Method and apparatus for embedded sensors in diagnostic and therapeutic medical devices

Abstract

The present invention relates to miniature biosensor technology which can be directly embedded into medical device technology to create a new category of multifunctional smart medical devices. The resulting data from these smart medical devices results in wireless communication networks and standardized referenceable databases, which are used in the creation of best practice guidelines, clinical decision support tools, personalized medicine applications, and comparative technology assessment.

What is claimed is: 
     
         1 . A method of assessing performance of a device disposed in a body of a patient, comprising:
 providing a device, including at least one of a medical device and/or a biosensor having at least one sensor, said device being disposed in the body of the patient and configured to collect data from the body of the patient;   recording said data in a database of a processor located internally or externally of the body of the patient;   performing an automated data audit on said data on condition that said device fails to record said data in said database;   identifying a source responsible for said failure to record said data;   removing said device responsible for said data failure from ongoing data collection and analysis on condition of continued data failure in said data recording.   
     
     
         2 . The method of  claim 1 , wherein removal of said device includes one of removal of said device being monitored for data collection or removal of said device from the body of the patient. 
     
     
         3 . The method of  claim 1 , wherein said device includes one of catheters, nanobots, or capsules having at least one of self-contained sensors, reservoirs or injectors that store and release a plurality of chemical compounds. 
     
     
         4 . The method of  claim 3 , wherein said device releases at least one of said plurality of chemical compounds to assist in one of device calibration or accuracy of usage of said chemical compounds. 
     
     
         5 . The method of  claim 4 , wherein said calibration of said device is performed via wireless communication. 
     
     
         6 . The method of  claim 5 , wherein on calibration analysis and determining that said calibration is in error,
 mathematically correcting said data of said device.   
     
     
         7 . The method of  claim 6 , wherein on condition that said calibration analysis exceeds a predefined quality assurance threshold, said device is prevented from said continued data collection and analysis. 
     
     
         8 . The method of  claim 1 , wherein said data collection and analysis is performed in real time. 
     
     
         9 . The method of  claim 1 , wherein said at least one sensor includes at least one multifunctional sensor, and each function of said at least one sensor is independently analyzed for quality assurance. 
     
     
         10 . The method of  claim 1 , wherein said at least one sensor is an embedded sensor, and said at least one sensor emits a homing signal. 
     
     
         11 . The method of  claim 10 , wherein an authentication prompt causes said at least one sensor to emit said homing signal and said authentication prompt includes a predetermined signal specific to each said device based upon a registration data of each said device. 
     
     
         12 . The method of  claim 11 , further comprising:
 a quality assurance or quality control test device which recognizes said homing signal and which travels to said device to perform a synchronization process with said device such that said test device is directly aligned with said at least one sensor and allows testing and analysis of said at least one sensor.   
     
     
         13 . The method of  claim 12 , wherein physical integrity of said device is performed by ultrasound. 
     
     
         14 . The method of  claim 12 , wherein said test device is modified to create surgical functionality to repair said device. 
     
     
         15 . The method of  claim 12 , wherein said synchronization process allows continuous data collection and analysis with neighboring sensors which provides differentiation between pathology-related and artifact-related data abnormalities. 
     
     
         16 . The method of  claim 15 , wherein on condition that said data is abnormal and unsubstantiated by comparable measurements in said neighboring sensors or repeated measurements from said at least one sensor, then an alert for additional testing is issued to a user. 
     
     
         17 . The method of  claim 1 , wherein security for operation of said device includes at least one of: biometrics, alpha numeric information, textual information, speech recognition, facial recognition, a randomized computer-generated authorization query upon data access request, or a tiered prioritization schema for data or authorization privileges based on clinical importance and sensitivity of said data or requested actions. 
     
     
         18 . The method of  claim 17 , wherein each said device has a different level of assigned security in accordance with device functionality or clinical importance. 
     
     
         19 . The method of  claim 1 , wherein additional data recorded in said database regarding pre-existing patient or technology risk factors or concomitant disease is correlated with said data.