US20220378449A1

US20220378449A1 - Systems and methods for removal of blood and thrombotic material

Info

Publication number: US20220378449A1
Application number: US17/886,020
Authority: US
Inventors: David M. Look; Bradley S. Culbert
Original assignee: Walk Vascular LLC
Current assignee: Walk Vascular LLC
Priority date: 2018-07-19
Filing date: 2022-08-11
Publication date: 2022-12-01
Also published as: US20200022711A1; US20220387052A1; US11678905B2

Abstract

A system for aspirating thrombus that includes an aspiration catheter, a tubing set connected to the aspiration catheter, a pressurization element configured to couple to the tubing set and further configured to pressurize fluid from a first fluid source or allow pressurized fluid from the first fluid source to be transferred through a supply lumen of the aspiration catheter, and a sheath through which the aspiration catheter can be advanced.

Description

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 16/516,190, filed Jul. 18, 2019, which claims the benefit of priority to U.S. Provisional Patent Application No. 62/700,763, filed on Jul. 19, 2018, which are herein incorporated by reference in their entireties for all purposes. Priority is claimed pursuant to 35 U.S.C. § 119 and 35 U.S.C. § 120.

BACKGROUND OF THE INVENTION

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.

DESCRIPTION OF THE RELATED ART

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 the pull in, macerate and transport thrombotic material away from the distal tip using a mechanical auger, systems that use very high pressure to macerate the thrombus and create a venturi effect to flush the macerated material away.

SUMMARY OF THE INVENTION

In one embodiment of the present disclosure, a method for improving a flow condition through a catheter includes providing an aspiration catheter including an elongate shaft configured for placement within a blood vessel of a subject, 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 an open distal end, and an opening at or near the distal end of the supply lumen, the opening configured to allow the injection of pressurized fluid from a first fluid source 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, providing a sheath including a proximal end, a distal end and a lumen extending between the proximal end and the distal end, the lumen configured for placement of the aspiration catheter therethrough, the sheath further including an extension conduit in fluid communication with the lumen of the sheath and extending from the sheath, the extension conduit configured for coupling to a second fluid source, providing a seal associated with the proximal end of the sheath and configured to seal the lumen of the sheath around the elongate shaft of the aspiration catheter when the aspiration catheter is in place within the sheath, providing a tubing set including 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 the first fluid source, wherein the tubing set is configured to couple to a pump 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 distal end of the supply lumen, coupling the distal end of the first conduit of the tubing set to the aspiration lumen of the aspiration catheter, coupling the proximal end of the first conduit of the tubing set to the vacuum source, coupling the distal end of the second conduit to the supply lumen of the aspiration catheter, coupling the proximal end of the second conduit to the first fluid source, inserting the distal end of the sheath within the vasculature of a subject, placing the aspiration catheter through the sheath and advancing the aspiration catheter such that the open distal end of the aspiration lumen of the aspiration catheter is distal to the distal end of the sheath and is in proximity to a thrombus within a blood vessel of the subject, coupling the extension conduit to the second fluid source, and activating the pump such that pressurized fluid from the first fluid source is applied to the proximal end of the supply lumen of the aspiration catheter, wherein when sufficient flowable material is present adjacent the open distal end of the aspiration lumen, at least some of the flowable material is caused to flow through the aspiration lumen from the open distal end to the proximal end, and into an interior of the vacuum source, and when insufficient flowable material is present adjacent the open distal end of the aspiration lumen, fluid from the second fluid source is caused to flow through the lumen of the sheath from the proximal end to the distal end, and at least some of the fluid from the second fluid source is delivered into the blood vessel of the subject.
In another embodiment of the present disclosure, a method for identifying a no flow or low flow condition through a catheter includes providing an aspiration catheter including an elongate shaft configured for placement within a blood vessel of a subject, 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 an open distal end, and an opening at or near the distal end of the 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 supply lumen, providing a sheath including a proximal end, a distal end and a lumen extending between the proximal end and the distal end, the lumen configured for placement of the aspiration catheter therethrough, the sheath further including an extension conduit in fluid communication with the lumen of the sheath and extending from the sheath, the extension conduit configured for coupling to a second fluid source, the extension conduit fluidly coupled to a valve having a first position configured to selectively couple the extension conduit to a fluid source containing a contrast agent and a second position configured to selectively couple the extension conduit to a fluid source containing substantially no contrast agent, providing a seal associated with the proximal end of the sheath and configured to seal the lumen of the sheath around the elongate shaft of the aspiration catheter when the aspiration catheter is in place within the sheath, providing a tubing set including 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, wherein the tubing set is configured to couple to a pressurization element 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 distal end of the supply lumen, coupling the distal end of the first conduit of the tubing set to the aspiration lumen of the aspiration catheter, coupling the proximal end of the first conduit of the tubing set to the vacuum source, coupling the distal end of the second conduit to the supply lumen of the aspiration catheter, coupling the proximal end of the second conduit to the first fluid source, inserting the distal end of the sheath within the vasculature of a subject, placing the aspiration catheter through the sheath and advancing the aspiration catheter such that the open distal end of the aspiration lumen of the aspiration catheter is in proximity to a thrombus within a blood vessel of the subject, coupling the extension conduit to at least the fluid source containing a contrast agent, placing or maintaining the valve in the first position, and activating the pressurization element such that pressurized fluid from the first fluid source is applied to the proximal end of the supply lumen of the aspiration catheter, wherein when sufficient flowable material is present adjacent the open distal end of the aspiration lumen, at least some of the flowable material is caused to flow through the aspiration lumen from the open distal end to the proximal end, and into an interior of the vacuum source, and when insufficient flowable material is present adjacent the open distal end of the aspiration lumen, fluid from the fluid source containing a contrast agent is caused to flow through the lumen of the sheath between the proximal end and the distal end, and at least some of the fluid from the fluid source containing a contrast agent is delivered into the blood vessel of the subject.
In yet another embodiment of the present disclosure, a method for identifying a no flow or low flow condition through a catheter includes providing an aspiration catheter including an elongate shaft configured for placement within a blood vessel of a subject, 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 an open distal end, and an opening at or near the distal end of the 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 supply lumen, providing a sheath including a proximal end, a distal end and a lumen extending between the proximal end and the distal end, the lumen configured for placement of the aspiration catheter therethrough, the sheath further including an extension conduit in fluid communication with the lumen of the sheath and extending from the sheath, the extension conduit configured for coupling to a second fluid source, the second fluid source containing a contrast agent, providing a seal associated with the proximal end of the sheath and configured to seal the lumen of the sheath around the elongate shaft of the aspiration catheter when the aspiration catheter is in place within the sheath, providing a tubing set including 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, wherein the tubing set is configured to couple to a pressurization element 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 distal end of the supply lumen, coupling the distal end of the first conduit of the tubing set to the aspiration lumen of the aspiration catheter, coupling the proximal end of the first conduit of the tubing set to the vacuum source, coupling the distal end of the second conduit to the supply lumen of the aspiration catheter, coupling the proximal end of the second conduit to the first fluid source, inserting the distal end of the sheath within the vasculature of a subject, placing the aspiration catheter through the sheath and advancing the aspiration catheter such that the open distal end of the aspiration lumen of the aspiration catheter is in proximity to a thrombus within a blood vessel of the subject, coupling the extension conduit to at least the fluid source containing a contrast agent, and activating the pressurization element such that pressurized fluid from the first fluid source is applied to the proximal end of the supply lumen of the aspiration catheter, wherein when sufficient flowable material is present adjacent the open distal end of the aspiration lumen, at least some of the flowable material is caused to flow through the aspiration lumen from the open distal end to the proximal end, and into an interior of the vacuum source, and when insufficient flowable material is present adjacent the open distal end of the aspiration lumen, fluid from the fluid source containing a contrast agent is caused to flow through the lumen of the sheath between the proximal end and the distal end, and at least some of the fluid from the fluid source containing a contrast agent is delivered into the blood vessel of the subject.
In still another embodiment of the present disclosure, a system for aspirating thrombus includes an aspiration catheter including an elongate shaft configured for placement within a blood vessel of a subject, 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 an open distal end, and an opening at or near the distal end of the 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 supply lumen, a tubing set including 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 distal end of the supply lumen, a sheath having a proximal end, a distal end and a lumen extending between the proximal end and the distal end, the lumen configured for placement of the aspiration catheter therethrough, the sheath further including an extension conduit in fluid communication with the lumen of the sheath and extending from the sheath, the extension conduit configured for coupling to a second fluid source, a seal associated with the proximal end of the sheath and configured to seal the lumen of the sheath around the elongate shaft of the aspiration catheter when the aspiration catheter is in place within the sheath, and wherein the extension conduit is configured to allow fluid from the second fluid source to flow through the lumen of the sheath from the proximal end of the sheath to the distal end of the sheath when the open distal end of the aspiration lumen of the aspiration catheter is extended outside of the lumen of the sheath in a blood vessel and is in proximity to the distal end of the sheath, and when insufficient flowable material is present adjacent the open distal end of the aspiration lumen, such that a negative pressure gradient supplied by the vacuum source further causes a significant volume of the fluid from the second fluid source to actively flow through the aspiration lumen from the open distal end to the proximal end and into an interior of the vacuum source.
In yet another embodiment of the present disclosure, a system for aspirating thrombus includes an aspiration catheter including an elongate shaft configured for placement within a blood vessel of a subject, 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 an open distal end, and an opening at or near the distal end of the 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 supply lumen, a tubing set including 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 distal end of the supply lumen, a sheath having a proximal end, a distal end and a lumen extending between the proximal end and the distal end, the lumen configured for placement of the aspiration catheter therethrough, the sheath further including an extension conduit in fluid communication with the lumen of the sheath and extending from the sheath, the extension conduit configured for coupling to a second fluid source, the extension conduit fluidly coupled to a valve having a first position configured to selectively couple the extension conduit to a fluid source containing a contrast agent and a second position configured to selectively couple the extension conduit to a fluid source containing substantially no contrast agent, a seal associated with the proximal end of the sheath and configured to seal the lumen of the sheath around the elongate shaft of the aspiration catheter when the aspiration catheter is in place within the sheath, and wherein the aspiration catheter has a first position within the sheath wherein the open distal end of the aspiration lumen of the aspiration catheter is outside of the lumen of the sheath and distal to the distal end of the sheath, and wherein the aspiration catheter has a second position within the sheath wherein the open distal end of the aspiration lumen of the aspiration catheter is within the lumen of the sheath and proximal to the distal end of the sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of an aspiration system, according to an embodiment of the present disclosure.

