Abstract: Apparatus for sealing a puncture communicating with a blood vessel includes a pair of syringe barrels having sealing components therein, and a plunger assembly biased to slide within the barrels from proximal to distal positions for injecting the components through outlets of the barrels. An auto-injector assembly is coupled to the plunger apparatus, and includes a spring mechanism locked in an inactive condition and an actuator activatable to release the spring mechanism, whereupon the spring mechanism automatically advances the plunger assembly towards the distal position to inject the components from the barrels. A valve coupled to the outlets and movable from a first position for mixing and/or reconstituting the sealing components from vials, a second position where the outlets communicate with a delivery line for delivering the sealing components into a puncture, and a third position for closing the outlets.

Abstract: A needle assembly has a first body and a guide rod supported for sliding movement between an extended position and a retracted position. A second body is attached to the guide rod. The second body is relatively farther from the first body when the guide rod is in the extended position and relatively closer to the first body when the guide rod is in the retracted position. The guide rod is biased to the extended position. The second body supports a venting needle that extends beyond the second body by a fixed length. A liquid handling needle is coupled to the first body. Sliding movement of the guide rod toward the retracted position retracts the second body and the venting needle relative to the liquid handling needle.

Abstract: A vascular access device comprises a bridge having first and second bores therethrough, a dilator in the first bore, and a needle guide in the second bore. The second bore is at an angle with respect to the first bore such that the needle guide is at the angle with respect to the dilator. The device is useful, for example to achieve dual site entrance to a blood vessel.

Abstract: An arrangement for administering a medication to a patient. The arrangement is provided with a dual output element having first and second outputs, and an input for receiving the medication. A first catheter is coupled to the first output of the dual output element for delivering the medication intravenously, the first catheter being provided with a pressure valve that opens at a pressure P1. A second catheter is coupled to the second output of the dual output element for delivering the medication subcutaneously upon failure of the first catheter to deliver the medication intravenously, the second catheter being provided with a pressure valve that opens at a pressure P2, where P1>P2. A monitored radiopaque disk valve arrangement changes its status at a pressure P3 when a catheter occlusion is present, and is also used to obviate the need for two different types of catheters.

Abstract: Methods and compositions for use in perfusion applications are provided. In the subject methods, a subject or derivative thereof, e.g. isolated organ or tissue, is infused, perfused and/or transfused with at least two fluid compositions. The first fluid composition is a non-naturally occurring biological buffer free plasma-like solution and the second fluid composition is a fluid blood composition. In a preferred embodiment, an additional volume of the first solution, or a derivative thereof, is administered to the patient following introduction of the fluid blood composition. Also provided are kits and systems for performing the subject methods. The subject methods and compositions find use in variety of perfusion applications, including the treatment of hypothermic surgical applications, cryogenic procedures, and the like.

Abstract: A catheter system for injecting therapeutic agents including large molecules into the body. The catheter includes a distensible penetrating element with a distally locating expansion coil and a distally located chamber for holding a therapeutic agent which is to be injected into the body.

Abstract: A catheter for delivering a therapeutic or diagnostic agent to a branch blood vessel of a major blood vessel, generally comprising an elongated shaft having at least one lumen in fluid communication with an agent delivery port in a distal section of the shaft, an expandable tubular member on the distal section of the shaft, and a radially expandable member on the tubular member. The tubular member is configured to extend within the blood vessel up-stream and down-stream of a branch vessel, and has an interior passageway which is radially expandable within the blood vessel to separate blood flow through the blood vessel into an outer blood flow stream exterior to the tubular member and an inner blood flow stream within the interior passageway of the tubular member.

Abstract: Methods for the treatment of sepsis related cardiac dysfunction are disclosed.

