Systems and methods for removal of blood and thrombotic material

Abstract

To provide a system for aspirating a thrombus, the system including an aspiration catheter including: a supply lumen and an aspiration lumen each extending within an elongate shaft; and an opening at or near a 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 pumped through the supply lumen.SOLUTION: A system also includes: a tubing set including tubing, the tubing set having a distal end configured to couple to an aspiration lumen of the aspiration catheter and a proximal end configured to couple to a vacuum source; a tubing compression element configured to externally engage the tubing of the tubing set; and an activation interface configured to activate the tubing compression element to compress the tubing at a location between the proximal end of the tubing set and the distal end of the tubing set.SELECTED DRAWING: Figure 64

Description

[Technical field]

[0001]

[0001] The present disclosure relates to medical devices and methods of use thereof. More particularly, the present invention relates to aspiration and thrombus removal devices and methods of use thereof. [Background technology]

[0002]

[0002] Several devices and systems already exist to aid in the removal of thrombotic material, including simple suction tube devices that use a vacuum syringe to aspirate the thrombus into the syringe, simple flushing and aspirating devices, more complex devices that use a mechanical auger and include rotating components to pull, soften, and transport the thrombotic material away from the distal tip, and systems that use very high pressure to create a Venturi effect to flush away the softened material from the thrombus.

[0003]

[0003] All of the above mentioned devices have limitations as a result of their respective design characteristics. For example, simple aspiration catheters offer ease of use and rapid deployment, but can become blocked or otherwise inoperable when faced with older, more organized thrombotic material. Such devices must be removed, washed outside the body, and then reinserted into the vascular system, thereby extending the time required for the procedure and increasing the likelihood of kinking of the catheter shaft. Such kinking can reduce performance by reducing the cross-sectional area of ​​the catheter, or render the device unusable.

[0004]

[0004] Mechanical rotation devices use an auger to grab the thrombus and move it away from the target area. Some devices generate the moving force through a vacuum bottle, while others generate a pressure differential at the distal tip of the device through the auger acting as a low pressure pump. These devices typically operate slowly and do not provide any feedback to the physician as to when it is time to advance the device further into the lesion.

[0005]

[0005] Flushing-type devices include manual flushing-type devices in which the physician operates a manually driven pump to provide saline flow to the tip of the device for breaking up and aspirating thrombotic material, which can introduce performance variations based on the physician's ability to pump the device consistently throughout the entire procedure. Flushing devices further include high-pressure flushing devices that soften the clot and then transport the emulsified thrombotic material to a collection bag using a vortex flow generated by high pressure. These devices are effective in removing all levels of thrombotic material, but the pressure generated by the device is so great that its action on certain vessel walls can interfere with the myocardial stimulation mechanism and cause bradycardia events in certain patients, sometimes requiring that a pacing lead be placed in the patient's body prior to use. Furthermore, interaction with thrombotic material outside the catheter can allow the liberated material to escape the capture mechanism. Summary of the Invention

[0006]

[0006] In one embodiment of the present disclosure, a system for aspirating a thrombus includes an aspiration catheter comprising an elongate shaft configured for placement within a patient's blood vessel, a supply lumen having a proximal end and a distal end and an aspiration lumen having a proximal end and an open distal end, each extending within the shaft, and an opening at or near the distal end of the supply lumen configured to allow pressurized fluid to be pumped through the supply lumen to inject pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen, the opening being configured to permit injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen when pressurized fluid is pumped through the supply lumen; a tube set comprising a tube, the tube set having a distal end configured to be coupled to the aspiration lumen of the aspiration catheter and a proximal end configured to be coupled to a vacuum source; a tube compression element configured to externally engage a tube of the tube set at a location between the proximal end of the tube set and the distal end of the tube set; and an actuation interface configured to actuate the tube compression element to compress the tube at a location between the proximal end of the tube set and the distal end of the tube set.

[0007]

[0007] In another embodiment of the present disclosure, a system for aspirating thrombi is an aspiration catheter comprising an elongate shaft configured for placement within a patient's blood vessel, a supply lumen having a proximal end and a distal end, each extending within the shaft, and an aspiration lumen having a proximal end and an open distal end, and an opening in a wall separating the supply lumen and the aspiration lumen, at or adjacent the distal end of the supply lumen and in fluid communication with the interior of the aspiration lumen, located proximal to the open distal end of the aspiration lumen, the opening configured to generate a jet when pressurized fluid is pumped through the supply lumen of the aspiration catheter. The device comprises a catheter, a pressure sensor in fluid communication with the suction lumen of the suction catheter and configured to output a signal indicative of the measured pressure, a tube set comprising a tube extending proximally from the pressure sensor and configured to be in fluid communication with the suction lumen of the suction catheter and having a proximal end configured to be coupled to a vacuum source, a tube compression element configured to externally engage a tube of the tube set at a location between the proximal end of the tube set and the pressure sensor, and an actuation interface configured to actuate the tube compression element to compress the tube at a location between the proximal end and the pressure sensor.

[0008]

[0008] In yet another embodiment of the present disclosure, a system for aspirating a thrombus is an aspiration catheter comprising an elongate shaft configured for placement within a patient's blood vessel, a supply lumen having a proximal end and a distal end, each extending within the shaft, and an aspiration lumen having a proximal end and an open distal end, and a pressure adjusting device at or near the distal end of the supply lumen such that when pressurized fluid is pumped through the supply lumen, the pressure adjusting device at or near the distal end of the aspiration lumen allows for injection of pressurized fluid into the aspiration lumen. the pressure sensor in fluid communication with the aspiration lumen of the aspiration catheter and configured to output a signal indicative of the measured pressure; a tube set comprising a tube extending proximally from the pressure sensor and configured to be in fluid communication with the aspiration lumen of the aspiration catheter and having a proximal end configured to couple to a vacuum source; a tube compression element configured to externally engage a tube of the tube set at a location between the proximal end of the tube set and the pressure sensor; and an actuation interface configured to actuate the tube compression element to compress the tube at a location between the proximal end and the pressure sensor.

[0009]

[0009] In yet another embodiment of the present disclosure, a system for aspirating thrombi includes an aspiration catheter comprising: a supply lumen having a proximal end and a distal end; and an aspiration lumen having a proximal end and an open distal end; an opening at or adjacent the distal end of the supply lumen and fluidly connected to the interior of the aspiration lumen and located proximal to the open distal end of the aspiration lumen, the opening configured to generate a jet when pressurized fluid is pumped through the supply lumen; a connector hydraulically coupled to the proximal end of the aspiration lumen and having an internal cavity, a proximal end, and a distal end; and a pressure sensor disposed within the internal cavity of the connector, and a measurement device configured to receive a signal from the pressure sensor.

[0010]

[0010] In yet another embodiment of the present disclosure, a system for aspirating thrombi includes an aspiration catheter comprising a supply lumen having a proximal end and a distal end and an aspiration lumen having a proximal end and an open distal end, an opening at or adjacent the distal end of the supply lumen and fluidly connected to the interior of the aspiration lumen and located proximal to the open distal end of the aspiration lumen, the opening being configured to generate a jet when pressurized fluid is pumped through the supply lumen, and a connector hydraulically coupled to the proximal end of the aspiration lumen and having an internal cavity, a proximal end, and a distal end, the opening comprising a slit in a wall of a tubular structure surrounding the supply lumen.

[0011]

[0011] In yet another embodiment of the present disclosure, a method for removing a blood clot from a patient includes an aspirator comprising: a supply lumen having a proximal end and a distal end; an aspiration lumen having a proximal end and an open distal end; an opening at or adjacent the distal end of the supply lumen and in fluid communication with the interior of the aspiration lumen and disposed proximal to the open distal end of the aspiration lumen, the opening configured to generate a jet when pressurized fluid is pumped through the supply lumen; a connector hydraulically coupled to the proximal end of the aspiration lumen, the connector having an internal cavity, a proximal end, and a distal end; and a pressure sensor coupled to the proximal end of the supply lumen. The method includes providing a suction catheter; coupling or causing a coupling to a supply lumen of the suction catheter to a fluid source; coupling or causing a coupling to the suction lumen of the suction catheter to a vacuum source; coupling or causing a coupling to a pump that injects fluid from the fluid source, through the supply lumen and through the opening into the suction lumen; providing a control unit configured to adjust settings of the pump; and setting the pump with the control unit such that an input pressure to the supply lumen is between about 650 pounds per square inch and about 1200 pounds per square inch.

[0012]

[0012] In yet another embodiment of the present disclosure, a system for aspirating a thrombus includes a supply lumen having a proximal end and a distal end and an aspiration lumen having a proximal end and an open distal end, an opening at or adjacent the distal end of the supply lumen and in fluid communication with the interior of the aspiration lumen and located proximal to the open distal end of the aspiration lumen, the opening being configured to generate a jet when pressurized fluid is pumped through the supply lumen, and a connector hydraulically coupled to the proximal end of the aspiration lumen, the connector having an internal cavity having an inner surface, a proximal end, and a distal end, in communication with the internal cavity of the connector and configured to couple to an aspiration catheter. The suction catheter includes a connector having a first side port in fluid communication with the suction lumen of the catheter, the first side port having a significant interruption of the inner surface proximate a distal end of the connector.

[0013] In yet another embodiment of the present disclosure, a method for removing a thrombus from a patient includes the steps of providing an aspiration catheter comprising a supply lumen having a proximal end and a distal end and an aspiration lumen having a proximal end and an open distal end, an opening at or adjacent the distal end of the supply lumen and in fluid communication with an interior of the aspiration lumen and disposed proximal to the open distal end of the aspiration lumen, the opening configured to generate a jet when pressurized fluid is pumped through the supply lumen, and a connector hydraulically coupled to the proximal end of the aspiration lumen and having an internal cavity, a proximal end, and a distal end; placing a distal end of a guiding catheter into a blood vessel, the guiding catheter having an internal lumen configured for placing the aspiration catheter therein; and positioning the distal end of the guiding catheter adjacent the thrombus. the step of placing an aspiration catheter in the blood vessel through the inner lumen of the guiding catheter so as to contact the blood vessel; coupling or causing a coupling of the supply lumen of the aspiration catheter to a fluid source; coupling or causing a coupling of the aspiration lumen of the aspiration catheter to a vacuum source; coupling or causing a coupling of a first pump that injects fluid from the fluid source through the supply lumen and through the opening into the aspiration lumen; causing an injection of fluid from the fluid source through the supply lumen of the aspiration catheter via the first pump while the vacuum source is actively coupled to the aspiration lumen; determining that aspiration of thrombus through the aspiration lumen of the aspiration catheter is not occurring at a desired thrombus aspiration rate; and injecting an infusate into the blood vessel through the inner lumen of the guiding catheter to increase the thrombus aspiration rate.

[0014]

[0014] In yet another embodiment of the present disclosure, a method for removing a blood clot from a patient includes the steps of providing a suction catheter comprising a supply lumen having a proximal end and a distal end and an aspiration lumen having a proximal end and an open distal end, an opening at or adjacent the distal end of the supply lumen and in fluid communication with the interior of the aspiration lumen and disposed proximal to the open distal end of the aspiration lumen, the opening configured to generate a jet when pressurized fluid is pumped through the supply lumen, and a connector hydraulically coupled to the proximal end of the aspiration lumen and having an internal cavity, a proximal end, and a distal end; placing a distal end of a guiding catheter into a blood vessel, the guiding catheter having an internal lumen configured for placing the aspiration catheter therein; and positioning the distal end of the guiding catheter into the blood vessel, the guiding catheter having an internal lumen configured for placing the aspiration catheter therein. The method includes the steps of: positioning an aspiration catheter in the blood vessel through the inner lumen of the guiding catheter such that the distal end is adjacent to the thrombus; coupling or causing a coupling to the supply lumen of the aspiration catheter to a fluid source; coupling or causing a coupling to the supply lumen of the aspiration catheter to a fluid source; coupling or causing a coupling to a first pump that injects fluid from the fluid source, through the supply lumen and through the opening into the aspiration lumen; causing an injection of fluid from the fluid source through the supply lumen of the aspiration catheter via the first pump while a vacuum source is actively coupled to the aspiration lumen; determining that aspiration of the thrombus through the aspiration lumen of the aspiration catheter is not occurring at a desired thrombus aspiration rate; and rotating the guiding catheter within the blood vessel to increase the thrombus aspiration rate.

[0015] In yet another embodiment of the present disclosure, a method for removing a thrombus from a patient includes a supply lumen having a proximal end and a distal end, and an aspiration lumen having a proximal end and an open distal end, and an opening at or adjacent the distal end of the supply lumen, in fluid communication with the interior of the aspiration lumen and disposed proximal to the open distal end of the aspiration lumen, The method includes providing an aspiration catheter having an opening configured to generate a jet when pressurized fluid is pumped through the aspiration lumen, and a connector hydraulically coupled to a proximal end of the aspiration catheter, the connector having an internal cavity, a proximal end, and a distal end; positioning the aspiration catheter within the blood vessel such that the distal end of the aspiration catheter is adjacent the thrombus; coupling or causing a coupling to occur between the supply lumen of the aspiration catheter to a fluid source; coupling a first port of a four-way stopcock to the aspiration lumen of the aspiration catheter; coupling a second port of the four-way stopcock to a pressure sensor, the pressure sensor configured to transmit a signal to the controller; coupling a third port of the four-way stopcock to a vacuum source; and providing a port between the fluid source and the aspiration lumen. the step of coupling or causing a coupling of the pump; causing an infusion of fluid from the fluid source via the pump through the supply lumen of the suction catheter with the vacuum source actively coupled to the suction lumen, where the controller is configured to stop the pump when the four-way stopcock is in a first state such that the pressure sensor, the suction lumen, and the vacuum source are all in fluid communication and the pressure sensor sends a signal indicating that it is not in fluid communication with the vacuum source; and adjusting the four-way stopcock to a second state such that the pressure sensor maintains fluid communication with the vacuum source but the pressure sensor and the vacuum source are each no longer in fluid communication with the suction lumen, whereby the controller maintains operation of the pump while the suction lumen is not in fluid communication with the vacuum source.

[0016]

[0016] In yet another embodiment of the present disclosure, a first connector configured to removably couple to a proximal portion of an aspiration catheter comprising an aspiration catheter having a supply lumen having a proximal end and a distal end and an aspiration lumen having a proximal end and an open distal end, an opening at or adjacent the distal end of the supply lumen in fluid communication with an interior of the aspiration lumen and located proximal to the open distal end of the aspiration lumen, the opening configured to generate a jet when pressurized fluid is pumped through the supply lumen, and a second connector hydraulically coupled to the proximal end of the aspiration lumen and having an interior cavity. The first connector comprises a body having an interior, a distal end with a connection configured to sealably couple to the proximal end of the aspiration lumen of the aspiration catheter, a proximal end with an openable seal configured to seal over a guidewire, an aspiration port in fluid communication with the interior of the body and configured to couple to a vacuum source, and a pressure sensor in fluid communication with the interior of the body.

[0017]

[0017] In yet another embodiment of the present disclosure, a system for aspirating thrombi includes an aspiration catheter comprising: a supply lumen having a proximal end, a distal end and a wall; and an aspiration lumen having a proximal end and an open distal end; an orifice at or adjacent the distal end of the supply lumen and in fluid communication with the interior of the aspiration lumen, the orifice being positioned proximal to the open distal end of the aspiration lumen and configured to generate a jet when pressurized fluid is pumped through the supply lumen when the distal end of the aspiration catheter is immersed in an aqueous environment; and a first connector hydraulically coupled to the proximal end of the aspiration lumen; a distal connector having an internal passage and configured to hydraulically couple to the first connector, a proximal connector configured to couple to a vacuum source, and a pressure sensor comprising a valve positioned between the distal connector and the proximal connector, the valve having an open state and a closed state.

[0018] In yet another embodiment of the present disclosure, a method for removing a thrombus from a patient includes a supply lumen having a proximal end, a distal end and a wall, and an aspiration lumen having a proximal end and an open distal end, an orifice disposed at or adjacent the distal end of the supply lumen and in fluid communication with the interior of the aspiration lumen, proximal to the open distal end of the aspiration lumen, the orifice adapted to permit flow of pressure fluid through the supply lumen when the distal end of the aspiration catheter is immersed in an aqueous environment. the control circuitry is operable to receive a signal from the pressure sensor; coupling the distal connector of the pressure sensor to the first connector of the aspiration catheter; coupling the proximal connector of the pressure sensor to the vacuum source; coupling a supply lumen of the aspiration catheter to a pump having a control circuitry, the control circuitry being capable of receiving a signal from the pressure sensor; inserting at least a distal portion of the aspiration catheter into the patient's vasculature near or adjacent to the thrombus; and changing the valve from one of the open and closed states to the other of the open and closed states, such that a change in pressure can be detected by the control circuitry. [Brief description of the drawings]

[0019] [Figure 1] FIG. 1 is a schematic diagram of a system for aspirating thrombus, according to an embodiment of the present disclosure. [Diagram 2] FIG. 2 is a schematic diagram showing the proximal portion of the system for aspirating thrombus of FIG. 1 in more detail. [Diagram 3] 2 is a schematic diagram of a distal end portion of the system for aspirating thrombus of FIG. 1. [Figure 4] FIG. 13 is a plan view of disposable components of a system for aspirating thrombus according to an embodiment of the present disclosure. [Diagram 5] FIG. 5 is a detailed view of detail 5 of FIG. [Figure 6] FIG. 5 is a detailed view of detail 6 of FIG. [Figure 7] FIG. 5 is a detailed view of detail 7 of FIG. 4. [Figure 8] FIG. 5 is a detailed view of detail 8 of FIG. [Figure 9] 5 is a plan view of the distal end of the aspiration catheter of the system for aspirating thrombus of FIG. 4. [Figure 10] 10 is a cross-sectional view of FIG. 9 taken through line 10-10 as viewed inside a blood vessel. [Figure 11] FIG. 11 is a detailed view of detail 11 of FIG. [Figure 12] FIG. 2 is a perspective view of a pump base according to an embodiment of the present disclosure. [Figure 13] FIG. 13 shows that the piston of the system for aspirating thrombus is coupled to the saddle of a piston pump. [Figure 14] FIG. 10 is a cross-sectional view of the distal tip of the aspiration catheter of FIG. [Figure 15] FIG. 13 shows a cassette for coupling to a pump base. [Figure 16] FIG. 16 is a cross-sectional view of the cassette of FIG. 15. [Figure 17] FIG. 13 is a partial exploded view of the pump base of FIG. [Figure 18] 1 is a graph of pressure versus time for a piston pump. [Figure 19] FIG. 2 is a plan view of a piston and cassette of a piston pump according to an embodiment of the present disclosure. [Figure 20] 1 is a graph of pressure versus time for a piston pump. [Figure 21] FIG. 13 is a plan view of disposable components of a system for aspirating thrombus according to an embodiment of the present disclosure. [Figure 22] FIG. 22 is a detailed view of the catheter of the system for aspirating thrombus of FIG. 21. [Figure 23] FIG. 22 is a detailed view of the tubing set of the system for aspirating thrombus of FIG. 21. [Figure 24] FIG. 1 is an exploded view of a saline pump drive unit according to an embodiment of the present disclosure. [Diagram 25] FIG. 25 is an exploded view of the disposable piston pump head of the saline pump unit of FIG. 24. [Figure 26] 1 is a cross-sectional view of an aspiration catheter of a system for aspirating a thrombus inside a blood vessel according to an embodiment of the present disclosure. [Figure 27] FIG. 1 is a cross-sectional view of a catheter inside a blood vessel delivering a drug to a target site. [Figure 28] FIG. 1 is a cutaway perspective view of an aspiration catheter according to an embodiment of the present disclosure. [Figure 29] FIG. 1 is a cutaway perspective view of an aspiration catheter according to an embodiment of the present disclosure. [Diagram 30] FIG. 1 is a cutaway perspective view of an aspiration catheter according to an embodiment of the present disclosure. [Diagram 31] FIG. 1 is a cutaway perspective view of an aspiration catheter according to an embodiment of the present disclosure. [Diagram 32] FIG. 29 is a cutaway perspective view of the aspiration catheter of FIG. 28 with a large negative pressure applied to the aspiration lumen. [Diagram 33] FIG. 30 is a cutaway perspective view of the aspiration catheter of FIG. 29 with a large negative pressure applied to the aspiration lumen. [Diagram 34] FIG. 31 is a cutaway perspective view of the aspiration catheter of FIG. 30 with a large negative pressure applied to the aspiration lumen. [Diagram 35] FIG. 32 is a cutaway perspective view of the aspiration catheter of FIG. 31 with a large negative pressure applied to the aspiration lumen. [Diagram 36] FIG. 29 is a partial cutaway perspective view of the aspiration catheter of FIG. 28 with little or no negative pressure applied to the aspiration lumen. [Figure 37] FIG. 30 is a partial cutaway perspective view of the aspiration catheter of FIG. 29 with little or no negative pressure applied to the aspiration lumen. [Figure 38] FIG. 31 is a cutaway perspective view of the aspiration catheter of FIG. 30 with little or no negative pressure applied to the aspiration lumen. [Figure 39] FIG. 32 is a cutaway perspective view of the aspiration catheter of FIG. 31 with little or no negative pressure applied to the aspiration lumen. [Diagram 40] 29 is a cutaway perspective view of the aspiration catheter of FIG. 28 with a particular negative pressure applied to the aspiration lumen. [Diagram 41] FIG. 31 is a cutaway perspective view of the aspiration catheter of FIG. 30 with a particular negative pressure applied to the aspiration lumen. [Diagram 42] FIG. 1 is a cutaway perspective view of an aspiration catheter according to an embodiment of the present disclosure. [Diagram 43] FIG. 1 is a cutaway perspective view of an aspiration catheter according to an embodiment of the present disclosure. [Figure 44A] FIG. 1 is an end view of an aspiration catheter according to an embodiment of the present disclosure. [Figure 44B] FIG. 1 is a longitudinal cross-sectional view of an aspiration catheter according to an embodiment of the present disclosure. [Figure 45A] FIG. 1 is an end view of an aspiration catheter according to an embodiment of the present disclosure. [Figure 45B] FIG. 1 is a longitudinal cross-sectional view of an aspiration catheter according to an embodiment of the present disclosure. [Figure 46A] FIG. 1 is a longitudinal cross-sectional view of an aspiration catheter in a first state according to an embodiment of the present disclosure. [Figure 46B] FIG. 46B is a longitudinal cross-sectional view of the aspiration catheter of FIG. 46A in a second condition according to an embodiment of the present disclosure. [Figure 47] 1 is a cross-sectional view of a spray pattern of a suction catheter according to an embodiment of the present disclosure. [Figure 48] 1 is a cross-sectional view of a spray pattern of a suction catheter according to an embodiment of the present disclosure. [Figure 49] FIG. 1 is a partial cutaway view of a spray pattern of an aspiration catheter according to an embodiment of the present disclosure. [Figure 50] FIG. 1 is a partial cutaway view of a spray pattern of an aspiration catheter according to an embodiment of the present disclosure. [Figure 51] FIG. 1 is a partial cutaway view of a spray pattern of an aspiration catheter according to an embodiment of the present disclosure. [Figure 52] 1 is a cross-sectional view of a spray pattern of a suction catheter according to an embodiment of the present disclosure. [Figure 53] FIG. 1 is a cross-sectional view of a thrombus / blood clot being treated with an aspiration catheter according to an embodiment of the present disclosure. [Figure 54] FIG. 13 is another cross-sectional view of a thrombus / blood clot being treated with an aspiration catheter according to an embodiment of the present disclosure. [Figure 55] FIG. 13 is yet another cross-sectional view of a thrombus / blood clot being treated with an aspiration catheter according to an embodiment of the present disclosure. [Figure 56] FIG. 1 is a cross-sectional view of an aspiration system including an aspiration catheter and a curved mandrel instrument according to an embodiment of the present disclosure. [Figure 57] FIG. 57 is a cross-sectional view of the aspiration system of FIG. 56 in a deflected state. [Figure 58] FIG. 1 is an elevational view of a suction system according to an embodiment of the present disclosure. [Figure 59A] FIG. 1 is a cross-sectional view of an aspiration system including an aspiration catheter and a rotating wire according to an embodiment of the present disclosure. [Figure 59B] FIG. 59B is an elevational view of a rotating device for rotating the rotating wire of the embodiment of FIG. 59A. [Figure 60] 1 is a cross-sectional view of a system for removing an intracranial thrombus or hematoma through a window, opening, or hole in a patient's skull. [Figure 61] FIG. 1 is a plan view of a system for aspirating thrombus according to an embodiment of the present disclosure. [Figure 62] FIG. 62 is a cross-sectional view of the system for aspirating thrombus of FIG. [Figure 63] 1 is an illustration of a method for aspirating a thrombus according to an embodiment of the present disclosure. [Figure 64] FIG. 13 is a plan view of disposable components of a system for aspirating thrombus according to an embodiment of the present disclosure. [Figure 65] 65 is a cross-sectional view of the distal end of the aspiration catheter in the system for aspirating a thrombus of FIG. 64. [Figure 66] FIG. 65 is a detailed view of the y-connector of the suction catheter in the system for aspirating thrombus of FIG. [Figure 67] 65 is a partial cross-sectional view of an aspiration catheter in use in the system for aspirating thrombus of FIG. 64. [Figure 68] FIG. 68 is a detailed view of the orifice of the suction catheter of FIG. 67. [Figure 69] FIG. 67 is an enlarged view of the y-connector of FIG. 66 in use. [Figure 70] FIG. 65 is a plan view of another connector configuration for the suction catheter of FIG. 64 according to an embodiment of the present disclosure. [Figure 71] FIG. 65 is a plan view of another connector configuration for the suction catheter of FIG. 64 according to an embodiment of the present disclosure. [Figure 72] FIG. 1 is a top view of an aspiration system having an aspiration catheter with a valve in a first position according to an embodiment of the present disclosure. [Figure 73] FIG. 73 is a top view of the aspiration system of FIG. 72 having an aspiration catheter with the valve in a second position according to an embodiment of the present disclosure. [Figure 74] FIG. 73 is a top view of the aspiration system of FIG. 72 having an aspiration catheter with a valve in a third position according to an embodiment of the present disclosure. [Figure 75] FIG. 1 is a perspective view of an aspiration system including an aspiration catheter and a guiding catheter according to an embodiment of the present disclosure. [Figure 76] FIG. 13 is a plan view of another connector configuration for a suction catheter according to an embodiment of the present disclosure. [Figure 77] FIG. 1 is a perspective view of an aspiration system having a pinch valve. [Figure 78]FIG. 13 is a perspective view of a y-connector of an aspiration catheter of an aspiration system according to an embodiment of the present disclosure. [Figure 79] 13 is a top view of a connector configuration of a suction system according to an embodiment of the present disclosure. FIG. [Figure 80] 13 is a top view of a connector configuration of a suction system according to an embodiment of the present disclosure. FIG. [Figure 81] 13 is a top view of a connector configuration of a suction system according to an embodiment of the present disclosure. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020]

[0102] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

[0021]

[0103] It is to be assumed herein that all numerical values, whether expressly indicated or not, can be modified by the term "about". The term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term "about" can include numbers that are rounded to the nearest significant number.

[0022]

[0104] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0023]

[0105] 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 used in its sense including "and / or" unless the content clearly dictates otherwise.

[0024]

[0106] The following detailed description should be read with reference to the drawings, in which like 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.

