Abstract: The invention provides systems for treating an obstructed biological conduit that include administering to the conduit an agent that can degrade extracellular matrix of obstructing tissue. Particular methods include delivery of an enzyme or a mixture of several enzymes to the area or region of obstruction wherein the enzyme(s) have the capability to degrade extracellular matrix components within the obstruction thereby restoring the normal flow of transported fluid through the conduit. The invention also includes prophylactically dilating a section of conduit to minimize the risk of obstruction formation.

Abstract: A method and device are herein described to treat a target region of tissue, using at least one energy delivery device coupled to a power source and positioned in a treatment position so as to irreversibly electroporate tissue to ablate a target region, and introduce regenerative materials into a treated region.

Abstract: The control of fluid introduction into and out of body conduits such as vessels, is of great concern in medicine. As the development of more particular treatments to vessels and organs continues it is apparent that controlled introduction and removal of fluids is necessary. Fluid delivery and removal from such sites, usually referred to as irrigation and aspiration, using fluid exchange devices that control also need to be considerate of potential volume and/or pressure in a vessel or organ are described together with catheter and lumen configurations to achieve the fluid exchange. The devices include several electrically or mechanically controlled embodiments and produce both controlled and localized flow with defined volume exchange ratios for fluid management. The applications in medicine include diagnostic, therapeutic, imaging, and uses for the introduction or removal of concentrations of emboli within body cavities.

Abstract: Apparatus and methods for generating foam are disclosed. The inventions can be used for generating foam for sclerotherapy. A foaming element can be agitated within a foaming chamber by a drive unit that does not touch the foaming element, but actuates it from outside the foaming chamber. The foaming element and drive unit can be magnetically coupled. A syringe can be used to form a foaming chamber.

Abstract: A hemostatic system includes an inner tube and an injection sheath coupled to the inner tube. The injection sheath houses at least a section of the inner tube. The inner tube defines a first lumen configured to channel a fluid therethrough, and the injection sheath defines a second lumen configured to channel a hemocoagulant agent therethrough. An injection device is positionable within the injection sheath to facilitate channeling the hemocoagulant agent through the second lumen. The injection device defines a third lumen in fluid communication with the first lumen when the injection device is positioned within the injection sheath. The injection device includes a valve that is moveable to selectively restrict access to a portion of the injection device.

Abstract: Methods and apparatus for translating a continuous-delivery delivery profile into a plurality of periodic bolus deliveries.

Abstract: A blood volume control method has been developed including: monitoring a condition of a patient (such as hematocrit (Hct)), wherein the condition is indicative of blood volume in the patient; automatically determining that the condition indicates a low blood volume in the patient; automatically infusing an infusion solution into the patient in response to the determination of a low blood volume, and automatically adjusting the infusion to maintain the monitored condition at a predetermined value.

Abstract: Devices and systems for injecting fluids and/or other materials into a targeted anatomical location, in particular, a joint or intra-articular space, include a handpiece assembly having a needle extending from its distal end, a fluid delivery module comprising a cassette and a fluid transfer device. A conduit is generally configured to place the fluid delivery module in fluid communication with the handpiece assembly. Medicaments, formulations and/or other fluids or materials contained within vials that are secured to a cassette or other portion of the fluid delivery module can be selectively delivered into an anatomy through a needle located at the distal end of the handpiece assembly. In some embodiments, ultrasound or other imaging technologies can be used to locate a joint or other targeted anatomical location.

Abstract: A hydrogel based occlusion system, a method for occluding vessels, appendages or aneurysms, and a method for hydrogel synthesis are disclosed. The hydrogel based occlusion system includes a hydrogel having a shrunken and a swollen state and a delivery tool configured to deliver the hydrogel to a target occlusion location. The hydrogel is configured to permanently occlude the target occlusion location in the swollen state. The hydrogel may be an electro-activated hydrogel (EAH) which could be electro-activated with a delivery system to control the degree of swelling/shrinking.

