Aspiration systems, methods, and devices

Abstract

An aspiration catheter comprising an aspiration lumen configured to aspirate thrombus from a body lumen, a supply tube with a supply lumen configured to provide a high pressure fluid injection to the aspiration lumen, and a mounting ring disposed within the aspiration lumen. The supply tube is connected to the mounting ring to orient and position an orifice in the supply tube at a predetermined orientation and position.

Description

ASPIRATION SYSTEMS, METHODS. AND DEVICESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of United States Provisional Patent Application Serial No. 63 / 748,025, filed January 22, 2025, and entitled “ASPIRATION SYSTEMS, METHODS, AND DEVICES,” the disclosure of which is incorporated herein by this reference.BACKGROUND OF THE INVENTIONTechnical Field

[0002] The present disclosure pertains generally to medical devices and methods of their use. More particularly, the present invention pertains to aspiration and thrombectomy devices and methods of securely positioning an orifice of a supply tube at a desired position and orientation.Description of the Related Art

[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 to macerate the thrombus and create a venturi effect to flush the macerated material away. All of the devices described above have limitations as a result of individual design characteristics.SUMMARY

[0004] 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 aid in determining the scope of the claimed subject matter. Embodiments of the present invention provide systems, methods, and devices for aspirating thrombus or material within a patient’s body.

[0005] Implementations of the present invention solve one or more problems in the art with systems, methods, and devices for aspirating thrombus or material within a patient’s body. For instance, the present invention relates aspiration systems, methods and devices- Page 1 - Docket No. 22935.48afor forming an aspiration catheter and positioning at least one supply tube to provide high pressure fluid for injection into the aspiration lumen.

[0006] An embodiment of the present disclosure relates to an aspiration catheter including: a shaft body having a distal end; a radiopaque component disposed at or near the distal end of the shaft body, the radiopaque component having a distal end; a mounting ring disposed at or near the distal end of the radiopaque component, the mounting ring having a mounting feature; a supply tube connected to the mounting feature; and a jacket disposed about the shaft, radiopaque component, and mounting ring, and extending distally from the mounting ring.

[0007] An embodiment of the present disclosure relates to an aspiration catheter including: a shaft having an aspiration lumen therein and a distal end; a mounting ring disposed within the shaft at or near the distal end of the shaft, the mounting ring having a mounting feature; and a supply tube connected to the mounting feature such that an orifice of the supply tube is positioned at a predetermined orientation and at a predetermined distance from a distal most end of the shaft.

[0008] An embodiment of the present disclosure relates to a mandrel for use in manufacturing an aspiration catheter, the mandrel including: a first primary section; a second primary section; and a cutout in an outer surface that is configured to receive therein a supply tube in an aspiration catheter.

[0009] Additional features and advantages of exemplary implementations 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 implementations. The features and advantages of such implementations 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 implementations as set forth hereinafter.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Various objects, features, characteristics, and advantages of the invention will become apparent and more readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings and the appended claims, all of which form a part of this specification. In the Drawings, like reference numerals may be utilized to designate corresponding or similar parts in the various Figures, and the various elements depicted are not necessarily drawn to scale, wherein:- Page 2 - Docket No. 22935.48a

[0011] FIG. 1 is a plan view of exemplary' disposable components of a system for aspirating thrombus according to an implementation of the present disclosure.

[0012] FIG. 2 is a sectional view of an exemplary distal end of the aspiration catheter of the system for aspirating thrombus of FIG. 1 according to an implementation of the present disclosure.

[0013] FIG. 3 is a detail view of an exemplary y-connector of the aspiration catheter of the sy stem for aspirating thrombus of FIG. 1 according to an implementation of the present disclosure.

[0014] FIG. 4 is a plan view of exemplary components of a system for aspirating thrombus according to an implementation of the present disclosure.

[0015] FIG. 5 is a perspective view of an exemplary system for aspirating thrombus of FIG. 3 according to an implementation of the present disclosure.

[0016] FIG. 6 is a perspective view of an exemplary7aspiration catheter according to an implementation of the present disclosure.

[0017] FIG. 7 is a sectional view of an exemplary aspiration catheter according to an implementation of the present disclosure.

[0018] FIG. 8 is an elevational view of an exemplary mounting ring according to an implementation of the present disclosure.

[0019] FIG. 9 illustrates the exemplary aspiration catheter within a body lumen aspirating thrombus according to an implementation of the present disclosure.

[0020] FIG. 10A illustrates an exemplary mandrel used in manufacturing of an aspiration catheter according to an implementation of the present disclosure.

[0021] FIG. 10B illustrates a sectional view of an exemplary mandrel according to an implementation of the present disclosure.

[0022] FIG. 10C illustrates a sectional view of an exemplary aspiration catheter being manufactured with a mandrel according to an implementation of the present disclosure.DETAILED DESCRIPTION

[0023] 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- Page 3 - Docket No. 22935.48asuch 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.

[0024] One or more embodiments of the present disclosure may generally relate to manners of mounting a supply tube, with associated supply lumen to limit or prevent blockage of an aspiration lumen of an aspiration catheter. This limits the possibility’ of engagement or collection of thrombus, clots, or other aspirants between the supply tube and the aspiration catheter thereby reducing the aspiration effectiveness of the aspiration catheter.

[0025] While the present disclosure will describe a particular implementation of an aspiration catheter with supply tube mounts or other structures that can be used to position a supply tube of an aspiration system to limit or prevent blockage of an aspiration lumen of an aspiration catheter during aspiration of thrombus, clots, or other aspirants, it should be understood that the devices, systems, and method described herein may be applicable to other uses. Additionally, elements described in relation to any embodiment depicted and / or described herein may be combinable with elements described in relation to any other embodiment depicted and / or described herein.

