# US 12,178,660 B2 · Echogenicity quantitative test system for an echogenic medical device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,178,660 B2 - Document ID: US12178660B2 - Status: Granted - Kind: B2 - Application number: 17/000,540 - Filed: 2020-08-24 - Published: 2021-02-25 - Granted: 2024-12-31 - Earliest claimed: 2019-08-22 - Assignees: Becton, Dickinson and Company - Applicants: Becton, Dickinson and Company - Inventors: Qingqing Fan; Irene Gao - Web page: https://patentgrep.com/patent/US12178660B2 ## CPC - A61B 8/58: {Testing, adjusting or calibrating the diagnostic device} - G01S 7/5205: {Means for monitoring or calibrating} - G01S 15/8938: {using transducers mounted for mechanical movement in two dimensions} - G06T 7/0012: {Biomedical image inspection} - G06V 10/22: by selection of a specific region containing or referencing a pattern; Locating or processing of specific regions to guide the detection or recognition - G06V 10/993: {Evaluation of the quality of the acquired pattern} - G01S 15/8915: {using a transducer array} - G06T 2207/10132: Ultrasound image - G06T 2207/30004: Biomedical image processing - G06V 2201/03: Recognition of patterns in medical or anatomical images - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - G01S: RADIO DIRECTION-FINDING; RADIO NAVIGATION; DETERMINING DISTANCE OR VELOCITY BY USE OF RADIO WAVES; LOCATING OR PRESENCE-DETECTING BY USE OF THE REFLECTION OR RERADIATION OF RADIO WAVES; ANALOGOUS ARRANGEMENTS USING OTHER WAVES - G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL - G06V: IMAGE OR VIDEO RECOGNITION OR UNDERSTANDING ## Abstract An echogenicity quantitative test system for a sample echogenic medical device includes a fixture into which the echogenic medical device is positioned in relation to an ultrasonic probe connected with an ultrasound diagnostic device. The fixture includes a frame; a probe holder having a first guide rod and a probe clamp configured to hold the ultrasonic probe and movably held on the first guide rod, and a sample holder having a second guide rod and a sample clamp configured to hold the medical device sample. The sample clamp is movably held on the second guide rod. The frame may include guide rails, and the first guide rod and the second guide rod are movably disposed in the guide rails so as to allow for adjustments to the relative positions of the ultrasonic probe and the sample echogenic medical device. ## Claims ### Claim 1 An echogenicity quantitative test system for a sample echogenic medical device, comprising: a test fixture including an ultrasonic probe, a probe holder having a first guide rod, a probe clamp configured to hold the ultrasonic probe and movably held on the first guide rod; and a holder having a second guide rod and a sample clamp configured to hold the sample echogenic medical device, the sample clamp being movably held on the second guide rod, the first guide rod and the second guide rod being movably disposed relative to the test fixture; wherein the probe clamp is movable along the first guide rod, while the sample clamp is movable along the second guide rod. ### Claim 2 (depends on 1) The system according to claim 1, wherein the test fixture includes a frame comprising guide rails for receiving the ends of the first and second guide rods. ### Claim 3 (depends on 1) The system according to claim 1, wherein the sample clamp is rotatable about the second guide rod so as to allow an angle adjustment. ### Claim 4 (depends on 1) The system according to claim 1, wherein the test fixture comprises an open frame, and further including a container configured to hold a test medium in which the sample echogenic medical device is located during the test. ### Claim 5 (depends on 4) The system according to claim 4, wherein the container is located on a lifting platform located directly below the ultrasonic probe. ### Claim 6 (depends on 1) The system according to claim 1, wherein the test fixture comprises a closed frame for receiving a test medium. ### Claim 7 (depends on 1) The system according to claim 1, wherein the ultrasonic probe has a main plane and a thickness, wherein an ultrasonic array acoustic wave emitting plane of the ultrasonic probe is parallel to the main plane and perpendicular to the thickness, and the main plane of the ultrasonic probe is perpendicular to the first guide rod and the second guide rod. ### Claim 8 (depends on 1) The system according to claim 1, further including an ultrasonic diagnostic device configured to read a mean grayscale value of a region of interest of the sample echogenic medical device or a test medium, read a mean grayscale value of an adjacent region having a similar number of pixels as a region of interest, and calculate a difference between the mean grayscale value of the region of interest and the mean grayscale value of the adjacent region. ### Claim 9 (depends on 8) The system according