# US 2017/0281064 A1 · System and method for early detection of post-surgery infection > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2017/0281064 A1 - Document ID: US20170281064A1 - Status: Published application - Kind: A1 - Application number: 15/512,251 - Filed: 2015-09-25 - Published: 2017-10-05 - Earliest claimed: 2014-09-26 - Assignees: Sofradim Production - Applicants: Sofradim Production - Inventors: Yves Bayon - Web page: https://patentgrep.com/patent/US20170281064A1 ## CPC - A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes} - A61B 5/14539: {for measuring pH} - A61B 5/412: {Detecting or monitoring sepsis} - A61M 1/73: {comprising sensors or indicators for physical values} - A61M 1/95: {with sensors for exudate composition} - A61B 2562/0271: Thermal or temperature sensors - A61M 2205/3324: PH measuring means - A61M 2205/3368: Temperature - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract In-vivo systems and methods for the detection of early signs of post-surgery infection are described. The in-vivo systems include a drain system with a tube configured to drain fluids from a surgery site, at least one sensor unit for sensing the presence of at least one infection biomarker, a processor for processing a signal generated by the at least one sensor unit, a transmitter for transmitting the signal, and a notification system for receiving the signal, analyzing the signal by comparing it to a threshold, determining presence of infection, and generating an indication on the presence of infection. ## Claims ### Claim at position 1 1-23. (canceled) ### Claim 24 A system for detecting early signs of post-surgery infection in a patient, said system comprising: a drain system comprising a tube configured to drain fluids from a surgery site; at least one sensor unit for sensing a presence of at least one infection biomarker; a processor for processing a signal generated by said at least one sensor unit; a transmitter for transmitting the signal; and a notification system for receiving the signal, analyzing the signal by comparing the signal to a threshold, determining the presence of infection, and generating an indication on the presence of infection. ### Claim 25 (depends on 24) The system according to claim 24, wherein said at least one sensor unit is located along the tube. ### Claim 26 (depends on 24) The system according to claim 24, wherein said at least one sensor unit is located within the tube. ### Claim 27 (depends on 24) The system according to claim 24, wherein said at least one sensor unit comprises a memory unit. ### Claim 28 (depends on 24) The system according to claim 24, wherein said at least one sensor unit comprises a heating resistor for controlling a temperature within said at least one sensor unit. ### Claim 29 (depends on 24) The system according to claim 24, wherein said at least one sensor unit comprises an illumination source and a photodetector. ### Claim 30 (depends on 29) The system according to claim 29, wherein said at least one sensor unit further comprises a sol-gel material located between the illumination source and the photodetector. ### Claim 31 (depends on 24) The system according to claim 24, wherein said at least one sensor unit comprises at least a first and second sensor unit. ### Claim 32 (depends on 24) The system according to claim 24, further comprising a suction element for drawing the fluids from the surgery site through the tube. ### Claim 33 (depends on 24) The system according to claim 24, wherein said at least one infection biomarker is an indirect infection biomarker. ### Claim 34 (depends on 24) The system according to claim 24, wherein said at least one infection biomarker is a direct infection biomarker. ### Claim 35 (depends on 24) The system according to claim 24, wherein said at least one infection biomarker is selected from the group consisting of pH, lactic acid, flow rate of exudate, immune-modulating mediators, pancreas enzymes, inflammatory parameters, and metabolic parameters, or a combination thereof. ### Claim 36 (depends on 24) The system according to claim 24, wherein said at least one infection biomarker is a bacteria species selected from the group consisting of Escherischia coli, Pseudomonas spp., Pseudomonas aeruginosa, Pseudomonas putida, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus spp., Enterococcus spp., Klebsellia spp., Proteus spp., Serratia spp., Morganella spp. and other Enterobacteriaceae, or a combination thereof. ### Claim 37 (depends on 24) The system according to claim 24, wherein the system comprises a first sensor unit for sensing an infection biomarker selected from the group consisting of pH, lactic acid, flow rate of exudate, immune-modulating mediators, pancreas enzymes, inflammatory parameters, and metabolic parameters, or a combination thereof, and a second sensor unit for sensing an infection biomarker selected from the group consisting of Escherischia coli, Pseudomonas spp., Pseudomonas aeruginosa, Pseudomonas putida, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus spp., Enterococcus spp., Klebsellia spp., Proteus spp., Serratia spp., Morganella spp. and other Enterobacteriaceae, or a combination thereof. ### Claim 38 (depends on 37) The system according to claim 37, wherein the notification system comprises an analyzer for analyzing signals detected by the first and second sensor units and determining the presence of infection. ### Claim 39 (depends on 24) The system according to claim 24, wherein the notification system comprises an analyzer for analyzing the processed signal and determining the presence of infection. ### Claim 40 (depends on 39) The system according to claim 39, wherein the analyzer further determines the stage of infection. ### Claim 41 (depends on 40) The system according to claim 40, wherein when said at least one infection biomarker is pH; a first indication is generated if the level of pH is equal to or below 7.1, and a second indication is generated if the level of pH is equal to or below 6.8. ### Claim 42 (depends on 40) The system according to claim 40, wherein when said at least one infection biomarker is lactic acid; a first indication is generated if the mean increase rate of concentration of lactic acid is above a threshold of 0.1 mM/hr for longer than 1 hour post-surgery, a second indication is generated if the mean increase rate is above the threshold for longer than 3 hours post-surgery, and a third indication is generated if the mean increase rate is above the threshold for longer than 6 hours post-surgery. ### Claim 43 (depends on 40) The system according to claim 40, wherein when said at least one infection biomarker is a flow rate of exudate; a first indication is generated 6 hours post-surgery if the flow rate is above 5 ml/hr, a second indication is generated 6 hours post-surgery if the flow rate is above 10 ml/hr, and a third indication is generated 6 hours post-surgery if the flow rate is above 20 ml/hr. ### Claim 44 (depends on 40) The system according to claim 40, wherein when said at least one infection biomarker is a bacteria species; a first indication is generated if Colony Forming Units (CFU) is above 102 CFU/ml, a second indication is generated if CFU is above 103 CFU/ml, and a third indication is generated if CFU is above 104 CFU/ml. ### Claim 45 (depends on 24) The system according to claim 24, wherein the indication is displayed on a display unit. ### Claim 46 (depends on 24) The system according to claim 24, wherein said at least one sensor unit senses the presence of said at least one infection biomarker continuously. ### Claim 47 (depends on 24) The system according to claim 24, wherein said at least one sensor unit senses the presence of said at least one infection biomarker periodically. ### Claim 48 A method for determining early signs of post-surgery infection in a patient, said method comprising: sensing a presence of at least one infection biomarker by using a sensor incorporated in a drain system; processing signals generated by the sensor; transmitting the signals to a notification system; receiving the signals by the notification system; analyzing the signals by comparing the signals to a threshold; and determining the presence of infection.