[0026] A system 100 for aspirating thrombus is illustrated in FIGS. 1-5. System 100 for aspirating thrombus includes a pump 101, an aspiration catheter 102, and a tubing set 103. The aspiration catheter 102 and the tubing set 103 represent disposable components 104, and the pump 101, and the pump’s associated pump base, is a reusable component. It is not necessary to sterilize the pump 101 as it may be kept in a non-sterile field or area during use. The aspiration catheter 102 and the tubing set 103 may each be supplied sterile, after sterilization by ethylene oxide gas, electron beam, gamma, or other sterilization methods. The aspiration catheter 102 may be packaged and supplied separately from the tubing set 103, or the aspiration catheter 102 and the tubing set 103 may be packaged together and supplied together. Alternatively, the aspiration catheter 102 and tubing set 103 may be packaged separately, but supplied together (i.e., bundled).

[0027] The aspiration catheter 102 has a distal end 105 and includes an over-the-wire guidewire lumen / aspiration lumen 106 extending between an open distal end 107, and a proximal end 108. The proximal end may comprise or be connected to ay-connector 110. The catheter shaft 111 of the aspiration catheter 102 is connected to the y-connector 110 via a protective strain relief 112. In other embodiments, the catheter shaft 111 may be attached to the y-connector 110 with a luer fitting. The y-connector 110 includes a first- Page 4 - Docket No. 22935.48afemale luer 113 which communicates with a catheter supply lumen 114 (FIG. 2), and a second female luer 115 which communicates with the guidewire lumen / aspiration lumen 106.

[0028] A spike 116 for coupling to a fluid source (e.g., saline bag, saline bottle) allows fluid to enter through an extension tubing 118 and flow into a supply tube 119. An optional injection port 120 allows injection of materials or removal of air. A cassette 121 having a moveable piston 122 is used in conjunction with a mechanical actuator 123 of the pump 101. Fluid is pumped into an injection tube 124 from action of the cassette 121 as applied by the actuator 123 of the pump 101. A male luer 126, hydraulically communicating with the catheter supply lumen 114, via the injection tube 124. is configured to attach to the female luer 113 of the y-connector 110.

[0029] Accessories 128 are illustrated that are intended for applying a vacuum source, such as a syringe 130 having a plunger 132 and a barrel 134, to the aspiration lumen 106 of the aspiration catheter 102. The syringe 130 is attached to a vacuum line 136 via the luer 140 of the syringe 130. A stopcock 138 may be used on the luer 140 to maintain the vacuum, or alternatively, the plunger 132 may be a locking variety of plunger that is configured to be locked in the retracted (vacuum) position. A male luer 142 at the end of the vacuum line 136 may be detachably secured to the female luer 115 of the y-connector 110 of the aspiration catheter 102. As shown in more detail in FIG. 3, a pressure transducer or sensor 144 is secured inside an internal cavity 146 of the y-connector 110 proximal to the female luer 113 and the female luer 1 15. A valve 150, for example a Touhy-Borst, at the proximal end of the y-connector 110 allows hemostasis of the guidewire lumen / aspiration lumen 106 around a guidewire 148. In other embodiments, the valve 150 may comprise a longitudinally spring-loaded seal. The guidewire 148 may be inserted entirely through the guidewire lumen / aspiration lumen 106. Signals output from the pressure sensor 144 are carried through a cable 152 to a connector 154. The connector 154 is plugged into a socket 156 of the pump 101. Pressure related signals may be processed by a circuit board 158 of the pump 101. The pressure transducer or sensor 144 may be powered from the pump 101, via the cable 152. The accessories 128 may also be supplied sterile to the user.

[0030] A foot pedal 160 is configured to operate a pinch valve 162 for occluding or opening the vacuum line 136. The foot pedal 160 comprises a base 164 and a pedal 166 and is configured to be placed in a non-sterile area, such as on the floor, under the procedure table / bed. The user steps on the pedal 166 causing a signal to be sent along a- Page 5 - Docket No. 22935.48acable 168 which is connected via a plug 170 to an input jack 172 in the pump 101. The vacuum line 136 extends through a portion of the pump 101. The circuit board 158 of the pump may include a controller 174 configured to receive one or more signals indicating on or off from the foot pedal 160. The controller 174 of the circuit board 158 may be configured to cause an actuator 176 carried by the pump 101 to move longitudinally to compress and occlude the vacuum line 136 between an actuator head 178 attached to the actuator 176 and an anvil 180, also carried by the pump 101. By stepping on the pedal 166, the user is able to thus occlude the vacuum line 136, stopping the application of a negative pressure. In some embodiments, as the pedal 166 of the foot pedal 160 is depressed, the controller may be configured to open the pinch valve 162.

[0031] The pressure transducer or sensor 144 thus senses a negative pressure and sends a signal, causing the controller to start the motor 182 of the pump 101. As the effect via the electronics is substantially immediate, the motor 182 starts pumping almost immediately after the pedal 166 is depressed. As the pedal 166 of the foot pedal 160 is released, the controller 174 then causes the pinch valve 162 to close. The pressure transducer or sensor 144 thus senses that no negative pressure is present and the controller 174 causes the motor 182 of the pump 101 to shut off. Again, the effect via the electronics is substantially immediate, and thus the motor 182 stops pumping almost immediately after the pedal 166 is depressed. During sterile procedures, the main interventionalist is usually "‘scrubbed’7such that the hands only touch items in the sterile field. However, the feet / shoes / shoe covers are not in the sterile field. Thus again, a single user may operate a switch (via the pedal 166) while also manipulating the aspiration catheter 102 and guidewire 148. However, this time, it is the sterile field hands and non-sterile field feet that are used. Alternatively, the foot pedal 160 may comprise two pedals, one for occlude and one for open. In an alternative foot pedal embodiment, the pedal 166 may operate a pneumatic line to cause a pressure activated valve or a cuff to occlude and open the vacuum line 136, for example, by forcing the actuator head 178 to move. In another alternative embodiment, the pedal 166 may turn, slide, or otherwise move a mechanical element, such as a flexible pull cable or push rod that is coupled to the actuator 176, to move the actuator head 178. The cable 168 may be supplied sterile and connected to the base 164 prior to a procedure. The occlusion and opening of the vacuum line 136 thus acts as an on and off switch for the pump 101 (via the pressure transducer or sensor 144). The on / off function may thus be performed by a user whose hands can focus on manipulating sterile catheters, guidewires, and accessories, and whose foot can turn the pump on and off in a non-sterile- Page 6 - Docket No. 22935.48aenvironment. This allows a single user to control the entire operation or the majority of operation of the system 100 for aspirating thrombus. This can be an advantage in terms of a rapid, synchronized procedure, but is also helpful in laboratories where additional assistants are not available. The actuator 176 and anvil 180 may be controlled to compress the vacuum line 136 with a particular force, and the actuator 176 may be controlled to move at a particular speed, either when compressing or when removing compression. Speed and force control allows appropriate response time, but may also be able to add durability to the vacuum line 136, for example, by not over-compressing. The foot pedal 160 may communicate with the pinch valve 162 via a wired connection through the pump 101 or may communicate with the pinch valve 162 wirelessly. Additionally, or alternatively, the pump may be controlled by buttons 184.

