Abstract: The present invention relates to implantable medical devices and methods that employ these medical devices to treat heart valves. In one embodiment, a medical device is provided comprising a body. The body may have a portion thereof including therapeutic agent and can be configured to support the device proximate a heart valve. Methods in accordance with embodiments of the present invention may also include providing a medical device having a body with at least a portion thereof including a therapeutic agent. These methods may also include positioning the medical device in a location proximate to a downstream surface of the heart valve and securing the device. The therapeutic agent released may then be delivered to the heart valve.

Abstract: An introducer sheath. The introducer sheath includes a tubular body. The tubular body extends from a distal end toward a proximal end. The tubular body includes a lumen. The lumen is defined at least partially by a wall. The tubular body includes a secondary channel. The secondary channel is disposed within the wall. The secondary channel is configured to receive a guidewire.

Abstract: An embolic capturing device for capturing emboli within a body lumen is disclosed. The embolic capturing device (10) comprises a filtering basket (20) and at least one coil (22) attached to the basket. The filtering basket includes a frame (23) and a filtering body (30) disposed on the frame. The at least one coil is attached to the filtering body for filtering emboli in the body lumen.

Abstract: Neuromodulation assemblies (200) include an extravascular prosthesis (202) disposed around and contacting at least a portion of an exterior surface (204) of a vessel (V) and a radially expandable intravascular prosthesis (206) contacting an interior surface (208) of the vessel. The neuromodulation assemblies are configured to compress, pinch, or squeeze a target nerve within the adventitia of the vessel between the extravascular and intravascular prostheses in order to impinge and disrupt the target nerve, thereby blocking or stopping nerve signal transduction. Neuromodulation assemblies configured in accordance with the present technology may also utilize radio-frequency energy, a drug, and/or magnetic attraction to block nerve signal transduction for neuromodulation thereof.

Abstract: A cannula assembly for directing blood from the heart of a patient and a minimally invasive method of implanting the same. The cannula assembly includes a flexible cannula body having a proximal end and a distal end with a receiving portion, and a transseptal tip having a distal end and a proximal end with an engaging portion. First and second anchors are coupled to the transseptal tip and configured to be deployed from a contracted state to an expanded state. The engaging portion of the transseptal tip is operable to removably engage the receiving portion of the flexible cannula body in vivo.

Abstract: A self-centering central access catheter includes a multi-lumen catheter body, a first port associated with a first lumen, and a second port associated with a second lumen. The first and second ports are disposed proximate a distal end of the multi-lumen catheter. A diametrically expansible member is circumferentially coupled to a multi-lumen catheter body and positioned intermediate the first port and the second port. The diametrically expansible member comprises a first portion that is immovably fixed to the multi-lumen catheter body and a second portion that is movably coupled to the multi-lumen catheter body.

Abstract: A combined multi-lumen central access catheter and an embolic filter including ports proximal and distal the filter for fluid infusion and/or pressure sensing and infusion ports in the catheter to permit infusion of bioactive agents, flushing agents and/or contrast agents. The embolic filter may be removably coupled to the multi-lumen catheter for temporary placement and retrieval under recommended indications.

Abstract: A system (1) and a device (3) is used in a fundoplication procedure in order to avoid over-tightening of the fundus of the stomach when the fundus is being wrapped around the esophagus (7) adjacent the lower oesophageal sphincter (5). The device (3) comprises a catheter (8) having a primary balloon (12) located at a distal end (9) thereof which is inflatable with a saline solution by a primary pump (26). A pair of spaced apart primary stimulating electrodes (32) on the catheter (8) within the primary balloon (12) receive a stimulating current signal from a constant current signal generator (40) under the control of a microprocessor (43), which reads voltage signals from spaced apart primary receiving electrodes (35) on the catheter (8) in the balloon (12).

Abstract: Sinusitis, mucocysts, tumors, infections, hearing disorders, choanal atresia, fractures and other disorders of the paranasal sinuses, Eustachian tubes, Lachrymal ducts and other ear, nose, throat and mouth structures are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies and endoscopic studies.

