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 use thereof.
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 fluid 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. For example, simple aspiration catheters offer ease of use and rapid deployment but may become blocked or otherwise inoperable when faced with older, more organized thrombotic material. Such devices must be removed and cleared outside the body and then re-inserted into the vasculature, which lengthens the time needed for the procedure and increases the opportunity to kink the catheter shaft. Such kinks may reduce performance by decreasing the cross-sectional area of the catheter or may render the device inoperable.
Mechanical rotary devices use an auger to grab and carry the thrombus away from the target area. Some create transport force via vacuum bottles while others create differential pressure at the distal tip of the device with the auger acting as a low-pressure pump. These devices typically work slowly and offer the physician no feedback as to when the device should be advanced further into the lesion.
Flushing type devices include manual flush type devices in which the physician manipulates a hand-driven pump to provide flowing saline at the tip of the device to break up and aspirate the thrombus material, which may introduce performance variations based on the ability of the physician to consistently pump the device over the duration of the procedure.
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.
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 to aspiration catheters that prevent vessel tissue from being drawn into an aspiration lumen of the aspiration catheter and coming into close proximity to an orifice for jetted or pressurized fluid from one or more supply lumens during aspiration; a system for aspirating thrombus, comprising an aspiration catheter including an elongate shaft configured for placement within a blood vessel of a subject, one or more supply lumens and an aspiration lumen each extending along the shaft, and an opening (or “orifice”) at or near the distal end of the one or more supply lumen, the opening configured to allow the injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is caused or allowed to flow through the one or more supply lumen; a tubing set comprising a first conduit having a distal end configured to couple to the aspiration lumen of the aspiration catheter and a proximal end configured to couple to a vacuum source, and a second conduit having a distal end configured to couple to the one or more supply lumen of the aspiration catheter and a proximal end configured to couple to a first fluid source; a pressurization element configured to couple to the tubing set and further configured to pressurize fluid from the first fluid source or allow pressurized fluid from the first fluid source to be transferred to the one or more supply lumens, such that the pressurized fluid is capable of flowing through the one or more supply lumens from the proximal end of the supply lumen to the distal end of the supply lumen; and wherein the vacuum source comprises a vacuum canister having two or more ports, including a first port configured to couple to a proximal end of the first conduit of the tubing set, and wherein the vacuum canister is configured to separate thrombus from aspirant delivered via the first conduit of the tubing set.
In still another configuration an aspiration catheter of this disclosure includes an elongate shaft configured for placement within a blood vessel, a supply lumen and an aspiration lumen each extending along the shaft, the supply lumen having a proximal end and a distal end, and the aspiration lumen having a proximal end and a distal opening, an orifice at or near the distal end of the supply lumen, the orifice being configured to allow injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is delivered through the supply lumen, and a tissue encroachment prevention assembly for preventing the blood vessel from being drawn into said aspiration lumen and coming into close proximity to the orifice of the supply lumen during aspiration.
In still another configuration an aspiration catheter of this disclosure includes an elongate shaft configured for placement within a blood vessel, the elongate shaft having a distal end with an opening at the distal end, a supply lumen and an aspiration lumen each extending along the shaft, the supply lumen having a proximal end and a distal end, and the aspiration lumen having a proximal end and a distal opening, an orifice near the distal end of the supply lumen, the orifice being configured to allow injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is delivered through the supply lumen, and a means for preventing the blood vessel from being drawn into the aspiration lumen and into close proximity to the orifice of the supply lumen during aspiration.
In still another configuration an aspiration catheter of this disclosure includes an elongate shaft configured for placement within a blood vessel, the elongate shaft having a distal end with an opening at the distal end, a supply lumen and an aspiration lumen each extending along an interior of the shaft, coextensive with the shaft, the supply lumen having a proximal end and a distal end, and the aspiration lumen having a proximal end and a distal opening, an orifice near the distal end of the supply lumen, the orifice being configured to allow injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is pumped through the supply lumen, and a tissue encroachment prevention assembly for preventing the blood vessel from being drawn into the aspiration lumen and into close proximity to the orifice of the supply lumen during aspiration, the tissue encroachment prevention assembly comprising at least one of a cage-like structure.
In still another configuration, system of this disclosure includes an aspiration catheter comprising an elongate shaft configured for placement within a blood vessel of a subject, a supply lumen and an aspiration lumen each extending along an interior of the elongate shaft, and an orifice at or near a distal end of the supply lumen, the orifice being configured to allow injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is caused or allowed to flow through the supply lumen. The system also can include a tubing set comprising a first conduit having a distal end configured to couple to the aspiration lumen of the aspiration catheter and a proximal end configured to couple to a vacuum source, and a second conduit having a distal end configured to couple to the supply lumen of the aspiration catheter and a proximal end configured to couple to a first fluid source, a pressurization element configured to couple to the tubing set and further configured to pressurize fluid from the first fluid source or allow pressurized fluid from the first fluid source to be transferred to the supply lumen, such that the pressurized fluid is capable of flowing through the supply lumen from the proximal end of the supply lumen to the orifice at or near the distal end of the supply lumen, a means for preventing the blood vessel from being drawn into the aspiration lumen and into close proximity to the orifice of the supply lumen during aspiration.
In still another configuration, system of this disclosure includes an aspiration catheter comprising an elongate shaft configured for placement within a blood vessel of a subject, a supply lumen and an aspiration lumen each extending along an interior of the elongate shaft, and an orifice at or near a distal end of the supply lumen, the orifice being configured to allow injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is caused or allowed to flow through the supply lumen. The system also can include a tubing set comprising a first conduit having a distal end configured to couple to the aspiration lumen of the aspiration catheter and a proximal end configured to couple to a vacuum source, and a second conduit having a distal end configured to couple to the supply lumen of the aspiration catheter and a proximal end configured to couple to a first fluid source, a pressurization element configured to couple to the tubing set and further configured to pressurize fluid from the first fluid source or allow pressurized fluid from the first fluid source to be transferred to the supply lumen, such that the pressurized fluid is capable of flowing through the supply lumen from the proximal end of the supply lumen to the orifice at or near the distal end of the supply lumen, and a tissue encroachment prevention assembly for preventing the blood vessel from being drawn into the aspiration lumen and into close proximity to the orifice of the supply lumen during aspiration.
In still another configuration, an aspiration catheter of this disclosure includes an elongate shaft configured for placement within a blood vessel, a supply lumen and an aspiration lumen each extending along an interior of the shaft, coextensive with the shaft, the supply lumen having a proximal end and a distal end, and the aspiration lumen having a proximal end and a distal opening, an orifice at or near the distal end of the supply lumen, the orifice configured to allow injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is pumped through the supply lumen, and a means for preventing the blood vessel from being drawn into said aspiration lumen and coming into close proximity to the orifice of the supply lumen during aspiration.
In still another configuration, an aspiration catheter includes: an elongate shaft configured for placement within a blood vessel, the elongate shaft having an aspiration lumen extending therethrough, the aspiration lumen having an opening at a distal end of the elongate shaft; a supply lumen extending along the shaft, the supply lumen having a distal end and an orifice at or near the distal end, the orifice being configured to allow injection of pressurized fluid into the aspiration lumen at or near a distal end of the aspiration lumen when the pressurized fluid is delivered through the supply lumen; and a tissue encroachment prevention assembly for preventing the blood vessel from being drawn into the aspiration lumen and coming into close proximity to the orifice of the supply lumen during aspiration, the tissue encroachment prevention assembly comprising one or more atraumatic members that expend distally from the elongate shaft and across the opening to the aspiration lumen.