Abstract: Cardiomyopathy may be treated by distributing a space-occupying diastole-assist agent within the myocardium or within the cardiac venous system in a pattern about one or more chambers of the heart, such that the space-modifying agent integrates into and thickens at least part of the cardiac wall about the chamber so as globally to reduce wall stress, stabilize or even reduce chamber size, and/or improve diastolic function. Some patterns also cause a beneficial global reshaping of the chamber. These changes occur quickly and are sustainable, and have a rapid and sustainable therapeutic effect on cardiac function. Patterns of distribution of space-occupying agent within the myocardium for global resizing may also be used or augmented to treat localized conditions such as myocardial infarctions, overt aneurysm of the ventricular wall as typically forms in response to large transmural myocardial infarctions, and mitral regurgitation due to a noncompliant mitral valve.

Abstract: The present invention relates to methods and devices for administration of vaccines and gene therapeutic agents into the intradermal layer of skin.

Abstract: Materials, methods, and systems for targeted and non-targeted therapeutic delivery in vivo utilizing cavitation-mediated ultrasonic drug delivery are described. Noninvasive sonic energy being applied to the patient in a controlled fashion at the treatment area results in controlled acoustic cavitation at said region, and cell and tissue specific drug delivery. Microbubbles, both in the form of contrast agents, and/or other active agents infused into the patient, and/or bubbles formed from previous ultrasound exposure, allow for predictable cavitation thresholds, requiring much lower incident ultrasound intensities for permeating tissue. Further, methods and systems are provided that result in more spatially regular areas of controlled tissue permeability upon treatment, limiting cytotoxicity and sonolysis, and maximizing intracellular drug delivery.

Abstract: Intramedullary access or infusion devices that includes a tubular conduit having a distal end and a proximal end with a length sufficient to pass through the cortical region to the cancellous region of a bone; a flange circling the outside of the proximal end of the conduit; and a penetrable diaphragm positioned within the tubular conduit, are described. The devices may be placed in bone and later used, for example, as a site for administering a pharmacologically active agent.

Abstract: A single-use system for separating blood and producing platelet concentrates includes an elongated container for receiving blood from a patient. The container has a movable plunger mounted within the blood container for expressing blood fractions separated during centrifugation of the container through a first port mounted at one end of said container, a second port mounted on the plunger, and a third port mounted on a plunger rod attached to the plunger.

Abstract: Structurally supportive material is implanted or injected into cardiac veins as discrete masses at various sites in the cardiac venous system to reinforce the myocardium for the purpose of preventing, moderating, stopping or reversing negative cardiac remodeling due to various adverse cardiac conditions, both acute and chronic, or for the purpose of treating localize anomalies of the heart, or for both purposes. The sites may be arranged in a pattern about one or more chambers of the heart such that the masses cooperatively reduce stress in the chamber wall and reduce chamber size. Some patterns also cause a beneficial global reshaping of the chamber. These changes occur quickly and are sustainable, and have a rapid and sustainable therapeutic effect on cardiac function.

Abstract: An apparatus for warming fluids includes a heating element having a resistance value that limits an amount of heat dissipated from the heating element to a threshold temperature value in response to a specific amount of electrical energy being applied to the heating element. A fluid carrying member may have the heating element coupled thereto to transfer heat from the heating element to a fluid within the fluid carrying member. A power supply may control a temperature of the fluid so as not to exceed the threshold temperature value by applying the specific amount of electrical energy to the heating element.

Abstract: Treatment of aneurysmal blood vessels with local delivery of therapeutic agents thereby reduces or lessens the severity of an aneurysm, and, where used in conjunction with the placement of an excluding device, provides for more rapid recovery of the blood vessel from any disturbance occurring during placement of the excluding device. Therapeutic agents are placed in the aneurysmal site in a time-release carrier medium, such that the therapeutic agent is released into the aneurysmal site over a period of time without the need to provide systemic introduction of the therapeutic agent. The carrier may be introduced through the patient's dermis, such as with the use of a laparoscope, or intravascularly, through the use of a catheter. The carrier may be in a solid matrix, viscous liquid or liquid form.

