Abstract: Methods and devices to detect analyte in body fluid are provided. Embodiments include enhanced analyte monitoring devices and systems.

Abstract: Methods to generate luminal organ profiles using impedance. One embodiment of such a method comprises the steps of introducing an impedance device having at least two detection electrodes positioned in between at least two excitation electrodes into a treatment site of a luminal organ at a first position, measuring a first treatment site conductance at the first position using the impedance device and at least two injections of solutions having different conductivities, moving the impedance device to a second position in the luminal organ, measuring a second treatment site conductance at the second position using the impedance device and the at least two injections of solutions having different conductivities, calculating a first position cross-sectional area using the first treatment site conductance and a second position cross-sectional area using the second treatment site conductance, and constructing a profile of the treatment site.

Abstract: A nerve surveillance electrode assembly for a surgical access instrument including a substrate, at least one electrode, at least one lead, and a connector such that the nerve surveillance electrode assembly may be selectively applied to a surgical access instrument in such a way that the nerve surveillance electrode assembly is positioned to detect nerves while the surgical access instrument is being advanced toward a surgical target site.

Abstract: An electrode catheter device with indifferent electrode for direct current tissue therapies is disclosed. An example of the catheter device has a flexible tubing with at least one ablation electrode. The catheter device also may also be used with a sheath for introducing the flexible tubing inside a patient's body. An indifferent electrode on the sheath can provide a ground for a direct current (DC) pulse to deliver electrical energy and create an electrical field adjacent a tissue. Various other embodiments are also disclosed.

Abstract: Methods of using the device for conducting business transactions are also included. An impedance spectroscopy system for monitoring ischemic mucosal damage in hollow viscous organs comprises a sensor catheter and an impedance spectrometer for electrically driving the catheter to obtain a complex tissue impedance spectrum. Once the catheter is in place in one of a patient's hollow viscous organs, the impedance spectrometer obtains the complex impedance spectrum by causing two electrodes in the tip of the catheter to inject a current into the mucosal tissue at different frequencies, while two other electrodes measure the resulting voltages. A pattern recognition system is then used to analyze the complex impedance spectrum and to quantify the severity of the mucosal injury. Alternatively, the complex impedance spectrum can be appropriately plotted against the spectrum of normal tissue, allowing for a visual comparison by trained personnel.

Abstract: An implantable electrode lead including an elongated electrode lead body having a proximal end and a distal end, at least one electrical supply lead which is enclosed in an electrically insulating material to electrically insulate the supply leads against the surroundings of the electrode lead, at least one electrically active surface which is disposed on the distal end, or in the vicinity thereof, and is connected to the at least one electrical supply lead, by way of which therapeutic signals can be output and/or diagnostic signals can be received, a plug disposed on the proximal end, which is electrically connected to the at least one electrical supply lead and can be connected to an electro-medical implant, and at least one preformed and/or stiffened section of the electrode lead body, which has an additional preformation and/or stiffening structure, by way of which the section is preformed and/or stiffened.

Abstract: Provided are an apparatus and a method for controlling human body contact of ground electrode, and a human body communication system using the same. The apparatus includes a resistance measuring unit for applying a predetermined voltage to a human body through a signal electrode, to measure a resistance value between the signal electrode and the ground electrode; a contact control unit for determining whether the ground electrode needs to contact the human body by using the measured resistance value, to provide control information associated with human body contact; and a contact performing unit for bringing the ground electrode into contact or out of contact with the human body according to the control information.

Abstract: Cardiac catheters, including a lasso catheter, are provided for use in a system for electrical mapping and ablation of the heart has an array of raised, circumferential ring bump electrodes wherein each circumferential electrode has multiple perforations, which are in fluid communication with a cavity or chamber formed under the surface of the circumferential ring. The cavity is formed 360° around the outer surface or loop lumen of the lasso segment of the catheter which is in fluid communication with a breach hole (or holes) drilled through loop lumen and in fluid communication with an irrigating lumen. Each circumferential ring has a breach hole (or holes) that range from smaller to larger from the proximal end of the loop segment to the distal end of the loop segment in one embodiment.

