wherein the pressure transducer within the handle is configured to measure pressure within the aspiration lumen, to determine whether the distal end of the elongate shaft is in contact with thrombus, is in contact with a vessel wall, or is in a free bloodstream.

[0118] Embodiment 18. The system of any of the preceding embodiments, wherein a distal tip of the handle is selectively illuminated in a specified color, and / or a haptic vibrator motor in the handle is actuated, depending on whether the distal end of thePage 21 Docket No 22935 56A - 16097WOO1elongate shaft is in contact with thrombus, is in contact with a vessel wall, or is in a free bloodstream, to indicate an operational status of the system to a user.

[0119] Embodiment 19. The system of embodiment 15, wherein the vacuum switch ring selectively contacts an operation switch of the at least one printed circuit board to actuate aspiration through the aspiration lumen, when the vacuum switch ring is slid proximally.

[0120] Embodiment 20. The system of any of the preceding embodiments, wherein the handle further comprises teeth for securing an electrical cable that provides power to the handle.

[0121] Embodiment 21. The system of any of the preceding embodiments, wherein components of the handle are configured to snap together, rather than using screws to hold the components together.

[0122] Embodiment 22. The system of any of the preceding embodiments, wherein the at least one supply lumen includes more than one orifice, so as to deliver a plurality of pressurized fluid jets into the aspiration lumen.

[0123] The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.Page 22 Docket No 22935 56A - 16097WOO1

Claims

CLAIMSWhat is claimed is:

1. A handle for a steerable thrombectomy catheter system for aspirating thrombus, the handle comprising:a handle body; anda vacuum switch ring at a distal end of the body, the vacuum switch ring being configured to selectively actuate aspiration and / or pressurized fluid jet flow at a distal end of a thrombectomy catheter of the system.

2. The handle of claim 1, wherein the vacuum switch ring is configured to slide axially to selectively actuate aspiration and / or pressurized fluid jet flow at the distal end of the thrombectomy catheter.

3. The handle of claims 1 or 2, wherein the vacuum switch ring is configured to slide axially a distance within a range of about 1 mm to about 5 mm, or about 2 mm to about 3 mm.

4. The handle of any of the preceding claims, wherein the vacuum switch ring is biased distally.

5. The handle of any of the preceding claims, wherein the vacuum switch ring is spring loaded.

6. The handle of any of the preceding claims, wherein the vacuum switch ring is biased distally, and configured to actuate aspiration and / or pressurized fluid jet flow at the distal end of the thrombectomy catheter upon a user sliding the vacuum switch ring proximally.

7. The handle of any of the preceding claims, wherein the vacuum switch ring is configured to actuate aspiration and / or pressurized fluid jet flow when slid proximally, the system maintaining the aspiration and / or pressurized fluid jet flow until the vacuum switch ring is slid proximally a second time.

8. The handle of any of the preceding claims, wherein the vacuum switch ring includes one or more external ribs for improved grip.

9. A steerable thrombectomy catheter system for aspirating thrombus, the system comprising:an elongate shaft configured for placement within a blood vessel of a subject;Page 23 Docket No 22935 56A - 16097WOO1an aspiration lumen extending along the elongate shaft;at least one supply lumen extending along the elongate shaft, wherein the at least one supply lumen includes an orifice configured to allow a pressurized fluid jet to flow into the aspiration lumen;a pressurized fluid source in communication with the at least one supply lumen to provide the pressurized fluid to the supply lumen; anda handle for steering at least a distal end of the elongate shaft and for controlling aspiration and / or pressurized fluid jet flow at the distal end of the elongate shaft, the handle being located at a proximal end of the elongate shaft, the handle including a handle body and a vacuum switch ring at a distal end of the handle body, the vacuum switch ring being configured to selectively actuate aspiration and / or pressurized fluid jet flow at the distal end of elongate shaft.

10. The system of claim 9, wherein the handle includes a selectively illuminated distal tip for indicating operational status of the system.

11. The system of claims 9 or 10, wherein the handle includes a haptic vibrator motor for indicating operational status of the system.

12. The system of any of the preceding claims, wherein the vacuum switch ring comprises a collar, wherein rotation of the collar of the vacuum switch ring steers the distal end of the elongate shaft through a wire puller mechanism.

13. The system of claim 12, wherein the collar includes left hand internal threads and right hand internal threads, the left hand internal threads and right hand internal threads being operatively coupled to wire pullers within the handle that are oppositely threaded relative to one another, so that the wire pullers move in opposite axial directions when the collar is rotated, the wire pullers being operatively connected to the distal end of the elongate shaft, so as to steer the distal end of the elongate shaft upon rotation of the collar.

14. The system of claims 12 or 13, wherein the collar is restrained axially by a snap ring and / or a thrust ring.

15. The system of any of the preceding claims, wherein the handle further comprises at least one printed circuit board.Page 24 Docket No 22935 56A - 16097WOO116. The system of claim 15, wherein the at least one printed circuit board includes a pressure transducer in operative communication with a vacuum port of the handle, for measuring pressure within the aspiration lumen.

17. The system of claim 16, wherein the pressure transducer within the handle is configured to measure pressure within the aspiration lumen, to determine whether the distal end of the elongate shaft is in contact with thrombus, is in contact with a vessel wall, or is in a free bloodstream.

18. The system of any of the preceding claims, wherein a distal tip of the handle is selectively illuminated in a specified color, and / or a haptic vibrator motor in the handle is actuated, depending on whether the distal end of the elongate shaft is in contact with thrombus, is in contact with a vessel wall, or is in a free bloodstream, to indicate an operational status of the system to a user.

19. The system of claim 15, wherein the vacuum switch ring selectively contacts an operation switch of the at least one printed circuit board to actuate aspiration through the aspiration lumen, when the vacuum switch ring is slid proximally.

20. The system of any of the preceding claims, wherein the handle further comprises teeth for securing an electrical cable that provides power to the handle.

21. The system of any of the preceding claims, wherein components of the handle are configured to snap together, rather than using screws to hold the components together.

22. The system of any of the preceding claims, wherein the at least one supply lumen includes more than one orifice, so as to deliver a plurality of pressurized fluid jets into the aspiration lumen.Page 25 Docket No 22935 56A - 16097WOO1

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