Device and Method for Simulation of Surface Bleedings

Abstract

The invention relates to a device to simulate a surface bleeding, comprising: —A source of a blood liquid, in particular a synthetic blood liquid or a blood liquid having been removed from a human body; A pump system connected to the source of blood liquid and configured to provide a controlled flow of said blood liquid; A wound simulator having an open chamber connected to the pump system to receive the controlled flow of blood liquid, wherein the wound simulator comprises a set of interchangeable plates, each plate having a plurality of holes arranged through said plate according to a specific pattern, wherein the specific pattern is different for each plate of the set of interchangeable plates, and. each plate being adapted to be removably mounted on the wound simulator to close the open chamber, so that blood liquid flows out of the chamber through the holes of the plate mounted on the wound simulator. The invention also relates to methods of use of such simulating device.

1 . A device to simulate a surface bleeding, comprising:
 A source of a blood liquid, in particular a synthetic blood liquid or a blood liquid having been removed from a human body;   A pump system connected to the source of blood liquid and configured to provide a controlled flow of said blood liquid;   A wound simulator having an open chamber connected to the pump system to receive the controlled flow of blood liquid, wherein the wound simulator comprises a set of interchangeable plates,
 each plate having a plurality of holes arranged through said plate according to a specific pattern, wherein the specific pattern is different for each plate of the set of interchangeable plates, and 
 each plate being adapted to be removably mounted on the wound simulator to close the open chamber, so that blood liquid flows out of the chamber through the holes of the plate mounted on the wound simulator. 
   
     
     
         2 . The device of  claim 1 , wherein the plates of the set of interchangeable plates have holes arranged according to specific patterns of different surface areas. 
     
     
         3 . The device of  claim 1 , wherein the plates of the set of interchangeable plates have holes arranged according to specific patterns of different sizes. 
     
     
         4 . The device of  claim 1 , wherein the holes are provided in each of the interchangeable plates at a density of at least 50 holes/cm 2 . 
     
     
         5 . The device of  claim 1 , wherein the holes are provided in each of the interchangeable plates at a density of 100 holes/cm 2 . 
     
     
         6 . The device of  claim 1 , wherein the number and diameter of the holes provided in each of the interchangeable plates are set to reproduce the visual appearance of a bleeding surface. 
     
     
         7 . The device of  claim 6 , wherein the holes provided in each one of the interchangeable plates have all the same diameter, said diameter being comprised between 0.2 mm and 1 mm. 
     
     
         8 . The device of  claim 6 , wherein the holes provided in each one of the interchangeable plates have all the same diameter, said diameter being of 0.5 mm. 
     
     
         9 . The device of  claim 1 , wherein the holes provided in each one of the interchangeable plates are regularly spaced apart in the corresponding specific pattern, with a pitch comprised between 0.4 mm and 2 mm. 
     
     
         10 . The device of  claim 1 , wherein the holes provided in each one of the interchangeable plates are regularly spaced apart in the corresponding specific pattern, with a pitch of 1 mm. 
     
     
         11 . The device of  claim 1 , wherein the wound simulator further comprises a gravity fed gutter system to drain out the blood liquid having passed through the holes of the plate and guide it into a receiving container. 
     
     
         12 . The device of  claim 1 , further comprising a pressure monitoring system connected to the pump system to measure the pressure of the blood liquid supplied to the chamber of the wound simulator. 
     
     
         13 . The device of  claim 1 , wherein the pump system comprises a peristaltic pump provided with tubing for circulation of the blood liquid from the blood source to the open chamber. 
     
     
         14 . The device of  claim 1 , wherein the pump system comprises a pump controller for control of the flow of the blood liquid from the blood source to the open chamber. 
     
     
         15 . A method for simulating a plurality of different surface bleedings with the device comprising:
 A source of a blood liquid, in particular a synthetic blood liquid or a blood liquid having been removed from a human body;   A pump system connected to the source of blood liquid and configured to provide a controlled flow of said blood liquid;   A wound simulator having an open chamber connected to the pump system to receive the controlled flow of blood liquid, wherein the wound simulator comprises a set of interchangeable plates,
 each plate having a plurality of holes arranged through said plate according to a specific pattern, wherein the specific pattern is different for each plate of the set of interchangeable plates, and 
 each plate being adapted to be removably mounted on the wound simulator to close the open chamber, so that blood liquid flows out of the chamber through the holes of the plate mounted on the wound simulator, 
   
       wherein each surface bleeding is simulated by mounting on the wound simulator a specific plate chosen among the set of interchangeable plates, and adjusting the flow of blood liquid provided by the pump system to a specific value. 
     
