Methods, devices, and systems for postconditioning with clot removal

An apparatus comprising:

• a catheter,
• a balloon disposed on the catheter at a distal end of the catheter, the catheter including an orifice for inflating the balloon,
• a stent in the vicinity of a distal end of a wire that extends through a lumen to an end of the catheter, and
• a sealing interface between the wire and the lumen, nearer to the distal end of the catheter than is the orifice for inflating the balloon, that is adapted to seal the lumen so that the balloon may be inflated.

An assembly configured to treat ischemic in a patient, comprising:

• a catheter with a proximal region, distal region, and a single lumen;
• a flow modulation member coupled to the proximal region of the catheter and comprising an inflatable balloon able to reversibly decrease and increase the flow of fluid through the blood vessel at least twice, and thereby modulate blood flow through the blood vessel, wherein the inflatable balloon has a balloon inflation aperture continuous with the single lumen and able to receive inflating fluid from the single lumen;
• a pushwire with a proximal end and a distal end, wherein the pushwire is at least partially within the single lumen;
• a flow restoration member for increasing the flow of blood through the clot, coupled to the distal end of the pushwire;
• and
• one or more sealing members adapted to decrease the flow rate of inflating fluid leaving the single lumen.

A method of using an assembly able to treat ischemia in a patient, comprising:

• identifying a blood clot in a blood vessel;
• inserting a catheter into the blood vessel, the catheter including a proximal region, a distal region, and a single lumen, wherein a pushwire with a proximal end and a distal end is placed at least partially within the single lumen;
• modulating blood flow in the blood vessel by selectively decreasing and increasing the flow of fluid through the blood vessel with a flow modulation member at least twice, wherein the flow modulation member is coupled to the distal region of the catheter and comprises an inflatable balloon having a balloon inflation aperture with the single lumen and adapted to receive inflating fluid from the single lumen, wherein one or more sealing members are provided along the lumen to reduce the volumetric flow rate of inflating fluid leaving the single lumen;
• and
• increasing the flow rate in the blood vessel by translating the catheter relative to the pushwire to deploy a flow restoration member, wherein the flow restoration member is coupled to the pushwire near the distal end of the pushwire and comprises a self-expanding scaffoldable to engage the clot.

An assembly able to treat ischemia in a patient, comprising:

• an intermediate catheter with a proximal region, a distal region, and a single intermediate lumen;
• a flow modulation member coupled to the proximal region of the intermediate catheter and comprising an inflatable balloon to reversibly decrease and increase the flow of fluid through a blood vessel for modulating blood flow through the blood vessel, wherein the inflatable balloon has a balloon lumen continuous with the single intermediate lumen and receives inflating fluid from the lumen of the intermediate catheter;
• a microcatheter with a single microcatheter lumen, wherein the microcatheter is at least partially within the lumen of the intermediate catheter;
• a pushwire with a proximal end and a distal end, wherein the pushwire is at least partially within the lumen of the microcatheter;
• a flow restoration member coupled to the distal end of the pushwire and comprising a self-expanding scaffoldable to engage a clot in a blood vessel;
• and
• one or more sealing members able to reduce the volumetric flow rate of inflating fluid leaving the single intermediate lumen.

A method of using an assembly able to treat ischemia in a patient, comprising:

• identifying a target blood clot in a blood vessel;
• inserting into the blood vessel an intermediate catheter with a proximal region, a distal region, and a single intermediate lumen, wherein a microcatheter with a single microcatheter lumen is at least partially within the single intermediate lumen, wherein a pushwire with a proximal end and a distal end is at least partially within the lumen of the microcatheter;
• modulating blood flow in the blood vessel by reversibly decreasing and increasing a flow of fluid through the blood vessel with a flow modulation member at least twice, wherein the flow modulation member is coupled to the distal region of the intermediate catheter and comprises an inflatable balloon having a balloon lumen continuous with the single intermediate lumen and able to receive inflating fluid from the single intermediate lumen;
• reducing a rate of inflating fluid leaving the single intermediate lumen using one or more sealing members;
• and
• increasing the flow rate in the blood vessel by translating the intermediate catheter relative to the pushwire to deploy a flow restoration member.

