Abstract: A system for examining a colon includes a catheter, such as a rectal catheter, having a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end of the catheter, and a flexible tube coupled with the catheter. The system includes a first balloon located adjacent a distal end of the flexible tube, and a second balloon extending around the catheter and being located between the distal and proximal ends of the catheter, whereby the distance between the first and second balloons is adjustable by sliding the flexible tube through the central lumen of the catheter. The first and second balloons are inflatable for isolating a section of a colon, and a gas or contrast agent may be introduced into the isolated colon section for conducting the examination.

Abstract: An apparatus including a cannula having a dimension suitable for insertion into a blood vessel and an expandable body coupled thereto, the expandable body comprising a first expandable member and a second expandable member to isolate a length of the vessel upon expansion within the blood vessel. The expandable body having an intermediate expandable member along a working length between the first expandable member and the second expandable. A method including introducing a cannula and an expandable body coupled thereto into a blood vessel at a point coextensive with a treatment site and expanding a first expandable member and a second expandable member of the expandable body to isolate a length of the vessel adjacent the treatment site. The method further including delivering a treatment agent to a vessel region between the first expandable member and the second expandable member while inflating and deflating an intermediate expandable member.

Abstract: Catheter balloon assemblies (10) for delivering a therapeutic agent to a body vessel are provided, as well as related methods of manufacturing and methods of treatment. The catheter balloon assemblies may include a concentrically disposed dual balloon assembly at the distal portion of the catheter having an inner balloon (44), a porous outer balloon (42) concentrically arrayed around the inner balloon and a catheter shaft (30) adapted to deliver a therapeutic agent to the body vessel through the apertures in the outer balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a body vessel, where the therapeutic agent may be delivered from the catheter shaft through apertures in the outer balloon directly to the wall of the body vessel.

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 combination dilatation and drug delivery device includes a flexible catheter, a drug delivery sheath mounted to a distal end region of the catheter and a dilatation balloon also mounted to the catheter and contained within a compartment formed by the sheath. The sheath is radially expandable by supplying a liquid therapeutic agent to the compartment under a moderate pressure. The dilatation balloon is expandable by providing a dilatation fluid to the balloon under a much higher pressure. The sheath can be formed of a highly elastic material or can be made quite thin, and in either case is mounted independently of the dilatation balloon. Thus when radially expanded, the sheath is moved into a conforming contact with surrounding vascular tissue. The conforming contact protects tissue and the therapeutic agent from exposure to blood, and more effectively confines the therapeutic agent to the intended treatment area.

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: Devices, methods, and systems for measuring the size of gastric pouches. At least some embodiments include a catheter comprising an outer elongate tube, an inner elongate tube disposed within the outer elongate tube, a proximal balloon attached to the outer elongate tube, a distal balloon having a first end attached to the outer elongate tube and a second end attached to the inner elongate tube, at least two detection electrodes positioned on the outer elongate tube relative to at least two excitation electrodes, and a pressure transducer positioned on the outer elongate tube.

Abstract: Methods of coating a stent subsequent to mounting or crimping of the stent on a balloon of a catheter assembly are disclosed. One method includes forming a sacrificial layer on a balloon of a catheter assembly; followed by mounting a stent on the balloon, the stent including struts separated by gaps; followed by forming a stent coating on the stent; and followed by removal of the sacrificial layer. Another method includes mounting a stent on a balloon, the stent including struts separated by gaps; followed by forming a sacrificial layer on the balloon in the areas of the gaps between struts of the stent; followed by forming a coating on the stent; and followed by removing the sacrificial layer, wherein the coating remains on an outer surface of the stent.

Abstract: A shunt includes a first occlusion assembly and a second occlusion assembly. The first occlusion assembly includes a first occlusion fluid conduit that carries an inflation fluid from a fluid source to a first balloon of the shunt. The second occlusion assembly includes a second occlusion fluid conduit that carries an inflation fluid from a fluid source to a second balloon of the shunt. The first occlusion assembly includes a first color and the second fluid assembly includes a second color, distinct from the first color. The distinctive colorings of the first and second occlusion fluid conduits remain visible within an operative field during an endarterectomy procedure and allow a user to distinguish the first occlusion assembly from the second occlusion assembly during the procedure.