FIG. 2 is a sectional view of the distal end of the aspiration catheter of the system for aspirating thrombus of FIG. 1 .

FIG. 3 is a perspective view of a modification of the aspiration system having an alternative pinch valve, according to another embodiment of the present disclosure.

FIG. 4 is plan view of the aspiration system of FIG. 1 , in a second condition.

FIG. 5 is plan view of the aspiration system of FIG. 1 , in a third condition.

FIG. 6 is a detail view of the distal end of the guide sheath of FIG. 5 .

FIG. 7 is a plan view of an alternative aspiration system to the aspiration system of FIG. 1 , according to an embodiment of the present disclosure.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.
FIGS. 1-3 illustrate a system for aspirating thrombus 2400, including an aspiration catheter 1930, a pump base 200, and a guide sheath 2450. The aspiration catheter 1930 has been inserted through the guide sheath 2450, which includes a proximally-located hemostasis valve 2452 configured for sealing around the shaft 2454 of the aspiration catheter 1930. Alternatively, the hemostasis valve 2452, instead of being part of the guide sheath 2450, may be a separate hemostasis valve that is configured to be coupled to the guide sheath 2450, for example, by a luer fitting or a y-connector. Fluid (e.g., saline) may be injected through the interior lumen 2456 of the guide sheath 2450, and around the shaft 2454 of the aspiration catheter 1930 by attaching a syringe or pump (not shown) to the luer connector 2458 of an extension tube 2460. A guidewire 1902 can be used to track the aspiration catheter 1930 through a patient's vasculature, for example, a blood vessel 1999 having a thrombus 1995. The distal end 2451 of the guide sheath 2450 and the distal end 1997 of the aspiration catheter 1930 are shown in FIG. 1 within the blood vessel 1999 and in relation to the thrombus 1995.
FIG. 2 illustrates the distal end 2451 of the aspiration catheter 1930 and the guidewire 1902. The guidewire 1902 is free to be moved distally or proximally in the longitudinal direction, or to be rotated within the aspiration lumen/guidewire lumen 1932 that extends through the aspiration catheter 1930. The distal end 1901 of the guidewire 1902 may be shapeable, for example, to create a “J”-tip for selectability of vessels or through stenoses or obstructions. A high-pressure injection lumen 1934 is contained within a tube 1936 having a large diameter portion 1938 and a small diameter portion 1940. The small diameter portion 1940 may transition from the large diameter portion 1938 via a neckdown or tapered portion 1942. The small diameter portion 1940 is blocked using a blocking material 1944, which may include a polymer, adhesive, or epoxy adhered to the internal walls of the small diameter portion 1940. Alternatively, the small diameter portion 1940 may be crimped, tied off, sealed, or otherwise occluded, without the use of a blocking material 1944. An orifice 1946 in a wall 1948 of the tube 1936 is configured to create a jet from high pressure fluid injected through the high-pressure injection lumen 1934. The jet exiting the high-pressure injection lumen 1934 through the orifice 1946 and entering the aspiration lumen 1932 is configured to impinge on an inner wall 1950 of the aspiration lumen/guidewire lumen 1932. Aspiration may be performed with the guidewire 1902 in place within the aspiration lumen/guidewire lumen 1932, or may be performed with the guidewire 1902 retracted proximally of the longitudinal location of the orifice 1946, or even with the guidewire 1902 completely removed from the aspiration lumen/guidewire lumen 1932. In cases wherein the guidewire 1902 is left in place (as shown in FIG. 2 ), during aspiration, the guidewire 1902 may be rotated or otherwise manipulated so that it does not significantly impede the jetting through the orifice 1946, or in some cases, the jet itself may be sufficient to force the guidewire 1902 into a position that does not impede the jetting against the inner wall 1950. The pump base 200 (FIG. 1 ) is configured to interface with a cassette 116 which is a component of accessories 2057 (part of a tubing set 1638) to pressurize fluid from a fluid source 20. A standard hospital saline bag may be used as fluid source 20; such bags are readily available to the physician and provide the necessary volume to perform the procedure, for example 500 ml or 1,000 ml. In other cases, a saline bottle may be used. A spike 102 can be placed into a septum of the saline bag and communicates with extension tubing 122. Liquid injectate is pumped downstream at the piston pump 305 (or other pump), which pulls more liquid injectate (for example from a saline bag) through a check valve 126 and through a supply tube 130, forcing it into a fluid supply line 1646. An injection port 128 may be used in some cases for injecting other materials such as drugs into the system, or for removing air from the system or priming the system. The spike 102 may be packaged with a removable protective spike cover. Particular configurations of the aspiration catheter 1930, pump base 200, and tubing set 1638 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 Materials,” which is hereby incorporated by reference in its entirety for all purposes.
A connector 1642 is coupled to the aspiration catheter 1930, and includes a female luer sideport 1644 configured to allow injection through the high-pressure injection lumen 1934 of the tube 1936 (FIG. 2 ) via the fluid supply line 1646. The fluid supply line 1646 includes a male luer 1648, which is connectable to the sideport 1644. The connector 1642 includes a barbed fitting 1650 (sideport) which is configured for attachment of a vacuum line 1652 having a plastic or elastomeric tubular end 1654 configured for sealingly forcing over the barbed fitting 1650. In some embodiments, the barbed fitting 1650 may also include a female luer, so that either the barbed fitting 1650 or the female luer may be chosen as the attachment site. The connector 1642 further includes a Touhy-Borst valve 1656 which may be sealed (closed) if a guidewire 1902 is not used, or may be opened to allow the passage of a guidewire 1902 through the connector 1642 and the aspiration lumen 1932 of the aspiration catheter 1930, and may then be sealed over the guidewire 1902. The Touhy-Borst valve 1656 may include a distal male luer 1657 configured to secure to a female luer 1659 at the proximal end of the connector 1642. In alternate embodiments, the Touhy-Borst valve 1656 may be permanently connected or formed on the connector 1642. The Touhy-Borst valve 1656 is optional, because in some catheter configurations, the clearance around the guidewire at one or more portions of the connector 1642 may be small enough to create sufficient fluid (blood) flow resistance over a length to allow an acceptable hemostasis with little or no backdrip of blood.