Abstract: A minimally invasive endoscopic surgical procedure or an endoscopic surgical procedure through natural orifices which includes: introducing a spacial structure in a shrunken state into a body cavity by a spacial structure introduction portion; enlarging the spacial structure in the body cavity; setting the enlarged spacial structure in a predetermined position in the body cavity and supporting the tissues inside of the body cavity with the set spacial structure; inserting a distal end of at least an endoscope or a treatment instrument from at least a part of an opening portion of the spacial structure, and orienting the distal end to a pathological lesion located on the inner side of the tissues inside of the body cavity which is supported by the spacial structure.

Abstract: A catheter for the local delivery of therapeutic agents and methods of using the same for the treatment or prevention of disease are disclosed. A catheter may include a tubular net and a guidewire attached to the tubular net longitudinally along the abluminal side of the net. The catheter may further include a tubular member that opens onto the abluminal side of the tubular net.

Abstract: A medical device can be used to drain fluids from the body during a medical procedure that requires the insertion of a medical instrument into an anatomical lumen or cavity. The device generally allows the simultaneous introduction of the medical instrument into the body and drainage of fluid out of the body during a medical procedure.

Abstract: The invention comprises a method and apparatus for treatment of a body part. More particularly, a method and apparatus for heat treatment of tissue using a catheter inserted into a body part is described along with means for positioning the catheter and means for positioning a set of electrodes relative to a tissue sample for treatment. Still more particularly, radio frequency energy at about 400 to 500 kilohertz is used to provide heat for the tissue treatment.

Abstract: Described here are paranasal sinus devices for treating paranasal sinus conditions. The devices include a cavity member, ostial member, and nasal portion. One or more of the cavity member, ostial member, and nasal portion may deliver an active agent for sustained release to treat the paranasal sinus condition. Exemplary paranasal sinus conditions are sinus inflammation due to functional endoscopic sinus surgery (FESS) and rhinosinusitis.

Abstract: A catheter for collecting fluid such as blood from a vessel such as a coronary sinus of a patient has an elongated, flexible tubular portion and an annular sealing member spaced from a distal end of the tubular member. A proximal end of the tubular member is adapted to be connected to a source of suction for applying suction to a collection lumen of the tubular member. The distal end is placed in a blood vessel with the sealing member spaced from opposing surface of the vessel in an absence of a suction applied to the collection lumen. Suction is applied to the collection lumen in an amount sufficient to draw blood from the vessel through the fluid inlet and into the collection lumen and further sufficient to urge the opposing surface of the vessel to migrate into sealing engagement with the sealing member.

Abstract: A multilumen catheter assembly including an elongated body defining a first lumen having a sidewall extending between its proximal end and a first lumen distal end proximate the body distal end and a first distal opening disposed proximate the first lumen distal end, and a second lumen connected to the sidewall and extending between the proximal end and a second lumen distal end proximate the body distal end, the second lumen distal end distal of the first lumen distal end. The second lumen includes a second distal opening disposed distally of the first distal opening. A self-expanding protector adjoins the elongate body distally of the first distal opening and extends from an inner edge along the elongate body outwardly and proximally to a free proximal edge that extends circumferentially about the elongate body proximate the first distal opening. The protector defins through-ways that permit blood flow past the protector.

Abstract: Methods and systems for delivering toxin and toxin fragments to a patient's nasal cavity provide for both release of the toxin and delivery of energy which selectively porates target cells to enhance uptake of the toxin. The use of energy-mediated delivery is particularly advantageous with light chain fragment toxins which lack cell binding capacity.

Abstract: An apparatus for installation of a tunneled vascular catheter into a patient's right atrium from the left side of their upper body. The apparatus comprises a dilator and a peel-away sheath. The dilator has a distal end portion and a proximal end portion interconnected by a shaft portion, with a lumen extending therethrough. The distal end portion is curved about 1° to about 3° from the longitudinal axis of the shaft portion. The end of the proximal end portion is provided with a flange. The total length of the dilator is about 3 cm to about 6 cm. The distal end of the peel-away sheath is provided a flange for contacting the flange at the end of the proximal end portion of the dilator. The length of the peel-away sheath is about 2.5 cm to about 4.5 cm.

