Abstract: Deflectable catheters, hemostasis valves, and materials for the same are disclosed. The deflectable catheters and hemostasis valves can be made at least partially, if not entirely, from a fluoroelastomer and ePTFE combination. A deflectable region of the catheters can be articulated to form simple and/or complex curves.

Abstract: A steerable endoscope system includes a continuum manipulator, a plurality of syringes, and a steerable tip. The continuum manipulator includes a plurality of spaced discs and a plurality of backbones each extending through all discs. A bending movement of the continuum manipulator changes a varying linear displacement of each backbone. Each backbone is further coupled to a different one of the syringes such that the linear displacement of each backbone pushes or pulls a piston of the corresponding syringe by a varying amount. The steerable tip includes a plurality of bellows each pneumatically coupled to a different syringe such that movement of the piston of a syringe causes the corresponding bellow to inflate or deflate. Because the distal end of each bellow is fixedly coupled to the same end effector, variations in the amount of inflation or deflation on each bellow causes a bending of the steerable tip.

Abstract: An intravascular blood pump may have a catheter (10) and a pumping device (1) attached to the catheter (10). The catheter (10) extends along a longitudinal axis and has a distal end (11) and a proximal end (12) opposite the distal end (11). The catheter (10) may have a tubular stiffening structure (15) extending longitudinally between the proximal end (12) and the distal end (11) of the catheter (10). The tubular stiffening structure (15) has a lumen (21) and a proximal end (17) and a closed distal end (16) opposite the proximal end (17), wherein the lumen (21) of the stiffening structure (15) is configured to receive a pressurized fluid having an over-pressure of at least 5 bar.

Abstract: Example embodiments relate to devices, systems, and methods for performing a diagnostic and/or therapeutic action. The system may comprise an elongated main body having a first end. The system may further comprise an anchor assembly attached to the main body near the first end of the main body. The anchor assembly may comprise a first expandable member. The first expandable member may be configurable to expand radially away from the main body. The anchor assembly may further comprise a second expandable member provided between the first expandable member and the first end of the main body. The second expandable member may be configurable to expand radially away from the main body. The anchor assembly may be operable to secure the main body with respect to an interior wall forming the cavity of the patient.

Abstract: Articulation devices, systems, methods for articulation, and methods for fabricating articulation structures will often include simple balloon arrays, with inflation of the balloons interacting with elongate skeletal support structures so as to locally alter articulation of the skeleton. The skeleton may comprise a simple helical coil or interlocking helical channels, and the array can be used to locally deflect or elongate an axis of the coil under control of a processor. Liquid inflation fluid may be directed so as to pressurize the balloons from an inflation fluid canister, and may vaporize within a plenum or the channels or balloons of the articulation system, with the inflation system preferably including valves controlled by the processor. The articulation structures can be employed in minimally invasive medical catheter systems, and also for industrial robotics, for supporting imaging systems, for entertainment and consumer products, and the like.

Abstract: The invention relates to a catheter for the directional conductance of a body fluid, particularly blood. The catheter includes a line segment which has a film tube defining an inner volume. A first port connects the inner volume to an external volume and a second port, arranged distally from the first port, connects the inner volume with the external volume. During operation of the catheter, the body fluid is conducted in the inner volume directionally between the first and second ports. The line segment includes a reinforcement running in the interior of the film tube. The film tube has a foldable section, a connecting region whereat the film tube is connected to the reinforcement, and a stabilized section having a structured profile.

Abstract: Catheter-supported therapeutic and diagnostic tools can be introduced into a patient body with a sheath slidably disposed over the tool. Once the tool is aligned with a target tissue, a fluid-driven actuator can move the sheath axially from over the tool, for example, to allow a stent, stent-graft, prosthetic valve, or the like to expand radially within the cardiovascular system, without having to transmit large deployment forces along the catheter shaft and sheath from outside the patient. Well-behaved articulation structures will often include simple balloon arrays, with inflation of the balloons interacting with elongate skeletal support structures so as to improve articulation behavior of the skeleton. The array can be used to improve uniformity of bending along a segment of a flexible body such as a catheter.

Abstract: Disclosed herein are detachment mechanisms for vaso-occlusive devices that allow for rapid operator-controlled release of the vaso-occlusive device into the selected site. Also disclosed are vaso-occlusive assemblies comprising these detachment mechanisms and methods of using these detachment mechanisms and vaso-occlusive assemblies.

