Abstract: A medical device, system, and method having a flexible shaft and a multi-core fiber within the flexible shaft. The multi-core fiber includes a plurality of optical cores dedicated for shape sensing sensors, and a plurality of optical cores dedicated for force sensing sensors. A tip assembly can comprise a tip electrode and a coupler comprising at least one fiber support tube center. A distal portion of the coupler can be coupled to a proximal portion of the tip electrode. The tip assembly can further comprise a multi-core fiber comprising a plurality of cores and a fiber support tube. A proximal portion of the fiber support tube can be coupled to the at least one fiber support tube center.

Abstract: An apparatus includes a sheath configured to be at least partially inserted into a body of a patient, the sheath having a distal end and a proximal end; a housing coupled to the proximal end of the sheath; and a control mechanism operably coupled to the housing and slidable to move the sheath relative to the housing. The control mechanism includes a locking mechanism for locking the control mechanism in place relative to the housing; a deflection mechanism for articulating a distal end of the sheath; and a saddle slidable relative to the locking mechanism and the deflection mechanism. A device is coupled to the saddle and is extendable from and retractable within the sheath.

Abstract: A medical device includes: an elongated tube having a wall defining a lumen for the elongated tube, wherein the wall of the elongated tube comprises a first opening; and a first actuating element coupled directly or indirectly to the wall of the elongated tube; wherein at least a part of the first actuating element and the first opening of the wall are located at a same longitudinal position with respect to a longitudinal axis of the elongated tube; and wherein the first actuating element is configured to change size to induce stress and/or displacement at the wall of the elongated tube to cause the elongated tube to bend.

Abstract: A biopsy needle has a cylindrical shell outer cannula and a stylet consisting of an inner stylet and outer stylet, both of which are inserted into the cylindrical cannula. The outer stylet has a series of strain relieved slits which provide bending over a deflection region in one direction, and the outer stylet is formed from a material such as a shape memory alloy (SMA) having a superelastic phase. The deflection is generated by an SMA wire spanning a deflection extent and attached to the outer stylet on either side of the deflection extent. The inner stylet, when positioned inside the outer stylet, has one or more actuation fibers which couple optical energy into the SMA wire, causing a deflection of the outer stylet over the deflection extent, with the optical energy provided to the actuation fibers for control of the deflection. Additional fibers may be placed in the inner stylet to measure temperature and to measure deflection.

Abstract: A delivery device for delivering a pacing lead to the His bundle of a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal tip, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position spaced from the distal tip of the sheath. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a straight configuration to a dual hinged curved configuration that positions the electrodes in the vicinity of the bundle of His.

Abstract: A medical device drive apparatus for inserting an elongated medical device into a blood vessel includes a sub-drive unit that enables fine movement of the elongated medical device and a main drive unit that enables long distance movement of the elongated medical device, in which the sub-drive unit includes a sub-drive unit body and a sub-movable portion movable with respect to the sub-drive unit body, and information on minute force applied to the elongated medical device is calculated based on information on acceleration of the sub-movable portion.

Abstract: An intravascular sensor device can be used to guide treatment of a diseased blood vessel in the body of a patient. In some examples, the intravascular sensor device includes a pressure sensor and an ultrasound transducer. The intravascular sensor device is used to measure a pressure within the diseased blood vessel and acquire an ultrasound image of the diseased blood vessel. The pressure may be measured during hyperemic blood flow that is caused by a pharmacologic vasodilator drug. The measured pressure can be used to calculate a fractional flow reserve value. The ultrasound image can be used to determine a physical dimension of the blood vessel, such as cross-sectional area. The fractional flow reserve value and physical dimensions of the blood vessel can be used to optimize patient treatment.

Abstract: When inserting a catheter or other medical equipment into a child or adolescent or other paediatric patient, ECG signals may be recorded from the catheter and the location of the catheter determined by analysing the ECG signals. A signal processor and user interface may receive recorded signals in real-time from the catheter while the catheter is inserted into the paediatric patient. The signal processor may analyse the ECG signals to determine the location of the catheter in the paediatric patient. The user interface may display the location of the catheter and other pertinent information to a user while the user is inserting the catheter. One method for determining the location may include determining R-wave and P-wave peaks of the ECG signal and determining the location from an average location of the R-wave and P-wave peaks in the ECG signal.

