Abstract: Provided herein are bone grafts and methods of making and using the same, as well as products and kits that include such bone grafts. In particular, bone grafts are provided that include collagen Type I and one or more different types of mineral compositions having different dissolution properties and/or sizes, to enhance bone regeneration throughout the bone healing phase.

Abstract: An apparatus for use in a multi-orientation liquid collection canister to collect liquid from a tissue site is provided. The apparatus includes a substantially planar, liquid-air separator disposed on at least one wall of the multi-orientation liquid collection canister to prevent the liquid from exiting the multi-orientation liquid collection canister. The apparatus further includes an elongated member connected to the liquid-air separator and extending away from the liquid-air separator into a first space of the multi-orientation liquid collection canister. The elongated member has a membrane defining a second space along at least a portion of a length of the elongated member. At least a portion of the membrane allows gaseous communication between the first space and the second space.

Abstract: Technology for preparing a dialysis fluid capable of flexibly changing bicarbonate ion concentration and maintaining concentrations of electrolytes such as potassium, calcium, and magnesium at constant levels during dialysis according to the disease state of a patient. A three-component dialysate containing an agent S containing sodium chloride, an agent B containing sodium bicarbonate, and an agent A containing electrolyte components other than sodium chloride and sodium bicarbonate, with suitable adjustment of the amount of the agent B during dialysis fluid preparation maintains concentrations of trace metal ions such as potassium ions, calcium ions, and magnesium ions in a dialysis fluid at constant levels and flexibly changes the bicarbonate ion concentration therein. Adjusting the ratio between the amount of the agent S and agent B when the dialysate is used also makes it possible to maintain the sodium ion concentration at a constant level or flexibly change the sodium ion concentration.

Abstract: A human-computer interface device comprising an array of elements wherein each element is pivotally coupled to an adjacent first element by a first pivotal coupling and to an adjacent second element by a second pivotal coupling, the first pivotal coupling being operable to pivot about an axis which is substantially orthogonal to an axis about which the second pivotal coupling is operable to pivot.

Abstract: Disclosed herein is a cannula assembly for directing the flow of material from an organ chamber, e.g., blood from the left chamber of the heart, and methods of placing the cannula assembly in fluidic communication with the chamber. The cannula assembly includes an elongate tubular member and a coupling assembly disposed at the distal end of elongate tubular member. The elongate tubular member includes a lumen extending from a distal opening at the distal end to a proximal opening at the proximal end. The coupling assembly includes a retaining element and a retention member configured to cooperate with each other and with the portion of the organ wall surrounding the opening in the wall to couple or anchor cannula system to the wall and to provide fluidic communication between the distal opening of the elongate tubular member and the organ chamber.

Abstract: Exemplary embodiments comprise AV fistulas and other anastomotic devices for creating new or reinforcing existing side-branch vessels, and/or bridging neighboring vessels together. An exemplary embodiment may comprise a sidewall port, such as a flanged sidewall port, and/or flow frame design, such as a partially bare, flexible stent or a whisk, for purposes of creating a transmural flow. Another exemplary embodiment may comprise a compliant vessel support to aid in the transition from device to vessel and/or vessel to device, and to promote vessel dilation.

Abstract: Disclosed is a blood ingredient separator capable of assuring purity of such as separated blood components or stem cells as well as preventing contamination by ambient air during the process of separating components, while simplifying the processes compared to the related art. The ingredient separator includes: a hollow body which includes a flow tube formed at one end portion thereof for communicating body fluids, and a stopper disposed at the other end portion thereof; and a plunger which is movably installed back and forth in the body to vary a space between the flow tube and a top of the plunger thereof; wherein the plunger has a collection portion formed on the top thereof, and a backward movement of the plunger is limited by the stopper.

Abstract: A portable pump for infusing liquid substances into a body is provided. The pump has a casing and electromechanical members for converting rotary motion of a motor shaft into linear sliding motion of a pusher for causing movement of a plunger slideable within an interchangeable reservoir in which the substance to be infused is contained in a housing. The housing communicates through an opening formed in a casing wall through which the reservoir can be inserted into and removed from the housing and from which an appendix of the reservoir protrudes for the exit of the substance. The housing has a distal portion with mechanical means for reversible engagement of the reservoir end opposite to the appendix and a proximal portion provided with an annular sealing gasket which surrounds the reservoir and forms a seal between the reservoir and casing wall.