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.
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:
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.
One or more embodiments of the present disclosure may generally relate to preventing tissue, such as tissue of a lumen receiving an aspiration catheter, from being drawn into an aspiration lumen of the aspiration catheter and coming into close proximity to an orifice for jetted fluid from one or more supply lumens during aspiration. By preventing the tissue from being brought towards the fluid jetted or ejected from the orifice through the tissue encroachment prevention assembly, or by a means for preventing the blood vessel from being drawn into the aspiration lumen, tissue damage is prevented during aspiration of a thrombus. Thus, the aspiration process is safer for a patient.
While the present disclosure will describe a particular implementation of preventing tissue from being drawn into an aspiration lumen of the aspiration catheter and coming into close proximity to an orifice for jetted fluid from one or more supply lumens during aspiration, 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.
A system 100 for aspirating thrombus is illustrated in
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 comprising a y-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 female luer 113 which communicates with a catheter supply lumen 114 (
A spike 116 for coupling to a fluid source 224 (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.
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
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 cable 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.
The pressure sensor or transducer 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 sensor or transducer 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 released. During sterile procedures, the main interventionalist is usually “scrubbed” such 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 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 environment. 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 both 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.
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 sensor 144. In fact, in some embodiments, the pressure sensor 144 may even be absent from the system 100 for aspirating thrombus, the foot pedal 160 being used as a predominant control means.
Turning to
A system 200 for aspirating thrombus is illustrated in
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 (
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
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 carry a basket 254 for placement of components, products, documentation, or other items.
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 259b 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 catheter 202 (similar to luer 115), and connects the second connector 272 of the sterile suction tubing 216 to port 259a 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 handpiece 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 handpiece 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.
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 278 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 Feb. 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 (
The lid 260 may comprise two or more ports, including the first port 259a and second port 259b 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 ports. Sterile suction tubing 216 may be connected to the lid 260 of the vacuum canister 218 at a first port 259a 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 259b 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 259b so as to prevent aspirant from traveling along the non-sterile suction tubing 217 from the vacuum canister 218 to the vacuum source.
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 (about 1638.71 cubic centimeters), or receptacles having a diameter of approximately 5.0 inches (about 12.70 centimeters) and a height of approximately 7.0 inches (about 17.78 centimeters), have been found to provide sufficient volumetric capacity.
Returning to
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).
Turning to
As shown in more detail in
The supply lumen 314 may be configured to provide a high pressure fluid injection, such as saline, within the aspiration lumen 306 for macerating a thrombus as it is aspirated, such as illustrated in
The radiopaque ring 329 also aids with reducing the likelihood of the distal end 305 collapsing during movement through the circulatory vessels where the distal end 305 can encounter vascular tortuosity. With the outer jacket 317d extending to the distal opening 307, flexibility of the distal end 305 is maintained. The radiopaque ring 329 provides structure to keep the distal opening 307 open and prevent the outer jacket 317d and jacket 317b collapsing during jetting and/or aspiration.
The shaft 311 can include one or more openings 327 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 311. Additionally, the shaft 311 can be formed from polymers, metals, alloys, braided structures, coiled structures, and combinations or modifications thereof. Furthermore, the jacket 317b and outer jacket 317d can be formed of a variety of polymers and copolymers, plastics, PEBAX, HYTREL, rubber, nylon, polyethylene, polyurethane, polyester and combinations or modifications thereof.
In some situations, during aspiration, damage to the vessel might occur because the vessel wall is drawn into the aspiration lumen 306 and comes into contact with the pressurized fluid injection (e.g., a high pressure saline spray at, for example, 650 psi) from supply lumen 314. Therefore, a tissue encroachment prevention assembly can prevent aspiration catheter 302 from damaging the vessel during aspiration. The tissue encroachment prevention assembly can be selectively added to the distal end 305 of the aspiration catheter 302 or the distal end 305 can be modified or changed to accommodate the tissue encroachment prevention assembly.
As illustrated in
As illustrated in 9a and 9b, the tissue encroachment prevention assembly 450a comprises a base 452a, having a generally cylindrical form or ring-like form, from which extends a tine assembly 454a terminating in an atraumatic member 456a (
The base 452a is has a generally cylindrical form or ring-like form having holes 458a dispersed throughout the base 452a that aid with mounting the base 452a between the jacket 417b and the jacket 417d, and more generally mounting the base to the distal end 405 of the shaft 411. In this illustrated configuration, the polymer forming the jacket 417d flows into the holes 458a to join the base 452a to the shaft 411. Optionally, the polymer forming the jacket 417b can also flow or reflow into the holes 458a of the base 452a. In either case, the base 452a becomes joined, coupled, or mounted to the shaft 411. It will be understood that instead of flowing or reflowing the material forming the jackets 417b, 417d, the base 452a can be mounted to the shaft 411a using adhesives, glues, thermal bonding, laser welding, welding, soldering, mechanical fasteners, such as rivets, detents, threads, modifications or combinations thereof, crimping, or combinations and modifications thereof.
The base 452a has an internal diameter ranging from about 2 mm to about 3 mm, from about 3 mm to about 4 mm, from about 4 mm to about 6 mm, from about 6 mm to about 8 mm, from about 2 mm to about 8 mm, or is in a range between any two of the foregoing. The base 452a has an outside diameter ranging from about 2.2 mm to about 3.2 mm, from about 3.2 mm to about 4.2 mm, from about 4.2 mm to about 6.2 mm, from about 6.2 mm to about 8.2 mm, from about 2 mm to about 9 mm, or is in a range between any two of the foregoing. The base 452a has a length ranging from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 4 mm to about 6 mm, from about 6 mm to about 8 mm, about 1 mm to about 8 mm, or is in a range between any two of the foregoing. Stated another way, the base 452a has an internal diameter ranging from about 0.079″ to about 0.118″, from about 0.118″ mm to about 0.157″, from about 0.157″ to about 0.236″, from about 0.236″ to about 0.315″, from about 0.079″ to about 0.315″, or is in a range between any two of the foregoing. The base 452a has an outside diameter ranging from about 0.087″ to about 0.126″, from about 0.126″ to about 0.165″, from about 0.165″ to about 0.244″, from about 0.244″ to about 0.323″, from about 0.118″ to about 0.354″, or is in a range between any two of the foregoing. The base 452a has a length ranging from about 0.039″ to about 0.079″, from about 0.079″ to about 0.157″, from about 0.157″ to about 0.236″, from about 0.236″to about 0.315″, about 0.039″ to about 0.315″, or is in a range between any two of the foregoing.
Extending from a distal end 460a of the base 452a is the tine assembly 454a. The tine assembly 454a includes tines 462a having a generally elongate form and a generally rectangular cross-section (although circular, oval, square, polygonal, and combinations or modifications thereof are also possible), as shown in
An angle of inclination of the tines 462a in relation to the longitudinal axis L can vary based upon at least a length of the tines 462a. Longer tines provide increased flexibility to the tine assembly 454a, while also providing larger gaps 464a. Similarly, shorter tines provide decreased flexibility to the tine assembly 454a, while providing smaller gaps 464a. As such, depending upon the particular elasticity of the vessel tissue, different configurations of the tissue encroachment prevention assembly 450a are possible. For instance, a length of the tines can range from about 5 mm to about 6 mm, from about 6 mm to about 10 mm, from about 10 mm to about 20 mm, from about 20 mm to about 25 mm, from about 5 mm to about 25 mm, or is in a range between any two of the foregoing. Stated another way, a length of the tines can range from about 0.2″ to about 0.24″, from about 0.24″ to about 0.39″, from about 0.39″ to about 0.79″, from about 0.79″ to about 0.98″, from about 0.2″ to about 0.98″ mm, or is in a range between any two of the foregoing. An angle α between a tine and the longitudinal axis L can range from about 5 degrees to about 30 degrees, from about 30 degrees to about 45 degrees, from about 45 degrees to about 60 degrees, from about 5 degrees to about 60 degrees, or is in a range between any two of the foregoing.
