Abstract: The invention generally relates to systems and methods for stress testing to failure tubular mesh devices, specifically, one or more stents or mesh grid tubes. A radial compression method of stress to fatigue is developed by placing a tubular medical implant within a lower than normal compliance test vessel. A radial expansion method of stress to fatigue is developed by placing higher than normal compliance tubes within a tubular medical implant. A method for radial expansion and radial compression is conducted by placing a higher than normal compliance tube through the mesh device and the placing the tube and device within a lower than normal compliance test vessel. Each method is tested on a tester that operates by delivering pulsatile flow with varying pressures, frequencies and testing parameters. Fracture of the test subject is visualized by high speed camera.

Abstract: A method of determining the endurance limit of an implantable medical device is disclosed. The method utilizes a mock vessel that has a compliance that is higher or lower than the normal compliance of a human vessel for which the device is to be used. The device is deployed into the mock vessel and a curable liquid is used to form a layer over the device on the surface of the lumen of the mock vessel. High pressure pulsatile pressurization is applied to the lumen of the mock vessel to cause a failure of the implantable medical device. The amount and cycles of pressure necessary to cause a failure may be used to determine the endurance limit of the implantable medical device.

Abstract: A method of determining the endurance limit of an implantable medical device is disclosed. The method utilizes a mock vessel that has a compliance that is higher or lower than the normal compliance of a human vessel for which the device is to be used. The device is deployed into the mock vessel and a curable liquid is used to form a layer over the device on the surface of the lumen of the mock vessel. High pressure pulsatile pressurization is applied to the lumen of the mock vessel to cause a failure of the implantable medical device. The amount and cycles of pressure necessary to cause a failure may be used to determine the endurance limit of the implantable medical device.

Abstract: The invention generally relates to systems and methods for stress testing to failure tubular mesh devices, specifically, one or more stents or mesh grid tubes. A radial compression method of stress to fatigue is developed by placing a tubular medical implant within a lower than normal compliance test vessel. A radial expansion method of stress to fatigue is developed by placing higher than normal compliance tubes within a tubular medical implant. A method for radial expansion and radial compression is conducted by placing a higher than normal compliance tube through the mesh device and the placing the tube and device within a lower than normal compliance test vessel. Each method is tested on a tester that operates by delivering pulsatile flow with varying pressures, frequencies and testing parameters. Fracture of the test subject is visualized by high speed camera.

Abstract: An acute medical particulate testing device for determining particle shed from a medical device during implantation. The device includes a closed loop system through which a solution is forcibly passed. An inlet port allows a catheter-mounted medical device to be incorporated into the flow loop. At least one tortuous passage is provided to replicate the vascular pathway and tortuosity which simulates the turns and bends and rubbing that affect particulate release from an implantable medical device as it is passed through the vasculature. A debubbler is provided to remove air bubbles from the solution before it is passed into a particle counting device that counts particle shed from the medical device during the simulated implantation. A filter having desired porosity removes particles from the solution. A final filter system removes all particles and air bubbles from the solution before it is re-circulated through the loop.

Abstract: An acute medical particulate testing device for determining particle shed from a medical device during implantation. The device includes a closed loop system through which a solution is forcibly passed. An inlet port allows a catheter-mounted medical device to be incorporated into the flow loop. At least one tortuous passage is provided to replicate the vascular pathway and tortuosity which simulates the turns and bends and rubbing that affect particulate release from an implantable medical device as it is passed through the vasculature. A debubbler is provided to remove air bubbles from the solution before it is passed into a particle counting device that counts particle shed from the medical device during the simulated implantation. A filter having desired porosity removes particles from the solution. A final filter system removes all particles and air bubbles from the solution before it is re-circulated through the loop.

Abstract: A self-retaining artificial spinal disc is formed of a flexible material and has a peripheral lip or meniscus extending from its top and/or bottom surface. The meniscus/menisci encircle portions of vertebrae adjacent the implant site, to enhance retention of the artificial spinal disc when seated in the spinal column. The meniscus/menisci for example snugly overlie the vertebral portions, and foster a suction seal between the disc and the adjacent vertebrae. The disc may be formed as an integral whole, or as two half-discs joinable by gluing, melting or like methods. In a related method, a self-retaining artificial spinal disc is formed in layers, by pouring and drying measures of liquid disc solution in a mold. A meniscal extension is formed from the disc body. Drugs or salts may be added to the disc layers, for example to provide an artificial spinal disc with time-release antibiotics or a desired porosity.

Abstract: A self-retaining artificial spinal disc is formed of a flexible material and has a peripheral lip or meniscus extending from its top and/or bottom surface. The meniscus/menisci encircle portions of vertebrae adjacent the implant site, to enhance retention of the artificial spinal disc when seated in the spinal column. The meniscus/menisci for example snugly overlie the vertebral portions, and foster a suction seal between the disc and the adjacent vertebrae. The disc may be formed as an integral whole, or as two half-discs joinable by gluing, melting or like methods. In a related method, a self-retaining artificial spinal disc is formed in layers, by pouring and drying measures of liquid disc solution in a mold. A meniscal extension is formed from the disc body. Drugs or salts may be added to the disc layers, for example to provide an artificial spinal disc with time-release antibiotics or a desired porosity.

Abstract: Apparatuses and methods for determining particle shed rates of implantable or inter-dwelling devices are disclosed. Durability test apparatuses with integrated particle counters produce time-dependent particle shed rate profiles. The apparatuses are designed to accommodate pulsatile flow, resembling a heartbeat at the implantable device. In an embodiment, the pulsatile flow is converted to a steady flow before fluid enters the integrated particle counter.