Abstract: Methods and devices and systems including a data collection module for receiving and storing analyte data over a predetermined time period from a subject, a user interface unit coupled to the data collection module for providing one or more indication related to the analyte data, a control unit coupled to the data collection module and the user interface unit to control, at least in part the operation of the data collection module and the user interface unit, a communication module coupled to the control unit for communicating one or more signals associated with the analyte data to a remote location, where the user interface unit is configured to operate in a prospective analysis mode including substantially real time output of the analyte level received by the data collection module, and a retrospective analysis mode including limited output of information to the subject during the predetermined time period, and further where the communication module is configured to communicate with the remote location afte

Abstract: An electrode has a unitary ring with an exterior surface, an interior surface, and at least two edges. The electrode also includes a seat formed in at least the exterior surface of the unitary ring. The seat is configured and arranged for attachment of a terminal end of a lead wire, disposed in the seat, to the electrode. A lead includes a lead body; a plurality of electrodes disposed at the distal end of the lead body; and a plurality of lead wires. Each electrode includes a unitary ring and a seat in the unitary ring. The unitary ring has an exterior surface and an interior surface and defines a hollow center region. The seat is formed as a depression of a portion of the unitary ring. Each of the lead wires extends along the lead body and is attached to a corresponding electrode at the seat of the corresponding electrode.

Abstract: An intracerebral probe (11) comprising a first part (20) with laser or cryogenic treatment means and further comprising a hollow second part (22) surrounding the first, the first part sliding inside the second part along its longitudinal axis (A); and a plurality of detectors (16) distributed along a portion of the second part (22) in such a manner as to be capable of identifying a brain dysfunction zone along the longitudinal axis (A) of the second part. Advantageously, the probe presents a lateral treatment window enabling the action of the treatment means to be directed. The invention also provides a kit and a treatment system including such a probe, and the use thereof of treating cell dysfunctions that give rise to neurological or psychiatric symptoms.

Abstract: A medical apparatus, including a reference probe having a flexible insertion tube with a distal end for insertion into a body cavity, a pair of isolated electrodes fixedly attached to the distal end, and a position sensor fixedly located in the distal end. The apparatus also includes a supplementary probe having an electrode fixed thereto. The apparatus further includes a processor, configured to inject respective alternating currents into the pair of isolated electrodes so as to generate an electrical field therefrom, to measure a potential generated at the electrode of the supplementary probe in response to the electrical field, and to evaluate a location of the supplementary probe with respect to the reference probe in response to the measured potential and in response to a position of the distal end indicated by the position sensor.

Abstract: A method of manufacturing an implantable medical lead is disclosed herein. The method may include: providing a lead body including a proximal end, a distal end, and an electrode near the distal end; provide a conductor extending between the proximal and distal ends; providing a crimp including a ribbon-like member and extending the ribbon-like member around the conductor; and mechanically and electrically connecting the ribbon-like member to the electrode.

Abstract: An apparatus includes a guide wire configured to be inserted into a passage of a living body, and at least one electrical conductor and electrical insulation covering a surface of the conductor with a gap formed in the electrical insulation at a predefined position on the guide wire. A processor is configured to measure an electrical impedance of the body between the conductor at the gap and one or more electrodes fixed to the body, and to calculate a location of the gap within the passage in the body in response to the measured impedance.

Abstract: In certain variations, methods, systems and/or devices for enhancing conductivity of an electrical signal through a subject's skin using one or more microneedle electrodes are provided. A microneedle electrode may be applied to the subject's skin by placing the microneedle electrode in direct contact with the subject's skin. The microneedles of the microneedle electrode may be inserted into the skin such that the microneedles pierce stratum corneum of the skin up to or through dermis of the skin. An electrical signal passes or is conducted through or across the microneedle electrode and the subject's skin, where impedance of the microneedle electrode is minimal and greatly reduced compared to existing technologies.

Abstract: A biosensor is proposed for insertion into the subcutaneous tissue of a user wherein the biosensor includes at least one flexible substrate (2) and at least one electrode (5) on at least one surface (9) of the substrate and at least one contacting element (3). The contacting element is connected to the electrode. The substrate has at least one kink (4), at which the substrate is at least partly kinked such that the surface is subdivided into at least two interconnected outer surfaces (9a, 9b, 9c).

Abstract: An implantable medical lead including a proximal end portion and a distal end portion and an electrical conductor electrically connected to the proximal end portion of the lead body. Also, the lead has at least one electrode connected to the distal end portion of the lead body and connected to the electrical conductor. The electrode includes a conductive base structure, a first set of pores formed on an outer surface of the conductive base structure, the first set of pores having an average first pore dimension of between about ¼th and about 1/100th an electrode dimension, and a second set of pores formed on at least a portion of the first set of pores, the second set of pores having an average second pore dimension of between about ¼th and about 1/100th average first pore dimension.