[0025]

[0107] FIG. 1 is a schematic diagram illustrating an auxiliary aspiration system 10. The aspiration system 10 includes a remote handpiece 12 that includes a fluid pump 26 and an operator control interface 6. In one contemplated embodiment, the system 10 is a single-use disposable unit. The aspiration system 10 includes a fluid irrigation lumen 2 (or high pressure infusion lumen) and an aspiration lumen 4, and may further include an extension tube 14 that allows for independent operation of the catheter 16 without the need for repositioning of the handpiece 12 during a procedure performed by the aspiration system 10. The extension tube 14 may also act as a pressure accumulator. High pressure fluid flows from a displacement pump, a pump 26 that may comprise a pulse with each stroke of the pump 26, generating a sinusoidal pressure map that includes distinct changes between the peaks and valleys of each sine wave. The extension tube 14 may match the pump 26 and expand and contract in unison with each pump pulse to reduce the pressure changes caused by the pump pulse and generate a smooth or smoother fluid flow at the tip of the catheter 16. Any tube that includes suitable compliance characteristics may be used. The extension tube 14 may be permanently attached to the pump 26 or may be attached to the pump 26 by a connector 44. The connector 44 is preferably configured to ensure that the extension tube 14 cannot be incorrectly attached to the pump 26.

[0026]

[0108] The interface connector 18 joins the extension tube 14 and the catheter 16 together. In one contemplated embodiment, the interface connector 18 can include a filter assembly 8 between the high pressure fluid infusion lumen 2 of the extension tube 14 and the high pressure infusion lumen 36 of the catheter 16 (FIG. 3). The catheter 16 and extension tube 14 can be permanently joined by the interface connector 18. Alternatively, the interface connector 18 can include a standard connection such that a selected catheter 16 can be attached to the extension tube 14.

[0027]

[0109] Attached to the handpiece 12 are a fluid source 20 and a vacuum source 22. A standard hospital saline bag can be used as the fluid source 20, as such a bag is readily available to the physician and provides the necessary volume to perform the procedure. A vacuum bottle can provide the vacuum source 22, or the vacuum source 22 can be provided by a vacuum canister, syringe, vacuum pump or other suitable vacuum source.

[0028]

[0110] In one embodiment contemplated, the catheter 16 includes a variable stiffness ranging from a stiffer proximal end to a more flexible distal end. The change in stiffness of the catheter 16 can be achieved by a single tube with no radial joint between two adjacent tube pieces. For example, the shaft of the catheter 16 can be made from a single length of metal tubing with a length of tubing that is helically cut to provide flexure of the shaft. The variable stiffness can be created by varying the pitch of the helical cut over different lengths of the metal tube. For example, the pitch of the helical cut can be larger at the distal end of the device to provide greater flexure (where the helical cut turns are tighter together). Conversely, the helical cut at the proximal end can be more reduced to provide increased stiffness (where the helical cut turns are farther apart). In some embodiments, a single jacket can cover the length of the metal tube to provide a vacuum-tight catheter shaft. An inner layer or lining of a lubricious material, such as a fluoropolymer including PTFE, and an outer layer or sheath of PEBAX may encapsulate or sandwich the spiral-cut metal tubing. The spiral-cut tubing is encapsulated in a manner that stops short of the distal end of the catheter, thereby providing a more flexible tip. Other features of the catheter 16 are described below with reference to FIG. 3.

[0029]

[0111] FIG. 2 is a schematic diagram showing the handpiece 12 and the proximal portion of the auxiliary catheter aspiration system 10 in more detail. The handpiece 12 includes a control box 24 in which the power and control system is located. The pump 26 can be a motor-driven displacement pump with a constant output in some embodiments. The pump displacement relative to the catheter volume, together with the placement of the orifice 42 (outlet) of the catheter high pressure lumen 36 inside the aspiration lumen 38 (FIG. 3), ensures that substantially all pressurized fluid is exhausted by the aspiration lumen, so that no energy is transferred from the saline pump to the patient. A prime button 28 is mechanically coupled to the prime valve 30. When preparing the device for use, it is useful to evacuate all air from the pressurized fluid system to reduce the possibility of air embolism. By depressing the prime button 28, the user couples the fluid source 20 to the vacuum source 22 via the pump 26. This forces the fluid (e.g., 0.9% NaCl solution, or "saline," or "normal saline," or "heparinized saline") through the entire pump system, removing all air and ensuring the system is primed for safe operation. A pressure / vacuum valve 32 is used to switch the vacuum on and off simultaneously with the fluid pressure system. One possible valve 32 is a vented one-way valve. Such a valve is useful with manual or electronic valve systems because it acts as a form of tamper-evident safety by mechanically and automatically coupling the operation of the two prime systems. The inclusion of the pressure / vacuum valve 32 eliminates the possibility of switching the vacuum on without further driving the fluid system.

[0030]

[0112] The operator control interface 6 may include an electronic control board 50 that is powered by a power system 48 (such as a battery or wire) and may be operated by a user through the use of one or more switches 52 and one or more indicator lights 54. The control board 50 further monitors and controls several device safety features, including over-pressure detection, air bubble detection, and vacuum loading. A pressure sensor 64 monitors the pressure (i.e., injection pressure) and detects air bubbles. The optical device 66 may alternatively or in combination be used to sense air bubbles. In one embodiment considered, pump pressure is proportional to the current required to generate that pressure. As a result, if the current required by the pump 26 exceeds a preset limit, the control board 50 will disable the pump 26 by cutting off power to the pump 26. Air bubble detection may also be monitored by monitoring the current required to drive the pump 26 at any particular moment. In order for the displacement pump 26 to reach high fluid pressures, there should be little or no air (which is highly compressible) present in the pump 26 or the connection system (including the catheter 16 and extension tube 14). The fluid volume is small enough that any air in the system would result in no pressure being generated at the pump head. The control board monitors the pump current for any sudden downward changes that may indicate air has entered the system. If the rate of decline is faster than a preset limit, the control board 50 will disable the pump 26 by cutting off power to the pump 26 until the problem is corrected. Similarly, blockages in the high pressure lumen 36 (FIG. 3), which may be due to the ingress of organized or fibrous thrombi, or solid emboli, can be sensed by monitoring the current running through the pump 26. In normal use, the current fluctuations of the pump 26 are relatively large. For example, the pump 26 may be configured such that during normal operation, there is a change in current of 200 milliamps or more, so that if the current fluctuation drops below 200 milliamps, air is confirmed and the system is shut down. Alternatively, a current fluctuation in the range of, for example, 50 milliamps to 75 milliamps may be used to confirm air in the system. In addition, an increase in current or a current fluctuation may indicate the presence of a clot or thrombus inside the high pressure lumen 36. For example, a current of more than 600 milliamps may indicate that a thrombus partially or completely occludes the high pressure lumen 36 or even the aspiration lumen 38 (FIG. 3).

[0031]

[0113] A vacuum line 56 coupled to the vacuum source 22 may be coupled to a pressure sensor 58. If the vacuum of the vacuum source 22 is low (i.e., the absolute pressure drops) or if a leak is detected in the vacuum line 56, the control board 50 will disable the pump 26 until the problem is corrected. The pressure sensor 58 can also be part of a safety circuit 60 that will prevent the pump 26 from operating if no vacuum is present. Thus, a comprehensive safety system 62 including the safety circuit 60, the pressure sensor 64 and / or the optical device 66, and the pressure sensor 58 requires both pump pressure and vacuum pressure for the system to operate. If a problem exists (e.g., an unacceptably low pump pressure or lack of a valid vacuum), the control board 50 will prevent the user from operating the aspiration system 10 until all problems are corrected. This will prevent air from being injected into the patient's body and will ensure that the aspiration system 10 is not operated with incorrect parameters. Alternatively, instead of a direct coupling (e.g., electrical, optical), the pressure sensor 58 may be configured to transmit a wireless signal to the control board 50, or any other component (e.g., an antenna) coupled to or in communication with the control board 50, to remotely control the operation of the pump 26. Remote control is possible whether the pump is inside the sterile field or outside the sterile field.

[0032]

[0114] FIG. 3 is a schematic diagram of the distal end portion 68 of the auxiliary catheter aspiration system 10, showing the catheter 16 in more detail. In some embodiments, the catheter 16 is a single operator exchange catheter and includes a short guidewire lumen 34 attached to the distal end of the device. The guidewire lumen 34 can be between about 1 cm and about 30 cm in length, or between about 5 cm and 25 cm in length, or between about 5 cm and 20 cm in length, or about 13.5 cm in length. In other embodiments, a full length guidewire lumen (extending the length of the catheter 16) can be used. For example, a catheter 16 sized for use on peripheral vessels, including peripheral arteries, may incorporate a full length guidewire lumen. In some embodiments, the suction itself can function as a guidewire lumen. The suction lumen 38 includes a distal opening 40 that allows a vacuum (e.g., from the vacuum source 22) to draw the thrombotic material into the suction lumen 38. The high pressure lumen 36 includes a distal orifice 42 that is disposed proximal to the distal opening 40 a set amount. For example, the distal orifice 42 can be disposed proximal to the distal opening 40 about 0.508 mm (0.020 inches), or about 0.508 ± mm 0.076 mm (0.020 inches ± 0.003 inches), or another desired amount. The orifice 42 is configured to spray across the suction lumen to soften and / or thin the thrombotic material for transport to the vacuum source 22, for example, by lowering the effective viscosity of the thrombotic material. The axial location of the fluid orifices 42 is preferred such that the spray pattern interacting with the opposing lumen wall creates a spray mist and does not create a vortex pattern that may force thrombotic material out of the distal opening 40. The spray pattern may be present at least when the distal end of the catheter 16 is within an aqueous environment, such as a body lumen containing a blood vessel. The aqueous environment may be at body temperature, such as, for example, between about 35.0° C. and about 40.0° C., or between about 36.0° C. and about 38.0° C. The system may be configured such that the irrigation fluid exits the pump at a pressure between about 3.447 megapascals (500 pounds per square inch) and about 10.342 megapascals (1500 pounds per square inch). In some embodiments, after head pressure loss along the high pressure lumen 36, the irrigation fluid exits the orifice 42 at between about 4.137 megapascals (600 pounds per square inch) and about 8.274 megapascals (1200 pounds per square inch), or between about 4.816 megapascals (650 pounds per square inch) and about 5.861 megapascals (850 pounds per square inch).

[0033]

[0115] FIG. 4 illustrates a system 100 for aspirating a thrombus, according to an embodiment of the present disclosure. The system 100 for aspirating a thrombus shown in FIG. 4 displays disposable components 101 including a tubing set 103 and an aspiration catheter 118, which are configured to attach to a vacuum source 22, a fluid source 20 (FIGS. 1 and 2), a pressure monitor (not shown), and a pump base 200 (FIG. 12). The system 100 for aspirating a thrombus is further configured to be used with a guidewire. Starting with the components of the tubing set 103, a spike 102 (shown in more detail in FIG. 5) is configured to be coupled to a fluid source 20, such as a saline bag. The saline bag can contain a volume of saline equal to about 1000 ml or about 500 ml. The saline can be normal, can be heparinized, or can contain one or more therapeutic agents. Other liquids can also be used in place of normal saline or saline mixtures, including lactated Ringer's solution, hypertonic saline, even solutions containing blood products. The saline or other liquid can be at room temperature or can be warmed or cooled (e.g., to permanently or temporarily increase or decrease activity). A connector 104 (shown in more detail in FIG. 7), such as a Luer connector, is configured to couple to a vacuum source 22. The vacuum source 22 can be a vacuum bottle or vacuum canister containing a volume between 20 ml and 500 ml. Alternatively, the vacuum source 22 can be a 60 ml syringe, the plunger of which is retracted after coupling to the connector 104. It can be a lockable plunger, which is locked to maintain the ejected plunger position. In some cases, the vacuum source 22 can be a 20 ml syringe or a 30 ml syringe. An exemplary syringe with a lockable plunger is the VacLok® syringe sold by Merit Medical Systems, Inc. of South Jordan, Utah, USA. The vacuum source 22 can also be a vacuum pump with or without a collection vessel.A pressure transducer 106 capable of measuring vacuum (configured to measure positive pressure, but including a positive pressure sensor capable of measuring negative pressure) is coupled to the vacuum line 108 via a y-connector 110. A signal from the pressure transducer 106 travels along a cable 112 (FIG. 7), which also supplies a voltage to the pressure transducer 106. A connector 114 (also shown in FIG. 6) couples the cable 112 to a pressure monitor or pump base 200. The cassette 116 is a disposable component attachable to the pump base 200 (FIG. 12) to allow pressurized infusion of infusate (such as saline). The cassette 116 is described in more detail in connection with FIG. 6. A suction catheter 118, including a distal end 120, is shown in more detail in FIG. 8.

[0034]

[0116] 5, spike 102 communicates with extension tube 122. Infusate is pumped downstream with a piston pump, which pulls more infusate (e.g., from a saline bag) through a check valve 126 and through a supply tube 130. An injection port 128 can be used to inject other materials into the system or to remove air or keep the system primed. Spike 102 can be housed by a removable spike cover 124.

[0035]

[0117] As can be seen in FIG. 6, the cassette 116 pulls infusate from the supply tube 130 and pressurizes the infusion tube 152 (along with the pump base 200). Further details of the cassette 116 will be described along with the description of the overall piston pump. FIG. 7 shows further details of the pressure transducer 106 for measuring vacuum. The pressure transducer 106 is coupled to the y-connector 110 by a luer fitting 154. The infusion tube 152 and the vacuum line 108 communicate with the lumen of the catheter shaft 142. For example, the infusion tube 152 can be fluidly connected to a supply tube 168 (FIGS. 9-11), such as a polyimide or stainless steel or high strength thin walled Nitinol tube. This distal supply tube 168 can be internal to the catheter shaft 142, with an annulus therebetween forming the aspiration lumen 160 (FIGS. 9-11). A strain relief 156 protects the catheter shaft 142 from kinking and other damage. In any case where a luer fitting 154 is used (on any connection), a custom luer containing an additional O-ring may be used to allow the connection to withstand elevated pressures. In some embodiments, custom connectors may be utilized to improve high pressure resistance. In some embodiments, pressures of 6.89 megapascals (1200 pounds per square inch) or more may be achieved without leakage or causing separation of the catheter.

[0036]

[0118] 8, the aspiration catheter 118 is illustrated as a single operator exchange catheter and includes a guidewire tube 132 attached to a distal end 120 on one end of the aspiration catheter 118. The guidewire tube 132 can be between about 1 cm and 30 cm in length, or between about 5 cm and 25 cm in length, or between about 5 cm and 20 cm in length, or about 13.5 cm in length. The guidewire tube 132 includes a distal end 136 and a proximal end 138, and a single guidewire lumen 134 passing between the two ends 136 and 138. The guidewire lumen 134 can be configured to fit a 0.014 inch guidewire diameter, a 0.018 inch guidewire diameter, or some other guidewire diameter. To fit a 0.014 inch guidewire, the lumen inner diameter can be about 0.016 inch. The guidewire tube 132 may be constructed from multiple materials including nylon, polyethylene, PEBAX®, polyester, PET, or may be constructed from composite or co-extruded materials. For example, the inner layer may comprise high density polyester or FEP, PTFE, ETFE, or other material for high lubricity, and the outer layer may include PEBAX, nylon, or other material for a combination of mechanical strength and flexibility. A tie layer may be used between the inner and outer layers, such as linear low density polyester. The catheter 118 may include a composite catheter shaft 142 including an inner support structure 144 covered by a polymer jacket 146. The inner support structure 144 may be, for example, a tubular braid made of flattened stainless steel or round wire, or one or more composite materials. The inner support structure 144 can be a helical coil of several helical coils. The inner support structure 144 can also be a helically cut hypodermic tube made, for example, from 304 stainless steel or nickel-titanium. The helically cut hypodermic tube can include a pitch of about 4 mm to 6 mm, or about 5 mm, to increase stiffness at the proximal end, and transition to a pitch of about 0.75 mm to 1 mm, or about 0.87 mm, at the distal end 150 of the inner support structure 144. Between these two different pitch sections can be intermediate pitch sections, for example, a section including a pitch between about 2 mm and about 5 mm, and another section including a pitch between about 1 mm and about 2.5 mm. The inner support structure 144 can terminate at a transition region 148, such that only the polymer jacket 146 can extend to the distal end 136 of the aspiration catheter 118. The catheter tip section 140 is described in more detail in connection with FIGS. 9-11.

[0037]

[0119] 9-11 show an open distal end 158 of the aspiration lumen 160 for aspirating thrombus. A skive 162 is formed in the polymer jacket 146 to aid in the entry of aspirated thrombus 164 into the aspiration lumen 160 (in the direction of arrow 180) in combination with the vacuum generated by the vacuum source 22. The skive 162 also minimizes the chance of the open distal end 158 being sucked against the vessel wall 166. A distal supply tube 168 includes a closed distal end 170, which can be plugged during manufacture using, for example, an adhesive, epoxy, hot melt adhesive, or interference member. Alternatively, the distal supply tube 168 can be plugged by melting a portion thereof. The distal supply tube 168 includes a lumen 176 extending its length and an orifice 172 formed through its wall 174 adjacent and proximal to the closed distal end 170. The orifice 172 may include a diameter of between about 0.002 inches and about 0.004 inches, or about 0.0031 inches. The inner diameter of the distal supply tube 168 may be between about 0.012 inches and about 0.019 inches, or between about 0.014 inches and about 0.017 inches, or about 0.0155 inches. The lumen 176 of the distal supply tube 168 is an extension of the overall flow path emanating from the fluid source 20, which includes the extension tube 122, the supply tube 130, the interior of the cassette 116, and the infusion tube 152. In some embodiments, the lumen 176 of the distal supply tube 168 can be tapered, for example, from an inner diameter of about 0.0155 inches at the proximal portion to an inner diameter of about 0.011 inches at the distal portion. In some embodiments, the equivalent of a tapered portion can be achieved by bonding different diameter tubes together, resulting in a stepped-down tube inner diameter. In some embodiments, tapered different diameter tubes can be bonded together for a combination of tapering and step-down diameters.As described in conjunction with a piston pump, a pump output pressure wave of about 600 to 800 MPa causes infusate to flow (arrow 182) through a flow path including the distal supply tube 168 and a fluid jet 178 exits the orifice 172 at high velocity. The fluid jet 178 would impinge on an inner wall 181 of the aspiration lumen 160 directly adjacent the orifice 172 in the absence of flow (e.g., no vacuum) through the aspiration lumen 160. Depending on the amount of vacuum present, the fluid jet may bend as shown. The fluid jet 178 acts to soften and thin the blood clot 164 entering the aspiration lumen 160. The flow rate of the infusate (e.g., saline) and the magnitude of the vacuum are controlled such that about 50% to about 95% of the volume of the mixture of saline and blood flowing through the proximal aspiration lumen 160 is blood. Alternatively, about 90% of the volume is blood. In other embodiments, the flow rate of the infusate (e.g., saline) and the magnitude of the vacuum are such that about 50% to about 70% of the volume of the mixture of saline and blood flowing through the proximal suction lumen 160 is blood. The fluid jet 178 is controlled to be blood. Alternatively, about 60% of the volume is blood. This softening and thinning ensures that there is a continuous flow through the aspiration lumen 160, so that the aspiration lumen 160 will not become blocked. The fluid jet 178 is configured to be contained within the aspiration lumen 160 and will not exit into a blood vessel or other body lumen.

[0038]

[0120] The axial center of the orifice 172 is about 0.013 inches to about 0.033 inches, or 0.016 inches to about 0.026 inches, proximal to the proximal-most portion of the open distal end 158, as illustrated by distance D in FIG. 11. FIG. 14 is a cross-sectional view of the catheter tip section 140 at the axial center of the orifice 172. The orifice 172 is oriented generally along the vertical midline 184 of the aspiration lumen 160, or within ±a, where the angle a is about 20°. The angle a can vary in different embodiments between about 1° and about 45°, or between about 20° and about 35°. The guidewire tube 132 may be secured to the polymer jacket 146 by an attachment material 186, such as an adhesive, epoxy, hot melt, or other material. The guidewire tube 132 may be secured along its entire length or at discrete locations along its length to maximize flexibility. The distal supply tube 168 may be secured inside the aspiration lumen 160 by an attachment material 188, such as an adhesive, epoxy, hot melt, or other material. The polymer jacket 146 may comprise a number of different materials, including PEBAX, nylon, or polyurethane. In some embodiments, the polymer jacket may be partially melt bonded to the distal supply tube 162 and / or the guidewire tube 132 to minimize the wall thickness of the assembly.

[0039]

[0121] FIG. 12 illustrates a pump base 200 for coupling to a cassette 116 of a system 100 for aspirating thrombi. A housing 202 is attached to an IV pole clamp 204 and contains control circuitry and a motor for operating a piston pump system 300 (FIG. 13) that includes the combined pump base 200 and cassette 116. Actuation of a motor and cam within the pump base 200 cyclically drives a saddle 206 (up and down) within a window 208 to move a piston 210 within the cassette 116 (FIG. 13). A peg 212 of the cassette 116 is inserted into a cavity 216 in the pump base 200. A biased snap 214 locks into one or more grooves 218 in the pump base 200. Either the cavity 216 or the groove 218 can contain one or more switches that sense the presence of the cassette 116. For example, a cassette for a particular mold may include a first number (or combination) of pegs 212 or biased snaps 214, but another particular mold may include a different number (or combination) of pegs 212 or biased snaps 214, which are recognized by the system. A flat surface 224 of the elastomeric frame 222 engages the edge 220 of the cassette 116 to provide additional protection. An upper space 226 is configured to engage or closely match the supply tube 130, and a lower space 228 is configured to engage or closely match the fill tube 152. The saddle 206 has a semi-cylindrical cavity 236 that snaps over a cylindrical engagement surface 238 on the piston 210. The saddle further includes an upper edge 240 and a lower edge 242 that axially engage a first abutment 244 and a second abutment 246 of the piston 210, respectively. A user interface 230 on the pump base 200 includes one or more buttons 232 and one or more indicators 234 that allow a user to operate and evaluate the system 100. For example, the buttons may include a start button to begin aspiration, a stop button to stop aspiration, a prime button to prime the system with fluid infusate and remove air, or a pause button. Other data entry keys are also possible.The cassette 116 can include one or more interface components 248. For example, the cassette 116 can be attached to the pump base 200. When the pump base 200 is connected to the interface component 248, the resistor value can be measured by the pump base 200 via contacts 247, 249. This allows the pump base to determine the appropriate parameters for operating a particular type of system 100. For example, a first resistor containing a first resistance can be used by a first type, and a second resistor containing a second resistance can be used by another type. Alternatively, the interface component 248 can incorporate an RFID chip, such as a read RFID chip or a read / write RFID chip. This allows certain data (pump operating pressure, RPM of motor output, etc.) to be recorded within the pump base 200 or connected hardware and identified for each patient.

[0040]

[0122] Figures 15 and 16 illustrate cassette 116 with most of its internal components visible. Figure 16 is a cross-sectional view of cassette 116. Cassette 116 includes an internal feed cylinder 252 and an internal injection cylinder 254, which are cylindrical cavities extending into the interior of cassette 116. Piston 210 includes a feed shaft 256 and an injection shaft 258, with feed shaft 256 including an O-ring 266 for sealably coupling with feed cylinder 252 and injection shaft 258 including an O-ring 268 for sealably coupling with injection cylinder 254. Each O-ring 266, 268 resides within a cylindrical groove 290, 292 around each shaft portion 256, 258. When the piston 210 moves in a first direction 276, an internal ball valve 272 (FIG. 16) stops injectate (saline) from flowing through an internal conduit 274 in the supply shaft 256 of the piston 210, but when the piston 210 moves in a second direction 278, the internal ball valve 272 allows injectate to flow through the internal conduit 274 and through an internal conduit 282 in the injection shaft 258. The ball valve 272 is axially held between a spherical annular recess 284 in the interior of the supply shaft 256 and a recess 286 containing a passage conduit in the injection shaft 258. The supply shaft 256 and the injection shaft 258 may be held together by a threaded connection 288. When the piston 210 moves in the first direction 276, the injection shaft 258 and O-ring 268 of the piston 210 force the injectate through the injection tube 152. Above the infusion tube 152, a protective tube 280 is shown. In FIG. 15, the infusion shaft 258 is shown at the bottom of the infusion pulse. The infusate is filtered through an in-line filter 262, which can be a 40-50 micron filter and includes a thickness of about 0.762 mm (0.030 inches). The in-line filter 262 is configured to keep particulates out of the infusate. Even if the infusate is circulated through the aspiration catheter 118 without entering the blood vessel, the filtering provided by the in-line filter 262 is an added safety step. However, this step ensures that particulates do not block the small orifice 172 (FIG. 11).When the piston 210 moves in the second direction 278, the supply shaft 256 and O-ring 266 of the piston 210 sealably move together inside the supply cylinder 252, but the ball valve 272 allows injectate to pass through the internal conduits 274, 282 of the piston 210 and fill the injection cylinder 254. Injectate can enter from the supply tube 130 through the check valve assembly 270, which includes the O-ring 264 and the check valve 250. The check valve 250 allows injectate to enter the interior of the cassette 116 from the supply tube 130, but does not allow it to move from the cassette 116 to the supply tube 130. The check valve 250 can be configured such that air cannot move (open) the check valve 250, due at least in part to low viscosity, thereby preventing air from proceeding through the system. In some embodiments, the piston 210 can be a single piece (monolithic) design that includes a hole into which a check valve is press-fitted or glued in. A check valve that fits into this assembly can be supplied by Lee Company of Westbrook, Connecticut, USA.

[0041]

[0123] The volume of injectate injected per cycle ranges from about 0.02 ml to about 41 ml, or about 0 The usable volume of the injection cylinder 254 may range from about 0.04 ml to about 2.0 ml, or from about 0.06 ml to about 0.08 ml, or about 0.07 ml. The usable volume of the injection cylinder 254 (volume that can be injected) may be configured to be less than the usable volume of the supply cylinder 252 (volume that can be filled from the supply cylinder 252) to ensure sufficient filling of the injection cylinder 254. For example, the usable volume of the injection cylinder 254 may be from about 0.05 ml to about 0.12 ml, and the usable volume of the supply cylinder 252 may be from about 0.07 ml to about 0.16 ml. A usable volume ratio R between about 1.15 and about 2.00, or between about 1.25 and about 1.85, or about 1.40. U is considered, in which case, R U =V SCU / V ICU and V SCU = the available volume of the supply cylinder 252, and V ICU = the usable volume of the fill cylinder 254.

[0042]

[0124] Average flow rate between about 5 ml / min and about 100 ml / min. In some embodiments for use in coronary applications, 20 ml / min may be desired. In some embodiments for use in peripheral applications, 50 ml / min may be desired.

[0043]

[0125] 18 illustrates a graph 600 of a curve 602 of pressure (P) versus time (T) for a piston pump. The peaks 604 and valleys 606 of the curve 602 vary depending on the design of the piston and cylinder of the piston pump, and in particular the usable volume fraction R U 19, the piston 608 may be moved to a first diameter D measured at the compressed O-ring 601. 1 , and a second diameter D measured at the compressed O-ring 603 2 (when placed inside cylinders 605 and 607 of cassette 609). Thus, the diameter of cylinders 605, 607 is diameter D 1 and D. 2 The diameter D is also defined as 1 , D 2 , and the length of the cylinders 605, 607 are determined by the available volume ratio R U When is adjusted to be optimized as described above, the curve 610 illustrated in Figure 20 can be produced. Curve 610 includes less well defined peaks 614 and valleys 616, thus producing less variation in flow amplitude and a more stable injection.

[0044]

[0126] The partially exploded view of pump base 200 in Figure 17 illustrates the internal mechanism for linear drive (up and down) of saddle 206 attached to saddle stage 310. Motor 302 is controlled by circuit board 304 and actuated by user interface 230 (Figure 12), whose indicator 234 is illuminated by LED 306. Motor 302 rotates cam 316, which includes track 330. Saddle stage 310 includes pin 318 extending from its underside. Pin 318 can be press-fit, glued, or screwed into place inside saddle stage 310. The saddle stage 310 is fixed to the two slides 312, 314 by screws through holes 326, 328, and the rotational motion of the cam 316 causes the pin 318 to track along the path 330 of the cam 316, thereby causing the saddle stage 310 attached to the slides 312, 314 to slide up and down in a cyclical motion. The shape of the cam determines the amount of acceleration and deceleration of the motion. The upper post 322 and the lower post 324 serve as guides and / or stops for the saddle stage 310. The connector 114 of the pressure transducer 106 for measuring vacuum can be plugged into the socket 308 (as shown in FIG. 12), and pressure-related signals can be processed by the circuit board 304. The entire pump base 200 is reusable.