Abstract: An infusor system for administering medications to a venous blood vessel in the body of a patient. The infusor system includes a flexible, elongated delivery tube having opposite ends. One of the ends is couplable to a supply of liquid medication, which is remote from the venous blood vessel. The system further includes a delivery component coupled to the other end of the delivery tube. This delivery component is adaptable to be placed in confronting relationship with the venous blood vessel so that medication from said supply may be introduced directly into the venous blood vessel and distributed in the body of the patient. The infusor system further includes a pressure-altering device used for increasing intraabdominal pressure in the body of the patient. Sampling of venous blood from the meningorrhachidian vasculature is also possible.

Abstract: A method of vascularizing cardiac tissue using an instrument through the vascular system to an entry situs located at or adjacent the cardiac tissue is provided including providing a flowable agent comprising microspheres or microparticles having a particulate size range of 1 micron to 1 mm, introducing the agent through the instrument, imparting a particle moving force through the instrument that is generated externally to cause the microspheres or microparticles to pass directly through contiguous tissue to target cardiac tissue, the particle-moving force imparting a high pressure on the agent of several thousand psi, the microspheres or microparticles passing through the contiguous tissue without any mechanical means, whereupon the microspheres or microparticles directly enter the target cardiac tissue, forming channels in the wall of the myocardium at spaced locations and in communication with the interior of the heart, and introducing the flowable agent in the channels.

Abstract: A system for delivering ultrasound energy to a treatment section in a vessel is disclosed. The system includes a sheath with a utility lumen and an energy delivery section at least partially constructed from a material which transmits ultrasound energy. The system also includes a drug delivery member having a plurality of drug delivery ports which are positioned adjacent the energy delivery section. The system further includes an elongated body including at least one ultrasound element and configured to be movably positioned within the utility lumen to transmit the ultrasound energy from the ultrasound element through the energy delivery section.

Abstract: A method and device for the treatment of an aneurysm are provided. Different therapeutic agents are delivered to the aneurysmal site by a reservoir and delivery means in a localized, and, in some embodiments, time-released regimen, to treat, limit and reduce the severity of the aneurysm.

Abstract: A method for enlarging a peripheral vein so as to facilitate venipuncture of the vein by topically applying a vasodilator salt compound to skin overlying the vein and permitting the salt compound to cause the vein to enlarge by causing the vein to fill with blood.

Abstract: A medical device may include a vascular access device having a body and a membrane of the body. The membrane communicates with a pathogenic environment and discourages adhesion of a pathogen to the membrane. A method of discouraging a pathogen from residing on the membrane of a vascular access device includes providing a vascular access device with a body having a membrane and discouraging a pathogen from residing on the membrane.

Abstract: A catheter for percutaneous insertion includes a sheath portion, an insertion member, an injection needle, and paired electrodes. The sheath portion has a lumen extending therein. The insertion member is disposed slidably in the lumen of the sheath portion and provided with a distal end portion capable of protruding from a distal end portion of the sheath portion. The injection needle is disposed in the distal end portion of the insertion member for injecting a therapeutic composition to a target tissue. The paired electrodes are disposed in a distal end portion of the catheter for measuring impedance.

Abstract: A mixture for intravenous injection to treat damaged vascular structures contains a mixture of carbamide peroxide and a sclerosing agent. The injected mixture expresses blood from the affected vascular structure by formation of bubbles, in situ. The bubbles carry the sclerosing agent into contact with the lining of the vascular structure resulting in destruction. The size of the bubbles may be varied by adding hydrogen peroxide and varying the proportions of carbamide peroxide and hydrogen peroxide in the mixture.

Abstract: A disposable high density optically readable polydeoxynucleotide array with integral fluorescence excitation and fluorescence emission channels is described. The compact array size allows integration into several types of interventional devices such as catheters, guidewires, needles, trocars and may be used intraoperatively. Highly sensitive monitoring of the metabolic and disease pathways of cells in vivo under varying chemical, genetic and environmental conditions is afforded.