Attached to distal ends 466a of the tines 462a is the atraumatic member 456a. In this particular configuration, the atraumatic member 456a includes a generally spherical ball 468a having apertures 470a to receive the distal ends 466a, such as illustrated in
As mentioned above, the base 452a (or more generally the tissue encroachment prevention assembly 450a) can replace the radiopaque ring 329 (
Turning to
Turning to
As illustrated, the tissue encroachment prevention assembly 450b extends from the shaft 411 and includes a base 452b having a generally cylindrical form or ring-like form, a tine assembly 454b extending from the base 452b, and an atraumatic member 456b disposed or arranged at a distal end of the tissue encroachment prevention assembly 450b. The combination of the base 452b, the tine assembly 454b, and the atraumatic member 456b forms a cage-like structure that allows clot, thrombus, aspirant, blood, etc. to flow into the aspiration lumen 406 and prevent vessel tissue from being drawn into the aspiration lumen 406. A portion of the tissue encroachment prevention assembly 450b optionally extends from and/or forms a distal opening 407b of the aspiration catheter 402. The tines 462b forming the tine assembly 454b taper from the base 452b towards the atraumatic member 456b that is mounted to distal ends 466b of the tines 462b. This configuration provides more open space towards the atraumatic member 456b in order to allow a clot to be easily drawn in, while preventing the vessel tissue from being drawn into close proximity to the high pressure saline spray from the supply lumen.
Turning to
As illustrated, the tissue encroachment prevention assembly 450c includes a base 452c, a tine assembly 454c extending from the base 452c having a generally cylindrical form or ring-like form, and an atraumatic member 456c disposed or arranged at a distal end of the tissue encroachment prevention assembly 450c. The combination of the base 452c, the tine assembly 454c, and the atraumatic member 456c forms a cage-like structure that allows clot, thrombus, aspirant, blood, etc. to flow into the aspiration lumen 406 and prevent vessel tissue from being drawing into the aspiration lumen 406. The width of the tines 462c forming the tine assembly 454c taper from the base 452c towards the atraumatic member 456c that is mounted to distal ends 466c of the tines 462c. This configuration provides more open space towards the atraumatic member 456c in order to allow a clot to be easily drawn in, while preventing the vessel tissue from being drawn into close proximity to high pressure saline spray from the supply lumen.
As illustrated in
Turning to
As illustrated in
As illustrated in
The base 452d has a generally cylindrical form or ring-like form having holes 458dthat aid with mounting the base 452d between the jacket 417b and the jacket 417d, and more generally mounting the base to the distal end 405 of the shaft 411. In this illustrated configuration, the polymer forming the jacket 417d flows into the holes 458d to join the base 452d to the shaft 411. Optionally, the polymer forming the jacket 417b can also flow or reflow into the holes 458d of the base 452d. In either case, the base 452d becomes joined, coupled, or mounted to the shaft 411. It will be understood that instead of flowing or reflowing the material forming the jackets 417b, 417d, the base 452d can be mounted to the shaft 411 using adhesives, glues, thermal bonding, laser welding, welding, soldering, mechanical fasteners, such as rivets, detents, threads, brazing, modifications or combinations thereof, crimping, or combinations and modifications thereof.
Extending from a distal end 460d of the base 452d is the tine assembly 454d. The tine assembly 454d includes tines 462d having a generally elongate form. The tines are inclined toward the atraumatic member 456d, with the atraumatic member 456d having a dimension D1 across or transverse to a longitudinal axis L of the tissue encroachment prevention assembly 450d that is smaller than a dimension D2 across or transverse to the longitudinal axis L of the base 452d. This tapered configuration aids with steering the aspiration catheter 402 and provides gaps 464d that allow aspirant and thrombus to pass, while preventing tissue from being drawn into the aspiration lumen 406. Since the tines 462d are inclined towards the atraumatic member 456d, the gaps 464d also form a tapered configuration, however, this need not be case and the gaps 464d can have various shapes and forms to prevent passage of tissue.
Disposed between adjacent tines 462d is a mesh 490d that is proximal to the open space near the high pressure saline spray from supply lumen 414. The mesh 490d provides an additional barrier to prevent vessel tissue from being drawn into the aspiration lumen 406 and into close proximity to the pressurized fluid injection from supply lumen 414. The mesh 490d can include a mesh body 492d with openings 494d that allow blood, clot, or other aspirant to flow into the aspiration lumen 406.
The mesh 490d can be formed at the same time as the tines 462d, such as when the base 452d and tine assembly 454d are cut from a hypotube, for instance. In still another configuration, the base 452d, the mesh 490d, the tines 462d and the shaft 411 are cut from a hypotube, for instance. Alternatively, the mesh 490d can be joined, attached, or otherwise coupled to the base 452d and/or one or more tines 462d such as by welding, laser welding, soldering, gluing, thermal bonding, mechanical attachment, brazing, or combinations or modifications thereof. For instance, when the mesh 490d includes interlaced filaments, wires, threads, etc., a material, such as metallic, polymeric, carbon-fiber, etc. punched, cut, or otherwise formed with the openings 494d, or some other structure, the mesh 490d can be joined, attached, or otherwise coupled to one or more of the base 452d and the tines 462d. In still another configuration, the base 452d can be an extension of the shaft 411 and so the base 452d and the mesh 490d can be formed as part of the shaft 411 to which is attached the tines 462d.
Attached to distal ends 466d of the tines 462d is the atraumatic member 456d. In this particular configuration, the atraumatic member 456d includes a generally spherical ball 468d having an aperture 470d to receive the distal ends 466d, such as illustrated in
As mentioned above, the base 452d (or more generally the tissue encroachment prevention assembly 450d) can replace the radiopaque ring 329 (
Turning to
The tissue encroachment prevention assemblies of
Generally, the tissue encroachment prevention assemblies of
As illustrated in
The tines 462e can complete one turn, less than one turn, or multiple turns between the base 452e and the atraumatic member 456e. A tine 462e extends “one turn” as it spirals, twists, or extends in a helical fashion about 360 degrees around the longitudinal axis L. As illustrated in
As illustrated in
The tines 462f can complete one turn, less than one turn, or multiple turns between the base 452f and the 456f. A tine 462f extends “one turn” as it spirals, twists, or extends in a helical fashion about 360 degrees around the longitudinal axis L. As illustrated in
As illustrated in
The tines 462g can complete one turn, less than one turn, or multiple turns between the base 452g and the 456g. A tine 462g extends “one turn” as it spirals, twists, or extends in a helical fashion about 360 degrees around the longitudinal axis L. As illustrated in
Formed in the atraumatic member 456g is a through-hole 472g that can accommodate a guidewire or other structure to aid with guiding an aspiration catheter to clot or thrombus to be removed. The through-hole 472g can include chamfers or other structures to guide the guidewire, for instance, through the through-hole 472g. The through-hole 472g can accommodate a 0.014″ guidewire. More generally, each through-hole 472g can have a diameter ranging from about 0.36 mm to about 0.51 mm, from about 0.51 mm to about 0.61 mm, from about 0.61 mm to about 0.71 mm, from about 0.71 mm to about 0.81 mm, from about 0.36 mm to about 0.81 mm, or is in a range between any two of the foregoing. Stated another way, each through-hole 472g can have a diameter ranging from about 0.01″ to about 0.02″, from about 0.02″ to about 0.024″, from about 0.024″ to about 0.028″, from about 0.028″ to about 0.032″, from about 0.01″ to about 0.032″, or is in a range between any two of the foregoing. Additionally, each through-hole 472g of the atraumatic member 456g can have the same or different size and/or shape.