Abstract: Disclosed embodiments include apparatuses for holding an endoscope handle and locking out an angulation lever of an endoscope handle. Given by way of illustration only and not of limitation, in an embodiment an illustrative apparatus includes: a frame; a support mechanism attached to the frame and configured to hold thereon an endoscope handle having an angulation lever; an attachment device configured to hold an endoscope handle in place on the support mechanism; and an angulation lever engagement mechanism configured to prevent an angulation lever of an endoscope handle from returning to a neutral position.

Abstract: Aspects of the present disclosure are directed toward systems and methods for detecting force applied to a distal tip of a medical catheter. A medical catheter includes a deformable body near a distal tip of the catheter that deforms in response to a force applied at the distal tip, and a sensor detects various components of the deflection. Processor circuitry may then, based on the detected components of the deformation, determine a force applied to the distal tip of the catheter.

Abstract: A biopsy needle has a central axis and includes one or more sensing regions, each sensing region formed by a plurality of sensing optical fibers located over a particular extent of said central axis and inside the outer shell of the needle. The sensing optical fibers are coupled to a wavelength interrogator. A steerable catheter has a central axis and outer shell, the outer shell coupled to a plurality of optical fibers in sensing regions and actuation regions, the sensing regions formed over particular extents of the central axis by bonding gratings to the inner surface of the outer shell, and the actuation regions formed by coupling optical energy into shape memory alloys bonded to the outer shell.

Abstract: A deflection device of steerable endoscope includes a first base, a second base, elastic reposition members and tendon wires. The second base is located above the first base along the endoscope center axis. The elastic reposition members are inlaid between the first and the second bases. Each elastic reposition member includes a first plate connecting to the first base, a second plate connecting to the second base, and a waveform bar connecting the first and the second plates. The wave-height of the waveform bar is not parallel to the endoscope center axis. The tendon wires are located on the two opposite sides of each elastic reposition member. The tendon wires are parallel to and distant from the endoscope center axis. Bending of the steerable endoscope is precisely controlled, and structure of the deflection device is simplified in the invention.

Abstract: A stereoscopic optical system including: left and right channels; an electromagnetic actuator including a stator and rotor; wherein first optical components of the left channel are arranged in a left tube and second optical components of the right channel are arranged in a right tube; the stator is arranged outside the guide tubes; the rotor includes a left rotor, in which one or more of the first optical components is accommodated, and a right rotor, in which one or more of the second optical components is accommodated; the left and right rotors are mounted in one of the left and right tubes to be movable in a longitudinal axial direction; the left and right rotors include paramagnetic and/or ferromagnetic material and are movable by an electromagnetic field; the stator includes distal and proximal permanent magnets oppositely polarized; and the stator includes an electric coil for generating the electromagnet field.

Abstract: Disclosed herein are various systems and methods for guiding, supporting, and/or housing instruments. One exemplary system includes a guide tube having a manipulation section and mated with rails carrying instrument control members. Moving the rails with respect to the guide tube, or another point of reference, can control movement of the manipulation section.

Abstract: Provided is a nursing bed based on heart rate monitoring and voice recognition. The nursing bed includes a nursing bed body, a drive motor and a controller. The nursing bed body includes a bed body fixed part, a bed body movable part and a connector. The bed body fixed part is hinged with a side of the connector, and the bed body moveable part is connected with another side of the connector fixedly. A motor base of the drive motor is installed on the bed body fixed part fixedly, an output shaft of the drive motor is connected with another part of the connector in a meshing manner, and the drive motor is configured to drive the bed body moveable part to swing through the connector.

Abstract: An introducer for facilitating implantation of a therapy element into a patient defines a lumen configured to receive the therapy element. At least a portion of the introducer is configured to preferentially flex in at least a first direction over at least a second direction. That is, at least a portion of the introducer is predisposed to bend in a particular direction. In some embodiments, the introducer may also resist bending in one or more directions.