Abstract: An endoscopy system including a balloon-equipped endoscope including a balloon which is configured for slidable frictional engagement with an interior wall of a body passageway and axial stretching of the interior wall when inflated to a slidable frictional engagement pressure and displaced axially along the body passageway and a balloon inflation subsystem operative to selectably inflate the balloon to the slidable frictional engagement pressure.

Abstract: Methods and systems for regulating aortic regurgitation during aortic valve replacement or repair procedures utilize a temporary aortic valve (TAV) catheter and a controller. The temporary aortic valve catheter has an expandable occlusion device which can partially occlude the aortic lumen during ventricular diastole with a lesser occlusion during ventricular systole. Exemplary balloon structures include multiple, independently inflatable balloons which are inflated in synchrony with the cardiac cycle by the controller. By controlling aortic regurgitation, the repair or replacement protocols can be conducted with less interference from blood flow.

Abstract: The present invention provides an articulating retractor including: a plurality of distal segments, a distal segment of the plurality of distal segments being movable relative to others of the plurality of distal segments; a plurality of proximal segments, a proximal segment of the plurality of proximal segments being movable relative to others of the plurality of proximal segments, the proximal segment corresponding to the distal segment; and multiple sets of cables, the proximal segment connected to its corresponding unit of the distal segment, by a set of cables, such that movement of the proximal segment causes corresponding reciprocal movement of the distal segment. The mechanisms of the articulating retractor may also be combined in such a way to remotely mimic finger movements for manipulation of an object or body tissue.

Abstract: The invention provides an articulating mechanism useful, for example, for remote manipulation of various surgical instruments and diagnostic tools within, or to, regions of the body. Movement of segments at the proximal end of the mechanism results in a corresponding, relative movement of segments at the distal end of the mechanism. The proximal and distal segments are connected by a set of cables in such a fashion that each proximal segment forms a discrete pair with a distal segment. This configuration allows each segment pair to move independently of one another and also permits the articulating mechanism to undergo complex movements and adopt complex configurations. The articulating mechanisms may also be combined in such a way to remotely mimic finger movements for manipulation of an object or body tissue.

Abstract: The invention provides an articulating mechanism useful, for example, for remote manipulation of various surgical instruments and diagnostic tools within, or to, regions of the body. Movement of segments at the proximal end of the mechanism results in a corresponding, relative movement of segments at the distal end of the mechanism. The proximal and distal segments are connected by a set of cables in such a fashion that each proximal segment forms a discrete pair with a distal segment. This configuration allows each segment pair to move independently of one another and also permits the articulating mechanism to undergo complex movements and adopt complex configurations. The articulating mechanisms may also be combined in such a way to remotely mimic finger movements for manipulation of an object or body tissue.

Abstract: A system and method for tissue thermotherapy including a source for generating a vapor phase media for treating a space in a human body, such as and intraluminal or intracavity space. The system further includes a filtering member for allowing a recirculation of flowable media about an interface with tissue, wherein the filtering member prevent ablation detritus from interfering with media outflows from the working end.

Abstract: The invention provides surgical or diagnostic tools and associated methods that offer user control for operating remotely within regions of the body. These tools include a proximally-located actuator for the operation of a distal end effector, as well as proximally-located actuators for articulational and rotational movements of the end effector. Control mechanisms and methods refine operator control of end effector actuation and of these articulational and rotational movements. An articulation lock allows the fixing and releasing of both neutral and articulated configurations of the tool and of consequent placement of the end effector. The tool may also include other features. A multi-state ratchet for end effector actuation provides enablement-disablement options with tactile feedback. A force limiter mechanism protects the end effector and manipulated objects from the harm of potentially excessive force applied by the operator.

Abstract: A self propelled, endoscopic apparatus formed of a flexible, fluid-filled toroid and a motorized or powerable frame The apparatus may be used to advance a variety of accessory devices into generally tubular spaces and environments for medical and non-medical applications. The apparatus when inserted into a tubular space or environment, such as the colon of a patient undergoing a colonoscopy, is advanced by the motion of the toroid. The toroid's surface circulates around itself in a continuous motion from inside its central cavity along its central axis to the outside where its surface travels in the opposite direction until it again rotates into its central cavity. As the device advances within the varying sizes, shapes and contours of body lumens, the toroid compresses and expands to accommodate and navigate the environment. The motion of the toroid can be powered or unpowered and the direction and speed may be controlled.

