Safety and Precision of Implanted Intrathecal Pumps December

AMF Mission The Alfred Mann Foundation is a medical research foundation dedicated to bringing advanced medical technologies to the public to provide significant improvements to the health, security and quality of life for people suffering from debilitating medical conditions 2 Non Profit 501(c)(3) Foundation

AMF Medical Device History 3

Historical Pump Safety Concerns Pocket Refills Cessation of Flow –Blocked Catheter –Pump Malfunction Over delivery from High Pressure Compatibility with MRI 4

New Safety Features Negative Pressure Reservoir –Syringe empties into Patient Inlet, no push –Safety valve stops fill at lower pressure –Low pressure reservoir assures no over delivery Catheter Pressure Sensor –Monitors pressure, alarms on blockage –Can detect occlusions in use Pumping Mechanism Monitor –Pump alarms on inability to deliver 5

Negative Pressure Reservoir Refill –Insertion of Refill Syringe automatically fills –Assurance of pump entry means NO Pocket Refills Safety –Fluid cannot “leak” into patient From reservoir into catheter From reservoir into pocket 6

Safety Valve 7 Pressure >10psi Cover Pressure

Catheter Pressure Sensor Internal Monitor of downstream Pressure –Will sense blockage within 4 hours No need to wait for next refill visit Prevents unnecessary rate increases Can prevent Baclofen withdrawal –Maintains History log of pressure Analysis of patient complaints Prevents unnecessary procedures 8

Precise Delivery Pumping mechanism relies on single piston –One Piston stroke with each Electronic pulse –Determined by activation not by amount –Each Stroke length about 150 microns –Each pulse delivers 250 nanoliters repeatedly Pumping mechanism independent of pressure –Volume not affected by reservoir fill level –Volume not affected by drug type/concentration 9

Bypass Check Valve Pole Button Piston Main Check Valve Solenoid Pumping Mechanism 10

Thank You 11