# US 10,869,622 B2 · Body fluid leakage detection aqueous composition > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,869,622 B2 - Document ID: US10869622B2 - Status: Granted - Kind: B2 - Application number: 16/478,629 - Filed: 2018-12-20 - Published: 2019-11-14 - Granted: 2020-12-22 - Earliest claimed: 2017-12-20 - Assignees: Magle Chemoswed Holding AB; Universität Heidelberg - Applicants: Magle Chemoswed Holding AB; UniversitäT Heidelberg - Inventors: Henrik Johansson; Peter Schuisky; Thomas Pausch; Thilo Hackert - Web page: https://patentgrep.com/patent/US10869622B2 ## CPC - A61B 5/14539: {for measuring pH} - A61B 5/1473: invasive, e.g. introduced into the body by a catheter - A61B 17/06166: {Sutures (suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M)} - A61B 17/0644: {penetrating the tissue, deformable to closed position} - A61K 49/006: {Biological staining of tissues in vivo, e.g. methylene blue or toluidine blue O administered in the buccal area to detect epithelial cancer cells, dyes used for delineating tissues during surgery} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract A body fluid leakage detection aqueous composition, for use e.g. in intraoperative pancreatic fluid leakage detection. The composition comprises a gelling agent, increasing the viscosity of the composition, and buffering species, the composition thereby being buffered. The gelling agent is cross-linked α-glucan microspheres. Further, the composition comprises a pH-indicator. The pH of the composition is at least 0.1 pH units lower, or higher, than a pKa of the pH-indicator. ## Claims ### Claim 1 A body fluid leakage detection aqueous composition, wherein the composition is a pancreatic fluid leakage detection aqueous composition, the composition comprising a gelling agent, increasing the viscosity of the composition, wherein the gelling agent is cross-linked α-glucan microspheres, and buffering species, the composition thereby being buffered, wherein the composition further comprises a pH-indicator selected from the group consisting of bromothymol blue, phenol red, anthocyanins, and neutral red, wherein the pH of the composition is at least 0.1 pH units lower than a pKa of the pH-indicator, wherein the pH of the composition is in the range of 4 to 6, and wherein the pKa of the pH-indicator is in the range of 6 to 8. ### Claim 2 (depends on 1) The body fluid leakage detection aqueous composition according to claim 1, wherein the gelling agent is cross-linked starch microspheres or cross-linked dextran microspheres. ### Claim 3 (depends on 2) The body fluid leakage detection aqueous composition according to claim 2, wherein the composition comprises 5 to 25 wt % cross-linked starch microspheres or cross-linked dextran microspheres. ### Claim 4 (depends on 3) The body fluid leakage detection aqueous composition according to claim 3, wherein the degree of cross-linking, expressed as the weight ratio cross-linker:starch, or as ratio cross-linker:dextran, is in the range 12 to 20 wt %. ### Claim 5 (depends on 3) The body fluid leakage detection aqueous composition according to claim 3, wherein a volume based mean diameter (D[4,3]), as determined in accordance with ISO 13 320:2009 by using laser diffraction, of the cross-linked starch microspheres, or the cross-linked dextran microspheres, as present in the composition, is 100 to 1000 μm. ### Claim 6 (depends on 1) The body fluid leakage detection aqueous composition according to claim 1, wherein the pH of the composition is at least 0.2 pH units lower than the pKa of the pH-indicator. ### Claim 7 (depends on 1) The body fluid leakage detection aqueous composition according to claim 1, wherein the pH-indicator is bromothymol blue. ### Claim 8 (depends on 1) The body fluid leakage detection aqueous composition according to claim 1, wherein the pH of the composition is between 5 and 6. ### Claim 9 (depends on 1) The body fluid leakage detection aqueous composition according to claim 1, wherein the buffering species being present in an amount of 0.1 to 30 mM. ### Claim 10 (depends on 9) The body fluid leakage detection aqueous composition according to claim 9, wherein the composition is phosphate buffered. ### Claim 11 (depends on 1) The body fluid leakage detection aqueous composition according to claim 1, wherein the composition comprises: 13 to 17 wt % of the gelling agent, the gelling agent being cross-linked starch microspheres, the cross-linked starch microspheres being cross-linked by epichlorohydrin; 0.005 to 0.25 wt % of the pH-indicator, the pH-indicator being bromothymol blue; at least 75 wt % water; and optionally phosphate buffered saline; wherein: the cross-linked starch microspheres have a degree of cross-linking of 13.5 to 18.5 wt %; and the buffer concentration is 0.5 to 10 mM. ### Claim 12 (depends on 1) The body fluid leakage detection aqueous composition according to claim 1, wherein the aqueous composition further comprises: a preservative; and/or saline. ### Claim 13 (depends on 1) The body fluid leakage detection aqueous composition according to claim 1, wherein the pKa of the pH-indicator is in the range 6.5 to 7.5. ### Claim 14 (depends on 1) The body fluid leakage detection aqueous composition according to claim 1, wherein the pancreatic fluid leakage detection aqueous composition is for use in detecting pancreatic fluid leakage in conjunction with pancreatic surgery. ### Claim 15 A method for detecting pancreatic fluid leakage in conjunction with pancreatic surgery, the method comprising: applying a pancreatic fluid leakage detection aqueous composition to a tissue surface of the pancreas during pancreatic surgery, wherein the composition comprises a gelling agent, increasing the viscosity of the composition, wherein the gelling agent is cross-linked α-glucan microspheres, and buffering species, the composition thereby being buffered, wherein the composition further comprises a pH-indicator, wherein the pH of the composition is at least 0.1 pH units lower than a pKa of the pH-indicator, wherein the pH of the composition is in the range 4 to 6, and wherein the pKa of the pH-indicator is in the range 6 to 8; and detecting and localizing any leakage of pancreatic fluid on the tissue surface of the pancreas by a change in color of the pancreatic fluid leakage detection aqueous composition. ### Claim 16 (depends on 15) The method for detecting pancreatic fluid leakage in conjunction with pancreatic surgery according to claim 15, wherein the pancreatic fluid leakage detection aqueous composition is applied after closure of the pancreatic remnant in distal pancreatectomy with ligature treatment. ### Claim 17 (depends on 15) The method for detecting pancreatic fluid leakage in conjunction with pancreatic surgery according to claim 15, wherein the method further comprises the step of: stopping a detected leakage. ### Claim 18 (depends on 17) The method for detecting pancreatic fluid leakage in conjunction with pancreatic surgery according to claim 17, wherein the leakage is stopped by ligature treatment or by application of staples. ### Claim 19 (depends on 7) The body fluid leakage detection aqueous composition according to claim 7, wherein the composition comprises 0.001 to 0.5 wt % of bromothymol blue. ### Claim 20 (depends on 11) The body fluid leakage detection aqueous detection composition according to claim 11, wherein the composition comprises: 14 to 16 wt % of the gelling agent, the gelling agent being cross-linked starch microspheres, the cross-linked starch microspheres being cross-linked by epichlorohydrin; 0.01 to 0.1 wt % of the pH-indicator, the pH-indicator being bromothymol blue; at least 75 wt % water; and phosphate buffered saline; wherein: the cross-linked starch microspheres have a degree of cross-linking of 15.0 to 17.0 wt %; and the buffer concentration is 1.0 to 5 mM.