Patent Description:
A prevalent cause of adult mortality in developed countries is atherosclerotic vascular disease.

For example, occlusion of a coronary artery subsequent to a plaque rupture remains one of the most frequent causes of myocardial infarction.

To treat such ailment, percutaneous coronary intervention is an efficient reperfusion method when performed promptly. Yet, the opening of coronary arteries is an invasive and risky procedure. Despite efficient and prompt intervention, some patients will present a condition known as no-reflow in which, in spite of the fact that the coronary artery is opened without residual stenosis, myocardial perfusion is diminished. No-reflow may be caused by two distinct phenomenon. A first one is the distal embolization of microparticles in blood vessels. A second phenomenon is reperfusion injury, which increases myocardial damage despite restoring blood flow in the artery.

Aspiration catheters are efficient in removing blood clots from arteries in the myocardial infarction status, in an effort improve the blood flow in the infarction zone. However, despite their efficiency, such catheters do not necessarily prevent the distal embolization of microparticles subsequent to their use. Also, such catheters do not allow drug infusion distally to the occlusion prior to thrombus aspiration to limit reperfusion injury.

Document <CIT> discloses a catheter assembly.

It is therefore an aim of the present disclosure to provide a novel device for infusing pharmacologic agents and/or performing thrombus aspiration in atherosclerotic vascular disease.

The present disclosure provides also a non-claimed method for infusing pharmacologic agents and/ or performing thrombus aspiration in artherosclerotic vascular disease.

Therefore, in accordance with an aspect of the present disclosure, there is provided a catheter assembly comprising a distal shaft having a guide lumen and an infusion lumen; a proximal shaft connected to the distal shaft, the proximal shaft defining an aspiration lumen opening at or near the distal shaft, and an inflating lumen; an inflatable member at a distal end of the inflating lumen, the inflatable member configured to inflate upon receiving a fluid from the inflating lumen; a stylet tube extending along the aspiration lumen and in fluid communication with the infusion lumen, the stylet tube configured to supply the infusion lumen with a pharmacologic agent; wherein the catheter assembly is configured to be displaced percutaneously in an artery by the guide lumen moving along a guide wire.

Further in accordance with the aspect, for instance, a catheter hub may be at a proximal end of the proximal shaft.

Still further in accordance with the aspect, for instance, the catheter hub is in fluid communication with the stylet tube, with the aspiration lumen and with the inflating lumen.

Still further in accordance with the aspect, for instance, the catheter hub has a port dedicated to the inflating lumen.

Still further in accordance with the aspect, for instance, a three-way valve may be on the port dedicated to the inflating lumen.

Still further in accordance with the aspect, for instance, radio-opaque markers may be provide dat or near opposed ends of the infusion lumen.

Still further in accordance with the aspect, for instance, the stylet is removable from the aspiration lumen prior to aspiration.

Still further in accordance with the aspect, for instance, the distal shaft has an aspiration port in fluid communication with the aspiration lumen.

Still further in accordance with the aspect, for instance, a proximal end of the guide lumen is at the distal shaft.

Still further in accordance with the aspect, for instance, a guide wire may be part of the catheter assembly.

In accordance with another aspect of the present disclosure, which is not covered by the claims, there is provided a use of a catheter assembly for removing a thrombus from an artery, comprising: a guide wire for being percutaneously positioned into an artery toward the thrombus; a distal shaft of a catheter for being moved along the guide wire until a tip of an infusion lumen of the distal shaft passes through the thrombus to a distal location; an inflatable member on the catheter and in fluid communication with an inflating lumen of the catheter for inflating and blocking the artery proximally of the thrombus; an aspiration lumen in the catheter extending into a proximal shaft of the catheter to reach a position proximal to the thrombus, for aspiring the thrombus; and a stylet removably in the aspiration lumen of proximal shaft and in fluid communication with the infusion lumen for infusing at least one pharmacologic agent distally to the thrombus via the infusion lumen.

In accordance with another aspect of the present application, which is not covered by the claims, there is provided a method for treating an artery having a thrombus comprising: percutaneously positioning a guide wire into an artery toward the thrombus; moving a distal shaft of a catheter along the guide wire until a tip of an infusion lumen of the distal shaft passes through the thrombus to a distal location, while an inflatable member and an aspiration lumen extending into a proximal shaft of the catheter are proximal to the thrombus; and infusing at least one pharmacologic agent distally to the thrombus via the infusion lumen.

