Abstract: Systems and methods are provided for signaling a condition of an infusion assembly. A system may comprise an elastomeric pump that includes a chamber for receipt of a volume of fluid, an outer layer configured to expand and contract as the chamber receives and dispenses fluid, and a passive indicator provided on the outer layer for signaling a change in the volume of fluid in the chamber. The system further may comprise an image capture device configured to capture an image of the pump, and a processing system configured to process the image to signal the condition of the infusion assembly to a user of the system. A method may comprise capturing an image of a pump; processing the image; and displaying information to a user of the pump to communicate the condition of the pump to the user. Elastomeric pumps for infusion assemblies also are provided.

Abstract: The present disclosure is directed to an ultrasonic catheter assembly. More specifically, the catheter assembly includes a catheter and one or more piezoelectric or echogenic components. The catheter has a side wall that extends from a proximal end and a distal end that defines a lumen extending from the proximal end to the distal end. Thus, the lumen is configured to deliver a treatment fluid from the proximal end to the distal end. In addition, the piezoelectric component(s) are configured with the side wall of the catheter and/or embedded at least partially within the side wall of the catheter. As such, the piezoelectric component(s) are configured to enhance ultrasonic imaging of the catheter, e.g. when activated by a stimulator assembly.

Abstract: The present disclosure is directed to an ultrasonic catheter assembly. More specifically, the catheter assembly includes a catheter and one or more piezoelectric or echogenic components. The catheter has a side wall that extends from a proximal end and a distal end that defines a lumen extending from the proximal end to the distal end. Thus, the lumen is configured to deliver a treatment fluid from the proximal end to the distal end. In addition, the piezoelectric component(s) are configured with the side wall of the catheter and/or embedded at least partially within the side wall of the catheter. As such, the piezoelectric component(s) are configured to enhance ultrasonic imaging of the catheter, e.g. when activated by a stimulator assembly.

Abstract: Systems and methods are provided for signaling a condition of an infusion assembly. A system may comprise an elastomeric pump that includes a chamber for receipt of a volume of fluid, an outer layer configured to expand and contract as the chamber receives and dispenses fluid, and a passive indicator provided on the outer layer for signaling a change in the volume of fluid in the chamber. The system further may comprise an image capture device configured to capture an image of the pump, and a processing system configured to process the image to signal the condition of the infusion assembly to a user of the system. A method may comprise capturing an image of a pump; processing the image; and displaying information to a user of the pump to communicate the condition of the pump to the user. Elastomeric pumps for infusion assemblies also are provided.

Abstract: An elastomeric pump having at least one sensor for sensing changes in elongation of a bladder of the pump is provided. Also provided is an infusion assembly including an elastomeric pump having a bladder, at least one sensor for sensing changes in elongation of the bladder, and an indicator for providing one or more outputs of the sensor. The sensor may be a flexible sensor positioned in contact with the bladder of the pump, or a dielectric material may be incorporated into the material the bladder is made from such that the dielectric elastomer material of the bladder forms the sensor.

Abstract: A system for delivering fluid to a user transcutaneously includes a subcutaneous infusion cannula base assembly, a cannula inserter assembly and a fluid connection assembly. The subcutaneous infusion cannula base assembly is configured to be located on the user's skin. The cannula inserter assembly is coupled to the cannula base assembly and is configured to drive an infusion cannula through the user's skin in a nominally helical trajectory. The fluid connection assembly is configured to fluidically connect the cannula base assembly to a source of delivery fluid. Cannula and stylet assemblies configured for helical or non-helical insertion are also disclosed.

Abstract: Embodiments of devices and methods to maintain preservative concentration in a medication delivered using a medical device are provided. A barrier layer can be used to prevent migration of preservatives. A vent can be used to allow release of preservatives prior to delivery to the patient. An absorbent element can be used to maintain preservative concentration at a desired level. A filter can be used to capture particulates from the medication prior to delivery to a patient.

Abstract: A system for delivering fluid to a user transcutaneously includes a subcutaneous infusion cannula base assembly, a cannula inserter assembly and a fluid connection assembly. The subcutaneous infusion cannula base assembly is configured to be located on the user's skin. The cannula inserter assembly is coupled to the cannula base assembly and is configured to drive an infusion cannula through the user's skin in a nominally helical trajectory. The fluid connection assembly is configured to fluidically connect the cannula base assembly to a source of delivery fluid. Cannula and stylet assemblies configured for helical or non-helical insertion are also disclosed.

Abstract: A system for delivering fluid to a user transcutaneously includes a torsion spring, a drive wheel, a linear slide having a stylet attached thereto, and a cannula. The torsion spring, when actuated, is configured to rotate the drive wheel to cause the linear slide to move axially to drive the stylet and cannula into a user-s skin.

Abstract: The present invention is directed to a system and method for automatic detection, localization, and semantic segmentation of at least one anatomical object in a parameter space of an image generated by an imaging system. The method includes generating the image via the imaging system and providing the image of the anatomical object and surrounding tissue to a processor. Further, the method includes developing and training a parameter space deep learning network comprising convolutional neural networks to automatically detect the anatomical object and the surrounding tissue of the parameter space of the image. The method also includes automatically locating and segmenting, via additional convolutional neural networks, the anatomical object and surrounding tissue of the parameter space of the image. Moreover, the method includes automatically labeling the identified anatomical object and surrounding tissue on the image. Thus, the method also includes displaying the labeled image to a user in real time.

Abstract: Systems and methods are provided for signaling a condition of an infusion assembly. A system may comprise an elastomeric pump that includes a chamber for receipt of a volume of fluid, an outer layer configured to expand and contract as the chamber receives and dispenses fluid, and a passive indicator provided on the outer layer for signaling a change in the volume of fluid in the chamber. The system further may comprise an image capture device configured to capture an image of the pump, and a processing system configured to process the image to signal the condition of the infusion assembly to a user of the system. A method may comprise capturing an image of a pump; processing the image; and displaying information to a user of the pump to communicate the condition of the pump to the user. Elastomeric pumps for infusion assemblies also are provided.

