Abstract: A packaging system is disclosed for shipping a prosthetic tissue valve in a storage solution and preparing and loading of the bioprosthetic valve onto a catheter-based delivery system. The packaging system includes a fluid tight container filled with the storage solution attached to a delivery catheter, wherein the container surrounds the prosthetic tissue valve that is in a pre-loaded position on the delivery catheter during shipment and storage. The prosthetic tissue valve may include an attachment mechanism that attaches to the delivery catheter to properly position the tissue valve for loading within the delivery catheter. In another embodiment where the prosthetic tissue valve is not attached to the delivery catheter during shipment, the attachment mechanism may interact with the prosthetic tissue valve shipping container to prevent the bioprosthetic valve from moving during shipment.

Abstract: An arteriovenous shunt assembly including a shunt and a pull wire operated flow control mechanism. The shunt has a tubular body that defines a fluid passageway between a first end and a second end thereof The pull wire mechanism includes a portion disposed around the tubular shunt in at least one loop. The at least one loop may be selectively tightened or loosened remotely from the shunt to regulate the rate of blood flow through the tubular shunt.

Abstract: A thin-film device system includes a substrate and a plurality of pillars. The plurality of pillars project from a surface of the substrate. Each of the plurality of pillars have a perimeter that includes at least four protrusions that define at least four recessed regions between the at least four protrusions. Each of the at least four recessed regions of each of the plurality of pillars receives one protrusion from an adjacent one of the plurality of pillars. A thin-film device is fabricated over the plurality of pillars.

Abstract: A tissue stabilizer including an elongated arm, a collet, and a head-link assembly. The collet is disposed at a distal end of the arm. The head-link assembly includes a tube and a spreading mechanism. The tube forms an intermediate section and opposing arms each terminating at a tip. The spreading mechanism can adjust a lateral distance between the tips, and includes first and second articulating members each having a leg and a collet interface body. The first member further includes a female hinge feature, whereas the second member includes a male hinge feature differing from the female hinge feature. The legs of are mounted to discrete regions of the tube, and the male hinge feature is pivotably coupled to the female hinge feature. Automatic spreading of a lateral distance between the tips occurs in response to a compressive force applied to the collet interface bodies.

Abstract: A method of manufacturing an energy storage device for a medical device that includes creating an aperture in a case. The aperture includes an inner surface. The method also includes introducing an electrolyte into the case through the aperture and moving a sealing member into the aperture. The sealing member includes an outer surface. Furthermore, the method includes sealing the aperture only with the sealing member and creating a substantially hermetic seal between the inner surface of the aperture and the outer surface of the sealing member.

Abstract: Heart valve prostheses are provided for replacing a cardiac valve. The heart valve prosthesis includes a self-expanding frame including a first portion and a second portion. In the collapsed configuration, the first portion is positioned adjacent to the second portion. In the expanded configuration, the first portion moves to be positioned within an interior area of the second portion.

Abstract: According to an embodiment of the present invention, a steerable elongated medical device includes an outer tube extending between an outer tube proximal segment and an outer tube distal segment, and having an outer tube wall forming an outer tube lumen and an elongated outer tube slot through the outer tube wall to the outer tube lumen. The elongated outer tube slot has a first portion and a second portion and is formed between an outer tube slot proximal end and an outer tube slot distal end and extends axially along the outer tube distal segment through an outer tube slot length to define a cutaway portion of the outer tube. A reinforcing sleeve is positioned within the outer tube lumen and extends between a reinforcing sleeve proximal end and a reinforcing sleeve distal end.

Abstract: Neuromodulation cryotherapeutic devices and associated systems and methods are disclosed herein. A cryotherapeutic device configured in accordance with a particular embodiment includes an elongated shaft and a cooling assembly at distal portion of the shaft. The shaft can be configured to locate the distal portion intravascularly at a treatment site within or otherwise proximate a renal artery. The cryotherapeutic device can further include a supply lumen configured to carry liquid refrigerant toward the cooling assembly. The cooling assembly can include an applicator in fluid communication with the supply lumen and configured to deliver cryotherapeutic cooling to nerves proximate the target site when in a deployed state.

Abstract: A computer system receives, before a start of a trial of a medical therapy, data that configure the computer system to detect alert conditions indicative of occurrences of failure modes identified as being potentially associated with an institutional ethics committee such as an Institutional Review Board (IRB) that reviews the trial. Respective mitigation procedures are defined for the failure modes before the start of the trial. The mitigation procedures indicate procedures to mitigate occurrences of the failure modes. Furthermore, the computer system receives IRB activity data indicative of activities performed by the IRB. The computer system detects, based on the IRB activity data that one of the alert conditions has occurred. The alert condition is indicative of an occurrence of a given one of the failure modes. In response to detecting that the alert condition has occurred, the computer system outputs an alert.