An assembly able to treat ischemia in a patient, comprising:

• a catheter with a proximal end, a distal end, and at least two catheter lumina;
• one or more flow modulation members coupled to the catheter and comprising an inflatable balloon able to reversibly decrease and increase a flow of fluid through a blood vessel with a flow modulation member at least twice, wherein the inflatable balloon has a balloon lumen continuous with a first catheter lumen and able to receive inflating fluid from the first catheter lumen, wherein a distal end of the first catheter lumen is closed;
• one or more pushwires with a proximal end and a distal end, wherein a first pushwire of the one or more pushwires is placed at least partially within a second catheter lumen;
• and
• one or more flow restoration members are coupled to the first pushwire near a distal end of the first pushwire.

A method of using an assembly able to treat ischemia in a patient, comprising:

• identifying a blood clot in a blood vessel;
• inserting a catheter into the blood vessel the catheter including a proximal end, a distal end, and at least two catheter lumina, wherein a pushwire with a proximal end and a distal end is placed at least partially within a first catheter lumen;
• modulating blood flow in the blood vessel by reversibly decreasing and increasing a flow of fluid through the blood vessel with a flow modulation member at least twice, wherein the flow modulation member is coupled to the proximal end of the catheter and comprises an inflatable balloon having a balloon lumen continuous with a second catheter lumen receiving inflating fluid from the second catheter lumen, wherein one or more sealing members slow a flow rate of the inflating fluid that leaves the second catheter lumen;
• and
• increasing the flow rate in the blood vessel by translating the catheter relative to the pushwire to deploy a flow restoration member, wherein the flow restoration member is coupled to the pushwire near the distal end of the pushwire and comprises a self-expanding scaffoldable to engage the clot.

An assembly able to treat ischemia in a patient, comprising:

• an intermediate catheter with a proximal end, a distal end, and at least two intermediate catheter lumina;
• one or more flow modulation members coupled to the intermediate catheter and comprising an inflatable balloon or membrane able to reversibly reduce and increase a flow of fluid through a blood vessel at least twice for modulating blood flow through the blood vessel, wherein the inflatable balloon has a connecting lumen continuous with a first intermediate catheter lumen and receives inflating fluid from the first intermediate catheter lumen, wherein the distal end of the first intermediate catheter lumen is closed;
• one or more microcatheters with a microcatheter lumen, wherein the microcatheter lumen is at least partially within a second intermediate catheter lumen;
• one or more pushwires with a proximal end and a distal end, wherein a first pushwire of the one or more pushwires is at least partially within the microcatheter lumen;
• and
• one or more flow restoration members coupled to near a distal end of the first pushwire and comprising a self-expanding scaffold that engages a clot in a blood vessel.

A method of using an assembly to treat ischemia in a patient, comprising:

• identifying a blood clot in a blood vessel;
• inserting into the blood vessel an intermediate catheter with a proximal end, a distal end, and at least two intermediate catheter lumina, wherein a microcatheter with a microcatheter lumen is placed at least partially in a first intermediate catheter lumen, wherein a pushwire with a proximal end and a distal end is placed at least partially in the microcatheter lumen;
• modulating blood flow in the blood vessel by reversibly decreasing and increasing a flow of fluid through the blood vessel with a flow modulation member at least twice, wherein the flow modulation member is coupled to the proximal end of the intermediate catheter and comprises an inflatable balloon having a balloon lumen continuous with a second intermediate catheter lumen and able to receive inflating fluid from the second intermediate catheter lumen;
• and
• increasing the flow of blood in the blood vessel by translating the intermediate catheter relative to the pushwire to deploy a flow restoration member, wherein the flow restoration member is coupled to the pushwire near the distal end of the pushwire and comprises a self-expanding scaffoldable to engage the blood clot.

An assembly adapted to engage a clot in a blood vessel, comprising:

• a catheter with a proximal end, a distal end, and at least one lumen;
• a pushwire with a proximal end and a distal end, wherein the pushwire is at least partially within the at least one lumen;
• and
• a clot capture member coupled to the pushwire near the distal end of the pushwire and comprising a self-expanding scaffold that is capable of engaging a clot in a blood vessel when the catheter is moved so that the self-expanding scaffold is not completely within the catheter,
• wherein the self-expanding scaffold comprises open cells formed by a pattern of struts,
• wherein the open cells have a hexagonal cell shape able to facilitate engagement with the clot.

