Abstract: A method of manufacturing a drug delivery device includes forming a undercoat on an outer surface of a dipping mandrel, forming a tack coat on an outer surface of the undercoat, depositing granular particles on at least a portion of the tack coat, forming an overcoat on the formed tack coat, trapping the granular particles between the tack coat and the overcoat and removing an outermost portion of the overcoat to expose a portion of the granular particles. A system for treating a vascular condition includes a catheter having an inflation lumen, an elastomeric drug delivery device disposed on the catheter and in fluid communication with the inflation lumen, a plurality of expandable pores disposed within an outer layer of the elastomeric drug delivery device and at least one therapeutic agent disposed within at least a portion of the plurality of expandable pores.

Abstract: Medical devices formed using a sacrificial structure, and processes of forming the devices therefrom.

Abstract: Some embodiments of a system or method for treating heart tissue can include a catheter device that provides a user with the ability to perform a number of heart treatment tasks (before, during, and after a cardiac surgery or a percutaneous coronary intervention). In particular embodiments, the catheter device can be used to (i) precondition heart muscle tissue before the heart is isolated from the circulatory system, (ii) deliver cardioplegia into the coronary sinus during the cardiac surgery when the heart is isolated from the circulatory system, and (iii) control the blood flow through the heart after the heart is reconnected with the circulatory system. In some embodiments, the catheter device can perform some or all of: (i) intermittently occluding the coronary sinus, (ii) delivering a treatment fluid into the coronary sinus, and (iii) monitoring a flow rate of blood passing from the coronary sinus to the right atrium.

Abstract: The catheter comprises a catheter tube formed of two superposed tubular layers of materials which differ from one another. A tubular mediator layer is arranged between the layers to provide an adhesive anchorage for the layers.

Abstract: An extractable device is used to insert a medicinal filling into a vertebral body. The device comprises a filling member and a pasty medicine. The filling member is made of a flexible and permeable wall and is provided with a holding portion and an injection port via which the pasty medicine is injected into the holding portion after the filling member is inserted into the vertebral body. The holding portion is provided with an opening which is releasably lashed by one end of one or more threads so as to make the opening leakproof. Upon completion of solidification of the pasty medicine in the holding portion of the filling member, other end of the thread is pulled to unlash the opening of the holding portion, thereby enabling the filling member to be extracted from the vertebral body so as to leave only the medicine in the vertebral body.

Abstract: A catheter capable of rapid inflation and deflation and operation by one individual.

Abstract: An elongate shaft of a medical catheter including a thermoset polymeric tubular member including a skived distal portion. The skived distal portion includes a distally extending trough having a convex surface and a concave surface. A thermoplastic tubular sleeve may be positioned over at least a portion of the skived distal portion of the thermoset polymeric tubular member. In some instances, the thermoplastic tubular sleeve includes a crescent-shaped tubular portion defining a crescent-shaped lumen. The trough of the skived distal portion may extend through the crescent-shaped lumen. The thermoplastic tubular sleeve is thermally bonded to the inner and outer tubular members of a distal section of the elongate shaft at a guidewire port joint.

Abstract: A balloon dilation catheter comprising a tubular member having a proximal end and a distal end. An inflatable balloon is disposed at the distal end of the tubular member. A first lumen is disposed in the tubular member and in is communication with an interior of the inflatable balloon. A second lumen is disposed in the tubular member for receiving a guidewire substantially along a portion of its length. The second lumen has a first opening in the proximal region of the tubular member and a second opening at the distal region of the tubular member. A first slit is disposed longitudinally in the tubular member and extends along at least a portion of the tubular member, the first slit comprising a first pair of longitudinal edges in a side by side relationship.

Abstract: The disclosure provides apparatus and methods a flow adapter for use with a medical introducer. The flow adapter comprises a housing, a connector disposed on the distal end of the housing, a valve member disposed within the housing, and a side port disposed on the housing. The housing comprises a first opening in a proximal end of the housing, a second opening in a distal end of the housing, and a passageway extending between the first and second openings. The first and second openings and the passageway are configured for the passage of an elongate medical device there through. The connector is in communication with the second opening and is configured for attachment to the medical introducer. The valve member disposed within the housing is configured to prevent the leakage of blood from the adapter. The side port disposed on the housing is configured to be attached to a source of flushing fluid.

