Abstract: Apparatus for filtering and entrapping debris in the vascular system of a patient, the apparatus including a filter to allow blood to flow therethrough and to restrict passage of debris, wherein the filter captures debris carried in a first direction of blood flow. The apparatus further includes an entrapment mechanism which allows passage of debris and blood therethrough, in the first direction of blood flow and prevents debris passage in a second direction. The entrapment mechanism and filter allow blood and debris therethrough in the first direction of blood flow. The entrapment mechanism prevents debris flow in the second direction of blood flow. A method for filtering and entrapping debris in the vascular system includes inserting the apparatus into the vascular system, allowing blood and debris carried therein to flow through the entrapment mechanism, and removing the apparatus and accumulated debris from the vascular system.

Abstract: Devices and methods for performing intravascular procedures without cardiac bypass include embodiments of temporary filter devices, temporary valves, and prosthetic valves. The temporary filter devices have a cannula which provides access for surgical tools for effecting repair of cardiac valves. The cannula may have filters which prevent embolitic material from entering the coronary arteries and aorta. The valve devices may also have a cannula for insertion of the valve into the aorta. The valve devices expand in the aorta to occupy the entire flow path of the vessel and operate to prevent blood flow and to permit flow through the valve. The prosthetic valves include valve fixation devices which secure the prosthetic valve to the wall of the vessel. The prosthetic valves are introduced into the vascular system in a compressed state, advanced to the site of implantation, and expanded and secured to the vessel wall.

Abstract: Apparatus and methods for injecting biological agents into tissue. Devices are provided having elongate shafts and distal injection heads for transversely driving needles into tissue and injecting medical agents into the tissue through the needles. A longitudinal force directed along the shaft can be translated to a needle driving force transverse to the shaft. Some devices provide controllably variable needle penetration depth. Devices include mechanical needle drivers utilizing four link pantographs, rack and pinions, and drive yokes for driving a first needle bearing body toward a second tissue contacting body. Other devices include inflatable members for driving and retracting needles. Still other devices include magnets for biasing the needles in extended and/or retracted positions. The invention includes minimally invasive methods for epicardially injecting cardiocyte precursor cells into infarct myocardial tissue.

Abstract: A clip of a self-closing type is used for valve repair. The clip is generally U-shaped with two end points separated from each other when it is constrained to be in an open configuration, but tends to coil up to assume its natural closed configuration if the constraint is removed. At least one end point is connected through a suture to a tissue-penetrating needle. A needle holder has an outer tube and an inner member which has a slit at the front and is slidable inside the outer tube. They are designed such that the slit can grab the needle tightly or release it as the inner member is moved backward or forward with respect to the outer tube. With the needle secured at the front, the needle holder is passed through a cannula inserted through an incision and the needle penetrates the leaflets such that the clip can be positioned with its end points hooked to the pair of leaflets to be stitched together.

Abstract: A heart valve sewing prosthesis including an intrinsically conductive polymer. The invention includes annuloplasty rings and bands, and sewing rings or cuffs for prosthetic heart valves. Some annuloplasty rings and sewing rings include fabric that is coated with an intrinsically conductive polymer. The coating can be formed over individual filaments or fibers, or on the fabric surface as a surface layer. One intrinsically conductive polymer is polypyrrole. The intrinsically conductive polymer can be doped to facilitate the intrinsic conductivity. Some devices have a polypyrrole surface layer doped with dialkyl-napthalene sulfonate. The intrinsically conductive polymer can be deposited on a fabric using in-situ polymerization of monomeric or oligomeric species, together with a dopant. Animal studies using implanted annuloplasty rings having an intrinsically conductive polymer coating have demonstrated a substantial reduction in pannus formation and inflammatory response.

Abstract: The current invention discloses a method for treating infracted/ischemic injury to a myocardium by injecting a substance into the myocardium. The injected substance helps to prevent negative adaptive remodeling by providing mechanical reinforcement or mechanical reinforcement combined with biological therapy. A number of substances for injection are disclosed, including multi component substances such as platelet gel, and other substances. The substances disclosed may contain additives to augment/enhance the desired effects of the injection. The invention also discloses devices used to inject the substances. The devices can include means for ensuring needles do not penetrate beyond a desired depth into the myocardium. The devices can also include needles having multiple lumens such that the components of the platelet gel will be combined at the injection site and begin polymerization in the myocardium.