Further in accordance with the aspect, for instance, inflating the inflatable member may occur proximally to the thrombus. In the present disclosure, proximally may refer to positions upstream of a thrombus relative to blood flow, while distal may refer to positions downstream of a thrombus relative to blood flow.

Still further in accordance with the aspect, for instance, inflating the inflatable member proximally to the thrombus is performed prior to infusing at least one pharmacologic agent distally to the thrombus.

Still further in accordance with the aspect, for instance, inflating the inflatable member is performed during fluoroscopy to monitor the inflating.

Still further in accordance with the aspect, for instance, further an aspiration may be performed via the aspiration lumen to aspire the thrombus.

Still further in accordance with the aspect, for instance, positioning the catheter and passing of the tip are done by moving the catheter over a guide wire.

Still further in accordance with the aspect, for instance, moving the distal shaft of the catheter over the guide wire includes only the distal shaft being engaged onto the guide wire by a guide lumen thereof.

Still further in accordance with the aspect, for instance, infusing at least one pharmacologic agent includes infusing the pharmacologic agent in a tube of a stylet extending to the infusion lumen.

Still further in accordance with the aspect, for instance, infusing the pharmacologic agent in a tube of a stylet extending to the infusion lumen includes infusing the pharmacologic agent in the tube of the stylet passing through the aspiration lumen.

Still further in accordance with the aspect, for instance, the stylet is optionally from the aspiration lumen prior to using the aspiration lumen to aspire the thrombus.

Referring to <FIG>, a catheter assembly in accordance with the present disclosure is generally shown at <NUM>. The catheter assembly <NUM> may be used for the infusion of pharmacologic agents and for thrombus aspiration in accordance with the methodology described for method <NUM> of <FIG> as described hereinafter, through the method <NUM> and the catheter assembly <NUM> may not be mutually exclusive. In some variants, the method <NUM> may be used with a catheter assembly differing the catheter assembly <NUM>, and the catheter assembly <NUM> may be used with a method differing from the method <NUM> of <FIG>.

The catheter assembly <NUM> is introduced over a guide wire <NUM> that is inserted into any appropriate vessel of the vascular system, such as the coronary artery, with a view to attend to a thrombus. As detailed hereinafter, the catheter assembly <NUM> has a hydrophilic surface, so as to slide within the artery with reduced invasiveness.

The catheter assembly <NUM> may have one or more of the guide wire <NUM>, though the guide wire <NUM> may be an add-on that is not part of the catheter assembly <NUM>, a proximal shaft <NUM>, a distal shaft <NUM>, a catheter hub <NUM>, and/or a stylet <NUM>, though the stylet <NUM> may not be part of the catheter assembly <NUM>. Other components may be part of the catheter assembly <NUM>, such as any of those described herein through <FIG>. The guide wire <NUM> is the guide upon which parts of the catheter assembly <NUM> will be slid or guided in order to reach a target zone.

The catheter assembly <NUM> includes the proximal shaft <NUM>, the distal shaft <NUM> and/or may include the catheter hub <NUM>. It may also be said that the guide wire <NUM> may be part of the catheter. The proximal shaft <NUM> is between the distal shaft <NUM> and the catheter hub <NUM>, and serves as a canal for fluid displacement (and possibly solids), among other functions, in a distal direction and/or proximal direction. The proximal shaft <NUM> may be the longest component of the catheter (e.g. depending on whether the guide wire <NUM> is part or not of the catheter).

<FIG> are schematic views and may not be representative of the length of the proximal shaft <NUM> relative to the distal shaft <NUM> and catheter hub <NUM>. The distal shaft <NUM> is at the distal end of the proximal shaft <NUM> and may be one of the output ends of the catheter. The catheter hub <NUM> may be located outside of the body during a procedure, while the proximal shaft <NUM> is mostly in the body - it may gradually be inserted into the body -, and the distal shaft <NUM> is within the body. The catheter hub <NUM> is the interface that may be manipulated by an operator, to perform infusion, inflating and aspiration, for example. The stylet <NUM> may be used in the infusion of a pharmacologic agent in the human body, and may also be referred to as a tube. In a variant, the stylet <NUM> provides some rigidity to the catheter assembly <NUM>, and may be optionally used to transmit a push force when positioning the catheter device in the vessel. As a possibility, the stylet <NUM> is a one-time use device.