Abstract: A method of providing a patient controlled analgesia to a pediatric patient including connecting a patient controlled analgesia system, such as an infusion pump and hand control, to an intravenous line of the pediatric patient and securing the hand control in a patient interface object, such as a stuffed toy having an internal void for receiving the hand control and an actuator affixed within the void. The patient is informed that pressing the area of the stuffed toy proximate to the actuator results in relieving pain experienced by the patient. Furthermore, an Internet address that is specific to the pediatric patient is provided to the patient for instructions on use of the combined patient controlled analgesia system and the patient interface object.

Abstract: Methods and systems for treating pleural disease comprising a providing a low dosage of a sclerosing agent over a period of time. Certain examples include catheter with a sclerosing agent that is inserted into the pleural space. The sclerosing agent is released in a sustained-release manner over a period of time to achieve diffuse pleurodesis of the pleural layers.

Abstract: An access port, wherein the access port may include a body having an exterior surface and a chamber defined therein, a bore defined in the body providing fluid communication between the chamber and the exterior surface, a needle in fluid communication with the chamber, a passage defined in the body providing communication between the chamber and the exterior surface, a seal secured within the passage, and an actuator in communication with the needle, configured to move the needle relative to the passage or move the passage relative to the needle.

Abstract: The invention provides methods for treating an obstructed biological conduit that include administering to the conduit an agent that can degrade extracellular matrix of obstructing tissue. Particular methods include delivery of an enzyme or a mixture of several enzymes to the area or region of obstruction wherein the enzyme(s) have the capability to degrade extracellular matrix components within the obstruction thereby restoring the normal flow of transported fluid through the conduit. The invention also includes prophylactically dilating a section of conduit to minimize the risk of obstruction formation. The invention further includes methods for prolonging patency of hemodialysis access.

Abstract: A method for starting an intravenous fluid line (IV) is disclosed where a combination of a syringe body with hypodermic needle, a dual ampoule with separate reservoirs for bicarbonate and an anaesthetic, a trocar and a cannula are configured so that the steps of injecting a wheal of a buffered anaesthetic, retracting the needle tip, lancing a vein with the trocar, and withdrawing the trocar tip so that the cannula remains in place in the vein may be accomplished in a single coordinated action by one skilled in the method, such as with one hand while the other hand performs manipulations on the vein and IV site.

Abstract: Method of preparing a clogged animal vessel, e.g. chronic total occlusion of an artery so as to be capable of crossing by a guidewire of an intraluminal device, e.g., angioplasty balloon. The method includes delivering an angiogenic agent to the occlusion site to promote angiogenesis within the occlusion to increases susceptibility to crossing.

Abstract: A microplegia console for controlling the delivery of cardioplegia to a patient, comprising an integrated display/touch screen for displaying cardioplegia information and patient information and allowing inputting of parameters via the display/touch screen into the console for computer-controlled perfusion of cardioplegia into the patient. The invention further comprises a method for delivery of cardioplegia to a patient, including defining and selecting a protocol from a displayed list and sequencing a series of the protocols. The invention also comprises a method for cardioplegia delivery to achieve aortic valve closure. Additionally, the invention comprises a method for activating an icon whereby, upon a first selection of the icon, displaying an indicia indicating that the icon has been first selected; and upon a second selection of the icon, activating the icon.

Abstract: A tube comprising an inner layer, an outer layer and a barrier layer disposed between the inner layer and the outer layer, wherein the barrier layer is bound to the outer layer by a layer of adhesive disposed between the outer layer and the barrier layer and the barrier layer is bound to the inner layer by a layer of adhesive disposed between the inner layer and the barrier layer, wherein the inner layer comprises a polyethylene, the outer layer comprises a thermoplastic polyurethane and the barrier layer comprises a material that acts as a barrier to gas.