Abstract: The present invention relates to medical devices that can be placed in bodily conduits. The invention particularly relates to balloons and catheters using such balloons for administering treatments to widen constricted passages, deliver therapeutic agents, deliver endoprosthesis' or perform other medical procedures. The balloon catheter can include an expandable balloon disposed adjacent a distal end of an elongated catheter shaft. The balloon can be constructed of a novel absorbable biomaterial.

Abstract: Described is a medical device and method for allowing fenestration of the aortic wall while maintaining distal perfusion and preventing external bleeding. The device isolates a segment of the aortic wall from the flowing column of blood using a balloon mounted on a metal alloy strut assembly. The strut assembly expands radially from a collapsed, low-profile configuration when uncovered by a constraining outer sheath. Aortic blood flow is allowed through the flow passage thus contained by the strut assembly within the center of the balloon. The balloon is inflated to contact the aortic wall. The balloon contains a pocket shaped to allow aortic fenestration. The balloon contains radiopaque markers to facilitate orientation and positioning of the pocket within the aorta. Other embodiments using spaced balloons are also disclosed.

Abstract: Devices and methods to treat atrial fibrillation via inhibition of nerves which innervate the pulmonary vein are provided.

Abstract: A method of increasing blood flow through an obstructed blood vessel includes providing an expandable member substantially made of a mesh having a plurality of interstices. The expandable member is inserted into the blood vessel, positioned within the blood vessel with the proximal member end upstream of the distal member end and the member body located radially adjacent at least a portion of an obstruction, and expanded to bring at least a portion of the member body into contact with the obstruction. An outward radial force is exerted on the obstruction to dislodge at least one fragment from the obstruction and to enhance blood flow through the blood vessel past the obstruction. The at least one fragment is passed through at least one interstice of the member body in the radial direction, and is selectively retained within the expandable member.

Abstract: A system including a catheter and an expandable member. The catheter includes an independent inflation lumen and an separate independent deflation lumen capable of sequential inflation and deflation of an expandable member in rapid succession, such as less than five seconds.

Abstract: A pre-assembled kit for administering ischemic postconditioning comprising a catheter and a handle having a fluid circuit to control and modulate flow of inflation fluid to and from a balloon wherein the catheter is free from additional assembly and preparation procedures such that it is ready-to-use within a variety of vessel sizes.

Abstract: A safety trocar assembly incorporating an airbag is provided to prevent overpenetration of the safety trocar assembly through an abdominal wall and into a body cavity. The safety trocar assembly includes an airbag cannula having an expandable airbag proximal of the distal end of the cannula. A sensing device is located at a distal end of the cannula for detecting changes in conditions at the distal end of the cannula. A trigger mechanism is provided on the cannula and operates to inflate the airbag in response to a change in condition detected by the sensing device.

Abstract: A catheter (100) having a first lumen (110) having a first distal tip (112) and a second lumen (130) having a second distal tip (132). The first and second distal tips (112,132) include openable portions that are normally closed when undeflected by lumen fluid pressure imbalance relative to the blood pressure of the patient. The first lumen (110) has an openable portion, flap (114) that opens proximally into the first lumen when the first lumen is under negative pressure to withdraw blood from the vessel through the first lumen to be dialysed (but that can open distally into the vessel under positive lumen pressure to permit blood flow into the vessel).

Abstract: An embolic protection filtering device having an improved filter loop and methods of making and using the same. The filter loop may include a coil or coil region and a flattened region. Additionally, the filter loop may include a loop tip.

Abstract: A balloon is inflated from a collapsed configuration, then deflated. A polymeric stent is then disposed over the deflated balloon and the stent crimped to the balloon.