[0032] It should be noted that in certain embodiments, the pinch valve 162 and the foot pedal 160 may be incorporated for on / off operation of the pinch valve 162 on the vacuum line 136, without utilizing the pressure transducer or sensor 144. In fact, in some embodiments, the pressure transducer or sensor 144 may even be absent from the system 100 for aspirating thrombus, the foot pedal 160 being used as a predominant control means.

[0033] Turning to FIG. 2, a supply tube 186, which contains the catheter supply lumen 114, freely and coaxially extends within the over-the-wire guidewire lumen / aspiration lumen 106. At least a distal end 185 of the supply tube 186 is secured to an interior wall 190 of the guidewire lumen / aspiration lumen 106 of the catheter shaft 111 by adhesive, epoxy, hot melt, thermal bonding, or other securement modalities. A plug 192 is secured within the catheter supply lumen 114 at the distal end 185 of the supply tube 186. The plug 192 blocks the exit of pressurized fluid, and thus the pressurized fluid is forced to exit through an opening or orifice 194 in the wall 196 of the supply tube 186. The free, coaxial relationship between the supply tube 186 and the catheter shaft 111 along their respective lengths (the supply tube 186 and the catheter shaft 111 being optionally coextensive), allows for improved flexibility. In some embodiments, in which a stiffer proximal end of the aspiration catheter 102 is desired (e.g., for pushability or even torqueability), the supply tube 186 may be secured to the interior wall 190 of the guidewire lumen / aspiration lumen 106 of the catheter shaft 111 along a proximal portion of the aspiration catheter 102, but not along a distal portion. This may be appropriate if, for example, the proximal portion of the aspiration catheter 102 is not required to track through tortuous vasculature, but the distal portion is required to track through tortuous vasculature. The free, substantially unconnected, coaxial relationship between the supply tube 186 and the catheter shaft 111- Page 7 - Docket No. 22935.48aalong their respective lengths, may also be utilized to optimize flow through the guidewire lumen / aspiration lumen 106, as the supply tube 186 is capable of moving out of the way due to the forces of flow (e.g., of thrombus / saline) over its external surface, such that the remaining inner luminal space of the guidewire lumen / aspiration lumen 106 selfoptimizes, moving toward the lowest energy condition (least fluid resistance) or toward the largest cross-sectional space condition (e.g., for accommodating and passing pieces of thrombus).

[0034] A system 200 for aspirating thrombus is illustrated in FIGS. 4-5. The system 200 for aspirating thrombus is similar to the system 100 and so the disclosure related to the system 100 is also applicable to the description of system 200. An aspiration catheter 202 is similar to the aspiration catheter 102 of FIGS. 1-3 and as such the description related to the aspiration catheter 102 of FIGS. 1-3 is also applicable to the description of the aspiration catheter 202.

[0035] The aspiration catheter 202 is configured for aspirating thrombus from peripheral vessels, but may also be configured with a size for treating coronary, cerebral, pulmonary or other arteries, or veins. The aspiration catheter 202 / system 200 may be used in interventional procedures, but may also be used in surgical procedures. The aspiration catheter 202 / system 200 may be used in vascular procedures, or non-vascular procedures (other body lumens, ducts, or cavities). The catheter 202 comprises an elongate shaft 204 configured for placement within a blood vessel of a subject; a catheter supply lumen 114 (FIG. 2) and aguidewire / aspiration lumen 106, each extending along the shaft, the supply lumen 114 having a proximal end 147 and a distal end 185, and the aspiration lumen 106 having a proximal end 145 (FIG. 3) and an open distal end 107 (FIG. 2); and an opening or orifice 194 at or near the distal end 185 of the supply lumen 114, the opening configured to allow the injection of pressurized fluid into the aspiration lumen 106 at or near the distal end 107 of the aspiration lumen 106 when the pressurized fluid is pumped through the supply lumen 114. In some embodiments, the opening or orifice 194 may be located proximal to the distal end 185 of the supply lumen 114. In some embodiments, the distal end 185 of the supply lumen 114 may comprise a plug 192. A pump set 210 (e.g., tubing set) is configured to hydraulically couple the supply lumen 114 to a pump within a saline drive unit (SDU) 212, for injecting pressurized fluid (e.g., saline, heparinized saline) through the supply lumen 114. Suction tubing 214, comprising sterile suction tubing 216 and non-sterile suction tubing 217, is configured to hydraulically couple a vacuum canister 218 to the aspiration lumen 106. A filter 220 may be carried in-line on the suction tubing- Page 8 - Docket No. 22935.48a214, for example, connected between the sterile suction tubing 216 and the non-sterile suction tubing 217, or on the non-sterile suction tubing 217. The fdter 220 is configured to capture large elements such as large pieces of thrombus or emboli.

