Abstract: The invention generally relates to devices and methods that provide for guided delivery of a heart replacement valve or other implant into the vasculature. In certain embodiments, a delivery device of the invention includes an outer sheath and an inner sheath moveably disposed within the outer sheath. The outer sheath includes a first imaging element and defining a center lumen that leads to an opening. The outer sheath is further configured to releasably hold an implant within the center lumen. The first imaging element is configured to at least partially surround the center lumen such that the implant is deployable through the first imaging element. The inner sheath is configured to engage with and deploy the implant out of the opening of the elongate body and into a body lumen.

Abstract: An intravascular ultrasound (IVUS) device that includes a flexible elongate member having a proximal portion and a distal portion; a controller coupled to the distal portion of the flexible elongate member; an ultrasound transducer disposed at the distal portion of the flexible elongate member and in communication with the controller; a pressure transducer disposed at the distal portion of the flexible elongate member and in communication with the controller; and plurality of conductors extending from the controller to the proximal portion of the catheter, at least one conductor of the plurality of conductors being configured to carry both the signals representing information captured by the ultrasound transducer and information captured by the pressure transducer.

Abstract: An intravascular imaging device is provided. In one embodiment, the intravascular imaging device includes a flexible elongate member sized and shaped for insertion into a vessel of a patient, the flexible elongate member having a proximal portion and a distal portion; an imaging assembly disposed at the distal portion of the flexible elongate member, the imaging assembly including: a flex circuit; a conductor extending along the flexible elongate member and in electrical communication with the flex circuit; and a support member around which the flex circuit is positioned, the support member including a conductive portion electrically coupled to the support member.

Abstract: The invention provides methods and devices for treating liver cirrhosis or portal hypertension by creating an intrahepatic shunt, or new passage, from a portal vein of a patient to a hepatic vein using a device with intravascular imaging capabilities and pressure sensing capabilities or positioning mechanisms. The integration of intravascular imaging aids in the precise placement of the shunt and pressure measurement may verify successful shunt creation. An apparatus may include a catheter with an extended body for insertion into a hepatic vein of a patient, an intravascular imaging device and a needle exit port on the distal portion of the extended body, and a needle disposed within a lumen in the catheter and configured to be pushed out of the exit port and extend away from a side of the extended body, in which the needle includes a pressure sensor.

Abstract: An intravascular ultrasound (IVUS) device that includes a flexible elongate member having a proximal portion and a distal portion; a controller coupled to the distal portion of the flexible elongate member; an ultrasound transducer disposed at the distal portion of the flexible elongate member and in communication with the controller; a pressure transducer disposed at the distal portion of the flexible elongate member and in communication with the controller; and plurality of conductors extending from the controller to the proximal portion of the catheter, at least one conductor of the plurality of conductors being configured to carry both the signals representing information captured by the ultrasound transducer and information captured by the pressure transducer.

Abstract: Handheld steering devices for use with intravascular devices and associated systems and methods are disclosed. In some instances, the handheld steering device includes a housing sized and shaped for grasping by a hand of a user, the housing including a proximal portion and a distal portion, wherein the distal portion includes an opening sized and shaped to receive an intravascular device; an adaptor positioned within the opening of the housing, the adaptor including a bore sized and shaped to allow a proximal end of the intravascular device to pass therethrough; a steering controller coupled to the housing; and an actuator positioned within the housing and in communication with the steering controller, the actuator interfacing with the proximal end of the intravascular device based on inputs to the steering controller to steer a distal end of the intravascular device. Associated systems and methods are also disclosed.

Abstract: Intraluminal imaging devices and methods of assembling the intraluminal imaging devices are provided. For example, an intraluminal imaging device can include a flexible elongate catheter body and a rigid imaging assembly coupled to a distal portion of the elongate catheter body. A distal portion of the inner member is positioned within a lumen of the imaging assembly, and the flexible elongate member comprises a strain relief layer positioned around the inner member. A distal portion of the strain relief layer is positioned radially between the inner member and the imaging assembly, and a proximal end of the strain relief layer is positioned distally of a proximal end of the inner member, forming a transition region. The transition region can prevent bending or kinking of the flexible elongate catheter body when the intraluminal imaging device is navigating tortuous regions of the patient's anatomy.

Abstract: Imaging devices, systems, and methods are provided. Some embodiments of the present disclosure are particularly directed to imaging a region of interest in tissue with photoacoustic and ultrasound modalities. In some embodiments, a medical sensing system includes one or more external optical emitters and a measurement apparatus configured to be placed within a vascular pathway. The one or more optical emitters and the measurement apparatus may be moved together synchronously. The measurement apparatus may be configured to receive sound waves created by the interaction between emitted optical pulses and tissue, and transmit and receive ultrasound signals. The medical sensing system may also include a processing engine operable to produce images of the region of interest and a display configured to visually display the image of the region of interest.

Abstract: An imaging catheter assembly is provided. In one embodiment, the imaging catheter assembly includes a flexible elongate member comprising a distal portion and a proximal portion; a tip member coupled to a distal end of the distal portion of the flexible elongate member, wherein the tip member includes a tubular body comprising a closed distal end, an opened proximal end, and a proximal curved top outer wall extending from the proximal opened end and tapering into a distal flat top outer wall towards the closed distal end; and an imaging component mounted within the tip member. In one embodiment, the imaging catheter assembly includes a flexible elongate member; a tip member coupled to a distal end of the flexible elongate member, wherein the tip member includes a cylindrical body and a uniform outer diameter; and an imaging component mounted within the tip member.