Abstract: The present invention relates to implantable medical devices coated with polymer having hemocompatible and/or prohealing moieties appended thereto and to their use in the treatment of vascular diseases.

Abstract: A disposable cassette for mixing a drug in a vial includes a liquid inlet for connection to a liquid supply, a first vial spike, a second vial spike, a chamber and a valve mechanism. The chamber, the first and second vial spikes, and the liquid inlet are in fluid communication with each other. The valve mechanism may be actuated to control flow between the chamber, the vial receptacles and the liquid inlet.

Abstract: Devices, systems, and methods are provided for controlling an inflammatory response in a subject. Devices, systems, and methods are provided that alter the functional structure of one or more inflammatory mediators in the peripheral blood of the subject. The device or system is useful in a method for treating an inflammatory disease or condition in the subject.

Abstract: A system and method of treating urinary incontinence including a catheter and injection guide operatively disposed together. At least one needle is operatively disposed within at least one lumen and at least one channel extending through the catheter and injection guide respectively. The injection guide is transformable from a pre-injection configuration for placement in the bladder to an injection configuration for injection of a pharmaceutical such as botulinum toxin into the bladder tissue. Upon introduction of the pharmaceutical to the bladder tissue, symptoms of incontinence are alleviated.

Abstract: A method for injecting a therapeutic agent into a target tissue, the method comprising: (a) providing an expandable member; (b) positioning said expandable member in proximity to the target tissue; (c) Introducing the therapeutic agent into the expandable member until a desired pressure is achieved; and (d) creating a plurality of small apertures in the expandable member.

Abstract: An intravenous infusion device (10) comprises a fluid drip chamber (11) having an inlet (12) and an outlet (13). A floating plug (14) provides an indication of fluid level and when the fluid is exhausted the plug (14) settles in the outlet (13) and, being made from a soft deformable material, effectively forms a bung preventing air entering the line (4). It is thus a simple matter to replace an associated fluid bottle (2) and allow the replenished fluid to flow with minimal interruption or intervention. By providing the plug (14) with a flexible skirt or fin (15) and providing the chamber (11) with a conical end section (16) an enhanced seal is provided by the fin (15) engaging the conical section (16). In a further enhancement the conical section (16) has an opaque lower section (17) and the plug (14) is thus obscured from view as the fluid is depleted providing an enhanced visual indication that the fluid bottle (2) is empty.

Abstract: Apparatus and methods are described for effective removal of emboli or harmful fluids during therapeutic and diagnostic vascular procedures, such as angiography, balloon angioplasty, stent deployment, laser angioplasty, atherectomy, and intravascular ultrasonography. A catheter with an occluder mounted at its distal end creates an occlusion proximal to the lesion and provides a pathway for introducing a treatment catheter. Prior to, during or subsequent to the procedure, suction is activated to establish retrograde flow to remove emboli from the site. Additionally, a thin catheter with a distal fluid ejection nozzle may be introduced distal to the treatment site to rinse emboli from the treatment site. The suction flow and/or ejected fluid flow may be varied in a pulsatile manner to simulate regular blood flow and/or perturb settled emboli into being captured that may otherwise not be collected. The method establishes a protective environment before any devices enter the treatment site.

Abstract: Devices, systems, and methods are provided for controlling an inflammatory response in a subject. Extracorporeal devices, systems, and methods are provided that alter the functional structure of one or more inflammatory mediators in the peripheral blood of the subject. The device or system is useful in a method for treating an inflammatory disease or condition in the subject.

Abstract: Apparatus and methods for inhibiting the introduction of air into the body during a percutaneous procedure.