Accessories 2057 include a syringe 2049 having a plunger 2067 and a barrel 2099. The syringe 2049 is coupled to the vacuum line 1652 via a luer 2065. The syringe 2049 is configured as a vacuum source, to apply a negative pressure on the aspiration lumen 1932 of the aspiration catheter 1930, for example, to aid in the aspiration of thrombus or other materials from a blood vessel 1999 and into the open distal end 1931 (FIG. 2 ) of the aspiration lumen 1932. A stopcock 2047, connected between the syringe 2049 and the vacuum line 1652, may be used to maintain the negative pressure gradient, or, the plunger 2067 may be a locking variety of plunger that is configured to be locked in the retracted (vacuum) position with respect to the barrel 2099. Vacuum bottles may be used in place of the syringe 2049, or a vacuum canister, syringe, a vacuum pump or other suitable vacuum or negative pressure sources. A particular alternative vacuum source is shown in the alternative embodiment of FIG. 7 . The system for aspirating thrombus 2400′ in FIG. 7 is identical to the system for aspirating thrombus 2400 in FIG. 1 , but the syringe 2049 is replaced by a vacuum pump 2051. The vacuum pump 2051 is coupled to the vacuum line 1652 by a luer 2053. Thus, in all practicable locations wherein the syringe 2049 is descried herein, the vacuum pump 2051 may alternatively be used.
Returning to FIG. 1 , a foot pedal 2021 is configured to operate a pinch valve 1610 for occluding (closing) or opening the vacuum line 1652. The foot pedal 2021 comprises a base 2025 and a pedal 2027, 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 2027 causing a signal to be sent along a cable 2029 which is connected via a plug 2041 to an input jack 2037. The input jack 2037 is shown in FIG. 1 remote from the pump base 200, but alternatively may be located on the pump base 200. A circuit board 304 of the pump (FIG. 3 ) may include a controller 303 configured to receive one or more signals indicating on or off from the foot pedal 2021, either by a direct electrical connection, or wirelessly (remotely). The controller 303 of the circuit board 304 may be configured to cause an actuator 2031 of the pinch valve 1610 to move longitudinally to compress and occlude the vacuum line 1652 between an actuator head 2033 (attached to the actuator 2031) and an anvil 2035, also carried by the pinch valve 1610. By stepping on the pedal 2027, the user is able to thus occlude the vacuum line 1652, stopping the application of a negative pressure from the syringe 2049 onto the aspiration lumen 1932. Also, by stepping on the pedal 2027, the user may cause the opposite action, wherein the actuator head 2033 opens the vacuum line 1652, by moving away from the anvil 2035. The anvil 2035 may have a flat (planar) shape, or a U-shape (e.g., semicylindrical), or a V-shape (e.g., a V-block) where it contacts the tubing of the vacuum line 1652. Furthermore or alternatively, the actuator head 2033 itself may have a flat (planar) shape, or a U-shape (e.g., semi-cylindrical), or a V-shape (e.g., a V-block) where it contacts the vacuum line 1652. The foot pedal 2021 may operate by alternately causing the actuator 2031 to move in a first direction and a second, opposite direction, respectively, with alternate applications of the pedal 2027. In some embodiments, when the pedal 2027 of the foot pedal 2021 is depressed, the controller 303 may be configured to open the pinch valve 1610. A pressure transducer 2006 is carried within the female luer 1659 of the connector 1642, but may be alternatively placed at other locations along the aspiration path. The pressure transducer 2006 thus senses a negative pressure and sends a signal to the pump base 200 via a cable 112, causing the controller 303 to start the motor 302 of the pump base 200, which is configured to drive the piston pump 305. The cable 112 includes a connector 114 for connecting electrically to the pump base 200. Because the effect via the electronics is substantially immediate, the motor 302 initiates the piston pump 305 almost immediately after the pedal 2027 is depressed. When the pedal 2027 of the foot pedal 2021 is released, the controller 303 then causes the pinch valve 1610 to close. The pressure transducer 2006 thus senses that no negative pressure is present and causes the motor 302 of the pump base 200 to shut off. Again, the effect via the electronics is substantially immediate, and thus the motor 302 stops operating the piston pump 305 almost immediately after the pedal 2027 is depressed. During sterile procedures, the main interventionalist is usually “scrubbed” such that the user's hands are only intended to touch items in the sterile field. However, the feet/shoes/shoe covers are typically not in the sterile field. Thus, again, a single user may operate a switch (via the pedal 2027) while also manipulating the aspiration catheter 1930, guide sheath 2450, and guidewire 1902. However, this time, it is the sterile field hands and non-sterile field feet that are used. Alternatively, the foot pedal 2021 may comprise two pedals, one configured to command occlusion and one configured to command opening. In an alternative foot pedal embodiment, the pedal 2027 may operate a pneumatic line to cause a pressure activated valve or a cuff to occlude or open the vacuum line 1652, for example, by forcing the actuator head 2033 to move. In another alternative embodiment, the pedal 2027 may turn, slide, or otherwise move a mechanical element, such as a flexible pull cable or push rod that is coupled to the actuator 2031, to move the actuator head 2033. The cable 2029 may be supplied sterile and connected to the base 2025 prior to a procedure. The occlusion and opening of the vacuum line 1652 thus acts as a on and off switch for the pump base 200 (via the pressure sensor 2006), as described in relation to FIG. 1 . 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 motor 302 (and thus pump 305) 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 for aspirating thrombus 2400, 2400′. 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 2031 may be controlled to compress the vacuum line 1652 against the anvil 2035 with a particular force, and the actuator 2031 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 1652, for example, by eliminating or reducing overcompression of the vacuum line 1652.