Referring to <FIG>, the proximal shaft <NUM> is shown as having an elongated body, that is merely shown schematically but that may be substantially longer than what is shown in <FIG>. The proximal shaft <NUM> may have a monoblock body, for instance that may be extruded. Other constructions include a combination of materials, braiding, etc. The proximal shaft <NUM> may include an outer sheath that incorporates therein different tubes that may define different lumens, as described below, or may be monoblock and define one or more of these lumens. The proximal shaft <NUM> may also have different constructions, such as by forming an outer jacket supporting different tubes, that will define different types of lumens. The following description pertains to a monoblock body for the shaft portion of the proximal shaft <NUM>, though other types of constructions are considered, and are suggested as well where applicable.

Referring to <FIG>, the proximal shaft <NUM> defines an aspiration lumen <NUM>, and an inflating lumen <NUM>. An inflatable member <NUM>, such as a balloon, is provided at the distal end of the proximal shaft <NUM> and is in fluid communication with the inflating lumen <NUM>, such that the balloon <NUM> may be inflated. While the inflatable member <NUM> may be positioned at or near the distal end of the proximal shaft <NUM>, it may also be located at a junction between the proximal shaft <NUM> and the distal shaft <NUM>, and/or may be part of the distal shaft <NUM>. The inflatable member <NUM> may be any suitable type of inflatable material, such as a balloon. According to an embodiment, the inflatable member <NUM> is made of a substantially compliant membrane, so as to distribute inflating pressure uniformly on the inner surface of the artery or other vessel.

The aspiration lumen <NUM> is open-ended at the distal end of the proximal shaft <NUM>. In an embodiment, the aspiration lumen <NUM> is part of an aspiration tube. Such an aspiration tube may be made from a combination of layers, such as polytetrafluoroethylene, a stainless steel braid (e.g., <NUM>" (<NUM>) thickness for <NUM>" (<NUM>) width of flat wire with <NUM> pics/in (<NUM> pics/cm)), and a polyether block amide lumen (e.g., Pebax™. As an example, the aspiration lumen <NUM> may have an inner diameter of <NUM>" (<NUM>), though this is merely given as an example. A typical inner diameter of the aspiration lumen <NUM> ranges from <NUM>" (<NUM>) to <NUM>" (<NUM>), though it may be outside this range. If an aspiration tube is present, it may have a wall thickness of <NUM>" (<NUM>) and an outer diameter of <NUM>" (<NUM>), again with these values merely provided as examples. Other dimensions are considered as well. According to an embodiment, a polytetrafluoroethylene (PTFE) tube is placed over a mandrel also covered with PTFE, and the stainless steel braid is then positioned on the PTFE.

As observed in <FIG>, the aspiration lumen <NUM> hosts the stylet <NUM>, such that the pharmacological agent may be infused through the aspiration lumen <NUM>, via the stylet <NUM>, though the infusion lumen of the stylet <NUM> may be isolated from the aspiration lumen <NUM>. During use, the open distal end of the aspiration lumen <NUM> is proximally behind the open distal end of the stylet <NUM>, and is hence proximally located in the artery relative to a position of the inflatable member <NUM>.

The inflating lumen <NUM> may or may not be part of an inflating tube. The inflating lumen <NUM> opens into the inflatable member <NUM> at the front end of the catheter assembly <NUM>, for injection of a fluid into the inflatable member <NUM> via the inflating lumen <NUM>. According to an embodiment, the inflating lumen <NUM> is part of a tube that may be made from a single extruded material. However, a combination of layers may be considered as well, such as high-density polyethylene (e.g., HDPE LR734, <NUM>%) and/or polyether block amide (e.g., Pebax™ <NUM>, <NUM>% of outer layer) and/or Plexar™ (e.g., middle layer of Plexar™ <NUM>). As an example, the inflating lumen <NUM> may have an inner diameter of <NUM>", though this is merely given as an example. A typical inner diameter of the inflating lumen <NUM> ranges from <NUM> to <NUM>". (<NUM> to <NUM>) If present, the inflating tube may have a wall thickness of <NUM>" (<NUM>) and an outer diameter of <NUM>" (<NUM>), again with these values merely provided as examples. Other dimensions are considered as well. Any appropriate type of fluid may be used. For instance, a mixture of saline and iodine contrast is commonly used for inflating balloons in percutaneous coronary intervention. The fluid used to inflate an inflatable member may have suitable contrast to be detected via radiographic imaging.

Referring to <FIG> and <FIG>, the distal shaft <NUM> is shown as having a body tapering from a proximal end toward a distal end, to facilitate its displacement in a vessel. The distal shaft <NUM> may also have a monoblock body, for instance that may be extruded, but this is only an option as the distal shaft <NUM> may be constituted of more than one component. For example, the distal shaft <NUM> may also have different constructions, such as by forming an outer jacket supporting different tubes, that will define different types of lumens.

