BACKGROUND OF THE INVENTION

Field 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.

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. Flushing devices also include high pressure flushing devices that macerate the thrombus and then, using a vortex created by the high pressure fluid, transport the emulsified thrombotic material to a collection bag. These devices are effective at removing all levels of thrombotic material, but the pressure created by the device is so great that its action against certain vessel walls may interrupt the heart muscle stimulation mechanism and create a bradycardia event in certain patients, sometimes requiring that a pacing lead be placed in the patient prior to use. Further, interacting with the thrombotic material outside of the catheter may allow loose material to escape the capture mechanism.

SUMMARY OF THE INVENTION

In one embodiment of the present disclosure, a system for aspirating thrombus and delivering an agent includes an aspiration catheter having a supply lumen and an aspiration lumen, the supply lumen having a proximal end, a distal end, and a wall, the aspiration lumen having a proximal end, an open distal end, and an interior wall surface adjacent the open distal end, and at least one orifice at or adjacent the distal end of the supply lumen, in fluid communication with the aspiration lumen, the at least one orifice located proximally of the open distal end of the aspiration lumen, wherein the at least one orifice is configured to create a spray pattern when pressurized fluid is pumped through the supply lumen such that the spray pattern is caused to impinge on the interior wall surface of the aspiration lumen when a distal end of the aspiration catheter is immersed within an aqueous environment, and such that the spray pattern upon impinging on the interior wall surface is caused to transform into at least a substantially distally-oriented flow capable of exiting the open distal end of the aspiration lumen.

In another embodiment of the present disclosure, a method for delivering an agent includes providing an aspiration catheter having a proximal end and a distal end and including a supply lumen having a proximal end, a distal end, and a wall, an aspiration lumen having a proximal end, an open distal end, and an interior wall surface adjacent the open distal end, and at least one orifice at or adjacent the distal end of the supply lumen, in fluid communication with the aspiration lumen, the at least one orifice located proximally of the open distal end of the aspiration lumen, wherein the at least one orifice is configured to create a spray pattern when pressurized fluid is pumped through the supply lumen, inserting the distal end of the aspiration catheter into a blood vessel such that the open distal end of the aspiration lumen is adjacent a thrombus, and injecting an agent through the supply lumen such that the spray pattern of the agent generally flows in a first direction out of the at least one orifice and against the interior wall surface of the aspiration lumen, whereby after the spray pattern of the agent reaches the interior wall surface of the aspiration lumen the majority of the spray pattern of the agent flows in a second direction distally out the open end of the aspiration lumen and adjacent the thrombus, wherein the second direction is different from the first direction.

In yet another embodiment of the present disclosure, a method for visualizing a thrombectomy process includes providing an aspiration catheter having a supply lumen and an aspiration lumen, the supply lumen having a distal end and a wall, the aspiration lumen having an open distal end and an interior wall surface, an orifice adjacent the distal end of the supply lumen, in fluid communication with the interior of the aspiration lumen, the orifice located proximally of the open distal end of the aspiration lumen, inserting the distal end of the aspiration catheter into a blood vessel such that the open distal end of the aspiration lumen is adjacent a thrombus, injecting fluid including a radiopaque contrast media through the supply lumen while visualizing a radiographic or fluoroscopic image, and identifying a boundary of the thrombus.

In still another embodiment of the present disclosure, a system for aspirating thrombus includes an aspiration catheter having a supply lumen and an aspiration lumen, the supply lumen having a distal end and a wall, the aspiration lumen having an open distal end and an interior wall surface, an orifice adjacent the distal end of the supply lumen, in fluid communication with the interior of the aspiration lumen, the orifice located proximally of the open distal end of the aspiration lumen, wherein the orifice is configured to create a spray pattern when pressurized fluid is pumped through the supply lumen, and a mandrel having a proximal end and a distal end, the distal end including a curve greater than 90°, and including a concave portion configured to engage a distal end of the aspiration catheter, wherein the orifice is translatable in a transverse direction to a longitudinal axis of the aspiration catheter by traction applied on the mandrel.

In yet another embodiment of the present disclosure, a system for aspirating thrombus includes an aspiration catheter having a supply lumen and an aspiration lumen, the supply lumen having a distal end and a wall, the aspiration lumen having an open distal end and an interior wall surface, an orifice adjacent the distal end of the supply lumen, in fluid communication with the interior of the aspiration lumen, the orifice located proximally of the open distal end of the aspiration lumen, wherein the orifice is configured to create a spray pattern when pressurized fluid is pumped through the supply lumen such that the spray pattern impinges on the interior wall surface of the aspiration lumen when a distal end of the aspiration catheter is immersed within an aqueous environment, and an elongate wire having a proximal end and a distal end, the distal end including an enlarged portion, wherein the elongate wire is configured to be rotatable such that the enlarged portion is capable of disrupting at least a portion of a thrombus.

In still another embodiment of the present disclosure, a system for removing intracranial blood or thrombus includes a probe having a supply channel and an aspiration channel, the aspiration channel having a distal end and a proximal end, the supply channel having a distal end and a wall, the aspiration channel having an opening at or adjacent its distal end and an interior wall surface, an orifice adjacent the distal end of the supply channel and in fluid communication with the interior of the aspiration channel, wherein the orifice is configured to create a spray pattern when pressurized fluid is pumped through the supply channel such that the spray pattern impinges on the interior wall surface of the aspiration channel, and an ultrasound device at or adjacent the opening of the aspiration channel, and configured to operate at a frequency of between about 1 kHz and about 20 MHz.

In yet another embodiment of the present disclosure, a method for removing intracranial blood or thrombus from a patient includes placing an introducer through an aperture formed in the patient's skull, placing a trocar through the introducer, advancing an ultrasound device through the trocar to a treatment location within the intracranial space, transmitting ultrasound energy at one or more frequencies between about 1 kHz and about 20 MHz from the ultrasound device, and removing the blood or thrombus from the patient through a probe having a supply channel and an aspiration channel, the aspiration channel having a distal end and a proximal end, the supply channel having a distal end and a wall, the aspiration channel having an opening at or adjacent its distal end and an interior wall surface, an orifice adjacent the distal end of the supply channel and in fluid communication with the interior of the aspiration channel, wherein the orifice is configured to create a spray pattern when pressurized fluid is pumped through the supply channel such that the spray pattern impinges on the interior wall surface of the aspiration channel, wherein the blood or thrombus is removed through the aspiration channel.