Abstract: A medicament injection kit, for use in occluding a renal artery and a renal vein in a kidney and injecting a therapeutic medicament into the kidney so as to pressurize the kidney, includes: an artery catheter which includes a first balloon capable of occluding the renal artery; a vein catheter which includes a second balloon capable of occluding the renal vein; a syringe for injecting the therapeutic medicament, the syringe being capable of being connected to at least one of the artery catheter and the vein catheter; and a syringe for pressurizing the inside of the kidney by injecting a liquid, the syringe being capable of being connected to at least one of the artery catheter and the vein catheter.

Abstract: The present invention regards a therapeutic delivery balloon and includes a system for delivering therapeutic to an irregular interior vessel surface. This system includes a catheter having a proximal end, a distal end, and an internal lumen; a source of fluid in communication with the internal lumen of the catheter; and, a first inflatable balloon having an exterior surface, wherein the balloon is hyper-deformable, is in communication with the internal lumen of the catheter, and has an exterior surface in communication with a therapeutic when the balloon is in expanded state.

Abstract: Several embodiments of an endourethral prosthesis, assembly, and attendant methods are provided for patients presenting with lower urinary tract symptoms (LUTS) or urinary retention. The endourethral prosthesis includes a reversibly expandable element disposed circumferentially about, and longitudinally along a tubular member adapted to receive urine. The tubular member is positionable within a lower urinary tract such that the reversibly expandable element operatively engages a structure of the lower urinary tract so as to prevent migration of the prosthesis so positioned. The reversibly expandible element is in non-reversible fluid communication with the tubular element for selective expansion thereof, the reversibly expandible element is further operatively engagable so as to discharge fluid non-reversibly received from the tubular member exterior to same.

Abstract: A catheter and a method for using the catheter for site specific delivery of agents to or collecting agents from biological spaces. The catheter includes inflatable balloons which when inflated in a target segment of a biological space, create closed agent delivery pockets for the delivery or collection of agents from a defined space.

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 thrombolysis catheter system having a fixed length infusion zone is disclosed. The invention contemplates apparatus, method and kit aspects. The apparatus, which has the capability to track a guidewire, uses a multilumen catheter to deliver radially thrombolytic agent to an infusion zone defined by one or more balloon means. In one aspect, with an occluder means, a primary lumen of the catheter is used both for catheter placement and delivery of fluid. The method discloses utilization of radiopaque indicia to place the catheter in proximity to the occlusion or diseased tissue to be treated. The kit includes a catheter of the invention in conjunction with a steerable guidewire and a tip occluder wire, either or both of the tip occluder wire and the guidewire having an enlargement on their distal tip which cooperates with a reduced diameter portion of the catheter lumen.

Abstract: Flexible treatment catheters are configured to be inserted into a body lumen or cavity to deliver heated fluid through at least one fluid lumen therein to thermally treat or ablate a targeted site in a biological subject. The flexible treatment catheters can include improved thermally insulated regions comprising a mixture formed of liquid elastomeric (such as a polyurethane) mixture (which transitions to a solid state) and miniaturized hollow plastic bodies positioned between the outer wall of the treatment catheter and the fluid lumen. The thermally insulated region is configured such that, measured ex vivo, the treatment catheter can present a maximum temperature of below about 45° C. on the external surface of the outer wall of the treatment catheter when the treatment catheter circulates fluid having an inlet temperature of above or between about 60°-62° C.

Abstract: A combination dilatation and drug delivery device includes a flexible catheter, a drug delivery sheath mounted to a distal end region of the catheter and a dilatation balloon also mounted to the catheter and contained within a compartment formed by the sheath. The sheath is radially expandable by supplying a liquid therapeutic agent to the compartment under a moderate pressure. The dilatation balloon is expandable by providing a dilatation fluid to the balloon under a much higher pressure. The sheath can be formed of a highly elastic material or can be made quite thin, and in either case is mounted independently of the dilatation balloon. Thus when radially expanded, the sheath is moved into a conforming contact with surrounding vascular tissue. The conforming contact protects tissue and the therapeutic agent from exposure to blood, and more effectively confines the therapeutic agent to the intended treatment area.