As illustrated in
The tines 462i can complete one turn, less than one turn, or multiple turns between the base 452i and the 456i. A tine 462i extends “one turn” as it spirals, twists, or extends in a helical fashion about 360 degrees around the longitudinal axis L. As illustrated in
As mentioned above, the tissue encroachment prevention assemblies of
Turning to
As illustrated in
In positioning the screw member 517e, a direction of wrapping the screw member 517e around the shaft body 517a, and/or the jacket 517b, is the same as a screw direction of the tissue encroachment prevention assembly, i.e., a turn direction of the tines 462 of the tine assemblies 454. This allows rotation of the shaft, aided by the screw member, to rotate the tissue encroachment prevention assembly in a direction that screws the tissue encroachment prevention assembly into and/or through the clot or thrombus CT, such as illustrated in
The jacket 517b, the screw member 517e, and shrink tube 517f can be formed of various types of polymeric material. For instance, the jacket 517b, the screw member 517e, and shrink tube 517f can be formed of PEBAX, polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET) combinations or modifications thereof. Additionally, the shrink tube 517f can be formed of a low friction polytetrafluoroethylene (PTFE) tubing. Optionally, the shrink tube 517f can have striping, spiral, etc. of an of the proceeding.
Turning to
As illustrated in
To form the shaft 511b, the first coil member 513b is stretched along the longitudinal axis L to provide a series of gaps into which the second coil member 515b is wrapped or disposed. When the longitudinal force is released, the second coil members 515b are sandwiched between coils of the first coil member 513b. The second coil member 515b can be held by the force applied by the first coil member 513b and/or the shrink tube 517f. Additionally, or alternatively, the second coil member 515b can be welded, such as by laser welding, or otherwise attached to the first coil member 513b to provide better resistance against longitudinal stretching of the shaft 511b. In another configuration, the first coil member 513b and the second coil member 515b are wrapped together around a mandrel to form the shaft 511b. The mandrel maintains the inside diameter of the aspiration lumen 506b, while the differences in wall thicknesses, i.e., first wall thickness 519b and the second wall thickness 521b, create the stepped or screw outer surface 523b. After jacketing the first coil member 513b and the second coil member 515b with the shrink tube 517f, the shaft 511b shows a helical outer structure, i.e., the outer surface 523b, which will help the aspiration catheter 502b to advance forward when turned into the direction of the helix and, therefore, will better engage with the thrombus.
As described in relation to aspiration catheter 502a, forming the shaft 511b, the first coil member 513b and the second coil member 515b are wrapped in the same direction as a screw direction of the tissue encroachment prevention assembly, i.e., a turn direction of the tines 462 of the tine assembly 454. This allows rotation of the shaft, aided by the screw member, to rotate the tissue encroachment prevention assembly in a direction that screws the tissue encroachment prevention assembly into and/or through the clot or thrombus CT. The screwing action can also engage cutting edges (e.g., edges 496i of
The first coil member 513b and the second coil member 515b can be formed of wires or members having a variety of different cross-sectional shapes. A cross-sectional shape of the first coil member 513b and the second coil member 515b can be round, oval, polygonal, square, rectangular, or combinations or modifications thereof. A cross-sectional shape of the first coil member 513b can be different from that of the second coil member 515b, such as in size, shape, etc.
The first coil member 513b and the second coil member 515b can be formed of a variety of different materials, such as but not limited to metals, alloys, polymers, composites, combinations of modifications thereof. A material forming the first coil member 513b can be different from that of the second coil member 515b.
The shrink tube 517f can be formed of various types of polymeric material. For instance, the shrink tube 517f can be formed of low friction polytetrafluoroethylene (PTFE), PEBAX, polyethylene terephthalate (PET), fluorinated ethylene propylene (FEP), combinations or modifications thereof. Optionally, the shrink tube 517f can have striping, spiral, etc. of an of the proceeding.
Turning to
As illustrated in
As described in relation to aspiration catheter 502a, forming the shaft 511c, the second coil member 515c is wrapped in the same direction as a screw direction of the tissue encroachment prevention assembly, i.e., a turn direction of the tines 462 of the tine assembly 454, with the first coil member 513c being wrapped in the opposite direction. This allows rotation of the shaft, aided by the screw member, to rotate the tissue encroachment prevention assembly in a direction that screws the tissue encroachment prevention assembly into and/or through the clot or thrombus CT. The screwing action can also engage cutting edges (e.g., edges 496i of
The second coil member 515c being wrapped in an opposite direction to the first coil member 513c provides better resistance against longitudinal stretching of the shaft 511c. The degree of stretching can also be varied by changing a pitch of the second coil member 515c to provide more close or more open form to the second coil member 515c. After jacketing the first coil member 513c and the second coil member 515c with the shrink tube 517f, the shaft 511c shows a helical outer structure, i.e., the outer surface 523c, which will help the aspiration catheter 502c to advance forward when turned into the direction of the helix and, therefore, will better engage with the thrombus.
The first coil member 513c and the second coil member 515c can be formed of wires or members having a variety of different cross-sectional shapes. A cross-sectional shape of the first coil member 513c and the second coil member 515c can be round, oval, polygonal, square, rectangular, or combinations or modifications thereof. A cross-sectional shape of the first coil member 513c can be different from that of the second coil member 515c, such as in size, shape, etc.
The first coil member 513c and the second coil member 515c can be formed of a variety of different materials, such as but not limited to metals, alloys, polymers, composites, combinations of modifications thereof. A material forming the first coil member 513c can be different from that of the second coil member 515c.
The shrink tube 517f can be formed of various types of polymeric material. For instance, the shrink tube 517f can be formed of low friction polytetrafluoroethylene (PTFE), PEBAX, polyethylene terephthalate (PET), fluorinated ethylene propylene (FEP), combinations or modifications thereof. Optionally, the shrink tube 517f can have striping, spiral, etc. of an of the proceeding.
As mentioned above, during aspiration, damage to the vessel might occur because the vessel wall is drawn into the aspiration lumen and comes into contact with the pressurized fluid injection from a supply lumen. The tissue encroachment prevention assemblies disclosed herein prevent an aspiration catheter from damaging the vessel during aspiration. The tissue encroachment prevention assemblies described thus far are fixed to an end of the aspiration catheter and extend distally from a distal end of the aspiration catheter in a pre-deployment state as the aspiration catheter is moved through the tortuous patient anatomy, during deployment of the aspiration catheter to aspirate clot or thrombus, and during withdrawal of the aspiration catheter following completion of clot or thrombus removal. While having a fixed tissue encroachment prevention assembly extending distally from an end of the aspiration catheter is one configuration, in other configurations, a deployable and retractable tissue encroachment prevention assembly is also contemplated. The deployable and retractable tissue encroachment prevention assembly simplifies passage through the tortuous patient anatomy, while preventing vessel tissue from being drawn into an aspiration lumen of the catheter or toward or into close proximity to a high pressure saline spray from a supply lumen and associated orifice.