Abstract: An intraluminal catheter device having an expandable member formed of a matrix of fiber elements, the expandable member including a hydrogel polymer having a therapeutic agent incorporated therein. The hydrogel polymer can be coated on the fiber elements in a co-axial configuration. The fiber elements may also have a second coating including a protective substance surrounding the hydrogel polymer having a therapeutic agent therein. The matrix of fiber elements can be formed by electrospinning. A process of delivering a therapeutic agent to a target site includes providing an intraluminal catheter device having an expandable member formed of a matrix of fiber elements, the expandable member including a hydrogel polymer having a therapeutic agent dispersed therein, and advancing the catheter device at a desired treatment site.

Abstract: Methods of manufacturing a medical article that include radial deformation of a polymer tube are disclosed. A medical article, such as an implantable medical device or an inflatable member, may be fabricated from a deformed tube.

Abstract: A rapid exchange balloon catheter having a proximal end and a distal end, said catheter comprising: a tubular metal shaft body extending from the proximal end along a majority of the total length and having an inflation lumen arranged therein, a plastics distal end portion bonded to the metal body in extension thereof, said distal end portion being provided with an inflation lumen in communication with a balloon, and a guide wire lumen, said guide wire lumen extending from a proximal side port to a distal end opening. To reduce the resistance to kinking, the metal body comprises a transitional region having reduced stiffness at the position of bonding to the plastics distal end portion compared to a more proximal position along the metal body.

Abstract: A bifurcated balloon for in vivo use, comprises: a proximal hollow tubular element, two bifurcating hollow tubular elements extending distally from a distal end of the proximal hollow tubular element, each of the two elements comprising: a first distal tubular element guidable into a first branch of a vessel bifurcation, and a second distal tubular element guidable into a second branch of the vessel bifurcation. The bifurcated balloon further comprises a longitudinal chamber extending from a distal end of the first distal tubular element, and a first substantially longitudinal guidewire channel passing through the longitudinal chamber, the first guidewire channel having two ends of which a first end passes through a proximal portion of the longitudinal chamber.

Abstract: Apparatus and methods are provided for providing access to a body lumen, e.g., to deliver a pacing lead within a patient's heart. The apparatus includes a tubular member including a proximal end, a distal end sized for insertion into a body lumen, and a lumen extending therebetween. An elongate member extends from the distal end of the tubular member. An expandable sheath extends along at least a portion of the elongate member, the sheath being expandable from a contracted condition to facilitate insertion into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen communicating with the tubular member lumen. A stylet or other shaped element is insertable into the elongate member for changing a shape of at least a distal tip of the elongate member, e.g., for accessing side branches extending from a body lumen, e.g., within a patient's coronary venous system.

Abstract: Disrupting tissue and devices and systems for disrupting tissue. The disclosure describes ways to deliver moieties to a target tissue, where the target tissue in general is not at the point of introduction, in such a way that minimal damage is produced in the tissue at the point of introduction. In some embodiments this is accomplished by jetting fluid at high velocity into the target tissue. The disclosure further describes novel agents deliverable in such systems for use in remodeling tissues. Some of these agents comprise a liquid while others do not. Additionally, although not specifically described in detail much of the disclosure may additionally be used in the delivery of therapeutic drugs.

Abstract: A catheter (200) for insertion into a hollow viscus of a subject, comprising: a drainage opening (204) and an instillation opening at a distal end an inlet port (209) at a proximal end for instilling a fluid; an outlet port (205) at the proximal end for draining fluid from the viscus; a drainage channel (201) connecting the drainage opening to the outlet port; an instillation channel (211) connecting the inlet port to the instillation opening; a valve (223) proximate the drainage channel at the distal end for closing it against the entry of fluid from the viscus; a valve control port (220) at the proximal end for receiving a control fluid under pressure; and a control channel (222) connecting the valve control port to the valve such that the valve is responsive to admitted control fluid under pressure to close itself.