Abstract: A disposable, integrated extracorporeal blood circuit employed during cardiopulmonary bypass surgery performs gas exchange, heat transfer, and microemboli filtering functions in a way as to conserve volume, to reduce setup and change out times, to eliminate a blood reservoir, and to substantially reduce blood-air interface. Blood from the patient or prime solution is routed through an air removal device that is equipped with air sensors for detection of air. An active air removal controller removes detected air from blood in the air removal device. A disposable circuit support module is used to mount the components of the disposable, integrated extracorporeal blood circuit in close proximity and in a desirable spatial relationship to optimize priming and use of the disposable, integrated extracorporeal blood circuit. A reusable circuit holder supports the disposable circuit support module in relation to a prime solution source, the active air removal controller and other components.

Abstract: A device for holding a surgical suture including a base, a guide body, a cam body, a bearing member, and a spring member. The base has a top side, a front edge, and a back edge. The guide body projects from the top side of the base and defines a guide face having an entrance side and an exit side. The entrance side is adjacent the front edge and the exit side is adjacent the back edge. The cam body is pivotally mounted to the top side and forms a toothed surface positioned to selectively secure a surgical suture against the guide face. The spring member is positioned between the cam body and the bearing member, biasing the toothed surface toward the guide face.

Abstract: Tissue connector assemblies having at least two piercing members, each releaseably coupled to a surgical fastener such as a surgical clip. A flexible member such as a suture may be used to couple one or both piercing members to respective ends of the fastener.

Abstract: A heart valve assembly includes an annular prosthesis and a valve prosthesis. The annular prosthesis includes an annular ring for dilating tissue within a biological annulus and a conformable sewing cuff extending radially from the annular member. The valve prosthesis includes a frame and a valve component. The annular ring is introduced into the biological annulus to dilate tissue surrounding the biological annulus and the sewing cuff conforms to tissue above the biological annulus. Fasteners are directed through the sewing cuff to secure the annular prosthesis to the biological annulus. The annular prosthesis may include a baleen element for biasing fabric on the annular ring outwardly to enhance sealing against the biological annulus. A valve prosthesis is then advanced into the sinus cavity, and secured relative to the annular prosthesis. The sewing cuff may enhance a seal between the valve prosthesis and annular prosthesis.

Abstract: A disposable, integrated extracorporeal blood circuit employed during cardiopulmonary bypass surgery performs gas exchange, heat transfer, and microemboli filtering functions in a way as to conserve volume, to reduce setup and change out times, to eliminate a venous blood reservoir, and to substantially reduce blood-air interface. Blood from the patient or prime solution is routed through an air removal device that is equipped with air sensors for detection of air. An active air removal controller removes detected air from blood in the air removal device. A disposable circuit support module is used to mount the components of the disposable, integrated extracorporeal blood circuit in close proximity and in a desirable spatial relationship to optimize priming and use of the disposable, integrated extracorporeal blood circuit. A reusable circuit holder supports the disposable circuit support module in relation to a prime solution source, the active air removal controller and other components.

Abstract: A method of thermal ablation using high intensity focused ultrasound energy includes the steps of positioning one or more ultrasound emitting members within a patient, emitting ultrasound energy from the one or more ultrasound emitting members, focusing the ultrasound energy, ablating with the focused ultrasound energy to form an ablated tissue area and removing the ultrasound emitting member.

Abstract: Methods and devices for point of care determination of heparin concentration in blood are described. Cartridges including protamine ion sensitive electrodes (ISEs) and reference electrodes and systems for automatically determining heparin concentration in the cartridges are provided. Some systems add blood to a protamine bolus sufficient to bind all heparin, leaving excess protamine. The excess protamine concentration can be determined by measuring the initial slope of the electrode potential rate of change, and comparing the slope to known protamine concentration slope values In some cartridges, an oscillating pressure source moves the blood-protamine mixture back and forth across the protamine ISE. Some systems also use a second blood sample having the heparin removed or degraded to create a blank reference sample. Protamine ISEs can include polyurethane polymer, DNNS ionophore, and NPOE plasticizer.