Turning to
As illustrated in
The aspiration lumen 606 is formed towards a center of the shaft 611, such as illustrated in
With continued reference to
Disposed within the tissue encroachment prevention assembly lumen 632 is the tissue encroachment prevention assembly 650. The tissue encroachment prevention assembly 650 can be advanced from within the tissue encroachment prevention assembly lumen 632 through movement of a handle or other actuator disposed at the handpiece 233 (
The elongate member 642 can be a wire, a hollow tube, a rod, combinations or modifications thereof that is formed to return to a pre-defined shape, i.e., the coiled state, following advancing the tissue encroachment prevention member 676 from the elongate member 642. For instance, the tissue encroachment prevention member 676, and the elongate member 642 as a whole, can be formed of a shape memory material, such as a shape member alloy or metal or a shape member polymer, a spring steel or alloy, combinations of modifications thereof. Alternatively, the tissue encroachment prevention member 676 can be formed of a material, or otherwise worked to form the pre-defined shape, while a reminder of the elongate member 642, such as first portion 646, is formed of a different material. For instance, the first portion 646 can be formed of stainless steel, while the tissue encroachment prevention member 676 is formed of Nitinol.
A pitch and number of the coils also can be varied to increase or decrease a flexibility of the tissue encroachment prevention member 676. The pitch can range from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 4 mm to about 6 mm, from about 6 mm to about 10 mm, from about 1 mm to about 10 mm, from about 2 mm to about 8 mm, or is in a range between any two of the foregoing. Stated another way, the pitch can range from about 0.039″ to about 0.079″, from about 0.079″ to about 0.157″, from about 0.157″ to about 0.236″, from about 0.236″ to about 0.394″, from about 0.039″ to about 0.394″, from about 0.079″ to about 0.315″, or is in a range between any two of the foregoing. The number of turns or coils associated with the tissue encroachment prevention member 676 can range from about 2 to about 4 from about 4 to about 6, from about 6 to about 12, from about 2 to about 12, or is in a range between any two of the foregoing. The material selected for the tissue encroachment prevention member 676 can also aid with varying a resiliency, flexibility, spring force, and elasticity of the tissue encroachment prevention member 676 and its ability to rebound or move the distal end of the aspiration catheter 602 from a tissue wall.
Turning to
Turning to
As illustrated in
The aspiration lumen 706 is formed towards a center of the shaft 711, in a similar manner to shaft 611, as illustrated in
With continued reference to
Disposed within the tissue encroachment prevention assembly lumen 732 is the tissue encroachment prevention assembly 750. The tissue encroachment prevention assembly 750 can be advanced from within the tissue encroachment prevention assembly lumen 732 through movement of a handle or other actuator disposed at the handpiece 233 (
A first portion 746 of the elongate member 742 maintains the same shape or state inside or outside of the tissue encroachment prevention assembly lumen 732, while a second portion 748 of the elongate member 742, which includes a tissue encroachment prevention member 776, transitions to a second state in which the tissue encroachment prevention member 776 will prevent the vessel tissue from being drawn into close proximity to a high pressure saline spray from the supply lumen 714. As the tissue encroachment prevention member 776 transitions to the second state, the tissue encroachment prevention member 776 transitions to a coiled state having a coil axis CA that is transverse to a longitudinal axis L of the aspiration catheter 702 and forms an outwardly tapered coiled structure. While the tissue encroachment prevention member 776 extends across a distal opening 707 of the aspiration lumen 706, clot, thrombus or aspirant can still flow through gaps 756 between adjacent coils. The larger dimensioned or diameter coil distal end 760 provides a larger contact surface with vessel tissue to prevent the vessel tissue from being drawn towards the aspiration lumen 706 and into contact with the high pressure spray or jet from the orifice 794 of the supply lumen 714.
The elongate member 742 can be a wire, a hollow tube, a rod, combinations or modifications thereof that is formed to return to a pre-defined shape, i.e., the coiled state, following advancing the tissue encroachment prevention member 776 from the elongate member 742. For instance, the tissue encroachment prevention member 776, and the elongate member 742 as a whole, can be formed of a shape memory material, such as a shape member alloy or metal or a shape member polymer, a spring steel or alloy, combinations of modifications thereof. Alternatively, the tissue encroachment prevention member 776 can be formed of a material, or otherwise worked to form the pre-defined shape, while a reminder of the elongate member 742, such as first portion 746, is formed of a different material. For instance, the first portion 746 can be formed of stainless steel, while the tissue encroachment prevention member 776 is formed of Nitinol.
The coiled body of the tissue encroachment prevention member 776 has a pre-formed shape with one or more turns or coils, with the number and pitch of the coils being selected to allow clot, thrombus, or aspirant to pass through the gaps 756 and into the aspiration lumen 706. The pitch and number of the coils also can be varied to increase or decrease a flexibility of the tissue encroachment prevention member 776. The pitch can range from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 4 mm to about 6 mm, from about 6 mm to about 10 mm, from about 1 mm to about 10 mm, or is in a range between any two of the foregoing. Stated another way, the pitch can range from about 0.039″ to about 0.079″, from about 0.079″ to about 0.157″, from about 0.157″ to about 0.236″, from about 0.236″ to about 0.394″, from about 0.039″ to about 0.394″, or is in a range between any two of the foregoing. The number of turns or coils associated with the tissue encroachment prevention member 676 can range from about 2 to about 4 from about 4 to about 6, from about 6 to about 12, from about 2 to about 12, or is in a range between any two of the foregoing. The material selected for the tissue encroachment prevention member 776 can also aid with varying a resiliency, flexibility, spring force, and elasticity of the tissue encroachment prevention member 776 and its ability to rebound or move the distal end of the aspiration catheter 702 from a tissue wall.
Turning to
Turning to
Turning to
As illustrated in
Unlike the aspiration catheters 602 and 702, however, the tissue encroachment prevention assembly lumen 832 terminates proximal a distal opening 807 of a distal end 805 of the aspiration catheter 802. Instead, the tissue encroachment prevention assembly lumen 832 extends through a wall 836 of the shaft 811, with a tissue encroachment prevention assembly lumen distal opening 834 facing outwardly from the wall 836—i.e., the tissue encroachment prevention assembly lumen distal opening 834 faces in a direction transverse to a direction in which the distal opening 807 of the aspiration lumen 806 faces. This allows a tissue encroachment prevention member 876 to exit the aspiration catheter 802 proximal the distal end 805 and/or the distal opening 807, as will be described in more detail hereinafter.
The aspiration lumen 806 is formed towards a center of the shaft 811, such as illustrated in
With continued reference to
Disposed within the tissue encroachment prevention assembly lumen 832 is the tissue encroachment prevention assembly 850. The tissue encroachment prevention assembly 850 can be advanced from within the tissue encroachment prevention assembly lumen 832 through movement of a handle or other actuator disposed at the handpiece 233 (
The elongate member 842 can be a wire, a hollow tube, a rod, combinations or modifications thereof that is formed to return to a pre-defined shape, i.e., the coiled state, following advancement of the tissue encroachment prevention member 876 from the elongate member 842. For instance, the tissue encroachment prevention member 876, and the elongate member 842 as a whole, can be formed of a shape memory material, such as a shape member alloy or metal or a shape member polymer, a spring steel or alloy, combinations of modifications thereof.