Abstract: A method of inhibiting restenosis is disclosed. The method includes reducing contaminants during manufacturing of angioplasty devices and during angioplasty procedures. An angioplasty device is preferably examined for contaminants prior to the angioplasty procedure, and the contaminants are reduce if present.

Abstract: A method for the treatment of thrombosed hemodialysis access grafts or fistulas defining a shunt positioned between an arterial side and a venous side is achieved by inserting a balloon catheter within the shunt, wherein the balloon catheter includes a distal balloon and at least one infusion aperture located proximally of the distal balloon. Thereafter, the balloon catheter is advanced within an arterial anastomosis at an artery-shunt juncture and the distal balloon is inflated. A thrombolytic agent is then injected through the infusion apertures of the balloon catheter into the shunt to chemically destroy clot material within the shunt, wherein by applying the thrombolytic agent with the distal balloon inflated at the arterial anastomosis the possibility of the clot material moving into the artery is prevented and there is no need to worry about the migration of the clot into the arterial system and the resulting complications.

Abstract: Methods are provided for partial aortic occlusion for cerebral perfusion augmentation in patients suffering from global or focal cerebral ischemia. The descending aorta is accessed. A device is then located downstream from the takeoff of the brachiocephalic artery. The device is operated to at least partially obstruct blood flow in the aorta during systole and diastole. A physiologic parameter can be measured. The device can then be adjusted to modify the degree of obstruction based on the measured physiologic parameter.

Abstract: The invention relates to methods for preventing and treating disseminating cancers. Inhibition metastases of a primary tumor to a liver tissue is carried out by directly contacting a liver tissue with Taurolidine.

Abstract: A method for reducing distal embolization during insertion of devices to treat plaque, thrombi and other intravascular occlusions. Using a guide catheter, a guidewire is delivered to a site proximal to the lesion. An aspiration catheter is then introduced over the guidewire, and the two are moved together in a distal to proximal direction across the occlusion. The aspiration catheter is then moved in a proximal to distal direction while continuously aspirating, which prevents embolization of any particles which may be created during the crossing of the guidewire.

Abstract: A dilating and support apparatus with disease inhibitors and methods for use is disclosed that is particularly useful for repairing and/or serving as a conduit for body passageways that require reinforcement, dilatation, disease prevention or the like. Such apparatuses are utilized to deliver a therapy, that therapy being from a family of devices, drugs, or any of a variety of other elements to a specific location within the body. The instant disclosure provides a system of combining a novel radial deployment and/or drug delivery therapy with existing balloon dilatation therapy into one device. This combination will yield a significant decrease in cost to the healthcare system as well as providing a therapy to the patient with increased safety and efficacy. Further, the instant invention provides a novel and improved platform for synthetic/tissue interface between the device and the body.

Abstract: An apparatus and method to treat vulnerable plaque. In one embodiment, the apparatus has an elongated catheter body adapted for insertion in a body lumen, with a drug delivery device attached near a distal portion of the elongated body. The drug delivery device is configured to deliver a biologically active agent to stabilize a vulnerable plaque.

Abstract: This invention is a cannulation apparatus, and related methods for providing indirect access to a surgical site within a patient. The cannulation apparatus includes at least two fluid flow paths that are slidable coupled (40) (50) to one another, and selectively positional within the patient. The first, the second flow path s may be advanced through a single incision disposed remotely from the surgical field to first, and second predetermined locations within the patient. Exemplary sites for the incision include the groin region or in the neck region of the patient. The cannulation apparatus, and method of the present invention are particularly suited for use in providing cardiopulmonary support during cardiac surgery, including coronary artery bypass graft surgery. The cannulation apparatus of the present invention also provides an entry site for one or more support devices used in the surgical procedure.

Abstract: A needle assembly includes a needle hub with opposite proximal and distal ends and a passage extending between the ends. The needle cannula has a proximal end mounted in the passage of the hub and a distal end aligned at an angle to the proximal end. Wings project transversely from the hub to facilitate a temporary affixation of the needle assembly to a patient. A safety shield is hingedly mounted to the hub and can be rotated from an open position spaced from the needle cannula so that the distal end of the needle cannula can be used to deliver a drug to a patient. The shield also can be rotated to a closed position where the distal end of the needle cannula is safely enclosed within the shield. Locking structure on the shield prevents re-exposure of the needle cannula.