Abstract: A catheter system is provided. The system includes a catheter having an elongated flexible body and one or more electroactive polymer actuators disposed along the elongated flexible body. The electroactive polymer actuators are adapted to cause a change in configuration of the elongated flexible body. The system also includes a controller adapted to transmit the control signal to the electroactive polymer actuators. The controller includes a memory storing a plurality of control signals corresponding to a plurality of predetermined configurations of the catheter and a user-interface coupled to the memory. The user-interface is configured to select one or more configurations from the plurality of predetermined configurations in response to user input.

Abstract: A probe, consisting of a flexible insertion tube, for insertion into a subject via a body lumen. The probe includes a sequence of tubular modules contained within the insertion tube, each module having a rigid tube segment having a preset shape and containing internal grooves on an interior surface of the tube segment. The probe further includes a flexible expander tube, which is threaded through the sequence of tubular modules and has external grooves configured to engage the internal grooves within the tube segment of each of the tubular modules when the expander tube is expanded, so as to hold the tubular modules in mutual alignment, wherein the tubular modules are able to move out of mutual alignment when the expander tube is unexpanded. The probe also has an expansion element, which is insertable through the flexible expander tube so as to expand the expander tube.

Abstract: An apparatus is presented for use with a biologically-compatible-fluid pressure source.

Abstract: Disclosed herein is a delivery composition for administering a hydrophobic active agent. In one embodiment, a delivery composition for local administration of a hydrophobic active agent to a tissue or organ of a patient is disclosed. In one embodiment, the delivery composition includes a cationic delivery agent, a therapeutically effective amount of a hydrophobic active agent and a pharmaceutically acceptable aqueous carrier. In one embodiment, the cationic delivery agent includes polyethyleneimine (PEI). In an embodiment, the invention includes a drug delivery device including a substrate; and coated therapeutic agent particles disposed on the substrate, the coated therapeutic agent particles comprising a particulate hydrophobic therapeutic agent; and a vinyl amine polymer. Methods of making the delivery composition, as well as kits and methods of use are also included herein.

Abstract: Apparatus and methods for attaching and forming enclosed inflatable members on an endoscope assembly with a disposable sheath are disclosed. In one embodiment, an apparatus includes a flexible and resilient cuff member that is positioned on the outer surface of the disposable sheath and sealably and fixedly bonded to the sheath cover material at the cuff edges to form an annular space capable of being inflated. The inflatable member formed thereby is inflated through a lumen internal to the sheath that has an opening into the interior annular space. The inflatable member may be inflated to exert a longitudinal force on the insertion tube, thereby moving the endoscope assembly along a body passage. Alternately, a sheath may include a plurality of inflatable cuffs that may be inflated to create an isolated space therebetween within the body passage.

Abstract: Methods and devices described for improved catheters including those having a deflectable section to allow for expansion while maintaining flow through a vessel.

Abstract: An expansion device includes an inflatable balloon moveable from an unexpanded configuration to an expanded configuration configured to pass through soft tissue between two adjacent teeth of a patient when in the unexpanded configuration. The an expansion device also includes an inflation tube having one end connected to the inflatable balloon and another end serving as an entry port for an inflation fluid. The inflatable balloon has a triangular shape when in the expanded configuration.

Abstract: Medical devices having electrically conductive pathways are disclosed. More particularly, the disclosure is directed to catheter shafts including an electrically conductive wire embedded in a polymeric tube. The disclosure is also directed to catheter shafts including an electrically conductive media coextruded in a polymeric tube. The disclosure is also directed to catheter shafts including electrically conductive pathways formed with electrically conductive ink, paste, adhesive and/or epoxy.

Abstract: A non-compliant medical balloon comprises a base balloon including a pair of spaced-apart, generally conical end sections and a generally cylindrical center section connected therebetween. A braided fabric sleeve surrounds at least a portion of the base balloon, wherein the sleeve is formed of at least three substantially inelastic fibers intertwined in such a way that no two of the three fibers are twisted exclusively around one another. The sleeve is permanently affixed to the outer surface of the base balloon so as to prevent excessive expansion of the base balloon when the base balloon is internally pressurized.