     
         16 . The method of  claim 15 , comprising the simulation of several sets of surface bleedings, wherein:
 a first set of surface bleedings is simulated to represent a first degree of severity of surface bleeding, each of the surface bleedings being simulated by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior to 0 mL/min and inferior to 4.8 mL/min;   a second set of surface bleedings is simulated to represent a second degree of severity of surface bleeding, each of the surface bleedings being simulated by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 4.8 mL/min and inferior to 12.0 mL/min.   a third set of surface bleedings is simulated to represent a third degree of severity of surface bleeding, each of the surface bleedings being simulated by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 12.0 mL/min and inferior to 25.3 mL/min.   a fourth set of surface bleedings is simulated to represent a fourth degree of severity of surface bleeding, each of the surface bleedings being simulated by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 25.3 mL/min and inferior to 102.0 mL/min.   a fifth set of surface bleedings is simulated to represent a fifth degree of severity of surface bleeding, each of the surface bleedings being simulated by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 102.0 mL/min.   
     
     
         17 . The method of  claim 15 , comprising the simulation of several sets of surface bleedings, wherein:
 a first set of surface bleedings is simulated to represent a first degree of severity of surface bleeding, said first set of surface bleedings comprising
 at least one surface bleeding being simulated by mounting a plate with through holes arranged according to a pattern of 1 cm 2  and by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior to 0 mL/min and inferior to 4.8 mL/min; 
 at least one surface bleeding being simulated by mounting a plate with through holes arranged according to a pattern of 10 cm 2  and by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior to 0 mL/min and inferior to 9.1 mL/min; 
 at least one surface bleeding being simulated by mounting a plate with through holes arranged according to a pattern of 50 cm 2  and by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior to 0 mL/min and inferior to 13.5 mL/min; 
   a second set of surface bleedings is simulated to represent a second degree of severity of surface bleeding, said second set of surface bleedings comprising
 at least one surface bleeding being simulated by mounting a plate with through holes arranged according to a pattern of 1 cm 2  and by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 4.8 mL/min and inferior to 12.0 mL/min; 
 at least one surface bleeding being simulated by mounting a plate with through holes arranged according to a pattern of 10 cm 2  and by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 9.1 mL/min and inferior to 20.0 mL/min; 
 at least one surface bleeding being simulated by mounting a plate with through holes arranged according to a pattern of 50 cm 2  and by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 13.5 mL/min and inferior to 28.0 mL/min; 
   a third set of surface bleedings is simulated to represent a third degree of severity of surface bleeding, said third set of surface bleedings comprising
 at least one surface bleeding being simulated by mounting a plate with through holes arranged according to a pattern of 1 cm 2  and by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 12.0 mL/min and inferior to 25.3 mL/min; 
 at least one surface bleeding being simulated by mounting a plate with through holes arranged according to a pattern of 10 cm 2  and by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 20.0 mL/min and inferior to 71.3 mL/min; 
 at least one surface bleeding being simulated by mounting a plate with through holes arranged according to a pattern of 50 cm 2  and by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 28.0 mL/min and inferior to 117.3 mL/min; 
   a fourth set of surface bleedings is simulated to represent a fourth degree of severity of surface bleeding, said fourth set of surface bleedings comprising
 at least one surface bleeding being simulated by mounting a plate with through holes arranged according to a pattern of 1 cm 2  and by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 25.3 mL/min and inferior to 102.0 mL/min; 
 at least one surface bleeding being simulated by mounting a plate with through holes arranged according to a pattern of 10 cm 2  and by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 71.3 mL/min and inferior to 147.4 mL/min; 
 at least one surface bleeding being simulated by mounting a plate with through holes arranged according to a pattern of 50 cm 2  and by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 117.3 mL/min and inferior to 192.7 mL/min; 
   a fifth set of surface bleedings is simulated to represent a fifth degree of severity of surface bleeding, said fifth set of surface bleedings comprising
 at least one surface bleeding being simulated by mounting a plate with through holes arranged according to a pattern of 1 cm 2  and by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 102.0 mL/min; 
 at least one surface bleeding being simulated by mounting a plate with through holes arranged according to a pattern of 10 cm 2  and by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 147.4 mL/min; 
 at least one surface bleeding being simulated by mounting a plate with through holes arranged according to a pattern of 50 cm 2  and by adjusting the flow of the blood liquid provided by the pump system to a specific value being chosen superior or equal to 192.7 mL/min. 
   
     
     
         18 . The method of  claim 15 , wherein each of the simulated surface bleedings is recorded as a video. 
     
     
         19 . A method of preparation of at least a training set of videos comprising the following subsequent steps:
 Selecting a plurality of videos of simulated surface bleedings and affecting to each one of the selected videos a score corresponding to a degree of severity of surface bleeding, wherein each video is a recording of a specific surface bleeding simulated with a device comprising:
 A source of a blood liquid, in particular a synthetic blood liquid or a blood liquid having been removed from a human body; 
 A pump system connected to the source of blood liquid and configured to provide a controlled flow of said blood liquid; 
 A wound simulator having an open chamber connected to the pump system to receive the controlled flow of blood liquid, wherein the wound simulator comprises a set of interchangeable plates,
 each plate having a plurality of holes arranged through said plate according to a specific pattern, wherein the specific pattern is different for each plate of the set of interchangeable plates, and 
 each plate being adapted to be removably mounted on the wound simulator to close the open chamber, so that blood liquid flows out of the chamber through the holes of the plate mounted on the wound simulator, 
 
 wherein each surface bleeding is simulated by mounting on the wound simulator a specific plate chosen among the set of interchangeable plates, and adjusting the flow of blood liquid provided by the pump system to a specific value, 
   Classifying the selected videos in a specific order for visualization, wherein the score of each of the videos is to be displayed with the corresponding video.   
     