Abstract: The invention provides a medical device having a catheter and one or more expandable constricting/occluding members. The catheter has a lumen communicating with a port at its distal end. The lumen and port are adapted for introduction of therapeutic or diagnostic devices, including an angioplasty/stent catheter and an atherectomy catheter, into a vertebral or basilar artery. The constrictor/occluder is mounted proximal to the port 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 vertebral and/or basilar procedures by reversing blood flow in the vertebral artery toward the subclavian artery are disclosed.

Abstract: A flexible tissue injection catheter is used to accomplish injections at a precisely controlled depth of precisely controlled volumes of a therapeutic or diagnostic agent into an interior body cavity, such as the epicardium or myocardium of the heart. In one embodiment, the invention method includes repeated injections at spaced intervals along the myocardium or epicardium of sterile fluid containing autologous bone marrow aspirate to promote angiogenesis. For myocardial injection, depth penetration is controlled by using a catheter that allows the operator to control depth penetration by means of an adjustable needle stop attached to the catheter handle. In another embodiment depth penetration during epicardial injections is controlled by use of an injection catheter having an operator-controlled adjustable needle stop that produces a sensible signal, such as a visible or audible signal, marking each increment of needle tip exposed by operation of the adjustable needle stop.

Abstract: The invention provides a nested tubing cannula which comprises outer and inner elongate tubular members, both having a proximal end, a distal end, and a lumen therebetween. The inner tubular member is sealed at its distal end and is nested substantially coaxially within the lumen of the outer tubular member, so that the gap between the inner and the outer tubular member defines a second lumen whereas the first lumen is the lumen of the inner tubular member. A tubular sleeve is disposed coaxially between the inner and outer tubular members. A balloon is mounted on a distal region of the outer tubular member and is in communication with the first lumen. The cannula further comprises a port proximal or distal the balloon occluder and is in communication with the second lumen. Methods for making the devices herein are disclosed.

Abstract: The present invention provides a mechanism by which the physical properties of diseased blood vessel walls can be manipulated to achieve an effective vessel lumen diameter for a prolonged period of time. The methods and devices of the present invention selectively isolate and treat the medial or adventitial layers of these diseased blood vessels. The invention is based on the delivery of proteolytic enzymes and crosslinking agents via specialized delivery devices to a select layer of the diseased blood vessel wall. By isolating and treating these layers of the artery, collagen degrading and collagen crosslinking agents can be delivered so as to affect the diameter of the blood vessels and control blood flow therein.

Abstract: A catheter system for injecting therapeutic agents including large molecules into the body. The catheter includes a distensible penetrating element with a distally locating expansion coil and a distally located chamber for holding a therapeutic agent which is to be injected into the body.

Abstract: A method for the treatment of a stenosis or an occlusion in a blood vessel is disclosed in which a main catheter is first delivered to a site proximal to the occlusion. The main catheter may include an occlusive device at its distal end. An inner catheter or elongate member (e.g., a guidewire) having an occlusive device at its distal end is delivered to the site of the occlusion, and the occlusive device is activated at a site distal to the occlusion. A therapy catheter is then introduced to treat the occlusion. Next, a catheter is delivered just proximal to the occlusive device, and this catheter is used to aspirate and/or irrigate the area removing particles and debris. The aspiration and irrigation steps are preferably repeated until the particles and debris are removed. Perfusion may be performed by using a perfusion-filter distal of the lesion to be treated or a hypotube which extends beyond the occlusive device attached to the guidewire.

Abstract: Methods and systems for inhibiting neointimal hyperplasia and treating vulnerable plaque comprise direct needle injection of estrogen into a perivascular space or adventitial tissue.

Abstract: A method for treating priapism in a mammal by administration of a botulinum toxin.

