# US 2019/0378261 A1 · Automated failure detection for medical device testing systems and methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0378261 A1 - Document ID: US20190378261A1 - Status: Published application - Kind: A1 - Application number: 16/437,809 - Filed: 2019-06-11 - Published: 2019-12-12 - Earliest claimed: 2018-06-11 - Assignees: Dynatek Labs, Inc. - Applicants: Dynatek Labs, Inc. - Inventors: Mark Alan Schultz; Donald John Rohde; Christopher Conti - Web page: https://patentgrep.com/patent/US20190378261A1 ## CPC - G06T 7/0006: {using a design-rule based approach} - G06T 7/001: {using an image reference approach} - A61F 2/90: characterised by a net-like or mesh-like structure - G06T 7/13: Edge detection - G06T 7/174: involving the use of two or more images - G06T 7/246: using feature-based methods, e.g. the tracking of corners or segments - G06T 7/254: involving subtraction of images - G06T 7/62: of area, perimeter, diameter or volume - A61F 2/82: Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents (stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07) - A61F 2240/008: Means for testing implantable prostheses - G06T 2207/10016: Video; Image sequence - G06T 2207/30052: Implant; Prosthesis - G06T 2207/30101: Blood vessel; Artery; Vein; Vascular - G06T 2207/30136: Metal - G06T 2207/30164: Workpiece; Machine component - G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract Systems and methods are described for capturing images of articles under test and processing the images to automatically detect the failure of a test article. The described methods include optimizing image capture to allow for the use of low cost imaging devices instead of high speed cameras or other expensive equipment. The described methods also include several methods for processing the images to identify the occurrence of a failure event. ## Claims ### Claim 1 A system for identifying a failure of an implantable medical device during testing thereof, the system comprising: a mock vessel having a lumen for receiving the implantable medical device; a pump in fluidic communication with the mock vessel for pumping a fluid through the mock vessel in a pulsatile flow with a pressure cycle; a camera for capturing a sequence of images of the implantable medical device; a signal processor attached to the a camera for receiving, storing, and processing the sequence of images; wherein the signal processor processes the sequence of images to select a set of images taken at a selected time in the pressure cycle of the pulsatile flow; wherein the signal processor processes the set of images to identify the failure of the implantable medical device. ### Claim 2 (depends on 1) The system of claim 1 wherein the selected time is the moment of highest fluid pressure in the lumen of the mock vessel during the pressure cycle. ### Claim 3 (depends on 1) The system of claim 1 wherein the images in the set of images comprise asynchronous images. ### Claim 4 (depends on 1) The system of claim 1 wherein each image in the set of images is captured after a selected interval of time has elapsed after the capture of a preceding image; wherein the selected interval of time is less than or greater than the length of the pressure cycle. ### Claim 5 (depends on 4) The system of claim 4 wherein the signal processor selects a subset of the set of images by selecting images from the set of images that are separated by a selected number of intervening images. ### Claim 6 (depends on 5) The system of claim 5 wherein the signal processor generates a video from the subset of the set of images. ### Claim 7 (depends on 1) The system of claim 1 wherein the sequence of images comprises both asynchronous images and synchronous images. ### Claim 8 (depends on 1) The system of claim 1 wherein each image in the set of images is captured when the pressure in the lumen of the mock vessel is greater than a high pressure threshold value. ### Claim 9 (depends on 8) The system of claim 8 further comprising a pressure indicator light in the field of view of the camera, the pressure indicator light configured to illuminate when the pressure in the lumen of the mock vessel is greater than the high pressure threshold value. ### Claim 10 (depends on 1) The system of claim 1 wherein the signal processor processes each image in the set of images to detect a characteristic of at least one edge of the implantable medical device and compare the characteristic to a characteristic of the edge detected in a preceding image in the sequence of images. ### Claim 11 (depends on 10) The system of claim 10 wherein the characteristic of each edge of the implantable medical device is a slope of a line fit to the edge of the implantable medical device. ### Claim 12 (depends on 10) The system of claim 10 wherein the characteristic of each edge is the distance from a point on the edge to a point on another edge. ### Claim 13 (depends on 1) The system of claim 1 wherein the signal processor processes each image in the set of images to detect at least one width measurement of the implantable medical device and compare the at least one width measurement to a width measurement detected in a preceding image in the set of images. ### Claim 14 (depends on 13) The system of claim 13 wherein the at least one width measurement is measured by selecting a line of pixels from the image and identifying the outermost pixels in that line of pixels that are representative of a structure of the implantable medical device. ### Claim 15 (depends on 14) The system of claim 14 wherein the implantable medical device is a stent and the structure of the implantable medical device is a wire component of the stent. ### Claim 16 (depends on 1) The system of claim 1 wherein the signal processor processes each image to measure for a plurality of lines of pixels in the image at least one characteristic of the implantable medical device. ### Claim 17 (depends on 16) The system of claim 16 wherein the at least one characteristic for each line in the plurality of lines in each image comprises a location of a left outermost pixel that is representative of the implantable medical device or a location of a right outermost pixel that is representative of the implantable medical device. ### Claim 18 (depends on 17) The system of claim 17 wherein the signal processor calculates for each image an average value for each characteristic. ### Claim 19 (depends on 17) The system of claim 17 wherein the signal processor calculates a slope intercept formula for the at least one characteristic for at least two lines of pixels in each image. ### Claim 20 (depends on 19) The system of claim 19 where the signal processor identifies a change in the slope intercept formula for a subsequent image in the sequence of images as the failure of the implantable medical device. ### Claim 21 (depends on 1) The system of claim 1 wherein the signal processor selects a search area in each image in the sequence of images and measures a characteristic of the implantable medical device in the search area. ### Claim 22 (depends on 21) The system of claim 