Abstract: The present invention is a method of using a safety shield assembly having a shield and a collar and more particularly a method of using a safety shield assembly with a fluid handling device whereby the shield may be pivoted with respect to the collar. Preferably, a method of using a safety shield assembly with a needle assembly, an intravenous infusion set a syringe, a catheter or other fluid handling devices or assemblies that contain piercing elements.

Abstract: A method and system for delivering a medicinal agent to a treatment site within a limb of a patient. An infusion catheter is inserted into a blood vessel and advanced to the treatment site. To prevent blood flow through the treatment site from carrying away the medicinal agent, the blood flow in the limb is stopped by applying external pressure with a constriction device, such as a pressure cuff or a tourniquet, and/or with a balloon on the catheter. The medicinal agent is then injected through the catheter. Optionally, the infusion process is repeated in successive cycles that are separated by a rest period in which blood flow in the limb is allowed to resume. A controller automates the process. Preferably a distal constriction device is used to prevent the medicinal agent from flowing out of the treatment area into tissue distal of the treatment area.

Abstract: A method and system for delivering a medicinal agent, such as a therapeutic drug or diagnostic agent, to a treatment site within a limb of a patient. An infusion catheter is inserted into a blood vessel and advanced to the treatment site. To prevent blood flow through the treatment site from carrying away the medicinal agent, the blood flow in the limb is stopped by applying external pressure with a constriction device, such as a pressure cuff coupled to an inflation pump, or a tourniquet. The medicinal agent is then injected through the catheter with an infusion pump while the blood flow is stopped. Optionally, the infusion process is repeated in successive cycles that are separated by a rest period in which blood flow in the limb is allowed to resume. A controller can be used to automate the process.

Abstract: A wire guided fluid catheter assembly having a collapsible guidewire lumen. Pressurization of a fluid lumen in the catheter assembly collapses the guidewire lumen, thereby increasing the fluid flow capacity of the catheter assembly.

Abstract: Apparatus and methods are disclosed for performing beating heart surgery. Apparatus is disclosed comprising a cannula having a proximal end and a distal end; an aortic filter in connection with the cannula, the aortic filter having a proximal side and a distal side; a check valve in connection with the cannula, the check valve disposed on the distal side of the aortic filter; and a coronary artery filter in connection with the cannula, the coronary artery filter having a proximal end and a distal end, and the distal end of the coronary artery filter extending distally away from the distal end of the cannula. A method is disclosed comprising providing apparatus for performing beating heart surgery; deploying the apparatus in an aorta; performing a procedure on the aortic valve; and removing the apparatus from the aorta.

Abstract: Methods are provided for conducting surgical procedures in a patient wherein, during the surgical procedure, autonomous ventricular electrical conductivity and escape beats are reversibly and transiently suppressed to facilitate the surgical procedure. Also provided are compositions which are capable of inducing ventricular asystole in a patient. The compositions may include an AV node blocker. In one embodiment, compositions including an atrioventricular (AV) node blocker and a &bgr;-blocker are provided, wherein the &bgr;-blocker is present in an amount sufficient to substantially reduce the amount of AV node blocker required to induce ventricular asystole in the patient. The compositions and methods may be used for inducing temporary ventricular asystole in a beating heart, and to facilitate the performance of a variety of surgical techniques, including minimally invasive microsurgical techniques.

Abstract: Acute care method and apparatus for treating a patient experiencing thrombotic vascular occlusion includes introducing a selected dose of an active agent proximate a vascular occlusion in the patient in order to lyse the vascular occlusion and radiating the vascular occlusion and active agent.

Abstract: A method and several assemblies for the reducing of mineralization of cardiovascular tissue in vivo is provided. The method involves contacting cardiovascular tissue, such as a valve or a vessel, with an acidic treatment solution. One apparatus is a balloon catheter assembly for the infusion of an acidic treatment solution into a define area of a cardiovascular tissue. A second apparatus is a flexible cup which forms a defined area with the wall of a vessel for the introduction of an acidic treatment solution for the reduction of mineralization of a vessel. A third apparatus is an assembly for the introduction of an acidic treatment solution on one side of a valve, and the removal of the acidic treatment solution from the opposite side of the valve. Each apparatus can take the form of an elongated catheter for use in minimally invasive procedures or as hand held devices for use in an open surgical field.

