Abstract: Systems for gaining access into a body of a patient around an implanted body of an elongate medical device include a sheath having a deformable wall that allows insertion of the device body into a lumen surrounded by the sheath wall. The sheath wall may include first and second edges that extend from a proximal end to a distal end of the lumen, or just extend along a distal portion of the lumen. A tool, which includes a groove sized to grasp about a circumference of the device body, may facilitate insertion of the device body into the lumen of those sheath embodiments that include the first and second edges, by spreading at least one of the first and second edges of the wall apart from the other of the first and second edges while the device body is grasped within the tool.

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: A computer system is configured before a start of a trial of a medical therapy to detect alert conditions. The alert conditions are indicative of occurrences of failure modes identified as being potentially associated with the trial. During the trial, the computer system receives trial data. The computer system detects, based on the trial data, that one or more of the alert conditions have occurred. In response to detecting that an alert condition has occurred, the computer system outputs an alert associated with a mitigation procedure defined for the given failure mode before the start of the trial. The mitigation procedure indicates a procedure to mitigate the occurrence of the given failure mode.

Abstract: Systems for gaining access into a body of a patient around an implanted body of an elongate medical device include a sheath having a deformable wall that allows insertion of the device body into a lumen surrounded by the sheath wall. The sheath wall may include first and second edges that extend from a proximal end to a distal end of the lumen, or just extend along a distal portion of the lumen. A tool, which includes a groove sized to grasp about a circumference of the device body, may facilitate insertion of the device body into the lumen of those sheath embodiments that include the first and second edges, by spreading at least one of the first and second edges of the wall apart from the other of the first and second edges while the device body is grasped within the tool.

Abstract: Systems for gaining access into a body of a patient around an implanted body of an elongate medical device include a sheath having a deformable wall that allows insertion of the device body into a lumen surrounded by the sheath wall. The sheath wall may include first and second edges that extend from a proximal end to a distal end of the lumen, or just extend along a distal portion of the lumen. A tool, which includes a groove sized to grasp about a circumference of the device body, may facilitate insertion of the device body into the lumen of those sheath embodiments that include the first and second edges, by spreading at least one of the first and second edges of the wall apart from the other of the first and second edges while the device body is grasped within the tool.

Abstract: Systems for gaining access into a body of a patient around an implanted body of an elongate medical device include a sheath having a deformable wall that allows insertion of the device body into a lumen surrounded by the sheath wall. The sheath wall may include first and second edges that extend from a proximal end to a distal end of the lumen, or just extend along a distal portion of the lumen. A tool, which includes a groove sized to grasp about a circumference of the device body, may facilitate insertion of the device body into the lumen of those sheath embodiments that include the first and second edges, by spreading at least one of the first and second edges of the wall apart from the other of the first and second edges while the device body is grasped within the tool.

Abstract: Described are combinations of implantable and external means for providing pain relief to patients suffering from prostatitis, prostatalgia or prostatodynia which employ electrical and/or magnetic stimulation to effect such relief. Implantable medical electrical leads or wireless modules comprising one or more electrodes deliver electrical stimulation to a selected site of a patient adjacent, around or in one of the sacral nerve or branches or portions thereof, the pudendal nerve or branches or portions thereof, the hypogastric nerve or branches or portions thereof, the prostatic plexus nerve or branches or portions thereof, the sacral splanchnic nerve or branches or portions thereof, or the pelvic splanchnic nerve or branches or portions thereof in an amount or degree sufficient to provide at least partial relief from pain intramuscular lead system. Optionally, an external or internal drug pump may be employed in conjunction with the electrical stimulation provided to the patient.