US-12619799-B2 - System and methods for simulation of medical devices

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.

Inventors

• Ross Kenyon

Assignees

• REGENERON PHARMACEUTICALS, INC.

Dates

Publication Date

20260505

Application Date

20220331

Claims (19)

1. 1 . 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.
2. 2 . The method of claim 1 , wherein the accelerated testing time is generated based on the reference creep strain, a reference stress, and the accelerated temperature.
3. 3 . The method of claim 1 , wherein the second medical device approval indication approves the second medical device and the second medical device rejection indication rejects the second medical device.
4. 4 . The method of claim 2 , further comprising: generating a second accelerated testing creep strain based on a second accelerated testing of the first medical device, the second accelerated testing conducted based on the accelerated temperature, the accelerated testing time, and the accelerated stress; and outputting one of a predictive modulus approval indication or a predictive modulus rejection indication, based on comparing the second accelerated testing creep strain and the reference creep strain.
5. 5 . The method of claim 1 , wherein the second medical device is manufactured based on a medical device design corresponding to the first medical device, wherein the raw creep modulus data is based on the first medical device.
6. 6 . The method of claim 1 , wherein the predictive modulus is generated based on a three-dimensional (3D) interpolation of the raw creep modulus data.
7. 7 . The method of claim 1 , wherein the raw creep modulus data is generated based on one of simulated strain or experienced strain.
8. 8 . 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.
9. 9 . The method of claim 8 , wherein the predictive modulus is generated based on a three-dimensional (3D) interpolation of the raw creep strain data.
10. 10 . The method of claim 8 , wherein a first creep strain for a first duration of time, a first amount of stress, and a first temperature is different than a second creep strain for the first duration of time, the first amount of stress, and a second temperature.
11. 11 . The method of claim 8 , wherein the reference creep strain corresponds to a reference temperature, a reference time, and a reference stress.
12. 12 . The method of claim 11 , wherein the reference temperature is an ambient temperature, the reference time is an anticipated shelf life for the medical device, and the reference stress is an anticipated amount of stress.
13. 13 . The method of claim 8 , wherein the predictive modulus approval indication approves the predictive modulus and the predictive modulus rejection indication rejects the predictive modulus.
14. 14 . 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.
15. 15 . The system of claim 14 , wherein the accelerated testing time is generated based on the reference creep strain, a reference stress, and the accelerated temperature.
16. 16 . The system of claim 14 , wherein the second medical device approval indication approves the second medical device and the second medical device rejection indication rejects the second medical device.
17. 17 . The system of claim 14 , wherein the second medical device is manufactured based on a medical device design corresponding to the first medical device, wherein the raw creep modulus data is based on the first medical device.
18. 18 . The system of claim 14 , wherein the predictive modulus is generated based on a three-dimensional (3D) interpolation of the raw creep modulus data.
19. 19 . The system of claim 14 , wherein the raw creep modulus data is generated based on one of simulated strain or experienced strain.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63/169,601, filed Apr. 1, 2021, the entire disclosure of which is hereby incorporated herein by reference in its entirety. FIELD OF DISCLOSURE Aspects of the present disclosure relate to designing and testing devices, e.g., medical devices such as auto-injectors, based on simulating device properties and/or age testing. More specifically, embodiments of the present disclosure relate to auto-injectors and methods for developing auto-injectors and related components that meet quality and use criteria. INTRODUCTION Various available medical devices, such as auto-injectors, include a plurality of components. The medical devices as a whole and/or one or more of the plurality of components are often required to meet quality or use criteria so the medical devices can operate in an acceptable manner for duration of their respective lifespans. Deviation from the quality or use criteria may result in sub-optimal performance or failure of the medical devices. However, testing multiple iterations of a medical device design and updating the device and/or its components to meet the quality or use criteria may not be possible due to time and/or cost constraints. Accordingly, an efficient way to determine whether a medical device with a given design meets one or more quality or use criteria is required. SUMMARY Disclosed herein are methods and systems to analyze medical devices and/or designs. In one embodiment of the present disclosure a method for determining accelerated testing parameters for a medical device includes receiving raw creep modulus data relating creep strains to durations of stress and amounts of stress, as a factor of a range of temperatures; generating a predictive modulus based on the raw creep modulus data; and generating, using the predictive modulus, one or more of an accelerated testing time, an accelerated stress, or an accelerated temperature. The accelerated testing time is generated based on a reference creep strain, a reference stress, and the accelerated temperature. The method includes generating an accelerated testing creep strain based on accelerated testing of the medical device, the accelerated testing conducted based on the accelerated temperature, the accelerated testing time, and the accelerated stress; and outputting one of a medical device approval indication or a medical device rejection indication based on comparing the accelerated testing creep strain and the reference creep strain. The approval indication approves the medical device and the rejection indication rejects the medical device. The method further includes generating an accelerated testing creep strain based on accelerated testing of the medical device, the accelerated testing conducted based on the accelerated temperature, the accelerated testing time, and the accelerated stress; and outputting one of a predictive modulus approval indication or a predictive modulus rejection indication, based on comparing the accelerated testing creep strain and the reference creep strain. The medical device is manufactured based on a medical device design corresponding to another medical device, wherein the raw creep modulus data is based on the other medical device. The predictive modulus is generated based on a three-dimensional (3D) interpolation of the raw creep strain data. The raw creep strain data is generated based on one of simulated strain or experienced strain. In another embodiment of the present disclosure a method for method for validating a predictive modulus for a medical device includes receiving raw creep strain data relating creep strain values to durations of stress and amounts of stress, as a factor of a range of temperatures; generating a predictive modulus, 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; and outputting one of an approval indication or a rejection indication based on comparing the accelerated testing creep strain and the reference creep strain. According to the method, the predictive modulus is generated based on a three-dimensional (3D) interpolation of the raw creep strain data. A first creep strain for a first duration of time, a first amount of stress, and a first temperature is different than a second creep strain for the first duration of time, the first amount of stress, and a second temperature. The reference creep strain corresponds to a reference temperature, a reference time, and a reference stress. The reference temperature is an ambient temperature, th