[0045]

[0127] The inner contour diameter of the cam 316 may be sized and / or shaped to control the stroke length and amount of pulsatility (i.e., the difference between high and low pressure) of the piston 210. In some cases, reducing the stroke length reduces the amount of pulsatility. In intracardiac applications, such as coronary artery applications, reducing the amount of pulsatility can reduce the frequency of bradycardia. Compensating for a lower stroke length To achieve this and maintain sufficient overall flow rate, the rotational speed of the cam (i.e., revolutions per minute) may be increased by, for example, increasing the motor output speed, either by adjusting the applied voltage or by increasing the applied voltage.

[0046]

[0128] Another embodiment of a system 800 for aspirating a thrombus is illustrated in FIG. 21. The system 800 for aspirating a thrombus includes three main components: the pump base 200 of FIG. 12, the suction catheter 818, and the tubing set 803. The suction catheter 818 and the tubing set 803 represent disposable components 801, while the pump base 200 is a reusable component. There is no need to sterilize the pump base 200 since it is kept in a non-sterile field or area during use. The suction catheter 818 and the tubing set 803 can each be supplied sterile after sterilization by ethylene oxide gas, electron beam, gamma radiation, or other sterilization methods. The suction catheter 818 can be packaged and supplied separately from the tubing set 803, or the suction catheter 818 and the tubing set 803 can be packaged and supplied together. Alternatively, the suction catheter 818 and tubing set are packaged separately but provided together (i.e., bundled). As shown in Figures 21 and 22, the suction catheter 818 and tubing set 803 share many of the same features as the suction catheter 118 and tubing set 103 of Figure 4, but are configured to be more easily separable from one another and allow for additional procedural compatibility. The suction catheter 818 includes a distal end 820 comprising a guidewire tube 832 including a distal tip 836, and a proximal end 819 comprising a y-connector 810. A catheter shaft 842 of the suction catheter 818 is coupled to the y-connector 810 via a protective strain relief 856. In other embodiments, the catheter shaft 842 may be attached to the y-connector 810 by a Luer fitting. The y-connector 810 can have a first female luer 851 that communicates with the catheter supply lumen (as in catheter 118 in Figures 4, 8-11) and a second female luer 855 that communicates with the catheter suction lumen (as in catheter 118 in Figures 4, 8-11).

[0047]

[0129] Turning to FIG. 23, the tube set 803 is shown in more detail. A spike 802 for coupling to the fluid source 20 (FIG. 1) allows fluid to pass through an extension tube 822 and a check valve 826 into a supply tube 830. An optional injection port 828 allows for the injection of material or removal of air, as described in connection with the previous embodiment. The cassette 816 is used in conjunction with the pump base 200 and is similar in structure and function to the cassette 116 in FIGS. 15 and 16. Fluid is drawn from the cassette 816 into an injection tube 852. A male luer 854 is configured to attach to the female luer 851 of the y-connector 810.

[0048]

[0130] Returning to FIG. 21, an attachment 857 is shown intended to apply a vacuum source 22 including a syringe 849 with a plunger 867 to a catheter 818. The syringe 849 is attached to a syringe extension tube 859 via a luer 865 of the syringe 849. A stop cock 847 can be used to maintain the vacuum or the plunger 867 can be a variety of locking plungers. A luer 861 of the syringe extension tube 859 is coupled to a pressure transducer 806, which includes a male luer 863 for coupling to a connector 804 (e.g., a female luer) of a vacuum line 808. A male luer 853 at the end of the vacuum line 808 can be removably secured to a female luer 855 of a y-connector 810 of the suction catheter 818. A signal from the pressure transducer 806 is conveyed through a cable 812 to a connector 814. The connector 814 plugs into a socket 308 (FIG. 12) of the pump base 200. A signal of the relevant pressure can be processed by the circuit board 304 of the pump base 200. The pressure transducer 806 is connected to the The power can be from the pump base 200. The accessories 857 can be supplied to the user in a sterile condition.

[0049]

[0131] In use, the pump base 200 is outside of the sterile field. Because the operation of the pump base 200 can be controlled by the presence or absence of pressure, a user working within the sterile field can turn the pump on or off without touching the non-sterile pump base 200. For example, the pump can be started by placing a vacuum on the system (e.g., pulling the plunger 867 of the syringe 849). The pump can then be stopped by removing the vacuum on the system (unlatching and allowing the plunger 867 of the syringe 849 to release, or opening the stop cock 847). The syringe 849, or a combination of the syringe 849 and the stop cock 847, can function as a sterile on / off button for the pump base 200. Alternatively, the suction catheter 818 can be used initially without the pump base 200, and only suction is applied to the suction lumen. In certain cases, if the aspiration lumen becomes occluded, the distal end 820 of the aspiration catheter 818 can be pulled back from the clot, and the pump base 200 and tubing set 803 can be coupled to the aspiration catheter 818, which can then be actuated by forced infusion of saline to increase suction and clear the aspiration lumen, further helping to ensure that any clots occluding the aspiration lumen are not inadvertently transported into the patient's vasculature.

[0050]

[0132] 24 and 25 illustrate a saline pump drive unit 400 including a fully disposable pump head 500. The saline pump drive unit 400 is configured to be usable with the catheters 16, 118 described herein, or other embodiments of aspiration systems with fluid infusion. In FIG. 24, a bottom case 402 and a top case 404 including a label 406 are secured together by screws 408. A battery pack 410 and an electronic control module 412 are housed inside the bottom case 402 and the top case 404. A battery cover 416 holds the battery pack 410 in place. In some embodiments, the battery pack 410 can provide a DC voltage of 18 volts, however systems utilizing other voltages are possible. A user interface 414 allows operation of the saline pump drive unit. If a vacuum bottle is incorporated as the vacuum source 22, a vacuum bottle sleeve 418 can be used. A spike 420 can be in communication with the fluid source 20, and fluid infusate passes from the fluid source 20 through an extension tube 422 to the disposable piston pump head 500. Saline can be kept primed throughout the system by an automatic prime ("autonomous prime") system as described herein in connection with the previous embodiment, or can be primed by gravity from a saline bag located above the rest of the system (e.g., on an IV pole). A valve on the lowest part of the system can be opened to keep the entire system primed.

[0051]

[0133] As illustrated in FIG. 25, the disposable piston pump head 500 is configured to couple to a motor shaft 504 of a motor 502 that is powered by a battery pack 410 of the saline pump drive unit 400. A motor plate 506 and a body 508 of the disposable piston pump head 500 are secured together by screws 510 to hold the internal components of the disposable piston pump head 500. A first follower plate 512 and a second follower plate 514 are held together by screws 516 and a boss 518 extending from the first follower plate 512. The first follower plate 512 and the second follower plate 514 rotatably hold a cam 520. The cam can be asymmetric (as shown) or alternatively symmetric. Asymmetry can be incorporated to control the amount of noise in the pump and the contour shape helps customize the shape of the pressure wave and the function of the pump. The first Bushing 522 and second bushing 524 are rotatably retained on first pin 526 and second pin 528. The pins 526, 528 are inserted into cylindrical cavities 530, 532 in respective follower plates 512 and 514.

[0052]

[0134] In use, the disposable piston pump head 500 can be attached to the motor 502 of the saline pump drive unit 400 by a user bringing the motor plate 506 closer to the motor shaft 504 so that the D-shaped hole 534 in the cam 520 presses up the D-shaped motor shaft 504. Alternatively, the D-shape can be other non-circular shapes, including but not limited to an ellipse, an oval, or a rectangle. In operation, the motor 502 rotates the motor shaft 504, which in turn rotates the cam 520. The cam 520 rotates, forcing the bushings 522, 524 to push the first follower plate 512 and the second follower plate 514 back and forth in a first direction 536 and a second direction 538. A saddle 544 is supported on the second follower plate 514, and the piston 210 can be coupled to the saddle 544 in the same manner as described herein with other embodiments. The supply cylinder 552 and the infusion cylinder 554 in the body 508 are similar to the supply cylinder 252 and the infusion cylinder 254 of the cassette 116 of the system 100. The piston 210 of the cassette 116 may be used in the disposable piston pump head 500. The numbered components associated with the piston 210 in FIG. 25 are similar to the components described in association with the piston 210 in FIGS. 15 and 16. The outer diameter of the cam 520 may be sized and / or shaped to control the stroke length and amount of pulsatility (i.e., the difference between high and low pressure) of the piston 210. In some cases, decreasing the stroke length decreases the amount of pulsatility. In intracardiac applications, such as coronary artery applications, decreasing the amount of pulsatility may reduce the frequency of bradycardia. To compensate for the reduced stroke length and to maintain sufficient overall flow rate, the rotational speed of the cam (i.e., revolutions per minute) may be increased, for example, by increasing the motor output speed, either by adjusting the applied voltage or by increasing the applied voltage. In some embodiments, it may be desirable to control the pulsatility to adjust the size of the thrombus fragments being cut by fluid jet 178 (FIG. 11).A pulse frequency of 250 pulses / min (4.167 Hz) may be effective to ensure that the thrombus fragments severed by the fluid jet are relatively small and that the delivery of these fragments through the aspiration lumen 160 during aspiration is sufficient and does not tend to cause blockages. A vacuum spike 546 is used to couple to a vacuum source 22, such as a vacuum bottle held inside a vacuum bottle sleeve 418. A vacuum changeover valve 540 actuated against the bias of a spring 542 may be used to enable actuation of the pump. For example, the electronic control module 412 may be configured to automatically initiate operation of the motor 502 when the vacuum changeover valve 540 sends a signal corresponding to the operation of the vacuum changeover valve 540, which occurs when a valid vacuum is achieved. This control may be in lieu of, or in addition to, control from a vacuum pressure transducer, such as the pressure transducer 106. Thus, switching on the vacuum may be used to simultaneously switch on the motor 502, so that a single input initiates operation of the saline pump drive unit 400. Additionally, if a minimum infusate pressure is measured by an additional pressure transducer, the vacuum source 22 may be controlled by the electronic control module 412 (e.g., by opening or closing a solenoid). For example, if a pressure of about 0.62 megapascals (90 pounds per square inch) or greater is measured, the vacuum may be activated or communicated to the system. A useful feature of the saline pump drive unit 400 is that it only requires the user to assemble a single component to the shaft 504 of the motor 502.

[0053]

[0135] As previously mentioned, any embodiment of the present disclosure may be configured such that active flow of saline (or other) infusate cannot be achieved without a simultaneous vacuum applied for aspiration. A system according to any of the embodiments of the present disclosure may be configured such that the current driving the pump (e.g., the current driving the motor 302, 502) is monitored, or by any alternative monitoring method, if a change in condition occurs, such as air in the infusion system, or a blockage in any catheter lumen or extension tube, or a leak inside the system, the system may be configured to shut down to avoid accidents such as injection of air into the blood vessel or catheter, or damage to the system.

[0054]

[0136] FIG. 26 illustrates an aspiration catheter 700 inserted inside a blood vessel 165. The aspiration catheter 700 includes a guidewire lumen 702 that is secured to a distal end 704 of the aspiration catheter 700, allowing the aspiration catheter 700 to be tracked over a guidewire 706. A supply lumen 708 is secured inside the aspiration lumen 710. The supply lumen 708 extends through a tapered tube 712. In some embodiments, the tapered tube 712 may be made from polyimide. In some embodiments, the tapered tube 712 may include an inner lumen diameter that tapers from its proximal end to its distal end. For example, in some embodiments, the inner lumen diameter may taper from about 0.0155 inches to about 0.011 inches. The supply lumen 708 extends generally parallel to the suction lumen 710, but the distal end 714 of the tapered tube 712 curves toward an inner wall surface 716 of the suction lumen 710, such that an open end 718 of the supply lumen 708 acts as an orifice for applying a spray pattern 720. The open end 718 of the supply lumen 708 can further promote a jet or spray effect by including an inner diameter that is less than about 0.008 inches. In some embodiments, the open end 718 of the supply lumen 708 can include an inner diameter that is between about 0.003 inches and about 0.004 inches. The central orifice of the open end 718 can, in some embodiments, be about 0.013 inches to about 0.019 inches proximal to the proximal-most portion 724 of the open distal end 722 of the aspiration lumen 710, as illustrated by distance D in FIG. 26. The distal-most portion 726 of the open distal end 722 of the aspiration lumen 710, in the illustrated embodiment, is slightly distal to the proximal-most portion 724 and thus includes an angled skive, but the skive angle A is about 0.013 inches to about 0.019 inches proximal to the proximal-most portion 724 of the open distal end 722 of the aspiration lumen 710. sis not critical. A skive angle A between about 75° and about 89°, or between about 80° and about 85°, may be used to allow the majority of the thrombus to be pulled into the open distal end 722 of the aspiration lumen 710 as it is impinged by the high velocity exiting jet (e.g., saline) stream as illustrated by the spray pattern 720. s may be used.

[0055]

[0137] FIG. 27 illustrates the catheter 700 of FIG. 26 utilized to deliver a drug 730 to a target site 732 within a blood vessel 165. The target site 732 may include an atherosclerotic lesion 728 and / or a thrombus 734. Whereas aspiration of a thrombus as in FIG. 26 involves actively applying a vacuum (e.g., from a vacuum source) onto the aspiration lumen 710, the drug delivery illustrated in FIG. 27 utilizes the same catheter 700 but allows for precise and accurate measurement of the volumetric flow rate of drug 730 to be delivered into the blood vessel. This is accomplished by applying significantly less vacuum to the aspiration lumen 710, or no vacuum at all to the aspiration lumen. Accurate measurement in small, controlled volumes provides efficient use of typically expensive drugs and minimizes wasted drug. Additionally, due to the relatively small diameter of the delivery lumen 708, the relatively small volume, or dead space, of the delivery lumen 708 ensures that when the drug 730 is injected, even an extremely small amount of inadvertent injection cannot occur.

[0056]

[0138] In some embodiments, the drug 730 may be delivered at body temperature. In other embodiments, the drug 730 may be warmed and delivered at an elevated temperature to enhance the activity and effect of the drug. This may be done, for example, to obtain a more effective dosage with a smaller volume of drug. In other embodiments, the drug 730 may be cooled and delivered at a reduced temperature (i.e., relative to body temperature). The drug 730 may be cooled to control the activity level or to slow the activity of the drug (e.g., to activate downstream, at a point not reachable by the catheter 700). In some cases, the drug 730 may be cooled to add a conjoint therapeutic cooling effect on the tissue being treated. In some cases, the therapeutic cooling effect may be achieved solely from chilled saline or other aqueous non-drug medium.

[0057]

[0139] Some drugs 730 that may be delivered include thrombolytics (clot-busting drugs), such as streptokinase, tissue plasminogen activator (t-PA), recombinant or genetically modified tissue plasminogen activator, tenecteplase (TNK), urokinase, staphylokinase, and reteplase. Alternatively, stem cells or a "cocktail" containing stem cells may be delivered. In some cases, glycoprotein inhibitors (GPI's) may be injected through the supply lumen 708 of the aspiration catheter 700. Saline or other aqueous solutions may be delivered solely for selective dilution of blood at the target site 732. In some applications, solutions may be used that can exhibit a phase change, for example, when pressure or temperature is altered. In these applications, a liquid may be injected that becomes a gas when it exits a small orifice, for example, at the open end 718 of the supply lumen 708. Alternatively, a gas may be injected that becomes a liquid when forced through a small orifice, such as the open end 718 of the supply lumen 708. In any application in which a drug 730 or other material is injected into a blood vessel through the catheter 700, the injection of the drug 730 or other material may occur before, during, after, or instead of the aspiration procedure. Returning to the aspiration catheter 818 of FIGS. 21-22, if it is desired to transport a drug downstream of the supply lumen and into the blood vessel during the aspiration procedure, the tube set 803 can be removed from the aspiration catheter 818 by disconnecting the male luer 854 of the tube set 803 from the female luer 851 of the aspiration catheter 818, and the drug can be injected directly into the supply lumen at the female luer 851, for example, by a syringe or by a metering system including a syringe / syringe pump combination. By further removing the vacuum source from the female luer 855 of the aspiration catheter 818, the aspiration lumen then serves as a drain, so that the fluid being transported into the patient (e.g., into the blood vessel) is maintained at a controlled rate. Because the volume of the delivery lumen is relatively very small, only a small volume of drug is required to fill the delivery lumen and thus reach the distal tip of the aspiration catheter 818 .This allows for a very cost-effective procedure as very little drug needs to be wasted or discarded at the end of the procedure.

[0058]

[0140] In the embodiments described herein, a sterile flow path is provided extending all the way from the fluid source 20 to the distal opening 40 of the catheter 16 / the open distal end 158 of the catheter 118. In both the embodiments of the system 100 of Figures 4-17, the system 800 of Figures 21-23, and the embodiment of Figures 24-25, the disposable catheters and disposable pump sets are supplied sterile and are configured to be coupled to non-sterile (reusable) pump bases 200 or pump motors 502. These combinations allow the more expensive components to be reusable and the less expensive components to be reusable (and sterility maximized), thereby simultaneously maximizing cost containment and patient safety.

[0059]

[0141] FIG. 28 shows an aspiration catheter 900 comprising a shaft 901 containing an aspiration lumen 902 and a supply tube 903 having a supply lumen 904 (high pressure lumen). The supply tube 903 is secured to the inner wall 906 of the shaft 901, such as by adhesive, epoxy, mechanical fastening, or thermal bonding or adhesion. The supply lumen 904 is configured to transport a pressurized fluid 912, which may include saline, a lytic (thrombolytic) agent, a contrast agent, or other agents. In use, the pressurized fluid 912 exits an orifice 908 adjacent the distal end 910 of the supply lumen 904 in a spray pattern 914 and impacts an inner wall surface 916 of the aspiration lumen 902. The one or more agents may be undiluted or diluted (such as with saline). The jet spray impingement 911 impacting the inner wall surface 916 may form a distal element and / or a proximal element, as described in further detail in Figures 32, 36, and 40. The distal or proximal elements may be partially or entirely directed generally distally or generally proximally depending on factors, individually or in any combination, such as a particular level of positive pressure of pressurized fluid 912 in supply lumen 904, or a particular shape of orifice 908, or a particular level of negative pressure on suction lumen 902, or a particular shape of inner wall surface 916. A pump, syringe, or other pressurized source may be connected to the proximal end of supply lumen 904 to pressurize or pulsate supply lumen 904. In some embodiments, a pump base 200 (FIG. 12) may be used to supply and pressurize fluid 912 to supply lumen 904. Supply tube 903 includes a plug 918 blocking the end of supply lumen 904 such that pressurized fluid 912 is forced through orifice 908 and into suction lumen 902, with plug 918 acting to apply sufficient pressure so that pressurized fluid 912 hits inner wall surface 916.

[0060]

[0142] The spray pattern 914 may be directed by the orifice 908 toward the inner wall surface 916 at a right angle 914a (i.e., at a 90 degree angle) relative to the longitudinal axis 917 of the suction catheter 900, and / or at a distally facing oblique angle 914b or at a proximally facing oblique angle 914c, impinging on the inner wall surface 916. The spray pattern 914 may include two or three of these elements 914a, 914b, 914c.

[0061]

[0143] An alternative embodiment of an aspiration catheter 915 is shown in FIG. 29 and includes a shaft 921 having an aspiration lumen 922 and a supply tube 923 that includes a supply lumen 924 (high pressure lumen). The supply tube 923 is secured to an inner wall 926 of the shaft 921. The supply lumen 924 is configured to transport a pressurized fluid 912, which may include saline, a lytic (thrombolytic) agent, a contrast agent, or other agents. One or more of the agents may be undiluted or may be diluted (such as with saline). The pressurized fluid 912 exits an orifice 928 adjacent a distal end 920 of the supply lumen 924 in a spray pattern 919 and impinges on the inner wall surface 909 of the aspiration lumen 922. The inner wall surface 909 includes an additional element 929 (e.g., a deflection element) configured to deflect at least a portion of the spray pattern 919 in either a proximal or distal direction. The deflection element 929 includes a forward slope 927 and a reverse slope 925 that converge at a section line 931. The forward slope 927 is configured to deflect at least a portion of the spray pattern 919 in a distal direction, and the reverse slope 925 is configured to deflect at least a portion of the spray pattern 919 in a proximal direction. The jet spray impingement on the inner wall surface 909 may include distal and / or proximal elements, as described in more detail in FIG. 33 and FIG. 37. In other embodiments, the inner wall surface 909 may simply be a deformation of a portion of the inner wall surface 926 itself. This deformation may take the place of and act as the deflection element 929. The modification may be to angulate or shape the distal end 907 of the suction catheter 900 so that the inner wall 926 has, for example, one or more slopes or an angled, i.e., curved, surface.

[0062]

[0144] The distal or proximal element may be a portion of the pressurized fluid 912 within the supply lumen 924. The spray pattern 912 may be directed generally distally or generally proximally, either partially or entirely, depending on factors such as a certain level of positive pressure, or the particular shape of the orifice 928, or the particular level of negative pressure on the suction lumen 922, or the particular shape of the inner wall surface 909, individually or in any combination thereof. A pump, syringe or other pressure source may be coupled to the proximal end of the supply lumen 924 so that the supply lumen 924 can be pressurized or pulsated. The supply tube 923 includes a plug 932 blocking the distal end 920 of the supply lumen 924, which forces the pressurized fluid 912 through the orifice 928 and into the suction lumen 922, and the plug 932 acts to apply sufficient pressure so that the pressurized fluid 912 hits the inner wall surface 909 having the beveled surfaces 925, 927. In some embodiments, the portion of the spray pattern 919 that hits the forward beveled surface 927 is deflected distally. In some embodiments, the portion of the spray pattern 919 that strikes the reverse ramp 925 is deflected proximally. In some embodiments, a particular amount of negative pressure applied to the suction lumen 922 (e.g., by a vacuum source) controls the amount of the spray pattern 919 that strikes each ramp 925, 927.

[0063]

[0145] In the suction catheter 915 of Figure 29, the beveled surfaces 925, 927 of element 929 extend linearly from the section line 931, such that the effective inner diameter of the aspiration lumen varies linearly with longitudinal position along the beveled surfaces 925, 927. In contrast, Figure 30 illustrates an suction catheter 934 having non-linear (e.g., curved) beveled surfaces 942, 944 extending across the section line 933. The suction catheter 934 comprises a shaft 935 including an suction lumen 936 and a supply tube 937 having a supply lumen 938 (high pressure lumen). The suction catheter 934 further comprises a deflecting element 940 having beveled surfaces 942, 944, which have concave contours 946, 948, respectively, such that the effective inner diameter of the aspiration lumen varies non-linearly with longitudinal position along the beveled surfaces 942, 944. In some embodiments, the deflection element 940 may be configured to direct and / or deflect a spray pattern 947 (out of the orifice 949) that is narrow and / or includes a jet. In other embodiments, the deflection element 929 of the suction catheter 915 of FIG. 29 may be configured to direct and / or deflect a spray pattern 919 that is wide or highly divergent or diffuse.

[0064]

[0146] 31 shows an aspiration catheter 950 comprising a shaft 951 including an aspiration lumen 952 and a supply tube 953 having a supply lumen 954 (high pressure lumen). The aspiration catheter 950 further comprises a deflection element 956 having a single distally facing beveled surface 958 configured to deflect at least a portion of a spray pattern 960 exiting an orifice 962 in a generally distal direction.

[0065]

[0147] FIG. 32 shows the aspiration catheter 900 of FIG. 28 being used in a blood vessel 964 as part of an aspiration system 10, or a system 100, 800 for thrombus aspiration. FIG. 32 shows the aspiration catheter 900 in a first mode of operation configured to substantially aspirate the thrombus 966. A Venturi effect is created by the spray pattern 914, which may include a jet. Thus, a suction force is created at the distal opening 968 of the aspiration lumen 902, and the thrombus 966 is aspirated into the aspiration lumen 902. Also, an aspiration pressure (negative pressure) may be applied (e.g., by a vacuum source such as a syringe, vacuum chamber, or vacuum pump) at the proximal end of the aspiration lumen 902, thereby maintaining a flow of the thrombus 966 through the aspiration lumen 902. The impact of the spray pattern 914 of the pressurized fluid 912 on the inner wall surface 916 of the aspiration lumen 902 opposite the orifice 908 can also soften the thrombus 966 into small pieces 970, which can help lower the effective viscosity of the composite fluid flowing through the aspiration lumen 902. The application of a large vacuum / aspiration pressure to the proximal end of the aspiration lumen 902 can soften the thrombus 966 and the small pieces 970 of the thrombus 966. After impacting the inner wall surface 916, the spray pattern 914 is at least partially redirected into a generally proximally directed stream 955.

[0066]

[0148] FIG. 33 illustrates the aspiration catheter 915 of FIG. 29 being used in a blood vessel 964 as part of an aspiration system 10, or a system 100, 800 for thrombus aspiration. FIG. 33 illustrates the aspiration catheter 915 in a first mode of operation configured to substantially aspirate the thrombus 966. A Venturi effect is created by the spray pattern 919, which may include a jet. Thus, a suction force is created at the distal opening 972 of the aspiration lumen 922, and the thrombus 966 is aspirated into the aspiration lumen 922. Also, an aspiration pressure (negative pressure) may be applied (e.g., by a vacuum source such as a syringe, vacuum chamber, or vacuum pump) at the proximal end of the aspiration lumen 922, thereby maintaining a flow of the thrombus 966 through the aspiration lumen 922. The spray pattern 919 of pressurized fluid 912 impinging on the reverse slope 925 of the deflection element 929 opposite the orifice 928 can also soften the thrombus 966 into small pieces 970 and help lower the effective viscosity of the composite fluid flowing through the aspiration lumen 902. A large vacuum / aspiration pressure can be applied to the proximal end of the aspiration lumen 922 to optimize removal of the thrombus 966 and small pieces 970 of the thrombus 966. After impinging on the reverse slope 925 of the deflection element 929, the spray pattern 919 is at least partially redirected into a generally proximally directed flow 957.

[0067]

[0149] FIG. 34 illustrates the aspiration catheter 934 of FIG. 30 being used in a blood vessel 964 as part of an aspiration system 10, or a system 100, 800 for thrombus aspiration. FIG. 34 illustrates the aspiration catheter 934 in a first mode of operation configured to substantially aspirate the thrombus 966. A Venturi effect is created by the spray pattern 947, which may include a jet. Thus, a suction force is created at the distal opening 974 of the aspiration lumen 936, and the thrombus 966 is aspirated into the aspiration lumen 936. Also, an aspiration pressure (negative pressure) may be applied (e.g., by a vacuum source such as a syringe, vacuum chamber, or vacuum pump) at the proximal end of the aspiration lumen 936, thereby maintaining a flow of the thrombus 966 through the aspiration lumen 936. The spray pattern 947 of pressurized fluid 912 impinging on the reverse slope 944 of the deflection element 940 opposite the orifice 949 can also soften the thrombus 966 into small pieces 970 and help lower the effective viscosity of the composite fluid flowing through the aspiration lumen 936. A large vacuum / aspiration pressure can be applied to the proximal end of the aspiration lumen 936 to optimize removal of the thrombus 966 and small pieces 970 of the thrombus 966. After impinging on the reverse slope 944 of the deflection element 940, the spray pattern 947 is at least partially redirected into a generally proximally directed flow 959.