The distal shaft <NUM> may have an aspiration port 30A. In a variant, the aspiration lumen <NUM> in the proximal shaft <NUM> is in fluid communication with the body of the distal shaft <NUM> and thus with the aspiration portion 30A, with the aspiration port 30A opening into the vessel. Accordingly, the aspiration port 30A may be a suction port of the catheter. The distal shaft <NUM> may then taper to form a smaller cross-section that may be passed through a thrombus. In a variant, the aspiration lumen <NUM> in the proximal shaft <NUM> opens directly into the vessel, such that the distal shaft <NUM> is not part of the aspiration step.

The distal shaft <NUM> also has an infusion lumen <NUM>, that is used to deliver the pharmacologic agent at the distal end of the catheter. The infusion lumen <NUM> may be a passage of the stylet <NUM>, or may be in fluid communication with the distal end of the stylet <NUM> so as to receive the pharmacological agent and deliver same to the infusion target site. As observed, the infusion lumen <NUM> may have a funneling geometry in a distal direction. In <FIG>, this scenario is shown, i.e., the stylet <NUM> is fluidly connected to the infusion lumen <NUM>, for the pharmacologic agent to travel through the infusion lumen <NUM> and out of the distal tip of the distal shaft <NUM>. The funnel geometry of the infusion lumen <NUM> is optional, but is well suited to ensure that the stylet <NUM> is in fluid communication with and delivers its pharmacologic agent to the infusion lumen <NUM>.

The distal shaft <NUM> further includes a guide lumen <NUM> configured to be mounted onto the guide wire <NUM>, for relative movement between the guide wire <NUM> and the distal shaft <NUM>. In a variant, the guide lumen <NUM> opens at the distal end of the distal shaft <NUM>. In a variant, the guide lumen <NUM> ends at or near the proximal end of the distal shaft <NUM>, though it may also extend to part of the proximal shaft <NUM>, at an exit port <NUM>. In a variant, the guide lumen <NUM> has a length of about <NUM> inches ± <NUM> inches (about <NUM> ± <NUM>). Hence, the catheter may only have its distal shaft <NUM> mounted to the guide wire <NUM>, thereby limiting friction, and facilitating displacement. Hence, the catheter may slide along the guide wire <NUM> during its insertion in the vessel. The distal shaft <NUM>, that may also be part of the outer jacket of the catheter <NUM>, may have an hydrophilic surface, tapering in a distal direction. According to an embodiment, the distal shaft <NUM> is made of polyether block amide (e.g., Pebax™ <NUM>).

Markers <NUM> of detectable material may be provided at one or both extremities of the distal shaft <NUM> for localization thereof, such as at the distal tip of infusion lumen <NUM>. For instance, radio-opaque material may be used for fluoroscopic localization, such as platinum with an iridium content (e.g., <NUM>%). Alternatives are considered as well. According to an embodiment, the markers <NUM> have an inner diameter of <NUM>" (<NUM>), a wall of <NUM>" (<NUM>,<NUM>) and an outside diameter of <NUM>" (<NUM>). These values are merely provided as examples.

Referring to <FIG>, the catheter hub <NUM> is shown. The proximal shaft <NUM> may emerge out of the human body, such that the open external ends of the aspiration lumen <NUM> and inflating lumen <NUM> are outside of the body, so as to be connected to appropriate means, for example via the catheter hub <NUM>. The catheter hub <NUM> may have a central tubular portion 40A with a branch portion 40B diverging from the central tubular portion 40A. Other configurations are considered such as a single tubular portion with separate ports, a Y-shaped body, etc. In a variant, the central tubular portion 40A defines a flush port <NUM> through which suction will be exerted on the catheter, during aspiration. The flush port <NUM> may therefore be in fluid communication with the aspiration lumen <NUM>. The branch portion 40B may define the inflating port <NUM>, and may thus be in fluid communication with the inflating lumen <NUM>, so as to direct fluid into the inflatable member <NUM>. The flush portion <NUM> may optionally be provided with a valve <NUM> to control the suction effect. In a variant, the valve <NUM> is not part of the catheter assembly <NUM>. In a variant, the stylet <NUM> is fitted into the catheter via the central tubular portion 40A, though other arrangements are connected.