Abstract: An improved aortic cannula for use in heart bypass surgery comprises an elongated tube with a terminal end. The improvement relates to the provision of two large openings adjacent the terminal end of the cannula, and an inverted cup at the terminal end to redirect the flow of blood as the blood exits through the discharge openings. The cup deflects a portion of the blood rearwardly so as to slow the velocity of the blood. The openings and the cup serve to reverse the flow of blood toward the ascending aorta and away from the aortic arch so as to prevent dislodging plaque, and thereby decreasing the chances of stroke.

Abstract: A device and method for delivering and injecting fluid into heart tissue utilizing high pressure injection to increase injectate (fluid) retention in the heart tissue. The catheter includes a shaft having an infusion lumen extending therethrough, wherein the proximal end of the shaft connected to a pressurized fluid source capable of generating a transient pressure of more than 1000 psi. The distal end of the shaft includes a nozzle having an injection port in fluid communication with the infusion lumen such that fluid from the pressurized fluid source may be delivered to the heart tissue at a sufficiently high exit velocity to partially penetrate the heart tissue.

Abstract: Methods and devices are provided for at least reducing the mineral content of a vascular calcified lesion, i.e. a calcified lesion present on the vascular tissue of a host. In the subject methods, the local environment of the lesion is maintained at a subphysiologic pH for a period of time sufficient for the mineral content of the lesion to be reduced, e.g. by flushing the lesion with a fluid capable of locally increasing the proton concentration in the region of the lesion. Also provided are systems and kits for practicing the subject methods. The subject methods and devices find particular use in the treatment of vascular diseases associated with the presence of calcified lesions on vascular tissue.

Abstract: Methods are provided for locally administering an agent to a host. Specifically, the subject methods provide for the local administration of an agent to an interstitial space of a host. In the subject methods, an agent is retroinfused into a vessel of a host, typically a vein, under conditions sufficient for the agent to enter an interstitial space of the host proximal to the vessel location into which the agent is retroinfused. In practicing the subject methods, the agent is administered to the host in combination with the production of vascular stress at the site of administration, where the vascular tissue stress is sufficient to provide for transport of the agent from the vascular site of deposition into the target interstitial space. In a preferred embodiment, the agent is retroinfused at a pressure sufficient to provide for mechanical stress on the vessel proximal to the target interstitial space. Also provided are kits for use in practicing the subject methods.

Abstract: A method for closed-chest cardiac surgical intervention relies on viewing the cardiac region through a thoracoscope or other viewing scope and endovascularly partitioning the patient's arterial system at a location within the ascending aorta. The cardiopulmonary bypass and cardioplegia can be induced, and a variety of surgical procedures performed on the stopped heart using percutaneously introduced tools.

Abstract: A device cooperating with a pump for guiding a contrast medium from a source thereof to a catheter for delivery to a patient's vascular system The device comprises a dual check valve, a tubular member, an in-line check valve and a three-port stopcock. The dual check valve has an inlet port connectable to the source of contrast medium, an inlet-outlet port connectable to the pump, and an outlet port coupled to the tubular member. The in-line check valve is connected to the tubular member at a point spaced from the dual check valve for preventing fluid flow towards the dual check valve. The stopcock connected at a first port to the in-line check valve, a second port of the stopcock being operatively connectable to the catheter. Using this device, medical personnel infuses contrast medium into the patient from the source without having to disconnect any element from the device during the infusion process.