Abstract: A biopsy needle has a cylindrical shell outer cannula and a stylet consisting of an inner stylet and outer stylet, both of which are inserted into the cylindrical cannula. The outer stylet has a series of strain relieved slits which provide bending over a deflection region in one direction, and the outer stylet is formed from a material such as a shape memory alloy (SMA) having a superelastic phase. The deflection is generated by an SMA wire spanning a deflection extent and attached to the outer stylet on either side of the deflection extent. The inner stylet, when positioned inside the outer stylet, has one or more actuation fibers which couple optical energy into the SMA wire, causing a deflection of the outer stylet over the deflection extent, with the optical energy provided to the actuation fibers for control of the deflection.

Abstract: A surgical instrument includes a housing, an energizable member, a proximal hub, and a deployment mechanism. The energizable member is movable between a storage position and a deployed position. The proximal hub is disposed within the housing, coupled to the energizable member, and translatable relative to the housing along a translation axis to deploy the energizable member. The deployment mechanism is configured to selectively translate the proximal hub and includes an actuator movable along a surface of the housing that extends in non-parallel orientation relative to the translation axis. The actuator is operably coupled to the proximal hub and is movable along the surface of the housing in non-parallel orientation relative to the translation axis between a proximal position and a distal position to translate the proximal hub along the translation axis and move the energizable member between the storage position and the deployed position.

Abstract: A variable-stiffness actuator, installed in a flexible member and capable of providing different stiffnesses for the flexible member, includes a shape-memory member that can transit in phase between first and second phases and an inducing member that causes phase transition between the first and second phases into the shape-memory member. The shape-memory member takes, in the first stare, a flexible state in which it is easily deformable by an external force, so as to provide lower stiffness for the flexible member, and, in the second stare, a rigid state in which it tends to take a memorized shape against an external force, so as to provide higher stiffness for the flexible member. The actuator further includes a stiffness calculator that calculates the stiffness of the actuator.

Abstract: An apparatus includes a knob that is repositionable into a first position and a second position. The knob may be configured to control a first set of parameters in the first position and a second set of parameters in the second position. The apparatus may include a reconfigurable display configured to selectively display at least a first display configuration and a second display configuration. The system may be configured to display the first display configuration on the reconfigurable display when the knob is in the first position, and the system may be configured to display the second display configuration on the reconfigurable display when the knob is in the second position. The apparatus may also include a slider device having a set of rails defining a track between the rails. The knob may be slidable along the slider device into the first and second positions.

Abstract: A method of deploying an antenna of an ablation device includes the step of placing an introducing member relative to tissue. The introducing member is disposed on a distal end of a handle member. The method also includes the steps of advancing an antenna distally through the handle member and at least partially through the introducer and rotating the handle member about the longitudinal axis thereof relative to the antenna. The method also includes the step of moving the handle member proximally along the longitudinal axis thereof to retract the introducer proximally relative to the antenna such that the antenna is at least partially deployed relative to the introducer to treat tissue.

Abstract: A robotic catheter device cartridge may include a finger or a slider block generally disposed in a channel and engaged with a steering wire. The steering wire may control movement of a component having the steering wire engaged thereto when the finger or the slider block is linearly driven in a predetermined direction. The cartridge may be a transseptal cartridge having a transseptal needle connected thereto, a catheter cartridge having a catheter connected thereto, or a sheath cartridge having a sheath connected thereto.

Abstract: A spinal fusion system method and apparatus can include: providing segments including a first segment and a second segment; and coupling the first segment to the second segment with a flexible member, the flexible member configured to have a deformable state based upon a temperature of the flexible member being below a transition temperature range or based upon a stress being applied to the flexible member, and the flexible member configured to enter a shape-set state from the deformable state based on the temperature of the flexible member rising above the transition temperature range, or based upon the stress being removed from the flexible member and the temperature of the flexible member being above the transition temperature range.

Abstract: Disclosed herein are various instruments, systems, and methods of use. The instruments can have various control members and/or handles for controlling various degrees of freedom. In addition, the control members can include various control mechanisms for transferring user inputs from a handle to a distal portion of the instrument. In one aspect, an instrument can comprise a control member and a catheter. The catheter can be adjustably and/or detachably connected to the control member.