A particular configuration for a system for aspirating thrombus 2400 is illustrated in FIG. 3 , and comprises a pump base 200, a vacuum line 1652, and a pressure sensor 106 having a cable 112 for connecting to the pump base 200 and carrying signals from the pressure sensor 106. The other elements of the system for aspirating thrombus 2400 are the same as described in relation to FIG. 1 . A pinch valve 1610 is operable by a foot pedal (not shown, but similar to the foot pedal 2021 of the system for aspirating thrombus 2400 in FIG. 1 ). The foot pedal 2021 may communicate with the pinch valve 1610 via a wired connection through the pump base 200 or may communicate with the pinch valve 1610 wirelessly. The pinch valve 1610 in FIG. 3 extends from the pump base 200 and includes a pinch valve housing 1609 having an opening 1611 which is configured to hold a portion of the vacuum line 1652. Internal to the pinch valve housing 1609 are components equivalent to the actuator head 2033, actuator 2031, and anvil 2035 of the pinch valve 2023 of FIG. 1 , which are configured to compress an external portion of the tubing of the vacuum line 1652 when the foot pedal 2021 is depressed. The foot pedal 2021 may then be depressed a second time to release the compression on (decompress) the vacuum line 1652. The compression of the vacuum line 1652 may be configured to be a complete occlusion of the tubing, thus hydraulically isolating the syringe 2049 from the pressure sensor 106. An input port 1612 to the pressure sensor 106 may include a septum 1614 for adding or removing fluid within the vacuum line 1652 (e.g., via a hypodermic needle), or alternatively may include a luer connector and valve. The input port 1612 may also be used to remove air or to allow priming of the system. The pressure sensor 106 is thus configured to reside in a non-sterile field, and is capable of detecting the presence of vacuum (or negative pressure) or the lack of vacuum (or negative pressure) when the foot pedal is depressed by the foot of a user. For example, with the pinch valve 1610 closed via a signal (or resultant mechanical action) from foot pressure on the foot pedal, and thus no vacuum applied within the vacuum line 1606, fluid (such as saline) may be freely injected (proximal to distal) through the aspiration lumen 1932 of the aspiration catheter 1930 connected to the vacuum line 1652, and into the blood vessel 1999 of a patient. The pump base 200 may be configured (via the controller 303) to not pump saline when the lack of vacuum or negative pressure in the vacuum line 1652 is determined. Additionally, if vacuum or negative pressure is present, but is suddenly lost, the pump base 200 will shut down. As seen in FIG. 3 , the pinch valve 1610 is located between the syringe 2049 (or other vacuum source) and the pressure sensor 106, thus when the pinch valve 1610 shuts off the aspiration catheter 1930 from the syringe 2049, the pressure sensor 106 is still able to sense the condition within the aspiration lumen 1932 of the aspiration catheter 1930. In most cases, after the pinch valve 1610 is caused to close, the negative pressure within the aspiration lumen 1932 will rise toward the ambient pressure rather quickly. This change will be sensed by the pressure sensor 106. However, in cases in which a piece of thrombus causes a temporary or permanent clog in the aspiration lumen 1932, the pressure sensor 106 is able to sense these occurrences. For example, a large moving thrombus will delay the time that the internal pressure of the aspiration lumen 1932 rises to ambient pressure after the pinch valve 1610 is closed. A complete occlusion of the aspiration lumen 1932 by a thrombus may cause at least some level of negative pressure to remain in the aspiration lumen. Each of these potential occurrences can be identified by the pressure measured by the pressure sensor 106 or by the characteristic of the measured pressure over time. The controller 303 may be configured to send an error or to indicate that there is a temporary or permanent clog in the aspiration lumen 1932, for example, using a display, or a visual, audible, or tactile warning or alarm. The user may respond to this indication by removing and unclogging the aspiration catheter 1930, e.g., by moving a guidewire 1902 back and forth, or may determine that the aspiration catheter 1930 needs to be replaced. Thus, the ability of the pressure sensor 106 to monitor aspiration lumen pressure, regardless of whether the pinch valve 1610 is open or closed, offers an important safety control, as well as a general diagnostic of the state of the system (catheter flow status, etc.). Another general advantage of using a pinch valve 1610 is that blood only contacts the internal luminal wall of the vacuum line 1652, and thus is not forced within interstices of rotatable valves or other moving parts that otherwise could begin to stick or foul with biological material. The vacuum line 1652 is simply compressed an uncompressed, allowing a robust and durable design. The internal volume of the vacuum line 1652 easily maintains sterility. And, as the pinch valve 1610 is isolated from blood/thrombus, it is reusable. As an alternative or in addition to the foot pedal 2021, a push button 1607 may be provided on the pump base 200, or in a remote component. In a first embodiment, the push button 1607 may simply allow manual opening and closing of the pinch valve 1610 on the vacuum line 1652. A first push to compress the vacuum line 1652 and isolate the pressure sensor 106 from the syringe 2049 (and its negative pressure), and a second push to decompress the vacuum line 1652.
Alternatively, the push button 1607 may act as a reset button, and be configured to always open the pinch valve 1610 (when it is closed), or to make no change if the pinch valve 1610 is already open. In an embodiment having both the foot pedal 2021 and the push button 1067, with the push button 1607 configured as a reset button, activation of the foot pedal 2021 toggles the pinch valve 1610 open and closed, while activation of the push button 1607 always places or maintains the pinch valve 1610 in the open position. The push button 1607 may be a mechanical (doorbell) type button, or may be a touch switch (e.g., capacitive, resistive, or piezo), or in some embodiments may even be a toggle or rocker switch. The co-location of two or more of the syringe 2049, the pinch valve 1610, the pump base 200, and the push button 1607 may also be an advantage because it allows a quick assessment by an attending physician or medical personnel in a quick glance, for example, if otherwise focused on catheter manipulation in the sterile field.
An additional advantage supplied by the pinch valve 1610 is that the controller 303 may be configured to cause the piston pump 305 to operate whenever the pinch valve 1610 is in the open condition. Thus, there will always be at least some jet-induced maceration of thrombus while a vacuum is being applied to the aspiration lumen 1932. This minimizes or prevents the aspiration lumen 1932 clogging, which could occur if vacuum or negative pressure is being applied to a large portion of thrombus without any maceration (breaking into smaller pieces).
Returning to FIG. 1 , the plug 2041 contains an identification component 2043, which may be read by the circuitry (e.g., circuit board 304) coupled to the input jack 2037. In some embodiments, the identification component 2043 comprises a resistor having a particular value, for example, as part of a Wheatstone bridge. When the plug 2041 is connected to the input jack 2037, the circuitry of the input jack 2037 sends a current through the resistor, resulting in the pump base 200 being electronically placed into a “foot pedal” mode, wherein the foot pedal 2021 can be used to control the operation of the pinch valve 1610. Alternatively, when the plug 2041 is detached from the input jack 2037, and the circuitry is not able to identify the resistor, the pump base 200 is placed in a “manual” mode, wherein the pump 305 is controllable only by buttons (not shown). In other embodiments, instead of a resistor, the identification component 2043 may comprise an RFID (radiofrequency identification) chip, which is read by the circuitry when the plug 2041 is connected to the input jack 2037. In other embodiments, a proximity sensor, such as a Hall-effect device, may be utilized to determine whether the plug 2041 is or is not connected to the input jack 2037.
