Abstract: An endovascular system includes inner and outer catheters, a handle system operably coupled one end of the catheters, and a microvalve coupled to the other end of the catheters. The microvalve is constrained in a radially-collapsed closed configuration for advancement within a vessel to a treatment site. The handle system is operable to displace the inner and outer catheters portions relative to each other to move the microvalve between closed and open configurations. An indicator is provided to visually indicate the extent by which the microvalve is opened within the vessel.

Abstract: A method for delivering a therapeutic agent to a tumor through a target vessel includes delivering the therapeutic agent through a lumen of a catheter which has been coated or otherwise structured to reduce the wall shear stress during delivery of the immunotherapy and by generating turbulent flow during the delivery of the therapeutic agent.

Abstract: The present disclosure describes combination therapies for breast cancer comprising an oligonucleotide toll-like receptor 9 agonist and a PD-1 antagonist. In particular, the present disclosure describes combinations of a CpG-C type oligonucleotide and an anti-PD-1 antibody for the treatment of breast cancer. The combination may further comprise a taxane chemotherapeutic agent, in the presence or absence of a corticosteroid.

Abstract: A method includes providing microvalve device having inner and outer catheters, and a filter valve attached to the distal end of the inner and outer catheters. Longitudinal displacement of the inner catheter relative to the outer catheter moves the filter valve from a non-deployed configuration to a deployed configuration. With the inner catheter longitudinally advanced a first amount relative to the outer catheter, the filter valve is in a reduced first diameter for advancement of a guidewire to a target location. Once the filter valve reaches the target location, the inner catheter is moved relative to the outer catheter such that the filter valve assumes a larger second diameter. A therapeutic agent is infused through the inner catheter and beyond the filter valve.

Abstract: A method for delivering an immunotherapy agent to a tumor includes advancing the delivery device into a vessel of a patient, and infusing the agent under pressure into the vessel to penetrate the tumor. The delivery device prevents reflux of the agent toward non-treatment sites.

Abstract: A method of delivering a therapeutic agent into a patient vessel with a delivery device is provided. The delivery device includes an infusion lumen through which the agent is delivered, a vessel occluder that can be operated between a collapsed and an expanded configuration, and when in the expanded configuration occludes the vessel, and a pressure sensor shielded from the effects of turbulent flow at an exit of the infusion lumen. The shield pressure sensor is able to accurately sense pressure in the vessel. The sensed pressure is used to determine a dwell time for the vessel occluder in the expanded configuration.

Abstract: An endovascular treatment device for use in a vessel during a therapy procedure includes a catheter and a vessel occluder coupled to the catheter. The occluder includes a construction of elastic filaments that are fixed to the outer surface of the catheter. The filaments extend radially and distally outward from their proximal ends and then invert and are fixed back at the catheter proximal of the distal end of the catheter. The occluder can be elastically deformed to fit vessels of various sizes. The catheter includes a lumen through which a therapeutic agent is delivered beyond the occluder.

Abstract: An endovascular system includes inner and outer catheters, a handle system operably coupled one end of the catheters, and a microvalve coupled to the other end of the catheters. The microvalve is constrained in a radially-collapsed closed configuration for advancement within a vessel to a treatment site. The handle system is operable to displace the inner and outer catheters portions relative to each other to move the microvalve between closed and open configurations. An indicator is provided to visually indicate the extent by which the microvalve is opened within the vessel.

Abstract: A guiding catheter has a proximal portion constructed of a tubular braid and a shape-retentive distal portion including a superelastic hypotube cut to define particular mating, support, shape-retentive and flexibility characteristics. A tubular liner extends through both of the tubular braid and the hypotube. The hypotube is joined to the braid using a mechanical interlock that has high torque transfer from the braid to the hypotube. A short portion of high stiffness polymer tube is provided at a joint between the braid and the hypotube. A polymeric outer jacket is provided over the proximal and distal portions, including the polymer tube. The jacket is heat set over the hypotube to remove residual stress.

Abstract: An atraumatic vessel occlusive system includes a flexible tubular member with an infusion lumen, a vessel occluder mounted at the distal end of the tubular member, and a pressure sensor located within a chamber defined by the occluder. The occluder has a braided construct provided with a fluid impermeable membrane over its proximal portion and a fluid permeable covering over its distal portion. The pressure sensor is adapted to sense pressure within the vessel through the fluid permeable membrane without being subject to the effects of turbulent flow at the exit of the infusion lumen. The accurately sensed pressure can be used to determine a dwell time for the occluder.

