Abstract: The fluid delivery devices, systems and methods described herein include a subcutaneous port, a catheter, and a connection assembly configured to fluidly couple the port and catheter.

Abstract: Drug delivery systems and methods are disclosed herein. In some embodiments, a drug delivery system can be configured to deliver a drug to a patient in coordination with a physiological parameter of the patient (e.g., the patient’s natural cerebrospinal fluid (CSF) pulsation or the patient’s heart or respiration rate). In some embodiments, a drug delivery system can be configured to use a combination of infusion and aspiration to control delivery of a drug to a patient. Catheters, controllers, and other components for use in the above systems are also disclosed, as are various methods of using such systems.

Abstract: The disclosed systems and methods are configurable central nervous system (CNS) delivery solutions for therapeutics, such as genetic medicines. The systems and methods first infuse a therapeutic bolus within intrathecal space and subsequently infuse a flush fluid to move the therapeutic bolus rostrally toward a target area and achieve a desired spread in the spine and/or brain. The second location can be at a location caudal to the delivery location of the therapeutic bolus.

Abstract: The disclosed systems and methods are configurable central nervous system (CNS) delivery solutions for therapeutics, such as genetic medicines. The systems and methods first infuse a therapeutic bolus within intrathecal space and subsequently infuse a flush fluid to move the therapeutic bolus rostrally toward a target area and achieve a desired spread in the spine and/or brain. The second location can be at a location caudal to the delivery location of the therapeutic bolus.

Abstract: The disclosed systems and methods are configurable central nervous system (CNS) delivery solutions for therapeutics, such as genetic medicines. The systems and methods first infuse a therapeutic bolus within intrathecal space and subsequently infuse a flush fluid to move the therapeutic bolus rostrally toward a target area and achieve a desired spread in the spine and/or brain. The second location can be at a location caudal to the delivery location of the therapeutic bolus.

Abstract: Systems and methods are disclosed herein that generally involve CED devices with various features for reducing or preventing backflow. In some embodiments, CED devices include a tissue-receiving space disposed proximal to a distal fluid outlet. Tissue can be compressed into or pinched/pinned by the tissue-receiving space as the device is inserted into a target region of a patient, thereby forming a seal that reduces or prevents proximal backflow of fluid ejected from the outlet beyond the tissue-receiving space. In some embodiments, CED devices include a bullet-shaped nose proximal to a distal fluid outlet. The bullet-shaped nose forms a good seal with surrounding tissue and helps reduce or prevent backflow of infused fluid.

Abstract: Fluid delivery systems and methods of delivering an agent and treating a disorder are disclosed that include a subcutaneously implantable port having a body defining a chamber with an open top and a delivery opening and a septum coupled to the body to extend over the open top of the chamber. The systems and methods can further include an intrathecal catheter having an proximal end configured to be coupled to the port and fluidly coupled to the delivery opening of the chamber and a plug having a body with a passage to receive the intrathecal catheter therethrough. The plug can be configured to be inserted into the fascia to protect against leakage of cerebrospinal fluid.

Abstract: Systems and methods for flushing shunt systems are disclosed herein. In some embodiments, a flusher includes a pinch tube that extends over a flush dome such that a user can simultaneously close the pinch tube and actuate the flush dome with a single motion. Flushing and refill valves of the system can be disposed in a cartridge that is laterally-offset from the flush dome, advantageously reducing the height profile of the flusher. Flushers with integrated shunt valves are also disclosed, as are shunt systems with restricted and unrestricted modes for selectively limiting the instances in which a user can open an auxiliary flow path through the system.

Abstract: The fluid delivery devices, systems and methods described herein include a subcutaneous port, a catheter, and a connection assembly configured to fluidly couple the port and catheter.

Abstract: Automated drug delivery systems and related methods are disclosed herein. In some embodiments, these systems can reduce or eliminate infusion inconsistencies. An exemplary system can include a syringe actuator which can be controlled via electrical, mechanical, pneumatic, and/or hydraulic means to precisely infuse and/or withdraw material from a patient.

Abstract: Systems and methods for delivering a drug with a tracer or contrast agent are disclosed herein, as are systems and methods that generally involve CED devices with various features for reducing or preventing backflow. In some embodiments, CED devices include a tissue-receiving space disposed proximal to a distal fluid outlet. Tissue can be compressed into or pinched/pinned by the tissue-receiving space as the device is inserted into a target region of a patient, thereby forming a seal that reduces or prevents proximal backflow of fluid ejected from the outlet beyond the tissue-receiving space. In some embodiments, CED devices include a bullet-shaped nose proximal to a distal fluid outlet. The bullet-shaped nose forms a good seal with surrounding tissue and helps reduce or prevent backflow of infused fluid.

