Abstract: In a device for the intermittent occlusion of the coronary sinus, including a catheter with several lumens, an occlusion device fixed to the catheter and operable through at least one lumen of the catheter, and at least one pressure measuring device for measuring the fluid pressure in the coronary sinus, the catheter additionally comprises support means for supporting the catheter on the inner wall of the coronary sinus, which support means are reversibly placeable in abutment on the inner wall of the coronary sinus by an operating element.

Abstract: Devices, methods, and assemblies for perfusion therapy including cerebral perfusion therapy such as those for use in the treatment of acute ischemic stroke. The treatment includes delivery of blood to or about the vicinity of a thrombus site.

Abstract: A reduced pressure delivery system for applying reduced pressure tissue treatment to a tissue site is provided. The system includes a manifold delivery tube and a balloon having an inner space. The balloon is capable of assuming collapsed and expanded positions. The system further includes a manifold having a plurality of flow channels. The manifold is disposed within the inner space of the balloon. A sharp tip is configured to be delivered within the manifold delivery tube to puncture the balloon.

Abstract: A catheter having improved ability to cross body passage obstructions and that more easily allows backloading of a guidewire into the lumen of the catheter is comprised of a tip, a shaft, and a lumen. The distal end of the catheter tip is oriented at an angle other than 90° to the lengthwise axis of the catheter tip. A guidewire may be easily backloaded into the elongated catheter lumen at the location of the angled catheter tip.

Abstract: The present invention relates to balloon catheters for treating a luminal system of a patient. Specifically, the invention relates to catheters having a flexible membrane positioned at a distal portion of the catheter, the flexible membrane retained in a substantially unexposed conformation prior to deployment. Preferably the flexible membrane is capable of delivering a therapeutic agent to a localized environment when deployed to an exposed conformation.

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: Systems and methods for delivery of therapeutic and/or diagnostic compositions to an interventional site having diseased or newly treated tissue are provided. Integrated interventional catheter systems incorporating surfaces coated with a therapeutic composition, or tissue penetration members for scoring or disrupting tissue prior to or during administration of a therapeutic composition are provided. Infusion of therapeutic composition(s) may also be provided.

Abstract: An endoscopic device has a longitudinal member having a longitudinal axis, a bending portion formed on a distal end side of the longitudinal member, a lumen formed along the longitudinal axis of the longitudinal member, and an opening portion that communicate with the lumen, and opens toward the inner side of a bend of the bending portion when the bending portion is bent.

Abstract: Described in one aspect is a multi-pressure monitoring system for cell or other therapy includes a first catheter having a first lumen for accepting a treatment device, a second lumen for inflating a balloon, a pressure sensor for monitoring fluid pressure within the first lumen, and a flow restrictor such as a hemostasis valve for limiting the exchange of fluids into and out of the first lumen while treatment devices are present or exchanged in the first lumen. Also disclosed is a method of using the first catheter with a first pressure monitor coupled to the first pressure sensor along with a second catheter attached to a second pressure sensor coupled to a second pressure monitor. The second catheter is positioned within the first lumen of the first catheter during treatment operations and the first and second pressure monitors are used to verify proper pressures throughout the procedure.

Abstract: A catheter apparatus is provided with lumens for accommodating guidewires. The apparatus comprises an actuator controllable to move the distal ends of the lumens relative to each other. Accordingly, the separation of the guidewires can be controlled, enabling probing by the guidewires of different area of an occlusion in a blood vessel, such as a chronic total occlusion.

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: A hemodialysis catheter with an integrated means of displacing away from each other portions of a distal end of a tube assembly. The displacement serves to allow a fibrous sheath to be disrupted without removing the catheter from a patient.

Abstract: An embodiment of the present invention relates to a catheter comprising a dilatable balloon, characterized in that the primary balloon wall is produced from a material that comprises or consists of a polyamide/polyvinylpyrrolidone (PA/PVP) polymer mixture.