Abstract: Multi-luminal endoscopic systems for sterilely delivering deployable devices. The system comprises an outer catheter comprising a distal portion and a wall that encloses an outer lumen; an inner catheter movably disposed within the outer lumen and having an inner lumen; a balloon-tipped catheter movably disposed within the inner lumen and having a distal portion and a proximal portion, wherein the distal portion of the balloon-tipped catheter comprises a balloon; a deployable device within the outer lumen; an invertible sleeve within the outer lumen with a first section attached to the distal portion of the outer catheter and a second section attached to a push mechanism that is proximal to the deployable device; and wherein the balloon is expandable to contact the invertible sleeve to provide a seal to prevent bodily fluids from entering the outer lumen.

Abstract: A method for maintaining clear passageways in an extracorporeal blood flow system. The method comprises intermittently providing one or more anti-clotting agents to a passageway of the extracorporeal blood flow system. Also disclosed is an extracorporeal blood flow system. The system comprises a passageway, and a device operatively connected to provide one or more anti-clotting agents to a least a portion of said passageway.

Abstract: Catheters, balloons, and methods of manufacturing balloons for balloon catheters using lasers are disclosed. A catheter with a shaft sized for use with a 0.014 inch guide wire includes a polymeric balloon having a body portion with an inflated outer diameter of more than 6 millimeters. An inflatable balloon includes an inflated outer diameter to inner waist diameter ratio of 12.5 to 1. An inflatable polymeric balloon that has a body portion with two regions that have different molecular orientations is also provided. A method of processing an elongate polymeric material includes heating a portion of the polymeric material with a laser while longitudinally stretching the portion of the polymeric material. A method of manufacturing a balloon includes heating and longitudinally stretching a first and second portion of an elongate polymeric tube to form first and second end portion. The remaining body portion is radially expanded to form the balloon.

Abstract: The invention provides a medical device having a catheter and one or more expandable constricting/occluding members. The catheter is adapted for use with therapeutic or diagnostic devices, including an angioplasty/stent catheter and an atherectomy catheter. The constrictor/occluder is mounted at the distal end of the catheter. Manometers may be mounted distal to one or more constrictors for measuring pressure distal to the constrictor(s). Methods of using the devices for preventing distal embolization during extracranial or intracranial carotid procedures or vertebral artery procedures by reversing blood flow in an internal carotid artery, an external carotid artery, and/or a common carotid artery toward the subclavian artery are disclosed.

Abstract: Multiple-balloon catheters, and methods of treatment therewith, are provided including an inflatable inner balloon at least partially enclosed by an expandable outer balloon that has holes. The annular space between the inner balloon and the outer balloon is configured to promote delivery of the fluid evenly through holes in the outer 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 inner balloon may have various configurations including being tapered relative to the outer balloon. The outer 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 catheter assembly and method of using the catheter assembly is provided herein. The catheter assembly has a catheter shaft having an elongated body extending about a longitudinal axis, a proximal portion and a distal portion, an outer surface, and at least one lumen extending therethrough the elongated body at least one means for sealing at least a portion of the lumen of the bronchial vessel. At least a portion of the catheter assembly is configured for insertion into at least a portion of a bronchial vessel of a target lung region. The means for sealing is moveable between a collapsed state and an expanded state. At least a portion of the vessel can be sealed by inflating the means for sealing. The catheter assembly can then be used to infuse a dialysate solution into the target lung region.

Abstract: An apparatus for sealing a puncture includes a positioning member including a proximal end, a distal end sized for insertion into a puncture, an expandable element on the distal end, and a tension indicator on the proximal end. The tension indicator includes a distal housing portion fixed relative to the proximal end, and a proximal housing portion or handle movable proximally relative to the distal housing portion. The handle is biased towards the distal housing portion such that, when sufficient tensile force is applied between the expandable element and the handle, the handle moves away from the distal housing portion. During use, the distal end is introduced through a puncture into a vessel, the expandable element is expanded, and the positioning member is partially withdrawn until the expanded element contacts a wall of the vessel and the handle separates from the distal housing portion, indicating that sufficient tension is applied.