Abstract: Systems and methods are provided herein that generally involve shunting fluid, e.g., shunting cerebrospinal fluid in the treatment of hydrocephalus. Self-cleaning catheters are provided which include split tips configured such that pulsatile flow of fluid in a cavity in which the catheter is inserted can cause the tips to strike one another and thereby clear obstructions. Catheters with built-in flow indicators are also provided. Exemplary flow indicators include projections that extend radially inward from the interior surface of the catheter and which include imageable portions (e.g., portions which are visible under magnetic resonance imaging (MRI)). Movement of the flow indicators caused by fluid flowing through the catheter can be detected using MRI, thereby providing a reliable indication as to whether the catheter is partially or completely blocked.

Abstract: An image-guided lumbar puncture aspiration and injector system. The system includes an auto-injection device having a housing, at least one syringe having a fluid, a controller, a processor, a memory, and a display. An imaging device is communicatively coupled to the auto-injection device and captures images of a lumbar puncture area of a patient to be displayed on the display of the auto-injection device, helping identify a location for a lumbar puncture procedure. A needle assembly is coupled to the at least one syringe of the auto-injection device. An outer needle is adapted to be inserted into a location of the lumbar puncture area identified by the imaging device, and an inner needle is adapted to be inserted into the dura of the patient. The outer sheath needle protects the inner needle from contaminants. The controller operates the auto-injection device based on a programmed infusion and aspiration profile.

Abstract: Automated drug delivery systems and related methods are disclosed herein. In some embodiments, these systems can reduce or eliminate infusion inconsistencies. An exemplary system can include a syringe actuator which can be controlled via electrical, mechanical, pneumatic, and/or hydraulic means to precisely infuse and/or withdraw material from a patient.

Abstract: Systems and methods for delivering a drug with a tracer or contrast agent are disclosed herein, as are systems and methods that generally involve CED devices with various features for reducing or preventing backflow. In some embodiments, CED devices include a tissue-receiving space disposed proximal to a distal fluid outlet. Tissue can be compressed into or pinched/pinned by the tissue-receiving space as the device is inserted into a target region of a patient, thereby forming a seal that reduces or prevents proximal backflow of fluid ejected from the outlet beyond the tissue-receiving space. In some embodiments, CED devices include a bullet-shaped nose proximal to a distal fluid outlet. The bullet-shaped nose forms a good seal with surrounding tissue and helps reduce or prevent backflow of infused fluid.

Abstract: A therapy specific, pre-programmed, hand-held auto-injection device for delivering a drug to a patient includes a housing, a plurality of syringes carried by the housing, at least one actuator disposed within the housing coupled to the plurality of syringes, and a controller disposed within the housing and communicatively coupled to the at least one actuator. The controller is configured to receive an infusion and aspiration profile, which includes an infusion and aspiration protocol for controlling at least one of the plurality of syringes. The controller is also configured to operate the at least one actuator based on the infusion and aspiration protocol by either expelling a fluid from a respective barrel of the plurality of syringes into the infusion and aspiration location or drawing a fluid from the infusion and aspiration location into a respectively barrel of the plurality of syringes.

Abstract: Drug delivery systems and methods are disclosed herein. In some embodiments, a drug delivery system can be configured to deliver a drug to a patient in coordination with a physiological parameter of the patient (e.g., the patient's natural cerebrospinal fluid (CSF) pulsation or the patient's heart or respiration rate). In some embodiments, a drug delivery system can be configured to use a combination of infusion and aspiration to control delivery of a drug to a patient. Catheters, controllers, and other components for use in the above systems are also disclosed, as are various methods of using such systems.

Abstract: Fixation devices are disclosed herein that can be used to secure to a catheter. The fixation devices include a body having a central bore extending therethrough to receive a catheter and at least one end having a tapered profile tapering inwardly a distal edge thereof. The body can include an expanded intermediate portion, such as one or more bulbous portions. The fixation devices can also include suture openings or grooves to secure the devices to tissue.

Abstract: Methods and devices are disclosed herein that allow for infusion and aspiration through a single device. The device can be used to treat a stroke by delivering the device to the site of a blood clot and simultaneously or sequentially infusing a thrombolytic or other drug into the clot and aspirating the dissolving clot from the patient. The methods and devices can advantageously permit more efficient thrombolytic infusion and clot aspiration. Modular systems are also disclosed, as are methods of treating subdural hematoma or other conditions.

Abstract: Systems and methods are provided herein that generally involve shunting fluid, e.g., shunting cerebrospinal fluid in the treatment of hydrocephalus. Self-cleaning catheters are provided which include split tips configured such that pulsatile flow of fluid in a cavity in which the catheter is inserted can cause the tips to strike one another and thereby clear obstructions. Catheters with built-in flow indicators are also provided. Exemplary flow indicators include projections that extend radially inward from the interior surface of the catheter and which include imagable portions (e.g., portions which are visible under magnetic resonance imaging (MRI)). Movement of the flow indicators caused by fluid flowing through the catheter can be detected using MRI, thereby providing a reliable indication as to whether the catheter is partially or completely blocked.