Abstract: A perfusion catheter is used to avoid ischemia in case of failure of a conventional balloon angioplasty procedure on a stenotic blood vessel and a resulting partial or complete occlusion of the vessel. The balloon catheter is first removed from the vessel while the guide wire and the guide catheter are left in place. The perfusion catheter is immediately inserted into the guide catheter and run past the stenosis using the guide wire already in place. Blood is drawn from a side port in the sheath introduced at the point of entry into the vascular system of the patient under normal arterial pressure or after passing through an exterior pump for pressurization and re-injection in the perfusion catheter. Thus, blood flow to the part of the vessel past the occlusion can be reestablished within minutes of angioplasty failure and the patient can be stabilized in preparation for heart surgery.

Abstract: A ball-shaped implant made out of a pliable fiber. The fiber is introduced into the body and when it encounters body tissue it folds upon itself to form a ball-shaped implant. A fluid may be placed around the implant either to hold it in place or to add a biologically active agent to the implant. The fiber of the implant may be biodegradable, or hollow and porous to allow for drugs placed inside the fiber to be administered to the body. One end of the fiber may be long enough to extend out of the body for later removal.

Abstract: A flow-through blood treatment device such as a hemodialyzer comprises a housing, a blood inlet, a blood outlet, and at least one membrane in the housing defining a blood flow path between the blood inlet and outlet on one side of the membrane, plus a second flow path defined on the other side of the membrane. At least one of the blood inlet and outlet is connected to blood flow tubing, which blood flow tubing carries a connector spaced from the housing for access to the vascular system of a patient. The blood flow tubing also defines at least one connection site along its length permitting repeated, temporary connection and subsequent disconnection with branch conduits, for connection with sources of additive solutions or measuring devices. Typically, the blood flow tubing is free of permanently attached, flexible branch tubings a method of use in disclose.

Abstract: Catheter devices and methods for their use in enhancing fluid flow through a vascular site occupied by a vascular occlusion are provided. The subject catheter devices include at least a first, second and third lumen, where: (a) the first lumen is used for delivery of an acidic dissolution solution to the vascular site; (b) the second lumen is used for delivery of a buffer solution to the vascular site; and (c) the third lumen is used for removal of fluid from the vascular site. In many preferred embodiments, the first, second and third lumens are coaxial. In practicing the subject methods, the vascular site is flushed simultaneously with an acidic dissolution fluid and a buffer solution, where flushing is carried out in a manner such that only a surface of the vascular occlusion is contacted with the acidic dissolution fluid and the remainder of the vascular site is not contacted with fluid having a pH that is lower than about 4.

Abstract: A no-needle blood access device for hemodialysis comprising, an artificial conduit (12) whose opposite ends are anastomosed to a targeted artery or vein; a metallic body (20), the body including a cylindrical horizontal portion (22) covering the entire circumference of the conduit or an arcuate-shaped horizontal portion (50) covering at least an upper half of the circumference of the conduit, and a cylindrical vertical portion (24) connected to approximately the center of the upper part of the horizontal portion so as to be disposed perpendicular to the horizontal portion and defining a well (26) therein, the horizontal portion being provided at the part located at the bottom of the well with a first pair of apertures (30, 32), the conduit being provided at the corresponding part with a second pair of apertures (30, 32), whereby the well is in communication with the conduit through the apertures; and a pair of shutters (34, 36) slidably housed within opposed pockets formed in the upper part of the horizontal

Abstract: Methods and apparatus are provided for temporarily excluding an aneurysm or an arterio-venous fistula from a flow path by transluminally disposing a hollow balloon catheter structure within the aneurysm so that its proximal and distal ends extend past the aneurysm while maintaining continuity of the flow path, and then injecting a synthetic molding material or a biological hardening agent into the aneurysm cavity to cause solidification of the volume within the cavity. Once the material within the excluded aneurysm has solidified, the balloon catheter structure is deflated and removed, so that the hardened mass forms a new lining for the organ or vessel, and relieves the weakened tissue of the aneurysm or fistula from further flow-induced stress.