Abstract: System for detecting and removing gas bubbles from a vascular infusion line, including a cassette adapted for disposition intermediate the fluid line, the cassette including a flexible tube having an inlet port for connection to a supply side of the fluid line, an outlet port configured for connection to a patient side of the fluid line, and a purge port intermediate the inlet and outlet ports, and a base unit adapted to receive the cassette and monitor fluid flow through the tube, the base unit including a sensor to detect the presence of a gas bubble in the fluid flow, a pinch valve adapted to stop the flow of fluid, and a control unit adapted to operate the base unit so that (i) fluid is permitted to flow past the pinch valve when no gas bubble is detected; and (ii) fluid flow is arrested when a gas bubble is detected.

Abstract: The present invention relates to an arterial flashback confirmation chamber. Generally, the confirmation chamber is used with a vascular access device to allow an operator to see active arterial flashback confirmation for a period of time that is long enough to permit the operator to properly place the cannula of the vascular access device within a patient's artery. In some instances, the confirmation chamber comprises a flashback compartment, means for prolonging active arterial flashback confirmation, and a vent. Some examples of suitable prolonging means comprise a flashback compartment with a relatively large internal volume, circuitous tubing, an absorbent material, an orifice and/or tubing with a smaller inner diameter than the inner diameter of the cannula, and the like. Where the vascular access device comprises a catheter assembly, the catheter assembly and confirmation camber are optionally used with a guide wire and/or a blood sensor.

Abstract: A fluid infusion system is described. Certain embodiments include an infusion syringe assessment device that assesses one or more characteristics of an infusion syringe coupled to a fluid infusion pump during use. The system may include a fluid infusion pump configured to accept the infusion syringe. The fluid infusion pump may advance an infusion fluid to a test subject in accordance with an infusion routine based on one or more of the assessed characteristics of the infusion syringe. The infusion routine may include at least one rate, at least one volume, at least one start time, at least one end time, and/or at least one duration.

Abstract: A catheter for insertion into a vascular system of a patient and for directing fluid flow includes a catheter body having a longitudinal axis and longitudinally spaced proximal and distal catheter ends with an intermediate catheter portion defined therebetween. An intermediate catheter outlet in the catheter body is located in the intermediate catheter portion and is spaced longitudinally from the proximal and distal catheter ends. A first lumen is defined within the catheter body and has longitudinally spaced proximal and distal first lumen ends with a reversing bend located therebetween, the first lumen providing fluid communication between the proximal catheter end and the intermediate catheter outlet. The reversing bend is located longitudinally between the intermediate catheter outlet and the distal catheter end. The reversing bend directs fluid flow to turn approximately 180° as the fluid flows through the first lumen. A method of using the catheter is also described.

Abstract: A contrast media injection system detects the absolute position of the syringe ram using a non-contact sensor. A series of magnets and Hall-Effect sensors may be used or an opto-reflective system. Illuminated knobs that are connected to the drive mechanism for the syringe ram rotate with the drive and provide visual feedback on operation through the illumination. Analog Hall-Effect sensors are used to determine the presence or absence of magnets that identify the type of faceplate being used. The faceplates include control electronics, connected to the powerhead through connectors, which may be interchangeably used by the two faceplates. The faceplate electronics include detectors for automatically detecting the capacity of pre-filled syringes.

Abstract: An angioplasty catheter assembly having an anchoring catheter within a guide catheter such that the anchoring catheter anchors to the guide catheter and the inner wall of a coronary artery; the anchoring catheter has an opening in its tubular wall such that a guide wire and balloon dilatation catheter can be disposed therethrough and extending through the length of the anchoring catheter.

Abstract: A method includes inserting a distal end portion of a needle of a medical injector into a skin of a body. An energy source operatively coupled to the medical injector is actuated such that a dermal filler is conveyed from the medical injector into the skin through the distal end portion of the needle. The distal end portion of the needle is moved within the skin during the actuating.

Abstract: According to an aspect of the present disclosure, an anvil assembly for a circular stapling apparatus, is disclosed. The anvil assembly includes an anvil head configured to support an anvil plate thereon; a shaft extending from the anvil head and configured to selectively engage a connection member of the circular stapling apparatus; an anvil plate operatively connected to the anvil head, the anvil plate defining a plurality of staple forming pockets therein; and a wound treatment material disposed in each staple forming pocket of the anvil plate. The wound treatment material is at least one of an adhesive, a sealant, a hemostat and a medicament.