Abstract: A memory alloy is used during manufacture of a transducer. The memory of the alloy may correct for deviations or bending during manufacture, such as a superelastic alloy returning an array to a flat state after being twisted during handling. The memory of the alloy may cause a desired change in array geometry during manufacture, such as a shape memory alloy twisting an array into a curved or helix due to applied heat. The array may be fixed in place by the memory alloy or bonding after positioning by the memory alloy, preventing further substantial alteration.

Abstract: A method and apparatus for manipulating a surgical guidewire. The apparatus comprises a chuck for selectively coupling motive force to a surgical guidewire and an actuator, coupled to the chuck, for imparting an axial motive force to the chuck. Embodiments of the invention further comprise a method of using the apparatus.

Abstract: Disclosed herein are various systems and methods for guiding, supporting, and/or housing instruments. One exemplary system includes a guide tube having a manipulation section and mated with rails carrying instrument control members. Moving the rails with respect to the guide tube, or another point of reference, can control movement of the manipulation section.

Abstract: A catheter guide assembly includes an extended working channel having a proximal portion adjacent a proximal end and a distal portion adjacent a distal end, the extended working channel having a lumen configured to enable translation of an instrument therethrough. The extended working channel defines a radius formed on the distal portion, wherein the distal portion of the extended working channel is formed of a material having a durometer rating sufficient such that deflection of the distal portion is limited as the instrument is translated therethrough. The catheter guide assembly includes a control handle disposed at the proximal end of the extended working channel and operably coupled to the extended working channel, thereby enabling the extended working channel to advance and rotate.

Abstract: A catheterization device including a catheter, which has a deflectable steering end, and a control device for controlling the steering end. In order to limit operating forces of the catheterization device, the control device has an energy store, which is coupled in a force-transmitting manner to a force transmission element of the control device.

Abstract: A catheter includes an electromechanical polymer (EMP) actuator disposed in a steerable tip at the distal end of the catheter. When activated, the EMP actuator deflects the steerable tip through an angle between 0 and 270 degrees, thus permitting the operator to steer the steerable tip through the vasculature. The steerable tip also has at least a first relatively stiff region and a second relatively flexible region, and the EMP actuator is provided next to the first relatively stiff region so that the steerable tip may toward the flexible region when activated. In one implementation, an external interface allows a user to select by name one of many sets of control signals, with each set of control signals being signals calibrated for configuring the catheter to mimic a known catheter.

Abstract: The present invention describes a system for controlling a thin flexible thermoplastic catheter. The system includes a plurality of shape memory alloy filaments attached to the distal end of the catheter, each filament having a phase and a temperature; a means for receiving a strain value for at least one of the filaments; a means for determining the phase change that will results in the strain value, whereby the phase change is dependent on the temperature and the temperature is dependent on a voltage; and a means for setting the voltage in each filament thereby resulting in movement of the catheter. In addition, a three-degrees of freedom force sensor measures the magnitude and direction of the force exerted on the tip of the catheter. The catheter can be autonomously guided or it can be interfaced to a haptic device. The catheter can also be fitted with microtools.

Abstract: A device and method for inserting a variable stiffness catheter into a subject with a catheter body being in relatively stiff state at a first temperature and a more flexible state at a second temperature. A temperature sensitive polymer is incorporated into the catheter that varies in stiffness depending on the temperature. The stiffness of the catheter is regulated by being in thermal contact with a circulating fluid within the catheter, or by being connected to resistive members in thermal contact with temperature sensitive alloys or polymers. The variable stiffness catheter can therefore be guided through the vasculature while in a relatively flexible state, but be changed into a relative stiff state during ablation procedures.

Abstract: An apparatus for determining a length of a portion of a steering wire disposed within a bendable medical device includes an electrical contact slidably coupled with a steering wire, an electrical source configured to transmit an electrical signal through a portion of the steering wire, and a processor configured to monitor a parameter of the electrical signal at or about the electrical contact and configured to determine a length of a portion of the steering wire using the monitored parameter.

