AUTOMATIC VALIDATION TECHNIQUES FOR VALIDATING OPERATION OF MEDICAL DEVICES
First Claim
1. A method of testing a medical device, comprising:
- recording therapy parameter values describing therapy being delivered to a patient;
recording a sequence of patient parameter values indicative of at least one of posture and activity of the patient occurring while the therapy is being delivered;
controlling an automated device to reproduce the sequence of patient parameter values; and
validating that the medical device is delivering therapy in accordance with the recorded therapy parameter values while the medical device is experiencing conditions resulting from controlling of the automated device.
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Abstract
Techniques for validating operation of a medical device are disclosed. A data collection phase utilizes a first sensor carried by a patient to record patient parameter values indicative of conditions experienced by the patient (e.g, posture states.) Therapy parameter values describing therapy adjustments requested by the patient in response to the conditions are also recorded. Associations formed between the therapy parameter values and the patient parameter values are used to develop a closed-loop algorithm for control of an IMD having a sensor similar to the first sensor. An automated device such as a robotic arm uses the recorded patient parameter values to automatically reproduce, and to subject the IMD to, conditions present during the data collection phase. Therapy delivered by the IMD while under control of the closed-loop algorithm and while being subjected to the conditions is compared to the recorded therapy parameter values e to validate IMD operation.
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Citations
29 Claims
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1. A method of testing a medical device, comprising:
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recording therapy parameter values describing therapy being delivered to a patient; recording a sequence of patient parameter values indicative of at least one of posture and activity of the patient occurring while the therapy is being delivered; controlling an automated device to reproduce the sequence of patient parameter values; and validating that the medical device is delivering therapy in accordance with the recorded therapy parameter values while the medical device is experiencing conditions resulting from controlling of the automated device. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A system for automatically testing a medical device, comprising:
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a therapy delivery module to deliver therapy to a patient according to therapy parameter values; a sensor to sense patient parameter values indicative of one or more posture states assumed by the patient while the therapy is being delivered; and an automated system coupled to receive the patient parameter values and the therapy parameter values, to reproduce conditions indicated by the patient parameter values, and to validate that the medical device provides therapy according to the therapy parameter values while the medical device is subjected to the reproduced conditions. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28)
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29. A system to automatically verify operation of an implantable medical device, comprising:
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a first implantable medical device carried by a patient to deliver therapy to the patient according to therapy parameter values; a sensor carried by the patient to sense posture states assumed by the patient during delivery of the therapy; an automated device to automatically re-create the posture states; an automated programmer to automatically generate at least some of the therapy parameter values; a second implantable medical device to deliver therapy in response to the automatically-generated therapy parameter values while being subjected to the automatically re-created posture states; and compare logic communicatively coupled to the second implantable medical device to determine whether the therapy delivered by the second implantable medical device is substantially similar to the therapy delivered by the first implantable medical device.
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Specification