Alternatively, the tissue encroachment prevention member 876 can be formed of a material, or otherwise worked to form the pre-defined shape, while a reminder of the elongate member 842, such as first portion 846, is formed of a different material. For instance, the first portion 846 can be formed of stainless steel, while the tissue encroachment prevention member 876 is formed of Nitinol.
A pitch and number of the coils also can be varied to increase or decrease a flexibility of the tissue encroachment prevention member 876. The pitch can range from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 4 mm to about 6 mm, from about 6 mm to about 10 mm, from about 1 mm to about 10 mm, or is in a range between any two of the foregoing. Stated another way, the pitch can range from about 0.039″ to about 0.079″, from about 0.079″ to about 0.157″, from about 0.157″ to about 0.236″, from about 0.236″ to about 0.394″, from about 0.039″ to about 0.394″, or is in a range between any two of the foregoing. The number of turns or coils associated with the tissue encroachment prevention member 876 can range from about 2 to about 4 from about 4 to about 6, from about 6 to about 12, from about 2 to about 12, or is in a range between any two of the foregoing. The material selected for the tissue encroachment prevention member 876 can also aid with varying a resiliency, flexibility, spring force, and elasticity of the tissue encroachment prevention member 876 and its ability to rebound or move the distal end of the aspiration catheter 802 from a tissue wall.
Turning to
Turning to
The aspiration catheter 902 provides a barrier to tissue being drawn into an aspiration lumen, thereby controlling or limiting access to the aspiration lumen of the aspiration catheter such that tissue does not encroach or be drawn into the aspiration lumen and towards the high pressure spray from the supply lumen, while thrombus or aspirant is still capable of being collected.
As illustrated, the aspiration catheter 902 includes a shaft 911 with a tissue encroachment prevention assembly 950 disposed towards a distal end 905 of the shaft 911, with a portion of the tissue encroachment prevention assembly 950 extending distal a distal opening 907 of the aspiration catheter 902. A jacket 917b extends along the shaft 911, with the tissue encroachment prevention assembly 950 mounted to the jacket 917b. While illustrated as being mounted to the jacket 917b, it is understood that the tissue encroachment prevention assembly 950 can be mounted to a shaft body 917a of the shaft 911, optionally with the jacket 917b overlapping a portion of the tissue encroachment prevention assembly 950.
As illustrated, the tissue encroachment prevention assembly 950 extends from the shaft 911 and includes a base 952, an elongate member 954 extending from the base 952, and a tissue encroachment prevention member 976. The base 952 extends circumferentially around the shaft 911 and has a profile approximating a curvature of the outer surface 923b of the shaft 911.
In an alternative embodiment illustrated in
Returning to
Disposed at an end 978 of the elongate member 954 is the tissue encroachment prevention member 976 having a coiled body 988 with a coil axis CA that is transverse to a longitudinal axis L of the aspiration catheter 902. The coiled body 988 has a pre-formed shape with one or more turns or coils, with the number and pitch of the coils being selected to allow clot, thrombus, or aspirant to pass through the gaps 956 and into the aspiration lumen 906. The pitch and number of the coils also can be varied to increase or decrease a flexibility of the tissue encroachment prevention member 976. The pitch can range from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 4 mm to about 6 mm, from about 6 mm to about 10 mm, from about 1 mm to about 10 mm, or is in a range between any two of the foregoing. Stated another way, the pitch can range from about 0.039″ to about 0.079″, from about 0.079″ to about 0.157″, from about 0.157″ to about 0.236″, from about 0.236″ to about 0.394″, from about 0.039″ to about 0.394″, or is in a range between any two of the foregoing. The number of turns or coils associated with the tissue encroachment prevention member 976 can range from about 2 to about 4 from about 4 to about 6, from about 6 to about 12, from about 2 to about 12, or is in a range between any two of the foregoing. The material selected for the tissue encroachment prevention member 976 can also aid with varying a resiliency, flexibility, spring force, and elasticity of the tissue encroachment prevention member 976 and its ability to rebound or move the distal end of the aspiration catheter 902 from a tissue wall. The base 952, the elongate member 954, and the tissue encroachment prevention member 976 can be of a metal, alloy, shape-memory material, such as a shape member alloy or metal or a shape member polymer, a composite, a polymer, or combinations or modifications thereof. Additionally, the elongate member 954 and the tissue encroachment prevention member 976 can be a wire, a hollow tube, a rod, combinations or modifications thereof that is formed to return to a pre-defined shape, i.e., the coiled state.
Turning to
Attention is now directed to
The aspiration catheter 1000 can be any of the aspiration catheters described herein, so the disclosure related to the other aspiration catheters disclosed herein is also applicable to the aspiration catheter 1000. Additionally, the disclosure related to the other tissue encroachment prevention assemblies is also applicable to the tissue encroachment prevention assembly 1002.
As illustrated in
While the supply tube 1008 is illustrated as being positioned within the aspiration lumen 1006, this is only exemplary. As with other embodiments, disclose herein, the supply tube 1008 may be disposed within a lumen in the wall of the shaft 1004. In either case, the shaft 1004 can be a single-or multi-lumen extruded tube, such as a tube formed of a polymer, PEBAX, VESTAMID, nylon, polyurethane, combinations or modifications thereof, and optionally reinforced with braids, wires, etc. Alternatively, the shaft 1004 can be a hypotube or another tubular member.
The tissue encroachment prevention assembly 1002 includes one or more atraumatic members.
In some embodiments, the orientation of at least one of the atraumatic members may be determined at least in part by the direction of the spray from the orifice 1012 of the supply tube 1008. For instance, as shown in
As shown in
As alluded to above, the atraumatic members may be connected to the shaft 1004 in a fixed configuration. For instance, opposing ends of the atraumatic members may be secured to an interior surface of the aspiration lumen 1006, an exterior wall of the shaft 1004, or to the distal end of the shaft 1004. The attachment between the atraumatic members and the shaft 1004 may made via any suitable mean, including adhesives, welding, or the like. In some embodiments, the shaft 1004 may include recesses in the distal end thereof. The ends of the atraumatic members may be inserted and retained within the recesses.
In other embodiments, the atraumatic members may be movably associated with the shaft of the aspiration catheter such that they can be selectively moved between retracted and deployed states or configurations.
As shown in
An opposing second end 1020 of the atraumatic member 1014e may extend into a tissue encroachment prevention assembly lumen 1022 in the shaft 1004a. Extending proximally from the second end 1020 through the tissue encroachment prevention assembly lumen 1022 is an elongate member 1024.
The atraumatic member 1014e may be moved between the retracted state (
As the atraumatic member 1014e advances out of the tissue encroachment prevention assembly lumen 1022, the shape of the atraumatic member 1014e (or a portion thereof) may transition from a first state or shape (generally straight) when retained within the tissue encroachment prevention assembly lumen 1022 (see
The elongate member 1024 can be a wire, a hollow tube, a rod, combinations or modifications thereof. Similarly, the atraumatic member 1014e may be formed of a wire, a hollow tube, a rod, combinations or modifications thereof that is configured to return to a pre-defined shape, i.e., the arcuate shape, following advancing the atraumatic member 1014e from the tissue encroachment prevention assembly lumen 1022. In some embodiments, the atraumatic member 1014e may be formed of Nitinol. The material selected for the atraumatic member 1014e can also aid with varying a resiliency, flexibility, spring force, and elasticity of the atraumatic member 1014e and its ability to rebound or move the distal end of the aspiration catheter 1000a from a tissue wall.