[0068]

[0150] FIG. 35 shows the aspiration catheter 950 of FIG. 31, which is used within blood vessel 964 as part of aspiration system 10, or systems 100, 800 for thrombus aspiration. FIG. 35 shows the aspiration catheter 950 in a first mode of operation configured to substantially aspirate thrombus 966. A Venturi effect is created by spray pattern 960, which may include jets. Thus, a suction force is generated at distal opening 976 of suction lumen 952, and thrombus 966 is aspirated into suction lumen 952. Also, a suction pressure (negative pressure) may be applied at the proximal end of suction lumen 952 (e.g., by a vacuum source such as a syringe, vacuum chamber, or vacuum pump), thereby maintaining the flow of thrombus 966 through suction lumen 952. The spray pattern 960 of pressurized fluid 912 impinges on inner wall surface 978 proximal to deflector element 956, which faces orifice 962, thereby softening thrombus 966 into small pieces 970 and assisting in lowering the effective viscosity of the complex fluid flowing through suction lumen 952. By applying a large vacuum pressure / suction pressure at the proximal end of suction lumen 952, the removal of thrombus 966, and small pieces 970 of thrombus 966 can be optimized. After impinging on inner wall surface 978 proximal to deflector element 956, spray pattern 960 is converted into a flow 961 that is at least partially directed in a generally proximal direction.

[0069]

[0151] FIG. 36 illustrates the aspiration catheter 900 of FIG. 28 being used in a blood vessel 964 as part of an aspiration system 10, or a system 100, 800 for thrombus aspiration. FIG. 36 illustrates the aspiration catheter 900 in a second mode of operation, configured to deliver a fluid (such as a fluid containing a drug) distally from a distal opening 968 of the aspiration lumen 902. A spray pattern 914 of pressurized fluid 912 impinges on an inner wall surface 916 of the aspiration lumen 902 opposite the orifice 908, converting the spray pattern 914 at least partially into a generally distally directed flow 963. Also, because the aspiration pressure (negative pressure) may be reduced, stopped entirely, or simply not applied at the proximal end of the aspiration lumen 902, at least a portion of the spray pattern 914 may be converted into a generally distally directed flow 963 after impinging on the inner wall surface 916. In some embodiments, the orifice 908 and / or the inner wall surface 916 may be configured such that under some conditions the generally distally directed flow 963 itself may become a jet. The agent may include a lytic agent, such as a thrombolytic agent, or may include a contrast agent. The generally distally directed flow 963 may include 50% or more, 60% or more, 70% or more, 80% or more, or 90% or more, or 100% of the (deflected) spray pattern 914.

[0070]

[0152] FIG. 37 illustrates the aspiration catheter 915 of FIG. 29 being used within a blood vessel 964 as part of an aspiration system 10, or a system 100, 800 for thrombus aspiration. FIG. 37 illustrates the aspiration catheter 915 in a second mode of operation, configured to deliver a fluid (such as a fluid containing a drug) distally from a distal opening 972 of the aspiration lumen 922. A spray pattern 919 of the pressurized fluid 912 impinges on a forward slope 927 of a deflection element 929, which faces an orifice 928, converting the spray pattern 919 at least partially into a generally distally directed flow 965. Also, because the aspiration pressure (negative pressure) may be reduced, stopped entirely, or simply not applied at the proximal end of the aspiration lumen 922, at least a portion of the spray pattern 919 may be converted into a generally distally directed flow 965 after impinging on the forward slope 927 of the deflection element 929. In some embodiments, the orifice 928 and / or the forward slope 927 of the deflecting element 929 may be configured such that under some conditions the generally distally directed flow 965 may itself become a jet. The agent may include a lytic agent, such as a thrombolytic agent, or may include a contrast agent.

[0071]

[0153] FIG. 38 illustrates the aspiration catheter 934 of FIG. 30 being used within a blood vessel 964 as part of an aspiration system 10, or a system 100, 800 for thrombus aspiration. FIG. 38 illustrates the aspiration catheter 934 in a second mode of operation, configured to deliver fluid (such as a fluid containing a drug) distally from a distal opening 974 of the aspiration lumen 936. A spray pattern 947 of pressurized fluid 912 impinges on a forward slope 942 of the deflection element 940, which faces an orifice 949, converting the spray pattern 947 at least partially into a generally distally directed flow 967. Also, because the aspiration pressure (negative pressure) may be reduced, stopped entirely, or simply not applied at the proximal end of the aspiration lumen 936, at least a portion of the spray pattern 947 may be converted into a generally distally directed flow 967 after impinging on the forward slope 942 of the deflection element 940. In some embodiments, the orifice 949 and / or the forward bevel 942 of the deflecting element 940 may be configured such that under some conditions the generally distally directed flow 967 may itself become a jet. The agent may include a lytic agent, such as a thrombolytic agent, or may include a contrast agent.

[0072]

[0154] FIG. 39 illustrates the aspiration catheter 950 of FIG. 31 being used within a blood vessel 964 as part of an aspiration system 10, or a system 100, 800 for thrombus aspiration. FIG. 39 illustrates the aspiration catheter 950 in a second mode of operation, configured to deliver fluid (such as a fluid containing a drug) distally from a distal opening 976 of the aspiration lumen 952. A spray pattern 960 of pressurized fluid 912 impinges on a distally facing beveled surface 958 of the deflection element 956, opposite the orifice 962, converting the spray pattern 960 at least in part into a generally distally directed stream 969. Also, because the aspiration pressure (negative pressure) may be reduced, stopped entirely, or simply not applied at the proximal end of the aspiration lumen 952, at least a portion of the spray pattern 960 may be converted into a generally distally directed stream 969 after impinging on the distally facing beveled surface 958 of the deflection element 956. In some embodiments, the orifice 962 and / or the distally facing beveled surface 958 of the deflecting element 956 may be configured such that under some conditions the generally distally directed flow 969 may itself become a jet. The agent may include a lytic agent, such as a thrombolytic agent, or may include a contrast agent.

[0073]

[0155] Delivery of agents, including drugs, using the second mode of operation described with respect to the aspiration catheters 900, 915, 934, 950 in Figures 36-39 can be accomplished in a precise manner that allows for correct administration without wasting the often expensive drugs. The small internal diameter of the cross-sectional dimensions of the delivery lumens 904, 924, 938, 954 allows for precise, small doses of drug to be introduced, as well as avoiding unnecessary drug waste when it is desired to abruptly stop the infusion. This is a significant improvement over standard gravity-based infusion systems. Additionally, the use of the pump base 200 (Figure 12) to pressurize the delivery lumens 904, 924, 938, 954 to deliver the drug provides additional accuracy, control, and eliminates waste. This can reduce the cost of the procedure, increase the accuracy of drug administration (or contrast delivery, for example), and increase the speed of the procedure due to fewer corrections and repeat procedures, which can be another cost-saving factor in itself. Although the term "suction" is used in defining the suction lumens 902, 922, 936, 952 and the suction catheters 900, 915, 934, 950, it will be apparent that a user may choose to use the suction catheters 900, 915, 934, 950 only in the second mode described with respect to Figures 36-39, or in some cases, only in the second mode without any suction.

[0074]

[0156] Fig. 40 illustrates the aspiration catheter 900 of Fig. 28 being used within a blood vessel 964 as part of an aspiration system 10, or system 100, 800 for thrombus aspiration. Fig. 40 illustrates the aspiration catheter 900 in a third mode of operation configured to deliver a fluid (such as a fluid containing a medicinal agent) distally out of a distal opening 968 of the aspiration lumen 902 while also aspirating at least a portion of the thrombus 966. A spray pattern 914 of pressurized fluid 912 impacts an inner wall surface 916 of the aspiration lumen 902 opposite the orifice 908, causing the spray pattern 914 to split at least in part into a generally distally directed flow 963 and a generally proximally directed flow 955. At the proximal end of the aspiration lumen 902, aspiration pressure (negative pressure) may be applied, adjusted, increased, or decreased to convert at least a portion of the spray pattern 914 into a generally distally directed stream 963 after impacting the inner wall surface 916, and to convert at least a portion of the spray pattern 914 into a generally proximally directed stream 955 after impacting the inner wall surface 916. In some embodiments, the orifice 908 and / or the inner wall surface 916 may be configured such that under some conditions, the generally distally directed stream 963 itself may become a jet. The agent may include a lytic agent, such as a thrombolytic agent, or may include a contrast agent.

[0075]

[0157] FIG 41 shows the aspiration catheter 934 of FIG 30 being used within a blood vessel 964 as part of an aspiration system 10, or a system 100, 800 for thrombus aspiration. 41 illustrates the aspiration catheter 934 in a third mode of operation configured to deliver a fluid (such as a fluid containing a medicinal agent) distally out of a distal opening 974 of the aspiration lumen 936 while also aspiration at least a portion of the thrombus 966. A spray pattern 947 of pressurized fluid 912 impinges on the angled surfaces 942, 944 of the deflection element 940 opposite the orifice 949, causing the spray pattern 947 to split at least in part into a generally distally directed flow 967 and a generally proximally directed flow 959. At the proximal end of the aspiration lumen 936, aspiration pressure (negative pressure) may be applied, adjusted, increased, or decreased to convert at least a portion of the spray pattern 947 into a generally distally directed stream 967 after impacting the forward slope 942 of the deflection element 940, and to convert at least a portion of the spray pattern 947 into a generally proximally directed stream 959 after impacting the reverse slope 944 of the deflection element 940. In some embodiments, the orifice 949 and / or the forward slope 942 of the deflection element 940 may be configured such that under some conditions, the generally distally directed stream 967 may itself become a jet. The agent may include a lytic agent, such as a thrombolytic agent, or may include a contrast agent.

[0076]

[0158] 42 shows an aspiration catheter 1000 comprising a shaft 1001 including an aspiration lumen 1002, a first supply tube 1003 having a first supply lumen 1004, and a second supply tube 1005 having a second supply lumen 1006. The first supply tube 1003 and the second supply tube 1005 are secured to an inner wall 1008 of the shaft 1001. The first supply lumen 1004 is configured to deliver a pressurized fluid 912, which may include saline, a lytic (thrombolytic) agent, a contrast agent, or other agents. The pressurized fluid 912 exits a first orifice 1010 of the first supply lumen 1004 in a spray pattern 1014 and is directed at an oblique angle 1016 that is distally directed relative to a longitudinal axis 1018 of the aspiration catheter 1000. The second supply lumen 1005 is configured to deliver a pressurized fluid 912, which may include saline, a lytic (thrombolytic) agent, a contrast agent, or other agents. The pressurized fluid 912 exits a second orifice 1020 of the second supply lumen 1006 in a spray pattern 1022 and is directed at an oblique angle 1024 that faces proximally relative to the longitudinal axis 1018 of the aspiration catheter 1000. The one or more agents may be undiluted or diluted (e.g., with saline).

[0077]

[0159] The first curved hollow tip extension 1026 has an outer diameter at its proximal end 1012 for insertion into the first supply lumen 1004 of the first supply tube 1003. The curvature of the first curved hollow tip extension 1026 is such that the spray pattern 1014 exits the first orifice 1010 at a distally directed oblique angle 1016 such that a generally distally directed flow 1028 is directed or oriented out the open distal end 1030 of the aspiration lumen 1002. The second curved hollow tip extension 1032 has an outer diameter at its proximal end 1034 for insertion into the second supply lumen 1006 of the second supply tube 1005. The curvature of the second curved hollow tip extension 1032 causes the spray pattern 1022 to exit the second orifice 1020 at a proximally directed oblique angle 1024 such that a generally proximally directed flow 1038 is directed toward the inner wall surface 1040 of the aspiration lumen 1002. Negative pressure may be applied and adjusted at the proximal end of the aspiration lumen 1002 to adjust the extent of aspiration (e.g., of thrombus, or blood) and distal delivery of agent through the first orifice 1010.

[0078]

[0160] 43 shows an aspiration catheter 1050 comprising a shaft 1051 including an aspiration lumen 1052 and a first supply tube 1053 having a first supply lumen 1054. The first supply tube 1053 branches into a first tubular branch 1046 having a first branch lumen 1047 and a second tubular branch 1048 having a second branch lumen 1049. The first tubular branch 1046 and the second tubular branch 1048 are connected to the shaft 1051. The first supply lumen 1054, the first tubular branch 1046, and the second tubular branch 1048 are configured to transport a pressurized fluid 912, which may include saline, a lytic (thrombolytic) agent, a contrast agent, or other agents. The pressurized fluid 912 exits a first orifice 1058 of the first branch lumen 1047 in a spray pattern 1060 and is directed at a distally directed oblique angle 1062 relative to a longitudinal axis 1064 of the aspiration catheter 1050. The pressurized fluid 912 exits a second orifice 1066 of the second branch lumen 1049 in a spray pattern 1068 and is directed at a proximally directed oblique angle 1070 relative to a longitudinal axis 1064 of the aspiration catheter 1050. The one or more agents may be undiluted or diluted (e.g., with saline). An inner wall 1078 of the aspiration lumen 1052 may be provided with one or more deflection members 1072 having one or more slopes 1074, 1076 (e.g., a forward slope 1074 and a reverse slope 1076) for deflecting one or both of the spray patterns 1060, 1068 to generate a distally directed flow 1080 and / or a proximally directed flow 1082. In other embodiments, the forward slope 1074 and / or reverse slope 1076 may simply be a protrusion of the inner wall 1078 or may be formed by deflecting the shaft 1001.

[0079]

[0161] 44A shows a catheter 1200 comprising a shaft 1202 including a lumen 1203 and a supply tube 1204 having a supply lumen 1206. The supply tube 1204 has an orifice 1210 secured to an inner wall 1208 of the shaft 1202 and configured to direct pressurized fluid into a spray pattern 1212, which may form a jet. The spray pattern 1212 is directed to impinge on an opposing deflectable member 1214, which may be a separate piece secured to the inner wall 1208 of the shaft 1202 or may be a molded part of the shaft 1202. The lumen 1204 is a guidewire lumen configured to allow the catheter 1200 to track a guidewire (not shown). In use, the catheter 1200 is operated as an infusion catheter, and the guidewire may be retracted proximally of the orifice 1210 and deflection member 1214, so that it can function with reduced potential for interference. In some cases, the guidewire may be removed entirely. In other embodiments, the lumen 1204 may be an aspiration lumen configured to aspirate material, such as a thrombus or other emboli. The lumen may alternatively have other purposes, such as a conduit for larger volume injections or infusions. The deflection member 1214 has a flat surface extending transversely or radially and is configured to deflect the spray pattern 1212. For example, the deflection member 1214 may be configured to deflect the spray pattern 1212 to cause at least a portion of the agent delivered by the spray pattern 1212 to exit the distal opening 1215 of the lumen 1204.

[0080]

[0162] FIG. 44B shows a catheter 1216 with a shaft 1218 including a lumen 1220 and a supply tube 1222 having a supply lumen 1224. The supply tube 1222 is secured to an inner wall 1226 of the shaft 1218 and has an orifice 1228 configured to direct pressurized fluid into a spray pattern 1230, which may form a jet. The spray pattern 1230 is directed to impinge on an opposing deflectable member 1232, which may be a separate piece secured to the inner wall 1226 of the shaft 1218 or may be a molded part of the shaft 1218. The lumen 1220 may be a guidewire lumen, and / or an aspiration lumen, similar to the lumen 1203 of the catheter 1200 of FIG. 44A, or may have other purposes. The deflection member 1232 has a longitudinal, or axial, flat surface and is configured to deflect the spray pattern 1230. For example, the deflection member 1232 may deflect the spray pattern 1230 to direct at least a portion of the agent delivered by the spray pattern 1230 out of a distal opening 1234 of the lumen 1220. The present invention may be configured as follows.

[0081]

[0163] 45A shows a catheter 1236 comprising a shaft 1238 including a lumen 1240 and a supply tube 1242 having a supply lumen 1244. The supply tube 1242 is secured to an inner wall 1246 of the shaft 1238 and has an orifice 1248 configured to direct pressurized fluid into a spray pattern 1250, which may form a jet. The spray pattern 1250 is directed to impinge on an opposing deflectable member 1252, which may be a separate piece secured to the inner wall 1246 of the shaft 1238 or may be a molded part of the shaft 1238. The lumen 1240 is a guidewire lumen configured to allow the catheter 1236 to track a guidewire (not shown). In use, the catheter 1236 is operated as an infusion catheter and the guidewire may be retracted proximally of the orifice 1248 and the deflection member 1252 so that it can function with reduced potential for interference. In some cases, the guidewire may be removed entirely. In other embodiments, the lumen 1240 may be an aspiration lumen configured to aspirate material such as thrombus or other emboli. The lumen may alternatively have other purposes, such as a conduit for larger volume injections or infusions. The deflection member 1252 has a convex surface when viewed in end view and is configured to deflect the spray pattern 1250. For example, the deflection member 1252 may be configured to deflect the spray pattern 1250 to direct at least a portion of the agent delivered by the spray pattern 1250 out of a distal opening 1254 of the lumen 1240.

[0082]

[0164] FIG. 45B shows a catheter 1256 comprising a shaft 1258 including a lumen 1260 and a supply tube 1262 having a supply lumen 1264. The supply tube 1262 has an orifice 1268 secured to an inner wall 1266 of the shaft 1258 and configured to direct pressurized fluid into a spray pattern 1270, which may form a jet. The spray pattern 1270 is directed to impinge on an opposing deflection member 1272, which may be a separate piece secured to the inner wall 1266 of the shaft 1258 or may be a molded part of the shaft 1258. The lumen 1260 may be a guidewire lumen and / or an aspiration lumen, or may have other purposes. The deflection member 1272 has a convex surface when viewed from the side and is configured to deflect the spray pattern 1270. For example, the deflection member 1272 may be configured to deflect the spray pattern 1270 to cause at least a portion of the agent delivered by the spray pattern 1270 to exit a distal opening 1274 of the lumen 1260 .

[0083]

[0165] 46A and 46B show a catheter 1276 comprising a shaft 1278 including a lumen 1280 and a supply tube 1282 having a supply lumen 1284. The supply tube 1282 is secured to an inner wall 1286 of the shaft 1278 and has an orifice 1288 configured to direct pressurized fluid into a spray pattern 1290, which may form a jet. The spray pattern 1290 is directed to impinge on an opposing adjustable deflectable member 1292, which has at least two states, a first state (FIG. 46A) and a second state (FIG. 46B). In the illustrated embodiment, the adjustable deflectable member 1292 includes a balloon secured to the inner wall 1286 of the shaft 1278 such that the balloon may be inflated and deflated via a fluid passageway 1294 within or supported by the shaft 1278. An inflation device, with or without a volumetric measurement device, pressure sensor, and / or pressure gauge, may be coupled to the proximal end of fluid passageway 1294 to assist in inflating or deflating the balloon. Lumen 1280 is a guidewire lumen configured to allow catheter 1276 to track a guidewire (not shown). In use, the catheter The catheter 1276 may be operated as an infusion catheter, with the guidewire retracted proximally of the orifice 1288 and adjustable deflection member 1292, so that it can function with reduced potential for interference. In some cases, the guidewire may be removed entirely. In other embodiments, the lumen 1280 may be an aspiration lumen configured to aspirate material such as thrombus or other emboli. The lumen may alternatively have other purposes, such as a conduit for larger volume injections or infusions.

[0084]

[0166] The adjustable deflection member 1292 is configured to deflect the spray pattern 1290 in at least one of its two or more states. For example, the adjustable deflection member 1292 may be configured to deflect the spray pattern 1290 to cause at least a portion of the agent delivered by the spray pattern 1290 to exit a distal opening 1296 of the lumen 1280. In a first state, shown in FIG. 46A, the adjustable deflection member 1292 is contracted, in other words, its interior volume 1298 is substantially empty. For example, the first state may be desired when threading the catheter 1276 over a guidewire extending through the lumen 1280, or when applying aspiration through the lumen 1280 (with or without a guidewire in place). In another variation of the first state, an additional vacuum (negative pressure) may be placed and maintained in the fluid passageway 1294 (from an emptied syringe or emptied lock syringe at the proximal end of the fluid passageway 1294) to minimize the profile of the contracted adjustable biasing member 1292 and maximize the cross-sectional area of ​​the lumen 1280 in this region. In the second state, shown in FIG. 46B, fluid is injected (e.g., by a syringe or other type of inflation device) through the fluid passageway 1294 and into the interior volume 1298 of the adjustable biasing member 1292 via an opening 1299 between the fluid passageway 1294 and the interior volume 1298. The adjustable biasing member 1292 in the second state is configured to deflect the spray pattern 1290 in a desired direction, at least partially exiting through a distal opening 1296 of the lumen 1280. 46B as having a convex shape, in other embodiments, the balloon or other structure that makes up the adjustable deflection member 1292 may be made to form one or more linear slopes or other shapes. There may also be several different shapes or sizes that may be achieved by injecting different volumes of fluid into the interior volume 1298 to adjust the adjustable deflection member 1292 to several different states. During manufacture, the shape of the adjustable deflection member 1292 may be heat formed using one or more molds or fixtures.Yet another condition may also be possible in which the adjustable deflection member 1292 is expanded sufficiently to nearly or completely block the lumen 1280, or to partially or completely block the orifice 1288. This other condition may be desirable, for example, if an embolus has been aspirated into the catheter and it is desired to keep the embolus securely within the catheter 1276 while the catheter 1276 is removed from the patient.

[0085]

[0167] FIG. 47 shows a supply tube 1300 with a lumen 1302, a wall 1304, and an orifice 1306 through the wall 1304. The spray pattern 1308 emanating from the orifice 1306 emanates from the pressurized fluid in the lumen 1302 and results in a generally solid or straight stream without a significant increase in the width (or diameter) W of the stream. FIG. 48 shows a supply tube 1310 with a lumen 1312, a wall 1314, and an orifice 1316 through the wall 1314. The spray pattern 1318 emanating from the orifice 1316 emanates from the pressurized fluid in the lumen 1312 and results in a diverging stream with an included angle x. FIG. 49 shows a three-dimensional depiction of the diverging stream spray pattern 1320 such that the spray pattern 1320 is cone-shaped 1322.

[0086]

[0168] FIG. 50 illustrates a lumen 1326, a wall 1328, and an orifice 1328 through the wall 1328. 51 shows a supply tube 1324 with an orifice 1330. The spray pattern 1332 emanating from the orifice 1330 emanates from the pressurized fluid in the lumen 1326 and results in a hollow cone-shaped stream 1334. FIG. 51 shows a supply tube 1336 with a lumen 1338, a wall 1340, and a rectangular orifice 1342 through the wall 1340. The spray pattern 1344 emanating from the rectangular orifice 1342 emanates from the pressurized fluid in the lumen 1338 and results in a diverging wedge-shaped stream 1346.

[0087]

[0169] 52 shows a delivery tube 1348 with a lumen 1350, a wall 1352, and an orifice 1354 through the wall 1352. A spray pattern 1356 emanating from the orifice 1354 has a direction vector V that originates from the pressurized fluid within the lumen 1350 and is angled at an angle y relative to the axis AO of the orifice 1354. The direction vector represents a center of the spray pattern 1356. The spray pattern 1356 diverges and has an included angle x. The spray pattern has a distal-most end 1355 and a proximal-most end 1357. The distal-most end 1355 is angled at an angle z relative to the axis AO of the orifice 1354. D and the proximal end 1357 is at an angle z with respect to the axis AO of the orifice 1354. P In other embodiments, spray pattern 1356 may have a shape similar to any of spray patterns 1308, 1318, 1320, 1332, 1344 of Figures 47-51, or any other shape.

[0088]

[0170] The shapes of any of the spray patterns 1308, 1318, 1320, 1332, 1344, 1356 may be adjusted by modifying the configuration of the orifices in the wall of the supply tube (cross-sectional dimensions, diameter, length or wall thickness, angle, taper angle, cross-sectional shape) to facilitate the spray pattern(s) interacting with the inner wall surface 916, 1040, 1078 or deflection elements / members 929, 940, 956, 1072, 1214, 1232, 1252, 1272, 1292 to generate a number of different flow shapes, including generally distally directed flow and / or generally proximally directed flow. The spray patterns 1308, 1318, 1320, 1332, 1344, 1356 may be adjusted to have the physical characteristics of a jet, stream, mist, or other spray. The spray patterns 1308, 1318, 1320, 1332, 1344, 1356 may be convertible between these different modes, or shapes, by varying the pressure of the pressurized fluid.

[0089]

[0171] FIG. 53 shows an aspiration catheter 1360 inserted into a blood vessel 1362 (artery, vein, etc.) with an open distal end 1364 of an aspiration lumen 1366 adjacent a thrombus / blood clot 1368. The aspiration catheter 1360 further includes a supply tube 1370 having a supply lumen 1372 and a guide tube 1374 having a guidewire lumen 1376 configured to track a guidewire 1378. Diluted or undiluted contrast media is pressurized by a syringe, pump, or other means through the supply lumen 1372 and out an orifice 1380 at a distal end 1382 of the supply lumen 1372. The jet spray 1384 may include distal and / or proximal elements. The distal element 1386 (FIG. 54) may be a generally distally oriented element and may at least partially exit the open distal end 1364 of the aspiration lumen 1366. Once the distal element 1386 has filled the volume around the thrombus / blood clot 1368 (FIG. 54), it may be viewed radiographically or fluoroscopically and the boundary 1388 of the thrombus / blood clot 1368 may be identified. When the boundary 1388 is located as close as desired to the open distal end 1364 of the aspiration lumen 1366 of the aspiration catheter 1360, the user may wish to inject or pump (e.g., with a syringe or pump) through the supply lumen 1372 using high pressure to initiate or continue the thrombolytic procedure. In some cases, the user may use diluted or undiluted contrast agent to perform the thrombolytic procedure. In some cases, the diluted or undiluted contrast agent may be combined or mixed with a lytic agent. In other cases, The user may replace the diluted or undiluted contrast with saline or a dissolving agent, for example, by priming the supply lumen. If the boundary 1388 is located more distal than desired to the open distal end 1364 of the aspiration lumen 1366 of the aspiration catheter 1360, the user may choose to advance the aspiration catheter 1360 until the open distal end 1364 is in the desired proximity to the boundary 1388 of the thrombus / blood clot 1368. In some cases, the desired proximity may be when the open distal end 1364 contacts the boundary 1388 of the thrombus / blood clot 1368. In some cases, the desired proximity may be when the open distal end 1364 is about 1 mm away from the boundary 1388 of the thrombus / blood clot 1368. In some cases, the desired proximity may be when the open distal end 1364 is about 5 mm away from the boundary 1388 of the thrombus / blood clot 1368. Once the aspiration catheter 1360 has been advanced so that the open distal end 1364 is within a desired proximity of the boundary 1688 of the thrombus / blood clot 1368, the user may begin or continue the thrombolysis procedure.

[0090]

[0172] 55 illustrates how a user can continuously or temporarily inject or "puff" a small amount of contrast agent 1396 (or a mixture of contrast agents as previously described) to provide a persistent indication of the boundary 1388 of the thrombus / blood clot 1368 and the proximity of the open distal end 1364 of the aspiration lumen 1366 of the aspiration catheter 1360. In any of the embodiments illustrated herein, the distal end 1390 of the aspiration catheter 1360 may include an opaque marker or marker band 1392. In some embodiments, the catheter tube 1394 may be an impermeable tube, including, but not limited to, an impermeable material such as barium sulfate, tantalum oxide, or titanium oxide.

