Abstract: Module for driving an elongated flexible medical device in a first direction, comprising: a channel, on each side of the channel: a first and a second pulley comprising a drive surface, an elongated strip comprising a first face and an opposite second face, the first face cooperating with the drive surface of the pulleys, the second face cooperating with the flexible medical device, the strip being stretched by the pulleys with an elongated portion extending into the channel along the first direction, at least one of the pulleys being motorized.

Abstract: The present invention is directed to a multi-angulated catheter and methods of using the multi-angulated catheter. The multi-angulated catheter is so dimensioned as to facilitate accessing the left ventricle from an arm of a patient. The multi-angulated catheter generally includes in order: (a) a coiled end; (b) a first straight portion having a first straight portion length; (c) a first shaft including a distal end connected to the first straight portion and a proximal end opposite the distal end, the first shaft and the first straight portion defining a first obtuse angle, the first shaft having a first shaft length; and (d) a second shaft connected to the first shaft on said proximal end. The catheter is flexible so as to afford being straightened when it is advanced over a guide wire. The catheter resiliently returns to a multi-angulated position after the guide wire is withdrawn.

Abstract: A vascular guidewire system includes a tubular member which at least partially encloses a core wire. A first or distal gripper is connected with a handle to grip a proximal end portion of the tubular member. A second or proximal gripper is disposed in the handle and grips a proximal end portion of the core wire. A first or distal motor is disposed in the handle and is operable to rotate the core wire relative to the outer tubular member. A second or proximal motor is disposed in the handle and is operable to move the first or distal motor longitudinally relative to the handle to thereby move the core wire longitudinally relative to the outer tubular member. The second or proximal motor is disposed in a coaxial relationship with the first or distal motor. Rotational and/or longitudinally directed forces may be manually applied to the handle to move the tubular member and core wire relative to a patient's body.

Abstract: A coil assembly for guiding a magnetic object, such as an endoscopy capsule, in a workspace, wherein the magnetic object exhibits a magnetic dipole, includes different versions of coil assemblies having a number of individual coils and corresponding activation units for feeding current to the respective coils. The coil arrangement can have exactly eleven individual coils and eight power amplifiers, nine individual coils and seven power amplifiers, eight individual coils with six or seven power amplifiers, six individual coils with five power amplifiers, and five individual coils with five power amplifiers.

Abstract: An access system and method for obtaining access to the interior vascular structures or other regions or collections of fluid or fluid-filled cavities inside the body. The system and method provides for injection of contrast agents (to confirm ideal position or condition), the passage of guide wires, and the eventual catheterization of the heart and other parts of the body via the pathway established through the puncture of a femoral artery. The system and method provides the ability to inject a contrast material and pass a guide wire through the same introducer device simultaneously (without necessarily moving it or removing any parts), with the device designed to prevent the backflow of the contrast material through the guide wire port during the contrast injection process The ideal location of access in the vein or artery can be seen by injecting contrast from a needle inside the structure and then using fluoroscopy.

Abstract: A system (10) includes electromagnetic indicator coils (30) included in surgical devices, examples of surgical devices (20) including guidewires; surgical instruments including dilators, stents, catheters, jejunostomy tubes, and endoscopes; and indicator clips (used for marking a location within patient). An innovative device indicator is attachable to any surgical instrument to convert it to an electromagnetically monitorable instrument. A monitoring unit (50) detects electromagnetic fields from the electromagnetic indicator coils and displays the location and configuration of the electromagnetic indicator coils on a display unit (80). The relative positions and overall configuration of multiple devices—such as guidewires, instruments, and location marker indicator clips—can all be simultaneously electromagnetically monitored with the use of radiology.

Abstract: A method and apparatus for introducing a cardiac lead to an implantation site that includes a catheter body having an outer wall and a distal leader and having a proximal portion extending from the first proximal end to a second distal end. An inner member is positioned within an outer lumen of the catheter body and is spaced from the outer wall to form a first inner lumen for receiving a guide tool inserted therein and a second lumen for receiving the cardiac lead while the guide tool is positioned within the first inner lumen. A distal end of the inner member forms a first opening at a distal end of the first inner lumen and a second opening at a distal end of the second inner lumen, the first opening and the second opening positioned proximal the distal leader.