Abstract: A catheter shaft for a balloon dilation catheter to be utilized with a guidewire includes an outer tubular member having a bore, a proximal end and a distal end with a guidewire tubular member coaxially disposed within the bore such that the inner surface of the outer tubular member and the outer surface of the guidewire tubular member define an annular inflation/deflation lumen extending between the proximal end of the shaft and the distal end of the outer tubular member with a plurality of discrete, spaced apart legs extending radially outward from the guidewire tubular member that serve as a stop or stops preventing movement of the guidewire tubular member into the outer tubular member when the legs abut the distal end of the outer tubular member.

Abstract: A method of extravasated drug delivery is disclosed, including inserting a catheter with a first balloon, a second balloon, and a third balloon positioned between the first and second balloons and having a wall with an abrasive outer surface, into a bodily cavity, inflating the first and second balloons to create a chamber therebetween, stimulating a flow of blood cells by inflating the third balloon until the abrasive outer surface abrades tissue, and delivering the agent to the chamber. A balloon catheter system is also provided including a balloon having a wall with an abrasive outer surface for abrading tissue, a catheter having a first lumen for supplying fluid to the balloon to inflate the balloon such that the abrasive surface stimulates a flow of blood cells, and a second lumen for supplying an agent to tissue.

Abstract: Balloon catheters, and methods of treatment therewith, are provided including an inflatable first balloon at least partially enclosed by an expandable second balloon that has holes. The annular space between the first balloon and the second balloon is configured to promote delivery of the fluid evenly through holes in the second balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The first balloon may have various configurations including being tapered relative to the second balloon. The second balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.

Abstract: A therapeutic agent delivery device and method for eluting a therapeutic agent to a target location are disclosed. The device may comprise a first conductive element, a second conductive element, an electrochemical composition including an electrolyte and a therapeutic agent, and a permeable membrane covering the electrochemical composition. The first conductive element and the second conductive element are adapted to be connected to a voltage source. When the voltage source is connected to the first conductive element and the second conductive element, an electrochemical reaction occurs causing the therapeutic agent to pass through the permeable membrane and thereby to elute to a target location.

Abstract: The present invention provides a balloon which achieves diameters greater than 6 mm for securement to a catheter. The balloon includes an elastomeric generally hollow pressure expandable body which exhibits essentially radial symmetry and constant length when expanded under an internally applied minimum working pressure from an uninflated state.

Abstract: Devices to treat nerves which innervate blood vessels are provided.

Abstract: Methods are describe for treating intraluminal locations such as in a patient's lung. The device is a catheter which has an elongated shaft with an inner lumen, preferably defined by an inner tubular member, formed of heat resistant polymeric materials such as polyimide and high temperature vapor is directed through the inner lumen into the intraluminal location to treat tissue at and/or distal to the location. The outer surface of the catheter is also formed of heat resistant material. An enlarged or enlargeable member, such as a balloon, is provided on a distal portion of the catheter shaft to prevent proximal flow of the high temperature vapor upon discharge from the catheter.

Abstract: Catheter comprising an inner tubular member defining a fluid lumen and inflation lumen therein. An exterior surface of the inner tubular member defines a fluid flow port in fluid communication with the fluid lumen and located along a region of the inner tubular member. Catheter further includes an outer member having a distal section movable relative to the inner tubular member and having an interior surface. A piston balloon is coupled to the inner tubular member distal to the fluid flow port and is in fluid communication with the inflation lumen. A pressure chamber is in fluid communication with the fluid flow port. Fluid introduced through the inflation lumen inflates the piston balloon to seal against the interior surface and fluid introduced through the fluid flow port and into the pressure chamber applies a force to urge at least the distal section of the outer member in a proximal direction.

Abstract: An method and apparatus are disclosed including an expandable body having a diameter suitable for insertion into a blood vessel and capable of being modified from a first diameter to a second larger diameter in response to an inflation pressure. The expandable body includes an outer wall having a plurality of delivery outlets extending from a working length of the outer wall. The delivery outlets coincide with regions of a lesion exposed between a framework implanted within the vessel when the expandable body is in an expanded state. A treatment agent is delivered from the delivery outlets to regions of the lesion exposed between the implantable framework.