Turning to
When the atraumatic member 1014e contacts the vessel wall W, as the aspiration catheter 1000a is moved within the vessel lumen VL, the atraumatic member 1014e maintains a separation of the aspiration lumen 1006 and the wall tissue. This prevents tissue damage caused by vessel tissue being drawn into close proximity to a high pressure saline spray from the supply lumen. Additionally, the resiliency, flexibility, spring force, and elasticity of the atraumatic member 1014e provides a rebound force to move the distal end of the aspiration catheter 1000a, and thereby the distal opening of the aspiration lumen 1006, away from the vessel wall W so as to avoid damaging the wall or vessel tissue.
The gaps or spaces around the atraumatic member 1014e and/or between the atraumatic member 1014e and other atraumatic members allows passage of clot or aspirant A through the gaps or spaces and into the aspiration lumen, thereby allowing aspiration to continue.
Although the atraumatic members are shown as having a generally smooth arcuate shape, this is only exemplary. In other embodiments, while the atraumatic members may have a generally arcuate shape, the atraumatic members may include waves, spirals, or other shapes or contours along the arcuate shape.
In some embodiments, the atraumatic members may be formed of a radiopaque material, such as a material or alloy containing a material with a higher atomic mass such as tantalum, tungsten, platinum/iridium, gold, silver, and so forth
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 Jul. 21, 2020, and entitled, “Systems and Methods for Removal of Blood and Thrombotic Material” and U.S. Pat. No. 10,492,805, issued Dec. 3, 2019, and entitled, “Systems and Methods for Thrombosis and Delivery of an Agent.”
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 connection 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.
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%=10%), 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.
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 they appear, shall be construed as open-ended terminology, with the same meaning as if the phrase “at least” were appended after each instance thereof.
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.
Embodiment 1. An aspiration catheter comprising an elongate shaft configured for placement within a blood vessel, a supply lumen and an aspiration lumen each extending along the shaft, the supply lumen having a proximal end and a distal end, and the aspiration lumen having a proximal end and a distal opening, an orifice at or near the distal end of the supply lumen, the orifice being configured to allow injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is delivered through the supply lumen; and a tissue encroachment prevention assembly for preventing the blood vessel from being drawn into said aspiration lumen and coming into close proximity to the orifice of the supply lumen during aspiration.
Embodiment 2. The aspiration catheter of embodiment 1, further comprising one or more supply lumens, each having an orifice configured to allow injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is pumped through the supply lumen.
Embodiment 3. The aspiration catheter of any of embodiments 1-2, wherein the elongate shaft is a laser cut hypotube laminated by a polymer.
Embodiment 4. The aspiration catheter of any of embodiments 1-3, wherein the elongate shaft is a multi-lumen extruded polymer shaft.
Embodiment 5. The aspiration catheter of any of embodiments 1-4, further comprising a radiopaque ring near the distal end of the aspiration catheter.
Embodiment 6. The aspiration catheter of any of embodiments 1-5, wherein said tissue encroachment prevention assembly comprises a plurality of tines extending from a point at or near the opening at the distal end of the elongate shaft, the plurality of tines each having distal ends that are attached to a spherical ball and proximal ends that extend from the distal end of the elongate shaft, wherein the plurality of tines attached to the spherical ball are configured to form a cage-like structure that prevents vessel tissue from being drawn into the aspiration lumen and into close proximity to the orifice of the supply lumen.
Embodiment 7. The aspiration catheter of any of embodiments 1-6, wherein at least 3 tines extend from the aspiration lumen.
Embodiment 8. The aspiration catheter of any of embodiments 1-7, wherein the tines contain a spring element that allows the tines to bend.
Embodiment 9. The aspiration catheter of any of embodiments 1-8, further comprising a radiopaque ring encircling the catheter near the distal end of the aspiration catheter.
Embodiment 10. The aspiration catheter of any of embodiments 1-9, wherein the ring has holes dispersed throughout.
Embodiment 11. The aspiration catheter of any of embodiments 1-10, wherein a width of the tines is tapered towards the spherical ball.
Embodiment 12. The aspiration catheter of any of embodiments 1-11, wherein the tines are laser welded or soldered directly to a surface of the spherical ball.
Embodiment 13. The aspiration catheter of any of embodiments 1-12, wherein the spherical ball comprises a blind hole to receive the tines.
Embodiment 14. The aspiration catheter of any of embodiments 1-3, wherein the spherical ball is made of a radiopaque material.
Embodiment 15. The aspiration catheter of any of embodiments 1-14, further comprising a mesh configuration at the proximal ends of the tines.
Embodiment 16. An aspiration catheter comprising an elongate shaft configured for placement within a blood vessel, the elongate shaft having a distal end with an opening at the distal end, a supply lumen and an aspiration lumen each extending along the shaft, the supply lumen having a proximal end and a distal end, and the aspiration lumen having a proximal end and a distal opening, an orifice near the distal end of the supply lumen, the orifice being configured to allow injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is delivered through the supply lumen, and a means for preventing the blood vessel from being drawn into the aspiration lumen and into close proximity to the orifice of the supply lumen during aspiration.
Embodiment 17. The aspiration catheter of embodiment 16, wherein the means for preventing the blood vessel from being drawn into the aspiration lumen comprises a cage-like structure extending distally from a point at or near the opening at the distal end of the elongate shaft.
Embodiment 18. The aspiration catheter of any of embodiments 16-17, wherein the cage-like structure comprises a plurality of tines, the plurality of tines each having distal ends that are attached to a spherical ball to form the cage-like structure and proximal ends that extend from the distal end of the elongate shaft.
Embodiment 19. An aspiration catheter comprising an elongate shaft configured for placement within a blood vessel, the elongate shaft having a distal end with an opening at the distal end, a supply lumen and an aspiration lumen each extending along an interior of the shaft, coextensive with the shaft, the supply lumen having a proximal end and a distal end, and the aspiration lumen having a proximal end and a distal opening, an orifice near the distal end of the supply lumen, the orifice being configured to allow injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is pumped through the supply lumen, and a tissue encroachment prevention assembly for preventing the blood vessel from being drawn into the aspiration lumen and into close proximity to the orifice of the supply lumen during aspiration, the tissue encroachment prevention assembly comprising at least one of a cage-like structure.
Embodiment 20. The aspiration catheter of embodiment 19, said cage-like structure comprising a plurality of tines extending from a point at or near the opening at the distal end of the elongate shaft, the plurality of tines each having distal ends that are attached to a spherical ball and proximal ends that extend from the distal end of the elongate shaft, wherein the plurality of tines attached to the spherical ball prevent vessel tissue from being drawn into the aspiration lumen and into close proximity to the orifice of the supply lumen.
Embodiment 21. The aspiration catheter of any of embodiments 19-20, wherein at least 3 tines extend from the aspiration lumen.
Embodiment 22. The aspiration catheter of any of embodiments 19-21, wherein the tines contain a spring element that allows the tines to bend.
Embodiment 23. The aspiration catheter of any of embodiments 19-22, further comprising a radiopaque ring encircling the catheter near the distal end of the aspiration catheter.
Embodiment 24. The aspiration catheter of any of embodiments 19-23, wherein the plurality of tines extend from a base having holes dispersed throughout.
Embodiment 25. The aspiration catheter of any of embodiments 19-24, wherein a width of the tines is tapered towards the spherical ball.
Embodiment 26. The aspiration catheter of any of embodiments 19-25, wherein the tines are laser welded or soldered directly to a surface of the spherical ball.