Abstract: A balloon catheter including a connecting member, a catheter shaft, a balloon and a heat-generating member. The heat-generating member is in contact with a fluid in a distal portion of the catheter shaft. A method for treating a patient including introducing a low temperature fluid which flows through the balloon, introducing energy into a catheter shaft, and converting the energy into heat by a heat-generating member to heat the fluid, whereby an organ of the patient is heated and cooled. In the method, a portion of a diseased tissue of the organ is (i) heated from 35 to 40° C. to 60 to 80° C. within 30 seconds, (ii) expanded by applying a pressure of 500 kPa or smaller to the balloon, and (iii) cooled to 45° C. or lower within 40 seconds.

Abstract: A method of using a balloon catheter, comprising the steps of providing a balloon catheter, the balloon catheter comprising a balloon and a plurality of fins, the plurality of fins engaged to the balloon; inserting the balloon catheter into the vasculature; advancing the balloon catheter through the vasculature to a desired location; inflating the balloon when the balloon catheter is at the desired location; deflating the balloon; and directing the blood flow along the balloon thereby aiding rewrap.

Abstract: A liner is advanced through a narrowed region in a vessel such as the internal carotid artery. The liner is advanced through the narrowed region in a collapsed position. A stent is then advanced through the liner and expanded to open the narrowed region. The liner may also have an anchor, which expands an end of the liner before the stent is introduced.

Abstract: An arterial tamponade device is expandable between a collapsed condition and a fully expanded position and has opposite ends which are spaced farther apart in the expanded position. A foot or pressure pad is associated with at least one end of the device. The device is inserted into a body cavity in its collapsed state and is released at a predetermined location so that opposite ends of the device are biased away from one another and engage and apply pressure to opposite wall areas of the body cavity before the device is fully expanded, with the pressure pad positioned to apply pressure to a predetermined tissue area which includes a blood vessel so as to occlude or partially occlude the vessel and reduce or cut off blood flow to the body cavity.

Abstract: In one embodiment a large volume syringe pump assembly with a mechanism for facilitated manual driving (100) is connected to a large bore access cannula (200) which is placed percutaneously into the arrested left ventricular cavity of a victim. The cannula is equipped with balloons for sealing (212) and for immobilization (218). A large bore 3 way stopcock (208) is incorporated into the proximal end of cannula. The syringe pump assembly includes a large volume syringe (140) with a vent for air removal (141). A tubing length (148) is incorporated into the distal end of syringe. Tubing length has a connector at its distal end (150) for rapid connection to cannula. The syringe pump assembly includes a lever (122) pivotal attached to the syringe. By rearward manual movement of the lever the oxygenated blood is aspirated from the left ventricle and from the left atrium into the large volume syringe.

Abstract: An infusion catheter and method, with an elongated shaft having a guidewire lumen which has a proximal section and a common distal section extending to a distal port at a distal end of the shaft, and an infusion lumen which is in fluid communication with the distal port of the guidewire lumen and which joins the common distal section of the guidewire lumen at a location distal to the guidewire proximal port. A restricted passage from the infusion lumen to the common distal section of the guidewire lumen has a smaller transverse dimension than the guidewire lumen and a guidewire slidably disposed in the guidewire lumen.

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: The disclosure is directed to tubular bodies for catheters. An inner tubular catheter body has an inner layer, a braided portion over the inner layer and an outer layer. The outer layer is fused to the braided portion for a selected length or lengths of the inner tubular body and is unfused for a selected length or lengths to achieve the desired combination of stiffness and flexibility.

Abstract: A balloon catheter is disclosed including a “no-fold” balloon at a distal end thereof that surrounds a distal portion of a guidewire shaft having a compliant shaft or tubular section for selectively gripping a guidewire there within. Upon introduction of inflation fluid at low pressure values, the compliant shaft section of the guidewire shaft is radially compressed to “lock” onto the guidewire while an outer diameter of the no-fold balloon remains unchanged. The simultaneous compression of the compliant shaft section against a guidewire located within the guidewire lumen and the filling of the balloon with inflation fluid without expanding the balloon provides a clinician with a conjoined balloon catheter and guidewire ensemble that together may be pushed through a tight stenosis such as a chronic total occlusion (CTO).