Abstract: The invention relates to a sensor for in vivo measurements comprising a planar substrate, and a sensor shaft bearing several electrodes, and a sensor head for connecting the sensor, wherein the sensor head has metal surfaces as contact fields for contact making, which are connected to the electrodes by way of conductor paths. The sensor head protrudes laterally to the sensor shaft so that the contact fields are arranged laterally from the sensor shaft, whereas the conductor paths extend in parallel on the sensor head transversely to the longitudinal direction of the sensor shaft. Also disclosed is a system having a sensor as just described and a suitable plug connector therefor.

Abstract: An implantable medical electrical lead includes a plurality of conductors that extend continuously, without any intermediary junctions, between a plurality of electrodes and a corresponding plurality of contact members of an in-line connector terminal. A junction between each conductor and the corresponding contact member is preferably formed by first fitting a conductive sleeve, which is coupled to a proximal portion of the conductor, into an eyelet feature of the contact member, which is mounted on a strut member, and then welding the sleeve to the contact member at a pre-formed slot of the contact member, which extends along an external recessed surface thereof. The assembly of the connector terminal preferably completes the construction of the lead, wherein the proximal portion of each conductor is positioned in a helical path, which extends between an elongate body of the lead and the connector terminal, and along which a grip zone is formed.

Abstract: An efficient system for diagnosing arrhythmias and directing catheter therapies may allow for measuring, classifying, analyzing, and mapping spatial electrophysiological (EP) patterns within a body. The efficient system may further guide arrhythmia therapy and update maps as treatment is delivered. The efficient system may use a medical device having a high density of sensors with a known spatial configuration for collecting EP data and positioning data. Further, the efficient system may also use an electronic control system (ECU) for computing and providing the user with a variety of metrics, derivative metrics, high definition (HD) maps, HD composite maps, and general visual aids for association with a geometrical anatomical model shown on a display device.

Abstract: A biomedical conductor assembly adapted for at least partial insertion in a living body. The conductor assembly includes a plurality of the first electrical conductors each covered with an insulator and helically wound in a first direction to form an inner coil with a lumen. A plurality of second electrical conductors each including a plurality of un-insulated wires twisted in a ropelike configuration around a central axis to form a plurality of cables. Each cable is covered with an insulator and helically wound in a second opposite direction forming an outer coil in direct physical contact with the inner coil. The inner and outer coils are covered by an insulator. A method of making the conductor assembly and implanting a neurostimulation system is also disclosed.

Abstract: A system and method for an improved biological interface system that processes multicellular signals of a patient and controls one or more devices is disclosed. The system includes a sensor that detects the multicellular signals and a processing unit for producing the control signal based on the multicellular signals. The system may include improved communication, self-diagnostics, and surgical insertion tools.

Abstract: In one embodiment, a percutaneous stimulation lead for applying electrically stimulation pulses to tissue of the patient comprises: a plurality of electrode assemblies electrically coupled to a plurality of terminals through a plurality of conductors of the stimulation lead, wherein each electrode assembly is disposed in an annular manner around the lead body and each electrode assembly comprises (i) an electrode adapted to deliver electrical stimulation to tissue of a patient, (ii) an interior conductive layer, and (iii) a dielectric layer disposed between the electrode and the interior conductive layer; the electrode and interior conductive layer being capacitively coupled, the dielectric layer further comprising an inductor, the inductor being electrically connected to one of the plurality of conductors through the interior conductive layer, and the inductor being electrically coupled to the electrode.

Abstract: An energy management system that facilitates the transfer of high frequency energy induced on an implanted lead or a leadwire includes an energy dissipating surface associated with the implanted lead or the leadwire, a diversion or diverter circuit associated with the energy dissipating surface, and at least one non-linear circuit element switch for diverting energy in the implanted lead or the leadwire through the diversion circuit to the energy dissipating surface. In alternate configurations, the switch may be disposed between the implanted lead or the leadwire and the diversion circuit, or disposed so that it electrically opens the implanted lead or the leadwire when diverting energy through the diversion circuit to the energy dissipating surface. The non-linear circuit element switch is typically a PIN diode. The diversion circuit may be either a high pass filter or a low pass filter.