Abstract: An example of recovery catheter assembly comprises an actuator element and a mechanically radially expandable and contractible recovery device operably connected to the actuator element. The recovery device has proximal and distal blocking portions and a central portion therebetween. The recovery device is at least partially placeable in a first, radially collapsed configuration and in a second, radially expanded configuration by manipulation of the actuator element. When in the second, radially expanded configuration, the proximal and distal blocking portions have radial dimensions greater than the radial dimension of the central portion thereby at least partially defining a collection chamber at the central portion.

Abstract: A cannula having a proximal end, a distal end, and a lumen extending between the proximal and distal ends is provided. The diameter of the lumen of the cannula can be varied to take into account differences in the diameter of access and target vessels during cannulation. The cannula is further characterized by at least one mechanism that, upon actuation, serves to alter the conformation of the cannula between a normal profile conformation and a low profile conformation. The normal profile conformation is characterized by the cannula having a lumen diameter at the point of insertion, which is smaller than the lumen diameter both proximal and distal to the point of insertion, with the lumen diameter distal to the point of insertion also expandable to the diameter of the cannulated vessel of the patient. The low profile conformation is characterized by the cannula having a lumen diameter at the point of insertion that is greater than the lumen diameter distal to the point of insertion.

Abstract: Described here are self-expanding devices and methods of using and making them. The devices may be useful in a variety of locations within the body, for a number of different uses. In some variations, the devices have a first compressed configuration enabling low profile delivery through a delivery device, a second expanded configuration for apposition against tissue, and comprise either a single continuous filament or at least two non-intersecting filaments. In some variations, the device is formed into a shape having a series of peaks and valleys. At least one of the peaks and valleys may have a loop at then end thereof. At least a portion of these devices may be capable of biodegrading over a predetermined period of time, and the devices may be configured for drug delivery. Methods of treating one or more sinus cavities are also described here.

Abstract: A combined multi-lumen central access catheter and an embolic filter including ports proximal and distal the filter for fluid infusion and/or pressure sensing and infusion ports in the catheter to permit infusion of bioactive agents, flushing agents and/or contrast agents. The embolic filter may be removably coupled to the multi-lumen catheter for temporary placement and retrieval under recommended indications.

Abstract: An anatomic device delivery and positioning system has a stabilizing guide wire for placement of a catheter or other medical device or material into a vessel or cavity of a tissue or organ within a body of a living subject into which the guide wire is insertable. The guide wire includes an elongated member having a proximal end and a distal end, the proximal end to extend out of the body and the distal end to extend into the body, the distal end having an expandable portion that expands from a compressed condition when inside of a delivery tube or catheter to an expanded condition when outside of the delivery tube or catheter. A method is also disclosed of performing a percutaneous procedure within a vessel or cavity of a tissue or organ of a subject using the guide wire, particularly but not exclusively involving a heart procedure.

Abstract: A hemostatic valve apparatus used in medical procedures that provides rapid activation of a sealing mechanism resulting in lower blood loss during use of the sealing device. The valve apparatus incorporates an actuator and two mechanisms that counter-rotate opposite ends of a sealing tube.

Abstract: A medical device for the delivery of treatment fluid to body vessels is described. The device has a distal (21) and a proximal (20) end with a self-expanding, hollow tubular member (9) and a delivery catheter (10) suitable for deploying a self-expanding, tubular member (9). The tubular member (9) is configured to expand radially to form a central part (11) flanked by two annular ridges, which creates, in situ, an annular lumen that can apply treatment fluid locally to a vessel and a passageway that can maintain the flow of blood through the vessel. The device is particularly suited for minimally invasive and repeatable organ perfusion. A method for organ perfusion is also disclosed.

Abstract: Catheter or guidewire mounted automatic vessel occlusion and fluid dispersion devices that expand to occlude or partially occlude a vessel when a fluid is flowing in the catheter or guidewire, and that automatically collapse when fluid flow is stopped. Each occlusion device has an elastic skeleton covered with a flexible cover coupled thereto and may have a hole(s) or openings in its distal or proximal end thereof to allow controlled flow through the desired end of the occlusion device. The fluid may be a flush fluid for enabling or improving the performance of imaging devices and image enhancing fluids, of treatment fluids for localized treatment of a vessel or tissues in communication with the vessel and/or of the transmission of energy to the vessel wall and adjacent tissues. Various embodiments are disclosed.