Abstract: A catheter with a mechanism for omni-directional deflection of a catheter shaft includes a shaft assembly and a controller. The shaft assembly includes a first tubular component that has a preformed curvilinear distal section, a second, substantially straight tubular component with a main axis and an outer shaft. The first and second components are configured for slidable movement therebetween while preserving common rotation so that when the second component is axially moved in a distal direction, the second component deflects the preformed curvilinear section towards the main axis while orientation of the outer shaft is preserved. The controller is configured to effect relative axial movement between the first and second components as well as to effect rotation of the first and second components (and thus also of the preformed curvilinear distal section) without any rotation of the shaft relative to the handle.

Abstract: An endoscopic device capable of autonomous locomotion through a body cavity in a pre-established direction of displacement is described. The endoscopic device comprises a tubular body that extends between a front end portion and a rear end portion and a reinforcement structure distributed along the length of the tubular body. Each end portion includes an anchoring means for temporarily and alternately attaching the end portions to a wall of the body cavity.

Abstract: Complex steerable catheter visualization and tissue manipulation systems and their methods of use are disclosed herein. The deployment catheter is articulated using various steering mechanisms. Tissue visualization is accomplished from the visualization hood at the distal end of the deployment catheter, the hood having an ability to expand and other features to facilitate visualization and articulation at the tissue surface.

Abstract: A steerable element for use in surgery, comprising: an inflatable member; and an elongate frame azimuthally surrounding said inflatable member, wherein: said inflatable member is configured to press against said elongate frame on inflation so as to cause a change in the curvature of said elongate frame. A catheter, an insertion system, a medical implant comprising the steerable element, a delivery system comprising the steerable element, and a method of configuring the steerable element for use.

Abstract: The embodiments of the present invention relate to an endoscopic system and accessories. In particular, the various embodiments relate to endoscopic systems in which an accessory comprises a multi-lumen device that is capable of quantitatively delivering at least a catheter, a balloon, and a needle to a site. The accessory is configured to allow for individual, independent control of its components. For example, in some embodiments, the needle and guidewire can be independently controlled. In addition, the needle may be retracted back into an inner lumen of the catheter body. Accordingly, during use, the accessory of the embodiments allows the user to maintain access to an incision site without having to exchange or remove accessories for various parts of the procedure.

Abstract: Gastrointestinal apparatus (10) is provided, including a guiding element (16) and an inflatable mechanical device (96), adapted to pull the guiding element (16) through a colon of a patient. A gastrointestinal tool (12) is shaped to define a bore (14) therethrough, and the guiding element (16) is adapted to pass through the bore (14). Other embodiments are also described.

Abstract: A catheter having an elongate shaft including a plurality of apertures disposed along at least a length of the shaft to facilitate bending. The catheter includes an inflatable balloon, wherein a subset of the plurality of apertures provides fluid communication from an inflation lumen to the inflatable balloon.

Abstract: A medical treatment device enables an injection needle to accurately puncture brain tissue at a prescribed position and a drug solution to be injected into brain tissue, while avoiding damage to the brain tissue as the injection needle is handled. The use of the medical treatment device involves inflating a first balloon located on the outside of a catheter, directing a distal portion of a puncture needle, which is located inside the catheter, to outside the catheter through an opening in the catheter, after which the first balloon is deflated and a second balloon is inflated, and moving the catheter towards the brain tissue located on the opening side so that the injection needle projecting from the opening punctures the brain region.

Abstract: A remote guidance system for a medical device is provided that is capable of use with magnetic resonance imaging and other environments with a relatively high level of electromagnetic interference. In one embodiment, a fluid control system controls delivery of fluid to a fluid conduit supplying a fluid chamber of a fluid housing. A piston disposed within the fluid chamber moves in response to a change in fluid displacement in the chamber and causes corresponding movement of the medical device within a body. In another embodiment, means are provided for controlling a connector coupled to the medical device at a location outside the body wherein movement of the connector causes a corresponding movement of the medical device. A sensor generates a signal indicative of a characteristic associated with movement of the medical device. The sensor includes an optic fiber that transmits a light wave indicative of the characteristic.

Abstract: Some embodiments of a medical anchor device include an elongate body coupled with deployable subcutaneous anchors to secure a catheter instrument (or other medical instrument) in place relative to a skin penetration point. In some circumstances, the elongate body may be in the form of catheter hub body, and the subcutaneous anchors can be deployed from the hub body by adjustment of a movable actuator. A locking member can interact with the actuator so as to retain the actuator in the deployed orientation during the medical procedure.