It should be noted that in certain embodiments, the pinch valve 1610 and the foot pedal 2021 may be incorporated for on/off operation of the pinch valve 1610 on the vacuum line 1652, without utilizing the pressure sensor 106. In fact, in some embodiments, the pressure sensor 106 may even be absent from the system for aspirating thrombus 2400, the foot pedal 2021 being used as a predominant control means.
Returning to FIG. 1 , system for aspirating thrombus 2400 further comprises an auxiliary fluid supply system 310 that provides features that improve the efficiency of aspiration procedures performed using the guide sheath 2450 and the aspiration catheter 1930. The auxiliary fluid supply system 310 comprises at least a syringe 312 containing contrast media 314, either non-dilute, or diluted. The contrast media may be diluted 50/50 with normal saline (e.g., heparinized saline), or may be diluted to a ratio of 20% contrast media/80% normal saline. The percentage of contrast may be between about 10% and about 75%, or between about 15% and about 40%. The syringe 312 comprises a barrel 316 and a plunger 318, the barrel comprising a luer 320. The luer 320 may be directly coupled to the luer connector 2458 of the extension tube 2460 of the guide sheath 2450, to allow the interior lumen 2456 of the guide sheath 2450 to have access to the contrast media 314 of the syringe 312. The contrast media 314 allows real-time indication of the status of an aspiration procedure, as will be described. FIG. 1 depicts additional optional elements of the auxiliary fluid supply system 310, including a three-way stopcock 322 and a saline IV bag 324. The saline IV bag 324 may be placed within a pressure bag 326 configured to externally pressurize the internal contents of the saline IV bag 324, for example, to a pressure of 100 mm Hg or higher, or 150 mm Hg or higher, or 200 mm Hg or higher, or 250 mm Hg or higher, or 300 mm Hg or higher, using, for example, a pressure cuff surrounding the saline IV bag 324. The saline IV bag 324 may have a volume of normal saline or heparinized normal saline of 500 ml or 1,000 ml, in common embodiments. The luer 320 of the syringe 312 is coupled to an extension tube 328 having a luer 330 at its distal end. The luer 330 is connected to a first luer 332 of the three-way stopcock 322. The saline IV bag 324 includes a port 334 to which a spike 336 of an extension tube 338 is connected. The extension tube 338 includes a luer 340 at its opposite end which is connector to a second luer 342 of the threeway stopcock 322. A third luer 344 of the three-way stopcock 322 is connected to the luer connector 2458 of the extension tube 2460 of the guide sheath 2450. The three-way stopcock 322 includes a rotatable valve 346 having a projection 348 that is configured to be manipulated by a user to turn the rotatable valve 346. The projection 348 points toward the luer that will be closed (sealed) in that particular configuration. As shown in FIG. 1 , the first luer 332 is closed. Thus, the second luer 342 and the third luer 344 are open, allowing the interior lumen 2456 of the guide sheath 2450 to have access to saline 350 within the saline IV bag 324. The saline 350 serves also as a lubricating fluid, so that the system 2400 is self-lubricating. The spike 336 can include a drip chamber, which also allows certain visual feedback. For example, saline in the drip chamber will drip at a higher frequency when the open distal end 1931 of the aspiration lumen 1932 is located within free flowing blood, and will drip slower when the open distal end 1931 is adjacent to or within thrombus, and actively aspirating and/or macerating thrombus, and will drip very little or not at all when the aspiration lumen 1932 is occluded.
In use, the distal end 2451 of the guide sheath 2450 in placed within the blood vessel 1999 via an external puncture or cutdown. For example, via a femoral artery or radial artery. The aspiration catheter 1930 is placed through the guide sheath 2450 and the distal end 1997 of the aspiration catheter 1930 is tracked (e.g., over a guidewire 1902) to a location adjacent a thrombus 1995. The guidewire 1902, if used, may be removed from the aspiration catheter 1930, may be partially retracted, or may be left in place. With the hydraulic connections of FIG. 1 completed, the piston pump 305 is operated to inject high pressure saline through the high-pressure injection lumen 1934, and aspiration is performed through the aspiration lumen 1932 via the evacuated syringe 2049. The pump 305 delivers the high pressure fluid (e.g., saline) through the high-pressure injection lumen 1934 at an injection flow rate FR₁. The negative pressure P_Ninside the evacuated syringe 2049 creates, independent of the injection flow rate FR₁, a potential aspiration flow rate FR₂(e.g., the intended aspiration capacity from purely negative pressure application). With both the negative pressure P_Napplied and the injection flow rate FR₁applied, a total potential flow rate FR₃is defined by the equation:
FR ₃ =FR ₁ +FR ₂
The actual flow rate of the blood/thrombus being aspirated from the blood vessel 1999 may likely be less than the total potential flow rate FR₃. But in certain cases, the total potential flow rate FR₃is significantly decreased. For example, if the thrombus 1995 creates a significant occlusion within the blood vessel 1999, and if much or all of the blood or flowable macerated thrombus has been aspirated from the area of interest, there may not be sufficiently enough flowable material adjacent the thrombus 1995 to allow sufficient flow through the aspiration lumen 1932 of the aspiration catheter 1930, even if the aspiration lumen 1932 is not occluded. Thus, a significantly active flowing condition is not present to the extent that new portions of the thrombus 1995 may be sucked inside the open distal end 1931 of the aspiration lumen 1932. In some embodiments, the injection flow rate FR₁is configured to be between about 15 ml/min and about 50 ml/min, or between about 20 ml/min and about 40 ml/min, or between about 25 ml/min and about 35 ml/min. In some embodiments, the potential aspiration flow rate FR₂is configured to be between about 150 ml/min and about 600 ml/min, or between about 300 ml/min and 600 ml/min. or between about 350 ml/min and about 500 ml/min. With the rotatable valve 346 in the position of FIG. 1 , the interior lumen 2456 of the guide sheath 2450 is capable of allowing additional saline 350 from the saline IV bag 324 to flow into space 1994 adjacent the thrombus 1995, and adjacent the open distal end 1931 of the aspiration lumen 1932. The new bolus of injected/infused fluid can increase the flowable volume in the space 1994 and can reduce the bulk viscosity of saline/blood/thrombus. The initiation of aspiration at the target thrombus site and entry into the aspiration lumen 1932 of the aspiration catheter 1930 is facilitated. Once the