to claim 8, wherein the ultrasonic diagnostic device is configured to calculate at least three differences between the mean grayscale value of the region of interest and the mean grayscale value of the adjacent region, and calculate a mean value of the at least three differences. ### Claim 10 An echogenicity quantitative test system for a sample echogenic medical device, comprising: a test fixture including an ultrasonic probe, a probe holder having a first guide rod, a probe clamp configured to hold the ultrasonic probe and movably held on the first guide rod; and a holder having a second guide rod and a sample clamp configured to hold the sample echogenic medical device, the sample clamp being movably held on the second guide rod, the first guide rod and the second guide rod being movably disposed relative to the test fixture; wherein the test fixture comprises an open frame, and further including a container configured to hold a test medium in which the sample echogenic medical device is located during the test. ### Claim 11 An echogenicity quantitative test system for a sample echogenic medical device, comprising: a test fixture including an ultrasonic probe, a probe holder having a first guide rod, a probe clamp configured to hold the ultrasonic probe and movably held on the first guide rod; and a holder having a second guide rod and a sample clamp configured to hold the sample echogenic medical device, the sample clamp being movably held on the second guide rod, the first guide rod and the second guide rod being movably disposed relative to the test fixture; wherein the sample clamp is rotatable about the second guide rod so as to allow an angle adjustment. ### Claim 12 An echogenicity quantitative test system for a sample echogenic medical device, comprising: a test fixture including an ultrasonic probe, a probe holder having a first guide rod, a probe clamp configured to hold the ultrasonic probe and movably held on the first guide rod; and a holder having a second guide rod and a sample clamp configured to hold the sample echogenic medical device, the sample clamp being movably held on the second guide rod, the first guide rod and the second guide rod being movably disposed relative to the test fixture; wherein the test fixture comprises an open frame, and further including a container configured to hold a test medium in which the sample echogenic medical device is located during the test. ### Claim 13 An echogenicity quantitative test system for a sample echogenic medical device, comprising: a test fixture including an ultrasonic probe, a probe holder having a first guide rod, a probe clamp configured to hold the ultrasonic probe and movably held on the first guide rod; and a holder having a second guide rod and a sample clamp configured to hold the sample echogenic medical device, the sample clamp being movably held on the second guide rod, the first guide rod and the second guide rod being movably disposed relative to the test fixture; wherein the test fixture comprises a closed frame for receiving a test medium. ### Claim 14 An echogenicity quantitative test system for a sample echogenic medical device, comprising: a test fixture including an ultrasonic probe, a probe holder having a first guide rod, a probe clamp configured to hold the ultrasonic probe and movably held on the first guide rod; and a holder having a second guide rod and a sample clamp configured to hold the sample echogenic medical device, the sample clamp being movably held on the second guide rod, the first guide rod and the second guide rod being movably disposed relative to the test fixture; wherein the ultrasonic probe has a main plane and a thickness, wherein an ultrasonic array acoustic wave emitting plane of the ultrasonic probe is parallel to the main plane and perpendicular to the thickness, and the main plane of the ultrasonic probe is perpendicular to the first guide rod and the second guide rod. ### Claim 15 An echogenicity quantitative test system for a sample echogenic medical device, comprising: a test fixture including an ultrasonic probe, a probe holder having a first guide rod, a probe clamp configured to hold the ultrasonic probe and movably held on the first guide rod; and a holder having a second guide rod and a sample clamp configured to hold the sample echogenic medical device, the sample clamp being movably held on the second guide rod, the first guide rod and the second guide rod being movably disposed relative to the test fixture; further including an ultrasonic diagnostic device configured to read a mean grayscale value of a region of interest of the sample echogenic medical device or a test medium, read a mean grayscale value of an adjacent region having a similar number of pixels as a region of interest, and calculate a difference between the mean grayscale value of the region of interest and the mean grayscale value of the adjacent region.