Abstract: An infusion pump unit includes a housing sized to allow the pump unit to be carried as a portable unit. The housing contains a controllable pumping system for pumping fluid. The pump actuator is lighter, smaller, quieter and less power consuming.

Abstract: A drug delivery device which includes a fluid drug reservoir, a catheter, a controllable fluid transfer device, e.g., a pump mechanism or valve, and a drug delivery control means: The drug delivery control means comprises a controller, e.g., a microprocessor or microcontroller which is operable to automatically reduce the rate of drug delivery over a certain reduction interval (e.g., multiple days) from an initial dosage value to a final dosage value.

Abstract: A pump drive and a method thereof to dispense a liquid drug from a container having a plunger piston are disclosed. The pump drive provides a unidirectional clutch provided about a rotational axis which supports centrally a wheel. The clutch has an inner race operably connected to the plunger piston, wherein the clutch is configured to rotate both the inner race about the axis in unison with rotation of the wheel in only a first direction to advance the plunger piston, and to let the wheel rotate relative to the inner race about the axis in a second direction opposite to the first direction without advancing the piston plunger. The drive in one embodiment includes at least one shape memory alloy wire which when excited rotates the wheel in the first rotational direction to advance the piston plunger and dispense the liquid drug from the container.

Abstract: An infusion pump has a primary finger with an inclined surface, which is obliquely inclined to an advancing and retracting direction, and a secondary finger with an inclined surface, which is slidable relative to the inclined surface of the primary finger. When the primary finger is advanced, the secondary finger is retracted in proportion to the variation (increasing) in an entire width of an infusion tube, and when the primary finger is retracted, the secondary finger is advanced in proportion the variation (decreasing) in the entire width of the infusion tube. This configuration can suppress the occurrence of any gap between a tip surface of the secondary finger and an outer peripheral surface of the infusion tube in the advancing and retracting process of the primary finger. Consequently, this prevents the infusion tube from meandering, and suppresses the reduction in the accuracy of the rate of infusion.

Abstract: A computational catheter device including at least one lumen, pressure sensor(s), external sensor(s), a signal modeler, and a signal analyzer is provided. The pressure sensor generates a pressure signal for a dynamic body system, whereas the external sensor determines the fundamental frequency caused by cardiovascular pulsation or external oscillator. The signal modeler uses catheter location and the fundamental frequency to generate a predicted signal. This predicted signal may be compared to the actual pressure signal by the signal analyzer to generate a calibration. This calibration may include any of a measure of perivascular state, a waveform output which causes standing waves within the dynamic body system, a boundary condition for safe operations, and an indication of abnormal physiology for assistance in catheter navigation. The catheter device may also include an actuator which uses the calibration to achieve homeostasis by fluxing fluids and/or guiding catheter movements.

Abstract: Systems and methods for integrating a continuous glucose sensor 12, including a receiver 14, a medicament delivery device 16, a controller module, and optionally a single point glucose monitor 18 are provided. Integration may be manual, semi-automated and/or fully automated.

Abstract: A resettable drive mechanism for a drug delivery device (1) comprises a piston rod assembly (32) and an interaction member (23). The piston rod assembly (32) comprises a guide track (18) running along the piston rod assembly (32), the guide track (18) comprising at least one delivery section (18A) and at least one reset section (18B). The reset section (18B) is arranged to continue the delivery section (18A). The delivery section (18A) comprises at least one blocking means (19). The interaction member (23) is configured to cooperate with the guide track (18). For delivering a dose of a drug (24), the piston rod assembly (32) is axially displaceable in a dose delivery direction away from an axial starting position, the interaction member (23) cooperating with the delivery section (18A) and the blocking means (19) passing the interaction member (23) when the piston rod assembly (32) is displaced in the dose delivery direction.

Abstract: The present invention relates to a medical device for administering a medicinal product to a patient comprising at least one component (2, 8, 10, 12, 14, 15, 16, 17, 18, 20, 22, 24, 26, 28) comprising a material having an additive embedded therein, wherein the additive is adapted to provide a visually perceptible signal when exposed to electromagnetic radiation. The invention is particularly intended for drug delivery devices, such as e.g. of pen-type injectors. With the visually perceptible signal embedded in the at least one component, visually controlled assembly of such devices can be improved. Additionally the invention provides an effective means antagonize counterfeiting of drugs and of medical devices.