An assembly adapted for engaging a clot in a blood vessel, comprising:

• a catheter with a proximal end, a distal end, and at least one lumen;
• one or more pushwires with a proximal end and a distal end, wherein the pushwire is at least partially within the at least one lumen;
• and
• a clot capture member coupled to the distal end of the pushwire and comprising a self-expanding scaffold to engage a clot in a blood vessel when the catheter is retracted so as to at least partially not surround the self-expanding scaffold,
• wherein the self-expanding scaffold comprises open cells formed by a pattern of struts,
• wherein at least one of the struts has a cross-sectional shape with an angle less than 180 degrees oriented such that the angle protrudes outward from the self-expanding scaffold to facilitate engagement with the clot.

A method for engaging a clot in a blood vessel, comprising:

• identifying a blood clot in a blood vessel;
• inserting into the blood vessel a catheter with at least one lumen, wherein a pushwire with a proximal end and a distal end is placed at least partially within the at least one lumen, wherein a clot capture member comprising a self-expanding scaffold is coupled to the distal end of the pushwire;
• placing a distal end of the catheter proximate to the clot;
• retracting the catheter to unsheathe and allow the self-expanding scaffold to expand within the blood vessel, wherein the self-expanding scaffold comprises open cells formed by a pattern of struts, wherein the open cells have a hexagonal cell shape able to facilitate engagement with the clot;
• and
• extracting any clot material engaged by the self-expanding scaffold by removing the catheter and the pushwire from the blood vessel.

A method for engaging a clot in a blood vessel, comprising:

• identifying a blood clot in a blood vessel;
• inserting into the blood vessel a catheter with at least one lumen, wherein a pushwire with a proximal end and a distal end is placed at least partially within the at least one lumen, wherein a clot capture member comprising a self-expanding scaffold is coupled to the pushwire near the distal end of the pushwire;
• placing a distal end of the catheter close to a distal end of the clot;
• retracting the catheter to unsheathe and allow the self-expanding scaffold to expand within the blood vessel, wherein the self-expanding scaffold comprises open cells formed by a pattern of struts, wherein at least one of the struts has a cross-sectional shape with an angle less than 180 degrees oriented such that the angle protrudes outward from the self-expanding scaffold to facilitate engagement with the clot;
• and
• extracting any clot material engaged by the self-expanding scaffold by removing the catheter and the pushwire from the blood vessel.

An assembly able to prevent and/or treat ischemic stroke in a patient, comprising:

• a flow restoration member comprising a self-expanding scaffold capable of engaging a clot in a cerebral blood vessel;
• and
• a flow modulation member to reversibly decrease and increase a flow of fluid through the cerebral blood vessel with the flow modulation member at least twice, performing one or more postconditioning cycles in the cerebral blood vessel,
• wherein the members are able to be used simultaneously to prevent and/or treat ischemic stroke.

A method of preventing and/or treating ischemic stroke in a patient, comprising:

• identifying a blood clot in a cerebral blood vessel;
• inserting an assembly able to prevent, mitigate and/or treat ischemic stroke into the cerebral blood vessel, the assembly comprising:
• a flow restoration member comprising a self-expanding scaffoldable to engage a clot in the cerebral blood vessel;
• and
• a flow modulation member able to modulate blood flow in the cerebral blood vessel,
• wherein the members are able to be used simultaneously to prevent, mitigate, reduce and/or treat ischemic stroke;
• deploying the self-expanding scaffold to restore blood flow in the cerebral blood vessel;
• and
• performing one or more postconditioning cycles with the flow modulation member by reversibly decreasing and increasing a flow of fluid through the blood vessel at least twice.

A device for modulating blood flow, the device comprising:

• a flow modulation member having a plurality of self-expanding struts and a membrane capable of blocking blood flow;
• a pushwire, wherein the flow modulation member is attached to the pushwire;
• and
• a microcatheter with a lumen sized to receive at least a portion of the pushwire, the membrane capable of blocking blood flow attached to the microcather,
• wherein relative movement between the pushwire and the microcatheter in one direction unsheathes the flow modulation member, allowing the flow modulation member to expand, and
• wherein relative movement between the pushwire and the microcatheter in the opposite direction re-sheathes the flow modulation member, causing the flow modulation member to retract.

A device for engaging with a blood clot or embolus, the device comprising:

• a clot capture member attached to a push wire and having a plurality of self-expanding struts with an angular cross-sectional profile, wherein a point of the profile faces outward from the clot capture member;
• and
• a microcatheter for housing the clot capture member,
• wherein relative movement between the pushwire and the microcatheter in one direction unsheathes the clot capture member, causing the clot capture member to expand, and
• wherein relative movement between the pushwire and the microcatheter in the opposite direction re-sheathes the clot capture member, allowing the clot capture member to retract.