Abstract: An electromyographic recording electrode assembly for intraoperative nerve integrity monitoring includes cables enabled for connection to a nerve integrity monitor; an electrode hub connected to the one or more cables; and a needle electrode connected to the electrode hub. The needle electrode extends perpendicularly from an undersurface of the hub, and along a line of insertion into a patient. The needle electrode extends from the electrode hub to a first bend in a first direction, and extends from the first bend in a second direction to an end of the electrode, defining a proximal needle segment from the hub to the first bend, and a terminal needle segment from the first bend to the end of the electrode. The terminal needle segment and at least a portion of the proximal needle segment are insertable into a patient along the line of insertion.

Abstract: A shielded component or network for an active medical device (AMD) implantable lead includes (1) an implantable lead having a length extending from a proximal end to a distal end, all external of an AMD housing, (2) a passive component or network disposed somewhere along the length of the implantable lead, the passive component or network including at least one inductive component having a first inductive value, and (3) an electromagnetic shield substantially surrounding the inductive component or the passive network. The first inductive value of the inductive component is adjusted to a account for a shift in its inductance to a second inductive value when shielded.

Abstract: The present invention is a method and apparatus, in several embodiments, for providing protection in workplaces in which workers can be exposed to diseases and other contaminations from skin abrasions or punctures by contaminated objects. In its primary application it provides such protection at skin surfaces of healthcare patients into which needle electrodes have been inserted and, under certain conditions, can emerge. This bio-hazard occurs most often during patient-positioning when patients are unconscious due to anesthesia or other reasons. Protection is supplied in the first embodiment by a puncture-resistant head-covering; in the second by a pad that covers and secures needle electrodes, and; in a third as a tissue-penetrating, less hazardous stick-on electrode. The latter two embodiments have pressure-sensitive-adhesive coatings for adhesion to a patient's skin.

Abstract: An apparatus for mapping and/or ablating tissue includes a braided conductive member that that may be inverted to provide a ring-shaped surface. When a distal tip of the braided conductive member is retracted within the braided conductive member, the lack of a protrusion allows the ring-shaped surface to contact a tissue wall such as a cardiac wall. In an undeployed configuration, the braided conductive member is longitudinally extended, and in a deployed configuration, the distal end of the braided conductive member is retracted to invert the braided conductive member.

Abstract: In an automated methodology for carrying out in vivo cell patch clamping, a cell patch clamping device is automatically moved into position and targeted to a neuron. Neuron contact is determined by analyzing the temporal series of measured resistance levels at the cell patch clamping device as it is moved. The difference between successive resistance levels is computed and compared to a threshold, which must be exceeded for a minimum number of computations before neuron contact is assumed. Pneumatic control methods are used to achieve gigaseal formation and cell break-in, leading to whole-cell patch clamp formation. An automated robotic system capable of performing this methodology automatically performs patch clamping in vivo, automatically detecting cells by analyzing the temporal sequence of electrode impedance changes.

Abstract: An engagement system for a surgical sensor assembly, formed of a sensing component in a fixed position and a lead wire in an electrical communication therewith. The engagement system employs a jacket of heat shrink polymeric material to hold the sensing component to the lead wire and eliminates the employment of soldering and welding and crimping which can damage such sensing components. The system is employed in combination with catheters having a lumen for control wires for surgical instruments.

Abstract: An electrode arrangement is described for sensing electrical activity in target tissue. An inner electrode has an elongate electrode body formed as a cylindrical section with an inner penetrating end for insertion into the stapedius muscle target tissue. An outer electrode fits over the inner electrode and an outer penetrating end for insertion into the target tissue. The two electrodes are joined together with their electrode bodies in parallel so that the penetrating ends of the electrodes penetrate in the same direction into the target tissue to sense electrical activity in the target tissue.

Abstract: A method and apparatus for determining the volume of a pouch formed in a stomach during bariatric surgery comprises a balloon catheter having an inflatable balloon located at a distal end of a catheter for locating in the stomach. A pair of spaced apart stimulating electrodes are located on the catheter within the balloon and a plurality of spaced apart sensing electrodes are located on the catheter between the stimulating electrodes. The balloon in the stomach is inflated by a saline solution to define the interior of the pouch. By applying a constant current signal to the stimulating electrodes, the volume of the pouch is determined from signals read from the sensing electrodes.

Abstract: A pacing lead for a left cavity of the heart, implanted in the coronary system. One lead includes a telescopic microcable including multiple distinct bare areas that form a network of stimulation electrodes. The microcable includes a diameter providing for insertion of the microcable within smaller portions of the coronary vein system. The diameter may be selected from between 0.5 and 2 French. The microcable includes multiple strands twisted together. At least some strands incorporate either a core of radiopaque material wrapped by a sheath of mechanically durable material, or vice-versa. The bare areas that form the network of stimulation electrodes are provided on outward-facing portions of at least some of the strands.