Abstract: This application relates to a device for the local delivery of a substance to a mammary duct by ductal cannulation via an orifice on a nipple, wherein the substance may any substance or combinations of substances, such as for example, compositions capable of forming a solid or semisolid gel within the ducts, a marker, and/or an active agent which is preferably effective in treating and/or preventing breast cancer. More particularly, a device is disclosed comprising a probe for locating the orifice on the nipple, wherein the device is further configured to cannulate the duct and allow local delivery of a substance(s).

Abstract: Medical devices and methods for making and using the same. An example medical device may include an elongate core member having a proximal portion and a distal portion. The distal portion may include a distal end and a flattened region. The flattened region may be disposed proximally of the distal end. The flattened region may have a height and a width. The width may be twice or more as large as the height. A tubular member may be disposed over the distal portion. The tubular member may have a plurality of slots formed therein.

Abstract: Described herein is an apparatus that includes an endotracheal tube or airway device having a proximal end and a distal end and an occlusion cuff. The occlusion cuff includes a sensor for helping determine proper endotracheal or airway device placement.

Abstract: A method is described for producing printed patches to provide a plurality of color markings and high-contrast markings as aligned arrangements of fiducial points. The printed color markings facilitate optical image processing and the printed high-contrast markings facilitate high-contrast image processing. These fiducial points enable a visible area of interest to be located by a person and associated with relevant high-contrast imaging data. This method includes providing a patch; printing at least one arrangement of color markings on the patch; and printing at least one arrangement of high-contrast markings on the patch. According to further features of certain embodiments the markings are aligned, can designate the same point, or can be disjointed.

Abstract: A medical guidewire system for guiding thereon a medical implement includes an end effector, an actuation guidewire having a distal end permanently connected to the end effector, and a control assembly. The assembly has a handle, a shaft receiving the guidewire. The shaft has a proximal end permanently connected to the handle and a distal end temporarily connected to the end effector. A first actuator is movably connected to the handle and operatively connected to the guidewire to actuate the end effector. A second actuator is movably connected to the handle and operatively connected to a portion of the guidewire to disconnect the guidewire from the handle when actuated and, thereby, permit removal of the control assembly from the end effector and guidewire. When the control assembly is removed, the end effector and the guidewire form a surgical exchange or guidewire for guiding thereon the medical implement.

Abstract: Method for delivering a stent coupled with a catheter, to a selected position within a lumen of the body of a patient, the method includes the procedures of: selecting a single image of the lumen, among a plurality of images of an image sequence of the lumen, receiving a position input associated with the selected image and respective of the selected position, the position input is defined in a coordinate system respective of a medical positioning system (MPS), detecting the current position of the stent in the coordinate system, according to position data acquired by an MPS sensor attached to the catheter in the vicinity of the stent, superimposing on at least one maneuvering associated image of the lumen, at least one stent representation respective of the current position, and at least one marking representation respective of the position input, according to a real-time organ timing signal of an inspected organ of the body, maneuvering the catheter through the lumen, toward the selected position, according

Abstract: A method and apparatus for fluid delivery enables navigation through tortuous, spatially restricted body anatomy to access narrow diameter body lumens for the continuous delivery of fluids, including therapeutic fluids, to the lumen in an atraumatic manner that avoids damage to the body lumen. The fluid delivery device can have a flexible conduit having a proximal end, a distal end, and a lumen extending along an interior of the flexible conduit providing a fluid flow path between the proximal and distal ends, where the lumen transitions into a micro-lumen exiting through a port through which a high concentration of fluid injected into the lumen exits laterally out along an image viewable zone at the distal end of the flexible conduit. The flexible conduit has a maximum outer diameter sized sufficient to navigate narrow diameter body lumens.

Abstract: An obturator with an elongated shaft, a proximal end, a substantially closed distal end and a MRI detectable distal shaft portion, which does not interfere with magnetic resonance imaging of tissue proximate thereto. Preferably, the distal shaft portion has an effective MRI detectable mass so as to provide a clear, T1-weighted image within an outline of the distal shaft portion upon magnetic resonance imaging.