[0091]

[0173] 56 shows a catheter system 1400 including a catheter 1402 having a delivery lumen 1404 and a lumen 1406. A wall 1410 surrounding the delivery lumen 1404 has an orifice 1408. Extending through the lumen 1406 is a mandrel 1412 having a proximal end 1414 and a distal end 1416. The distal end 1416 may have a curved portion 1418 (or hook portion) that includes a concave surface 1420 that engages a wall 1422 of the catheter 1402. The mandrel 1412 may be configured for insertion through the lumen 1406 such that the concave surface 1420 engages the distal end 1424 (e.g., at the open distal end 1426) of the wall 1422, such that when a user applies a pulling force (arrow in FIG. 57 ) to the mandrel 1412, the distal end 1428 of the catheter 1402 is pulled in a proximal direction. This pulling force, combined with the column strength of the catheter 1402, causes the distal end 1428 of the catheter 1402 to deflect, as shown in FIG. 57 . In some cases, the amount of deflection may be controlled by a specific force applied to the proximal end 1414 of the mandrel 1412 (e.g., by hand or by a gripping tool coupled to the proximal end 1414 with a collet or other lock) such that a jet 1430 of fluid exiting the orifice 1408 is directed to impinge on an adjacent structure (such as a thrombus / blood clot 1432). In some embodiments, the lumen 1406 may function as an aspiration lumen and may be used to aspirate at least a portion of the thrombus 1432, according to other embodiments described herein. In this embodiment, the mandrel 1412 may also be used to separate the lumen 1406 from the thrombus 1432 when the thrombus 1432 engages the open distal end 1426 of the lumen 1406 by the vacuum. A contrast agent may be added to the fluid delivered through the supply lumen 1404 to better visualize the location and condition of the thrombus 1432. A contrast agent may be delivered through the lumen 1406 when the lumen 1406 is not actively being used for aspiration. The user may flex the distal end 1428 of the catheter 1402 back and forth so that the jets 1430 of fluid disrupt various sections / regions of the thrombus 1432.The user also applies a vacuum to the lumen 1406 to remove the broken down / softened thrombus from the blood vessel 1362, thus allowing for a more complete and efficient removal of the thrombus 1432.

[0092]

[0174] Figure 58 shows a catheter system 1434 that has most of the features of the catheter system 1400 of Figures 56 and 57, but with a preformed shape. The mandrel 1436 is configured to deflect the distal end 1438 of the catheter 1440, which further has a preformed curvature 1442. This allows for a large range of deflection angles F, allowing the jet 1444 to strike the thrombus in a variety of possible trajectories.

[0093]

[0175] 59A and 59B show an aspiration system 1450 including an aspiration catheter 1452 having a supply lumen 1454, an aspiration lumen 1456, and an orifice 1458 communicating the supply lumen 1454 with the aspiration lumen 1456, and a mandrel 1460 having a proximal end 1462 and a distal end 1464, the distal end 1464 having an extension 1466. The extension 1466 of the mandrel 1460 may include hooks (such as a Shepard curve), curves, or other structures that effectively disrupt the thrombus 1468 when the mandrel 1460 (and thus the extension 1466) is rotated 1470 and / or longitudinally translated 1472. The mandrel 1460 may be inserted through the aspiration lumen 1456 of the aspiration catheter 1452 and rotated by attaching the proximal end 1462 of the mandrel 1460 to a rotation device 1474. The rotation device 1474 may also translate the mandrel 1460 back and forth longitudinally. The rotation device 1474 may include devices such as the SPINR™ device sold by Merit Medical Systems, Inc. (South Jordan, Utah, USA) or the FireBow™ device sold by Vesatek, LLC (Irvine, Calif., USA). The extension 1466 may be used to disrupt the fibrous and / or calcified cap 1476 at one end of the thrombus 1468 by applying a disruptive force by rotating and / or cyclically displacing longitudinally. A convex, or blunt, portion 1478 of the extension 1466 may form an atraumatic end to the mandrel 1460. The rotation device 1474 comprises a handle 1480, a motor 1482, a rotatable chuck or lock 1484, and a transmission 1486 configured to couple motion of the motor with motion (e.g., rotation and / or longitudinal translation) of the rotatable chuck or lock 1484. The transmission 1486 may include a gearing in some embodiments. A switch 1488 may be pressed by a user to turn rotation / motion on or off while the user is holding the handle 1480.In some embodiments, mandrel 1460 may also be usable in a manner similar to mandrel 1412 of FIGS. 56 and 57, or mandrel 1436 of FIG.

[0094]

[0176] FIG. 60 illustrates a system for removing intracranial thrombus or intracranial hematoma (shown for simplicity as BC=blood clot) through a window, opening, or hole in the patient's skull. The window, opening, or hole may be created by any suitable device, including but not limited to a notched hand drill or other cutting element. With reference to FIG. 60, a trocar 1156, such as a four-channel trocar, may be introduced through an introducer 1100 near the treatment area where the blood clot BC is located. A visualization device 1158, such as a scope device, including but not limited to a NeuroPen (Medtronic Inc.), or Epic Microvision (Codman, J&J Company, Piscataway, NJ), may be introduced into the visualization channel of the trocar 1156, and an ultrasound device 1112 may be introduced into the working channel of the trocar 1156. The ultrasound device 1112 may transmit a frequency of, for example, about 1 kHz to about 20 MHz, and may be configured to destroy or break down the blood clot BC.

[0095]

[0177] FIG. 60 shows a cross-sectional view of the human skull and brain, showing the introducer 1100 placed through an opening in the skull. A trocar device 1156 is attached to the introducer 1100. 100 and positioned in the treatment area where the blood clot BC is located. The middle cerebral artery MCA is also shown. The trocar 1156 can often be introduced directly into the intracranial opening without the use of the introducer 1100. A visualization device 1158 may be introduced through the visualization channel of the trocar 1156. The visualization device 1158 is connected to a monitor (not shown) via a cable 1159. Some visualization devices (such as a scope) have an ophthalmic element that can be used for visualization instead of a monitor. An ultrasound device 1112 with a handle 1157 is introduced through the working channel of the trocar 1156. Prior to the procedure, the physician orients the trocar 1156 under the visualization device 1158 to the location of the blood clot BC and then positions the distal end of the ultrasound device 1112 inside the blood clot to enable delivery of ultrasound energy. The physician can simultaneously observe the treatment field with the visualization device 1158 while the treatment device 1112 dissolves the blood clot and aspirates it from the patient's head. The blood clot may be aspirated through an irrigation channel or an overflow channel, which is similar to the aspiration lumen of the aspiration catheter described herein. The blood clot may also be aspirated via the ultrasound device 1112. A suitable system for removing intracranial clots or hematomas is described in U.S. Patent Application Publication No. 2012 / 0330196, published Dec. 27, 2012, by Nita, entitled "Method and Apparatus for Removing Blood Clots and Tissue from the Patient's Head."

[0096]

[0178] To further enhance the ability to dissolve blood clots BC, it may be useful to deliver one or more therapeutic agents or micro- or nano-bubbles to the location of the blood clot. Such therapeutic agents, micro- or nano-bubbles can be delivered directly to the treatment site or mixed with conventional saline.

[0097]

[0179] Brain temperature is recognized as a major factor in ischemic brain injury. Clinical evidence has shown that hypothermia improves brain injury. Also, cooling the patient's head or entire body (whole body cooling) to 30°C or 35°C reduces ischemic brain injury, i.e., intracranial pressure and edema after ICH. Focused cranial cooling can be achieved by the simple method of placing ice or cooling gel packs around the head or neck. Whole body cooling may be achieved by infusing ice-cold saline using an intravenous (IV) technique.

[0098]

[0180] Any of the embodiments described herein may be used in conjunction with the Apollo™ System (Penumbra, Inc., Alameda, Calif., USA).

[0099]

[0181] A system 1900 for aspirating a thrombus is illustrated in FIG. 61 and includes an aspiration catheter 1930, a tubing set 1904 configured to infuse fluid at high pressure through at least a portion of the aspiration catheter 1930, and a vacuum set 1928 configured to couple a vacuum source 1929 to the aspiration catheter 1930. The aspiration catheter 1930 includes a y-connector 1910 having a female luer 1912 hydraulically coupled to its high pressure infusion lumen 1934 and a female luer 1914 hydraulically coupled to its aspiration lumen 1932. The high pressure infusion lumen 1934 may have similar characteristics to the high pressure infusion lumen 36 of the catheter 16 of FIG. 3. The aspiration lumen 1932 may have similar characteristics to the aspiration lumen 38 of the catheter 16 of FIG. 3. The tubing set 1904 may be coupled to a fluid source and pump, such as the fluid source 20 and pump 26 of FIG. 1. The tubing set 1904 includes an infusion tube 1906 coupled to a male luer 1908, which may be removably coupled to a female luer 1912 of a y-connector 1910 of the suction catheter 1930. 932 also functions as a guidewire lumen for placement of the guidewire 1902. The aspiration lumen / guidewire lumen 1932 extends the entire length of the aspiration catheter 1930, providing an "over the wire" system through which the guidewire 1902 can be delivered or tracked. The y-connector 1916 with the tow borst 1922 is attached to the y-connector 1910 of the aspiration catheter 1930 via its distal male luer 1918, which is hydraulically coupled to the female luer 1914 of the y-connector 1910. The tow borst 1922 can be adjusted to an appropriate amount to create a seal over the guidewire 1902. The tow borst 1922 can be adjusted, in some cases, to provide a slow and steady drip of blood (e.g., heparinized blood, or non-heparinized blood) from the tow borst 1922. This may be done to minimize blood stagnation in the aspiration lumen 1932. Alternatively, the Touhy Borst 1922 may be replaced with any other type of seal configured to permanently, adjustably, or removably seal around the guidewire 1902. The vacuum set 1928 includes a luer fitting 154 (e.g., a male luer) configured to attach to the female luer 1920 of the y-connector 1916. The vacuum set 1928 includes a pressure transducer 106 having an internal passage supported alongside a stop cock 1924. Proximal to the stop cock 1924, the vacuum line 1926 is configured to couple (through a connector or directly) to a vacuum source 1929. A signal from the pressure transducer 106 is carried by the cable 112 (e.g., to a circuit board 304 of the pump base 200 shown in FIG. 17). In alternative embodiments, the male luer 1918 and the female luer 1914 may be replaced by two connectors / couplings that are permanently attached to one another, or the y-connector 1910 and the y-connector 1916 may be constructed integrally. The other disposable components 101 are similar to those described in the system 100 for aspirating thrombus of FIG.

[0100]

[0182] FIG. 62 shows the distal end of the aspiration catheter 1930 and a guidewire 1902. The guidewire 1902 is free to move longitudinally distally or proximally or to rotate freely within the aspiration / guidewire lumen 1932. The distal end of the guidewire 1902 may be shaped to, for example, create a "J-shaped" tip to select a vessel or pass through a stenosis or occlusion. The high pressure infusion lumen 1934 is contained within a tube 1936 having a large bore section 1938 and a small bore section 1940. The small bore section 1940 may transition from the large bore section 1938 via a neck-down or tapered section 1942. The small bore section 1940 is blocked with a blocking material 1944, which may include a polymer, adhesive, or epoxy that adheres to the inner wall of the small bore section 1940. Alternatively, reduced diameter section 1940 may be crimped, ligated, sealed or plugged without the use of blocking material 1944. An orifice 1946 in wall 1948 of tube 1936 is configured to generate a jet from high pressure fluid injected through high pressure infusion lumen 1934. The jet exiting high pressure infusion lumen 1934 and entering aspiration lumen 1932 may be configured to impinge on an inner wall 1950 of aspiration / guidewire lumen 1932. Aspiration may be performed with guidewire 1902 disposed within aspiration / guidewire lumen 1932 or may be performed with guidewire 1902 retracted proximal to the longitudinal position of orifice 1946. If the guidewire is left in place (as shown in FIG. 62), the guidewire 1902 may be rotated during aspiration so as not to significantly obstruct the jet passing through the orifice 1946, and in some cases the jet itself may have enough force to push the guidewire 1902 into a position where it does not obstruct the jet being ejected against the inner wall 1950.

[0101]

[0183] Returning to FIG. 61, the stop cock 1924 may be operated by a user (doctor, technician, etc.) to turn the system 1900 on and off. The pressure transducer 106 sends its signal via cable 112 to a pump, such as the pump base 200 (FIG. 12). For example, , a circuit such as a microprocessor or microcontroller included in the circuit board 304 of the pump base 200 (FIG. 17) may be configured or configurable (e.g., programmable) to initiate starting or stopping of the pump by a change in pressure to a particular pressure value or with a particular slope of pressure change over time. A user, who may be wearing sterile gloves, can thus turn the system on and off without outside (e.g., non-sterile or non-cleaned) assistance, making the procedure easier and faster. In alternative embodiments, an extension tube may be placed between the stop cock 1924 and the pressure transducer 106. Although a one-way stop cock is shown generally in FIG. 61, other types of stop cocks may be used. In alternative embodiments, the stop cock 1924 may be replaced by other types of valves having on and off positions. In some embodiments, the circuit (e.g., the circuit board 304) is configured to provide a delay between receiving a signal from the pressure transducer 106 / cable 112 and a signal commanding the pump base 200 to begin pumping operation. The purpose of the delay is to allow the applied vacuum to initially engage the clot without injecting fluid, and then, after the delay, to allow injection of fluid (e.g., to soften the clot) once the clot is in a suitable position to be engaged and softened. In some embodiments, the circuit is configured to allow a delay of about 0.01 seconds to about 1.00 seconds. In some embodiments, the circuit is configured to allow a delay of about 0.10 seconds to about 0.25 seconds.

[0102]

[0184] An exemplary method of using the system for aspirating a thrombus is shown in FIG. 63. In step 1952, a user inserts a distal portion of an aspiration catheter 1930 into the vasculature of a patient, for example, at a target area near or adjacent to a thrombus. The user may choose to couple the aspiration catheter 1930 to other components before performing step 1952. In step 1954, the user couples a vacuum source 1929 to the aspiration lumen 1932 of the aspiration catheter 1930 by coupling a luer fitting 154 to a female luer 1920 of the y-connector 1916 and coupling a vacuum line 1926 to the vacuum source 1929. The coupling may be a luer coupling in the case of a syringe, or a friction fit, or a spike or other type of coupling. In some cases, the user may start with a stop cock 1924 between the vacuum source 1929 and the pressure sensor 106 in a closed position. In step 1956, the user couples the supply lumen 1934 of the suction catheter 1930 to the fluid source 20 and to the pump base 200 by coupling the male luer 1908 of the tubing set 1904 to the female luer 1912 of the y-connector 1910 of the suction catheter 1930. In step 1958, the user may turn on the pump base 200, for example, by pressing an "on" button. Step 1958 may be optional, for example, in embodiments of the pump base 200 that are configured to automatically sense attachment of components such as the suction catheter 1930, or the cassette 116, and / or the connector 114. Some examples include a proximity sensor, an RFID chip, a resistor having a particular value, or a switch supported on one or more of the connectors.

[0103]

[0185] In step 1960, the user changes the position or configuration of the valve of the stop cock 1924. For example, the user may switch the stop cock 1924 from an off position to an on position. When the stop cock 1924 is in the off position, the pressure sensor 106 is blocked from sensing pressure (e.g., negative pressure) inside the vacuum source 1929, and therefore does not sense pressure below a certain pressure threshold programmed into the circuit (e.g., circuit board 304). The circuit is configured (or configurable) to not activate the motor 302 of the pump base 200 when this condition is sensed, so that no pressurized fluid enters the suction lumen 1932 through the supply lumen 1934. By ensuring that the motor 302 does not pump pressurized fluid when the vacuum source 1929 is not actively aspirating through the suction lumen 1932, rupture of a clot within the patient's vasculature is avoided. If a clot is ruptured without being aspirated, a thromboembolism may be generated, which may cause a thromboembolism in the vasculature or in one part of the body. The blood clot may migrate or circulate to the blood vessels where it can cause damage (blockage, stroke, myocardial infarction, etc.). When the user opens the stop cock 1924, as in step 1960, and the pressure sensor 106 senses a pressure below a certain pressure threshold, the control circuitry starts the motor 302 to flow pressurized fluid through the supply lumen 1934 and into the aspiration lumen 1932, allowing the clot to be safely aspirated through the aspiration catheter 1930. The user may choose to move (distally or proximally, or rotate) the aspiration catheter 1930 within the blood vessel during aspiration.

[0104]

[0186] In step 1962, the user returns the position of the stop cock 1924 to its original position. For example, if the stop cock 1924 was switched to its on position in step 1960, the stop cock 1924 is then switched to its off position in step 1962. As an example, if the user uses the system 1900 to aspirate a clot after switching the stop cock 1924 to its on position in step 1960, the user may wish to end the aspiration and ends the aspiration by switching the stop cock 1924 to its off position in step 1962. When the user closes the stop cock 1924 and the pressure sensor 106 senses a pressure equal to or greater than a certain pressure threshold, as in step 1962, the control circuit stops the motor 302 to stop pumping pressurized fluid through the supply lumen 1934 into the aspiration lumen 1932, such that the aspiration of the clot is safely terminated. Thus, the user can control when aspiration occurs by simply switching the stop cock 1924 on and off. The stop cock 1924 functions as an electrical switch via pressure measurement by the pressure sensor 106 and control by the circuit board 304. This allows a user working in a sterile field, perhaps "cleaned," to avoid using switches (on the pump base 200 or elsewhere) that are not sterile and / or are remote or out of reach. The user does not need to issue verbal commands, which may not always have the same effect on other medical personnel. Thus, the user can quickly and immediately stop and start suction to best respond to a critical event. For example, if the user is aspirating a clot with the suction catheter 1930 and suddenly notices (e.g., via fluoroscopy) that something has changed in the blood vessel, the user can quickly switch the stop cock 1924 to the off position to stop the suction. The user may alternate between steps 1960 and 1962 while moving the suction catheter 1930 or stopping the suction catheter 1930 to optimize the suction procedure.

[0105]

[0187] In an alternative embodiment, the pressure sensor 106 may be coupled to the vacuum source 1929 for use in a manner similar to an on / off switch, but may not be coupled to the suction catheter 1930. For example, the pump base 200 of the system for aspirating a thrombus 100, or the saline pump drive unit 400 of the piston pump system 300, may be actuated to pump drug 730 through the supply lumen 708 of the suction catheter 700 while no suction is being applied through the suction lumen 710. A plug or closed stop cock (or other closed valve) may be located distal to the pressure sensor 106, while the cable 112 extending from the pressure sensor 106 is electrically coupled to the pump base 200, or the piston pump system 300. Thus, the signal from the pressure sensor 106 may be used to switch the pump base 200, or the piston pump system 300, on and off by switching the vacuum source 1929 on and off (or by coupling or disconnecting or adjusting the vacuum source 1929). This is done even if the vacuum source 1929 is not coupled to the suction lumen 710 of the suction catheter 700. Thus, automatic injection of medication 730 may be initiated or terminated simply by manipulating (e.g., switching or powering) the vacuum source 1929. In yet another embodiment, the suction catheter may be replaced with another catheter that does not have the suction lumen 710 but does have the delivery lumen 708. In this embodiment, the above When coupled as described, this also allows for automatic injection of chemical 730 by operation of vacuum source 1929 .

[0106]

[0188] To deliver the medication 730, the pump base 200 or the saline pump drive unit 400 may be used, with either embodiment providing precise delivery of the medication 730, an improvement over standard gravity-based injection systems, which have some accuracy limitations.

[0107]

[0189] Alternative embodiments are contemplated in which either the system for aspirating thrombus 100 or the piston pump system 300 includes a standard on-off power switch that can be used to start or stop pumping. The switch may be supported on the system for aspirating thrombus 100 or the piston pump system 300 itself, for example on the pump base 200 or the saline pump drive unit 400. Alternatively, the switch may be remote from the pump base 200 or the saline pump drive unit 400 and may be sterilized or sterilizable so that it can be maintained in a sterile field at or near the patient. The separate switch in some embodiments may include a vacuum selector valve 540 or the vacuum sensing method described above to control its operation (on / off). In some embodiments, the switch may be used to control other parameters besides on / off, for example, to control the speed of the pump motor or to control some safety function. In embodiments in which the switch controls the speed of the pump motor, there may be certain embodiments in which the switch includes a potentiometer to allow for the adjustment of a variable electrical resistance. Although the aspiration catheter 1930 in Figures 61-62 is shown as an over-the-wire catheter (the guidewire 1902 is inside the aspiration catheter 1930 for substantially the entire length of the aspiration catheter 1930), the aspiration catheter 1930 may alternatively be a single-operator exchange catheter with a short guidewire lumen (similar to the guidewire tube 132 of the aspiration catheter 118 in Figure 8).

[0108]

[0190] Another embodiment of a system 2000 for aspirating a thrombus is shown in FIG. 64. The system 2000 for aspirating a thrombus includes three main components: the pump base 200 of FIG. 12, the suction catheter 2018, and the tubing set 2003. The suction catheter 2018 and the tubing set 2003 represent disposable components 2001, while the pump base 200 is a reusable part. The pump base 200 does not need to be sterilized since it is placed in a non-sterile field or area during use. The suction catheter 2018 and the tubing set 2003 may each be supplied sterile after sterilization by ethylene oxide gas, electron beam, gamma radiation, or other sterilization methods. The suction catheter 2018 can be packaged and supplied separately from the tubing set 2003, or the suction catheter 2018 and the tubing set 2003 can be packaged and supplied together. Alternatively, the suction catheter 2018 and tubing set 2003 can be packaged separately but provided together (i.e., bundled). The suction catheter 2018 and tubing set 2003 share many of the same features as the suction catheter 118 and tubing set 103 of FIG. 4 and the suction catheter 818 and tubing set 803 of FIG. 21. The suction catheter 2018 has a distal end 2020 and includes an over-the-wire guidewire lumen / aspiration lumen 2032 extending between a distal tip 2036 and a proximal end 2019 comprising a y-connector 2010. The catheter shaft 2042 of the suction catheter 2018 is coupled to the y-connector 2010 via a protective strain relief 2056. In other embodiments, the catheter shaft 2042 can be attached to the y-connector 2010 by a luer fitting. The y-connector 2010 has a first female luer 2055 that communicates with the catheter supply lumen 2093 (FIG. 65), and a guidewire lumen / suction lumen. It has a second female luer 2051 in communication with the lumen 2032 .

[0109]

[0191] A spike 2002 for coupling with a fluid source 20 (FIG. 1) allows fluid to flow through an extension tube 2022 and into a supply tube 2030. An optional injection port 2028 allows for injection of material or removal of air as described in connection with the previous embodiment. In conjunction with the pump base 200, a cassette 2016 is used, similar in structure and function to the cassette 116 of FIGS. 15 and 16 and the cassette 816 of FIGS. 21 and 23. Fluid is pumped into the injection tube 2052 by the action of the cassette 2016 applied by the pump base 200. A male luer 2054 coupled to the distal end of the injection tube 2052 is configured to attach to a female luer 2055 of the y-connector 2010.

[0110]

[0192] An attachment 2057 is shown intended to apply a vacuum source 22, such as a syringe 2049 having a plunger 2067 and a barrel 2099, to the suction lumen 2032 of the catheter 2018. The syringe 2049 is attached to a vacuum line 2008 via a luer 2065 of the syringe 2049. A stop cock 2047 may be used to maintain the vacuum, or the plunger 2067 may be in the form of a locked plunger configured to be locked in a retracted (vacuum) position. A male luer 2053 at the end of the vacuum line 2008 may be removably secured to a female luer 2051 of a y-connector 2010 of the suction catheter 2018. As shown in more detail in FIG. 66, a pressure sensor 2006 is secured inside an internal cavity 2097 of the y-connector 2010 proximal to the female luer 2055 and the female luer 2051. A Touhy-Borst or similar valve 2095 at the proximal end of the y-connector 2010 allows hemostasis of the guidewire lumen / aspiration lumen 2032 around the guidewire 2091. In other embodiments, the valve 2095 may comprise a longitudinal spring-loaded seal. The entire guidewire 2091 may be inserted through the guidewire lumen / aspiration lumen 2032. A signal from the pressure sensor 2006 is conveyed through the cable 2012 to the connector 2014. The connector 2014 plugs into a socket 308 (FIG. 12) of the pump base 200. A signal of the relevant pressure may be processed by the circuit board 304 of the pump base 200. The pressure transducer 2006 may be powered from the pump base 200 via the cable 2012. The accessories 2057 may also be supplied to the user in a sterile condition. In some embodiments, pressure sensor 2006 may include a sensor used in a single-use LD20 liquid flow sensor manufactured by Sensirion AG, Stafa, Switzerland.

[0111]

[0193] As an alternative to the on / off switching function of the stop cock 1924 of the system 1900 for aspirating thrombus of FIG. 61, a foot pedal 2021 is configured to actuate a pinch valve 2023 to block or open the vacuum line 2008. The foot pedal 2021 includes a base 1025 and a pedal 2027 and is configured to be placed in a non-sterile area, such as on a floor, under a surgical table, etc. When a user presses the pedal 2027, a signal is sent to an input jack 2037 of the pump 200 through a cable 2029 coupled via a plug 2041. The vacuum line 2008 extends through a portion of the pump 200. The circuit board 304 of the pump (FIG. 17) may include a controller configured to receive one or more signals from the foot pedal 2021 indicating on or off. The controller on the circuit board 304 may be configured to move an actuator 2031 supported by the pump 200 longitudinally between an actuator head 2033 attached to the actuator 2031 and an anvil 2035 also supported by the pump 200 to compress and occlude the vacuum line 2008. By depressing the pedal 2027, the user can occlude the vacuum line 2008 and stop the application of negative pressure. Also, by depressing the pedal 2027, the user can cause the reverse action, which opens the vacuum line 2008 by moving the actuator head 2033 away from the anvil 2035. The anvil 2035 may be flat (planar) shaped, or U-shaped (e.g., semi-cylindrical), or V-shaped (e.g., V-block) and contacts the tube of the vacuum line 2008. Additionally, the actuator head 2033 may be flat (planar) shaped, or U-shaped (e.g., semi-cylindrical), or V-shaped (e.g., V-block) and contacts the vacuum line 2008. The foot pedal 2021 may be actuated by alternately depressing the pedal 2027 to alternately move the actuator 2031 in a first direction and an opposite second direction, respectively. In some embodiments, depressing the pedal 2027 of the foot pedal 2021 may cause the controller to open the pinch valve 2023. The pressure transducer 2006 thus senses the negative pressure and sends a signal to the controller to start the motor 302 of the pump 200. Since the effect via the electronics is nearly instantaneous, the motor 302 begins pumping nearly immediately upon depressing the pedal 2027. When the pedal 2027 of the foot pedal 2021 is released, the controller then closes the pinch valve 2023. The pressure transducer 2006 thus senses the absence of negative pressure and stops the motor 302 of the pump 200. Again, since the effect via the electronics is nearly instantaneous, the motor 302 stops pumping nearly immediately upon depressing the pedal 2027. During a sterilization procedure, the primary interventionist typically "washes" his or her hands, so that the hands only come into contact with items in the sterile field. However, the feet / shoes / shoe covers are not in the sterile field. Thus, a single user can still operate the switch (via the pedal 2027) while manipulating the catheter 2018 and the guidewire 2091. However, this time it is the hands in the sterile field and the feet in the non-sterile field that are used. Alternatively, the foot pedal 2021 may include two pedals, one for occlusion and one for opening. In an alternative foot pedal embodiment, the pedal 2027 may actuate the air delivery line, for example by moving the actuator head 2033, such that a pressure-activated valve or cuff occludes and opens the vacuum line 2008.In another alternative embodiment, the pedal 2027 may rotate, slide or move a mechanical element, such as a flexible pull cable or push rod, coupled to the actuator 2031 to move the actuator head 2033. The cable 2029 may be provided sterilized and coupled to the base 2025 prior to the procedure. The occlusion and opening of the vacuum line 2008 thus acts as an on-off switch for the pump 200 (via the pressure sensor 2006) as described in relation to FIG. 61. Thus, the user can focus on manipulating the sterile catheters, guidewires and accessories with both hands, while using their feet to turn the pump on and off in a non-sterile environment to perform the on / off function. This allows a single user to control the entire or majority of the operation of the system 2000 for aspirating a thrombus. This can be useful for rapid and synchronized procedures, but is also useful in laboratories where a separate assistant is not available. The actuator 2031 and anvil 2035 may be controlled to compress the vacuum line 2008 with a particular force, and the actuator 2031 may be controlled to move at a particular speed during compression or removal of the compressive force. Controlling the speed and force allows for adequate reaction time, but also allows for added durability to the vacuum line 2008, for example, by not over-compressing.