Abstract: The present invention relates to apparatus for retroperfusion of tissues and organs. The apparatus comprises a catheter with a proximal end for engaging a supply of the fluid medium, and a distal end having an expandable-contractible chamber for installation into suitable vessels or organs. The expandable-contractible chamber comprises a conduit element having a fluid-filled hollow wall defining a lumen. The conduit element has a first deformable inner-facing section approximate a proximal end of the conduit and a second deformable inner-facing section approximate a distal end of the conduit element. Controlled application of a pressure at a proximal end of the conduit element causes deformation of the conduit into the lumen at its distal end thereby occluding the flow of fluid medium through the catheter. Controlled release of the pressure releases deformation of the fluid-filled conduit at its distal end thereby unblocking the flow of the fluid medium through the catheter.

Abstract: An anti-clog suction tip apparatus includes a suction tip having a suction opening and an interior defining a suction channel. An ejection wire channel extends to a wire exit opening into the suction channel that is located proximate the suction opening. An ejection wire including a ball tip at an end thereof occupies the ejection wire channel and is transitionable between a retracted configuration and an advanced configuration such that, in the retracted configuration, the ejection wire including the ball tip is retained within the ejection wire channel and does not obstruct suctioning of debris through the suction channel; and in the advanced configuration, the ball tip of the ejection wire does not extend more than three millimeters beyond the suction opening.

Abstract: A delivery device for an annular implant that includes a balloon expansion mechanism and an annular implant having an adjustable dimension. The balloon expansion mechanism includes an inflation tube attached to a non-occluding balloon collar which is supported by trusses radially extending from a trocar. The annular implant further includes a flexible ring core, contiguous coiled spacers, and anchoring blocks. The flexible ring core is adjusted via a cinching mechanism. The anchoring blocks are spaced along the ring core by the contiguous coiled spacers, which keeps the distance between each pair of anchoring blocks equidistant as the ring core diameter is manipulated by the device user. The annular implant can also include gunbarrel elements housed in the trocar. Each gunbarrel element contains a gunbarrel pusher which drives an attachment element into the annular implant and annular tissue.

Abstract: Medical devices including a substrate that are expandable from a compressed state to an expanded state; a coating on the substrate, the coating having a drug agent incorporated therein; and a sheath over the coating. The sheath is expandable from a compressed state to an expanded state and has at least one perforation therein. The medical devices are configured such that when the substrate is in a compressed state, the sheath is also in a compressed state and the perforation is substantially closed. When the substrate is in an expanded state, the sheath is also in an expanded state and the perforation is substantially open. The invention also includes a method of using the medical devices for the controlled, localized delivery of a drug agent to a target location within a mammalian body.

Abstract: A method of treating tissue comprises introducing into a hollow organ a support device and, after insertion, arranging the support device into a non-yielding configuration substantially filling the hollow organ and substantially preventing walls of the hollow organ from moving inward in combination with inducing contraction of the hollow organ around the support device to cut off blood flow through at least a portion of the walls of the hollow organ and removing the support device after blood flow has been cut off for a predetermined time.

Abstract: The invention relates to a cannula for medical use, which is obstructed at the distal end thereof and which has an occlusion balloon enabling regionalization of the extracorporeal circulation, it being possible for said cannula to be multiperforated.

Abstract: A retrograde delivery catheter includes at its distal end an expandable member configured to at least partially occlude the coronary sinus of a patient's heart, and has a length and variable stiffness that allows the distal end to be selectively articulated so as to be positioned in the coronary sinus. The delivery catheter has a triple lumen construction with a primary lumen extending between the proximal and distal ends and configured to allow a cardioplegic fluid to be delivered to the coronary sinus. A second lumen provides for balloon inflation while a third lumen allows monitoring of a pressure within the coronary sinus. A torque may be applied and a reinforcement member within the delivery catheter provides improved torque transmission along the length of the catheter.