Abstract: A method of radiation sterilizing a plurality of stent-catheter assemblies includes positioning a plurality of stent-catheter assemblies on a fixture, each of the stent catheter assemblies being arranged in a planar configuration and disposed in corresponding planar packages supported on the fixture, wherein the packages are stacked horizontally on the fixture, and wherein the stents of the assemblies are positioned at a position in each package such that the stents are exposed to the same or substantially the same radiation; and exposing the packages to an incoming radiation beam, the radiation beam being at an acute angle to the planes of the planar configuration of the assemblies, wherein the packages are arranged such that a front end of the stack faces the radiation beam and a back end of the stack faces away from the radiation beam.

Abstract: A method of medical imaging includes creating an anatomical map of an inner wall of a cavity in a body of a subject by inserting a probe into the body and collecting data using the probe. A three dimensional (3-D) contour is delineated in a 3-D image of the cavity based on the map.

Abstract: A system to minimize fluid turbulence inside a tissue cavity during endoscopic procedures. A body tissue cavity of a subject is distended by continuous flow irrigation using a solenoid operated pump on the inflow side and a positive displacement pump, such as a peristaltic pump, on the outflow side, such that the amplitude of the pressure pulsations created by the outflow positive displacement pump inside the said tissue cavity is substantially dampened to almost negligible levels. The present invention also provides a method for accurately determining the rate of fluid loss into the subject's body system during any endoscopic procedure without utilizing any deficit weight or fluid volume calculation, the same being accomplished by using two fluid flow rate sensors. The present invention also provides a system of creating and maintaining any desired pressure in a body tissue cavity for any desired cavity outflow rate.

Abstract: Apparatus for use in deploying medical devices. The apparatus includes a wire having a diameter such that the wire can appropriately be used with either a corresponding over-the-wire configured catheter or a rapid-exchange configured catheter. The wire has a location at which it can be easily fractured, when desired, in order to convert the length of the wire from a length for use in an over-the-wire configuration to a rapid-exchange configuration.

Abstract: The invention relates to a guide wire for a medical instrument, which has a guide wire core (2) and a sheathing (3) that surrounds the guide wire core at least in sections. According to the invention, the sheathing (3), at least in a shaft section (5) joined to an end section (4), is provided with a rigidity greater than that of the guide wire core. The invention is for use, e.g. in medical instruments for magnetic resonance tomography (MRT) suitable applications.

Abstract: A system for and method of determining and compensating for the effect of a field influencing object on a field sensor, preferably a coil, that is within a navigational domain. The navigational domain contains navigational magnetic energy and disturbing magnetic energy, and the field influencing object produces the disturbing magnetic energy in response to the navigational magnetic energy. The correction system includes a first transmitter for projecting into the navigational domain field energy in a first waveform sufficient to induce a first signal value in the sensing coil. The system also includes a second transmitter for projecting into the navigational domain field energy in a second waveform sufficient to induce a second signal value in the sensing coil. The system further includes a signal processor for receiving the first signal value and for receiving the second signal value to determine the effect of the electrically conductive object on the field sensor.

Abstract: A guide wire for a catheter comprises an elongated hollow shaft has a lumen for delivering or leading away the fluid, and an insertion aid in the form of a flexible wire coil connected coaxially to a distal end of the hollow shaft. The wire coil has a guide wire tip arranged at a distal end, a core wire being arranged in the lumen of the hollow shaft to control the flexibility of the guide wire. The core wire extends out of the lumen and through the wire coil to the guide wire tip. A distal inner area of the wire coil adjacent to the guide wire tip in a proximal direction communicates with the lumen of the hollow shaft by means of a fluid channel formed next to the core wire and has at least one outwardly open passage opening for the fluid to be introduced or removed.

Abstract: A method of determining a three-dimensional (3D) position of a catheter tip includes: compensating a 2D position of the tip of the catheter for respiratory motion to generate a compensated 2D catheter position, generating weighted sample points around the compensated 2D catheter position, determining correspondent points of the weighted sample points in a 3D image, computing a weighted mean and a weighted covariance of each correspondent point, and determining the 3D position of the catheter tip in the 3D image from a fusion of the weighted means and weighted covariances.