[0112]

[0194] A particular configuration of a system 1600 for aspirating thrombus is shown in FIG. 77 and includes a pump 1602, a vacuum line 1606, and a pressure sensor 1608 with a cable 1604 coupled to the pump 1602 for transmitting a signal from the pressure sensor 1608. The pinch valve 1610 is actuatable with a foot pedal (not shown, but similar to the foot pedal 2021 of the system 2000 for aspirating thrombus of FIG. 64). The foot pedal 2021 may communicate with the pinch valve 1610 via a wired connection through the pump 1602, or may communicate with the pinch valve 1610 wirelessly. The pinch valve 1610 extends from the pump 1602 and includes a pinch valve housing 1609 having an opening 1611 configured to hold a portion of the vacuum line 1606. Inside the housing 1609 are the actuator head 2033, the actuator 2031, and the pinch valve 202 of FIG. There are components similar to the anvil 2035 at 3, which are configured to compress the exterior of the tubing of the vacuum line 1606 when the foot pedal 2021 is depressed. The foot pedal 2021 may then be depressed a second time to decompress (remove pressure from) the vacuum line 1606. Compressing the vacuum line 1606 may be configured to completely occlude the tubing, thereby isolating the vacuum source 22 from the pressure sensor 1608. The input port 1612 of the pressure sensor 1608 may include a septum 1614 for adding or removing fluid from the vacuum line 1606 (e.g., via a hypodermic needle) or, alternatively, a luer connector and valve. Thus, the pressure sensor 1608 is configured to be in a non-sterile field and can detect the presence or absence of a vacuum (negative pressure) when a user presses the foot pedal with their foot. For example, when a signal (or the result of a mechanical action) generated by pressing a foot pedal closes the pinch valve 1610, and thus no vacuum is applied in the vacuum line 1606, fluid (such as saline) may be pumped (proximal to distal) through the aspiration lumen of the aspiration catheter coupled to the vacuum line 1606 and into the patient's blood vessel. The pump 1602 may be configured (via an internal controller) not to pump saline when a lack of vacuum is determined to be present in the vacuum line 1606. Also, if a vacuum is present but is suddenly no longer present, the pump 1602 will stop. As shown in FIG. 77, the pinch valve 1610 is disposed between the vacuum source 22 and the pressure sensor 1608, such that when the pinch valve 1610 isolates the aspiration catheter 2018 from the vacuum source 22, the pressure sensor 1608 can still sense conditions within the aspiration lumen 2032 of the aspiration catheter 2018. In most cases, after the pinch valve 1610 is closed, the negative pressure in the aspiration lumen 2032 will rise rapidly to approach ambient pressure, a change that will be sensed by the pressure sensor 1608. However, if a temporary or permanent occlusion occurs in the aspiration lumen 2032 due to a clot fragment, the pressure sensor 1608 will be able to sense the occurrence of such an occlusion.For example, a large clot moving may cause a delay in the time it takes for the pressure in the aspiration lumen 2032 to rise to ambient pressure after the pinch valve 1610 is closed. If the clot completely blocks the aspiration lumen 2032, at least some negative pressure may remain in the aspiration lumen. Each of these potential events may be identified by the pressure measured by the pressure sensor 1608. The controller may be configured to issue an error or indicate, for example, by a display device or a visual, audio, or tactile warning or alarm, that there is a temporary or permanent blockage in the aspiration lumen 2032. The user may respond to this indication by, for example, moving the guidewire back and forth to clear the blockage in the aspiration catheter 2018, or may determine that the aspiration catheter 2018 needs replacing. Thus, the ability of the pressure sensor 1608 to monitor the pressure in the aspiration lumen provides important safety control, as well as routine diagnostics of the state of the system (such as catheter flow conditions), whether the pinch valve 1610 is open or closed. Another general advantage of using pinch valves 2023, 1610 is that blood only contacts the inner diameter of the vacuum line 2008, 1606, and therefore does not get into the gaps of rotary valves or other moving parts where biological material can begin to stick or clog. The vacuum line 2008, 1606 is simply compressed and decompressed, allowing for a robust and durable design. The interior volume of the vacuum line 2008, 1606 is easy to keep sterile. Also, the pinch valves 2023, 1610 are isolated from blood / thrombus, making them reusable. Co-locating two or more of the vacuum source 22, pinch valve, pump 1602, and push button 1607 may also be advantageous, for example, for a quick glance by the attending physician or medical personnel who tend to focus on manipulating the catheter in a sterile field.

[0113]

[0195] Another advantage of the pinch valve 1610 is that the controller may be configured to activate the pump whenever the pinch valve is in an open position, so that the jet flow will be at least partially suppressed while a vacuum is applied to the aspiration lumen 2032. Fragmentation of the clot occurs all the time, minimizing or preventing blockage of the aspiration lumen that can occur if vacuum is applied to a large portion of a clot that has not been fragmented (broken down into small pieces).

[0114]

[0196] Instead of or in addition to the foot pedal 2021, a push button 1607 may be provided on the pump 1062 or on a remote component. In a first embodiment, the push button 1607 may simply allow for manual opening and closing of a pinch valve 1610 in the vacuum line 1606. When first pressed, it compresses the vacuum line 1606 to isolate the pressure sensor 1608 from the vacuum source 22, and when pressed again, it releases the pressure on the vacuum line 1606. Alternatively, the push button 1607 may be configured to act as a reset button, always opening the pinch valve 1610 (when closed) or not changing if the pinch valve 1610 is already open. In embodiments having both a foot pedal 2021 and a push button 1067, the push button 1607 is configured as a reset button, such that actuation of the foot pedal 2021 toggles the pinch valve 1610 open or closed, and actuation of the push button 1607 causes or keeps the pinch valve 1610 in an open position at all times. The push button 1607 may be a mechanical (doorbell-style) button or a touch switch (e.g., capacitive, resistive, or piezoelectric switch), and in some embodiments may be a toggle switch or a rocker switch.

[0115]

[0197] Returning to FIG. 64, the plug 2041 includes an identification component 2043 that may be read by a circuit (e.g., circuit board 304) coupled to the input jack 2037 of the pump 200. In some embodiments, the identification component 2043 comprises a resistor having a particular value. When the plug 2041 is coupled to the input jack 2037, the circuit of the input jack 2037 sends a current through the resistor, so that the pump 200 is electronically in a "foot pedal" mode where the foot pedal 2021 can be used to control the operation of the pinch valve 1610. Alternatively, when the plug 2041 is removed from the input jack 2037 and the circuit cannot identify the resistor, the pump 200 is in a "manual" mode where the pump can only be controlled by the button 232 (FIG. 12). In other embodiments, instead of a resistor, the identification component 2043 may comprise an RFID (radio frequency identification) chip that is read by the circuit when the plug 2041 is coupled to the input jack 2037. In other embodiments, a proximity sensor, such as a Hall Effect device, may be used to determine whether the plug 2041 is coupled to the input jack 2037 .

[0116]

[0198] It should be noted that in some embodiments, the pinch valve 2023, 1610 and foot pedal 2021 may be incorporated for on / off operation of the pinch valve 2023, 1610 in the vacuum line 2008, 1606 without the use of a pressure sensor 2006, 1608. Indeed, in some embodiments, the system 2000, 1600 for aspirating thrombus may lack a pressure sensor 2006, 1608 and the foot pedal 2021 may be used as the primary means of control.

[0117]

[0199] Turning to FIG. 65, a supply tube 2087 including a catheter supply lumen 2093 extends freely and coaxially within the over-the-wire guidewire lumen / aspiration lumen 2032. A distal end 2089 of the supply tube 2087 is secured to an inner wall 2085 of the guidewire lumen / aspiration lumen 2032 of the catheter shaft 2042 by adhesive, epoxy, heat melt, thermal bonding or other bonding method. A plug 2083 is secured within the catheter supply lumen 2093 at the distal end 2089 of the supply tube 2087. Pressurized fluid exits through an orifice 2081 in a wall 2079 of the supply tube 2087 as the plug 2083 blocks the egress of pressurized fluid. The free coaxial relationship of the supply tube 2087 and the catheter shaft 2042 along their respective lengths enhances flexibility. In some embodiments where it is desirable to have a stiff proximal end of the aspiration catheter 2018 (e.g., for pushability or torqueability), the supply tube 2087 may be secured to the inner wall 2085 of the guidewire lumen / aspiration lumen 2032 of the catheter shaft 2042 along the proximal portion of the aspiration catheter 2018 but not the distal portion. This may be appropriate, for example, when the proximal portion of the aspiration catheter 2018 is not required to be tracked through a tortuous vasculature, but the distal portion does need to be tracked through a tortuous vasculature. The free and generally uncoupled coaxial relationship between the supply tube 2087 and the catheter shaft 2042 along their respective lengths can also be used to optimize flow through the guidewire lumen / aspiration lumen 2032 by allowing the force of flow (e.g., of thrombus / saline) past the outer surface of the guidewire lumen / aspiration lumen 2032 to move the supply tube 2087 to a separate position, thereby causing the remaining luminal space of the guidewire lumen / aspiration lumen 2032 to self-optimize toward a minimum energy condition (minimum fluid resistance) or a maximum cross-sectional space condition (e.g., to accommodate and pass thrombus fragments).

[0118]

[0200] In FIG. 67, the distal end 2089 of the supply tube 2087 is shown in relation to the distal tip 2036. The orifice 2081 is a circumferential slit in the wall 2079 of the supply tube 2087 and has a width W and an arc length L (FIG. 68). For catheters having a diameter of about 3 French to about 14 French, or about 5 French to about 10 French, or about 8 French, the width W of the slit may range from about 0.0005 inches to about 0.0025 inches, or about 0.0010 inches to about 0.0020 inches, and the arc length L may range from about 0.002 inches to about 0.015 inches, or about 0.004 inches to about 0.012 inches, or about 0.005 inches to about 0.010 inches.

[0119]

[0201] Pressurization of the fluid (e.g., saline) by the pump base 200 / cassette 2016 combination and through the catheter supply lumen 2093 and out of the orifice 2081 may form a spray pattern 2077 whose shape is controlled at least in part by the dimensions of the orifice 2081, as well as by the wall thickness of the wall 2079, the viscosity of the fluid or slurry being aspirated, and the flow characteristics (e.g., flow rate) of the fluid or slurry being aspirated. The spray pattern 2077 produced by the orifice 2081, which is a circumferential slit, is particularly effective at cutting and disrupting portions of the thrombus within a significant sector of the inner wall 2085 of the guidewire lumen / aspiration lumen 2032.

[0120]

[0202] Turning to FIG. 69, a y-connector 2010 is shown in use for a thrombus aspiration procedure, having a distal end 2075 and a proximal end 2073. The structure of the y-connector 2010 is particularly unique for optimizing the flow 2071 of the fluid or slurry being aspirated, for example, minimizing turbulence, maximizing flow rate, and / or minimizing pressure loss. The second female luer 2051 (side port) is closer to the distal end 2075 of the y-connector 2010 than the first female luer 2055 (side port). The y-connector 2010 includes an internal cavity 2097 having an inner surface 2063. The second female luer 2051 has an interior space 2069 and an opening 2101 in communication with the internal cavity 2097 of the y-connector 2010, the opening 2101 having a distal end 2061 and a proximal end 2059. The opening 2101 of the second female luer 2051 is the first significant discontinuity or interruption in the inner surface 2063 of the internal cavity 2097 of the y-connector 2010 when traveling from the distal end 2075 to the proximal end 2073. Thus, the flow of aspirate (aspirated fluid / slurry) is effectively diverted from the internal cavity 2097 to the interior space 2069 of the second female luer 2051 before it is able to significantly contact or interface with other portions of the interior of the y-connector 2010. For example, the first female luer 2055 (side port) has an interior space 2103, the majority of which is enclosed by the proximal portion 2105 of the supply tube 2087 and the inner surface 2063 of the supply tube 2087. and an adhesive 2111 (e.g., glue, epoxy, hot melt) that secures the proximal portion 2105 of the tube 2087 to the inner wall 2107 of the first female luer 2055. The adhesive 2111 and / or the portion 2109 where the proximal portion 2105 of the supply tube 2087 protrudes into the internal cavity 2097 of the y-connector 2010 is a second significant discontinuity or interruption in the inner surface 2063 of the internal cavity 2097 of the y-connector 2010 as it travels from the distal end 2075 to the proximal end 2073. Because the second female luer 2051 (side port) is closer to the distal end 2075 of the y-connector 1010 than the first female luer 2055 (side port), the aspirated fluid or slurry flow 2071 is avoided from contacting the second discontinuity / interruption. The internal cavity 2097, the internal space 2069, and the internal space 2103 may each have a circular cross-section with a cylindrical inner surface. Alternatively, each or all may have a non-circular (such as elliptical) cross-section. In addition to the second female luer 2051 (side port) being close to the distal end 2075 of the y-connector 2010, the inner diameter of the internal space 2069 may be large enough so as not to restrict flow. The length of the internal space 2069 may also be short enough so as not to restrict flow.

[0121]

[0203] In use, the first female luer 2055 of the system 2000 for aspirating a thrombus is coupled to a fluid source 20 and the second female luer 2051 is coupled to a vacuum source (e.g., syringe 2049) by a user or assistant. The cassette 2016 is then coupled to the pump base 200 as described herein. The pump base 200 is then actuated, and fluid from the fluid source 20 is pumped through the supply lumen 2093 and into the aspiration lumen 2032 through the orifice 2081. The pump base 200 is manipulated or commanded to adjust the settings of the pump base 200. For example, the pump base 200 may be actuated such that the input pressure of the supply lumen 2093 is between about 650 pounds per square inch and about 1200 pounds per square inch. The pump base 200 may be operated such that the input pressure of the supply lumen 2093 is between about 650 and about 1000 pounds per square inch. The pump base 200 may be operated such that the input pressure of the supply lumen 1093 is between about 800 and about 1000 pounds per square inch. The pulsatility of the pump may also be adjusted to increase or decrease the frequency of the ejection pulses. A total flow rate of between about 25 and about 35 milliliters per minute may be used, or between about 28 and about 33 milliliters per minute, or between about 30 and about 32 milliliters per minute.

[0122]

[0204] FIG. 70 shows an aspiration catheter 2018A having a y-connector 2200 including a distal end 2202 and a proximal end 2204 being used during a thrombus aspiration procedure. The aspiration catheter 2018A is similar to the aspiration catheter 2018 described in connection with FIG. 64. The structure of the y-connector 2200, as in the y-connector 2010 of FIG. 69, is unique in particular to optimize the flow 2071 of the aspirated fluid or slurry, e.g., to minimize turbulence, maximize flow rate, and / or minimize pressure loss. The second female luer 2206 (side port) is closer to the distal end 2202 of the y-connector 2200 than the first female luer 2208 (side port). The y-connector 2200 includes an internal cavity 2210 having an inner surface 2212. The second female luer 2206 has an interior space 2214 and an opening 2216 in communication with the interior cavity 2210 of the y-connector 2200, the opening 2216 having a distal end 2218 and a proximal end 2220. The opening 2216 of the second female luer 2206 is the first significant discontinuity or interruption in the inner surface 2212 of the interior cavity 2210 of the y-connector 2200 as it travels from the distal end 2202 to the proximal end 2204. Thus, the flow of aspirate (aspirated fluid / slurry) is effectively diverted from the interior cavity 2210 to the interior space 2214 of the second female luer 2206 before it is allowed to significantly contact or interface with other parts of the interior of the y-connector 2200. For example, the first female luer 2208 (side port) is an internal space 2214 of the second female luer 2206. 2222, the majority of which is the proximal portion 2224 of the supply tube 2226 and an adhesive 2228 (e.g., glue, epoxy, hot melt) securing the proximal portion 2224 of the supply tube 2226 to the inner wall 2230 of the first female luer 2208. The portion 2232 where the adhesive 2228 and / or the proximal portion 2224 of the supply tube 2226 protrudes into the internal cavity 2210 of the y-connector 2200 is a second significant discontinuity or interruption in the inner surface 2212 of the internal cavity 2210 of the y-connector 2200 when moving from the distal end 2202 to the proximal end 2204. The second female luer 2206 (side port) is closer to the distal end 2202 of the y-connector 2200 than the first female luer 2208 (side port), thereby avoiding the aspirated fluid or slurry flow 2071 from contacting the second discontinuity / interruption. The internal cavity 2210, the internal space 2214, and the internal space 2222 may each have a circular cross-section with a cylindrical inner surface. Alternatively, each or all may have a non-circular (e.g., elliptical) cross-section.

[0123]

[0205] The sensor connector 2234 and the valve connector 2236 are coupled in series to the y-connector 2200. A male luer 2238 at a distal end 2240 of the sensor connector 2234 is coupled to a female luer 2242 at a proximal end 2204 of the y-connector 2200. A male luer 2244 at a distal end 2246 of the valve connector 2236 is coupled to a female luer 2248 at a proximal end 2250 of the sensor connector 2234. The sensor connector 2234 has an internal bore 2252 with a pressure sensor 2006 within the internal bore 2252. A signal from the pressure sensor 2006 is conducted via a cable 2012 as described in previous embodiments herein. A Touhy-Borst or similar valve 2254 at the proximal end 2235 of the valve connector 2236 allows for hemostasis of the guidewire lumen / aspiration lumen 2032 around the guidewire 2091. In other embodiments, the valve 2254 may comprise a spring-loaded seal. The guidewire 2091 is inserted fully through the guidewire lumen / aspiration lumen 2032 and passes through the bore 2256 of the valve connector 2236, the internal bore 2252 of the sensor connector 2234, and the internal cavity 2210 of the y-connector 2200. In this configuration, the sensor connector 2234 and / or the valve connector 2236 may be easily replaced as needed while maintaining the aspiration catheter 2018A in place, e.g., within a blood vessel.

[0124]

[0206] FIG. 71 shows an aspiration catheter 2018B having a y-connector 2300 including a distal end 2302 and a proximal end 2304 being used during a thrombus aspiration procedure. The aspiration catheter 2018B is similar to the aspiration catheter 2018 described in connection with FIG. 64. The structure of the y-connector 2300, as in the y-connector 2010 of FIG. 69, is unique in particular to optimize the flow 2071 of the aspirated fluid or slurry, e.g., to minimize turbulence, maximize flow rate, and / or minimize pressure loss. The second female luer 2306 (side port) is closer to the distal end 2302 of the y-connector 2300 than the first female luer 2308 (side port). The y-connector 2300 includes an internal cavity 2310 having an inner surface 2312. The second female luer 2306 has an interior space 2314 and an opening 2316 in communication with the interior cavity 2310 of the y-connector 2300, the opening 2316 having a distal end 2318 and a proximal end 2320. The opening 2316 of the second female luer 2306 is the first significant discontinuity or interruption in the inner surface 2312 of the interior cavity 2310 of the y-connector 2300 as it travels from the distal end 2302 to the proximal end 2304. Thus, the flow of aspirate (aspirated fluid / slurry) is effectively diverted from the interior cavity 2310 to the interior space 2314 of the second female luer 2306 before it is able to significantly contact or interface with other parts of the interior of the y-connector 2300. For example, the first female luer 2308 (side port) has an interior space 2322, the majority of which is filled with a proximal portion 2324 of a supply tube 2326 and a bonding material that secures the proximal portion 2324 of the supply tube 2326 to an inner wall 2330 of the first female luer 2308. 2328 (e.g., glue, epoxy, hot melt). The portion 2332 where the bonding material 2328 and / or the proximal portion 2324 of the supply tube 2326 protrudes into the internal cavity 2310 of the y-connector 2300 is a second significant discontinuity or interruption in the inner surface 2312 of the internal cavity 2310 of the y-connector 2300 as it travels from the distal end 2302 to the proximal end 2304. The second female luer 2306 (side port) is closer to the distal end 2302 of the y-connector 2300 than the first female luer 2308 (side port), thus avoiding the aspirated fluid or slurry flow 2071 from contacting the second discontinuity / interruption. The internal cavity 2310, the internal space 2314, and the internal space 2322 may each have a circular cross-section with a cylindrical inner surface. Alternatively, each or all may have a non-circular (eg, elliptical) cross-section.

[0125]

[0207] The sensor connector 2334 and the valve connector 2336 are coupled to the y-connector 2300. A male luer 2338 at the distal end 2340 of the valve connector 2336 is coupled to a female luer 2342 at the proximal end 2304 of the y-connector 2300. A male luer 2344 at the distal end 2346 of the sensor connector 2334 is coupled to a female luer 2348 at the intermediate portion 2350 of the valve connector 2336. The sensor connector 2334 has an internal bore 2352 with a pressure sensor 2006 therein. Signals from the pressure sensor 2006 are conducted via the cable 2012 as described in the previous embodiment herein. A Touhy-Borst or similar valve 2354 at the proximal end 2335 of the valve connector 2336 allows for hemostasis of the guidewire lumen / aspiration lumen 2032 around the guidewire 2091. In other embodiments, the valve 2354 may comprise a spring-loaded seal. The guidewire 2091 is fully inserted through the guidewire lumen / aspiration lumen 2032 and passes through the bore 2356 of the valve connector 2336 and the internal cavity 2310 of the y-connector 2300. In this configuration, the sensor connector 2334 and / or the valve connector 2336 may be easily replaced as needed while maintaining the aspiration catheter 2018B in place, e.g., within a blood vessel. The sensor connector 2334 further comprises an inlet 2358, which may be used to inject a fluid, such as saline or contrast, or a mixture of the two. The inlet 2358 may comprise a female luer configured to mate with a male luer of a syringe. In some embodiments, the inlet 2358 may comprise a rubber septum 2360 configured to be repeatedly penetrated by a needle of a syringe. In alternative embodiments, the pressure sensor 2006 may be located at some other location.

[0126]

[0208] 72-74 show a system 2400 for aspirating a thrombus. The system 2400 for aspirating a thrombus has many similarities to the system 1900 for aspirating a thrombus of FIG. 61 and uses some of the components of the system 1900 for aspirating a thrombus, including an aspiration catheter 1930, a y-connector 1910 having a female luer 1912 hydraulically coupled to a high pressure infusion lumen 1934 (FIG. 62) and a female luer 1914 hydraulically coupled to an aspiration lumen 1932 (FIG. 62), another y-connector 1916 having a male luer 1918 and a female luer 1920, a towbar 1922, an infusion tube 1906 having a male luer 1908, a pressure transducer 106 electrically connected to a cable 112, and a vacuum line 1926 having a luer fitting 2455. The luer fitting 2455 in the system 2400 for aspirating a thrombus of FIGS. 72-74 is a male luer connector, although in alternative embodiments it may be another type of connector. The suction catheter 1930 is inserted through a guiding catheter 2450, which has a hemostatic valve 2452 configured to seal around the shaft 2454 of the suction catheter 1930. A fluid (e.g., saline) is introduced into the inner lumen 2454 of the guiding catheter 2450 by attaching a syringe or pump to the luer coupling 2458 of the extension tube 2460 while a stop cock 2462 coupled to the luer coupling 2458 is left open. 6 and around the shaft 2454 of the aspiration catheter 1930. The stop cock 2462, however, is shown in a closed position in Figures 72-74. A guidewire 1902 can be used in conjunction with the system 2400 for aspirating a thrombus.

[0127]

[0209] A novel feature of the system 2400 for aspirating thrombus of Figures 72-74 is a four-way stopcock 2402 coupled between the vacuum line 1926, the pressure transducer 106, and the aspiration catheter 1930. The four-way stopcock 2402 includes a male luer 2404 fluidly coupled to a female luer 1920 of the y-connector 1916, a female luer 2406 fluidly coupled to a (male) luer fitting 2455 of the vacuum line 1926, and a female luer 2408 fluidly coupled to a male luer 2457 of the pressure transducer 106. The four-way stopcock 2402 includes a main housing 2410 having three inlets / outlets 2412, 2414, 2416 and a rotatable valve body 2418 that is rotated via a protrusion 2420. In FIG. 72, the valve disc 2418 is in the "aspirate" position, allowing fluid communication between all of the pressure transducer 106, the vacuum line 1926 (and thus the syringe 2049), and the aspiration lumen 1932 of the aspiration catheter 1930. The distal end 1997 of the aspiration catheter 1930 is shown within a blood vessel 1999 having a thrombus 1995. The protrusion 2420 points toward the "closed" side of the valve disc 2418, and thus in FIG. 72, none of the three inlets / outlets 2412, 2414, 2416 are closed. For example, a controller supported by the circuit board 304 of FIG. 17 is configured to receive a signal from the pressure transducer 106 to obtain information about the pressure sensed by the pressure transducer 106. The controller is further configured to stop operation of the pump 200 if the signal received from the pressure transducer 106 indicates that the pressure transducer is not in communication with negative pressure ("vacuum"), which is intended to ensure that infusion of fluid through the high pressure infusion lumen 1934 occurs only when the vacuum source causes the aspiration lumen 1932 to actively aspirate the clot 1995. For example, in FIG. 73, the user has switched the valve body 2418 in relation to the vacuum line 1926, and the syringe 2049, to the "off" position. The inlets / outlets 2412, 2414 are open and the inlet / outlet 2416 is closed. Thus, the pressure transducer 106 does not measure the negative pressure in the vacuum line 1926, but instead measures the pressure near the proximal end of the aspiration lumen 1932 (actually, the pressure adjacent the interior of the female luer 1920 of the y-connector 1916).After the valve disc 2418 is switched to this particular "off" position, the pressure measured by the pressure transducer 106 increases and the controller stops operation of the pump 200. The intent is to ensure that no injection occurs into the blood vessel or disrupts a clot within the blood vessel when suction is not actively occurring.

[0128]

[0210] However, it may be desirable to perform high power pulses, or high power injections, with the pump 200 without actively applying a vacuum to the aspiration lumen 1932 of the aspiration catheter 1930. The four-way stopcock 2402 allows the pressure transducer 106 (and therefore the controller) to be "tricked" without reprogramming or reconfiguring the controller. Turning to FIG. 74, the valve body 2418 has been switched by the user to the "high power injection" position, and the pressure transducer 106 is in fluid communication with the vacuum line 1926 (and vacuum source / syringe 2049), but the aspiration lumen 1932 of the aspiration catheter 1930 is not in fluid communication with the vacuum line 1926 (or vacuum source / syringe 2049) or the pressure transducer 106. The inlet / outlet 2412 is closed, isolating the aspiration lumen 1932 from the pressure transducer 106 and vacuum line 1926. The inlet / outlet ports 2414 / 2416 are open, allowing fluid communication only between the pressure transducer 106 and the vacuum line 1926. Thus, it is still possible to inject fluid (via the controller) through the high pressure infusion lumen 1934 and out of the orifice 1946 (FIG. 62) of the high pressure infusion lumen 1934 and out of the distal orifice of the aspiration lumen 1932 into the blood vessel 1999. The high power pulse, or high power infusion, can be used to remove thrombus 1995 located within the blood vessel 1999. The high power pulse may be used to deliver a strong disturbance to the thrombus 1995, or may be used to increase the amount of low viscosity fluid 1993 (e.g., saline) around the thrombus 1995 (to aid in subsequent aspiration attempts). A contrast agent may be added to or used as the infusion fluid, such that the high power pulse increases radiopacity in the blood vessel 1999 near the thrombus 1995.