Abstract: The present invention is directed to an echogenic member assembly for use with a catheter assembly. The echogenic member assembly includes at least one echogenic member having a cylindrical body extending between a first end and a second end. Thus, the body defines a longitudinal length between the first and second ends. Further, the cylindrical body has an exterior surface extending from the first end to the second end. The exterior surface includes a plurality of discontinuities arranged in a predetermined pattern so as to enhance ultrasonic imaging. In addition, the longitudinal length of the echogenic member is less than a total length of a catheter of the catheter assembly. As such, the echogenic member provides enhanced ultrasonic imaging to the catheter assembly without compromising the inherent flexibility of the catheter.

Abstract: Systems and methods are provided for signaling a condition of an infusion assembly. A system may comprise an elastomeric pump that includes a chamber for receipt of a volume of fluid, an outer layer configured to expand and contract as the chamber receives and dispenses fluid, and a passive indicator provided on the outer layer for signaling a change in the volume of fluid in the chamber. The system further may comprise an image capture device configured to capture an image of the pump, and a processing system configured to process the image to signal the condition of the infusion assembly to a user of the system. A method may comprise capturing an image of a pump; processing the image; and displaying information to a user of the pump to communicate the condition of the pump to the user. Elastomeric pumps for infusion assemblies also are provided.

Abstract: The present invention is directed to a system and method for providing navigational directions to a user to locate a target anatomical object during a medical procedure via a medical imaging system. The method includes selecting an anatomical region surrounding the object; generating a plurality of real-time two-dimensional images of scenes from the anatomical region and providing the plurality of images to a controller; developing and training a deep learning network to automatically detect and identify the scenes from the anatomical region; automatically mapping each of the plurality of images from the anatomical region based on a relative spatial location and a relative temporal location of each of the identified scenes in the anatomical region via the deep learning network; and providing directions to the user to locate the object during the medical procedure based on the relative spatial and temporal locations of each of the identified scenes.

Abstract: The present invention is directed to a system and method for enhancing in situ visualization of a target site within a patient during a medical procedure using fluorescence. As such, the system includes a plurality of fluorescent molecules configured to selectively target and bind to one or more locations at the target site within the patient and a delivery mechanism for delivering the fluorescent molecules into the patient. In addition, the system includes a detection device configured to generate a detectable signal containing information relating to the target site and send the detectable signal to an imaging system for viewing by a user, such as a physician. Thus, the fluorescent molecules enhance in situ visualization of the target site when viewed through the skin of the patient.

Abstract: The present invention is directed to a system and method for providing navigational directions to a user to locate a target anatomical object during a medical procedure via a medical imaging system. The method includes selecting an anatomical region surrounding the object; generating a plurality of real-time two-dimensional images of scenes from the anatomical region and providing the plurality of images to a controller; developing and training a deep learning network to automatically detect and identify the scenes from the anatomical region; automatically mapping each of the plurality of images from the anatomical region based on a relative spatial location and a relative temporal location of each of the identified scenes in the anatomical region via the deep learning network; and providing directions to the user to locate the object during the medical procedure based on the relative spatial and temporal locations of each of the identified scenes.

Abstract: The present invention is directed to a system and method for automatic detection, localization, and semantic segmentation of at least one anatomical object in a parameter space of an image generated by an imaging system. The method includes generating the image via the imaging system and providing the image of the anatomical object and surrounding tissue to a processor. Further, the method includes developing and training a parameter space deep learning network comprising convolutional neural networks to automatically detect the anatomical object and the surrounding tissue of the parameter space of the image. The method also includes automatically locating and segmenting, via additional convolutional neural networks, the anatomical object and surrounding tissue of the parameter space of the image. Moreover, the method includes automatically labeling the identified anatomical object and surrounding tissue on the image. Thus, the method also includes displaying the labeled image to a user in real time.

Abstract: A system for delivering fluid to a user transcutaneously includes a subcutaneous infusion cannula base assembly, a cannula inserter assembly and a fluid connection assembly. The subcutaneous infusion cannula base assembly is configured to be located on the user's skin. The cannula inserter assembly is coupled to the cannula base assembly and is configured to drive an infusion cannula through the user's skin in a nominally helical trajectory. The fluid connection assembly is configured to fluidically connect the cannula base assembly to a source of delivery fluid. Cannula and stylet assemblies configured for helical or non-helical insertion are also disclosed.

Abstract: A system for delivering fluid to a user transcutaneously includes a subcutaneous infusion cannula base assembly, a cannula inserter assembly and a fluid connection assembly. The subcutaneous infusion cannula base assembly is configured to be located on the user's skin. The cannula inserter assembly is coupled to the cannula base assembly and is configured to drive an infusion cannula through the user's skin in a nominally helical trajectory. The fluid connection assembly is configured to fluidically connect the cannula base assembly to a source of delivery fluid. Cannula and stylet assemblies configured for helical or non-helical insertion are also disclosed.

Abstract: The present invention is directed to a system and method for echogenically enhancing a target site within a patient during a medical procedure. The system includes an imaging system having a display for viewing the target site, a plurality of metallic particles configured to selectively target and bind to one or more locations at the target site, and a delivery mechanism for delivering the plurality of metallic particles into the patient towards the target site. As such, the method includes delivering, via the delivery mechanism, the plurality of metallic particles into the patient and allowing the metallic particles to selectively target and bind to the target site. The method also includes viewing, via a display of an imaging system, the target site with the plurality of metallic particles bound thereto.