Abstract: A method and apparatus are disclosed for delivery of a drug to a recipient. In some embodiments, the delivery apparatus may unseal a drug containing reservoir. In some embodiments, the delivery rate may be controlled and/or adjustable. Optionally the apparatus may be disposable. Optionally, the apparatus may have a low profile and/or be wearable and/or attachable to the recipient. Optionally, discharge of the drug and/or unsealing of the reservoir may be driven by a plunger moving parallel to the base of the apparatus. Optionally, the apparatus may release a hypodermic needle into the recipient. Optionally, release of the hypodermic needle may be in a direction non-parallel and/or orthogonal to the direction of movement of the plunger. Optionally, prior to release, the hypodermic needle may be preserved in an aseptic state by a needle opening septum sealing a needle opening. Optionally, upon release, the hypodermic needle may pierce the needle opening septum.

Abstract: A medicament container for a liquid medicament is disclosed, the medicament container includes a flexible bag with an outlet, the bag surrounded by a braid, arranged for lengthening and narrowing when being pulled in longitudinal direction (L).

Abstract: An arrangement for coupling a plunger to either a syringe or a stopper arranged in the syringe. The arrangement includes a syringe holder which is slidably arranged in a housing. The syringe holder is provided with at least one resilient syringe holder arm arranged distally, the syringe holder arm having an inclined surface for bearing against a shoulder, which is arranged at the plunger. The syringe holder arm is supportable by an inner surface of the housing in order to prevent it from being flexed outward in a first position. A widened portion is provided in the housing for allowing the syringe holder arm to flex outwards and disconnect from the plunger when in a more proximal position so as to switch load of the plunger from the syringe to the stopper.

Abstract: A maximum settable dose feature is disclosed that is set by a user or health care professional one time that prevents future injections from exceeding the desired maximum dose. The feature includes a locking band initially in an unlocked configuration, which transforms to a locked configuration when activated after setting a desired maximum dose. The feature can include a trigger mechanism to transform the locking band to the locked configuration.

Abstract: The present invention relates to a drug delivery device, in particular to the dose display mechanism of a drug delivery device comprising: a housing of substantially tubular shape and having at least a first dose displaying window, a dose setting dial rotatably arranged in the housing) and comprising a first and a second helical dose indicating scale on its peripheral surface, wherein the information contents of the first dose indicating scale and the second dose indicating scale are arranged in different orientations.

Abstract: A medicated module for an injection system to co-deliver at least two medicaments is disclosed where a primary delivery device containing a primary medicament accepts a medicated module containing a single dose of a secondary medicament and where both medicaments are delivered through a hollow needle. The medicated module is initially in a locked state until attached to a drug delivery where interaction of the cartridge holder with the module bypass housing changes the module to a triggerable state. The medicated module does not require the user to manually engage a reservoir containing the secondary medicament. Instead, a biasing member automatically activates the reservoir when the needle guard is retracted when the module is in the triggerable state. The needle guard prevents accidental needle sticks before and after an injection, and locks after removal from the injection site.

Abstract: A reservoir assembly for a medicated module includes a primary cavity for holding a medicament, a sump region, and a flexible element. The flexible element is configured to allow for fluid communication between the primary cavity and the sump region during a filling process for the reservoir. Further, the flexible element is configured to prevent fluid communication between the primary cavity and the sump region after the filling process.

Abstract: A device vibrates body tissue to reduce pain experience by the body tissue in a therapeutic procedure. The device includes a frame and a tip connectable to the frame which can be activated to produce vibration. An electromagnetic reader is connected to the frame and includes an antenna for sending and receiving electromagnetic radiation. An electromagnetic tag is connected to the removable tip, and also has an antenna for sending and receiving electromagnetic radiation in communication with the electromagnetic reader antenna. The antennas are disposed proximate to each other when the removable tip is connected to the frame, whereby the electromagnetic tag can transmit information to the electromagnetic reader.

Abstract: A dry powder inhalation apparatus operable by breath of a user which provides for controlled and smooth transfer of medicament during multiple actuations by a user. A mechanism of the apparatus for achieving this controlled and smooth transfer includes a device normally held adjacent a reservoir for receiving medicament in a cup or receptacle and which is generally movable transversely of a longitudinal axis of the apparatus to delivery channels of the apparatus. This bodily shifting of the device is achieved by a yoke acting on an abutment thereof. Spillage of medicament in the apparatus is avoided.