[0129]

[0211] In some circumstances, during an aspiration procedure, it may become difficult to aspirate the thrombus 1995 through the aspiration lumen 1932 of the aspiration catheter 1930. One reason this may occur is that if the thrombus 1995 surrounding the distal end 1997 of the aspiration catheter 1930 is substantially viscous, the thrombus 1995 may flow into the distal opening, making it difficult to pass through the aspiration lumen 1932 of the aspiration catheter 1930. In such circumstances, a syringe, or a second pump, may be attached to the luer coupling 2458 of the extension tube 2460 (with the stopcock 2062 in the open position), and saline (and / or contrast agent) may be injected through the inner lumen 2456 of the guiding catheter 2450. The outer diameter of the aspiration catheter 1930 is sized sufficiently smaller than the inner diameter of the inner lumen 2456 of the guiding catheter 2450 so that it can be manually injected without distortion. The use of at least some contrast agent allows visual diagnosis of not only the catheter flow state (e.g., aspiration), but also the location of the thrombus and even the shape or contour of the thrombus. The distal end 2451 of the guiding catheter may be moved (if necessary) to place it in sufficient proximity to the distal end 1997 of the aspiration catheter 1930 and / or the target portion of the thrombus 1995 to be aspirated. Injecting a bolus of fluid having a viscosity substantially similar to that of water or saline, or at least a viscosity similar to that of water or saline or even blood, makes it easier to initiate aspiration at the target thrombus site and into the aspiration lumen 1932 of the aspiration catheter 1930. This may occur due to a decrease in overall viscosity (volume viscosity). When a pump is applied to the high pressure injection lumen 1934 to cause the somewhat diluted thrombus 1991 to begin flowing through the aspiration catheter, it becomes easier to continue the aspiration procedure because it is now in a dynamic state rather than the initial static state. The procedure may be continuously or continuously assessed using pressure sensor 106 or by visualization with angiography / fluoroscopy.In some embodiments, a second pump (not shown) may be attached to the luer coupling 2458 of the extension tube 2460 and triggered by a controller supported either by the first pump 200, 400 or by the pressure sensor 106. The second pump may be turned on or off based on meeting or crossing a threshold pressure measured by the pressure sensor 106.

[0130]

[0212] Alternatively, saline, contrast or other fluids may be injected in a retrograde fashion by switching the valve body 2418 of the four-way stopcock 2402 to a specific "off" position in FIG. 73. This stops the pump 200 from running if it has not already been stopped by other means. The luer cap 2422 of the pressure transducer 106 may then be removed and fluid may be injected retrograde (e.g., with a syringe) from the proximal end to the distal end, through the access luer 2424 of the pressure transducer 106, through the aspiration lumen 1932, and out the distal opening of the aspiration lumen 1932 into the blood vessel. The valve body 2418 may be used as a sterile on / off switch to perform several different subprocedures of the aspiration / thrombectomy procedure.

[0131]

[0213] 75 shows a system 2400 for aspirating a thrombus, further comprising a guiding catheter 2426 (or long sheath) configured to position the aspiration catheter 1930. A blood vessel 2428 contains a thrombus 2430 therein. The guiding catheter 2426 includes a tubular shaft 2434, a distal opening 2436, and a valve 2444 with a side port extension tube 2442 having a luer 2444 for injection, and a stopcock 2446. 75 , the distal end 1997 of the aspiration catheter 1930 extends from the distal opening 2436 of the guiding catheter 2426 to perform a thrombectomy procedure according to embodiments described herein. During the procedure, if a user determines that aspiration of the thrombus 2430 through the aspiration lumen 1932 of the aspiration catheter 1930 is not occurring at a desired thrombus aspiration rate (flow rate, mass removal rate, etc.), the user grasps the guiding catheter 2426 by the tubular shaft 2434 and rotates the guiding catheter 2426 (in the direction of the arrow) within the blood vessel 2428 to increase the thrombus aspiration rate. Circumferential shear forces generated by the rotating cylindrical surface area of ​​the tubular shaft 2434 of the guiding catheter 2426 serve to break up or soften the thrombus, especially in the area near the distal opening 2436. The state of thrombus aspiration may be determined by data received from the pressure transducer 106 or by visual evidence (amount of thrombus passing therethrough, as seen through a transparent tube or connector). The guiding catheter 2426 may be rotated about the axis 2427 while the aspiration catheter 1930 has fluid injected through the high pressure infusion lumen 1934 and / or when a vacuum source (syringe 2049) is applied to the aspiration lumen 1932. Alternatively, the pump 200 and / or the vacuum source may be temporarily stopped while the guiding catheter 2426 is rotating. 75, the extension tube 2442 and luer 2444 are decoupled from any fluid source to facilitate disconnected rotatability of the guiding catheter 2426. The inner material of the valve 2440 is typically low friction, allowing for smooth, sealed rotation over the shaft of the suction catheter 1930. Alternatively, instead of the valve 2440, the guiding catheter may have a proximal luer connector and be attached to a rotatable y-connector or other rotatable (swivelable) connector, which also allows the guiding catheter 2426 to rotate.

[0132]

[0214] 76 shows an aspiration catheter 1518 having a y-connector 1500 including a distal end 1502 and a proximal end 1504 configured for use in a thrombus aspiration procedure. The y-connector 1500 includes a first female luer 1508 (side port) that allows for injection through the interior of a supply tube 1526 of the aspiration catheter 1518. The first female luer 1508 (side port) has an interior space 1522 that is mostly occupied by a proximal portion 1524 of the supply tube 1526 and a bonding material 1528 (e.g., glue, epoxy, hot melt) that secures the proximal portion 1524 of the supply tube 1526 to an inner wall 1530 of the first female luer 1508. The portion 1532 where the bonding material 1528 and / or the proximal portion 1524 of the supply tube 1526 protrude into the internal cavity 1510 of the y-connector 1500 may create a discontinuity or interruption in the inner surface 1512 of the internal cavity 1510 of the y-connector 1500. The internal cavity 1510 and the internal space 1522 may each have a circular cross-section with a cylindrical inner surface. Alternatively, each or all may have a non-circular (e.g., elliptical) cross-section. The female luer 1508 is configured to attach to the male luer 2054 of the infusion tube 2052 such that pressurized saline may be infused through the supply tube 1526. The proximal end 1504 of the y-connector 1500 includes a female luer 1542.

[0133]

[0215] The mating connector 1536 has a male luer 1538 at its distal end 1540 that is configured to mate with the female luer 1542 of the y-connector 1500. The mating connector 1536 has a first internal bore 1556 and a second internal bore 1552 that are in communication with each other, the second internal bore 1552 having a pressure sensor 2006 communicating therein. Signals from the pressure sensor 2006 are conducted via a cable 2012 as described in the previous embodiment herein. A Touhy-Borst, etc. valve 1554 at the proximal end 1535 of the mating connector 1536 closes the guidewire luer 1538 around the guidewire 2091. 20, the guidewire 2091 is inserted fully through the guidewire lumen / aspiration lumen 2032 and passes through the bore 1556 of the mating connector 1536 and the internal cavity 1510 of the y-connector 1500. The mating connector 1536 further comprises a female luer 1506 configured to attach to the male luer 2053 of the vacuum line 2008. In this configuration, the mating connector 1536 may be easily replaced as needed while maintaining the suction catheter 1518 in place, e.g., within the blood vessel. The mating connector 1536 further comprises an inlet 1558, which may be used to inject fluids such as saline or contrast, or a mixture of the two, when suction is not actively occurring. The inlet 1558 may include a female luer configured to mate with a male luer of a syringe. In some embodiments, the inlet 1558 may include a rubber septum 1560 configured to be repeatedly penetrated by a syringe needle. During aspiration, a vacuum is applied to the female luer 1506 and pressure is measured by the pressure sensor 2006.

[0134]

[0216] FIG. 78 illustrates a connector 1620 for use with embodiments of suction catheters described below, including the suction catheter 1616 of FIG. 79. The connector 1620 has a molded, cast, or formed body that may comprise a rigid polymer such as polycarbonate, acrylic, polyester-polycarbonate blend, or acrylonitrile-butadiene-styrene (ABS). The connector 1620 comprises a body 1619 including a proximal female luer 1634 having male threads 1635. The connector 1620 further comprises a first side port 1622 having a female luer 1621 and male threads 1637. The connector 1620 further comprises a second dual-use side port 1628 having a female luer 1629 and male threads 1639. The side port 1628 further comprises a barbed fitting 1633, which allows for a male luer to be attached to the female luer 1629 (or to the female luer 1629 and threads 1639, if threaded) or a friction fit (lumen inner diameter) to the barbed fitting 1633. The barbed fitting 1633 may be particularly useful for friction fitting to vacuum line tubing. The versatile utility of the side port 1628 allows for easy use with a variety of commercially available vacuum sources, including, but not limited to, syringes, VacLok® syringes, vacuum pumps, house vacuum lines, vacuum canisters, or vacuum bottles. When the side port 1628 is used for infusion, the female luer 1629 is typically used, but the barbed fitting 1633 also allows for alternative infusion connections.

[0135]

[0217] FIG. 79 shows a suction catheter 1616 comprising a shaft 1618 and a connector 1620. The connector 1620 comprises a female luer side port 1622 that allows for injection through the interior of the supply tube 1623 of the suction catheter 1616 via a fluid supply line 1624 having a male luer 1626 that is coupled to the female luer 1621 of the side port 1622. The connector 1620 comprises a barbed attachment side port 1628 configured to attach a vacuum line 1630 having a plastic or elastomeric tubular end 1632 configured to press sealingly over the barbed fitting 1628. The tubular end may be Tygon®, PVC, silicone or other suitable material. Connector 1620 further comprises a proximal female luer 1634, which is shown capped with a luer cap 1636. If the suction catheter 1616 is to be used without a guidewire, then the luer cap 1636 may be left in place over the luer 1643. If a guidewire is to be used, then the luer cap 1636 may be removed from the luer 1634, and the guidewire is inserted through the interior of connector 1620 and through the aspiration lumen of the aspiration catheter 1616. Alternatively, a guidewire may be inserted through the interior of connector 1620 and through the aspiration lumen of the aspiration catheter 1616. To do this, the luer cap 1636 may be removed and a separate pump and infusion tube with a male luer may be attached to the female luer 1634 of the connector 1620. The pump may be used, for example, to apply positive pressure to force saline distally when no significant or no vacuum is being applied to the aspiration lumen via the vacuum line 1630. The purpose of injecting fluid via a separate pump may be to clear any possible blockages in the aspiration lumen. Clearing blockages may be particularly useful in the case of veins, where embolism of distal occluding material (such as blood clots) that has been expelled from the aspiration lumen and entered the vein is less of a problem than embolism in coronary or cerebral artery procedures. In some cases, the fluid injected to clear a blockage in the aspiration lumen may be replaced with an injection of contrast agent (undiluted or diluted) to aid in visualization of the target area, for example, by fluoroscopy. Injecting fluid through the aspiration lumen can help reduce the volume viscosity of the thrombus and the blood surrounding it (at the target site), aiding in its subsequent aspiration into the aspiration lumen of the aspiration catheter 1616.

[0136]

[0218] FIG. 80 shows a suction catheter 1638 comprising a shaft 1640 and a connector 1642. The connector 1642 comprises a female luer side port 1644 that allows for injection through the interior of the supply tube 1647 of the suction catheter 1638 via a fluid supply line 1646 having a male luer 1648. The connector 1642 comprises a barbed fitting 1650 (side port) configured to attach a vacuum line 1652, the barbed fitting 1650 having a plastic or elastomeric tubular end 1654 configured to press sealingly over the barbed fitting 1650. In some embodiments, the barbed fitting 1650 may further comprise a female luer. The connector 1642 further comprises a Touhy Borst valve 1656, which may be sealed (closed) when a guidewire is not in use, may be open to allow a guidewire to pass through the connector 1642 and the aspiration lumen of the aspiration catheter 1638, and may be sealed over the guidewire. The Touhy Borst valve 1656 may comprise a distal male luer 1657 configured to be secured to a female luer 1659 at the proximal end of the connector 1642. In alternative embodiments, the Touhy Borst valve 1656 may be permanently coupled to or formed on the connector 1642. As an alternative to operating the foot switch 2021 to activate the pinch valve 1610 (FIG. 77) (FIG. 64), the vacuum line 1652 (FIG. 80) may be manually clamped or unclamped to open or close the vacuum line 1652. The manual clamp is placed at a location on the vacuum line between the vacuum source 22 and the pressure sensor 1608 (FIG. 77) and, if there is a pinch valve 1610 along the vacuum line 1652, the pinch valve 1610 must be opened to allow this manual clamp function. Alternatively, in lieu of a manual clamp, the vacuum line 1652 may be removed by pulling the elastomeric tubular end 1654 from the barbed fitting 1650, capping or blocking the lumen of the vacuum line 1652.

[0137]

[0219] FIG. 81 shows an aspiration catheter 1658 comprising a shaft 1660 and a connector 1662. The connector 1662 comprises a female luer side port 1664 that allows for injection through the interior of the supply tube 1667 of the aspiration catheter 1658 via a fluid supply line 1666 having a male luer 1668. The connector 1662 comprises a barbed fitting 1670 (side port) configured to attach a vacuum line 1672, the barbed fitting 1670 having a plastic or elastomeric tubular end 1674 configured to press sealingly over the barbed fitting 1670. In some embodiments, the barbed fitting 1670 may further comprise a female luer. The connector 1662 further comprises a proximal female luer 1676. The y-connector 1678 includes a male luer 1680 that is attached to the female luer 1676 of the connector 1662. The y-connector 1678 is connected to the Touhy Borst valve 1662. 682, which may be sealed (closed) when a guidewire is not in use, may be open to allow a guidewire to pass through the y-connector 1678, the connector 1662, and the aspiration lumen of the aspiration catheter 1658, or may be sealed over the guidewire. The y-connector 1678 further comprises a female luer side port 1684 to which a syringe or other instrument may be coupled, for example, to inject fluids or drugs. A separate pump with a male luer and infusion tube may be attached to the luer side port 1684 of the y-connector 1678 to access the aspiration lumen of the aspiration catheter 1658. The pump may be used, for example, to apply positive pressure to force saline distally when no significant or no vacuum is being applied to the aspiration lumen via the vacuum line 1672. The purpose of injecting fluid via a separate pump may be to clear any possible blockages in the aspiration lumen. Clearing of the clog may be particularly useful in the case of veins, where embolism of distal occluding material (such as blood clots) exiting the aspiration lumen and entering the vein is not as problematic as embolism in coronary or cerebral artery procedures. In some cases, the fluid injected to clear the aspiration lumen may be replaced with an injection of contrast agent (undiluted or diluted) to aid in visualization of the target area, for example, by fluoroscopy. Injecting fluid through the aspiration lumen may help reduce the volume viscosity of the thrombus and the blood (at the target site) surrounding the thrombus for later aspiration into the aspiration lumen of the aspiration catheter 1658. Injection of contrast agent, saline, or other fluid may be performed by pump or by hand / syringe injection via attachment to the female luer side port 1684. Alternatively, the male luer 1680 may be disconnected from the female luer 1676 of the connector 1662, the y-connector 1678 removed, and then a pump or syringe may be attached to the female luer 1676 for injection.

[0138]

[0220] In some cases, some or all of the devices described herein may be doped with, made of, coated with, or otherwise include radiopaque materials. A radiopaque material is understood to be a material that can produce a relatively bright image on a fluoroscopy screen or other imaging technique during a medical procedure. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. One or more hydrophilic or hydrophobic lubricious coatings may be used to improve the trackability of the aspiration catheter 118 through the blood vessel.

[0139]

[0221] In some examples, MRI compatibility can be provided in parts of the devices described herein. For example, to improve compatibility with magnetic resonance imaging (MRI) machines, it may be desirable to make various parts of the devices described herein from materials that do not substantially distort the MRI image or cause substantial artifacts (gaps in the image). Some ferromagnetic materials are not suitable, for example, because they may generate artifacts in the MRI image. In some cases, the devices described herein can include materials that the MRI machine can image. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), nitinol, and the like, and other materials.

[0140]

[0222] In some examples, some of the devices described herein can include a coating, such as a lubricious coating or a hydrophilic coating. A hydrophobic coating, such as a fluoropolymer, provides dry lubricity. A lubricious coating improves steerability and improves lesion crossing ability. Suitable lubricious polymers are known in the art and include, for example, silicones. Examples of hydrophilic polymers include high density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxide, polyvinylpyrrolidone, polyvinyl alcohol, hydroxyalkyl cellulose-based materials, algins, saccharides, caprolactone, and mixtures and combinations thereof. The hydrophilic polymers can be mixed among themselves or with a prescribed amount of a water insoluble mixture (containing several polymers) to produce a coating with suitable lubricity, adhesion and solubility.

[0141]

[0223] 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, which is, of course, defined in the language of the appended claims.

[0142]

[0224] Although embodiments of the present disclosure have been shown and described, various modifications may be made without departing from the scope of the present disclosure. It is contemplated that embodiments of the present disclosure have utility in a variety of blood vessels, including, but not limited to, coronary arteries, carotid arteries, intracranial / cerebral arteries, inferior vena cava, superior vena cava, and other blood vessels (e.g., in the case of deep vein thrombosis or pulmonary embolism), peripheral arteries, vascular bypass, grafts, vasculopathy, and atria. This includes, but is not limited to, any blood vessel that includes a diameter of about 2 mm or greater. For many applications, an outer diameter of the aspiration catheter 118 of about 7 French or less is contemplated, although in certain applications it may be larger. In some embodiments, a diameter of the aspiration catheter 118 of about 6 French or less is contemplated. Embodiments of the present invention may be used in non-vascular applications, such as, for example, a body lumen or cavity that includes a material buildup that needs to be softened and / or removed.

[0143]

[0225] Various combinations or subcombinations of the specific forms and aspects of the embodiments disclosed above can be made and still fall within one or more of the present disclosures. Moreover, any particular form, aspect, method, property, feature, quality, attribute, element, etc. associated with an embodiment can be used in all other embodiments described herein. Thus, it should be understood that various forms and aspects of the disclosed embodiments can be combined with or substituted for each other to form various modes of the disclosed invention. Thus, it is intended that the scope of the present disclosure disclosed herein should not be limited by the specific disclosed embodiments described above. Moreover, the present disclosure is susceptible to various modifications and alternative forms, specific examples of which are shown in the drawings and described in detail herein. However, it should be understood that the present disclosure should not be limited to the specific forms or methods disclosed, but on the contrary, the present disclosure can encompass all modifications, equivalents, and alternatives falling within the spirit and scope of the various described embodiments and the appended claims. Any method disclosed herein need not be performed in the order listed. The methods disclosed herein include specific acts performed by a medical practitioner, but those acts may further include the teachings of a third party, either explicitly or implicitly.

[0144]

[0226] The ranges disclosed herein include all overlaps, subranges, and combinations thereof. Words such as "up to," "at least," "greater than," "less than," "between" and the like include the recited numbers. As used herein, the numbers listed after terms such as "approximately," "about," and "approximately" represent amounts that are inclusive of the recited numbers (e.g., about 10%=10%) and that still perform the desired function or achieve the desired result. For example, the terms "approximately," "about," and "approximately" can refer to amounts that are less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the recited amount.

Claims

1. 1. A suction catheter comprising: an elongate shaft configured for placement within a patient's vasculature; a supply lumen having a proximal end and a distal end and an aspiration lumen having a proximal end and an open distal end, each extending within said shaft; an opening at or near the distal end of the supply lumen, the opening being configured to allow for injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen upon pumping of the pressurized fluid through the supply lumen; a suction catheter comprising: a tubing set comprising a tube, the tubing set having a distal end configured to be coupled to the suction lumen of the suction catheter and a proximal end configured to be coupled to a vacuum source; a tube compression element configured to externally engage the tube of the tubing set at a location between the proximal end of the tubing set and the distal end of the tubing set; an actuation interface configured to actuate the tube compression element to compress the tube at the location between the proximal end of the tubeset and the distal end of the tubeset; and A system for aspirating a thrombus comprising:

2. The system for aspirating thrombus according to claim 1 , further comprising a pressure sensor in fluid communication with the aspiration lumen of the aspiration catheter and configured to output a signal indicative of a measured pressure.

3. 3. The system for aspirating thrombus as described in claim 2, wherein the actuation interface is further configured to actuate the tube compression element to decompress the tube at the location between the proximal end of the tubing set and the distal end of the tubing set.

4. 3. The system for aspirating thrombi as described in claim 2, wherein the actuation interface is further configured to actuate or not actuate a pump configured to pump pressurized fluid through the supply lumen of the aspiration catheter.

5. 5. The system for aspirating thrombi as described in claim 4, wherein an output signal of the pressure sensor is configured to activate or not activate the pump configured to pump pressurized fluid through the supply lumen of the aspiration catheter.

6. The system for aspirating thrombi according to claim 4 , wherein the tube compression element is configured to be supported by the pump configured to pump pressurized fluid through the supply lumen of the aspiration catheter.

7. The system for aspirating thrombus of claim 4 , further comprising a pump configured to pump pressurized fluid through the supply lumen of the aspiration catheter.

8. The system for aspirating thrombi according to claim 2 , wherein the pressure sensor is supported by the tubing set between the proximal end of the tubing set and the distal end of the tubing set.

9. The system for aspirating thrombus according to claim 1 , wherein the operating interface is configured to be disposed and operated in a non-sterile field.

10. The system for aspirating thrombus according to claim 1 , wherein the actuation interface is a foot pedal.

11. The system for aspirating thrombus according to claim 1 , wherein the actuation interface is a push button.

12. The system for aspirating thrombi according to claim 1 , wherein the compression of the tube by the tube compression element comprises complete occlusion of the tube.

13. 2. The system for aspirating thrombus according to claim 1, wherein the tube compression element comprises a base having a first surface and a moving element having a second surface, the first surface comprising at least one of a planar shape, a U-shape, and a V-shape, and the second surface comprising at least one of a planar shape, a U-shape, and a V-shape.

14. The system for aspirating thrombus according to claim 1 , wherein the actuation interface is configured to actuate the tube compression element by transmitting an electrical signal.

15. The system for aspirating thrombus according to claim 1 , wherein the actuation interface is configured to actuate the tube compression element by transmitting a pressure impulse.

16. The system for aspirating thrombus according to claim 1 , wherein the actuation interface is configured to actuate the tube compression element by moving a mechanical element coupled to the tube compression element.

17. The system for aspirating thrombus according to claim 1 , wherein the actuation interface is configured to actuate the tube compression element via a wireless signal.

18. The system for aspirating thrombi according to claim 1 , wherein the opening comprises a circumferentially extending slit in a wall separating the supply lumen and the aspiration lumen.

19. The system further includes a connector hydraulically coupled to the proximal end of the aspiration lumen, the connector having an internal cavity, a proximal end, and a distal end; 2. The system for aspirating thrombus of claim 1, wherein the connector includes a first side port in communication with the internal cavity of the connector and in fluid communication with the aspiration lumen of the aspiration catheter, the internal cavity of the connector having an inner surface, and the first side port comprising a significant interruption of the inner surface proximate the distal end of the connector.

20. 20. The system for aspirating thrombi according to claim 19, wherein the connector further comprises a second side port in fluid communication with the supply lumen, the second side port being located proximal to the first side port.

21. 1. A suction catheter comprising: an elongate shaft configured for placement within a patient's vasculature; a supply lumen having a proximal end and a distal end and an aspiration lumen having a proximal end and an open distal end, each extending within said shaft; an opening in a wall separating the supply lumen and the aspiration lumen, the opening being located at or adjacent the distal end of the supply lumen and in fluid communication with the interior of the aspiration lumen, the opening positioned proximal to the open distal end of the aspiration lumen, the opening configured to generate a jet when pressurized fluid is pumped through the supply lumen of the aspiration catheter; a suction catheter comprising: a pressure sensor in fluid communication with the aspiration lumen of the aspiration catheter and configured to output a signal indicative of a measured pressure; a tubing set including a tube extending proximally from the pressure sensor and configured to be in fluid communication with the aspiration lumen of the aspiration catheter, the tubing set having a proximal end configured to couple to a vacuum source; a tube compression element configured to externally engage the tube of the tube set at a location between the proximal end of the tube set and the pressure sensor; an actuation interface configured to actuate the tube compression element to compress the tube at the location between the proximal end and the pressure sensor; A system for aspirating a thrombus comprising:

22. The system for aspirating thrombus according to claim 21 , wherein the operating interface is configured to be disposed and operated in a non-sterile field.

23. The system for aspirating thrombus according to claim 21 , wherein the actuation interface is a foot pedal.

24. The system for aspirating thrombus according to claim 21 , wherein the actuation interface is a push button.

25. 22. The system for aspirating thrombus as described in claim 21, wherein the actuation interface is further configured to actuate the tube compression element to decompress the tube at the location between the proximal end of the tubing set and the pressure sensor.

26. The system for aspirating thrombi according to claim 21 , wherein the compression of the tube by the compression element comprises complete occlusion of the tube.

27. The system for aspirating thrombus according to claim 21 , wherein the actuation interface is configured to actuate the tube compression element by transmitting an electrical signal.

28. The system for aspirating thrombus according to claim 21 , wherein the actuation interface is configured to actuate the tube compression element by transmitting a pressure impulse.

29. The system for aspirating thrombus according to claim 21 , wherein the actuation interface is configured to actuate the tube compression element by moving a mechanical element coupled to the tube compression element.

30. The system for aspirating thrombus according to claim 21 , wherein the actuation interface is configured to actuate the tube compression element via a wireless signal.

31. The actuation interface is adapted to activate or deactivate a pump configured to pump pressurized fluid through the delivery lumen of the aspiration catheter. The system for aspirating a thrombus according to claim 21 , configured as follows:

32. 32. The system for aspirating thrombi as described in claim 31, wherein the output signal of the pressure sensor is configured to activate or not activate the pump.

33. 32. The system for aspirating thrombi according to claim 31, wherein the tube compression element is supported by the pump.

34. 22. The system for aspirating thrombi as described in claim 21, wherein the pressure sensor is supported by the tubing set.

35. 22. The system for aspirating thrombi according to claim 21, wherein the tubing set has a distal end configured to releasably couple with the proximal end of the aspiration lumen of the aspiration catheter.

36. The system for aspirating thrombi according to claim 21 , wherein the opening comprises a circumferentially extending slit in the wall.

37. The system further includes a connector hydraulically coupled to the proximal end of the aspiration lumen, the connector having an internal cavity, a proximal end, and a distal end; 22. The system for aspirating thrombi as described in claim 21, wherein the connector includes a first side port in communication with the internal cavity of the connector and in fluid communication with the aspiration lumen of the aspiration catheter, the internal cavity of the connector having an inner surface, and the first side port comprising a significant interruption of the inner surface proximate the distal end of the connector.

38. 38. The system for aspirating thrombi as described in claim 37, wherein the connector further comprises a second side port in fluid communication with the supply lumen, the second side port being proximal to the first side port.

39. 1. A suction catheter comprising: an elongate shaft configured for placement within a patient's vasculature; a supply lumen having a proximal end and a distal end and an aspiration lumen having a proximal end and an open distal end, each extending within said shaft; an opening at or near the distal end of the supply lumen, the opening being configured to allow for injection of pressurized fluid into the aspiration lumen at or near the distal end of the aspiration lumen upon pumping of the pressurized fluid through the supply lumen; a suction catheter comprising: a pressure sensor in fluid communication with the aspiration lumen of the aspiration catheter and configured to output a signal indicative of a measured pressure; a tubing set including a tube extending proximally from the pressure sensor and configured to be in fluid communication with the aspiration lumen of the aspiration catheter, the tubing set having a proximal end configured to couple to a vacuum source; a tube compression element configured to externally engage the tube of the tube set at a location between the proximal end of the tube set and the pressure sensor; an actuation interface configured to actuate the tube compression element to compress the tube at the location between the proximal end and the pressure sensor; A system for aspirating a thrombus comprising:

40. 40. The system for aspirating thrombus of claim 39, wherein the operating interface is configured to be disposed and operated in a non-sterile field.

41. 40. The system for aspirating thrombus as described in claim 39, wherein the actuation interface is a foot pedal.

42. 40. The system for aspirating thrombus as described in claim 39, wherein the actuation interface is a push button.

43. 40. The system for aspirating thrombi as described in claim 39, wherein the actuation interface is further configured to actuate the tube compression element to decompress the tube at the location between the proximal end of the tubing set and the pressure sensor.

44. 40. The system for aspirating thrombi as described in claim 39, wherein the compression of the tube by the compression element comprises complete occlusion of the tube.

45. 40. The system for aspirating thrombus according to claim 39, wherein the actuation interface is configured to actuate the tube compression element by transmitting an electrical signal.

46. 40. The system for aspirating thrombus according to claim 39, wherein the actuation interface is configured to actuate the tube compression element by transmitting a pressure impulse.