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: A catheter and catheter system for treatment of a blood vessel of a patient include an elongate flexible catheter body with a radially expandable structure. A plurality of electrodes or other electrosurgical energy delivery surfaces can radially engage material to be treated when the structure expands. A material detector near the distal end of the catheter body may measure circumferential material distribution, and a power source selectively energizes the electrodes to eccentrically treat of a body lumen.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade within the wall to release the drug to produce a therapeutic effect. The preparation can be coupled to a delivery mechanism having one or more balloons or other expandable devices which are expandable responsive to a condition in the small intestine or other GI lumen to advance the preparation out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: Embodiments of this invention include hand-held handles and systems for balloon-tipped catheter interventions that enable a user to appreciate a combination of palpable sensations as though his or her hand is actual anatomic tissue in situ in real time. The system may include a haptic handle coupled to the proximal end of the catheter where the haptic handle includes a balloon-shaped haptic interface that exhibits geometric characteristics reflecting an anatomy of the interventional balloon and provides tangible sensations representative of tissues surrounding the interventional balloon. Multiple sensors and actuators may be used to create a non-virtual, transparent experience communicated to a user with a three dimensional, volumetric haptic display.

Abstract: Medical devices and methods for delivering a therapeutic agent to a heart valve.

Abstract: A perfusion circuit and a use thereof for delivering a substance to a subject's heart in situ during cardiopulmonary bypass surgery are provided. The perfusion circuit defines a path for re-circulating a solution containing a macromolecular complex through a coronary circulation circuit through a subject's heart during a surgical procedure in which the substance is prevented from being delivered to the subject's other organs.

Abstract: A catheter system suitable for the retrieval of debris and other solid or liquid matter from body passages, and the removal of said matter from the body. More particularly, a catheter system including two or more concentrically-arranged conduits and an inflatable element connected therebetween, wherein the inflatable element is arranged such that it may entrap solid or liquid matter in an internal annular cavity.

Abstract: Systems and methods are disclosed for the treatment of a target tissue by directionally delivering energy and/or bioactive materials to achieve a therapeutic effect. A balloon catheter system having a balloon portion and a plurality of electrodes may be energized to selectively deliver energy, bioactive materials, or a combination thereof to target tissue including tissues disposed about a lumen. The tissue may be targeted by applying energy, making tissue impedance analysis, and further selectively energizing electrodes through the use of an energy source with a controller.

Abstract: Devices and methods are configured to allow transcervical or subclavian access via the common carotid artery to the native aortic valve, and implantation of a prosthetic aortic valve into the heart. The devices and methods also provide means for embolic protection during such an endovascular aortic valve implantation procedure.

Abstract: A balloon catheter having a multilayer catheter shaft is formed to have an inner layer and an outer layer, where the inner layer and outer layer are selected from materials that enhance the pushability of the catheter while preserving the flexibility. Using a combination of a high Shore D duromater value material and a lower Shore D duromater value material, various combinations of multilayer catheter shafts are disclosed utilizing different glass transition temperatures and block copolyamides to obtain the desired characteristics.

Abstract: A drug delivery system that can be deployed from a catheter and retained within the bladder for delivery of treatment drug solutions over a period of time. The delivery system includes an inflatable or expandable delivery element that can be collapsed within the catheter tip for navigation into the bladder before being inflated or expanded within the bladder. The inflated or expanded delivery element can engage the bladder walls or sized to be too large to be passed from the bladder such that the delivery element is retained within the bladder after inflation or expansion to administer a treatment drug solution over an extended period of time.

Abstract: Embodiments are presented of a balloon assembly operable to provide a balloon diameter vs. balloon pressure profile generally depicting a balloon inflation sequence providing at least one intermediate inflated diameter and a final inflated diameter of a balloon such that the balloon attains the at least one intermediate diameter at a predetermined pressure, and attains the final diameter at a final predetermined pressure that is lower than a predetermined pressure of a last intermediate pressure.

Abstract: Adjustable balloon catheter including an inner tubular member that has an inflation lumen defined therein. An expandable member is coupled to the distal end portion of the inner tubular member and has an inner chamber in fluid communication with the inflation lumen. The expandable member is transitionable between a deflated configuration and an inflated configuration. The expandable member defines has a non-cylindrical shape along at least a portion of a working length thereof when in the inflated configuration. An outer tubular member is movable relative to the inner tubular member, the outer tubular member includes a distal end. The outer tubular member is moveable between an extended position disposed over the expandable member and a retracted position proximal to the extended position. The outer tubular member is selectively positioned between the extended position and the retracted position to define an exposed length of the working length of the expandable member.