Abstract: A method of assembling an intravascular imaging device is provided. In one embodiment, the method includes obtaining a support member having a body portion including a plurality of recesses longitudinally spaced from one another; positioning a flex circuit around the support member such that the flex circuit is radially spaced from the body portion of the support member; and filling a space between the flex circuit and the support member with a backing material through the plurality of recesses of the body portion. In one embodiment, an intravascular imaging device includes a flexible elongate member; an imaging assembly including: a flex circuit; and a support member around which the flex circuit is disposed, the support member having a body portion including plurality of recesses, wherein the support member defines lumen in fluid communication with a space between the flex circuit and the support member via the plurality of recesses.

Abstract: An intraluminal system for aspirating biological material from a lumen of a patient includes a disposable intraluminal device having a proximal portion and a distal portion. The system includes a disposable pump configured to aspirate the biological material from the lumen of the patient. The disposable pump is coupled to the proximal portion of the intraluminal device. The disposable pump comprises a pump chassis that houses: an inlet port configured to sealably attach to the proximal portion of the intraluminal device; an outlet port configured to expel the aspirated biological from the pump; and a flow controller configured to adjust a fluid flow through the pump, wherein the pump chassis is sized and shaped to be manually supported by a user.

Abstract: The present invention generally relates to a rapid exchange configuration that reduces the profile of a catheter riding on a guidewire and minimizes guidewire resistance. According to certain embodiments, a body of the catheter includes a distal portion and a proximal portion. The distal portion defines a guidewire lumen and includes a guidewire exit port being open in an proximal direction and leading to the guidewire lumen. A proximal section of the guidewire lumen is straight.

Abstract: An intravascular imaging device is provided. In one embodiment, the intravascular imaging device includes a flexible elongate member sized and shaped for insertion into a vessel of a patient, the flexible elongate member having a proximal portion and a distal portion; an imaging assembly disposed at the distal portion of the flexible elongate member, the imaging assembly including: a flex circuit; a conductor extending along the flexible elongate member and in electrical communication with the flex circuit; and a support member around which the flex circuit is positioned, the support member including a conductive portion electrically coupled to the support member.

Abstract: Imaging devices, systems, and methods are provided. Some embodiments of the present disclosure are particularly directed to imaging a region of interest in tissue with photoacoustic and ultrasound modalities. In some embodiments, a medical sensing system includes one or more external optical emitters and a measurement apparatus configured to be placed within a vascular pathway. The one or more optical emitters and the measurement apparatus may be moved together synchronously. The measurement apparatus may be configured to receive sound waves created by the interaction between emitted optical pulses and tissue, and transmit and receive ultrasound signals. The medical sensing system may also include a processing engine operable to produce images of the region of interest and a display configured to visually display the image of the region of interest.

Abstract: A method of assembling an intravascular imaging device (102) is provided. In one embodiment, the method includes obtaining a support member having a body portion including a plurality of recesses longitudinally spaced from one another (405); positioning a flex circuit around the support member such that the flex circuit is radially spaced from the body portion of the support member (410); and filling a space between the flex circuit and the support member with a backing material through the plurality of recesses of the body portion (420). In one embodiment, an intravascular imaging device includes a flexible elongate member; an imaging assembly including: a flex circuit; and a support member (330) around which the flex circuit is disposed, the support member having a body portion including plurality of recesses (339), wherein the support member defines lumen in fluid communication with a space between the flex circuit and the support member via the plurality of recesses.

Abstract: Handheld steering devices for use with intravascular devices and associated systems and methods are disclosed. In some instances, the handheld steering device includes a housing sized and shaped for grasping by a hand of a user, the housing including a proximal portion and a distal portion, wherein the distal portion includes an opening sized and shaped to receive an intravascular device; an adaptor positioned within the opening of the housing, the adaptor including a bore sized and shaped to allow a proximal end of the intravascular device to pass therethrough; a steering controller coupled to the housing; and an actuator positioned within the housing and in communication with the steering controller, the actuator interfacing with the proximal end of the intravascular device based on inputs to the steering controller to steer a distal end of the intravascular device. Associated systems and methods are also disclosed.

Abstract: The present invention generally relates to a rapid exchange configuration that reduces the profile of a catheter riding on a guidewire and minimizes guidewire resistance. According to certain embodiments, a body of the catheter includes a distal portion and a proximal portion. The distal portion defines a guidewire lumen and includes a guidewire exit port being open in an proximal direction and leading to the guidewire lumen. A proximal section of the guidewire lumen is straight.

Abstract: An intraluminal imaging device includes a flexible elongate shaft including a distal portion and a proximal portion, wherein the flexible elongate shaft is configured for insertion into a patient body; a distal tip that comprises an imaging element and is operably associated with the distal portion of the flexible elongate shaft; and a control handle coupled to the proximal portion of the flexible elongate shaft, wherein the control handle includes: a first actuator configured to position the imaging element within the patient body; and a first frictional member coupled to the first actuator and arranged to contact the first actuator to control positioning of the imaging element. Associated devices, systems, and methods are also provided.

Abstract: An imaging catheter is provided. In one embodiment, the imaging catheter includes a flexible elongate member that includes a proximal portion formed of a first material embedded with a first braid with a first braid pitch; a distal portion formed of a second material embedded with a second braid with a second braid pitch, wherein the second material is a lower durometer than the first material and wherein the second braid pitch is a higher per inch count than the first braid pitch such that the distal portion is more flexible than the proximal portion; a primary lumen extending between the proximal portion and the distal portion; and a plurality of secondary lumens extending between the proximal portion and the distal portion; and an imaging component coupled to the distal portion of the flexible elongate member.

Abstract: The invention includes catheters that have therapeutic agent- and therapeutic energy-delivery capability. In particular embodiments, the catheters include only a single therapeutic energy transducer that is configured to deliver energy to over half of the circumference of the catheter. The therapeutic catheters of the invention allow for faster and more effective thrombus removal because of the simultaneous delivery of therapeutic agents and energy.