Abstract: Coupler assemblies and methods are disclosed as the coupler assemblies may be used with a catheter. An exemplary coupler assembly includes a spherical linkage coupler for a catheter. The coupler comprises a first cylinder portion for connecting to a structure, and a second cylinder portion for connecting to a distal end of a body of the catheter. The coupler also comprises a spherical linkage including at least two link arms. Each of the two link arms are connected on one end to the first cylinder portion and on the other end to the second cylinder portion. The two link arms connect a portion of the structure to the distal end of the catheter and enable the structure to move relative to the distal end of the catheter in response to an external force exerted on the structure.

Abstract: A nerve monitoring system facilitates monitoring an integrity of a nerve.

Abstract: Method and apparatus for inserting at least a portion of a sensor into a patient is provided.

Abstract: A system and method of identifying and communicating with an interventional medical device is provided. The system includes a novel catheter handle operably coupled to the shaft of a catheter at the distal end and an electrophysiology recording system at the proximal end. The catheter handle includes a visual identification system visible through a lens on the catheter handles and a microcontroller with a memory structure, the memory structure including catheter identification information. The visual identification system includes a light emitting diode, which is visible from the outside of the catheter handle through the lens. When a user of the EP recording system selects a desired color for the coupled catheter, the desired color is communicated to the microcontroller in the catheter handle and the microcontroller causes the visual identification to display the requested color so that the desired color is visible by the user.

Abstract: A catheter comprises an elongated shaft having a proximal shaft section and a shapeable shaft section distal to the proximal section, an inner lumen extending within the proximal and shapeable shaft sections; a shaping member slidably disposed within the inner lumen and extends into the shapeable shaft section; a shape memory member adjacent to the shaping member in the inner lumen of the shapeable shaft section, wherein the shaping member and the shape memory member are coupled by a coupling coil; and a handle having an operating lever, wherein the handle receives the proximal shaft section and the shaping member for operating the shapeable shaft section.

Abstract: An operating room connector is used in conjunction with a multiple electrode SCS system which can easily detach and connect to an external trial stimulator (ETS). By connecting the electrode SCS system to a stylet handle, and then locking the stylet handle within a slot of the connector platform, a user is able to minimize the required steps in connecting the ETS to the implanted SCS lead system. The ETS can then be used to readjust the position of the electrode array(s) previously implanted to deliver an optimal stimulation therapy.

Abstract: An implantable sensor module and medical device includes a housing having an inner shell having a thickness extending between an inner wall and an outer wall and an outer layer, wherein the inner shell and the outer layer form a substantially flat portion. A shoulder extends adjacent to a diaphragm to extend the outer layer laterally away from a central medial line extending between edges of the diaphragm. A recess portion is formed between the diaphragm and an inner side of the outer layer, and an over-fill channel is formed by the outer layer extending through the outer layer from an opening formed at the outer wall to an opening formed along the inner side of the outer layer extending along the substantially flat portion.

Abstract: Single injection methods for obtaining conductance measurements within luminal organs using impedance devices. In at least one method embodiment, the method is performed by introducing at least part of an impedance device into a mammalian luminal organ, the impedance device comprising an elongated body and a detector positioned along the elongated body, obtaining conductance measurements indicative of a fluid native to the mammalian luminal organ and indicative of a fluid injection while the detector is present within and outside of the lumen of the outer sheath, and calculating a size parameter of the mammalian luminal organ based in part upon some of the obtained conductance measurements.

Abstract: Catheters and methods are provided for performing medical procedures, such as tissue ablation, adjacent the ostia of anatomical vessels, such as pulmonary veins. The catheter comprises an elongated flexible integrated catheter body having proximal and distal shaft portions and at least one operative element carried by the distal shaft portion. The distal shaft portion has a proximal section configured to be internally actuated (e.g., using a steering mechanism or pre-shaping the proximal section) to form a simple curve with an apex that can be inserted into the vessel ostium, an intermediate section pre-shaped to form a curve that bends opposite the simple curve, and a distal section configured to be placed into a non-radial relationship (tangential or oblique) with the vessel ostium when the apex of the simple curve is inserted into the vessel ostium.