Abstract: In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device within a patient comprising an elongated outer sheath forming an inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath with a stopper. The inner sheath further includes a tether configured to form a loop on a distal side of the stopper, the loop being configured to engage a looped element of the implantable medical device to couple the implantable medical device to the inner sheath. The stopper is slidable relative to the outer sheath. The tether is configured to release the looped element of the implantable medical device from the inner sheath by opening the tether loop when a portion of the stopper is located distally relative to the distal opening of the outer sheath.

Abstract: In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device within a patient, the kit comprising an elongated outer sheath forming an inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath with an inflatable member at its distal portion. The inflatable member is inflatable from a proximal end of the inner sheath to close-off the distal opening of the outer sheath when inflated. The inner sheath further includes a stopper proximally located relative to the inflatable member. The inflatable member is remotely controllable from a proximal end of the inner sheath to retract in a proximal direction towards the stopper. The inflatable member can be retracted in a proximal direction towards the stopper and past an implantable medical device positioned within a distal portion of the outer sheath.

Abstract: A vessel occlusion apparatus includes an elongate shaft having a fluid delivery lumen; and an expandable member carried on a distal end portion of the shaft, the expandable member comprising a body defining an interior region, the interior region in communication with the fluid delivery lumen, the body comprising a wall having one or more embedded fluid pockets therein, each of the one or more pockets containing a fluid capable of being imaged, e.g., having echogenic qualities for detection using ultrasound imaging.

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 method of extravasated delivery of a therapeutic and/or diagnostic agent to tissue is provided including inserting a catheter with a first balloon, a second balloon and a third balloon into a bodily cavity, inflating the first and second balloons by supplying fluid thereto to create a chamber, delivering the agent to the chamber, and increasing fluid pressure within the chamber by inflating the third balloon to facilitate extravasation of the agent into tissue. A multi-balloon catheter system is also provided including a catheter having a first balloon, a second balloon and a third balloon, and a fluid source that inflates the first and second balloons by supplying fluid thereto to create a chamber, wherein the catheter includes a fluid pathway for delivering the agent, and the fluid source increases fluid pressure within the chamber by supplying fluid to the third balloon such that the agent is extravasated into tissue.

Abstract: A vascular closure device that includes an inflation tube, a flashback tube, a dual lumen tube, a bond portion, and an inflatable balloon. The inflation tube defines an inflation lumen. The flashback tube defines a flashback lumen. The dual lumen tube has first and second lumens and is positioned distal of the inflation tube and flashback tube. The inflation tube and flashback tube are integrally connected to the dual lumen tube at the bond portion with the inflation lumen in fluid communication with the first lumen and the flashback lumen in fluid communication with the second lumen. The inflatable balloon is mounted at a distal end of the dual lumen tube and is in fluid communication with the inflation lumen.

Abstract: Systems and methods are provided for performing a medical procedure within a patient's body that involves a thoracic duct including an ostium communicating with the patient's venous system. A distal end of a catheter is introduced through the patient's venous system into a body lumen adjacent the ostium of the thoracic duct. An expandable member on the distal end of the tubular may be expanded adjacent the ostium, e.g., within the body lumen or the thoracic duct itself, and used to isolate the thoracic duct from the body lumen, whereupon a medical procedure may be performed via the thoracic duct. For example, lymphatic fluid may be removed from the thoracic duct through a lumen of the tubular member and/or one or more agents may be introduced into the thoracic duct through the tubular member.

Abstract: The present invention relates to phase separated polymeric regions and to their use in conjunction with implantable or insertable medical devices. In some aspects of the invention, phase separated polymeric regions are provided that include (a) at least one biostable polymeric phase and (b) at least one biodisintegrable polymeric phase, which is of nanoscale dimensions and which undergoes biodisintegration such that the phase separated polymeric region becomes a nanoporous polymeric region in vivo. Other aspects of the invention are directed to methods of making implantable or insertable medical devices having at least one nanoporous polymeric region. These methods include (a) providing a phase separated polymeric region comprising a stable polymeric phase and a disintegrable polymeric phase of nanoscale dimensions, (b) selectively removing the disintegrable polymeric phase thereby producing the nanoporous polymeric region.