Abstract: A system includes a device having inner and outer catheters, and a filter valve attached to the distal end of the inner and outer catheters. Longitudinal displacement of the inner catheter relative to the outer catheter moves the filter valve from a non-deployed configuration to a deployed configuration. The device has a first configuration in which the distal end of the inner catheter is longitudinally advanced by a first distance relative to the distal end of the outer catheter and the filter valve assumes a stretched configuration, and a second configuration in which the distal end of the inner catheter is longitudinally advanced by a second distance relative to the distal end of the outer catheter to cause the filter valve to assume a diameter larger than in the stretched configuration.

Abstract: An apparatus includes a delivery catheter having a deployable dynamic valve that dynamically opens and closes in response to relative fluid pressure thereabout, particularly while in an anatomical lumen. The valve is maintained in a collapsed configuration during introduction to a treatment site. The valve is adapted to automatically move from the collapsed configuration to a deployed configuration at the treatment site.

Abstract: A guiding catheter has a proximal portion constructed of a tubular braid and a shape-retentive distal portion including a superelastic hypotube cut to define particular mating, support, shape-retentive and flexibility characteristics. A tubular liner extends through both of the tubular braid and the hypotube. The hypotube is joined to the braid using a mechanical interlock that has high torque transfer from the braid to the hypotube. A short portion of high stiffness polymer tube is provided at a joint between the braid and the hypotube. A polymeric outer jacket is provided over the proximal and distal portions, including the polymer tube. The jacket is heat set over the hypotube to remove residual stress.

Abstract: A treatment system includes a guide sheath, and a catheter provided with a pressure-controlled element. The pressure-control element preferably includes an expanded configuration adapted to extend across a small feeder vessel branching from the splenic vein. The pressure-control element is positioned with the feeder vessel, and a therapeutic agent is delivered under pressure directly into the feeder vessel, where it is forced to penetrate deep into tissue. Pressure responsive elements for monitoring intravascular pressure are also provided to time delivery of the therapeutic agent for maximum uptake by the target organ.

Abstract: Systems with pressure-responsive elements for monitoring intravascular pressure are also provided to time delivery of the therapeutic agent for maximum uptake by the target organ. Methods for treating tissues and organs via vascular pathways are provided.

Abstract: An endovascular microvalve device for use in a vessel during a therapy procedure includes a catheter and a filter valve coupled to the catheters. The filter valve is dynamically reconfigurable to automatically block and permit fluid flow through a vessel based on a local fluid pressure conditions about the filter valve. In embodiments, the filter valve has a proximal end fixed to the catheter, and a distal end which may be movable over the catheter. The lumen of the inner catheter delivers a therapeutic agent beyond the valve. The device is used to provide a therapy in which a therapeutic agent is infused into an organ.

Abstract: A treatment system includes a dual lumen catheter system. The first lumen is open to systemic circulation. The second lumen is open to a target delivery location. In an embodiment, a pressure-control element is provided that includes an expanded configuration adapted to constrain delivery through the second lumen to the target delivery location. Methods for treating tissues and organs via vascular pathways are provided.

Abstract: An endovascular microvalve device for use in a vessel during a therapy procedure includes a catheter and a filter valve coupled to the catheters. The filter valve is dynamically reconfigurable to automatically block and permit fluid flow through a vessel based on a local fluid pressure conditions about the filter valve. In embodiments, the filter valve has a proximal end fixed to the catheter, and a distal end which may be movable over the catheter. The lumen of the inner catheter delivers a therapeutic agent beyond the valve. The device is used to provide a therapy in which a therapeutic agent is infused into an organ.

Abstract: A therapeutic agent delivery system includes a catheter, a vascular occluder, a pressure sensor system, and a pump system. The vascular occluder is provided at the distal end of the catheter. The pressure sensor system is provided to sense pressure at the distal end of a catheter lumen, and provides feedback to the pump system. The pump system is adapted to control the rate of infusion of the therapeutic agent through the lumen of the catheter based on the pressure sensed by the pressure sensor system. A method includes deploying the occluder in a vessel, and then sensing a pressure in the vessel. The therapeutic agent is infused into the vessel at a flow rate based on the sensed pressure.

Abstract: A treatment system includes a guide sheath, and a catheter provided with a pressure-controlled element. The pressure-control element preferably includes an expanded configuration adapted to extend across a small feeder vessel branching from the splenic vein. The pressure-control element is positioned with the feeder vessel, and a therapeutic agent is delivered under pressure directly into the feeder vessel, where it is forced to penetrate deep into tissue. Pressure responsive elements for monitoring intravascular pressure are also provided to time delivery of the therapeutic agent for maximum uptake by the target organ. Methods for treating tissues and organs via vascular pathways are provided.