Abstract: An expandable tip cannula system, comprising: a hollow cannula shaft having a proximal end and a distal end; and an expandable tip mounted at the distal end of the hollow cannula shaft, the expandable tip comprising a plurality of generally-triangular shaped petals held together in a radially-inwardly tapered arrangement between adjacent petals, each petal comprising a nerve sensing electrode disposed therein.

Abstract: A method for making a medical electrical lead electrode assembly includes the steps of: forming an insulative carrier from an insulative material; coupling at least one conductive component to the carrier by inserting a pre-formed tab of the conductive component through the carrier, from a first side thereof to a second side thereof, so that the conductive component is secured to the carrier with the tab extending along a surface of the second side of the carrier and an inward facing surface of an electrode portion of the conductive component being disposed against a surface of the first side of the carrier; coupling an elongate flexible conductor to the tab of the component; and forming an insulative layer over the second side of the carrier, the tab and the conductor electrically coupled to the tab.

Abstract: A clamp for securing a terminal end of a wire to a surface electrode formed on a cylindrical tube includes a first semicylindrical element. A second semicylindrical element is configured to be attached to the first semicylindrical element to form a tubular clamp structure that is adapted to be clamped around the cylindrical tube. The tubular clamp structure includes an interior surface configured to securely hold a terminal end of a wire against a surface electrode formed on the cylindrical tube.

Abstract: An introducer sheath for a medical device is provided. The sheath includes a deformable, elongate body disposed about a longitudinal axis. The body has proximal and distal ends and defines a lumen extending between the proximal and distal ends and configured to allow passage of the medical device therethrough. The body is configured to allow an electric current to pass radially between a space outside of the body and the lumen such that the position of the medical device within a patient can be monitored and electrogram readings from body tissues can be measured while the device is in the sheath. In some embodiments of the invention, the body may include a one or more apertures extending from the radially outer surface of the body to the lumen or a portion of the body may be made from a conductive and/or fluid permeable material.

Abstract: A drive assembly for use in a robotic control and guidance system comprises a cartridge having an outer housing and a rotatable medical device assembly disposed therein. The rotatable assembly includes a medical device having proximal and distal ends, and a housing having first and second ends, and a longitudinal axis extending therethrough. The proximal end of the medical device is disposed within the housing, and the housing further comprises an opening through which the medical device extends outwardly from said housing. The rotatable assembly further comprises a drive interface coupled with the housing. The drive assembly further comprises a manipulation base comprising a mounting plate onto which the cartridge is removably attached, and a drive system mounted to the mounting plate. The drive system is configured to operatively engage the cartridge drive interface and to impart rotational movement onto the rotatable assembly through the drive interface.

Abstract: The present disclosure provides a method for improving imaging resolution of electrical impedance tomography (EIT). More specifically, the present disclosure forms virtual electrode(s) using an electric current steering technique, which is used to improve imaging resolution of an EIT system without physically increasing a number of conducting electrodes. The EIT system of the present disclosure may includes a plurality of conducting electrodes, at least one signal generator, at least one signal receiver and at least one electric current steering device. In other words, the present disclosure applies both the electric current steering technique and the virtual electrode technique to EIT. Consequently, imaging resolution of EIT can be improved without physically increasing the number of conducting electrodes.

Abstract: An implantable lead includes a plurality of conductors disposed in an elongated member. At least one of the conductors includes at least one unit that includes a first conductor segment extending along the elongated member from a beginning point to a first position, a second conductor segment extending along the elongated member from the first position to a second position, and a third conductor segment extending from the second position to an endpoint. An inner insulator layer is disposed along at least a portion of the elongated member and is formed of a material that is flowable to fill in at least some open spaces between portions of at least one of the units. An outer insulator layer is disposed over at least a portion of the inner insulator layer. The outer insulator layer has at least one physical characteristic different from the inner insulator layer.

Abstract: A medical device control handle has a first actuation assembly and a second actuation assembly, wherein each assembly has a shaft that is axially aligned but not rotationally coupled with the other shaft. The first actuation assembly includes a first actuation member and a clutch mechanism having a friction disk for generating frictional torque in rendering the first actuation member self-holding. The first actuation member has a cam portion adapted to impart translational motion and rotational motion for disengaging the clutch mechanism upon pivotation of the first actuation member, thus allowing rotation of the first shaft to manipulate a feature of the medical device, for example, deflection. The second actuation assembly includes a second actuation member and a translating member that is responsive to rotation of the second shaft so as to manipulate another feature of the medical device. The second actuation member is also self holding.