somewhat diluted thrombus begins to flow through the aspiration lumen 1932, the aspiration procedure tends to continue, as it is now in a dynamic state, instead of an initially static state. Thus, changing pressure gradients have caused saline 350 from the saline IV bag 324 to be pulled into the space 1994 automatically, because the pressure inside the saline IV bag 324 is greater than the pressure in the space 1994. Once aspiration flow is recovered and the aspiration of thrombus through the aspiration lumen 1932 resumes, the pressure gradient decreases, and less saline 350 from the saline IV bag 324 will be pulled into the space 1994 in the blood vessel 1999, adjacent the thrombus 1995, again, automatically. The on/off nature of the flow from the saline IV bag 324 and through the interior lumen 2456 of the guide sheath is pressure gradient controlled, and can occur automatically, in order to maintain an active aspiration of thrombus 1995. In the alternative, in the case of a completely clogged aspiration lumen 1932, the actual aspiration flow rate becomes zero. If the actual aspiration flow rate becomes less than the actual injection flow rate, then some injected fluid (saline, etc.) will likely be injected into the blood vessel. This may have negative consequences, such as blood vessel damage, uncontrolled vessel distension, or potentially dangerous thrombus dislodgement. The automatic control of additional injected saline, as described, serves to create an optimized volume during the procedure, analogous in some manner to the cutting fluid that is used in machining of metals. Viscosity is optimized for efficient jet application on the thrombus and aspiration flow.
Additional advantages related to the use of the syringe 312 containing contrast media 314 are described in relation to FIG. 4 . The rotatable valve 346 has been turned by the user so that the projection 348 points toward the second luer 342, thus closing off access of the saline IV bag 324 and opening access to the syringe 312 containing contrast media 314. Now, when performing the aspiration procedure in the identical manner as that described in relation to FIG. 1 , any changes in pressure gradient or changes in available flowable material that cause fluid to flow from proximal to distal through the interior lumen 2456 of the guide sheath 2450, will now pull contrast media 314 from the syringe 312 into the interior lumen 2456 and deliver it into the space 1994. Thus, upon monitoring the procedure by fluoroscopy (e.g., when stepping on the fluoroscopy pedal), injected contrast media 1993, because of its radiopacity, is visible to the user when this change in flow characteristics occurs. The user, thereby receives a visual feedback (e.g., a warning) on fluoroscopy, when key changes to the aspiration process occur. Thus, the status of flow is known by the user. The user is also able to see a maceration zone around the distal end 1997 of the aspiration catheter 1930. The contrast media 1993 itself can improve the aspiration as did the saline, by adding flowable volume and decreasing viscosity (in comparison to thrombus or blood, for example, depending on the particular contrast media, and/or any dilution utilized). However, in many cases, it is desired to control the total amount of contrast media injected during a procedure, to protect the patient's kidneys by reducing the burden on them. Thus, the user may switch the rotatable valve 346 into the position of FIG. 1 , to allow saline 350 to be pulled through the interior lumen 2456 of the guide sheath 2450 and into the blood vessel 1999 when the system is in the particular pressure or volume change state. The user may choose to change back and forth between the rotatable valve 346 position of FIG. 1 and of the rotatable valve 346 position of FIG. 4 . In alternative embodiments, the plunger 318 of the syringe 312 may be coupled to a mechanical or optical sensor, such as an encoder or linear encoder, that activates an alarm when the plunger 318 moves in relation to the barrel 316. An automated rotating device may even be coupled to the rotatable valve 346 and feedback may be applied by a controller 303, so that sensed movement of the plunger 318 in relation to the barrel 316 greater than a certain distance, greater than a certain velocity, or greater than a certain acceleration cause the rotatable valve 346 to be rotated from the position in FIG. 1 , to the position in FIG. 4 . This feedback may even be used to activate the fluoroscopy unit, so that the flow of contrast media 314 entering the blood vessel 1999 is immediately shown to the user on the fluoroscopy monitor. The majority of the contrast media 314 entering the blood vessel 1999 would be expected to very low when the aspiration procedure is correctly functioning (no clogs, sufficient flowable material), because any or most of the contrast media 314 injected into the blood vessel 1999 would be aspirated into the aspiration lumen 1932. Thus, the risk of high volumes of contrast added to the blood volume is significantly reduced. Also, with this technique the attending physician would likely not need to check the area of interest for flow (e.g., using angiograms or venograms) as often, thus, further minimizing contrast media 314 injected into the bloodstream of the patient. The method described herein is more efficient and faster than having to stop and “puff” some contrast intermittently. The user may also be able to visualize on fluoroscopy the contrast media 314 specifically moving from the interior lumen 2456 of the guide sheath 2450 to the open distal end 1931 of the aspiration lumen 1930.
FIG. 5 illustrates the system for aspirating thrombus 2400 with the rotatable valve 346 in the same position as in FIG. 4 , but with the open distal end 1931 of the aspiration lumen 1932 of the aspiration catheter 1930 pulled back to that it is entirely within the interior lumen 2456 of the guide sheath 2450. Alternatively, the guide sheath 2450 may be moved distally in longitudinal relation to the aspiration catheter 2450, or they both may be adjusted in relative longitudinal relation. A diagnostic method for assessment of system operation is described in relation to FIG. 5 . The user may pull the distal end 1997 of the aspiration catheter 1930 fully into the guide sheath 2450 in this manner, a bit like a turtle pulls its head into its shell, in order to determine particular diagnostics related to the aspiration procedure. In some cases, the aspiration catheter 1930 is pulled back so that the open distal end 1931 of the aspiration lumen 1932 is at least 1 mm within the guide sheath 2450, or at least 2 mm, or at least 3 mm, or at least 4 mm, or at least 5 mm, or at least 6 mm, or at least 7 mm, or at least 8 mm, or at least 9 mm, or at least 10 mm. In some cases, the aspiration catheter 1930 is pulled back so that the open distal end 1931 of the aspiration lumen 1932 is between about 1 mm and about 30 mm within the guide sheath 2450. In some cases, the aspiration catheter 1930 is pulled back so that the open distal end 1931 of the aspiration lumen 1932 is between about 1 mm and about 15 mm within the guide sheath 