Abstract: A needleless fluid injection device including a flexible shaft with a proximal end, a distal end, an injection lumen extending from the proximal end to the distal end of the shaft, and at least one injection orifice extending through a wall of the injection lumen at the distal end of the shaft. The injection lumen can include a depth-limiting system (462) at its distal end for controlling the depth of insertion of the injection lumen relative to a target tissue of a patient. The injection lumen can alternatively or additionally include at least one guidance feature. The injection lumen can alternatively or additionally include at least one flow-modifying protrusion extending from the inner tubular wall of the injection lumen and toward a longitudinal axis of the injection lumen.

Abstract: A medical device is provided for dilatation of a vessel and delivery of a therapeutic agent to a wall of the vessel. The medical device comprises a catheter, a balloon located at a distal end of the catheter, and a drug delivery extension. The drug delivery extension is configured to extend beyond an outer surface of the balloon when the balloon is in an expanded configuration in order to deliver the therapeutic agent to an area beyond the outer surface of the balloon. The drug delivery extension may be one or more tubes, elongate members and/or expandable structures. The drug delivery extension may include a sheath for drug delivery.

Abstract: An angioplasty procedure wherein a balloon dilatation catheter is movably positioned within an anchoring catheter and which in turn is located within a guiding catheter or wherein a balloon dilatation catheter is movably positioned within a guiding catheter and the anchoring catheter in turn is positioned on the external surface of the guiding catheter, or wherein a balloon dilatation catheter is movably positioned within a catheter which serves both as a guiding catheter and anchoring catheter. Additionally, valve elements are attached to the guiding and anchoring catheters to provide points of securement between the catheters and the balloon dilatation catheter and to prevent the backflow of blood through the catheter assembly. Actuation of the valve elements allows a doctor to control the movement of the catheters.

Abstract: One aspect of the invention is a method to vent gas from a body cavity during an endoscopic procedure. A body cavity is in fluid communication with an exhaust gas inlet of a vacuum break device. The vacuum break device has a chamber in fluid communication with both the inlet and an outlet. The chamber may comprise one or more openings in fluid communication with the atmosphere. A conduit in fluid communication with the exhaust gas outlet may be connected directly or indirectly to a suction source. The suction source may be activated.

Abstract: Apparatuses and methods for medication administration via a body cavity. In one aspect, a medication administration device includes: a tip portion having a plurality of holes and a balloon defining a balloon cavity. When the balloon is deflated the tip portion can be inserted into a body cavity, such as the rectum, to allow medication delivery through the holes in the tip portion. When inflated, the balloon can prevent the tip portion from being withdrawn from the body cavity and/or hold dispersed medication within the body cavity. The device further includes a port portion that has a first port and a second port, and an elongated tubular portion that is coupled between the tip portion and the port portion. The tubular portion has a first lumen connecting the first port to the plurality of holes in the tip portion, and a second lumen connecting the second port to the balloon cavity.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The distal end of the sheath is maintained in the first, low cross-sectional configuration and expanded using a radial dilatation device. In an exemplary application, the sheath is utilized to provide access for diagnostic or therapeutic procedures such as ureteroscopy, cardiac electrophysiology, gastroenterology, and spinal access.

Abstract: A tissue penetration device and method of using same. The tissue penetration device may optionally include sampling and analyzing functions, which may be integrated. An embodiment provides control of a lancet used for sampling blood. Electric field coils or solenoids may drive the lancet using electromagnetic force. Advancement and retraction of a lancet may be controlled by a feedback loop monitoring the position and velocity of the lancet embodiments of the lancet driver can be configured to follow a predetermined tissue lancing profile. Embodiments of the invention include a lancet and method for using a lancet to maintain the patency of the wound tract once the lancet has cut into the skin.