A system for achieving and modulating reperfusion, the system comprising:

• a flow modulation member capable of blocking blood flow;
• a pushwire with a self-expanding clot capture member attached toward a distal end, and,
• a microcatheter adapted to receive at least a portion of the pushwire,
• a pushwire, adapted to be introduced to vasculature through the microcatheter and wherein the self-expanding clot capture member is attached to the pushwire;
• and
• the flow modulation member is also attached to the pushwire;
• and
• wherein relative motion between the pushwire and the microcatheter in one direction is capable of unsheathing both the flow modulation member and the self-expanding clot capture member, causing one or both members to expand, and
• wherein relative motion between the pushwire and the microcatheter in an opposite direction is capable of re-sheathing one or both of the flow modulation member and the self-expanding clot capture member, causing one or both members to retract.

A system for achieving and modulating reperfusion of a vessel in the cerebral vasculature following ischemic stroke, the system comprising:

• a flow modulation member capable of reversibly reducing blood flow;
• a mechanism for selectively causing blood flow of the vessel to increase;
• and
• wherein the flow modulation member is adapted to reach a location of a clot via the endovascularture;
• the system adapted so that the flow modulation member is capable of performing at least two iterations of reducing and then varying flow in the vessel proximate to the location of the clot.

A method for modulating blood flow, the method comprising:

• inserting a microcatheter into a blood vessel;
• inserting a pushwire into the microcatheter, wherein a flow modulation member is attached to the pushwire, wherein the flow modulation member has a plurality of self-expanding struts and a membrane capable of blocking blood flow;
• translating the pushwire and the microcatheter relative to one another in one direction to unsheathe the flow modulation member, allowing the flow modulation member to expand;
• translating the pushwire and the microcatheter relative to one another in an opposite direction to re-sheathe the flow modulation member, causing the flow modulation member to retract;
• and
• repeating the translating steps at least once to modulate blood flow.

A method for modulating blood flow for the treatment of ischemic stroke, the method comprising:

• inserting a microcatheter and a fluid conduit into a blood vessel, wherein the fluid conduit is flexible and contiguous with the microcatheter, wherein a flow modulation member is attached to the microcatheter, and wherein the flow modulation member has an inflatable balloon capable of blocking blood flow;
• conducting inflation fluid to the balloon, causing the balloon to expand;
• conducting inflation fluid from the balloon, causing the balloon to retract;
• and
• repeating the conducting steps at least once to modulate blood flow.

A method for achieving and modulating reperfusion, the method comprising:

• inserting a microcatheter into an occluded blood vessel;
• inserting a pushwire into the microcatheter, wherein both a flow modulation member capable of blocking blood flow and a self-expanding clot capture member are attached to the pushwire;
• translating the pushwire or the microcatheter relative to one another in one direction to unsheathe one or both of the flow modulation member and the self-expanding clot capture member, causing one or both members to expand;
• and
• translating the pushwire and the microcatheter relative to one another in an opposite direction to re-sheathe one or both of the flow modulation member causing the flow modulation member to retract;
• and
• repeating the translating steps at least once to treat an occlusion and modulate reperfusion.

A method for achieving and modulating reperfusion, the method comprising:

• inserting a microcatheter into an occluded blood vessel;
• inserting a pushwire into the microcatheter, wherein a self-expanding clot capture member is attached to the pushwire;
• and
• a flow modulation member capable of blocking or reducing blood flow is attached to the microcatheter;
• translating the pushwire and the microcatheter relative to one another in one direction to unsheathe the self-expanding clot capture member, causing the self-expanding clot capture member to expand;
• and
• performing an expansion step to cause the flow modulation member to occlude or lessen flow;
• and
• repeating the expansion at least once to modulate reperfusion.

A system for achieving and modulating reperfusion, the system comprising:

• three catheters, a narrow catheter is inside an intermediate catheter, and the intermediate catheter is inside a largest catheter;
• wherein a pusher member is at least partially inside the narrow catheter;
• and the intermediate catheter has a flow modulation member capable of reversibly occluding or blocking flow near its distal end;
• a clot capture member;
• a pushwire, wherein the clot capture member is attached to the pushwire;
• wherein relative translation between the pushwire and the narrow catheter in one direction is capable of unsheathing the clot capture member, causing the clot capture member to expand.