2450. If the aspiration lumen 1932 is patent, and the contrast media 314 is able to be aspirated through the aspiration lumen 1932, then contrast media 314 will continue being pulled through the interior lumen 2456 of the guide sheath 2450 from proximal to distal, and will be pulled into the open distal end 1931 of the aspiration lumen 1932 (curved arrow, FIG. 6 ) and through the aspiration lumen 1932 proximal to distal. The plunger 318 of the syringe 312 will be seen by the user contracting into the barrel 316 of the syringe 312 (right to left in FIG. 5 ). If, however, the aspiration lumen 1932 of the aspiration catheter 1930 is clogged with relatively hard thrombus or one or more other materials, a non-aspiration condition will be demonstrated. The plunger 318 of the syringe 312 will not move in relation to the barrel 316 of the syringe 312. If there is an occlusion of the aspiration lumen 1932, the user is notified by the movement or lack of movement of the plunger 318, and will likely change out the aspiration catheter 1930 for another, or remove the aspiration catheter 1930 and declog the aspiration lumen 1932, for example by a hand injection with a small bore syringe, retrograde (proximal to distal) through the aspiration lumen 1932. Again, in other embodiments, mechanical or optical sensing may be used to automatically determine whether the plunger 318 is moving in relation to the barrel 316 or not, and an alarm or indicator may be broadcast to the user (audible, visual, tactile).
With the advantages of the retrograde flow through the guide sheath 2450, a significantly empty clot bed can fill itself to allow the thrombus 1995 to move, or come in contact with or be closer to the open distal end 1931 of the aspiration lumen 1932. The blood vessel wall can also be distended somewhat, allowing a larger volume of saline and blood within, the further aid the aspiration of thrombus. Using the contrast media 314, real-time visualization can be performed during manipulation (positioning/advancement/retraction) of the aspiration catheter 1930, and of the guide sheath 2450. The plunger 318 can be manually compressed to inject puffs of contrast media 314. Additionally, downstream drug migration can be minimized, if using “clot-busting” drugs injected through or mixed with the saline that is injected through the high pressure injection lumen 1934, because the periods of injection without aspiration (when the aspiration lumen 1932 is blocked) are minimized. Drug may include a lytic agent such as tPA (tissue plasminogen activator) or urokinase. The active use of the lytic agent can actually be more efficient, as less is wasted, and more is delivered to the appropriate target area of action. The lytic agent is delivered to a more dynamic surface area of the thrombus 1995, and is thus more effective in its action on the thrombus 1995. In cases where an active mechanical thrombectomy device is used, the ability to receive injectate from the guide sheath 2450 can serve to cool down a heated catheter tip. Additionally, the used of the contrast media 314 aids in the delineation of the borders of the thrombus 1995. The constant available supply of fluids from the guide sheath 314, both contrast media 314 and saline 350 allow the procedure to be optimized and tailored. Blood loss from excessive aspiration of blood and not thrombus can also be reduced.
Any of the embodiments described herein may be used conjunction with the Apollo™ System (Penumbra, Inc., Alameda, Calif., USA). The aspiration catheters described herein may be replaced by any standard aspiration catheter having one or more aspiration lumens. Aspiration catheters used herein may include the ACE™ or INDIGO® catheters produced by Penumbra, Inc. of Alameda, Calif., USA. The user may pull the distal end 1997 of the aspiration catheter 1930 fully into the guide sheath 2450 to mimic the separator device used in conjunction with the ACE™ or INDIGO® catheters. The coaxially placed tubes/shafts of the guide sheath 2450 and the aspiration catheter 1930 can be moved back and forth longitudinally in relation to each other to create additional shearing of any thrombus in the area, to further macerate the thrombus, or to reposition the thrombus in a more strategically aligned location.
In some instances, a degree of MRI compatibility may be imparted into parts of the devices described herein. For example, to enhance compatibility with Magnetic Resonance Imaging (MRI) machines, it may be desirable to make various portions of the devices described herein from materials that do not substantially distort MRI images or cause substantial artifacts (gaps in the images). Some ferromagnetic materials, for example, may not be suitable as they may create artifacts in an MRI image. In some cases, the devices described herein may include materials that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobaltchromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.
In some instances, some of the devices described herein may include a coating such as a lubricious coating or a hydrophilic coating. Hydrophobic coatings such as fluoropolymers provide a dry lubricity. Lubricious coatings improve steerability and improve lesion crossing capability. Suitable lubricious polymers are well known in the art and may include silicone and the like, hydrophilic polymers such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinylpyrrolidones, polyvinylalcohols, hydroxy alkyl cellulosics, algins, saccharides, caprolactones, and the like, and mixtures and combinations thereof. Hydrophilic polymers may be blended among themselves or with formulated amounts of water insoluble compounds (including some polymers) to yield coatings with suitable lubricity, bonding, and solubility.
It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. The scope of the disclosure is, of course, defined in the language in which the appended claims are expressed.
While embodiments of the present disclosure have been shown and described, various modifications may be made without departing from the scope of the present disclosure. Embodiments of the present disclosure are contemplated to have utility in a variety of blood vessels, including but not limited to coronary arteries, carotid arteries, intracranial/cerebral arteries, inferior and superior vena cavae and other veins (for example, in cases of deep venous thrombosis or pulmonary embolism), peripheral arteries, shunts, grafts, vascular defects, and chambers of the heart. This includes, but is not limited to, any vessel having a diameter of bout two mm or greater. An aspiration catheter 1930 outer diameter of about seven French or less is contemplated for many of the applications, though in certain applications, it may be larger. In some embodiments, an aspiration catheter 1930 diameter of about six French or less is contemplated. Embodiments of the present disclosure may even be used in non-vascular applications, for example body lumens or cavities having material accumulations that need to be macerated and/or removed.
It is contemplated that various combinations or subcombinations 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.