Abstract: This invention relates to a system and apparatus for retaining a prosthetic valve in a valve pocket suspended in a sealed container to protect from damage and contamination during shipment, handling and storage. The apparatus is an easy to open container having remote fill ports for adding a sterile liquid after enclosing the valve inside. A tamper evident seal is provided having a novel configuration to detect prior opening of the container. The apparatus includes an assembly having a shelf that is provided in a variety of configurations. The shelf has a mitral valve configuration and an aortic valve configuration. The shelf is selected based on the valve configurations and size. The system is easily assembled having a single variable component to adapt to a particular prosthetic valve to be stored. The present invention provides an apparatus for eliminating the need for direct attachment of the valve serial tag to the valve.

Abstract: A surgical apparatus for delivering a conductive fluid to a target site for subsequent formation of a virtual electrode to ablate bodily tissue at the target site by applying a current to the delivered conductive fluid. The surgical apparatus includes an elongated device forming a helical needle. The helical needle is configured to engage bodily tissue and is hollow for delivering conductive fluid from a fluid source. Finally, the helical needle terminates in a needle tip. In one preferred embodiment, an electrode is associated with the helical needle for applying a current to conductive fluid delivered from the helical needle. During use, following delivery of conductive fluid, the electrode applies a current to the delivered conductive fluid for creating a virtual electrode. The virtual electrode ablates bodily tissue contacted by the conductive fluid.

Abstract: The invention concerns an assembly comprising a valve prosthesis to be implanted and a support receiving said valve. The support comprises: at least a tubular portion made of a pliable material slightly stretchable in the circumferential direction; means for fixing said tubular portion to the wall of the corporeal duct; and a plurality of elongated reinforcing elements, arranged on the circumference of said tubular portion and linked to said tubular portion independently of one another; the valve is linked at least partly to said elongated reinforcing elements, in particular at the commissures of its leaflets, and said elongated reinforcing elements jointly form, in extended position, a structure having a predetermined diameter that ensures sufficient extension of said valve.

Abstract: Methodology for using laser machining techniques to modify a tissue for use in a medical device. In a representative mode of practice, relatively low energy laser machining is used to thin down at least a portion of a valved jugular vein. The thinned down vein may then be sutured to, or otherwise integrated with, a corresponding stent to make a percutaneous heart valve.

Abstract: A disposable, integrated extracorporeal blood circuit employed during cardiopulmonary bypass surgery performs gas exchange, heat transfer, and microemboli filtering functions in a way as to conserve volume, to reduce setup and change out times, to eliminate a venous blood reservoir, and to substantially reduce blood-air interface. Blood from the patient or prime solution is routed through an air removal device that is equipped with air sensors for detection of air. An active air removal controller removes detected air from blood in the air removal device. A disposable circuit support module is used to mount the components of the disposable, integrated extracorporeal blood circuit in close proximity and in a desirable spatial relationship to optimize priming and use of the disposable, integrated extracorporeal blood circuit. A reusable circuit holder supports the disposable circuit support module in relation to a prime solution source, the active air removal controller and other components.

Abstract: An electrosurgery medical device is enhanced with unique solution-assistance, and comprises, in combination, co-operating device jaws including jaw portions for manipulating tissue, and a plurality of solution infusion openings defined and spaced along each of the jaw portions, for receiving electrolytic solution and infusing the solution onto and into tissue to be manipulated, along said jaw portions. As preferred, the device further comprises at least one, and most preferably, many, longitudinal groove(s) along at least one and most preferably, both, of the jaw portions, with the solution infusion openings located in the groove or grooves. The solution is energized with RF energy and contributes to the functions and beneficial effects of the instrument. The solution exits the openings in the grooves at sufficient flow rates to separate substantially all the operative surfaces of the device from tissue, thereby substantially completely preventing adherence between the operative surfaces and tissue.

Abstract: Embodiments of the invention provide an ablation apparatus for ablating target tissue adjacent pulmonary veins of a patient. The ablation apparatus can include a tube capable of being advanced around the pulmonary veins to form a loop. The tube can receive or include electrodes to ablate target tissue. Some embodiments provide a loop ablation device, which may include a cannula and two or more electrode rods carrying two or more bipolar electrodes. The electrode rods can be advanced through the distal ends toward the proximal ends of the loop and toward the target tissue. The bipolar electrodes can receive energy to ablate the target tissue. The bipolar electrodes may be surrounded by the liquid within the cannula while ablating the target tissue. The loop ablation device can further include a rotating grasping mechanism coupled to the electrode rods.