Collets <NUM> may be provided to interconnect the hub <NUM> with the proximal shaft <NUM>, the collets <NUM> contributing to maintaining the fluid communication between components, as described above. If present, the tubes associated with the lumens <NUM> and/or <NUM>, and the stylet <NUM> may be equipped with suitable connectors (e.g., luers) for connection to the various devices (e.g., syringe). For example, one such connector is shown at <NUM> at the distal end of the stylet <NUM>. The stylet <NUM> may thus be connected to a source of pharmacologic agents, such as a syringe, etc, for the controlled infusion of pharmacologic agents passing through the catheter of the catheter assembly <NUM>. As mentioned above, the inflating lumen <NUM> is connected to a source of fluid for pressurization of the inflatable member <NUM>.

Referring to <FIG>, another embodiment of the catheter hub <NUM> is shown. In <FIG>, the catheter hub <NUM> may have a central tubular portion 40A with a branch portion 40B diverging from the central tubular portion 40A, and another branch portion 40C also diverging from the central tubular portion 40A. In a variant, the central tubular portion 40A defines at its proximal end the injection port, or at the proximal end of part 40A1. The branch portion 40B may define the inflating port <NUM>, and may thus be in fluid communication with the inflating lumen <NUM>, so as to direct fluid into the inflatable member <NUM>. The branch portion 40C may be the flush port <NUM> through which suction will be exerted on the catheter, during aspiration. The flush port <NUM> may therefore be in fluid communication with the aspiration lumen <NUM>. The flush portion <NUM> may optionally be provided with a valve <NUM> to control the suction effect, the valve being for example a three-way valve such as a three-way stopcock, as an example among others. In a variant, the valve <NUM> is not part of the catheter assembly <NUM>. In a variant, the stylet <NUM> is fitted into the catheter via the free end of the central tubular portion 40A, though other arrangements are connected.

Collet <NUM> may be provided to interconnect the part 40A1 of the hub <NUM> featuring the branch portion 40B with the part 40A2 of the hub featuring the branch portion 40C. The stylet <NUM> may be accessed when separating part 40A1 from part 40A2, as an example. Other collets may be present, such as to connect the central tubular portion 40A to the proximal shaft <NUM>, for example. The collet <NUM> contributes to maintaining the fluid communication between components, as described above. If present, the tubes associated with the lumens <NUM> and/or <NUM>, and the stylet <NUM> may be equipped with suitable connectors (e.g., luers) for connection to the various devices (e.g., syringe).

The aspiration lumen <NUM>, such as through the flush portion <NUM>, is connected to an aspiration mechanism, such as a vacuuming syringe or the like. Accordingly, an aspiration action performed at the external end of the catheter causes an aspiration at the open internal end of the aspiration lumen <NUM> (e.g., aspiration port 30A), such as at the distal end of the proximal shaft <NUM> or at an outlet end within the distal shaft <NUM>. As the open internal end of the aspiration lumen <NUM> is positioned adjacent to the blood clot in the thrombus aspiration application, the blood clot is vacuumed away from the artery via the aspiration lumen <NUM>.

Any appropriate material may be used for the shafts <NUM> and <NUM>, and/or tubes therein. According to other embodiments, the tubes and/or the stylet <NUM> is/are, for instance, made of polyimide of medical grade, or any other relatively compliant material. One material that may be used for the shafts <NUM> and/or <NUM> and/or stylet <NUM> is braided reinforced polyimide, to ensure that the aspiration lumen <NUM> retains its structurally integrity despite the vacuuming pressure, and to maintain the shape during insertion in the vessel, to avoid kinking. During manufacturing, an outer jacket making up the external body of the proximal shaft <NUM> may be slid over the tubes that would define the aspiration lumen <NUM> and/or the inflating lumen <NUM>. With tubes fixed and aligned with an outer jacket thereon, the assembly may be passed through a heated die, with the outer jacket fusing all together. Hence, these components are integrally connected to one another, if not monoblock.

Contemplated dimensions are set forth above, by way of example, and for illustrative purposes.

It is understood that the dimensions may be greater or smaller than those set forth above.

Now that the catheter assembly <NUM> has been described, its non-claimed use in a thrombus aspiration application is described, according to the method <NUM> of <FIG>. The non-claimed method <NUM> may thus be performed by the catheter assembly <NUM>, or by other catheter assemblies to infuse pharmacologic agents and perform thrombus aspiration. In a variant, the method <NUM> is performed on a cadaver, a model, or on a non-human animal.