Claims

What is claimed is:

1. 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 the shaft; and

an opening at or near the distal end of the 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 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 distal end of the supply lumen;

a sheath having a proximal end, a distal end and a lumen extending between the proximal end and the distal end, the lumen configured for placement of the aspiration catheter therethrough.

2. The system of claim 1, wherein the sheath further comprises an extension conduit in fluid communication with the lumen of the sheath and extending from the sheath, the extension conduit configured for coupling to a second fluid source

3. The system of claim 2, wherein the second fluid source comprises a contrast agent.

4. The system of claim 2, wherein the second fluid source further comprises a syringe having a barrel and a plunger longitudinally movable within the barrel, the barrel configured to contain the contrast agent.

5. The system of claim 2, wherein the second fluid source does not comprise a substantial amount of contrast agent.

6. The system of claim 2, wherein the extension conduit is hydraulically coupled to a valve having a first position configured to selectively couple the extension conduit to a third fluid source comprising a contrast agent and a second position configured to selectively couple the extension conduit to the second fluid source.

7. The system of claim 6, wherein the second fluid source comprises a saline bag.

8. The system of claim 6, wherein the second fluid source comprises a pressure bag configured to compress a saline bag.

9. 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 the shaft, the supply lumen having a proximal end and a distal end, and the aspiration lumen having a proximal end and an open distal end; and

10. The system of claim 9, wherein the sheath further comprises an extension conduit in fluid communication with the lumen of the sheath and extending from the sheath, the extension conduit configured for coupling to a second fluid source

11. The system of claim 10, wherein the second fluid source comprises a contrast agent.

12. The system of claim 10, wherein the second fluid source further comprises a syringe having a barrel and a plunger longitudinally movable within the barrel, the barrel configured to contain the contrast agent.

13. The system of claim 10, wherein the second fluid source does not comprise a substantial amount of contrast agent.

14. The system of claim 10, wherein the extension conduit is hydraulically coupled to a valve having a first position configured to selectively couple the extension conduit to a third fluid source comprising a contrast agent and a second position configured to selectively couple the extension conduit to the second fluid source.

15. The system of claim 14, wherein the second fluid source comprises a saline bag.

16. The system of claim 14, wherein the second fluid source comprises a pressure bag configured to compress a saline bag.

17. A system for aspirating thrombus, comprising:

an aspiration catheter comprising:

an elongate shaft configured for placement within a blood vessel of a subject;

a sheath having a proximal end, a distal end and a lumen extending between the proximal end and the distal end, the lumen configured for placement of the aspiration catheter therethrough, the sheath further comprising an extension conduit in fluid communication with the lumen of the sheath and extending from the sheath, the extension conduit configured for coupling to a second fluid source;

a seal associated with the proximal end of the sheath and configured to seal the lumen of the sheath around the elongate shaft of the aspiration catheter when the aspiration catheter is in place within the sheath; and

wherein the extension conduit is configured to allow fluid from the second fluid source to flow through the lumen of the sheath from the proximal end of the sheath to the distal end of the sheath when the open distal end of the aspiration lumen of the aspiration catheter is extended outside of the lumen of the sheath in a blood vessel and is in proximity to the distal end of the sheath, and when insufficient flowable material is present adjacent the open distal end of the aspiration lumen, such that a negative pressure gradient supplied by the vacuum source further causes a significant volume of the fluid from the second fluid source to actively flow through the aspiration lumen from the open distal end to the proximal end and into an interior of the vacuum source.

18. The system of claim 17, wherein the second fluid source further comprises a syringe having a barrel and a plunger longitudinally movable within the barrel, the barrel configured to contain a contrast agent.

19. The system of claim 17, wherein the extension conduit is hydraulically coupled to a valve having a first position configured to selectively couple the extension conduit to a third fluid source comprising a contrast agent and a second position configured to selectively couple the extension conduit to the second fluid source.

20. The system of claim 19, wherein the second fluid source comprises a pressure bag configured to compress a saline bag.