Abstract: Systems and methods for creating autologous monocuspid and bicuspid valves can include a catheter having a single expandable element or a double expandable element. Once the leaflets of the valve are created, various techniques can be used to fix the leaflets to the vessel wall or to each other, including clips, tissue anchors, adhesives, and heat.

Abstract: The present technology is directed generally to devices, systems, and methods for capturing and cutting fibrous and trabeculated structures (such as synechiae) in vessel lumens. In one embodiment, the present technology includes an intraluminal tissue modifying system configured to capture the fibrous structures, put the fibrous structures in tension, and controllably cut through the fibrous structures without applying appreciable additional force to the vessel wall. The system may include an expandable capture device and a cutting device.

Abstract: Medical systems, devices and methods for creation of autologous tissue valves within a mammalian body are disclosed. One example of a device for creating a valve flap from a vessel wall includes an elongate tubular structure having a proximal portion and a distal portion and a longitudinal axis; a first lumen having a first exit port located on the distal portion of the elongate tubular structure; a second lumen having a second exit port located on the distal portion of the elongate tubular structure; a recessed distal surface on the distal portion of the elongate tubular structure, wherein the recessed distal surface is located distally to the first exit port; and an open trough on the recessed distal surface extending longitudinally from the first exit port.

Abstract: Endovascular valve formation systems with imaging capabilities and associated devices and methods are disclosed herein. In some embodiments, a valve formation and imaging system can include, for example, (i) a valve formation device configured to access a vessel wall and dissect a portion of the vessel wall to form an autologous valve leaflet and (ii) an imaging device configured to image the vessel wall and components of the valve formation device during a valve formation procedure. In some embodiments, the imaging device is integrated into a distal end portion of the valve formation device. In some embodiments, the imaging device is a separate catheter device positionally coupled to the valve formation device and/or components thereof.

Abstract: A device and method for visualization of the intravascular creation of autologous valves, and particularly venous valve, is disclosed herein. One aspect of the present technology, for example, is directed toward a delivery catheter that can include a lumen configured to receive a dissection assembly and a trough having a plurality of transducers electrically coupled to a proximal portion of the delivery catheter. At least one of the transducers can be configured to emit a signal towards a portion of a blood vessel adjacent the trough, and at least one of the transducers can be configured to receive a reflection of the emitted signal.

Abstract: The present technology is directed generally to devices, systems, and methods for capturing and cutting fibrous and trabeculated structures (such as synechiae) in vessel lumens. In one embodiment, the present technology includes an intraluminal tissue modifying system configured to capture the fibrous structures, put the fibrous structures in tension, and controllably cut through the fibrous structures without applying appreciable additional force to the vessel wall. The system may include an expandable capture device and a cutting device.

Abstract: Intravascular devices and methods for intramural delivery of dissection fluids and infusates are disclosed herein. In some embodiments, the systems include an infusion assembly that can access a position in vessel adjacent an infusion site and advance a tissue manipulation component into the infusion site to deliver a therapeutic infusate. The infusion site can be an intraluminal space, such as within an obstructive material, adjacent the obstructive material, and/or within a boundary layer between the obstructive material and a vessel wall. The infusion assembly can further deliver an infusate that includes a therapeutic drug or other agent into the infusion site.

Abstract: The present technology relates generally to devices and methods for intravascular evaluation of blood vessels. Many embodiments of the technology relate to the intravascular evaluation of blood vessels before, during and after creation of autologous valves. In one embodiment, for example, the present technology is directed to a method comprising intravascularly delivering a delivery catheter to a target location adjacent a vessel wall and engaging the vessel wall along a portion of the delivery catheter. The method can further include determining the location of a first circumferential periphery of a dissection pouch formed within the vessel wall, determining the location of a second circumferential periphery of the dissection pouch, and determining an angular width of the dissection pouch based on the location of the first circumferential periphery and the second circumferential periphery.

Abstract: A system for creating an endoluminal valve from a blood vessel wall, includes: a tubular assembly having a longitudinal axis, a proximal end, a distal portion with a distal end, and a first lumen extending from the proximal end to a distal port located proximate the distal portion, the distal port located along the longitudinal axis, the distal portion having a supporting surface on a same side of the tubular assembly as the distal port, the supporting surface extending in a longitudinal direction and offset from a surface of the tubular assembly proximal the distal port and configured to contact the blood vessel wall; and a tissue dissection probe disposed within the first lumen, the tissue dissection probe having a fluid delivery lumen extending to a fluid delivery port located at a distal end of the tissue dissection probe, the tissue dissection probe configured to be inserted into the blood vessel wall.