Abstract: An instrument for facilitating insertion of a catheter through a subcutaneous tunnel includes a tunneling stylet defining a longitudinal axis and having leading and trailing ends, a bifurcated segment adjacent the leading end of the tunneling stylet and a releasable cover releasably mountable to the leading end of the tunneling stylet to substantially enclose the bifurcated segment. The bifurcated segment includes first and second elements adapted for reception within respective lumens of a catheter. The instrument may further include a dilation member which is releasably mountable to the leading end of the tunneling stylet in the absence of the releasable cover. The dilation member is dimensioned to generally increase an internal dimension of the subcutaneous tunnel. The first and second elements of the bifurcated segment each include an outer peripheral rib dimensioned to facilitate gripping engagement with an internal surface of respective lumens of the catheter.

Abstract: A catheter for delivering an agent to an injection site in a wall of a patient's body lumen, with an elongated shaft having a needle-through lumen slidably containing a needle therein, and an expandable member on the distal shaft section which has a collapsed configuration and a radially expanded configuration. In the radially expanded configuration, the expandable member supports the shaft in a position spaced away from the body lumen wall, and the needle slidably exits the needle-through lumen in the extended configuration through the port spaced away from the body lumen wall as a portion of the expandable member maintains the position of the port section of the shaft in the body lumen. The expandable member typically has an open-walled, helical, or lobed configuration providing a perfusion path along the expandable member.

Abstract: An agent delivery catheter and method configured to deliver an agent to an inner surface of a patient's body lumen wall by forming a funnel shaped agent containment chamber around at least one portion of the inner surface of the body lumen wall, while minimizing ischemic conditions during the procedure.

Abstract: The present invention provides a multi-directional needle assembly for injecting substance into at least one injection site of a patient's body, comprising: a. an elongated member having a distal end; said distal end having a plurality of openings disposed therein; b. a plurality of needles disposable at least partially within said elongated member, adapted to be reconfigured from a FOLDED configuration to a DEPLOYED configuration; said FOLDED configuration being characterized by the position of said needles within said elongated member; said DEPLOYED configuration being characterized by the protrusion of said needles out of said openings; the disposition of said openings is provided according to a predetermined scattering pattern such that (i) at least two separated areas within said distal end are provided for injection of said substance into at least two different injection locations at said injection site; and, (ii) a DEAD AREA between said two separated areas is obtained.

Abstract: An elongated hollow tube guiding catheter forming a portion of a guiding catheter includes a proximal end, distal end, and distal section. The distal section includes a curved section and a straight section. The curved and straight sections are shaped for facilitating introduction and retention of the catheter into the ostium of a renal artery. The system includes a dilator inserted into the catheter hollow tube with a curved distal section of the dilator opposingly extending opposite the curved distal section of the guiding catheter hollow tube. The guiding catheter includes a side arm positioned near the guiding catheter's proximal end with a multi-way stop cock fixedly attached onto a proximal end of the side arm tube.

Abstract: Systems, devices and methods for eluting an agent at a treatment site are disclosed. The devices include an expandable frame and at least one membrane. The membrane may carry an agent to elute at the treatment site. The membrane may allow blood flow at the treatment site during agent delivery.

Abstract: A method of treating a patient with a calcified aortic valve includes introducing a guide wire into a blood vessel. The guide wire is advanced through the aorta to the aortic valve and then through the aortic valve. A balloon dilatation catheter is introduced into the blood vessel over the guide wire. The balloon dilatation catheter includes an elongate body, a distal portion, a guide wire lumen, an inflation lumen, and a dilatation balloon. The balloon dilatation catheter further includes at least one deflection wire lumen, and at least one deflection wire residing in the at least one deflection wire lumen and having a distal end attached to the distal portion. The balloon dilatation catheter is advanced over the guide wire through the aorta, through the aortic valve, and the dilatation balloon is inflated.

Abstract: In certain embodiments, a device is configured to be delivered to the site of a nodule in the lung or other body organ or lumen. The device can be configured to attach directly to the target nodule or to tissue adjacent the target nodule. The device can be configured to provide repeatable access to the site of the target nodule. In some embodiments, the device includes a guide wire that can extend proximal the device. The guide wire can be configured to engage with a catheter or other medical device to provided repeatable and dependable navigation to the site of the target nodule. In some embodiments, the device can include a channel portion through which medical devices and/or instruments can be navigated. In some embodiments, the device can be deployed in the wall of an airway or other body lumen to provide transluminal access to a nodule outside of the lumen.