Abstract: A method and system for detecting a virtual electrode (VE) on a coronary sinus (CS) catheter in a fluoroscopic image sequence is disclosed. User inputs indicating locations of CS catheter electrodes and a location of a VE are received. A catheter electrode model and a VE part model is initialized in a first frame of the fluoroscopic image sequence. The VE is tracked by detecting electrode position candidates and catheter body point candidates in the subsequent frames of the fluoroscopic image sequence using respective trained detectors, tracking the catheter electrode model in the subsequent frames based on the detected electrode position candidates, generating VE part hypotheses in the subsequent frames based on detection of the most proximal electrode (MPE) in each subsequent frame, calculating a probability score for each of the VE part hypotheses, and selecting an VE part hypothesis with the highest probability score.

Abstract: A method of radiation sterilizing a plurality of stent-catheter assemblies includes positioning a plurality of stent-catheter assemblies on a fixture, each of the stent catheter assemblies being arranged in a planar configuration and disposed in corresponding planar packages supported on the fixture, wherein the packages are stacked horizontally on the fixture, and wherein the stents of the assemblies are positioned at a position in each package such that the stents are exposed to the same or substantially the same radiation; and exposing the packages to an incoming radiation beam, the radiation beam being at an acute angle to the planes of the planar configuration of the assemblies, wherein the packages are arranged such that a front end of the stack faces the radiation beam and a back end of the stack faces away from the radiation beam.

Abstract: A system and method of integrating electromagnetic microsensors into interventional endovascular devices such as guidewires for tracking guidewires within vessels of the body with the use of a surgical navigation system.

Abstract: A catheter procedure system including a user interface for receiving at least a first user input and a second user input and a guide catheter is provided. The catheter procedure system also includes a guide catheter actuating mechanism coupled to the guide catheter and a Y-connector. The guide catheter actuating mechanism is configured to advance and retract the guide catheter in response to the first user input and to rotate the guide catheter in response to the second user input. The catheter procedure system includes a first connector coupling the Y-connector to the guide catheter actuating mechanism, and the first connector is configured to allow the Y-connector to advance and retract with the guide catheter and to allow the guide catheter to rotate without also causing the Y-connector to rotate.

Abstract: A catheter includes a flexible braided shaft having a length sufficient to access a target vessel of the body, such as a renal artery. An electrode at the catheter's distal tip is configured to ablate extravascular target tissue, such as perivascular renal nerve tissue. An electrical conductor coupled to the electrode extends along a first lumen of the shaft. A second lumen of the shaft terminates at a port arrangement on an outer surface of the shaft near the electrode. The second lumen transports a contrast media from the catheter's proximal end and through the port arrangement. The catheter may include a steering arrangement and a lubricious coating on an outer surface of the shaft, allowing a clinician to navigate the catheter through vasculature and into the target vessel without use of a separate delivery sheath or guiding catheter.

Abstract: A guidewire can include a shaft or core wire that has a distal section configured for access to a vascular treatment site and a proximal section configured for intervention at a vascular treatment site. At least a portion of the distal section of the shaft or core wire can have a diameter that is greater than a diameter of the proximal section.

Abstract: A high-volume peripheral intravenous (IV) catheter and method includes an elongate stylet removably disposed in a lumen of an elongate catheter. The catheter has a proximal cylindrical shape from an inlet port transitioning at a transition to a distal tapered conical shape terminating at the outlet port, and having a larger internal diameter at the inlet port and a tapering smaller internal diameter between the transition and the outlet port. A plurality of side outlet ports is formed laterally through the catheter. A cross-sectional area of the outlet port and the side outlet ports together is equal to or greater than a cross-sectional area of the inlet port.

Abstract: A catheter that provides bi-directional steering and allows for deflection sensitivity adjustment includes a catheter body, a deflectable tip section and a control handle, wherein the control handle has a deflection member adapted for user manipulation, a deflection assembly responsive to the deflection member to draw on a tensile puller member for deflecting the tip section, and an adjustment mechanism adapted to adjust sensitivity of the deflection member. The adjustment mechanism also correspondingly adjusts a maximum degree of deflection of the tip section. The deflection assembly includes a rotatable pulley arm and two pulleys, and a deflection sensitivity adjustment mechanism with a cam device that varies a separation distance between the pulleys.