Abstract: A cannula has a distal portion which is angled relative to a proximal portion. The distal portion is straightened during introduction with a stiffening element. After introduction, the stiffening element is removed so that the distal portion angulates relative to the proximal portion so that the cannula can be moved out of the surgical field. The cannula preferably includes a stabilizing ring having suture holders. The stabilizing ring is also preferably angled relative to the cannula.

Abstract: A method and device for injecting fluid into a treatment area of a vessel wall is provided herein. A first version of the device includes an inflatable balloon mounted on a catheter and a plurality of dispensers extending outwardly and moving with the balloon. At least one fluid passageway connects each injector in fluid communication with a fluid source. During use of the device, the balloon is first positioned in a vessel proximate the treatment area. Next, the balloon is inflated to embed the dispensers into the vessel wall. Subsequently, the fluid from the fluid source is introduced into the fluid passageway and through the dispensers into the treatment area. A second version of the device includes a plurality of flexible tubes mounted between a multi-lumen catheter and a grommet. A push-pull wire is connected to the grommet and passed through a lumen of the multi-lumen catheter. The dispensers are mounted on each of the flexible tubes. During use, the device is first positioned in a vessel.

Abstract: The present invention relates to a transfection system comprising one or more Infiltrator catheters, one or more non-viral nucleic acids, and, where appropriate, suitable ancillary substances and/or additives, and to its preparation and use in somatic gene therapy.

Abstract: An apparatus and method for insertion of a catheter, such as an IAB catheter, into a blood vessel such that the cross-sectional area of the catheter will be minimized while the circumference of the catheter is maximized. The apparatus is formed as an oval tube of flexible plastic. When placed in a blood vessel, the catheter retains its oval configuration to minimize obstruction to blood flow. During inflation of the balloon bladder at the end of the catheter, the catheter retains its general oval shape. When the catheter is placed in the blood vessel by pre-loading the catheter over a guide wire and inserting the catheter and guide wire without an introducer sheath into the blood vessel both the catheter and its leading balloon bladder are approximately of the same perimeter thereby reducing the possibility of arterial bleeding.

Abstract: A method an apparatus for introducing an intravenous catheter. In one embodiment, a catheter having a flashback chamber is provided, the flashback chamber having a proximal end, a distal end and an inner wall. The distal end of the flashback chamber being in fluid communication with the catheter needle. A moveable member within the flashback chamber sealingly engages with the inner wall of the flashback chamber, the member being movable within the flashback chamber in a direction from the distal end to the proximal end of the flashback chamber. The movement of the member creates a vacuum within the flashback chamber.

Abstract: A pool filling nozzle is provided with a supporting bracket and a clamp to secure the nozzle to the top of a swimming pool wall or to a pool accessory such as a ladder step, a platform or a diving board. The bracket is L-shaped defining a top horizontal arm on which the nozzle is secured and a vertical arm provided with a central slot. The clamp is also L-shaped and defines a vertical arm in slidable guided contact with the vertical arm of the bracket and a horizontal arm extending substantially parallel and in the same direction to the horizontal arm of the bracket. A tightened releasably tightens the two vertical arms in adjusted position to adjust the spacing between the two horizontal arms. The clamp is reversible. Thus, the nozzle can be clamped to a swimming pool parts of a large range of thickness. The bracket and the clamp are preferably made of thin flexible material so that the two horizontal arms can be opened to easily clip the bracket to the pool part.

Abstract: A method for inducing angiogenesis in blood vessels proximal to ischemic tissue or proximal to stenosed regions including application of an estrogen compound to the blood vessel walls at a treatment site proximal to or upstream of the stenosis. A preferred delivery device is a double walled drug delivery catheter having porous outer walls. Another suitable delivery device is a drug injection device for injecting angiogenic material into blood vessel walls. One delivery method utilizes iontophoresis.

