Abstract: An assembly for reducing foreign body response in a subject caused by an invasive or non-invasive tissue injury at a target site. A base with aperture is secured to the subject in proximity to the target site with an implant extending therethrough. The base includes a sloped channel that receives an alignment tab of a housing, permitting vertical adjustment of the housing relative to the base along a continuum by rotation of the housing. The housing contains a transducer generating vibrations when activated, an acoustic horn in contact with the transducer transmitting the vibrations through the base aperture to the subject tissue at the target site, and a compressible polymer surrounding a portion of the horn at the terminal end of the housing that conforms to the subject's interface and transmits vibrations to the target site for reducing foreign body response or microgliosis in the subject.

Abstract: A handheld lancing device having anesthetic feature includes a housing removably retaining a disposable lancet. A carriage suspended within the housing by an isolation assembly may receive the lancet. A motor in mechanical communication with the lancet produces vibrations transmitted to contact surface, which vibrate a target lancing site prior to and during piercing. The target site is vibrated for a predetermined period of time before deploying the lancet. The isolation assembly permits movement of the carriage and/or lancet within the housing in one direction while limiting movement in other directions, and further dampens the vibrations of the motor from the housing held by the user. A force sensor detects force applied by the pressing of the contact surface against the skin of the patient. An indicator(s) perceivable to the user identifies when predefined positions of the lancet are reached for initiating vibration then triggering the lancet.

Abstract: A device for reducing foreign body response in a subject caused by an electrode implanted in a subject's tissue. A base is secured to the subject, having a base aperture in proximity to the target site. The base can receive and align a body thereon. A body contains a chamber extending between a chamber aperture, aligned with the base aperture, at one end and a chamber opening at an opposite end. The chamber contains an acoustic coupling medium, such as polyvinyl alcohol cryogel, transmits acoustic vibrations from a transducer without altering their frequency. The transducer is mounted to the device and is configured to transmit acoustic vibrations into the chamber and through said acoustic coupling medium to the subject tissue at the target site, creating an acoustic field in the target site sufficient to reduce foreign body response in the subject where the electrode contacts the target tissue.

Abstract: A medical instrument having integrated arms extending from a proximal end to a distal end, and a handpiece with actuators to control movement of the arms. The instrument includes an insertion tube having arm channel(s) for receiving an arm therethrough. Each arm includes an engagement member at the distal end of resilient material with a natural non-linear configuration when deployed but deforming when retracted into the arm channel when retracted. Arm channels may be located at different radial distances from one another in the insertion tube so the engagement members may be at radial angles relative to one another when deployed. Arms and engagement members are movable between at least a first position and second position relative to one another by rotation and/or translational motion of the corresponding actuator, to contact tissue or deflect a tool extended through the working channel of the endoscope.

Abstract: A device for engaging tissue includes a body disposable around the distal end of a medical instrument, such as an endoscope, and a handpiece. The body includes a primary channel for receiving the medical instrument and at least one arm channel for receiving an arm therethrough. At least one arm extends through the arm channel of the body and proximally to the handpiece. The arm includes an engagement member distally of the body, and may further include a bend between the body and engagement member. The engagement member is movable between a first position not contacting tissue and a second position contacting tissue. With multiple engagement members, the engagement members are farther apart from one another in the first position and closer together in the second position. Movement of the engagement members is controlled by selective and independent movement of the corresponding arms by rotational and/or translational motion.

Abstract: A lancing device with an ejector that is movably retained with a housing in proximity to a lancet and is selectively movable between a home position, a first eject position, an intermediate position defined by contact of the ejector with the lancet, and a second eject position. The ejector is rotatable to move from the home to first eject position and is linearly translatable to move between the first and second eject positions. The ejector includes an arm that extends within the housing and engages the lancet, an exterior portion that is actuated by a user, and a post extending therebetween. The post extends through a slot in the housing which limits the linear movement and direction of the ejector. Upon rotation of the ejector, the arm extends through an opening at the rear of the carriage holding the lancet to permit access to the lancet.