Abstract: A manually operated metered dose inhaler includes a dose counter chamber including a dose display tape driven by a ratchet wheel which is driven in turn by an actuator pawl actuated by movement of a canister, the tape unwinding from a stock bobbin during use of the inhaler, a rotation regulator being provided for the stock bobbin and including a wavelike engagement surface with concavities which engage against control elements in the form of protrusions on resilient forks of a split pin thereby permitting incremental unwinding of the stock bobbin yet resisting excessive rotation if the inhaler is dropped onto a hard surface.

Abstract: An atomizer for the delivery, and in particular, for the atomization of a formulation, particularly, a powder has a simple construction that makes a simple intuitive operation possible. In particular, such is achieved by the fact that the atomizer has a mouthpiece with an associated cover, so that opening and/or closing of the cover causes a delivery medium, in particular air, to be taken in and/or put under pressure by a delivery device, a spring store is put under tension and/or a preferably annular reservoir containing a plurality of doses of the formulation is further rotated.

Abstract: An inhaler is provided that includes a controller, a driver, an atomizer and one or more sensors for detecting information about a velocity of inhalation of a user of the inhaler. The controller is configured to dispense an inhalant from the inhaler during an inhalation of the user based on information about the velocity of inhalation of the user. Such information can include a duration of maximum inhalation velocity or an increase or maximum in the acceleration in inhalation velocity. Embodiments of the inhaler can be used to enhance the delivery of drugs and therapeutic agents for those patients having a weakened respiratory system who are unable to take a deep or full breadth, e.g., patients having asthma or COPD. Embodiments of the inhaler can be used to deliver a variety of drugs and therapeutic agents including agents for the treatment of asthma, diabetes, epilepsy and heart disease.

Abstract: A respiratory metabolic simulator includes a cell that produces CO2 and depletes O2, e.g., a direct methanol fuel cell having an external electrical circuit. An electric load is applied to the external electrical circuit of the direct methanol fuel cell to vary the electrical load applied to the external electrical circuit of the direct methanol fuel cell to produce carbon dioxide. The carbon dioxide generated by the direct methanol fuel cell is supplied to respiration gases produced by the respiratory metabolic simulator. The direct methanol fuel cell is also used to remove oxygen from the respiration gases prior to mixing the respiration gases and the carbon dioxide.

Abstract: A system for delivering a flow of breathing gas to a patient's airway that includes a gas flow generator and a patient circuit for communicating the flow of gas to the patient's airway. A sensor measures a characteristic associated with the flow of gas, such as flow rate, maximum average inspiratory flow, tidal volume or minute ventilation. A controller determines a first characteristic based on the measured characteristic and provides positive pressure support to the patient if the first characteristic is below a first target and provides a negative support if the first characteristic is above a second target. When the positive pressure support is provided, the pressure provided during inspiration is higher than the pressure provided during expiration. When the negative pressure support is provided, the pressure provided during inspiration is lower than the pressure provided during expiration.

Abstract: Feedback information is provided to a subject regarding reception of pressure support therapy, and/or other respiratory support therapy. The feedback information may indicate compliance to a respiratory therapy regimen. The feedback information is provided to the subject by transmitting the feedback information through a communication network to a client device associated with the subject. The feedback information may include a characterization of the therapy received by the subject with respect to a usage goal.

Abstract: A cushion comprises a substantially triangularly shaped frame from which extends a membrane. The membrane is spaced away from the rim of the frame, and its outer surface is of substantially the same shape as the rim. The seal forming portion thus contacts both the surface of the wearer's nose and a portion of the wearer's face. The shape of the seal forming portion is particularly suited to effectively seal the difficult region of the facial contour that is the crease between the sides of the nose and the face.

Abstract: A laryngeal mask airway device inserted in the pharynx of an unconscious patient to ventilate the lungs includes an airway tube and mask portion with cuff formation shaped to fit the actual and potential space surrounding the circumference of the inlet to the larynx. A piriform-fossa conduit is included in a cuff formation of such mask to facilitate insertion of orogastric tubes. Anatomically the piriform-fossa conduit travels around the laryngeal inlet through the piriform fossa to reach the upper esophagus. Structurally the piriform-fossa conduit travels through the lateral cuff formation with the inflatable cuff element. The distal orifice of the piriform-fossa conduit is on the outer perimeter of the cuff formation near the tip of the mask, does not intersect the medial line at the tip, and does not increase bulk in the distal cuff formation along the medial line.