Abstract: A catheter and a method for using the catheter for site specific delivery of agents to or collecting agents from biological spaces. The catheter includes an inner shaft longitudinally movable within an outer shaft, each shaft having at least one balloon and at least one lumen formed therein. The catheter prevents leaking through a biological membrane by sealing the catheter tip passageway through the biological membrane with inflatable balloons on either side of the biological membrane. Further, the inflated balloons secure the position of the catheter relative to the biological membrane and the biological space targeted for therapy or diagnosis.

Abstract: A vascular catheter assembly includes an over-the-wire stent deployment catheter and a flow-by-channel assembly. The stent deployment catheter is positioned just below the occluded artery in accordance with standard procedures. The flow-by-channel then shunts blood, and thus all friable plaque, from the high pressure carotid occlusion to the negative pressure extremity to effectively reverse the flow of blood through the occluded artery. The stent is then advanced into the narrowed artery and deployed. Thus, the vascular catheter assembly takes advantage of the collateral blood flow to solve the problem of stroke during endovascular procedures.

Abstract: A catheter and a method for using the catheter for site specific delivery of agents to or collecting agents from biological spaces. The catheter includes inflatable balloons which when inflated in a target segment of a biological space, create closed agent delivery pockets for the delivery or collection of agents from a defined space.

Abstract: A system and methods are described for performing catheter based procedures on high risk patients that mitigate the risk to the patient and extend the acceptable time window for response when emergencies or complications arise. The system is useful for stopped heart catheter procedures or as a safety backup in beating heart catheter procedures and is compatible with concurrent or sequential surgical interventions. The system combines a therapeutic or diagnostic catheter subsystem with a selective aortic perfusion and cardiopulmonary bypass subsystem. The catheter subsystem may include catheters for angioplasty, stent delivery, atherectomy, valvuloplasty or other diagnostic or therapeutic procedures.

Abstract: A system for controlling patient temperature uses a central venous line catheter having axially spaced distal and proximal heat exchange balloons. The central venous line catheter is provided with one or more lumens for providing access to the central blood supply of the patient, and with additional lumens for communicating heat exchange fluid to the balloons. Heat exchange fluid temperature is controlled through a feed back loop in which patient temperature is sensed and used to control a temperature control unit comprising a heating device and/or a cooling device in heat exchange relationship with the heat exchange fluid. A tubing set transports the heat exchange fluid between the central venous line and the temperature control unit, with a pump serving to circulate the fluid in a closed fluid circuit in the system.

Abstract: The present invention is directed to apparatus and methods for treating a vascular occlusion by providing an infusion catheter having an atraumatic tip and at least one delivery port configured to infuse fluid into the occlusion. The fluid that is infused dilutes the occlusion and reduces adhesion of the occlusion to an intima of the vessel wall, thereby causing the occlusion to dislodge. Emboli generated in the process are directed into an emboli removal catheter for removal.

Abstract: A medical device assembly is adapted to isolate the heart from systemic circulation while perfusing oxygenated blood to the systemic arterial circulation during a minimally invasive bypasss procedure. An arterial catheter with an external shunt valve forms a funnel which shunts antegrade aortic blood flow from the aortic root, into a distal flow port and through an internal flow lumen in the catheter, out an intermediate flow port along the catheter proximally of the anchor, and into the systemic arterial circulation. A distal internal valve selectively occludes the shunted antegrade aortic blood flow between the distal flow port and the intermediate flow port and isolates the left heart chambers from the systemic arterial circulation. Oxygenated blood may then flow from a cardiopulmonary bypass pump, distally through the internal flow lumen, out the intermediate port.

Abstract: The emboli protection system provides one or more inflatable blocking balloons for isolation of a section of a blood vessel to prevent migration of emboli from the section during an interventional procedure, and fluid infusion and evacuation ports for flushing emboli from the isolated section. One embodiment provides for a distal blocking balloon catheter, over which an interventional device can be introduced, and a proximal blocking balloon catheter to be introduced over the interventional device for isolating a portion of a blood vessel to be treated. The blocking balloons can be perforated to provide the infusion ports, and thrombolytic inflation fluid may be used to break down and dissolve thrombus and plaque in the isolated portion of the blood vessel.