Abstract: A method for increasing renal and/or coronary blood flow. A catheter is inserted into the descending aorta. An expandable member on a distal region of the catheter is positioned in the aorta downstream from the takeoff of a renal artery or downstream from a coronary ostium. The expandable member is expanded to partially occlude blood flow in the aorta. Blood pressure in the proximal aorta increases, blood pressure in the distal aorta decreases, and renal and/or coronary blood flow increases by this technique. Blood pressure in the proximal aorta may be measured to monitor the effects of the procedure. The expansion of the expandable member may be adjusted based on the measured blood pressure.

Abstract: Cross stream thrombectomy catheter and system for fragmentation and removal of thrombus or other material from blood vessels or other body cavities. High velocity saline jets emitted from a toroidal loop jet emanator or other jet emanator in a catheter distal end entrain fluid through inflow orifices, and with flow resistances create a back-pressure which drives cross stream streams through outflow orifices in a radial direction and thence radially and circumferentially to apply normal and drag forces on thrombotic deposits or lesions in the blood vessel or other body cavity, thereby breaking apart and transporting thrombus particles to be entrained through the inflow orifices, whereupon the high velocity jets macerate the thrombus particles which then transit an exhaust lumen or recirculate again via the outflow orifices.

Abstract: Methods and kits for delivering pharmaceutical agents to the adventitia and other regions outside the external elastic lamina (EEL) surrounding a blood vessel utilize a catheter having a needle. The needle is positioned in up to 5 mm beyond the EEL and delivers an amount of pharmaceutical agent sufficient to circumferentially permeate around the blood vessel and, in many cases, extend longitudinally and radially along the blood vessel. Confirmation that a delivery aperture of the needle lies beyond the EEL may be required before delivering the pharmaceutical agent.

Abstract: The invention relates to methods for preventing and treating disseminating cancers. Inhibition metastases of a primary tumor to a liver tissue is carried out by directly contacting a liver tissue with Taurolidine.

Abstract: A filter comprising a porous material is arranged in a generally conical shape having an expandable base and a vertex. An elongate member having a proximal end and a distal end is attached to the expandable base of the porous material at a first circumferential location of the expandable base and extends perpendicularly from a central axis of the filter. An aspiration tube, for removing embolic material under vacuum, communicates with an area at the first circumferential location of the expandable base. Methods of using the filter and occluding devices for protecting a patient from embolization during cardiovascular procedures are described.

Abstract: Catheter devices and methods are provided for enhancing fluid flow through a vascular site occupied by a calcified lesion. The catheter devices of the subject invention at least include, at their distal end, a proton generating means, and in many embodiments also include a flushing means. In using the subject devices, the distal end of the catheter is placed proximal to the vascular occlusion and protons are generated, e.g., via proton generation from water, in a manner sufficient to reduce the pH of the vascular site in the region proximal to the occlusion. The subphysiologic pH is maintained for a period of time sufficient for fluid flow through the vascular site to be enhanced. Also provided are kits comprising the subject catheter devices for use in the subject methods.

Abstract: Methods are provided for conducting diagnostic or therapeutic medical or surgical procedures in a patient wherein, during the procedure, autonomous ventricular electrical conductivity and escape beats are reversibly and transiently suppressed to facilitate the procedure. Also provided are compositions which are capable of inducing ventricular asystole in a patient. The compositions may include an atrioventricular (AV) node blocker. In one embodiment, compositions including an 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 techniques, including minimally invasive microsurgical techniques.

Abstract: A method and apparatus for closing a vascular wound includes a guidewire and/or other surgical implement extending from the wound. A hemostatic material is advanced over the surgical implement and into contact with an area of the blood vessel surrounding the wound. The surgical implement is removed. Blood soaks the hemostatic material, and blood clotting is facilitated by the hemostatic agent within the material. A sealing layer of adhesive can be applied to the hemostatic material, confining the blood flow to the material. Thus, the vascular puncture wound is sealed by natural blood clot formation.