Abstract: Systems and methods for performing a therapeutic red blood cell exchange procedure are disclosed. In one aspect, a system includes a first flow path for flowing whole blood from a patient. A separator communicates with the first flow path for separating at least red blood cells from plasma. Second and third flow paths communicate with the separator for respectively flowing the separated plasma and red blood cells from the separator. A flow controller is associated with the flow paths to control fluid communication between the flow paths. The controller is configured to perform the procedure to achieve a target fraction of patient cells remaining, target hematocrit, and a target patient fluid volume change at the completion of the procedure based on data input by the operator.

Abstract: Systems, methods, apparatus, and computer readable media are provided for disposable component authentication with respect to a biological fluid processing device instrument. An example instrument authentication system includes a computer facilitating configuration and operation of the biological fluid processing instrument using a disposable component. A first interface is provided by the computer and is used by a service technician to configure the biological fluid processing instrument for a number of disposable components and to provide a service technician with a validation code. A key generator is to accept the validation code from the service technician and generate an authentication key in response to the entered validation code. A second interface is provided by the computer, the second interface prompting the service technician to enter an authentication key, wherein the authentication key authorizes use of a certain number of disposable components for the biological fluid processing instrument.

Abstract: Systems and methods for determining when a fluid supply container of a blood processing apparatus becomes empty. The system uses a scale to monitor and detect when a fluid supply container is empty based on the rate of change of the container weight and whether the container weight is below a pre-established threshold, and a controller receives a signal from the scale and controls the operation of a pump to stop pumping when the fluid supply container is empty.

Abstract: Systems, methods, apparatus, and computer readable media are provided for disposable component authentication with respect to a biological fluid processing device instrument. An example instrument authentication system includes a computer facilitating configuration and operation of the biological fluid processing instrument using a disposable component. A first interface is provided by the computer and is used by a service technician to configure the biological fluid processing instrument for a number of disposable components and to provide a service technician with a validation code. A key generator is to accept the validation code from the service technician and generate an authentication key in response to the entered validation code. A second interface is provided by the computer, the second interface prompting the service technician to enter an authentication key, wherein the authentication key authorizes use of a certain number of disposable components for the biological fluid processing instrument.

Abstract: An valve prosthesis, such as an artificial venous valve, having a support frame and leaf structure comprising one or more leaflets in which the outer edge of each leaflet engages the inner circumference of the bodily passageway along a serpentine path urged against the passageway by an expandable frame, while the inner edges move in response to fluid to restrict retrograde flow. Optionally, one or more elements can extend from the support frame/leaf structure to provide centering support and/or protection from the leaflet adhering to the vessel wall. In one embodiment, the centering support structure comprises a second or third expandable frames attached to and extending from the proximal and/or distal ends of main valve structure and support frame. In another embodiment, one or more support elements extend outward from the valve support frame to engage the vessel wall to provide greater longitudinal stability.

Abstract: Implantable medical devices adapted to modify fluid flow within a body vessel are provided herein. The medical devices may include a fluid flow restricting channel configured to reduce longitudinal fluid flow in a retrograde direction or in an antegrade direction. Preferably, the medical devices are flow-modifying devices that reduce fluid flow through the medical device to a greater extent in a retrograde direction than in an antegrade direction. Methods of treatment comprising the step of implanting a flow-modifying medical device within a body vessel are also provided. Flow-modifying devices are useful, for example, in treating venous valve related conditions.

Abstract: Described are devices, methods, and systems for achieving occlusion of vascular vessels. Further described are certain reduced or low profile procedures and devices for the percutaneous occlusion of the saphenous vein, such as in the treatment of a varicose vein condition caused by venous reflux.

Abstract: Delivery systems for delivering and deploying expandable intraluminal medical devices within a body vessel are provided. A portion of the delivery system that includes the expandable intraluminal medical device orients itself about an axis based on characteristics of the body vessel, such as the relative orientation of major and minor axes of the vessel. This allows the intraluminal medical device to be deployed in the vessel in a desired orientation relative to the vessel. Embodiments can be used with any suitable intraluminal medical device, including valve devices, stents, drug-coated stents, filters, and other suitable devices. Methods of delivering and deploying intraluminal medical devices are also described.

Abstract: An expandable venous valve having a support structure that configured to enlarge the area adjacent to the valve structure such that the flow patterns of retrograde flow are modified in a way that facilitates the flushing of the pockets at the base of the valve area to prevent stagnation of bodily fluid, which in the venous system, can lead to thrombus formation. The enlarged pocket areas can be created by forming an artificial sinus adjacent the valve structure in an unsupported section of vessel wall between two support frame section or the support frame can comprise an expanded-diameter intermediate or proximal section that forms an artificial sinus adjacent the valve structure.