Abstract: A handset for operation and locking of an occlusion clearing device includes a body and movable cover. Valve(s) in fluid communication with tubing for aspiration or irrigation are located within the body. A locking mechanism having first and second components affixed at different points in the handset which are selectively movable relative to one another to transition between locked and unlocked positions. The first component is connected to and selectively movable relative to the cover. The second component engages a portion of the first component, causing the cover to move in an engagement direction as the first component is moved to a locked position. Movement of the cover in an engagement direction causes the valve(s) to change from a first to second position which controls the flow of fluid therethrough. An engagement surface of the second component engages and retains the first component in a locked position.

Abstract: A device for penetrating tissue with reduced force and placing a guidewire is provided. The device includes a driving actuator generating reciprocating motion at less than 20 kHz. A penetrating member having a lumen dimensioned to accommodate a guidewire is provided, and may be coaxial or axially offset from the driving actuator. A coupler mechanically connects the driving actuator and the penetrating member, transferring the reciprocating motion to the penetrating member. At least one frictional member facilitates the movement of the guidewire through the lumen for placement at the target tissue. The frictional member(s) may be operated manually or by a guidewire actuator. A housing including a channel also dimensioned to accommodate the guidewire may also be provided, and may further include the frictional member(s) for facilitating movement of the guidewire. A side port may also be included at the penetrating member or coupler for introduction of the guidewire.

Abstract: An insertion assembly for inserting a neural implant into target neural tissue. The insertion assembly includes a horn connecting to a vibrational actuator. A horn tip is configured to support an implant for insertion, such as the base of an implant having electrode(s). An implant stabilizer is displaceably affixed to the horn at a connection point for secure mounting while permitting flexing of the implant stabilizer. The implant stabilizer includes a first end positionable proximate to the horn tip and contacting the implant, and an opposite second end that may be selectively moved by force to adjust the position of the first end relative to the horn tip. A biasing member contacts the horn tip and first end of the implant stabilizer and urges the first end toward the horn tip to releaseably secure the implant to the horn tip. The biasing member may be selectively removed from the assembly.

Abstract: An automatic insertion device and method of using the same is provided. A vibrator and an extender are connected to a penetrating member and are both in electrical communication with a controller. A detector identifies a subcutaneous target for insertion and the insertion angle, distance and trajectory for the penetrating member are calculated. The vibrator provides vibrations to the penetrating member and the extender advances the penetrating member for insertion. The vibrator and extender are in electrical communication with one another during the insertion process and adjustments to the insertion speed are made based on feedback of vibrational load encountered by the vibrator during insertion, and adjustments to the vibrations are made based on feedback of insertion load encountered by the extender during insertion. Iterative samples are taken to constantly adjust the operation of one motor based on the operations and feedback from the other motor.

Abstract: A handheld lancing device having anesthetic feature includes a housing removably retaining a disposable lancet. A carriage suspended within the housing by an isolation assembly may receive the lancet. A motor in mechanical communication with the lancet produces vibrations transmitted to contact surface, which vibrate a target lancing site prior to and during piercing. The target site is vibrated for a predetermined period of time before deploying the lancet. The isolation assembly permits movement of the carriage and/or lancet within the housing in one direction while limiting movement in other directions, and further dampens the vibrations of the motor from the housing held by the user. A force sensor detects force applied by the pressing of the contact surface against the skin of the patient. An indicator(s) perceivable to the user identifies when predefined positions of the lancet are reached for initiating vibration then triggering the lancet.

Abstract: A tissue ablation device includes an ablation stem insertable into the working channel of a medical device such as endoscope for radiofrequency ablation of target tissue. The stem includes a sheath, cannula, and ablation wire concentrically disposed within one another. Each of the sheath, cannula and ablation wire are independently controllable by a dedicated positioner located in the handset. An end effector of tines is removably attached to the distal end of the ablation wire and expand radially outwardly when deployed to form a three-dimensional ablation zone. A motor provides repetitive reciprocating vibrations to generate axial displacement of the ablation wire and tines for increased accuracy in insertion into tissue. RF ablation is also provided through the ablation wire and tines. The end effector tines are removable to remain in the target tissue as a fiducial marker for later procedures.