Abstract: A vascular catheter assembly includes an over-the-wire stent deployment catheter and a flow-by-channel assembly. The stent deployment catheter is positioned just below the occluded artery in accordance with standard procedures. The flow-by-channel then shunts blood, and thus all friable plaque, from the high pressure carotid occlusion to the negative pressure extremity to effectively reverse the flow of blood through the occluded artery. The stent is then advanced into the narrowed artery and deployed. Thus, the vascular catheter assembly takes advantage of the collateral blood flow to solve the problem of stroke during endovascular procedures.

Abstract: The present invention provides methods for inhibiting or preventing hyperplastic intimal growth by intravascular administration of a composition comprising heparin, or a derivative thereof in conjunction with at least one electric pulse having sufficient strength and duration to cause electroporation of the cells lining the blood vessel. Such treatment inhibits or prevents hyperplastic intimal growth in vessels, such as arteries, as compared with a non-electroporated vessel to which the heparin, or derivative thereof, is administered.

Abstract: A preferred apparatus for delivering an intravascular drug such as a sclerosing agent (or a microfoam sclerosing agent) to a varicose vein includes a catheter having three concentric tubes. The innermost tube has a guide wire lumen and an inflation lumen. The distal end of the innermost tube has an integral inflatable occlusion balloon in fluid communication with the inflation lumen. The intermediate tube has a lumen through which the innermost tube extends. The distal end of the intermediate tube has a self-expanding balloon with a plurality of fluid pores in fluid communication with the intermediate tube lumen. The outer tube has a lumen through which the intermediate tube extends. Sclerosing agent is dispensed through the intermediate tube to pores located at the distal end of the intermediate tube or in the self-expanding balloon. Veins are sclerosed as the self-expanding balloon is pulled through and ultimately out of the vein.

Abstract: A medical injection device is provided which includes a shield system and a syringe which maybe coupled to the shield system. The shield system includes a syringe holder and a shield telescopically received in the holder and slidably coupled to the holder. A spring resiliently urges the shield from a retracted position to an extended position. Stop members are provided adjacent the distal end of the holder and the proximal end of the shield for maintaining the shield in the retracted position. The syringe is slidably coupled to the holder, and extends within the shield. Axial movement of the syringe with respect to the holder causes disengagement of the stop members, allowing the spring to move the shield to the extended position. Detents are provided on the holder for maintaining the shield in the extended position.

Abstract: Disclosed is a method of diverting blood from the adult retro hepatic Inferior Vena Cava (IVC) and the shunting of renal and infra renal IVC blood to the right atrium when desired during surgery on the liver, its vessels, or the retro hepatic IVC. The device has a distal component of critical length for the adult supra renal IVC. It is symmetrical on its mid horizontal axis permitting similar utility whether venous access was above or below the liver. It is a hollow plastic tube with two openings, one at each end of the tube, which has four intervening completely encircling balloons and is continuous with a proximal component which serves to manipulate the distal component within the venous system and to remotely inflate the balloons.

Abstract: Disclosed are medical devices of aliphatic polyketone polymers and/or polyketone polymer compositions comprising at least one aliphatic polyketone and at least one plasticizer. Also disclosed are polyketone compositions that comprise at least one aliphatic polyketone and at least one plasticizer.

Abstract: Disclosed are medical devices including a composition that includes an aliphatic polyketone and a thermoplastic polymer.

Abstract: The invention features a catheter particularly for the delivery of a therapeutically active substance comprising a catheter body and an inflatable structure comprising three inflatable elements and a diaphragm fixed to these elements and defining with them, a passage duct for the body fluid and a sealed cavity to contain a therapeutically active substance. The said first (3), second (4) and third (7) inflatable elements are made of one preformed piece consisting of a helically coiled tube, said third element (7) being constituted by one or more turns of the coil, the diameter of the said tube at the portion constituting the third element being less than the diameter of the said tube at the tube portions constituting the said first and second elements respectively and intended to rest against the internal wall of said body duct; the said catheter body is disposed inside the coil of the said tube, in the aforementioned duct. This invention is useful in the preventive treatment of restenosis.