Abstract: The invention relates to a catheter for introducing into a hollow human or animal organ. Said catheter comprises a catheter tip that protrudes forwards and a region that is encased by an expandable tubular hollow body and that is situated behind the catheter tip. Said catheter is characterised in that a wire spiral is located in the encased region. It can also be advantageous to provide a radiopaque ring, in particular a platinum, gold or tungsten ring, on a hollow shaft of the catheter, together with several rib-type projections running around the hollow shaft and projecting from the latter, in a region in front of and/or behind the radiopaque ring.

Abstract: Remote ischemic conditioning is applied during a revascularization procedure to prevent and/or reduce myocardial injury associated with myocardial infarction (MI) and the revascularization procedure such as percutaneous transluminal coronary angioplasty (PTCA). A percutaneous transluminal vascular intervention (PTVI) device used for the revascularization procedure, such as an introducer sheath or a guide catheter, includes an adjustable balloon to be positioned at a vascular site remote from the heart. The remote ischemic conditioning is applied by inflating and deflating the adjustable balloon, thereby causing temporary ischemia in the vascular site to activate the patient's intrinsic cardioprotective mechanism.

Abstract: A catheter assembly comprises a first catheter including a wall with an inner surface at least partially defining a lumen. A second catheter is connected to the wall of the first catheter and is disposed outward of the inner surface of the wall. The second catheter is at least partially covered by a sheath portion of the first catheter.

Abstract: A feeding tube apparatus is shown, with self propelled features that provide for placement in the postpyloric region of a patient.

Abstract: A device for interventional surgical or medical procedures is presented. The device is generally in the form of a balloon and is used to position itself or other working elements up against or through lumen walls in the body. The balloon is comprised of at least two materials of different elastic modulus, which allows for a flexible but relatively non-distensible, unfolding component of the balloon as well as an elastomeric, inflatable component of the balloon. The elastomeric component is fixedly attached to the flexible but relatively non-distensible component and together they form a pressure vessel that can be inflated within the lumens of the body.

Abstract: Apparatus and methods for locating morphological features within a body cavity using a catheter including proximal and distal ends, a transparent balloon carried on the distal end, and an optical imaging assembly carried on the distal end for imaging through the balloon. The balloon includes a channel extending therethrough to a lumen extending through the catheter. A guidewire or other localization member is received in the lumen that is extendable through the channel. During use, the catheter is inserted into a right atrium of a heart, and the balloon is expanded and placed against the wall of the heart to locate the coronary sinus. Sufficient force is applied to clear blood between the surface and the wall and clear the field of view of the imaging assembly. The catheter is manipulated to locate the coronary sinus, whereupon the localization member is advanced into the coronary sinus.

Abstract: Methods are disclosed for the providing oxygenated blood to venous circulation. Embodiments include a femoral access approach to the creation of an Aorta-caval fistula at the bifurcation of the Aorta and the Inferior Vena Cava; an apparatus for the creation, modification and maintenance of a fistula; and a method of supplying oxygenated blood to the venous circulation of a patient. The devices, systems and methods can be used to treat patients with one or more numerous ailments including chronic obstructive pulmonary disease, congestive heart failure, hypertension, hypotension, respiratory failure, pulmonary arterial hypertension, lung fibrosis and adult respiratory distress syndrome.

Abstract: A tube for use in gastrointestinal tract which allows administration of nutritional, medicinal, or other agent into gastrointestinal tract while preventing detention of digestive juices in esophagus, and which also prevents reflux of gastric contents. A detention-proof lumen is provided in tube body 12 of gastrointestinal tract tube 10 furnished with tube body 12 equipped with main lumen 12b and expansion lumen, such as balloon lumen 12c, and with an expander such as balloon 15 expanded by delivery of liquid or gas via the lumen provided on outer circumferential surface of tube body 12. Said detention-proof lumen communicates from a part more toward the base than the part where expander is provided on outer circumferential surface of tube body 12 to a part more toward the tip than part where the expander is provided on outer circumferential surface of tube body 12. An inner tube 18 used for liquid supply is provided movably within tube body 12.