Embodiment 27. The aspiration catheter of any of embodiments 19-26, wherein the spherical ball comprises a blind hole to receive the tines.
Embodiment 28. The aspiration catheter of any of embodiments 19-27, wherein the spherical ball is made of a radiopaque material.
Embodiment 29. The aspiration catheter of any of embodiments 19-28, further comprising a mesh configuration at the proximal ends of the tines.
Embodiment 30. The aspiration catheter of any of embodiments 19-29, further comprising one or more supply lumens, each having an orifice configured to allow injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is pumped through the supply lumen.
Embodiment 31. The aspiration catheter of any of embodiments 19-30, wherein the elongate shaft is a laser cut hypotube laminated by a polymer.
Embodiment 32. The aspiration catheter of any of embodiments 19-31, wherein the elongate shaft is a multi-lumen extruded polymer shaft.
Embodiment 33. The aspiration catheter of any of embodiments 19-32, further comprising a radiopaque ring near the distal end of the aspiration catheter.
Embodiment 34. A system for aspirating thrombus, comprising an aspiration catheter comprising an elongate shaft configured for placement within a blood vessel of a subject, a supply lumen and an aspiration lumen each extending along an interior of the elongate shaft, and an orifice at or near a distal end of the supply lumen, the orifice being configured to allow injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is caused or allowed to flow through the supply lumen, a tubing set comprising a first conduit having a distal end configured to couple to the aspiration lumen of the aspiration catheter and a proximal end configured to couple to a vacuum source, and a second conduit having a distal end configured to couple to the supply lumen of the aspiration catheter and a proximal end configured to couple to a first fluid source, a pressurization element configured to couple to the tubing set and further configured to pressurize fluid from the first fluid source or allow pressurized fluid from the first fluid source to be transferred to the supply lumen, such that the pressurized fluid is capable of flowing through the supply lumen from the proximal end of the supply lumen to the orifice at or near the distal end of the supply lumen and a means for preventing the blood vessel from being drawn into the aspiration lumen and into close proximity to the orifice of the supply lumen during aspiration.
Embodiment 35. The system for aspirating thrombus of embodiment 34, wherein the means for preventing the blood vessel from being drawn into the aspiration lumen and into close proximity to the orifice of the supply lumen during aspiration comprises a cage-like structure formed from a plurality of tines which extend from the distal end of the aspiration catheter and which each have distal ends that are attached to a spherical ball.
Embodiment 36. A system for aspirating thrombus, comprising an aspiration catheter comprising an elongate shaft configured for placement within a blood vessel of a subject, a supply lumen and an aspiration lumen each extending along an interior of the elongate shaft, and an orifice at or near a distal end of the supply lumen, the orifice being configured to allow injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is caused or allowed to flow through the supply lumen, a tubing set comprising a first conduit having a distal end configured to couple to the aspiration lumen of the aspiration catheter and a proximal end configured to couple to a vacuum source, and a second conduit having a distal end configured to couple to the supply lumen of the aspiration catheter and a proximal end configured to couple to a first fluid source, a pressurization element configured to couple to the tubing set and further configured to pressurize fluid from the first fluid source or allow pressurized fluid from the first fluid source to be transferred to the supply lumen, such that the pressurized fluid is capable of flowing through the supply lumen from the proximal end of the supply lumen to the orifice at or near the distal end of the supply lumen, and a tissue encroachment prevention assembly for preventing the blood vessel from being drawn into the aspiration lumen and into close proximity to the orifice of the supply lumen during aspiration.
Embodiment 37. The system for aspirating thrombus of embodiment 36, wherein the tissue encroachment prevention assembly for preventing the blood vessel from being drawn into the aspiration lumen and into close proximity to the orifice of the supply lumen during aspiration comprises a cage-like structure formed from a plurality of tines which extend from the distal end of the aspiration catheter and which each have distal ends that are attached to a spherical ball.
Embodiment 38. An aspiration catheter comprising an elongate shaft configured for placement within a blood vessel, a supply lumen and an aspiration lumen each extending along an interior of the shaft, coextensive with the shaft, the supply lumen having a proximal end and a distal end, and the aspiration lumen having a proximal end and a distal opening, an orifice at or near the distal end of the supply lumen, the orifice configured to allow injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when the pressurized fluid is pumped through the supply lumen, and a means for preventing the blood vessel from being drawn into said aspiration lumen and coming into close proximity to the orifice of the supply lumen during aspiration.
Embodiment 39. An aspiration catheter comprising: an elongate shaft configured for placement within a blood vessel, the elongate shaft having an aspiration lumen extending therethrough, the aspiration lumen having an opening at a distal end of the elongate shaft; a supply lumen extending along the shaft, the supply lumen having a distal end and an orifice at or near the distal end, the orifice being configured to allow injection of pressurized fluid into the aspiration lumen at or near a distal end of the aspiration lumen when the pressurized fluid is delivered through the supply lumen; and a tissue encroachment prevention assembly for preventing the blood vessel from being drawn into the aspiration lumen and coming into close proximity to the orifice of the supply lumen during aspiration, the tissue encroachment prevention assembly comprising one or more atraumatic members that expend distally from the elongate shaft and across the opening to the aspiration lumen.
Embodiment 40. The aspiration catheter of Embodiment 39, wherein at least one of the one or more atraumatic members comprises a wire having a first end and a second end that are connected to or otherwise associated with the distal end of the shaft.
Embodiment 41. The aspiration catheter of Embodiment 40, wherein at least a portion of the atraumatic member between the first and second ends thereof has and arcuate shape.
Embodiment 42. The aspiration catheter of Embodiment 40, wherein the first end and the second end are both fixedly attached to the shaft.
Embodiment 43. The aspiration catheter of Embodiment 40, wherein the first end is fixedly attached to the shaft and the second end is movable relative to the shaft such that the atraumatic member is selectively movable between a retracted state and a deployed state.
Embodiment 44. The aspiration catheter of Embodiment 43, wherein a portion of the atraumatic member is configured to move from a first shape when in the retracted state to a second shape when in the deployed state.
Embodiment 45. The aspiration catheter of Embodiment 43, wherein the second end is disposed within a tissue encroachment prevention assembly lumen within the shaft when in the retracted state.
Embodiment 46. The aspiration catheter of Embodiment 45, wherein the tissue encroachment prevention assembly further comprises an elongate member associated with the second end of the atraumatic member.
Embodiment 47. The aspiration catheter of Embodiment 46, wherein the elongate member is movably disposed within the tissue encroachment prevention assembly lumen.
Embodiment 48. The aspiration catheter of Embodiment 39, wherein at least one of the one or more atraumatic members comprises a radiopaque material.
Embodiment 49. The aspiration catheter of Embodiment 40, wherein at least one of the one or more atraumatic members comprises a length and a width, the length being a distance between the distal end of the shaft and a distal-most portion of the at least one atraumatic member, and the width being a distance between the first and second ends of the wire.
Embodiment 50. The aspiration catheter of Embodiment 49, wherein the length is greater than the width.
Embodiment 51. The aspiration catheter of Embodiment 49, wherein the length less than the width.
Embodiment 52. The aspiration catheter of Embodiment 49, wherein the length is equal to the width.
This application claims priority to and the benefit of U.S. Provisional Patent Application Ser. No. 63/613,971, filed Dec. 22, 2023, and entitled “CATHETER TIP FOR ASPIRATION SYSTEM,” the disclosure of which is incorporated herein by this reference.
Number | Date | Country | |
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63613971 | Dec 2023 | US |