# US 10,311,281 B2 · Quantitative structural assay of a nerve graft > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,311,281 B2 - Document ID: US10311281B2 - Status: Granted - Kind: B2 - Application number: 15/951,756 - Filed: 2018-04-12 - Published: 2018-08-16 - Granted: 2019-06-04 - Earliest claimed: 2015-05-28 - Assignees: Axogen Corporation - Applicants: AxoGen Corporation - Inventors: Curt Deister - Web page: https://patentgrep.com/patent/US10311281B2 ## CPC - G06V 20/698: {Matching; Classification} - G06T 7/0012: {Biomedical image inspection} - G06T 7/62: of area, perimeter, diameter or volume - G06V 20/695: {Preprocessing, e.g. image segmentation} - G06T 2207/10056: Microscopic image - G06T 2207/30024: Cell structures in vitro; Tissue sections in vitro - G06V: IMAGE OR VIDEO RECOGNITION OR UNDERSTANDING - G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL ## Abstract Techniques are described for determining the quality of a nerve graft by assessing quantitative structural characteristics of the nerve graft. Aspects of the techniques include obtaining an image identifying laminin-containing tissue in the nerve graft; creating a transformed image using a transformation function of an image processing application on the image; using an analysis function of the image processing application, analyzing the transformed image to identify one or more structures in accordance with one or more recognition criteria; and determining one or more structural characteristics of the nerve graft derived from a measurement of the one or more structures. ## Claims ### Claim 1 A method for assessing the quality of a nerve graft, the method comprising: obtaining an image identifying laminin-containing tissue in the nerve graft; creating a transformed image using a transformation function of an image processing application on the image; using an analysis function of the image processing application, analyzing the transformed image to identify one or more structures in accordance with one or more recognition criteria; determining one or more structural characteristics of the nerve graft derived from a measurement of the one or more structures; weighting at least one of the one or more structural characteristics by fascicle size; and assessing the quality of the nerve graft based upon the one or more structural characteristics, in which the one or more structural characteristics comprise at least one weighted structural characteristic. ### Claim 2 (depends on 1) The method of claim 1, wherein, before creating the transformed image, the method further comprises selecting one or more of an area of interest and a sampling window to delineate a selected image area, wherein the analyzing of the transformed image is performed only on the selected image area. ### Claim 3 (depends on 2) The method of claim 2, wherein the area of interest comprises a nerve fascicle. ### Claim 4 (depends on 1) The method of claim 1, wherein the one or more structures comprise an endoneurial tube. ### Claim 5 (depends on 1) The method of claim 1, wherein creating the transformed image comprises applying thresholding to the image. ### Claim 6 (depends on 5) The method of claim 5, wherein applying the thresholding comprises applying one or more of a threshold method, threshold color, a color space, and a dark background. ### Claim 7 (depends on 1) The method of claim 1, wherein the one or more recognition criterion comprises a size range of the one or more structures. ### Claim 8 (depends on 7) The method of claim 7, wherein the size range is from about 4.84 microns in diameter to about 16 microns in diameter. ### Claim 9 (depends on 1) The method of claim 1, wherein the one or more recognition criteria comprise a circularity range of the one or more structures. ### Claim 10 (depends on 9) The method of claim 9, wherein the circularity range is from about 0.5 to about 1.0. ### Claim 11 (depends on 1) The method of claim 1, wherein the one or more structural characteristics comprise the number of endoneurial tubes per area. ### Claim 12 (depends on 1) The method of claim 1, wherein the one or more structural characteristics comprise the percent of endoneurial tube lumen per area. ### Claim 13 (depends on 1) The method of claim 1, wherein the one or more structural characteristics comprise the total perimeter of endoneurial tube lumens per area. ### Claim 14 (depends on 1) The method of claim 1, further comprising: comparing the one or more structural characteristics to a qualitative assessment score. ### Claim 15 (depends on 1) The method of claim 1, further comprising: comparing the one or more structural characteristics to one or more reference ranges indicating an acceptable structural characteristic of the nerve graft. ### Claim 16 (depends on 1) The method of claim 1, further comprising: comparing the one or more structural characteristics to a bioassay result of the nerve graft. ### Claim 17 A method for assessing the quality of a nerve graft, the method comprising: obtaining an image of tissue, the image depicting a cross-section of the nerve graft, wherein the cross-section is treated with a stain that indicates the presence of laminin; selecting, using an image processing application, one or more nerve fascicles on the image; using the image processing application, creating a thresholded image, wherein the thresholded image distinguishes one or more visual aspects of the image; using a particle analysis feature of the image processing application on the thresholded image, identifying one or more structures contained within the boundary of the one or more nerve fascicles, wherein the particle analysis feature identifies the one or more structures in accordance with one or more recognition criteria; and determining one or more structural characteristics of the nerve graft derived from a measurement of the one or more structures; and assessing the quality of the nerve graft based upon at least one of the one or more structural characteristics. ### Claim 18 (depends on 17) The method of claim 17, wherein the one or more structural characteristics is one or more of: the number of endoneurial tubes per area, the percent of endoneurial tube lumens per area, and the total perimeter of endoneurial tube lumens per area. ### Claim 19 (depends on 17) The method of claim 17, further comprising: comparing the one or more structural characteristics to one or more of: a qualitative assessment score; one or more reference ranges indicating an acceptable structural characteristic of the nerve graft; and a bioassay result of the nerve graft. ### Claim 20 (depends on 17) The method of claim 17, wherein the stain is an immunoperoxidase stain.