Abstract: A method and apparatus are provided for introducing molecules such as genes and pharmaceutical compounds into living blood cells of a patient for therapeutic purposes. A device is placed into contact with the body of the patient for generating an electric field at a preselected location within a selected blood vessel. Preselected molecules are infused into the selected blood vessel. Simultaneously an electric signal is applied to the applied device to repeatedly subject a quantity of blood flowing within the selected blood vessel past the preselected location to electric fields of a predetermined amplitude and duration. The parameters of the electric fields are precisely controlled in order to make the walls of preselected cells in the blood transiently permeable to permit the molecules to enter said preselected cells without killing said cells.

Abstract: Methods are provided for conducting surgical procedures in a patient wherein, during the surgical procedure, autonomous ventricular electrical conductivity and escape beats are reversibly and transiently suppressed to facilitate the surgical procedure. Also provided are compositions which are capable of inducing ventricular asystole in a patient. The compositions may include an AV node blocker. In one embodiment, compositions including an atrioventricular (AV) node blocker and a .beta.-blocker are provided, wherein the .beta.-blocker is present in an amount sufficient to substantially reduce the amount of AV node blocker required to induce ventricular asystole in the patient. The compositions and methods may be used for inducing temporary ventricular asystole in a beating heart, and to facilitate the performance of a variety of surgical techniques, including minimally invasive microsurgical techniques.

Abstract: Methods and apparatus for percutaneously accessing an implanted port use an access cannula which is periodically introduced to an aperture on the implanted port so that the cannula passes through the same tissue tract. It has been found that repeated passage of the cannula through the same tissue tract reduces patient trauma, with minimized bleeding, reduction in sensitivity. The tract may be initially formed by percutaneously placing a penetrating element through intact skin to the port and leaving the element in place for a time sufficient to created the tract.

Abstract: A method and system for lysing a patient's heart tissue causing or involved with arrhythmia which includes an intravascular catheter with a relatively inelastic occlusion balloon on the distal end of the catheter which is inflated to block an artery or vein of the patient's heart so than when lysing fluid such as an ethanol solution is discharged from the distal port in the catheter the inflated balloon prevents the proximal refluxing of lysing medium into undesirable areas of the patient's heart. The inelastic balloon is configured to be inflated to a diameter of about 0.7 to about 1.3, preferably about 0.8 to about 1.2, times the diameter of the blood vessel in which the balloon is to be inflated so as to effectively occlude the passageway without damaging the wall of the blood vessel. The working length of the balloon is less than about 1.5 cm, preferably less than 0.75 cm.

Abstract: Disclosed are pharmaceutical composition of a sterile, injectable physiologically acceptable solution containing nitric oxide (NO), processes for preparing the compositions and a process for detecting physiologically present NO. With these NO solutions, NO in high doses can trigger locally in vessels, e.g. coronary vessels, specific local biological effects such as relaxation of the smooth vascular musculature, inhibition of thee adhesion of thrombocytes, etc., without producing systemic side-effects, such as for example, a critical drop in blood pressure, in spite of the high does. The detection process enables the presence of an endothelial dysfunction to be established from the whole blood of humans and other mammals.

Abstract: The present invention is directed to intraluminal shunt devices and methods of their use for delivering a drug or other fluid to a target vessel of a patient while also maintaining perfusion of blood through the vessel to reduce ischemia downstream of the vessel. The intraluminal shunt devices may generally include a primary elongate tubular member that is sized and dimensioned to be inserted into the target vessel, such as the right coronary artery. The primary tubular member includes at least one inner lumen which permits blood perfusion through the vessel. At least one secondary tubular member is provided which is in fluid communication with the primary tubular member. The secondary tubular member may be configured for drug or fluid delivery through the primary tubular member and into the vessel in either an anterograde or retrograde direction.

Abstract: Apparatus and methods are provided for utilizing a combination of ultrasonic energy and an echo contrast agent containing microbubbles, for substantially dissolving blood clots or other fistula obstructions. One embodiment of the present invention alternatively utilizes a selected dose of thrombolytic agent in combination with an echo contrast agent, for enhancing the thrombolytic action of a thrombolytic agent and removing a thrombosis from a fistula.