Abstract: A plunger-type control handle for controlling the deflection of a distal tip of a catheter. The control handle includes a spool driven by a gear, the spool being connected to the proximal end of at least one pull wire. For bi-directional deflection, a second proximal end of a pull wire is connected to the spool such that when one of the proximal ends is collected by the spool, the other of the proximal ends is released in an equal amount. The gear is operatively coupled to the plunger and engages a gear rack disposed on the control handle housing, such that when there is relative movement between the housing and the plunger, the gear and spool are rotated. In one embodiment, a switching mechanism is provided that reverses the rotation direction of the gear and spool, thereby providing full stroke resolution of the plunger in each of the bi-directional directions.

Abstract: Intravascular devices, systems, and methods are disclosed. In some embodiments, the intravascular device includes at least one artificial muscle segment. In some instances, the artificial muscle segment or a plurality thereof is configured to move a distal portion of the intravascular device, change the shape of the tip of the intravascular device, rotate a portion of the intravascular device, and any combination thereof. A method for using an associated intravascular device is also provided. The method includes inserting an intravascular device into a vessel of a patient. The intravascular device has an actuator segment. The method further includes moving a portion of the intravascular device by selectively rotating the actuator segment and returning the portion of the intravascular device to a pre-activation position by selectively deactivating the actuator segment.

Abstract: A system for deploying a shape memory catheterization device within a patient, includes a catheter for endovascular insertion of the shape memory catheterization device. A heat source heats the shape memory catheterization device above the transition temperature. A transformation data generator includes a circuit driver for driving a circuit that includes at least one inductive element of the shape memory catheterization device and a detection circuit for generating transformation data based on an inductance of the at least one inductive element, wherein the transformation data indicates a shape transformation of the shape memory catheterization device from a catheterization shape to a transformed shape.

Abstract: A system for deploying a shape memory catheterization device within a patient, includes a catheter for endovascular insertion of the shape memory catheterization device. A heat source heats the shape memory catheterization device above the transition temperature. A transformation data generator includes a circuit driver for driving a circuit that includes at least one resistive element of the shape memory catheterization device and a detection circuit for generating transformation data based on a resistance of the at least one resistive element, wherein the transformation data indicates a shape transformation of the shape memory catheterization device from a catheterization shape to a transformed shape.

Abstract: A system for deploying a shape memory catheterization device within a patient, includes a catheter for endovascular insertion of the shape memory catheterization device. A heat source heats the shape memory catheterization device above the transition temperature. A transformation data generator includes a circuit driver for driving a circuit that includes at least one capacitive element of the shape memory catheterization device and a detection circuit for generating transformation data based on a capacitance of the at least one capacitive element, wherein the transformation data indicates a shape transformation of the shape memory catheterization device from a catheterization shape to a transformed shape.

Abstract: A steerable sheath for a catheter delivery system and associated devices and methods are disclosed. In some embodiments, the catheter delivery system includes a catheter sheath having a steerable distal portion and a flexible elongate member connecting to a steering unit. The flexible elongate member has a central lumen through which a therapeutic or diagnostic device of a first modality can be inserted, used to perform a procedure, and then removed and replaced by a different therapeutic or diagnostic device while the catheter sheath remains substantially at the same location within a patient.

Abstract: An active catheter device is provided. At least one elongate catheter segment includes an elongate flexible tube member defining an axis, and a pair of ferrule members operably engaged with and spaced apart along the tube member. The ferrule members are not rotatable about the axis relative to each other. At least one articulation member is operably engaged with and extends at least between the ferrule members along the tube member. Each articulation member is configured to be actuatable to cause a change in a distance between the ferrule members so as to articulate the tube member. Associated systems and methods are also provided.

Abstract: A noncircular inner lumen guiding catheter with assisted variable support has an inner wall defining a noncircular cross-sectional shaped lumen for use in delivery of multiple microcatheters or other devices for treatment of neurovascular defects, such as for treatment of aneurysms. The noncircular inner lumen guiding catheter with assisted variable support includes torque transmittal guidance walls that are flexible linearly but not circumferentially, and that are neither collapsible nor kinkable. The noncircular shaped cross-section of the inner lumen may extend along the entire length of the catheter or a portion thereof, including distal or proximal.

Abstract: A catheter handle includes a handle body. A steering control mechanism is displaceably carried on the handle body. An electrode sheath carrier is carried on the handle body, the electrode sheath carrier being displaceable at least relative to the steering control mechanism.