[0036] The pump set 210 includes a saline spike 221 for connection to a port 222 of a saline bag 224, and an inline drip chamber 226 for visually assessing the movement of saline, as well as keeping air out of the fluid being injected. The saline bag 224 may be hung on an IV pole 227 on one or more hooks 228. A pressure sensor 230 such as a vacuum sensor may be used within any lumen of the pump set 210, the suction tubing 214, the supply lumen 114 or aspiration lumen 106 of the catheter 202, or any other component which may see fluid flow. The pressure sensor 230 is shown in FIG. 5 within a lumen at a junction between a first aspiration tube 232 and a control 233. A cable 234 carries signals output from the pressure sensor 230 to a controller 235 in the SDU 212. A connector 236, electrically connected to the cable 234, is configured to be detachably coupled to a mating receptacle 237 (e.g., input jack) in the SDU 212. The SDU 212 also may have a display 238, including an LCD screen or alternative screen or monitor, in order to visually monitor parameters and status of a procedure. In alternative embodiments, the pressure sensor 230 may be replaced by another type of sensor that is configured to characterize fluid flow. In some embodiments, the sensor is a flow sensor, such as a Doppler flow velocity7sensor.

[0037] The SDU 212 is held on a mount 240 by four locking knobs 242. The mount 240 is secured to a telescoping rod 244 that is adjustable from a cart base 245 via a cart height adjustment knob or other element 246. The mount 240 and a handle 247 are secured to the rod 244 via an inner post 248 that is insertable and securable within an inner cavity in the rod 244. The IV pole 227 secures to the mount 240 via a connector 250. The base 245 may include legs 252 having wheels 253 (e.g.. three or more wheels or four or more wheels) and may be movable via the handle 247. The system 200 may also carry7a basket 254 for placement of components, products, documentation, or other items.

[0038] In use, a user connects a first connector 256 at a first end 258 of the non-sterile suction tubing 217 to a second port 259 on the lid 260 of the canister 218, and connects a second connector 261 at a second end 262 of the non-sterile suction tubing 217 to a vacuum pump input 264 in the SDU 212. A vacuum pump 266 may be carried within the SDU 212 in order to maintain a vacuum / negative pressure within the canister 218. Alternatively, the vacuum inside the canister 218 may be maintained manually, without a vacuum pump, by evacuating the canister 218 via one or more additional ports 268. A user connects a first connector 270 of the sterile suction tubing 216 to an aspiration luer 271 of the aspiration- Page 9 - Docket No. 22935.48acatheter 202 (similar to luer 115), and connects the second connector 272 of the sterile suction tubing 216 to port 274 in the lid 260 of the canister 218. Connector 236 is then coupled to the mating receptacle 237 in the SDU 212 for communication with the control 233 and / or the pressure sensor 230. For instance, the connector 236 can be snapped into mating receptacle 237 in the SDU 212 for communication with elements of the control 233 and / or for communication with the pressure sensor 230. either via cable 234. and / or additional cables or wires. Alternatively, the connector 236 may couple to the mating receptacle 237 by clipping, friction fitting, vacuum fitting, or other means.

[0039] After allowing saline to purge through the supply tube 276, cassette 278, and injection tube 279 of the pump set 210, the user connects the luer connector 280 of the pump set 210 to a luer 282 of the aspiration catheter 202 (similar to luer 113). The cassette 278 (similar to cassette 121) is then attached to a saddle 283 in the SDU 212. The saddle 283 is configured to reciprocate a piston to inject the saline from the IV bag 224 at high pressure, after the cassette 121 is snapped in place, keeping the internal contents (e.g., saline) sterile. Systems configured for performing this type of sterile injection of high-pressure saline are described in U.S. Pat. No. 9,883,877, issued February 6, 2018, and entitled, “Systems and Methods for Removal of Blood and Thrombotic Material”, which is incorporated by reference in its entirety for all purposes. The SDU 212 is enclosed within a case 284 and a case lid 285. The controller 235 may reside on a circuit board 286. Noise from a motor 287 controlling the saddle 283 and from the vacuum pump 266 is abated by internal foam sections 288, 289. The saddle 283 may be moved directly by the motor 287, or may be moved with pneumatics, using a cycled pressurization. An interface panel 290 provides one or more switches 297 and the display 238. Alternatively, the cassette 121 may couple to the saddle 283 by clipping, friction fitting, vacuum fitting, or other means.

[0040] FIG. 5 illustrates aspects pertaining to the vacuum canister 218, in which aspirant (e.g., thrombus, blood, saline) that is evacuated from the patient through the aspiration lumen 106 is collected. The canister 218 may be held in a canister mount 292 carried by the IV pole 227, or alternatively carried by any other part of the system 200. A lid 260 is configured to cover a portion of the canister 218, such as in a snapping manner, to close an interior 296 of the canister 218. Alternatively, the lid 260 may couple to the canister 218 by screwing, clipping, friction fitting, or other means.

[0041] The lid 260 may comprise two or more ports, including the first port 268 and second port 259 for providing negative pressure / vacuum to the aspiration lumen 106. For example, the lid 260 may comprise two ports, three ports, four ports, or more than four- Page 10 - Docket No. 22935.48aports. Sterile suction tubing 216 may be connected to the lid 260 of the vacuum canister 218 at a first port 268 for transmitting a negative pressure to the sterile suction tubing 216 and to the aspiration lumen 106 of the aspiration catheter 102. Non-sterile suction tubing 217 may be connected to the lid 260 of the vacuum canister 218 at a second port 259 for providing a negative pressure to the vacuum canister 218. A negative pressure may be provided to the non-sterile suction tubing 217 (and to sterile suction tubing 216 and the aspiration lumen 106 connected therewith) by a vacuum source (e.g., a vacuum pump or syringe). The system 200 may also comprise means for sealing the two or more ports of the lid 260 when not in use, such as one or more port caps. A filter may be placed over an entry' to the second port 259 so as to prevent aspirant from traveling along the non-sterile suction tubing 217 from the vacuum canister 218 to the vacuum source.