Abstract: Methods are provided for conducting surgical procedures in a patient wherein, during the surgical procedure, autonomous ventricular electrical conductivity and escape beats are reversibly and transiently suppressed to facilitate the surgical procedure. Also provided are compositions which are capable of inducing ventricular asystole in a patient. The compositions may include an AV node blocker. In one embodiment, compositions including an atrioventricular (AV) node blocker and a .beta.-blocker are provided, wherein the .beta.-blocker is present in an amount sufficient to substantially reduce the amount of AV node blocker required to induce ventricular asystole in the patient. The compositions and methods may be used for inducing temporary ventricular asystole in a beating heart, and to facilitate the performance of a variety of surgical techniques, including minimally invasive microsurgical techniques.

Abstract: Targeted tissue in vivo is altered using focused energy to specifically control endothelial permeability and interstitial integrity. Image guidance may be used in combination with physical energy deposition to facilitate the targeted delivery of materials. The method of the invention serves as a platform for delivering pharmaceutical agents, nucleic acids, proteins, liposomes, etc. to cells.

Abstract: An apparatus and method for delivering diagnostic and therapeutic agents intravascularly in which the apparatus has a shape defined by a preset shape of a resilient fiber core. The resilient fiber core is covered by a soft polymer tubing or other polymer material to form a delivery apparatus that takes the shape of the resilient fiber core. Various shapes and structures are disclosed that infuse diagnostic and therapeutic agents through a lumen of the polymer tubing, that deliver the agents in the form of a soluble coating, and that circulate or contain a preloaded charge of radioactive material for intravascular radiotherapy. The resilient fiber core and soft polymer material permit the construction of a very small apparatus that can be removed easily following treatment. Various deployment systems are disclosed for deploying the delivery apparatuses into a vessel and for protecting against radiation exposure.

Abstract: A surgical cannula includes a generally hollow inlet portion which can receive a fluid flow and an angled outlet portion connected in fluid communication with the inlet portion. The outlet portion is disposed at an angle of less than 180 degrees with respect to the longitudinal axis of the inlet portion. The inlet portion is provided with a structure to impart a rotational component of flow to fluid before such fluid encounters the angled outlet portion.

Abstract: Methods and apparatus for percutaneously accessing an implanted port use a large bore coring needle. The coring needle is periodically introduced to an aperture on the implanted port so that the needle passes through the same tissue tract. It has been found that repeated passage of the needle through the same tissue tract reduces patient trauma, with minimized bleeding, reduction in sensitivity, in contrast to the use of non-coring needles.

Abstract: An endoscopic cardioplegic infusion cannula and its method of use is provided for occluding the ascending aorta and infusing cardioplegic fluid into the coronary arteries. A cannula is inserted suprasternally and the distal end of the cannula is inserted into the ascending aorta. An occlusion balloon on the distal end of the cannula is inflated and occludes the ascending aorta. Cardioplegic fluid is infused through the cannula proximal to the occlusion balloon and perfused into the coronary arteries. In order to effect a better seal where the distal end of the cannula is inserted into the ascending aorta, an outer sheath having a flange is advanced over the cannula into contact with the ascending aorta to compress a portion of the ascending aorta between the flange and the occlusion balloon. Cardiopulmonary bypass is effected in a known manner to supply the patient with oxygenated blood. The cannula and its method of use can be used in a closed or open chest procedure.

Abstract: A low profile wire perfusion catheter is disclosed for use in percutaneous transluminal coronary angioplasty. The catheter includes a wire configured to be inserted into a blood vessel. The wire is hollow and defines an axial lumen therein. An inflation balloon is attached directly to the wire and is configured to expand radially outward in response to inflation thereof. Inflow and outflow perfusion ports extend through the wire and communicate with the lumen to allow perfusion of blood across the balloon when the balloon is inflated within a blood vessel. Because the balloon is attached directly to the wire, the catheter has an advantageously low cross-sectional area.