Abstract: A handset for operation and locking of an occlusion clearing device includes a body and movable cover. Valve(s) in fluid communication with tubing for aspiration or irrigation are located within the body. A locking mechanism having first and second components affixed at different points in the handset which are selectively movable relative to one another to transition between locked and unlocked positions. The first component is connected to and selectively movable relative to the cover. The second component engages a portion of the first component, causing the cover to move in an engagement direction as the first component is moved to a locked position. Movement of the cover in an engagement direction causes the valve(s) to change from a first to second position which controls the flow of fluid therethrough. An engagement surface of the second component engages and retains the first component in a locked position.

Abstract: An occlusion clearing device and system for removing material from an artificial tube in situ includes a clearing stem having aspiration and irrigation conduits, where the irrigation conduit is disposed interior to, and terminates within the aspiration conduit. Material enters the clearing stem through aspiration, and irrigation is provided within the aspiration conduit to assist in aspiration through the clearing stem. A handset includes aspiration and irrigation tubing connecting to sources therefor, and further includes valves to control the flow through the tubing and conduits. These valves may be operated simultaneously with an actuator located on the handset, which may be done with one hand. A coupler at the operative end allows the clearing stem to gain access to the artificial tube for clearing while maintaining a closed system with a ventilator. Reciprocating motion may be generated and provided to the clearing stem to aid in occlusion removal.

Abstract: An occlusion clearing device for a patient has a housing with a motor(s) that generates repetitive motion, which is reciprocating, rotational or both. A clearing stem including a sheath that has a lumen, wherein aspiration is conducted through the sheath lumen. A wire is located in the sheath lumen and receives repetitive motion from the controller. The sheath terminates in a sheath end having at least one sheath opening. The wire terminates in a wire tip, which may be flat, helical, or tubular. The wire tip is positioned within the sheath end, in proximity to the sheath opening(s), and movement of the wire tip and/or sheath end relative to each other creates shearing forces that break up an adjacent occlusion.

Abstract: An occlusion clearing device for a patient has a housing with a motor(s) that generates repetitive motion, which is reciprocating, rotational or both. A clearing stem including a sheath that has a lumen, wherein aspiration is conducted through the sheath lumen. A wire is located in the sheath lumen and receives repetitive motion from the controller. The sheath terminates in a sheath end having at least one sheath opening. The wire terminates in a wire tip, which may be flat, helical, or tubular. The wire tip is positioned within the sheath end, in proximity to the sheath opening(s), and movement of the wire tip and/or sheath end relative to each other creates shearing forces that break up an adjacent occlusion.

Abstract: A device for penetrating tissue is provided that has a driving actuator with a body and motor shaft that is reciprocated. A coupler is attached to the motor shaft, and a key engages the driving actuator and coupler and limits rotational motion of the motor shaft and permits linear motion of the motor shaft. A penetrating member is carried by the coupler, and linear motion of the motor shaft is translated to the penetrating member to linearly reciprocate the penetrating member.

Abstract: A device for penetrating tissue for fluid collection and delivery is provided having a driving actuator interconnected to and driving axial reciprocating motion of a penetrating member. A hollow member attached between the penetrating member and a reservoir permits axial reciprocation of the penetrating member while isolating the vibrations from the reservoir. A handpiece allows for one-handed use of the device. A slider device attached to the reservoir permits one-handed delivery and extraction of materials from the reservoir.

Abstract: A device for gripping tissue that is inside of a patient for use in delivering therapy is provided. The device may include a first gear that rotates and that engages the tissue. A second gear that also rotates may be included and may likewise engage the tissue. A spacing mechanism may be included in the device that adjusts the spacing between the first and second gears such that the first and second gears are moved closer to one another and moved farther from one another.

Abstract: A device for penetrating tissue with reduced force and placing a guidewire is provided. The device includes a driving actuator generating reciprocating motion. A penetrating member having a lumen dimensioned to accommodate a guidewire is provided. A coupler mechanically connects the driving actuator and the penetrating member to transfer the reciprocating motion to the penetrating member. The penetrating member may be coaxial or axially offset from the driving actuator. At least one frictional member facilitates the movement of the guidewire through the lumen for placement at the target tissue. The frictional member(s) may be operated manually or by a guidewire actuator. A housing may also be provided including a channel also dimensioned to accommodate the guidewire, and may further include the frictional member(s) for facilitating movement of the guidewire. The channel and lumen are aligned to permit placement of the guidewire at the target site.