Abstract: The invention relates to a medical system for introducing a catheter into a blood vessel of a patient, having a computer and control unit, a means for creating a transparent general view of the position of the vessel, a catheter with a reversible inflatable balloon located in the front area, to the outside of which a stent can be fitted for implanting into the vessel, a position locating system for the catheter with position and location sensors that can determine the position and location of the catheter, the system with at least one OCT (optical coherence tomography) sensor at a catheter end for the close-up area, with at least one IVUS (intravascular ultrasound) imaging sensor at a catheter end for the remote area and the computer and control unit having image processing and image display functions for the image sensors.

Abstract: Methods and apparatus for delivery of substances or apparatus to target sites within the body of a human or animal patient. A vessel wall penetrating catheter is inserted into the vasculature, positioned and oriented within a blood vessel near the target extravascular site and a penetrator is advanced from the catheter in the direction of the target site. Thereafter, a delivery catheter is passed through a lumen of the penetrator to the target site. A desired substance or apparatus is then delivered to or obtained from the target site.

Abstract: An angiographic injector system and a method of controllably delivering medical fluid to a patient from an angiographic injector system are disclosed. A multiple processor control system is used to actively control the injection process and to monitor sensed functions of the system. The multiple processors provide dual redundancy safety circuits for critical control functions such as syringe motor drive speed and current. A motor/servo-amplifier nested control function is also disclosed. A unique method and apparatus are disclosed for establishing injection parameter default values just prior to an injection procedure that are based on physiological values of the patient to be treated. The injector system uses an interactive display panel that presents sequenced set-up screens to the user and which enables the user to select injection procedures, parameters and other modes of operation directly through the interactive panel.

Abstract: A robotic arm and control system includes a robotic arm which moves in response to one or more command signals. One or more “active” fiducials are located on the arm, each of which emits its own light. A 3D camera having an associated field-of-view is positioned such that at least one fiducial and a target object to be manipulated are in the FOV. To determine their spatial positions, the arm fiducials are activated and the target object is preferably illuminated with a scanning laser; the camera produces output signals which vary with the spatial locations of the fiducials and target object. A controller receives the output signals and uses the spatial position information as feedback to continuously guide the arm towards the target object. Multiple active fiducials may be employed, each having respective characteristics with which they can be differentiated.

Abstract: An intra-luminal device for the extraction of occlusive or partially occlusive material is disclosed. Said device comprises a novel catheter extension which minimizes cavitation of extracted fluids and also allows the better navigation of tortuous lumens or vasculature.

Abstract: An apparatus for targeting a desired target site on a body tissue that separates a first body cavity from a second body cavity of a patient includes a catheter having a longitudinally extending catheter lumen and adapted to provide access to the first body cavity. A framing member has a collapsed condition in which the framing member is adapted for insertion into the first body cavity through the catheter lumen and an expanded condition in which the framing member is adapted for placement within the first body cavity. The framing member has a framing member body. At least one target point is carried by the framing member and is adapted for placement adjacent the desired target site. At least one target wire is attached to at least one target point. At least a portion of the target wire extends through the catheter lumen. The target wire is substantially spaced apart from the framing member body. A method of using the apparatus is also described.

Abstract: An apparatus and method for curving a catheter after deployment include a catheter having a primary lumen, a secondary lumen, and a resilient fiber contained within the secondary lumen. The resilient fiber and the secondary lumen have corresponding, preformed curve shapes when the catheter is in a straight, unstressed condition. The resilient fiber is slidable within the secondary lumen to create a desired curve shape in the catheter as the curved portion of the resilient fiber slides into an originally straight portion of the secondary lumen. In another embodiment, the preformed curve shape of the resilient fiber is held in a straight condition within a stiff, marker ring segment of the catheter until after the catheter is deployed. Once deployed, the resilient fiber is slid out of the marker ring segment, and the preformed curve shape of the resilient fiber creates a corresponding curve shape in the catheter.

Abstract: The present invention provides a cardiac vascular occlusion system which includes inner and outer guide catheters and an occluding member disposed on the inner catheter. The occluding member may be deployed from a compressed to an expanded position to limit retrograde blood flow in a body lumen. The occluding member may be used when injecting a contrast agent into the body lumen.