21 wherein the characteristic of the implantable medical device is the number of pixels in the search area representative of a structure of the implantable medical device. ### Claim 23 (depends on 22) The system of claim 22 wherein the implantable medical device is a stent and the structure of the implantable medical device is a wire mesh component. ### Claim 24 (depends on 1) The system of claim 1 wherein the implantable medical device is a stent formed of a wire mesh, and the signal processor selects pixels in each image representative of the wire mesh. ### Claim 25 (depends on 24) The system of claim 24 wherein the signal processor locates discontinuities in the pixels representative of the wire mesh to identify a failure of the implantable medical device. ### Claim 26 (depends on 24) The system of claim 24 wherein the signal processor calculates differences between the pixels representative of the wire mesh in a plurality of images in the sequence of images to identify a failure of the implantable medical device. ### Claim 27 (depends on 1) A method of using the system of claim 1 to identify the occurrence of a failure event during testing of an implantable medical device, the method comprising the steps of: deploying the implantable medical device in the lumen of the mock vessel; attaching the lumen of the mock vessel to the pump; pumping a fluid through the mock vessel in a pulsatile flow having a pressure cycle; capturing a sequence of images of the implantable medical device; selecting a set of images from the sequence of images wherein each image is captured at a selected time in the pressure cycle; processing the images using the signal processor to identify the occurrence of the failure event. ### Claim 28 (depends on 27) The method of claim 27 wherein each image in the sequence of images is captured at the selected time. ### Claim 29 (depends on 27) The method of claim 27 wherein each image in the set of images is selected such that a capture time of the image is a selected interval of time after a capture time of a preceding image in the set of images. ### Claim 30 (depends on 29) The method of claim 29 wherein the selected time is substantially equal to the duration of the pressure cycle. ### Claim 31 (depends on 29) The method of claim 29 wherein the selected time is less than or greater than the duration of the pressure cycle. ### Claim 32 (depends on 27) The method of claim 27 wherein each image in the set of images is selected such that each image is separated from the preceding image in the set of images by a selected number of images in the sequence of images. ### Claim 33 (depends on 27) The method of claim 27 wherein each image in the set of images is captured when the pressure in the lumen of the mock vessel is greater than a high pressure threshold value. ### Claim 34 (depends on 27) The method of claim 27 wherein the system further comprises an indicator light in the field of view of the camera; and the method further comprises the steps of illuminating the indicator light when the pressure in the lumen of the mock vessel is greater than a high pressure threshold value; and the set of images is selected to include each image in the sequence of images wherein the indicator light is illuminated. ### Claim 35 (depends on 27) The method of claim 27 wherein the step of processing the images using the signal processor to identify the occurrence of the failure event further comprises the steps of: detecting a characteristic of at least one edge of the implantable medical device in each image in the set of images; comparing the characteristic to a characteristic of the edge detected in a preceding image in the set of images. ### Claim 36 (depends on 35) The method of claim 35 wherein the characteristic of at least one edge of the implantable medical device is a slope of a line fit to the at least one edge. ### Claim 37 (depends on 35) The method of claim 35 wherein the characteristic of at least one edge of the implantable medical device is the distance from a point on the edge to a point on a second edge. ### Claim 38 (depends on 27) The method of claim 27 wherein the step of processing the images using the signal processor to identify the occurrence of the failure event further comprises the steps of: detecting at least one width measurement of the implantable medical device in each image; comparing the at least one width measurement to a width measurement detected in a preceding image in the set of images. ### Claim 39 (depends on 38) The method of claim 38 wherein the step of detecting comprises the steps of: selecting a line of pixels from the image; identifying the outermost pixels in that line that are representative of a structure of the implantable medical device. ### Claim 40 (depends on 39) The method of claim 39 wherein the implantable medical device is a stent and the structure of the implantable medical device is a wire component of the stent. ### Claim 41 (depends on 27) The method of claim 27 wherein the step of processing the images using the signal processor to identify the occurrence of the failure event further comprises the steps of: detecting at least two pixels in each image representative of an edge of the implantable medical device; calculating a characteristic of the edge using the at least two pixels; comparing the characteristic of the edge in each image to the characteristic calculated from the preceding images in the set of images. ### Claim 42 (depends on 41) The method of claim 41 wherein the step of calculating a characteristic of the edge comprises calculating a slope intercept formula from the at least two pixels. ### Claim 43 (depends on 42) The method of claim 42 wherein the step of comparing the characteristic of the edge in each image comprises comparing the slope intercept formula of each image with the slope intercept of a preceding image. ### Claim 44 (depends on 42) The method of claim 42 wherein the step of comparing the characteristic of the edge in each image comprises comparing the slope intercept formula of each image to an average slope intercept of the preceding images in the set of images. ### Claim 45 (depends on 27) The method of claim 27 wherein the step of processing the images using the signal processor to identify the occurrence of the failure event further comprises the steps of: selecting a search area in each image in the set of images; measuring a characteristic of the implantable medical device in the search area. ### Claim 46 (depends on 45) The method of claim 45 wherein the characteristic of the implantable medical device in the search area is the number of pixels in the search area representative of a structure of the implantable medical device. ### Claim 47 (depends on 27) The method of claim 27 wherein the implantable medical device is a stent formed of a wire mesh, and the step of processing the images using the signal processor to identify the occurrence of the failure event comprises the steps of: identifying pixels representative of the wire mesh; and locating discontinuities in the pixels representative of the wire mesh.