According to <NUM>, with the thrombus (a. , blood clot, plaque rupture, artery occlusion) being localized, a distal end of the guide wire <NUM> is percutaneously inserted onto a blood vessel (e.g., coronary artery), and is moved up to the thrombus. As an option, the guide wire <NUM> is moved through the thrombus. A proximal end of the guide wire <NUM> may be out of the body.

According to <NUM>, the catheter of the catheter assembly <NUM> is percutaneously inserted into the vessel proximally of the occlusion, to be directed distally in the vessel toward the thrombus, as being guided onto the guide wire <NUM>. In the case of the catheter assembly <NUM>, it is the distal shaft <NUM> that is mounted onto the guide wire <NUM> outside of the body, via the guide lumen <NUM>, to then be inserted into the vessel as slid along the guide wire <NUM>. The stylet <NUM> may be used to push the catheter into position, the stylet <NUM> having been assembled prior to step <NUM> (for example, as assembled), the stylet <NUM> being in fluid communication with the infusion lumen <NUM>. It may also be possible to insert the stylet <NUM> after the combination of the distal shaft <NUM> and proximal shaft <NUM> have being guided to the thrombus by moving onto the guide wire <NUM>.

According to <NUM>, a distal tip of the distal shaft <NUM> of the catheter assembly is directed through the blood clot. The infusion lumen <NUM> at the end of the distal shaft <NUM> has thus been guided along the guide wire in an over-the-wire or monorail fashion through the occlusion. Therefore, the tip of the infusion lumen <NUM> of the catheter is distal of the blood clot after insertion. In a variant, the distal shaft <NUM> may be localized by the presence of radio-opaque markers <NUM>. Fluoroscopic imagery or any other appropriate type of imaging may be used to locate the infusion tube relative to the thrombus in the treated vessel.

According to <NUM>, an inflatable member on the catheter assembly is inflated proximally of the blood clot. If the catheter assembly <NUM> is used, the inflatable member <NUM> is inflated via the inflating lumen <NUM>.

According to <NUM>, a pharmacologic agent (e.g., adenosine) is infused into the infarction zone distally of the occlusion. As the vessel is blocked by the occlusion and the inflated member <NUM>, the pharmacologic agent will diffuse and be absorbed distally to the blood clot. If the catheter assembly <NUM> is used, the infusion is performed via the stylet <NUM>, that has been inserted into the proximal shaft <NUM>. It may be required that the stylet <NUM> be slid into the aspiration lumen <NUM> and displaced in a distal direction, until the distal tip of the stylet <NUM> reaches the infusion lumen <NUM>. In a variant, as mentioned above, the stylet <NUM> is pre-positioned in fluid communication with the infusion lumen <NUM> such that the stylet <NUM> is moved into position in the vessel concurrently with the positioning of the catheter. This may consequently ensure that the stylet <NUM> is in suitable fluid communication with the infusion lumen <NUM> of the distal shaft <NUM>, for delivery of the pharmacologic agent. The infusion of the pharmacologic agent may also be performed prior to the inflation of the inflatable member <NUM>.

According to <NUM>, the blood clot is vacuumed out of the artery so as to open the artery. The aspiration lumen <NUM> of the catheter assembly <NUM> is distally positioned relative to the inflatable member <NUM>, such that the inflatable member <NUM> may not interfere with the vacuuming. In an embodiment, to increase the efficiency of the vacuuming, the stylet <NUM> is removed from the aspiration lumen <NUM>, prior to the vacuuming. Thus, the aspiration lumen <NUM> may serve as aspiration passage and as passage for the stylet <NUM> for the pharmacologic agent. Stated differently, the aspiration lumen <NUM> may serve for fluid movement in a distal direction, and in proximal direction. This may be simultaneous and/or sequential.

In one non-claimed embodiment, the aspiration is initiated while the inflatable member <NUM> is inflated. This causes a relative negative pressure between the tip of the aspiration lumen <NUM> or suction portion 30A and the thrombus. The aspiration may also be initiated after deflation of the inflatable member <NUM>. The deflation may also occur during the aspiration.

Subsequently, the various steps for terminating the intervention are performed, including the removal of the various units of the catheter assembly. For example, the balloon <NUM> may be deflated if it hasn't yet been deflated. The catheter may then be slid out of the vessel, as moved along the guide wire <NUM>. The guide wire <NUM> may be the last remaining component in the vessel. It is pointed out that the method <NUM> may be performed according to any suitable sequence.