Abstract: In order to make automatic suctioning of sputum in tracheotomy patients possible, the suctioning device includes a tracheal cannula having an external cannula and an internal cannula guided therein. The internal cannula is formed with suction openings for internal suctioning and is spaced apart from the external cannula to form a suction chamber. The suction chamber is connected to a suction connection, by way of which a suction apparatus can be connected. As an alternative, or in addition, the external cannula has additional suction openings for external suction in the region of a cuff. In this way, automated suctioning of sputum in patients, in particular in a gentle manner, is made possible.

Abstract: The present invention concerns a plaster for attaching a trachestoma valve or the like in connection with a tracheostoma on a person's neck. The plaster comprises a socket and an annular flange, communicating with a central opening of the flange which is connected with a single-coated adhesive tape which extends radially beyond the edge of the flange. The connection includes a first annular joint at or inwardly of the outer periphery of the flange, and a second annular joint located between the outer periphery of the flange and the inner periphery of the flange spaced radially from the first annular joint. A protecting liner covers the adhesive on the tape.

Abstract: A patient interface that is comfortable for a user to wear is disclosed. The patient interface includes a forehead rest and cushion. In particular the cushion includes a deformable resilient member that when compressed creates a uniformly and gradually increasing force while evenly distributing the pressure on the forehead of the patient.

Abstract: A catheter assembly includes an elongate member and a balloon. The elongate member defines at least one lumen and an outer surface. The outer surface defines at least one opening in fluid communication with the at least one lumen. The balloon is disposed within the at least one lumen. The balloon is inflatable such that a portion of the balloon expands from the at least lumen through the at least one opening. The expansion of the balloon increases the flow restriction through the at least one opening compared to the flow restriction through the at least one opening when the balloon is in a deflated condition. Methods for using a catheter assembly to remove occlusive material from a catheter are also described.

Abstract: Disclosed herein are a method and a medical system for utilizing of a intravascular ECG signal for central venous catheter placement. The medical system is capable of detecting the position of a catheter tip and assessing its location relative to the cavoatrial junction. The detection and assessment are performed by a multiscale analysis of the complexity of the intravascular signal data points.

Abstract: A catheter is disclosed having a flexible tubing with a proximal end and a distal end. The catheter comprising at least one movable magnet provided within the distal end of the flexible tubing. A control mechanism is operable to selectively activate the at least one movable magnet from the proximal end of the flexible tubing. The at least one movable magnet is responsive to an external magnetic field to position and guide the distal end of the flexible tubing within a body of a patient.

Abstract: A securement device for retaining medical tubing, catheters, and other medical fixtures proximal a patient's skin. The device has a base, at least one channel formed in the base, a flexible strap for overlying the base, and a coupling assembly for coupling the strap to the base. Embodiments for use with Foley catheters include a plurality of channels of differing diameters. Embodiments for use with a peripheral catheter include a single channel for retaining a spin nut. The coupling assembly includes left and right tracks in left and right sides of the base, and left and right rails on an underside of the flexible strap at left and right ends of a body of the strap. The left rail is removably coupled and held within the left track on the base, and the right rail is removably coupled and held within the right track on the base.

Abstract: An apparatus includes an inner catheter that is coupled to a handle and defines a lumen configured to receive a guidewire. An outer catheter is movably coupled to the handle and defines a first lumen in fluid communication with a distal opening and that is configured to introduce a therapeutic agent through the distal opening and into a target pancreatic artery(ies). The outer catheter defines a second lumen configured to receive at least a portion of the inner catheter. An actuator is coupled to the handle and configured to move the outer catheter relative to the handle. A first occlusion element is coupled to the inner catheter and a second occlusion element is coupled to the outer catheter and disposed proximal to the first occlusion element. A distance between the first occlusion element and the second occlusion element is adjustable when the outer catheter is moved relative to the handle.

Abstract: A metal balloon catheter having a main tubular body, a metal balloon proximate a distal end of the main tubular body, a central annulus extending along an entire longitudinal aspect of the catheter for accommodating a guidewire therethrough and an inflation annulus adjacent the central annulus which extends along the longitudinal axis of the main tubular body and terminates in fluid flow communication with an inflation chamber of the metal balloon. The metal balloon catheter may be either unitary integral metal catheter in which the main tubular body and the balloon are fabricated of metal, or it may consist of a polymeric main tubular body and a metal balloon.