Abstract: Methods of making a combination heat exchanger and oxygenator. A heat transfer tubing is wound about a core and a potting compound is applied to a portion of the wound tubing. The potting compound solidifies to form a potting structure defining an internal face substantially parallel with a longitudinal axis of the core. The assembly is cut along a line passing through the potting structure to define a core assembly having a cut face substantially parallel with the axis. The cut tubing forms a plurality of capillary tubes, each terminating at opposing, first and second ends, and each extending about the core along an arc angle of less than 360 degrees. An oxygenator bundle is formed as part of the core assembly and includes a plurality of gas exchange fibers. The core assembly is disposed within a housing having a blood inlet and a blood outlet.

Abstract: A device includes an inner shaft rotatable within an outer shaft for cutting tissue. Additionally, the device can deliver energy including bipolar radiofrequency energy for sealing tissue which may be concurrent with delivery of fluid to a targeted tissue site. An inner shaft can be formed of two portions separated by an insulating layer. The portions define electrodes for delivery of energy.

Abstract: An implantable flow restrictor device is disclosed for initially restricting, then gradually restoring blood flow through a body vessel after an interventional procedure. A self-expanding annular member having a constricted diameter gives the device a frustoconical configuration that reduces blood flow therethrough upon initial deployment at a treatment site. The annular member is constricted by a plurality of linkages that operate to allow the annular member to gradually expand, thereby transforming the flow restrictor device to a cylindrical configuration that allows unimpeded blood flow therethrough. In one embodiment, expansion of the annular member is achieved via biodegradation of the linkages. In another embodiment, expansion of the annular member is achieved via creep deformation of the linkages. The flow restrictor device may be attached to an endoluminal prosthesis, or may be a separate complementary component that is delivered during an interventional procedure.

Abstract: A method and system for detecting a short circuit during a radiofrequency ablation procedure. The method includes measuring an impedance of a pair of electrodes coupled to a treatment assembly of a medical device. Radiofrequency ablation energy is transmitted between the pair of electrodes. The transmission of radiofrequency ablation energy between the pair of electrodes is terminated when after a predetermined period of time the measured impedance in either of the electrodes in the pair of electrodes is below a predetermined threshold impedance value. An alert is generated indicating a short circuit between the pair of electrodes.

Abstract: Systems that sense the volume, activity or other parameters of the urinary bladder are described. The systems include at least two electrodes that are implanted at respective locations proximate the wall of the bladder, and may be located substantially opposite each other with respect to a center of the bladder. At least one of the electrodes receives an electrical signal emitted by another of the electrodes. Systems according to the invention detect an impedance through the bladder based on the signal, e.g., based on one or both of the current or voltage of the signal. Based on the detected impedance, the systems sense one or more parameters of the bladder, such as volume, activity, or the like, which influence the impedance. The detected impedance, or bladder parameter information derived from the impedance, may be stored for short- or long-term monitoring, or used to control delivery of a therapy to a patient.

Abstract: Neuromodulation cryotherapeutic devices and associated systems and methods are disclosed herein. A cryotherapeutic device configured in accordance with a particular embodiment includes an elongated shaft and a cooling assembly at a distal portion of the shaft. The shaft can be configured to locate the distal portion intravascularly at a treatment site within or otherwise proximate a renal artery. The cryotherapeutic device can further include a supply lumen configured to carry liquid refrigerant toward the cooling assembly. The cooling assembly can include an applicator in fluid communication with the supply lumen and configured to deliver cryotherapeutic cooling to nerves proximate the target site when in a deployed state.

Abstract: A lithium-ion battery having a wound electrode configuration includes a wound cell element that includes a positive electrode and a negative electrode, the positive electrode including a current collector and a first active material and the negative electrode including a current collector and a second active material. The second active material has a potential that is greater than 0.2 volts versus a lithium reference electrode. The wound cell element includes a region where an edge of the positive electrode is provided proximate an edge of the negative electrode and the second active material near the edge of the negative electrode does not extend beyond the first active material near the edge of the positive electrode.

Abstract: Neuromodulation cryotherapeutic devices and associated systems and methods are disclosed herein. A cryotherapeutic device configured in accordance with a particular embodiment of the present technology can include an elongated shaft having distal portion and a supply lumen along at least a portion of the shaft. The shaft can be configured to locate the distal portion intravascularly at a treatment site proximate a renal artery or renal ostium. The supply lumen can be configured to receive a liquid refrigerant. The cryotherapeutic device can further include a cooling assembly at the distal portion of the shaft. The cooling assembly can include an applicator in fluid communication with the supply lumen and configured to deliver cryotherapeutic cooling to nerves proximate the target site when the cooling assembly is in a deployed state.

Abstract: A delivery catheter includes a pre-formed and resilient heart-wrapping segment. The segment may have a relaxed span that allows the segment to wrap around a left side of a heart from an anterior epicardial surface to a posterior epicardial surface, when the catheter is advanced along the epicardial surface, having been inserted from a sub-xiphoid access site.