Abstract: Methods and devices for selectively removing an agent from a physiological site, e.g., a physiological efferent fluid collection site, are provided. Aspects of the invention include fluid removal (e.g., aspiration) devices having a fluid removal element and a flow modulator positioned at a distal end of the fluid removal element. The flow modulator is configured to converge intersecting fluid flow paths into the fluid removal element. Also provided are systems and kits for performing the subject methods. The subject invention finds use in a variety of different applications, including the selective removal of both therapeutic and diagnostic agents from a variety of different physiological sites.

Abstract: A catheter for introduction and removal of fluids from a body and tunneling device therefor, the catheter has a body having a first conduit for removing fluid from the body and a second conduit for delivering fluid to the body wherein at least a part of each of the conduits is integrally formed within a first end of the body of the catheter and extends along side one another. The first conduit extends beyond the second conduit and forms a terminal point of the first end and defines a first opening thereat and the second conduit extends to a point short of the terminal point defining a second opening. A bumper portion is adjacent the second opening extending toward the terminal point. Another part of each the first and the second conduits are disjoined and form part of a second Y-shaped end. The tunneling device has a channel to removably receive the catheter.

Abstract: The invention relates to a method of engrafting donor cells into injured myocardium. The method includes delivering donor cells to a delivery site adjacent to and downstream of a chronic total occlusion and treating the chronic total occlusion. The delivery device may be a catheter with a wireguide that may be provided by a retrograde approach via an un-occluded artery or antegrade approach through the chronic total occlusion. The invention also relates to a method of treating injured myocardium and cell compositions for treatment of injured myocardium.

Abstract: A method and device are herein described to treat a target region of tissue, using at least one energy delivery device coupled to a power source and positioned in a treatment position so as to irreversibly electroporate tissue to ablate a target region, and introduce regenerative materials into a treated region.

Abstract: A long catheter can be inserted into a patient while eliminating the need for a sterile field by incorporating the long catheter into an infusion tubing and carrying it in with the infusion. The long catheter has a structure that prevents it from leaving the infusion tubing when fully extended and therefore becomes a connector for fluids to transfer down the long catheter by infusion through the infusion tubing. Use of an adjustable seat connector allows the long catheter to be stopped at varying points during insertion and even to allow the long catheter to be reversed by pulling suction on the infusion tubing and retracting the long catheter back into the infusion tubing. The long catheter also remains within the sterile confines of the infusion tubing and therefore is prevented from becoming contaminated.

Abstract: An apparatus for treatment of tissue within a body requiring thermotherapy includes a catheter to be inserted into a bodily conduit, an energy-emitting source disposed within the catheter, a compression balloon surrounding the energy-emitting source where the compression balloon has an inflated diameter that is greater than that of the bodily conduit in a relaxed state and an outside surface of the balloon is coated with one of gene modifiers and drug or medication, and means for activating the energy-emitting source to radiate energy to heat the drug-coated compression balloon and tissue to be treated whereby the heated drug-coated compression balloon effectively delivers the one of the gene modifiers and drug or medication to a target area of the diseased tissue. In addition, methods for using the above apparatus to treat diseased tissue are disclosed.

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: Some embodiments an infusion pump system can be used to determine a user's total insulin load (TIL) that provides an accurate indication of the insulin previously delivered to the user's body which has not yet acted. In particular embodiments, the TIL can account for both the bolus deliveries and the basal deliveries that have occurred over a period of time. Such information may be useful, for example, when the infusion pump is operated in conjunction with a continuous glucose monitoring device.