47. 40. The system for aspirating thrombus according to claim 39, wherein the actuation interface is configured to actuate the tube compression element by moving a mechanical element coupled to the tube compression element.

48. 40. The system for aspirating thrombus according to claim 39, wherein the actuation interface is configured to actuate the tube compression element via a wireless signal.

49. 40. The system for aspirating thrombi as described in claim 39, wherein the actuation interface is further configured to activate or not activate a pump configured to pump pressurized fluid through the supply lumen of the aspiration catheter.

50. 50. The system for aspirating thrombi as described in claim 49, wherein the output signal of the pressure sensor is configured to activate or not activate the pump.

51. 50. The system for aspirating thrombi as described in claim 49, wherein the tube compression element is supported by the pump.

52. 40. The system for aspirating thrombi as described in claim 39, wherein the pressure sensor is supported by the tubing set.

53. 40. The system for aspirating thrombi as described in claim 39, wherein the tubing set has a distal end configured to releasably couple with the proximal end of the aspiration lumen of the aspiration catheter.

54. 40. The system for aspirating thrombi as described in claim 39, wherein the opening comprises a circumferentially extending slit in the wall.

55. The system further includes a connector hydraulically coupled to the proximal end of the aspiration lumen, the connector having an internal cavity, a proximal end, and a distal end; 40. The system for aspirating thrombi as described in claim 39, wherein the connector includes a first side port in communication with the internal cavity of the connector and in fluid communication with the aspiration lumen of the aspiration catheter, the internal cavity of the connector having an inner surface, and the first side port comprising a significant interruption of the inner surface proximate the distal end of the connector.

56. 56. The system for aspirating thrombi as described in claim 55, wherein the connector further comprises a second side port in fluid communication with the supply lumen, the second side port being proximal to the first side port.

57. 1. A suction catheter comprising: a supply lumen having a proximal end and a distal end and a suction lumen having a proximal end and an open distal end; an opening at or adjacent the distal end of the supply lumen, in fluid communication with the interior of the aspiration lumen, proximal to the open distal end of the aspiration lumen, the opening configured to generate a jet when pressurized fluid is pumped through the supply lumen; a connector hydraulically coupled to the proximal end of the aspiration lumen, the connector having an internal cavity, a proximal end, and a distal end; a pressure sensor disposed within the internal cavity of the connector; a suction catheter comprising: a measurement device configured to receive a signal from the pressure sensor; A system for aspirating a thrombus comprising:

58. 58. The system for aspirating a thrombus according to claim 57, wherein the aspiration lumen is configured for placement of a guidewire.

59. 59. The system for aspirating thrombi as described in claim 57 or 58, wherein the aspiration lumen extends the entire length of the aspiration catheter.

60. A system for aspirating thrombi as described in any one of claims 57 to 59, further comprising a valve supported by the proximal end of the connector, the valve providing access to at least a portion of the internal cavity of the connector and to the aspiration lumen of the aspiration catheter.

61. 61. The system for aspirating thrombus as described in claim 60, wherein the valve has an open configuration and a closed configuration, the open configuration allowing a guidewire to pass therethrough and the closed configuration allowing it to seal over the guidewire.

62. 62. The system for aspirating thrombi according to claim 60 or 61, wherein the valve comprises a Touhy-Borst.

63. 62. The system for aspirating thrombi according to claim 60 or 61, wherein the valve comprises a spring-loaded seal.

64. A system for aspirating thrombi as described in any one of claims 57 to 63, wherein the opening comprises a distal end of the supply lumen.

65. A system for aspirating thrombi according to any one of claims 57 to 63, wherein the opening comprises an orifice in a wall of a tubular structure surrounding the supply lumen.

66. 66. The system for aspirating thrombus as described in claim 65, wherein the orifice comprises a slit.

67. 67. The system for aspirating thrombi as described in claim 66, wherein the slit has a width oriented in the direction of the longitudinal axis of the aspiration catheter and an arc length oriented circumferentially on the outer surface of the tubular structure.

68. 68. The system for aspirating thrombus according to claim 67, wherein the width is between about 0.0010 inches and about 0.0025 inches.

69. 69. The system for aspirating thrombus as described in claim 68, wherein the width is about 0.0015 inches to about 0.0020 inches.

70. 68. The system for aspirating thrombi according to claim 67, wherein the arc length is between about 0.002 inches and about 0.010 inches.

71. 71. The system for aspirating thrombi as described in claim 70, wherein the arc length is between about 0.004 inches and about 0.008 inches.

72. 72. The system for aspirating thrombus as described in claim 71, wherein the arc length is between about 0.005 inches and about 0.007 inches.

73. A system for aspirating thrombi as described in any one of claims 57 to 72, wherein the connector comprises a first side port in communication with the internal cavity of the connector and in fluid communication with the aspiration lumen of the aspiration catheter.

74. 74. The system for aspirating thrombi as described in claim 73, wherein the internal cavity of the connector has an inner surface, and the first side port comprises a significant interruption of the inner surface proximate the distal end of the connector.

75. 75. The system for aspirating thrombus as described in claim 74, wherein the inner surface distal to the first side port comprises a cylindrical shape.

76. A system for aspirating thrombi as described in any one of claims 73 to 75, wherein the connector further comprises a second side port in fluid communication with the supply lumen.

77. 77. The system for aspirating thrombi as described in claim 76, wherein the second side port comprises a significant interruption in the inner surface proximal to the interruption in the first side port.

78. 64. A system for aspirating thrombi as described in any one of claims 57 to 63, wherein the aspiration lumen extends through a first tube and the supply lumen extends through a second tube, the second tube being contained within the first tube.

79. 79. The method of claim 78, wherein the second tube is secured to the first tube at a fixed location at or adjacent the distal end of the supply lumen, and the second tube is not secured to the first tube between the fixed location and the connector. for aspirating blood clots.

80. 1. A suction catheter comprising: a supply lumen having a proximal end and a distal end and a suction lumen having a proximal end and an open distal end; an opening at or adjacent the distal end of the supply lumen, in fluid communication with the interior of the aspiration lumen and proximal to the open distal end of the aspiration lumen, the opening configured to generate a jet when pressurized fluid is pumped through the supply lumen; a connector hydraulically coupled to the proximal end of the aspiration lumen, the connector having an internal cavity, a proximal end, and a distal end; A system for aspirating a thrombus comprising an aspiration catheter comprising: A system for aspirating thrombus, wherein the opening comprises a slit in a wall of a tubular structure surrounding the delivery lumen.

81. 81. The system for aspirating thrombi as described in claim 80, wherein the slit has a width oriented in the direction of the longitudinal axis of the aspiration catheter and an arc length oriented circumferentially on the outer surface of the tubular structure.

82. 82. The system for aspirating thrombus as described in claim 81, wherein the width is from about 0.0010 inches to about 0.0025 inches.

83. 83. The system for aspirating thrombus as described in claim 82, wherein the width is about 0.0015 inches to about 0.0020 inches.

84. 82. The system for aspirating thrombus as described in claim 81, wherein the arc length is between about 0.002 inches and about 0.010 inches.

85. 85. The system for aspirating thrombi as described in claim 84, wherein the arc length is between about 0.004 inches and about 0.008 inches.

86. 86. The system for aspirating thrombi as described in claim 85, wherein the arc length is between about 0.005 inches and about 0.007 inches.

87. a supply lumen having a proximal end and a distal end and a suction lumen having a proximal end and an open distal end; an opening at or adjacent the distal end of the supply lumen, in fluid communication with the interior of the aspiration lumen and disposed proximal to the open distal end of the aspiration lumen, the opening configured to generate a jet when pressurized fluid is pumped through the supply lumen; a connector hydraulically coupled to the proximal end of the aspiration lumen, the connector having an internal cavity, a proximal end, and a distal end; a pressure sensor coupled to the proximal end of the delivery lumen; providing a suction catheter comprising: coupling or causing a coupling of the supply lumen of the aspiration catheter to a fluid source; coupling or causing a coupling of the aspiration lumen of the aspiration catheter to a vacuum source; coupling or causing to be coupled a pump that pumps fluid from the fluid source, through the supply lumen, and through the opening into the aspiration lumen; providing a control unit configured to adjust settings of the pump; configuring the pump with the control unit to provide an input pressure to the supply lumen of between about 650 pounds per square inch force and about 1200 pounds per square inch force; 16. A method for removing a thrombus from a patient, comprising:

88. 88. The method for removing a blood clot from a patient of claim 87, wherein the setting step includes setting the pump with the control unit such that the input pressure of the supply lumen is between about 800 pounds per square inch and about 1000 pounds per square inch.

89. 89. A method for removing a blood clot from a patient as recited in claim 87 or 88, further comprising the step of adjusting the pulsatility of the pump.

90. 90. The method for removing a blood clot from a patient of claim 89, wherein adjusting the pulsatility of the pump comprises adjusting the frequency of ejection pulses.

91. 1. A suction catheter comprising: a supply lumen having a proximal end and a distal end and a suction lumen having a proximal end and an open distal end; an opening at or adjacent the distal end of the supply lumen, in fluid communication with the interior of the aspiration lumen, proximal to the open distal end of the aspiration lumen, the opening configured to generate a jet when pressurized fluid is pumped through the supply lumen; a connector hydraulically coupled to the proximal end of the aspiration lumen, the connector having an internal cavity having an inner surface, a proximal end, and a distal end, the connector including a first side port in fluid communication with the internal cavity of the connector and in fluid communication with the aspiration lumen of the aspiration catheter, the first side port comprising a significant interruption of the inner surface proximate the distal end of the connector; A system for aspirating a thrombus comprising an aspiration catheter comprising:

92. 92. The system for aspirating thrombus as described in claim 91, wherein the inner surface distal to the first side port comprises a cylindrical shape.

93. 93. The system for aspirating thrombi according to claim 91 or 92, wherein the connector further comprises a second side port in fluid communication with the supply lumen.

94. 94. The system for aspirating thrombi as described in claim 93, wherein the second side port comprises a significant interruption in the inner surface at a location proximal to the interruption in the first side port.

95. A system for aspirating thrombi as described in any one of claims 91 to 94, wherein the suction lumen extends through a first tube and the supply lumen extends through a second tube, the second tube being contained within the first tube.

96. 96. The system for aspirating thrombi as described in claim 95, wherein the second tube is fixed to the first tube at a fixed location at or adjacent to the distal end of the supply lumen, and the second tube is not fixed to the first tube between the fixed location and the connector.

97. The suction catheter comprises: a pressure sensor disposed within the internal cavity of the connector; a measurement device configured to receive a signal from the pressure sensor; The system for aspirating a thrombus according to any one of claims 91 to 96, further comprising:

98. A system for aspirating a thrombus according to any one of claims 91 to 97, wherein the aspiration lumen is configured for placement of a guidewire.

99. A system for aspirating thrombi as described in any one of claims 91 to 98, wherein the aspiration lumen extends along the entire length of the aspiration catheter.

100. A system for aspirating thrombi as described in any one of claims 91 to 99, further comprising a valve supported by the proximal end of the connector, the valve providing access to at least a portion of the internal cavity of the connector and to the aspiration lumen of the aspiration catheter.

101. 101. The system for aspirating thrombus as described in claim 100, wherein the valve has an open configuration and a closed configuration, the open configuration allowing a guidewire to pass therethrough and the closed configuration allowing it to seal over the guidewire.

102. 102. A system for aspirating thrombi as described in claim 100 or 101, wherein the valve comprises a Touhy-Borst.

103. 102. A system for aspirating thrombi as described in claim 100 or 101, wherein the valve comprises a spring-loaded seal.

104. A system for aspirating thrombi as described in any one of claims 91 to 103, wherein the opening comprises a distal end of the supply lumen.

105. A system for aspirating thrombi according to any one of claims 91 to 103, wherein the opening comprises an orifice in a wall of a tubular structure surrounding the supply lumen.

106. 106. The system for aspirating thrombus as described in claim 105, wherein the orifice comprises a slit.

107. The system for aspirating thrombi as described in claim 106, wherein the slit has a width oriented in the direction of the longitudinal axis of the aspiration catheter and an arc length oriented circumferentially on the outer surface of the tubular structure.

108. 108. A system for aspirating thrombi as described in claim 107, wherein the width is from about 0.0010 inches to about 0.0025 inches.

109. 109. The system for aspirating thrombus as described in claim 108, wherein the width is about 0.0015 inches to about 0.0020 inches.

110. 108. The system for aspirating thrombi as described in claim 107, wherein the arc length is between about 0.002 inches and about 0.010 inches.

111. 111. The system for aspirating thrombus as described in claim 110, wherein the arc length is about 0.004 inches to about 0.008 inches.

112. 112. The method of claim 111, wherein the arc length is between about 0.005 inches and about 0.007 inches. A system for aspirating thrombus.

113. A system for aspirating thrombi as described in any one of claims 91 to 96, wherein the proximal end of the connector comprises a first luer.

114. 114. The system for aspirating a thrombus as described in claim 113, wherein the first luer comprises a female luer.

115. The system for aspirating thrombus described in claim 113 or 114, further comprising a first proximal connector and a second proximal connector, the first proximal connector configured to fluidly couple to the second proximal connector, and at least one of the first proximal connector and the second proximal connector configured to fluidly couple to the first luer of the connector.

116. The system for aspirating thrombi as described in claim 115, wherein at least one of the first proximal connector and the second proximal connector comprises a proximal connector cavity, and further comprises a pressure sensor disposed within the proximal connector cavity of the connector.

117. 117. The system for aspirating thrombus described in claim 115 or 116, wherein at least one of the first proximal connector and the second proximal connector includes a valve providing access to the aspiration lumen of the aspiration catheter.

118. 118. A system for aspirating thrombi as described in claim 117, wherein the valve has an open configuration and a closed configuration, the open configuration allowing a guidewire to pass therethrough and the closed configuration allowing it to seal over the guidewire.

119. 119. A system for aspirating thrombi as described in claim 117 or 118, wherein the valve comprises a Touhy-Borst.

120. 119. A system for aspirating thrombi as described in claim 117 or 118, wherein the valve comprises a spring-loaded seal.

121. 117. The system for aspirating thrombi described in claim 115 or 116, wherein at least one of the first proximal connector and the second proximal connector comprises an inlet configured to allow injection of a liquid into the aspiration lumen of the aspiration catheter.

122. 117. The system for aspirating thrombus as described in claim 116, further comprising a measuring device configured to receive a signal from the pressure sensor.

123. a supply lumen having a proximal end and a distal end and a suction lumen having a proximal end and an open distal end; an opening at or adjacent the distal end of the supply lumen, in fluid communication with the interior of the aspiration lumen and disposed proximal to the open distal end of the aspiration lumen, the opening configured to generate a jet when pressurized fluid is pumped through the supply lumen; a connector hydraulically coupled to the proximal end of the aspiration lumen, the connector having an internal cavity, a proximal end, and a distal end; providing a suction catheter comprising: Positioning the distal end of a guiding catheter in a blood vessel, placing a distal end of a guiding catheter, the guiding catheter having an internal lumen configured for placing said aspiration catheter; positioning the aspiration catheter through the inner lumen of the guiding catheter and into the blood vessel such that a distal end of the aspiration catheter is adjacent to the thrombus; coupling or causing a coupling of the supply lumen of the aspiration catheter to a fluid source; coupling or causing a coupling of the aspiration lumen of the aspiration catheter to a vacuum source; coupling or causing to be coupled a first pump that pumps fluid from the fluid source, through the supply lumen and through the opening into the aspiration lumen; causing infusion of fluid from the fluid source through the delivery lumen of the aspiration catheter via the first pump with the vacuum source actively coupled to the aspiration lumen; determining that aspiration of the thrombus through the aspiration lumen of the aspiration catheter is not occurring at a desired thrombus aspiration rate; injecting an infusion fluid into the blood vessel through the inner lumen of the guiding catheter to increase the rate of thrombus aspiration; 16. A method for removing a thrombus from a patient, comprising:

124. 124. The method for removing a thrombus from a patient as recited in claim 123, wherein the step of injecting an injectate comprises manually injecting the injectate via a syringe.

125. 124. The method for removing a blood clot from a patient of claim 123, wherein the step of injecting an infusate comprises injecting the infusate via a second pump.

126. A method for removing a thrombus from a patient as described in any one of claims 123 to 125, wherein the step of injecting an infusion solution comprises injecting the infusion solution into the inner lumen of the guiding catheter through a side port of a y-connector coupled to a proximal end of the guiding catheter.

127. 127. The method for removing a thrombus from a patient according to any one of claims 123 to 126, wherein the infusion fluid comprises saline.

128. 128. A method for removing a thrombus from a patient according to any one of claims 123 to 127, wherein the injectate comprises a contrast agent.

129. 129. The method for removing a thrombus from a patient of claim 128, further comprising the step of using the contrast agent in combination with fluoroscopy to visualize the area adjacent to the thrombus.

130. 130. The method for removing a thrombus from a patient according to any one of claims 123 to 129, wherein the suction catheter further comprises a pressure sensor coupled to the suction lumen.

131. 131. The method for removing a thrombus from a patient as described in claim 130, wherein the step of determining that aspiration of the thrombus through the aspiration lumen of the aspiration catheter is not occurring at a desired thrombus aspiration rate includes evaluating data provided by the pressure sensor.

132. a supply lumen having a proximal end and a distal end and a suction lumen having a proximal end and an open distal end; a fluid communication lumen proximal to the open distal end of the aspiration lumen; an aperture configured to generate a jet when pressurized fluid is pumped through the supply lumen; a connector hydraulically coupled to the proximal end of the aspiration lumen, the connector having an internal cavity, a proximal end, and a distal end; providing a suction catheter comprising: placing the distal end of a guiding catheter within a blood vessel, the guiding catheter having an internal lumen configured for placing the aspiration catheter; positioning the aspiration catheter through the inner lumen of the guiding catheter and into the blood vessel such that a distal end of the aspiration catheter is adjacent to the thrombus; coupling or causing a coupling of the supply lumen of the aspiration catheter to a fluid source; coupling or causing a coupling of the aspiration lumen of the aspiration catheter to a vacuum source; coupling or causing to be coupled a first pump that pumps fluid from the fluid source, through the supply lumen and through the opening into the aspiration lumen; causing infusion of fluid from the fluid source through the delivery lumen of the aspiration catheter via the first pump with the vacuum source actively coupled to the aspiration lumen; determining that aspiration of the thrombus through the aspiration lumen of the aspiration catheter is not occurring at a desired thrombus aspiration rate; rotating the guiding catheter within the blood vessel to increase the rate of thrombus aspiration; 16. A method for removing a thrombus from a patient, comprising:

133. 133. A method for removing a thrombus from a patient as described in claim 132, wherein a proximal end of the guiding catheter is coupled to a rotatable connector, enabling the guiding catheter to be rotated while maintaining a fluid-tight connection with the inner lumen of the guiding catheter.

134. 133. The method for removing a thrombus from a patient as described in claim 132, further comprising the step of releasing a fluid coupling to a proximal end of the guiding catheter prior to performing the rotating step.

135. 135. The method for removing a thrombus from a patient according to any one of claims 132 to 134, wherein the suction catheter further comprises a pressure sensor coupled to the suction lumen.

136. 136. A method for removing a thrombus from a patient as described in claim 135, wherein the step of determining that aspiration of the thrombus through the aspiration lumen of the aspiration catheter is not occurring at a desired thrombus aspiration rate comprises evaluating data provided by the pressure sensor.

137. a supply lumen having a proximal end and a distal end and a suction lumen having a proximal end and an open distal end; an opening at or adjacent the distal end of the supply lumen, in fluid communication with the interior of the aspiration lumen and disposed proximal to the open distal end of the aspiration lumen, the opening configured to generate a jet when pressurized fluid is pumped through the supply lumen; a connector hydraulically coupled to the proximal end of the aspiration lumen, the connector having an internal cavity, a proximal end, and a distal end; providing a suction catheter comprising: positioning the aspiration catheter within the blood vessel such that a distal end of the aspiration catheter is adjacent the thrombus; coupling or causing a coupling of the supply lumen of the aspiration catheter to a fluid source; coupling a first port of a four-way stopcock to an aspiration lumen of the aspiration catheter; coupling a second port of the four-way stopcock to a pressure sensor, the pressure sensor configured to transmit a signal to a controller; coupling a third port of the four-way stopcock to a vacuum source; coupling or creating a coupling between the pump and the fluid source and the aspiration lumen; causing an infusion of fluid from the fluid source through the supply lumen of the aspiration catheter via the pump with the vacuum source actively coupled to the aspiration lumen, wherein the pressure sensor, the aspiration lumen, and the vacuum source are all in fluid communication when the four-way stopcock is in a first state, and the controller is configured to stop the pump when the pressure sensor sends a signal indicating that it is not in fluid communication with the vacuum source; adjusting the four-way stopcock to a second state such that the pressure sensor remains in fluid communication with the vacuum source, but the pressure sensor and the vacuum source are each out of fluid communication with the aspiration lumen, such that the controller maintains operation of the pump while the aspiration lumen is not in fluid communication with the vacuum source; 16. A method for removing a thrombus from a patient, comprising:

138. 138. The method for removing a blood clot from a patient as described in claim 137, further comprising the step of adjusting the four-way stopcock to a third state, wherein the pressure sensor is no longer in fluid communication with the vacuum source, such that the controller stops operation of the pump and fluid from the fluid source stops flowing through the supply lumen of the aspiration catheter.

139. a first connector configured to releasably couple to a proximal portion of the suction catheter, the aspiration catheter comprising: a supply lumen having a proximal end and a distal end; and an aspiration lumen having a proximal end and an open distal end; an opening at or adjacent the distal end of the supply lumen in fluid communication with the interior of the aspiration lumen, the opening proximal to the open distal end of the aspiration lumen, the opening configured to generate a jet when pressurized fluid is pumped through the supply lumen; and a second connector hydraulically coupled to the proximal end of the aspiration lumen, the second connector having an interior cavity; The first connector comprises: a body having an interior; a distal end including a connector configured to sealably couple to the proximal end of the aspiration lumen of the aspiration catheter; a proximal end including an openable seal configured to seal over the guidewire; a suction port in fluid communication with an interior of the body and configured to couple to a vacuum source; a pressure sensor in fluid communication with the interior of the body; A first connector comprising:

140. 140. The first connector of claim 139, wherein the distal end of the first connector comprises a male luer. connector.

141. 141. The first connector of claim 139 or 140, wherein the openable seal comprises a Touhy Borst.

142. 141. The first connector of claim 139 or 140, wherein the openable seal comprises a spring-loaded seal.

143. 1. A suction catheter comprising: a supply lumen having a proximal end, a distal end and a wall, and a suction lumen having a proximal end and an open distal end; an orifice at or adjacent the distal end of the supply lumen, in fluid communication with the interior of the aspiration lumen and disposed proximal to the open distal end of the aspiration lumen, the orifice configured to generate a jet when pressurized fluid is pumped through the supply lumen when the distal end of the aspiration catheter is immersed in an aqueous environment; a first connector hydraulically coupled to the proximal end of the aspiration lumen; a suction catheter comprising: a distal connector having an internal passageway and configured to hydraulically couple to the first connector, a proximal connector configured to couple to a vacuum source, and a valve disposed between the distal connector and the proximal connector, the valve having an open state and a closed state; and A system for aspirating a thrombus comprising:

144. 144. The system for aspirating thrombus as described in claim 143, wherein the distal connector of the pressure sensor is permanently attached to the first connector of the aspiration catheter.

145. 144. The system for aspirating thrombus as described in claim 143, wherein the distal connector of the pressure sensor comprises a male luer and the first connector of the aspiration catheter comprises a female luer.

146. A system for aspirating thrombus as described in any one of claims 143 to 145, wherein the proximal connector of the pressure sensor comprises a female luer.

147. A system for aspirating thrombi as described in any one of claims 143 to 145, wherein the proximal connector of the pressure sensor comprises a spike.

148. A system for aspirating thrombi as described in any one of claims 143 to 147, further comprising an extension tube disposed between the proximal connector and the distal connector.

149. A system for aspirating thrombi as described in any one of claims 143 to 147, further comprising an extension tube disposed between the proximal connector and the valve.

150. A system for aspirating thrombus as described in any one of claims 143 to 149, wherein the valve includes a stop cock.

151. 151. A system for aspirating thrombus as described in claim 150, wherein the stop cock comprises a one-way stop cock.

152. A system for aspirating thrombi as described in claims 143 to 151, further comprising a control circuit configured to receive a signal from the pressure sensor.

153. The system further comprises a pump configured to inject pressurized fluid through the delivery lumen of the suction catheter; 153. The system for aspirating thrombi as described in claim 152, wherein the control circuit is configured to start or continue operation of the pump, or to stop or leave the pump in an inactive state, based at least in part on a signal from the pressure sensor.

154. A system for aspirating thrombi as described in claim 152 or 153, wherein the pressure sensor is coupled to the control circuit via a cable configured to transmit the signal.

155. 154. A system for aspirating thrombi as described in claim 153, wherein the control circuit is configured to change the operating state of the pump when a change in pressure is detected.

156. 156. A system for aspirating thrombi as described in claim 155, wherein the control circuit is configured to initiate operation of the pump when a pressure below a pressure threshold is detected.

157. 156. A system for aspirating thrombi as described in claim 155, wherein the control circuit is configured to stop operation of the pump when a pressure above a pressure threshold is detected.

158. A system for aspirating a thrombus as described in any one of claims 143 to 157, wherein the aspiration lumen is configured to pass a guidewire.

159. The system for aspirating thrombus described in claim 158, wherein the proximal end of the aspiration lumen is configured to couple with the distal end of a y-connector having an adjustable proximal seal configured to seal around the guidewire.

160. 160. The system for aspirating thrombi as described in claim 159, wherein the adjustable proximal seal comprises a Touhy Borst.

161. a supply lumen having a proximal end, a distal end and a wall, and a suction lumen having a proximal end and an open distal end; an orifice at or adjacent the distal end of the supply lumen, in fluid communication with the interior of the aspiration lumen and disposed proximal to the open distal end of the aspiration lumen, the orifice configured to generate a jet when pressurized fluid is pumped through the supply lumen when the distal end of the aspiration catheter is immersed in an aqueous environment; a first connector hydraulically coupled to the proximal end of the aspiration lumen; providing a suction catheter comprising: providing a pressure sensor comprising a distal connector having an internal passageway and configured to be hydraulically coupled to the first connector, a proximal connector configured to be coupled to a vacuum source, and a valve disposed between the distal connector and the proximal connector, the valve having an open state and a closed state; coupling the distal connector of the pressure sensor to the first connector of the aspiration catheter; coupling the proximal connector of the pressure sensor to a vacuum source; coupling the supply lumen of the suction catheter to a pump having a control circuit, the control circuit capable of receiving a signal from the pressure sensor; At least a distal portion of the aspiration catheter is inserted into the patient near or adjacent to the thrombus. inserting the catheter into the vascular system of a subject; changing the valve from one of the open and closed conditions to another of the open and closed conditions, such that a change in pressure can be detected by the control circuit; 16. A method for aspirating a thrombus in a patient, comprising:

162. 162. A method for aspirating a thrombus from a patient as described in claim 161, wherein the step of changing comprises changing the valve from the closed state to the open state.

163. 163. The method for aspirating thrombus from a patient as described in claim 162, further comprising the step of changing the valve from the open state to the closed state.

164. 162. A method for aspirating a thrombus from a patient as described in claim 161, wherein the step of changing comprises changing the valve from the open state to the closed state.

165. 162. A method for aspirating a thrombus from a patient as described in claim 161, wherein the control circuit changes the pump from an inactive state to an active state.

166. 162. A method for aspirating a thrombus from a patient as described in claim 161, wherein the control circuit changes the pump from an activated state to an inactivated state.

167. 162. The method for aspirating a thrombus in a patient as described in claim 161, further comprising the step of moving the aspiration catheter while the valve is in the open position.

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