     
         20 . The method of  claim 19 , wherein the videos are classified for visualization according an increasing or decreasing order of the corresponding degrees of severity of surface bleeding. 
     
     
         21 . A method of preparation of at least a testing set of videos comprising the following subsequent steps:
 Selecting a plurality of videos of simulated surface bleedings and affecting to each one of the selected videos a score corresponding to a degree of severity of surface bleeding, wherein each video is a recording of a specific surface bleeding simulated with a device comprising:
 A source of a blood liquid, in particular a synthetic blood liquid or a blood liquid having been removed from a human body; 
 A pump system connected to the source of blood liquid and configured to provide a controlled flow of said blood liquid; 
 A wound simulator having an open chamber connected to the pump system to receive the controlled flow of blood liquid, wherein the wound simulator comprises a set of interchangeable plates,
 each plate having a plurality of holes arranged through said plate according to a specific pattern, wherein the specific pattern is different for each plate of the set of interchangeable plates, and 
 each plate being adapted to be removably mounted on the wound simulator to close the open chamber, so that blood liquid flows out of the chamber through the holes of the plate mounted on the wound simulator, 
 
 wherein each surface bleeding is simulated by mounting on the wound simulator a specific plate chosen among the set of interchangeable plates, and adjusting the flow of blood liquid provided by the pump system to a specific value, 
   Classifying the videos in a random order for visualization, wherein the score of each of the videos is not to be displayed with the corresponding video.   
     
     
         22 . A method of preparation of at least a training set of videos and at least a testing set of videos using a plurality of videos of simulated surface bleedings, wherein each video is a recording of a specific surface bleeding simulated with a device comprising:
 A source of a blood liquid, in particular a synthetic blood liquid or a blood liquid having been removed from a human body;   A pump system connected to the source of blood liquid and configured to provide a controlled flow of said blood liquid;   A wound simulator having an open chamber connected to the pump system to receive the controlled flow of blood liquid, wherein the wound simulator comprises a set of interchangeable plates,
 each plate having a plurality of holes arranged through said plate according to a specific pattern, wherein the specific pattern is different for each plate of the set of interchangeable plates, and 
 each plate being adapted to be removably mounted on the wound simulator to close the open chamber, so that blood liquid flows out of the chamber through the holes of the plate mounted on the wound simulator, 
   wherein each surface bleeding is simulated by mounting on the wound simulator a specific plate chosen among the set of interchangeable plates, and adjusting the flow of blood liquid provided by the pump system to a specific value,   
       wherein a score corresponding to a degree of severity of surface bleeding is affected to each one of the plurality of videos, comprising:
 preparing the training set of videos by selecting some videos of the plurality of videos, and classifying the selected videos in a specific order for visualization, wherein the score and information on the specific chosen plate of each of the videos are to be displayed with the corresponding video; 
 preparing the testing set of videos by selecting some videos of the plurality of videos, and classifying the selected videos in a random order for visualization, wherein the score of each of the videos is not to be displayed with the corresponding video, and wherein the selection and/or classification of the videos is different from the training set of videos. 
 
     
     
         23 . A method of training a person to recognize and classify a severity of a surface bleeding comprising the step of displaying a plurality of training videos in a specific order, wherein each one of the training videos shows a simulated surface bleeding and a score corresponding to the severity of said simulated surface bleeding. 
     
     
         24 . The method of  claim 23 , wherein the training videos are displayed according to an increasing or decreasing order of the corresponding degrees of severity of surface bleeding. 
     
     
         25 . The method of  claim 23 , comprising a subsequent step of testing the person in applying the following steps:
 displaying in a random order a plurality of testing videos each numerically labeled in sequence, wherein each one of the testing videos shows a simulated surface bleeding without any score corresponding to the severity of said simulated surface bleeding of simulated surface bleeding, and wherein the testing videos are different from the training videos and/or used in a different order;   requesting the person to give for each of the testing videos a score representative of the severity of the corresponding surface bleeding in the order of the numerically labeled sequence.   
     
     
         26 . A method of performing a clinical trial to assess hemostatic power of a product against surface bleeding, comprising the following steps:
 a) characterizing the severity of a baseline surface bleeding from a wound of a patient by affecting a score;   b) applying the product on the wound according to a specific protocol of use of the product;   c) at a predetermined time after step b), characterizing the severity of the remaining surface bleeding from the wound of the patient by affecting a score.   
     
     
         27 . The method of  claim 26 , wherein steps b) and c) are repeated several times after each characterization of the severity of the remaining surface bleeding in order to assess the hemostatic power of the product over time.