Abstract: Devices, systems, and methods are provided for controlling an inflammatory response in a subject. Extracorporeal devices, systems, and methods are provided that alter the functional structure of one or more inflammatory mediators in the peripheral blood of the subject. The device or system is useful in a method for treating an inflammatory disease or condition in the subject.

Abstract: Devices, systems, and methods are provided for controlling an inflammatory response in a subject. Devices, systems, and methods are provided that alter the functional structure of one or more inflammatory mediators in the peripheral blood of the subject. The device or system is useful in a method for treating an inflammatory disease or condition in the subject.

Abstract: The present disclosure describes a method for targeted delivery of permanently-acting or temporarily-acting neurotoxins, neurosuppressants, or other compounds having a neurologic effect to specific locations of the heart, including for example, but not limited to, nodes of the cardiac autonomic nervous system such as the atrial ganglionated plexi (GP). Chemical ablation of the atrial GP as described herein via magnetically-targeted magnetically-susceptible nanoparticles can effectively suppress GP activity and atrial fibrillation related, thereto without permanent damage to either myocardium or intrinsic CANS.

Abstract: A micropump device. The micropump device includes a first layer forming a first chamber configured to store a working material, a second chamber defined by a deflectable membrane in fluid communication with the first chamber and configured to deflect in response to a pressure increase in the first chamber in response to a volume increase in the first chamber, the second chamber configured to store a drug compound to be delivered to a subject's vascular system, and at least one needle in fluid communication with the second chamber and configured to penetrate a subject's skin to pump the drug compound in response to the deflection of the deflectable membrane.

Abstract: The present invention relates to a device for creating a vascular access for extracorporeal blood treatment including an electrically conductive puncture needle with a proximal endpiece, a distal endpiece, and a base body made of electrically non-conductive material into which the distal endpiece is inserted. In a properly arranged vascular access, the base body, including an electrically conductive contact element, lies on the skin of the patient, when the puncture needle is located within the vessel of the patient. A disconnection or dislocation is detected by the impedance between the electrically conductive puncture needle and the electrically conductive contact element being measured and compared to a limit value. If the impedance measured is within predetermined limits, this indicates a properly arranged vascular access. A disconnection or dislocation of the puncture needle leads to a strong variation in the impedance.

Abstract: A catheter assembly for use in accessing a vasculature of a patient during renal replacement or other therapies is disclosed. In one embodiment, the catheter assembly includes a catheter body that defines first and second lumens. The catheter body defines a distal tip region that includes a venous lateral opening that is in fluid communication with the first lumen and includes a distal-facing portion. The distal tip region further includes an arterial lateral opening that is in fluid communication with the second lumen, includes a distal-facing portion, and is substantially un-staggered with respect to the venous lateral opening. A distal end opening is defined on the distal tip region and is sized to pass a fluid therethrough. In one embodiment, the distal end opening is in fluid communication with a third lumen of the catheter body that can withstand high fluid flow rates associated with power injection of contrast media.

Abstract: A hemodialysis needle assembly and system that includes a first outer needle having a conical tip and a sidewall where the sidewall has a plurality of apertures located adjacent the tip, a second introducer needle located within the outer needle, a guide wire located within the introducer needle, and a spring motor removably secured to the outer needle. The introducer needle and the guide wire are inserted into a patient's vein and the spring motor releases the outer needle into the vein after the introducer needle and the guide wire are properly placed within the patient. The introducer needle, the guide wire, and the spring motor are removed from the patient after the outer needle is in place within the vein.

Abstract: The current invention relates to a process for increasing the efficacy of cancerous disease inhibiting therapeutic agents delivered to a treatment region of a tissue structure, such as a tumor. The multi-step procedure takes advantage of the resulting thermal stress response occurring as a result of exposure to the cold. Coordinating the thermal related stress response with the timing of cancerous disease inhibiting agent action provides a unique therapeutic regiment to treat tumors which provides a maximized effect on the tumor, protects normal cells, and activates local pro-inflammatory cells.