[0042] The vacuum canister 218 preferably has a sufficient volumetric capacity for receiving all aspirant collected during the surgical procedure. Receptacles having a volumetric capacity of approximately 100 cubic inches, or receptacles having a diameter of approximately 5.0 inches and a height of approximately 7.0 inches, have been found to provide sufficient volumetric capacity'.

[0043] Returning to FIG. 4, a solenoid 298 is carried internally in the SDU 212, and is configured to interface with the interior 296 of the canister 218, via the suction tubing 214, or via any additional tubing. The solenoid 298 is configured to vent the negative pressure inside the canister 218, by opening a valve 299 coupled to the solenoid (mechanically or electromagnetically) that opens the interior 296 of the canister 218 to ambient pressure. The venting allows any foaming of blood or fluid, such as any aspirated liquid, within the canister 218 to be reduced. Foaming can occur during a thrombolysis procedure due to cavitation, as air bubbles are formed. The solenoid 298 is then configured to close the valve 299, to allow negative pressure to again be built up within the interior 296 of the canister 218. The controller 235 is configured to automatically' energize the solenoid 298, in order to allow for the degassing / defoaming. For example, the controller 235 may send a signal to energize the solenoid 298 based on the measurement of a targeted negative pressure and / or a targeted time of aspiration cycle. In other cases, the controller 235 can send a signal to energize the solenoid 298 every minute, every five minutes, every ten minutes, etc. Additionally, a user can operate the controller 235, and more generally the controller 174, of the system 200 through the interface panel 290 to initiate degassing / defoaming of the interior 296. The venting may also be able to remove air bubbles inside the other lumens of the catheter and tubing sets.- Page 11 - Docket No. 22935.48a

[0044] In some embodiments, the controller 235 can output or send a signal to energize the solenoid 298 to open the valve 299, in order to stop any aspiration, while still allowing the SDU 212 to deliver saline, medication, or saline combined with medication (e.g., thrombolytic drugs), so that the fluids can be delivered out of the open distal end 107 (instead of being aspirated through the aspiration lumen 106).

[0045] Turning to FIGS. 6-8 illustrated is another configuration of an aspiration catheter 302 that can be used with the systems 100 or 200 for aspirating thrombus. As such, the aspiration catheters 102, 202, 302 may be similar or identical to one another in one or more aspects.

[0046] As shown in more detail in FIGS. 6-8, aspiration catheter 302 includes an aspiration lumen 306 formed by a shaft 311. such as a hypotube or flat coiled wire, j acketed by a polymer jacket or a polymer jacket laminated on the hypotube / flat coiled wire. For instance, a shaft body 317a is illustrated being jacketed by a jacket 317b, such as by heatshrinking or otherwise applying the jacket 317b to the shaft body 317a. In the illustrated embodiment, a portion of the jacket 317b extends distally beyond a distal end 325 of the shaft body 317a to form part of a distal end 305 of the aspiration catheter 302. The jacket 317b forms the distal most end 305a of the aspiration catheter 302 with a distal opening 307 therein.

[0047] The shaft 311, and particularly the shaft body 317a, can include one or more openings 327 (e.g., in a wall thereof) to increase a flexibility of shaft 311 to aid with advancement of the aspiration catheter 302 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 body 317a. Additionally, the shaft 311, or the shaft body 317a, can be formed from polymers, metals, alloys, braided structures, coiled structures, and combinations or modifications thereof. The shaft 311 can alternatively be a single or multilumen extruded polymer shaft. Furthermore, the jacket 317b can be formed of a variety of polymers and copolymers, plastics, PEBAX, HYTREL, rubber, nylon, polyethylene, polyurethane, polyester, polymer shrink tubing, such as polytetrafluoroethylene, fluorinated ethylene propylene, etc. and combinations or modifications thereof.

[0048] The distal end 305 of the aspiration catheter 302 includes a radiopaque (RO) component 329 for identifying the location of aspiration. The radiopaque component 329 optionally encircles the circumference of the aspiration catheter 302. In the illustrated embodiment, the RO component 329 is disposed at or extends distally from the distal end 325 of the shaft body 317a. In some embodiments, the RO component 329 is attached to- Page 12 - Docket No. 22935.48athe shaft body 317a (e.g., at the distal end 325) via welding, laser welding, brazing, soldering, adhesive, or other suitable connection methods. The RO component 329 can be formed of any suitable radiopaque material, such as tantalum, tungsten, platinum / iridium, gold, silver, and combinations or modifications thereof.

[0049] In the illustrated embodiment, the RO component 329 is formed of a coil. A coil configuration can allow for the RO component 329 and, thus, the distal end 305 to flex or bend. The flexibility of the distal end 305 can be varied by using coils having different dimensions, materials, and / or coil pitches. In other embodiments, the RO component 329 may not be a coil, but may be formed as a solid tube or other solid component. Even in such embodiments, the RO component 329 may be flexible to allow for the distal end 305 to flex or bend.

[0050] The jacket 317b protects a distal portion 385 of a supply tube 386 containing a supply lumen 314. The supply lumen 314 may be configured to provide a high pressure fluid injection, such as saline, within the aspiration lumen 306 (optionally coextensive with the supply lumen 314) for macerating a thrombus as it is aspirated, such as illustrated in FIG. 9 where the aspiration catheter 302 is disposed within a vessel lumen VL of a vessel V and aspirant A is being drawing into the aspiration lumen 306. The saline injection may occur through orifice 394 in a wall of and near the distal end of the supply lumen 314.

[0051] As illustrated in FIG. 7, the supply tube 386 includes a first section 386a and a second section 386b that are connected together. In the illustrated embodiment, the first and second sections 386a, 386b are connected together at or near the distal end 325 of the shaft body 317a. In other embodiments, however, the first and second sections 386a, 386b may be connected together proximal or distal to the distal end 325 of the shaft body 317a.

