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US 12,619,799 B2Granted
System and methods for simulation of medical devices
AssigneeRegeneron Pharmaceuticals, Inc.
InventorRoss Kenyon
Life of this patent
Estimating the term…
Abstract
Disclosed herein are devices and methods for generating and/or verifying a predictive temperature stress and time creep modulus, approving or rejecting a medical device, verifying a medical device design using a linear device model, and generating coefficients using thermal analysis.
Claims19
A method for determining accelerated testing parameters for a medical device, the method comprising:
- receiving raw creep modulus data relating creep strains to durations of stress and amounts of stress for a first medical device, as a factor of a range of temperatures;
- generating a predictive modulus for the first medical device based on the raw creep modulus data;
- generating, using the predictive modulus, an accelerated testing time, an accelerated stress, or an accelerated temperature;
- performing a first accelerated testing of a second medical device based on the accelerated testing time, the accelerated stress, or the accelerated temperature;
- determining a first accelerated testing creep strain based on the first accelerated testing of the second medical device;
- comparing an accelerated testing creep strain at a first target point of the first accelerated testing creep strain to a reference creep strain at a corresponding second target point of a reference creep strain associated with the first medical device, wherein the first target point is output by the predictive modulus;
- and
- outputting one of a second medical device approval indication or a second medical device rejection indication based on the first accelerated testing creep strain at the first target point not exceeding or exceeding the reference creep strain at the second target point by a threshold amount.
5 more elements
A method for validating a predictive modulus for a medical device, the method comprising:
- receiving raw creep strain data relating creep strain values to durations of stress and amounts of stress for a first medical device, as a factor of a range of temperatures;
- generating a predictive modulus for the first medical device, the predictive modulus being configured to output an accelerated temperature, an accelerated time, and an accelerated stress based on a reference creep strain;
- receiving the accelerated temperature, the accelerated time, and the accelerated stress based on the reference creep strain;
- receiving an accelerated testing creep strain for the medical device based on accelerated testing conducted based on the accelerated temperature, the accelerated time, and the accelerated stress;
- performing a first accelerated testing of the medical device based on the accelerated time, the accelerated stress, or the accelerated temperature;
- determining a first accelerated testing creep strain based on the first accelerated testing of the medical device;
- comparing an accelerated testing creep strain at a first target point of the first accelerated testing creep strain to a target reference creep strain at a corresponding second target point of the reference creep strain associated with the medical device;
- and
- outputting one of a predictive modulus approval indication or a predictive modulus rejection indication based on the first accelerated testing creep strain at the first target point not exceeding or exceeding the target reference creep strain at the second target point by a threshold amount.
6 more elements
A system comprising:
- an accelerated testing chamber configured to perform an accelerated testing;
- a memory storing instructions;
- and
- a processor operatively connected to the memory and configured to execute instructions to perform operations comprising:
- receiving raw creep modulus data relating creep strains to durations of stress and amounts of stress for a first medical device, as a factor of a range of temperatures;
- generating a predictive modulus for the first medical device based on the raw creep modulus data;
- and
- generating, using the predictive modulus, an accelerated testing time, an accelerated stress, or an accelerated temperature;
- performing, using the accelerated testing chamber, a first accelerated testing of a second medical device based on the accelerated testing time, the accelerated stress, or the accelerated temperature, wherein the processor is further configured to execute instructions to perform operations comprising:
- receiving a first accelerated testing creep strain based on the first accelerated testing of the second medical device;
- comparing an accelerated testing creep strain at a first target point of the first accelerated testing creep strain to a reference creep strain at a corresponding second target point of a reference creep strain associated with the first medical device, wherein the first target point is output by the predictive modulus;
- and
- outputting one of a second medical device approval indication or a second medical device rejection indication based on the first accelerated testing creep strain at the first target point not exceeding or exceeding the reference creep strain at the second target point by a threshold amount.
10 more elements
Dependencies are inferred from the claim text.