With reference to <FIG>, some steps may be done before or during the method <NUM>. The balloon <NUM> (<FIG>) may be prepared for use by attaching a three-way stopcock to the inflating port <NUM> of the catheter hub <NUM>. The inflating lumen <NUM> and a syringe <NUM> may have been primed beforehand. The syringe <NUM> may be a larger syringe, i.e., one with a greater volume of solution (e.g., <NUM>). The three-way valve <NUM> may have its the vertical port in the off position as in <FIG>. The syringe <NUM> may be attached to the valve <NUM>, at the proximal port as shown in <FIG>. To do so, the syringe <NUM> may have its plunger partially or fully depressed to the proximal port of the three-way valve <NUM>. Referring to <FIG>, the plunger of the syringe <NUM> may be pulled, and while maintaining the plunger in place, the valve <NUM> may be turned counter-clockwise to put the distal port in the OFF position thereby creating a vacuum inside the balloon <NUM>. The syringe <NUM> may be detached after use.

The stylet <NUM>, installed in the catheter assembly, may be flushed by attaching a syringe containing a liquid such as heparinized saline to the injection port at the free end of the central tubular portion 40A (if it is located there) of the catheter hub <NUM>. The plunger of the syringe may be depressed until a jet of fluid exits the distal tip of the catheter and droplets form at the back of the distal tip as in <FIG>. The catheter may also be flushed by attaching a syringe to the flush port <NUM> of the catheter and depressing the plunger until fluid exits the aspiration tip as in <FIG>. The syringe may be detached after use.

The catheter may be used with balloon inflation accessories. The balloon inflation accessories may be set up by connecting the syringe <NUM> filled with a liquid, such as at least <NUM> of a <NUM>:<NUM> v/v saline-contrast mixture (as an example among others), to the proximal port of the three-way valve <NUM> and depressing the plunger of the syringe <NUM> to purge air out of the vertical port of the three-way valve <NUM>. Another syringe <NUM>, such as one with a lesser volume, may also be filled with a fluid, such as <NUM>:<NUM> v/v saline-contrast mixture (as an example) to the vertical port of the three-way valve <NUM>.

The distal shaft <NUM> may be loaded over the guidewire <NUM> as in <NUM> of the method <NUM>. The catheter may be maneuvered under fluoroscopy until the and markers <NUM> are in the treatment area, whereby the foremost marker <NUM> is positioned distally to the thrombus. The balloon <NUM> may be inflated once the catheter is in the treatment area by turning the three-way valve <NUM> to put the vertical port to the OFF position thereby allowing the vacuum in the catheter to draw fluid from the syringe <NUM>. After a given amount of time, three-way valve <NUM> may be actuated to put the proximal port to the OFF position. Under fluoroscopy or like imagining, optionally, the syringe <NUM> may incrementally inflate the balloon <NUM>. Once the balloon <NUM> reaches the required occlusion diameter under fluoroscopy, the three-way valve <NUM> may be adjusted to put the distal port to the OFF position and maintain the inflation of the balloon <NUM> as in <FIG>.

With the valve <NUM> in the position of <FIG>, the catheter may also be used to deliver a pharmacologic agent by attaching a syringe with a desired infusion volume to the injection port (the free end of the central tubular portion 40A). The syringe may optionally have a flexible tube. For precaution, the plunger of the syringe may be pulled to withdraw any air bubbles. A continuous pressure may be applied on the plunger of the syringe to deliver the pharmacologic agent via the stylet <NUM> (<FIG>). The syringe may be removed after use.

The aspiration catheter assembly may be used with aspiration accessories. The aspiration accessories may be primed by attaching an extension tube to an aspiration syringe containing <NUM> to <NUM> of heparinized saline, the extension tube having a stopcock that can be placed in an open position to flush the entire length of the extension tube; the stopcock may be closed after flushing and the plunger of the aspiration syringe may be pulled until reaching its full extension before being locked in place.

After the infusion, the stylet <NUM> may be removed. In a variant, this is achieved by removing the part of the catheter hub <NUM> including the branch portion 40C, thereby liberating the aspiration lumen <NUM> (<FIG>).

The catheter may be prepared for aspiration by turning the three-way valve <NUM> to put the vertical port in the OFF position; the plunger of the syringe may be pulled to deflate the balloon <NUM>, which may be confirmed by fluoroscopy. The three-way valve <NUM> may then be rotated to put the distal port in the OFF position while maintaining the plunger in the pulled position. The two syringes may be removed after use. Then, as in <FIG>, the catheter may be used to aspirate by connecting an optional extension tube 82A of an aspiration syringe <NUM> attached to the aspiration port <NUM> of the catheter. If present, a valve <NUM> on the extension line 82A or elsewhere may be opened. These steps may occur throughout some of the steps of the method <NUM> of <FIG>.