Abstract: A self-cleaning suction device has a user's suction end that self-sanitizes externally and internally before and after use, as well as self-sanitizes internally during use. A cover opens to reveal the user's suction end within a containment unit. As the cover opens, the suction end travels from a lower chamber, proceeds through a middle chamber of a sanitizing agent, and is presented for use. After suction is complete, the suction end retracts through an upper chamber with, a scraping feature that removes debris from the outer surface of the mouthpiece, and proceeds down through the middle chamber of a sanitizing agent and a scraping feature that removes debris and the sanitizing agent from the outer surface of the user's suction end. Upon the sealing closure of the cover, the upper and middle chambers are flushed with a sanitizing agent, which is suctioned away along with any collected debris.

Abstract: An introducer sheath is described. The introducer sheath may include a tubular body. The tubular body may extend from a distal end toward a proximal end. The tubular body may include a lumen. The lumen may at least partially be defined by a wall. A channel may be disposed within the wall. The channel may be configured to receive a guidewire. The tubular body may include an expandable portion expandable to increase a cross-sectional area of the lumen.

Abstract: A method is described for decreasing activity of at least one sympathetic nerve, nerve fiber or neuron innervating at least one blood vessel in the pulmonary vasculature of a patient to ameliorate pulmonary hypertension. In one embodiment, the method may involve advancing an intravascular treatment device to a target location in a target blood vessel within the pulmonary vasculature of the patient and using the treatment device to decrease activity of at least one sympathetic nerve, nerve fiber or neuron innervating the target blood vessel at or near the target location to ameliorate pulmonary hypertension.

Abstract: There is disclosed a device for cannulation of a hollow organ, in particular of an arterial or venous blood vessel of a mammalian body, e.g., human, said device comprising a cannula that has a proximal end, a distal end, and a central section located between the proximal end and distal end. The distal end has an expandable structure which can be converted, for example by means of a dilator, from a non-expanded state to an expanded state, and the expandable structure comprises openings at least in the expanded state.

Abstract: An apparatus for removing body fluids from a body cavity by suction, such as a thorax, gastric or any other human body cavity or a wound, comprises means (9) to increase the pressure difference between a pressure in a drainage lumen (3) and a pressure in the atmosphere when an auxiliary lumen (5) is open. The apparatus enables removal of clots or other plugs of the catheter and drainage tube in an efficient and not patient disturbing way.

Abstract: An applicator for delivering brachytherapy includes elongate members movable between collapsed and expanded configurations for delivering brachytherapy within a lumpectomy cavity, a vaginal cavity, or other target region. The elongate members may be expandable into a symmetrical or asymmetrical expanded configuration, e.g., into a generally spherical, pear-shaped, or planar configuration. A system for delivering brachytherapy includes the applicator and an access device for lining and/or dilating a body cavity and/or for receiving the applicator therein. The access device is advanced into a body cavity, an expandable member on the access device is inflated, the applicator is advanced into the access device, and the elongate members are expanded to deliver radiation to the target region.

Abstract: An intravascular aspirating assembly comprising an elongate guidewire having a proximally facing filter disposed on a distal portion thereof, a single operator exchange aspiration catheter disposed on the guidewire, the aspiration catheter having a proximal end, a distal end and an aspiration lumen extending therebetween, an extension catheter slidably disposed in the aspiration lumen and having a length greater than that of the aspiration catheter.

Abstract: Surgical apparatus and method includes a cannula that houses an endoscope and supports a dilating element near a distal end of the cannula. The dilating element has a dimension which is greater than the diameter of the cannula for enlarging a surgical cavity in tissue as the cannula is advanced through tissue at a surgical site to provide working space adjacent a target vessel within which surgical instruments may be conveniently manipulated. The dilating element of oval sided shape permits surrounding tissue to be pushed away or otherwise displaced away from the target vessel atraumatically. A locking mechanism is disposed on the cannula, which accepts a succession of mating dilating elements of progressively larger dimensions for successive insertion and enlargement of a surgical cavity as required.

Abstract: A device for removing blood clots and methods of making and using the same. The clot pulling device may include a first spine, a second spine disposed parallel to the first spine, and a basket disposed between and coupled to the spines. In addition, a pushing member may be coupled to the first spine and extend proximally therefrom.