Abstract: A method of measuring blood pressure and velocity proximally and distally of a stenosis in a vessel carrying blood includes the steps of providing a guide wire having both a pressure sensor and a velocity sensor disposed on a distal region of the guide wire, introducing the guide wire into the vessel, advancing the guide wire to position the pressure sensor and the velocity sensor proximally and distally of the stenosis, and measuring the blood pressure and velocity proximally and distally of the stenosis with the pressure sensor and the velocity sensor.

Abstract: Disclosed herein is a method of radiation sterilizing a plurality of medical devices.

Abstract: An infusion media delivery device includes a housing having a base adapted to be secured to a user's skin. An infusion media reservoir is supported by the housing. A moveable hollow needle is selectively engageable with the reservoir to communicate infusion media from the reservoir. The needle is supported for movement relative to the housing base between a first position and a second position. The needle is spaced apart from a user's skin when in the first position and the base is secured to the user's skin, and the needle is arranged to pierce the user's skin when in the second position and the base is secured to the user's skin.

Abstract: The invention relates to one or several navigation aids whose position can be used to maintain the recorded state of at least one partial structure of a non-bone structure. The navigation aid(s) is/are inserted into the non-bone structure.

Abstract: A guidewire loader apparatus is provided for loading a guidewire into a lumen opening of a guidewire lumen of a medical device. The loader apparatus includes a first member defining a respective medical device receiving portion and a respective guidewire receiving portion in communication therewith via a respective interface portion. The loader apparatus further includes a second member configured for placement in an opposed relationship to the first member. The second member defines a respective medical device receiving portion and a respective guidewire receiving portion in communication therewith at a respective interface portion. The first member and the second member cooperatively associate with one another between a first position and a second position. In the first position, the medical device can be positioned into at least one respective medical device receiving portion.

Abstract: Methods for determining the size, pathology, and volume of embolic debris captured in an embolic protection filtering device. The methods may include providing an embolic protection filtering device and scanning the filtering device with a computed tomography scanner. The methods may also include analyzing digital images produced during the scanning step.

Abstract: A catheter having an internal advancing mechanism that can advance stiffening wires or other devices, has a catheter with a catheter body, a tip section distal the catheter body, a device extending through at least the catheter body, and a control handle proximal the catheter body, where the control handle has an advancing mechanism with a threaded member, an adjustment member, and a guided member to which the device is connected, and the advancing mechanism is configured to advance and retract the device along the catheter body as controlled by a user. Each of the threaded member and the adjustment member has a generally cylindrical configuration. The threaded member has an outer surface configured with a helical guide channel. The adjustment member is configured to guide the guided member to move within the helical guide channel to advance and retract the device. The adjustment member can be rotatable over the threaded member by the user to control advancement and retraction of the device.

Abstract: A tip of an elongate device is navigated into a particular tissue volume in order to examine the particular tissue volume in a body and part of the tissue volume is analyzed in real-time by way of a biosensor. In at least one embodiment, in the process, either the biosensor can be arranged on the tip of the device or the device includes a catheter, by which a substance to be analyzed is transported out of the tissue volume from the tip to the biosensor arranged at the proximal end of the catheter.

Abstract: A combination catheter enables performing an angiogram and an angioplasty (and repetitions of one or both) with the same catheter instrument, without removal from and re-insertion into an artery until the procedure is completed.

Abstract: A probe for insertion into the body of a subject includes a sensor, a first microcircuit, which stores first calibration data with respect to the sensor, and a first connector at the proximal end of the probe. A probe adapter includes a second connector, which mates with the first connector, a signal processing circuit, which is processes the sensor signal, and a second microcircuit, which stores second calibration data with respect to the signal processing circuit. A microcontroller in the adapter receives the first and second calibration data and computes combined calibration data. The adapter includes a third connector, which mates with a fourth connector on a console. The console includes signal analysis circuitry, which analyzes the processed signal using the combined calibration data provided by the probe adapter.

Abstract: An inserting shape detecting probe has a long and slender core wire, a plurality of shape detecting devices, signal lines, and an outer sheath. The plurality of shape detecting devices extended from the signal lines are fixed to the core wire at a predetermined interval. The core wire is inserted in the outer sheath. The inserting shape detecting probe has a thermal radiating member which is arranged along the outer circumference of at least one of the shape detecting devices.