Abstract: A method of producing a balloon of a balloon catheter includes the following method steps: providing a balloon body coupled to a proximal sleeve and a distal sleeve by transitional sections extending between the balloon body and the sleeves; creating folds in at least the distal sleeve; and stabilizing at least a distal section of the folds of the distal sleeve.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Abstract: A method for removing an object from a body lumen includes dispensing fluid into the body lumen, and causing the dispensed fluid to propel the object along the body lumen. A device for removing an object from a body lumen includes a fluid dispenser for dispensing fluid into the body lumen, and a pump in fluid communication with the dispenser.

Abstract: Systems capable of providing force and displacement outputs sufficient to actuate remote mechanisms to enhance catheter capabilities include both low-force and remote actuation arrangements. The remote actuation and low-force actuation systems may be used for catheter distal end deflection, sensor deployment, feedback controlled movement, fluid delivery rate and directional control applications as well as catheter retention mechanism deployment. Remote actuation mechanism may employ phase change based, magnetic based or hydraulic based. Low-force remote actuation structures include a coaxially-extending pull wire, a reaction member, and a remote mechanism responsive to the pull force.

Abstract: A balloon catheter is formed with a plurality of depressions. The balloon is coated with a matrix incorporating a therapeutic substance, which additionally fills the depressions. When the balloon is expanded within a body lumen, the therapeutic substance may diffuse into the lumen wall, or all or a portion of the coating transfers to the lumen wall. A lattice frame may surround the balloon, applied prior to coating if the coating is to transfer, operative to maintain a more linear balloon profile during inflation, promoting more even transfer pressure. A contrast dye is incorporated into the transferred coating, enabling ready location and inspection of the treated lumen area. Projections may alternately be formed in the balloon surface, operative to urge the coating and therapeutic substance between cells, or past cell layers of the lumen, to the interior of the lumen wall.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Abstract: A deflectable catheter assembly having a compression compensation mechanism is disclosed. The deflectable catheter assembly comprises a catheter shaft having a catheter proximal section and a catheter distal section. A therapeutic tool is disposed within the catheter shaft. A compression compensation mechanism is coupled to the therapeutic tool to compensate for a length change in the catheter shaft such as when the catheter shaft is deflected. The compression compensation mechanism includes a spring moveably disposed between a distal stop and a proximal stop that are attached to the therapeutic tool. A deployment slide is moveably disposed proximate to the spring and between the distal stop and the proximal stop. A catheter handle configured to house the compression compensation mechanism is coupled to the catheter shaft.

Abstract: The present invention includes a first balloon member having a first hollow portion that allows an insertion portion of the endoscope to pass therethrough; a first transmission member that transmits an advance/retreat action performed by an operator to the first balloon member; a second balloon member having a second hollow portion that allows the insertion portion of the endoscope to pass therethrough; a second transmission member that transmits an advance/retreat action performed by an operator to the second balloon member; and a control portion that controls supply and exhaust of fluid to and from the inside of the first balloon member and the second balloon member to expand or contract the first balloon member and the second balloon member.

Abstract: Devices for enhancing minimally invasive cardiac surgery include a visualization device including an inflatable balloon at or near the distal end. Some visualization devices also include one or more lumens for allowing the introduction of one or more devices to a surgical site through the visualization device. Systems of the invention involve a visualization device which has at least one lumen for allowing introduction of an ablation device and/or other devices. A visualization device with an inflatable balloon may be positioned to create a space between a heart and pericardium when the balloon is inflated.

Abstract: A non-compliant medical balloon comprises a base balloon including a pair of spaced-apart, generally conical end sections and a generally cylindrical center section connected therebetween. A braided fabric sleeve surrounds at least a portion of the base balloon, wherein the sleeve is formed of at least three substantially inelastic fibers intertwined in such a way that no two of the three fibers are twisted exclusively around one another. The sleeve is permanently affixed to the outer surface of the base balloon so as to prevent excessive expansion of the base balloon when the base balloon is internally pressurized.

Abstract: A medical instrument for suction and irrigation comprises an elongate shaft with a first channel serving as suction channel and with a second channel serving as irrigation channel, the shaft having a first tube which is closed in cross section and in which one of the channels is present. The shaft has a second tube which is open in cross section along its length and is placed with its open lengthwise side on an outside face of the first tube and secured sealingly thereon, the other channel being formed in the space between the outside face of the first tube and an inside face of the second tube. A method for production of the instrument is also described.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.