[0052] The first section 386a may extend in a free-floating manner proximally along the shaft 311 or the first section 386a may be attached to or integrally formed as part of an interior wall of the shaft 311. In the illustrated embodiment, the first section 386a is formed of a polyimide tube, but may be formed of other polymers and copolymers, plastics, PEBAX. HYTREL, rubber, nylon, polyethylene, polyurethane, polyester, and combinations or modifications thereof.

[0053] The second section 386b is connected to and extends distally from the first section 386a. For instance, the first and second sections 386a, 386 may be aligned end-to-end. A sleeve 390. may overlap the distal end of the first section 386a and a proximal end of the second section 386b. The sleeve 390 may be secured to the first and second sections 386a, 386b, with an adhesive, compression fitting, or other suitable attachment- Page 13 - Docket No. 22935.48amechanism. In any event, the junction between the first and second sections 386a, 386b may be configured to allow for the high pressure fluid to pass from the first section 386a to second section 386b (i.e., through the lumens therein that collectively form the supply lumen 314) and out of the orifice 394.

[0054] The sleeve 390 may be a polyimide tube or formed of other polymers and copolymers, plastics, PEBAX, HYTREL. rubber, nylon, polyethylene, polyurethane, polyester, polymer shrink tubing, such as polytetrafluoroethylene, fluorinated ethylene propylene, etc. and combinations or modifications thereof.

[0055] The second section 386b may be secured in place within the distal end 305 of the aspiration catheter 302. Securing the second section 386b in place within the distal end 305 may be particularly desirable to ensure that the orifice 394 is located at a desired position and oriented in a desired direction so as to be able to macerate the thrombotic material without damaging patient tissue.

[0056] To facilitate secured placement of the second section 386b, the distal end 305 of the aspiration catheter 302 may include a mounting ring 392. The mounting ring 392 may be securely positioned within the distal end 305. For instance, the mounting ring 392 may be secured to the distal end of the RO component 329. In some embodiments, the mounting ring 392 is formed of a metal that can be welded, brazed, or soldered to the RO component 329. In other embodiments, the mounting ring 392 may be formed of non-metal materials and may be secured to the RO component with an adhesive or other attachment method or mechanism.

[0057] As can be seen in FIGS. 6 and 8, the mounting ring 392 has a generally circular shape with an aperture 393 extending therethrough. The aperture 393 is sized to allow for thrombotic material to pass therethrough during an aspiration procedure.

[0058] In the illustrated embodiment, the mounting ring 392 also includes an additional ring 395 formed on an interior surface thereof. The additional ring 395 has an aperture 396 extending therethrough. The aperture 396 is sized to have the second section 386b of the supply tube 386 extend therethrough. In embodiments where the mounting ring 392 and the second section 386b are both formed of metals, the second section 386b may be secured to the mounting ring 392 (e.g., while at least partially within or extending through the aperture 396) via welding, laser welding, brazing, soldering, adhesive, friction fit, or the like. In embodiments where one or both of the second section 386b and the mounting ring 392 are made from non-metal materials, the second section 386b and the- Page 14 - Docket No. 22935.48amounting ring 392 may be secured together, with adhesive, chemical bonding, friction fit, or the like.

[0059] While the mounting ring 392 is illustrated as including the additional ring 395 with the aperture 396 therethrough, this is merely exemplary. In other embodiments, the mounting ring 392 may include other mounting features or surfaces where the second section 386b may be secured to the mounting ring 392. For instance, in some embodiments, the second section 386b may be secured to an interior surface of the mounting ring 392 (e.g., a surface that forms the aperture 393).

[0060] Regardless of how the second section 386b is secured to the mounting ring 392, the attachment therebetween may sure the second section 386b in place within the distal end 305 with the orifice 394 oriented is a desired direction or orientation within the distal end 305.

[0061] To further ensure the desired position of the second section 386b (and particularly the orifice 394) within the distal end 305, the jacket 317b can be trimmed to a predetermined length. For instance, the jacket 317b can be trimmed so that the distal most end 305a thereof is positioned distally from the orifice 394 by a predetermined length.

[0062] To facilitate trimming of the jacket 317b to the predetermined length, a mandrel may be used. Figures 10A-10B illustrate an example embodiment of a mandrel 400 that may be used in the trimming process. In the illustrated embodiment, the mandrel 400 has a generally cylindrical shape. The mandrel 400 includes a first primary section 402 and a second primary section 404. In the illustrated embodiment, the first primary section 402 has an outer dimension that is smaller than an outer dimension of the second primary section 404. As a result, a shoulder 406 is formed on the distal end of the second primary section 404.

[0063] The mandrel 400 also includes a cutout or recess 408 in an outer surface thereof. The cutout 408 extends proximally from a distal end of the mandrel 400. In the illustrated embodiment, the cutout 408 spans the first and second sections 402, 404. In other embodiments, the cutout 408 may only be formed in the first section 402. The second section 404 also includes a circumferential groove 410 formed in an outer surface thereof.

[0064] Once the shaft body 317a, RO component 329, mounting ring 392, and second section 386b have been assembled, but prior to the application of the jacket 317b, the mandrel 400 can be inserted into the assembly. For instance, the first primary section 402 can be inserted into or through the aperture 393 in the mounting ring 392 and. optionally,- Page 15 - Docket No. 22935.48ainto the RO component 329. The mandrel 400 can be inserted until the shoulder 406 engages or butts against the mounting ring 392.

[0065] The cutout 408 in the mandrel 400 is configured to receive the second section 386b of the supply tube 386 (and optionally the additional ring 395) therein. The cutout 408 thereby allows the mandrel 400 to be inserted into the assembly without disturbing the second section 386b of the supply tube 386.

[0066] Once the mandrel 400 is inserted into the assembly so that the shoulder 406 is engaged with the mounting ring 392, the jacket 317b can applied. During a typical jacketing application, the distal most end 305a of the jacket 317b will extend beyond the ultimately desired length. Accordingly, the jacket 317b can thereafter be trimmed or cut to length. For instance, a cutting tool can be inserted through the jacket 317b and into the circumferential groove 410. The circumferential groove 410 can guide the cutting tool as the entire circumference of the jacket 317b is cut to length.