The non-claimed method can be generally described as being for treating a thrombus (e.g., removing a thrombus) and may include percutaneously positioning a guide wire into an artery toward the thrombus; moving a distal shaft of a catheter along the guide wire until a tip of an infusion lumen of the distal shaft passes through the thrombus to a distal location, while an inflatable member and an aspiration lumen extending into a proximal shaft of the catheter are proximal to the thrombus; and infusing at least one pharmacologic agent distally to the thrombus via the infusion lumen.

Optionally, the non-claimed method may include inflating the inflatable member proximally to the thrombus the inflating may be performed prior to infusing at least one pharmacologic agent distally to the thrombus; performing an aspiration via the aspiration lumen to aspire the thrombus; positioning the catheter and passing of the tip are done by moving the catheter over a guide wire; moving the distal shaft of the catheter over the guide wire may include only the distal shaft being engaged onto the guide wire by a guide lumen thereof; infusing at least one pharmacologic agent includes infusing the pharmacologic agent in a tube of a stylet extending to the infusion lumen.

The catheter assembly comprises a distal shaft having a guide lumen and an infusion lumen; a proximal shaft connected to the distal shaft, the proximal shaft defining an aspiration lumen opening at or near the distal shaft, and an inflating lumen; an inflatable member at a distal end of the inflating lumen, the inflatable member configured to inflate upon receiving a fluid from the inflating lumen; a stylet tube extending along the aspiration lumen and in fluid communication with the infusion lumen, the stylet tube configured to supply the infusion lumen with a pharmacologic agent; wherein the catheter assembly is configured to be displaced percutaneously in an artery by the guide lumen moving along a guide wire.

Optionally, the catheter assembly may include a catheter hub at a proximal end of the proximal shaft. The catheter hub may be in fluid communication with the stylet tube, with the aspiration lumen and with the inflating lumen. The catheter hub may or may not have a port dedicated to the inflating lumen. A three-way valve on the port dedicated to the inflating lumen. Radio-opaque markers may be provided at or near opposed ends of the infusion lumen. The stylet is removable from the aspiration lumen prior to aspiration. Thus the aspiration lumen may be used for infusion (e.g., via the stylet or other tube) and for aspiration. The distal shaft has an aspiration port in fluid communication with the aspiration lumen. A proximal end of the guide lumen may be at the distal shaft.

The present disclosure also pertains to a non-claimed use of a catheter assembly, in the manner shown in the figures herein, the use of the catheter assembly for removing a thrombus from an artery, the use including: a guide wire for being percutaneously positioned into an artery toward the thrombus; a distal shaft of a catheter for being moved along the guide wire until a tip of an infusion lumen of the distal shaft passes through the thrombus to a distal location; an inflatable member on the catheter and in fluid communication with an inflating lumen of the catheter for inflating and blocking the artery proximally of the thrombus; an aspiration lumen in the catheter extending into a proximal shaft of the catheter to reach a position proximal to the thrombus, for aspiring the thrombus; and a stylet removably in the aspiration lumen of proximal shaft and in fluid communication with the infusion lumen for infusing at least one pharmacologic agent distally to the thrombus via the infusion lumen.

Claim 1:
A catheter assembly (<NUM>) comprising
a distal shaft (<NUM>) having a guide lumen (<NUM>);
a proximal shaft (<NUM>) connected to the distal shaft (<NUM>), the proximal shaft (<NUM>) defining an aspiration lumen (<NUM>) opening at or near the distal shaft (<NUM>), and an inflating lumen (<NUM>);
an inflatable member (<NUM>) at a distal end of the inflating lumen (<NUM>), the inflatable member (<NUM>) configured to inflate upon receiving a fluid from the inflating lumen (<NUM>);
wherein the catheter assembly (<NUM>) is configured to be displaced percutaneously in an artery by the guide lumen (<NUM>) moving along a guide wire (<NUM>);
characterized in that
the distal shaft (<NUM>) has an infusion lumen (<NUM>); and
a stylet tube (<NUM>) extends along the aspiration lumen (<NUM>) and is in fluid communication with the infusion lumen (<NUM>), the stylet tube (<NUM>) configured to supply the infusion lumen (<NUM>) with a pharmacologic agent.