Abstract: An implantable device for the treatment of hydrocephalus syndrome, characterized by a mechanical passive valve device designed to move the cerebrospinal fluid in the cranial site of the patient, comprising a cylindrical body, a piston, and a special spring exhibiting a non-linear characteristic and suitable for applying a force on the piston such that, when the pressure of the cerebrospinal fluid acting on the two opposite faces of the piston exceeds a certain value, a rapid displacement of the piston in the cylindrical body takes place due to the non-linear characteristic of the spring, with consequent aspiration, by the same piston, of a greater quantity of cerebrospinal fluid contained in the ventricle and, when the pressure of the cerebrospinal fluid falls below a certain value, the piston reacts and moves rapidly in a direction opposite to the first, so as to feed into the ventricle the cerebrospinal liquid previously aspirated.

Abstract: A sinus dilation instrument useful with a navigation system and including a handle, a rigid probe, a balloon, and an identifier device. The probe extends from the handle, forms a curved segment, and carries the balloon. The identifier device is programmed to generate a signal indicative of an instrument identification assigned to the instrument, and is a frontal, maxillary or sphenoid sinus instrument. The signal is formatted to be recognized by an IGS. Once connected, the IGS recognizes the instrument and can retrieve information indicative of a spatial location of the balloon, for example via an instrument tracking device. A surgeon can “plug and play” the sinus dilation instrument with the IGS to perform a procedure.

Abstract: Disclosed herein is a method of fractional treatment of tissue, the method comprising: creating at least one micro hole in a target tissue; and either a) applying pressure on said target tissue to decrease the patency of said at least one micro hole; administering material and/or fluid and/or drug onto said target tissue; releasing said applied pressure on said target tissue to increase the patency of said at least one micro hole; and propelling said material and/or fluid and/or drug into said at least one micro hole; or b) administering material and/or fluid and/or drug onto said target tissue under sub-atmospheric pressure conditions, the patency of said at least one micro hole being decreased; increasing the atmospheric pressure to atmospheric or above atmospheric conditions to thereby increase the patency of said at least one micro hole; and propelling said material and/or fluid/and/or drug into said at least one micro hole.

Abstract: A sealing assembly is utilized for a fluid infusion device that cooperates with a fluid reservoir having a reservoir port and a hollow fluid reservoir needle at least partially located within the reservoir port. The sealing assembly has a reservoir port receptacle with a proximal end, a distal end extending from the proximal end, and a needle opening formed in the distal end to receive the hollow fluid reservoir needle. The sealing assembly also has a fluid chamber located at least partially in the reservoir port receptacle, and a needle sealing element having a self-sealing needle opening formed therein. The needle sealing element is located within the reservoir port receptacle between the distal end and the fluid chamber. The self-sealing needle opening accommodates the hollow fluid reservoir needle when the reservoir port engages the reservoir port receptacle.

Abstract: A closure assembly structured for use with a female luer connector and operative to indicate an accomplished or attempted tampering thereof. A connector cover is movably and removably disposed within a housing and includes an interior chamber disposed and structured to receive an access port of the female connector. An indicator member is removably connected to an interior of the housing in surrounding relation to the connector cover and a drive assembly associated with both the connector cover and the housing is operable to concurrently rotate and axially advance the interior chamber into enclosing relation to the access port. Attempted removal of the housing from the female connector, such as by an applied axial force to the housing, will detach the indicated member from the housing and dispose it in a visually observable position surrounding the connector cover, thereby indicating attempted access.

Abstract: Valves, valved fluid transfer devices and ambulatory infusion devices including the same.

Abstract: An electrode array and a delivery assembly. The array is wrapped around a flexible core part of the delivery assembly. A sheath, also part of the delivery assembly, is disposed over the array and core. Steering cables extend through the core or sheath. Once the delivery assembly-encased array is inserted in the body, the combination is advanced to the tissue over which the array is to be deployed. By pulling on the steering cables the array and assembly are steered into position. Once the array is in position, the sheath is retracted, the array deploys over the target tissue.

Abstract: Methods, systems and devices for effectively and safely accessing and verifying a target site within a vessel or body cavity undergoing a catheter-based procedure or treatment. The present invention further includes the accurate delivery an instrument, an implantable device and/or materials to the target site. The present invention is particularly useful for transvenously assessing the suitability of a target site within the coronary vasculature for placement of a pacing electrode and transvenously placing the pacing electrode at the target site.