[0067] During the manufacturing process, the second section 386b of the supply tube 386 can be secured to the mounting ring 392 so that the orifice 394 is a positioned distally of the mounting ring 392 by a predetermined or desired distance. Additionally, the shoulder 406 and the circumferential groove 410 of the mandrel 400 may be spaced apart by a predetermined or desired distance. By spacing apart the mounting ring 392 and the orifice 394 and the shoulder 406 and the circumferential groove 410 and abutting the shoulder 406 against the mounting ring 392 during the trimming process, the jacket 317b can be trimmed to a predetermined or desired length so that the orifice 394 is spaced apart from the distal most end 305a of the completed aspiration catheter 302. Once the jacket 317b has been trimmed, the mandrel 400 can be removed from the aspiration catheter 302.

[0068] Although the systems for aspirating thrombus described herein are predominantly focused on aspiration, the systems may also, or alternatively, be configured for injecting or infusing fluids, with or without drugs, and may incorporate related features described in U.S. Pat. No. 10,716,583, issued July 21, 2020, and entitled, “Systems and Methods for Removal of Blood and Thrombotic Material’' and U.S. Pat. No. 10,492,805, issued December 3, 2019, and entitled, “Systems and Methods for Thrombosis and Delivery of an Agent.”

[0069] It is contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments disclosed above may be made and still fall within one or more of the embodiments. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in- Page 16 - Docket No. 22935.48aconnection with an embodiment can be used in all other embodiments set forth herein. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed embodiments. Thus, it is intended that the scope of the present disclosure herein disclosed should not be limited by the particular disclosed embodiments described above. Moreover, while the present disclosure is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the present disclosure is not to be limited to the particular forms or methods disclosed, but to the contrary, the present disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication.

[0070] The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “approximately”, “about”, and “substantially” as used herein include the recited numbers (e.g., about 10%=l 0%). and also 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 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount.

[0071] For purposes of the present disclosure and appended claims, the conjunction “or” is to be construed inclusively (e.g., “an apple or an orange” would be interpreted as “an apple, or an orange, or both”; e.g., “an apple, an orange, or an avocado” would be interpreted as “an apple, or an orange, or an avocado, or any two, or all three”), unless: (i) it is explicitly stated otherwise, e.g., by use of “either... or,” “only one of,” or similar language; or (ii) two or more of the listed alternatives are mutually exclusive within the particular context, in which case “or” would encompass only those combinations involving non-mutually-exclusive alternatives. For purposes of the present disclosure and appended claims, the words “comprising,” “including.” “having,” and variants thereof, wherever- Page 17 - Docket No. 22935.48athey appear, shall be construed as open-ended terminology, with the same meaning as if the phrase “at least” were appended after each instance thereof.

[0072] 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.

[0073] Embodiment 1. An aspiration catheter comprising: a shaft body having a distal end; a radiopaque component disposed at or near the distal end of the shaft body, the radiopaque component having a distal end; a mounting ring disposed at or near the distal end of the radiopaque component, the mounting ring having a mounting feature; a supply tube connected to the mounting feature; and a jacket disposed about the shaft, radiopaque component, and mounting ring, and extending distally from the mounting ring.

[0074] Embodiment 2. The aspiration catheter of embodiment 1 , wherein the supply tube is connected to the mounting feature such that an orifice of the supply tube is positioned at a predetermined orientation and at a predetermined distance from a distal most end of the jacket.

[0075] Embodiment 3. The aspiration catheter of any of embodiments 1-2, wherein the radiopaque component comprises a coil.

[0076] Embodiment 4. The aspiration catheter of any of embodiments 1-3, wherein the radiopaque component is welded, laser welded, brazed, or soldered to the shaft body.

[0077] Embodiment 5. The aspiration catheter of any of embodiments 1-4, wherein the mounting ring is welded, laser welded, brazed, or soldered to the radiopaque component.

[0078] Embodiment 6. The aspiration catheter of any of embodiments 1-5, wherein the supply tube is welded, laser welded, brazed, or soldered to the mounting ring.

[0079] Embodiment 7. The aspiration catheter of any of embodiments 1-6, wherein the supply tube has an orifice that is disposed distal to the mounting ring.

[0080] Embodiment 8. The aspiration catheter of any of embodiments 1-7, wherein the supply tube comprises a first section formed of a first material and a second section formed of a second material that is different from the first material.

[0081] Embodiment 9. The aspiration catheter of embodiment 8, wherein the first material is a polyimide and the second material is a metal.

[0082] Embodiment 10. An aspiration catheter comprising: a shaft having an aspiration lumen therein and a distal end; a mounting ring disposed within the shaft at or- Page 18 - Docket No. 22935.48anear the distal end of the shaft, the mounting ring having a mounting feature; and a supply tube connected to the mounting feature such that an orifice of the supply tube is positioned at a predetermined orientation and at a predetermined distance from a distal most end of the shaft.

[0083] Embodiment 11. The aspiration catheter of embodiment 10, wherein the shaft comprises a shaft body and a jacket, the jacket being disposed around the shaft body and extending distally from the shaft body.

[0084] Embodiment 12. The aspiration catheter of embodiment 11, further comprising a radiopaque component disposed between a distal end of the shaft body and the mounting ring.

[0085] Embodiment 13. The aspiration catheter of embodiment 12, wherein the radiopaque component comprises a coil.

[0086] Embodiment 14. The aspiration catheter of any of embodiments 10-13, wherein the supply tube comprises a first second and a second section.

[0087] Embodiment 15. The aspiration catheter of embodiment 14, wherein the first and second sections of the supply tube are joined together with a sleeve.

[0088] Embodiment 16. The aspiration catheter of embodiment 14 or 15, wherein the second section comprises the orifice.