Abstract: Methods of delivering a medical device to a point of treatment in a body vessel are described. In methods according to the invention, a reference device comprising a plurality of reference markings and a medical device comprising at least one position marker are provided. The reference device is associated with an external surface of the patient in a region adjacent the body vessel in which the medical device is to be implanted. A target implant site is determined and correlated with at least one selected reference marking on the reference device. The medical device is percutaneously advanced to the target implant site by visually referencing the at least one selected reference marking and the at least on position marker using an appropriate imaging system.

Abstract: Medical devices for implantation within a body vessel can include a remodelable material, such as an extracellular matrix material, positioned within a lumen defined by an outer covering material. The covering material is preferably substantially non-remodelable, and can be supported by a radially expandable frame. The medical device can also include a valve means positioned within the covering material. The valve means can include one or more valve leaflets formed from the remodelable material, and a separate valve support frame. One or more therapeutic agents can be associated with the remodelable material or the covering material.

Abstract: Medical devices for implantation in a body vessel are provided. A medical device according to the invention comprises a support structure and one or more graft members comprising a valve portion and a constraining portion. The support structure has a first, unexpanded configuration and a second, expanded configuration. The constraining portion is adapted to substantially prevent the support structure from achieving the second, expanded configuration. The valve portion is adapted to permit fluid flow through a body vessel in a first direction and substantially prevent fluid flow through the vessel in a second, opposite direction.

Abstract: Medical devices for implantation in a body vessel, and methods of using and making the same, are provided. A medical device can include a frame with one or more projections each having at least one edge extending from the surface of the frame, and a biocompatible, water-soluble removable material coated over at least a portion of the at least one edge. The projections can be barbs positioned to engage the interior wall of a body vessel or to attach a material, such as a valve leaflet or graft, to the frame. The removable material can be dissolved within a body vessel upon implantation, thereby exposing the at least one edge. Methods of making an implantable medical device and methods of treating a subject are also disclosed.

Abstract: Implantable medical devices, such as intraluminally implantable stents and valves, are provided having certain preferred shapes. Preferably, a portion of the implantable medical device can define a sinus region having a preferred geometry. The sinus region can have one or more preferred geometric configurations described herein, for example to mitigate or prevent thrombosis within a body vessel. The medical device can include a valve means, such as one or more valve leaflets positioned within the sinus region. The implantable medical devices can be delivered from a catheter within a body vessel, and are preferably expandable from a compressed configuration to a radially expanded configuration. The implantable frames can be self-expanding or balloon expandable. Portions of the medical device, such as the implantable frame or a valve leaflet, are optionally coated with one or more bioactive materials.

Abstract: The present invention provides self-expanding or otherwise expandable artificial valve prostheses for deployment within a bodily passageway, such as a vessel or duct of a patient. The valve prostheses include a support structure having an outer frame and supporting a valve leaflet.

Abstract: Endoluminally implantable medical devices having an electrolytically removable portion are provided, as well as methods pertaining to the same. The electrolytically removable portion can be dissolved within a body vessel after implantation of the medical device, by application of an electrical current from an electrode on a catheter inside the body vessel or by induction of an electrical current within the removable region. Electrolytic dissolution of the removable portion can alter the mechanical strength of the implanted frame within the body vessel. Medical devices can be an endovascular valve comprising a frame and one or more valve members adapted to regulate fluid flow in a body vessel, such as a vein.

Abstract: Medical devices for implantation in a body vessel, and methods of using and making the same, are provided. A medical device includes a frame and a cross-linkable material having at least one cross-linked region and a non cross-linked region, where the cross-linked region maintains the cross-linkable material in connection to the frame. A method of making an implantable medical device includes providing a frame and covering the frame with a cross-linkable material. The method also includes cross-linking at least one region of the cross-linkable material by joining a first region of the cross-linkable material to a second region of the cross-linkable material to form a point of attachment. A method of treating a subject includes the step of implanting the medical device at a point of treatment.

Abstract: A radially expandable artificial valve prosthesis for regulating fluid flow through a body vessel is provided. The prosthesis includes a radially expandable ring frame, at least one valve leaflet attached to the ring frame forming a valve pocket and a support structure attached to the ring frame and adapted to position the ring frame within the bodily passage. The height of the valve pocket is less than the maximum cross sectional dimension of the lumen defined by the expanded ring frame. The valve leaflet is allows fluid flow in a first, antegrade, direction and restricts flow in a second, retrograde direction.

Abstract: Implantable frames for use in body passages are provided herein. The implantable frames can include a plurality of hoop members joined by a plurality of longitudinal connecting members to form a tubular frame defining a cylindrical lumen. The plurality of longitudinal connecting members may include one or more pairs of closely-spaced longitudinal connecting members aligned substantially parallel to the longitudinal axis of the implantable frame. The circumferential distance between the closely-spaced longitudinal connecting members preferably subtends an angle less than (2?/n) radians, where (n) is an integer equal to the total number of longitudinal connecting members connecting two longitudinally adjacent hoop members.

Abstract: Described are percutaneous vascular valves (11) free of attached support structures and deployment systems (31) and methods for providing attachment of the valves within a vascular vessel.