Abstract: A catheter system and method that includes a catheter element sized to pass through blood vessels to an organ of an animal. A medical element can be disposed with respect to the catheter element so as to interact therewith, the medical element being capable of assuming and maintaining a curved configuration. An ablating or mapping tool can be disposed on either the medical element or the catheter element, or both. The catheter system can be used for inserting a stent graft limb branch into a stent graft body disposed in a living being, the stent graft body having a trunk and an opening for receiving said branch. A guide element is inserted through a vessel of the living being to the vicinity of the branch receiving opening of the stent graft body. The catheter system can include a hand control for manipulating the catheter system.

Abstract: An electronic apparatus includes a circuit portion that is configured to control an operation of the electronic apparatus and a heat-activated mechanical switch including, for example, a shape-memory material. The shape-memory material has a property such that the shape-memory material assumes a predetermined shape when the electronic apparatus is heated to a transition temperature. The shape-memory material disables the apparatus by acting on the circuit portion when the shape-memory material assumes the predetermined shape.

Abstract: A biopsy needle has a central axis and includes one or more sensing regions, each sensing region formed by a plurality of sensing optical fibers located over a particular extent of said central axis and inside the outer shell of the needle. The sensing optical fibers are coupled to a wavelength interrogator. A steerable catheter has a central axis and outer shell, the outer shell coupled to a plurality of optical fibers in sensing regions and actuation regions, the sensing regions formed over particular extents of the central axis by bonding gratings to the inner surface of the outer shell, and the actuation regions formed by coupling optical energy into shape memory alloys bonded to the outer shell.

Abstract: Deflectable catheter systems, apparatuses and methods utilizing thermal expansion to influence catheter deflection. A representative embodiment includes a catheter having one or more pull wires or other tensioning elements. One end of the tensioning element(s) is connected at a distal portion of the catheter to facilitate shaft deflection upon pulling the tensioning element(s). A heat-sensitive control member(s) is coupled to a proximal portion of the tensioning element(s). The elongate tensioning element(s) is pulled in a proximal direction to deflect the distal portion of the catheter in response to a temperature change applied to the heat-sensitive control member.

Abstract: A controller for use with a guidewire, such as a vascular guidewire, provides a mechanism for gripping and applying a torque to the guidewire without the need to thread the guidewire axially through the controller and at a location close to a point of access of the guidewire. In one embodiment, the controller includes a side-access, multi-part assembly including a collet or other gripping element that applies a uniform radially inward force on the guidewire. In another embodiment, for use with guidewires having active electrically controllable elements, the controller integrally or removably incorporates a switch or other mechanism to initiate an energized state. The controller thereby permits ergonomic, single-handed control of an electronically steerable guidewire, including axially displacing, torquing and steering the guidewire.

Abstract: Apparatus are provided for performing a procedure within a patient's body that include a tubular member including proximal and distal ends, a central axis or region extending therebetween, and a distal portion extending distally from an intermediate portion to the distal end. One or more accessory lumens and a steering element lumen extend between the proximal and distal ends, the steering element lumen offset from the central region within the distal portion such that a steering plane intersects the steering element lumen and the central axis. The distal portion includes a core member extending between the intermediate portion and the distal end, and stabilization elements embedded in the core member adjacent the accessory lumen and defining a stabilization plane that intersects the steering plane at a location offset from the central region, e.g., closer to the accessory lumen than the steering element lumen.

Abstract: Devices including a flexible substrate and a grafted polymer brush coating on at least one surface of the flexible substrate and methods for making and using such devices are provided herein. The grafted polymer brush included on the devices allow for controlled bending of the device during use.

Abstract: A catheter assembly comprises a deflectable catheter shaft comprising a distal end and a lumen extending therethrough. The catheter assembly further comprises least one pull wire comprising a distal portion comprising a side and a distal end, wherein the side comprises a first side portion and a second side portion. The catheter assembly further comprises a distal pull assembly operatively coupled to the at least one pull wire. The distal pull assembly comprises a longitudinal axis, a first surface, and a second surface. The first side portion of the at least one pull wire is adjacent to the first surface of the distal pull assembly, and the second side portion of the at least one pull wire is adjacent to the second surface of the distal pull assembly.