[0089] Embodiment 17. The aspiration catheter of any of embodiments 10-16, wherein the supply tube is connected to the mounting ring such that the orifice is positioned at a predetermined distance from the mounting ring.

[0090] Embodiment 18. The aspiration catheter of any of embodiments 10-17, wherein the mounting ring comprises an aperture therethrough configured to allow thrombotic material to pass therethrough during an aspiration procedure.

[0091] Embodiment 19. The aspiration catheter of any of embodiments 10-18, wherein the mounting features comprises an additional ring with an aperture therethrough, the aperture through the additional ring being configured to have the supply tube extend therethrough.

[0092] Embodiment 20. A mandrel for use in manufacturing an aspiration catheter, the mandrel comprising: a first primary section; a second primary section; and a cutout in an outer surface that is configured to receive therein a supply tube in an aspiration catheter.

[0093] Embodiment 21. The mandrel of embodiment 20, wherein the first primary section has a first outer dimension and the second primary section has a second outer dimension, the second outer dimension being different from the first outer dimension.- Page 19 - Docket No. 22935.48a

[0094] Embodiment 22. The mandrel of embodiment 20 or 21, further comprising a shoulder disposed between the first and second primary’ sections.

[0095] Embodiment 23. The mandrel of embodiment 22, wherein the second primary section comprises a circumferential groove.

[0096] Embodiment 24. The mandrel of embodiment 23, wherein the circumferential groove is spaced apart from the shoulder by a predetermined distance.

[0097] Embodiment 25. The mandrel of any of embodiments 20-24, wherein the cutout extends proximally’ from a distal end of the first primary' section.

[0098] Embodiment 26. The mandrel of any of embodiments 20-25, wherein the cutout spans the first and second primary sections.

[0099] 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 that come within the meaning and range of equivalency of the claims are to be embraced within their scope.- Page 20 - Docket No. 22935.48a

Claims

CLAIMS1. An aspiration catheter comprising:a shaft body having a distal end;a radiopaque component disposed at or near the distal end of the shaft body, the radiopaque component having a distal end;a mounting ring disposed at or near the distal end of the radiopaque component, the mounting ring having a mounting feature;a supply tube connected to the mounting feature; anda jacket disposed about the shaft, radiopaque component, and mounting ring, and extending distally from the mounting ring.

2. The aspiration catheter of claim 1, wherein the supply tube is connected to the mounting feature such that an orifice of the supply tube is positioned at a predetermined orientation and at a predetermined distance from a distal most end of the jacket.

3. The aspiration catheter of any of claims 1-2, wherein the radiopaque component comprises a coil.

4. The aspiration catheter of any of claims 1-3, wherein the radiopaque component is welded, laser welded, brazed, or soldered to the shaft body.

5. The aspiration catheter of any of claims 1-4, wherein the mounting ring is welded, laser welded, brazed, or soldered to the radiopaque component.

6. The aspiration catheter of any of claims 1-5, wherein the supply tube is welded, laser welded, brazed, or soldered to the mounting ring.

7. The aspiration catheter of any of claims 1-6, wherein the supply tube has an orifice that is disposed distal to the mounting ring.

8. The aspiration catheter of any of claims 1-7, wherein the supply tube comprises a first section formed of a first material and a second section formed of a second material that is different from the first material.

9. The aspiration catheter of claim 8, wherein the first material is a polyimide and the second material is a metal.

10. An aspiration catheter comprising:a shaft having an aspiration lumen therein and a distal end;a mounting ring disposed within the shaft at or near the distal end of the shaft, the mounting ring having a mounting feature; and- Page 21 - Docket No. 22935.48aa supply tube connected to the mounting feature such that an orifice of the supply tube is positioned at a predetermined orientation and at a predetermined distance from a distal most end of the shaft.

11. The aspiration catheter of claim 10, wherein the shaft comprises a shaft body and a jacket, the jacket being disposed around the shaft body and extending distally from the shaft body.

12. The aspiration catheter of claim 11, further comprising a radiopaque component disposed between a distal end of the shaft body and the mounting ring.

13. The aspiration catheter of claim 12, wherein the radiopaque component comprises a coil.

14. The aspiration catheter of any of claims 10-13, wherein the supply tube comprises a first second and a second section.

15. The aspiration catheter of claim 14, wherein the first and second sections of the supply tube are joined together with a sleeve.

16. The aspiration catheter of claim 14 or 1 , wherein the second section comprises the orifice.

17. The aspiration catheter of any of claims 10-16, wherein the supply tube is connected to the mounting ring such that the orifice is positioned at a predetermined distance from the mounting ring.

18. The aspiration catheter of any of claims 10-17, wherein the mounting ring comprises an aperture therethrough configured to allow thrombotic material to pass therethrough during an aspiration procedure.

19. The aspiration catheter of any of claims 10-18, wherein the mounting features comprises an additional ring with an aperture therethrough, the aperture through the additional ring being configured to have the supply tube extend therethrough.

20. A mandrel for use in manufacturing an aspiration catheter, the mandrel comprising:a first primary section;a second primary section; anda cutout in an outer surface that is configured to receive therein a supply tube in an aspiration catheter.

21. The mandrel of claim 20, wherein the first primary' section has a first outer dimension and the second primary' section has a second outer dimension, the second outer dimension being different from the first outer dimension.- Page 22 - Docket No. 22935.48a22. The mandrel of claim 20 or 21, further comprising a shoulder disposed between the first and second primary sections.

23. The mandrel of claim 22, wherein the second primary section comprises a circumferential groove.

24. The mandrel of claim 23, wherein the circumferential groove is spaced apart from the shoulder by a predetermined distance.

25. The mandrel of any of claims 20-24, wherein the cutout extends proximally from a distal end of the first primary section.

26. The mandrel of any of claims 20-25, wherein the cutout spans the first and second primary sections.- Page 23 - Docket No. 22935.48a

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