Abstract: A device and method for visualization of the intravascular creation of autologous valves, and particularly venous valve, is disclosed herein. One aspect of the present technology, for example, is directed toward a delivery catheter that can include a lumen configured to receive a dissection assembly and a trough having a plurality of transducers electrically coupled to a proximal portion of the delivery catheter. At least one of the transducers can be configured to emit a signal towards a portion of a blood vessel adjacent the trough, and at least one of the transducers can be configured to receive a reflection of the emitted signal.

Abstract: The present technology is directed generally to devices, systems, and methods for capturing and cutting fibrous and trabeculated structures (such as synechiae) in vessel lumens. In one embodiment, the present technology includes an intraluminal tissue modifying system configured to capture the fibrous structures, put the fibrous structures in tension, and controllably cut through the fibrous structures without applying appreciable additional force to the vessel wall. The system may include an expandable capture device and a cutting device.

Abstract: Intravascular devices and methods for intramural delivery of dissection fluids and infusates are disclosed herein. In some embodiments, the systems include an infusion assembly that can access a vessel wall at a depth within a layer of the vessel wall and advance a tissue manipulation component at approximately the same depth within the vessel wall to create an intramural space within the vessel layer. The infusion assembly can further deliver an infusate that includes a therapeutic drug or other agent into the intramural space.

Abstract: Endovascular valve formation systems with imaging capabilities and associated devices and methods are disclosed herein. In some embodiments, a valve formation and imaging system can include, for example, (i) a valve formation device configured to access a vessel wall and dissect a portion of the vessel wall to form an autologous valve leaflet and (ii) an imaging device configured to image the vessel wall and components of the valve formation device during a valve formation procedure. In some embodiments, the imaging device is integrated into a distal end portion of the valve formation device. In some embodiments, the imaging device is a separate catheter device positionally coupled to the valve formation device and/or components thereof.

Abstract: A system for creating an endoluminal valve from a blood vessel wall, includes: a tubular assembly having a longitudinal axis, a proximal end, a distal portion with a distal end, and a first lumen extending from the proximal end to a distal port located proximate the distal portion, the distal port located along the longitudinal axis, the distal portion having a supporting surface on a same side of the tubular assembly as the distal port, the supporting surface extending in a longitudinal direction and offset from a surface of the tubular assembly proximal the distal port and configured to contact the blood vessel wall; and a tissue dissection probe disposed within the first lumen, the tissue dissection probe having a fluid delivery lumen extending to a fluid delivery port located at a distal end of the tissue dissection probe, the tissue dissection probe configured to be inserted into the blood vessel wall.

Abstract: A device for manipulating tissue at a vessel includes an elongated member having a proximal end and a distal end, a guide member at the distal end of the elongated member, the guide member having a blunt distal tip for engagement against an interior wall of the vessel, and a tissue cutting device at the distal end of the elongated member, wherein the tissue cutting device has a sharp tip that is proximal to the blunt distal tip of the guide member.

Abstract: Systems and methods for creating autologous monocuspid and bicuspid valves can include a catheter having a single expandable element or a double expandable element. Once the leaflets of the valve are created, various techniques can be used to fix the leaflets to the vessel wall or to each other, including clips, tissue anchors, adhesives, and heat.

Abstract: Medical systems, devices and methods for creation of autologous tissue valves within a mammalian body are disclosed. One example of a device for creating a valve flap from a vessel wall includes an elongate tubular structure having a proximal portion and a distal portion and a longitudinal axis; a first lumen having a first exit port located on the distal portion of the elongate tubular structure; a second lumen having a second exit port located on the distal portion of the elongate tubular structure; a recessed distal surface on the distal portion of the elongate tubular structure, wherein the recessed distal surface is located distally to the first exit port; and an open trough on the recessed distal surface extending longitudinally from the first exit port.

Abstract: A device for manipulating tissue at a vessel includes an elongated member having a proximal end and a distal end, a guide member at the distal end of the elongated member, the guide member having a blunt distal tip for engagement against an interior wall of the vessel, and a tissue cutting device at the distal end of the elongated member, wherein the tissue cutting device has a sharp tip that is proximal to the blunt distal tip of the guide member.

Abstract: The present technology is directed generally to devices, systems, and methods for capturing and cutting fibrous and trabeculated structures (such as synechiae) in vessel lumens. In one embodiment, the present technology includes an intraluminal tissue modifying system configured to capture the fibrous structures, put the fibrous structures in tension, and controllably cut through the fibrous structures without applying appreciable additional force to the vessel wall. The system may include an expandable capture device and a cutting device.

Abstract: Systems and methods for creating autologous monocuspid and bicuspid valves can include a catheter having a single expandable element or a double expandable element. Once the leaflets of the valve are created, various techniques can be used to fix the leaflets to the vessel wall or to each other, including clips, tissue anchors, adhesives, and heat.