WO2016162415A1 - Dispositif et procédé pour simulation de saignements en surface - Google Patents

Dispositif et procédé pour simulation de saignements en surface Download PDF

Info

Publication number
WO2016162415A1
WO2016162415A1 PCT/EP2016/057611 EP2016057611W WO2016162415A1 WO 2016162415 A1 WO2016162415 A1 WO 2016162415A1 EP 2016057611 W EP2016057611 W EP 2016057611W WO 2016162415 A1 WO2016162415 A1 WO 2016162415A1
Authority
WO
WIPO (PCT)
Prior art keywords
blood liquid
simulated
plate
videos
bleeding
Prior art date
Application number
PCT/EP2016/057611
Other languages
English (en)
Inventor
William Spotnitz
Patricia Forest
Catherine Wittmann
Vincent Guyot
Sylvain Picot
Original Assignee
Biom'up
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from EP15305517.3A external-priority patent/EP3079139B1/fr
Priority claimed from US14/681,305 external-priority patent/US10283015B2/en
Application filed by Biom'up filed Critical Biom'up
Priority to US15/565,024 priority Critical patent/US20180102067A1/en
Priority to CA2981909A priority patent/CA2981909A1/fr
Priority to EP16717295.6A priority patent/EP3281187A1/fr
Priority to JP2017552945A priority patent/JP6655630B2/ja
Priority to BR112017021331-1A priority patent/BR112017021331B1/pt
Priority to CN201680032755.7A priority patent/CN107851402B/zh
Priority to AU2016245924A priority patent/AU2016245924B2/en
Publication of WO2016162415A1 publication Critical patent/WO2016162415A1/fr
Priority to HK18109347.1A priority patent/HK1249959A1/zh

Links

Classifications

    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G09B23/30—Anatomical models
    • G09B23/303—Anatomical models specially adapted to simulate circulation of bodily fluids
    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G09B23/30—Anatomical models
    • G09B23/34—Anatomical models with removable parts

Definitions

  • the invention relates to the medical field and more particularly the assessment of the severity of a surface bleeding, for example to determine the efficacy of a hemostatic agent on a wound.
  • An estimate of total intraoperative blood loss is an integral part of any surgical procedure and is considered routine care.
  • the wide variety of surgical specialties and operations make quantitative standardization of total blood loss difficult, yet estimates may still be provided.
  • Estimating total blood loss during a surgical procedure, supplemented with other variables such as blood pressure, are data helpful for the ongoing evaluation of the condition of a subject and the assessment/modification of intra- and post-operative management.
  • Such scale further appears not to be adapted to be used consistently to assess success/failure of a product vs. hemostasis.
  • This proposed scale does not include the full range of potential input and output domain data values for each proposed site, e.g. it does not include or distinguish life threatening as well as severe bleeding.
  • a goal of the invention is to propose a system and method to simulate surface bleedings and validate a bleeding severity assessment scale for further application, during surgery and/or in clinical trials for example.
  • a goal of the invention is in particular to provide a method that enables establishing a bleeding severity during intra-operative inclusion/exclusion assessment before randomization and investigational device placement.
  • Another goal of the invention is to provide a surface bleeding severity scale to be used for the consistent assessment of hemostatic success or failure. It would preferably include the full range of any potential input and output domain data values expected for bleeding severities seen during elective surgical procedures.
  • a further goal of the invention is to provide a system and method to create a surface bleeding model allowing for consistency in the assessments of success/failure of hemostasis, while not being dependent on an individual animal physiology.
  • Still another goal of the invention is to provide a system and method to ensure consistency of bleeding severity assessments across investigators testing a particular product, in particular in a clinical investigation, to ensure notably that similar bleeding severities are enrolled during the investigation.
  • a specific goal of the invention is to provide a system and method to be used during a clinical study of a hemostatic product, in particular to determine intraoperative eligibility of patients, as well as hemostatic success of the tested product.
  • a goal is to ensure consistent enrollment of target bleeding sites of bleeding severities to be treated for assessment of the hemostatic product under investigation and help ensure subject safety by excluding those who have a too severe bleeding.
  • Still another goal on the invention is to provide a system and method to help training and testing investigators to recognize a specific degree of surface bleeding and homogeneously assess such surface bleeding in a clinical investigation.
  • Example 1 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
  • Example 2 relates to the device of Example 1 , wherein the plates of the set of interchangeable plates have holes arranged according to specific patterns of different surface areas, in particular of different sizes.
  • Example 3 relates to the device of any one of Examples 1 or 2, wherein the holes are provided in each of the interchangeable plates at a density of at least 50 holes/cm 2 , and preferably of 100 holes/cm 2 .
  • Example 4 relates to the device of any one of Examples 1 to 3, 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.
  • Example 5 relates to the device of Example 4, wherein the holes provided in each one of the interchangeable plates have all the same diameter, preferably comprised between 0.2 mm and 1 mm, and most preferably of 0.5 mm.
  • Example 6 relates to the device of any one of Examples 1 to 5, wherein the holes provided in each one of the interchangeable plates are regularly spaced apart in the corresponding specific pattern, with a pitch preferably comprised between 0.4 mm and 2 mm, and most preferably of 1 mm.
  • Example 7 relates to the device of any one of Examples 1 to 6, 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.
  • Example 8 relates to the device of any one of Examples 1 to 7, further comprising a pressure monitoring system connected to the pump system to measure the pressure of the blood liquid supplied to the open chamber of the wound simulator.
  • Example 9 relates to the device of any one of Examples 1 to 8, 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.
  • Example 10 relates to the device of any one of Examples 1 to 9, 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.
  • Example 1 1 relates to a method for simulating a plurality of different surface bleedings with for instance the device of any of Examples 1 to 10, 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.
  • Example 12 relates to the method of Example 10, 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.
  • Example 13 relates to the method of Example 10, 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 o 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
  • o 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; o 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; o 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
  • o 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; o 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; o 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
  • 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
  • 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 1 17.3 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.
  • Example 14 relates to the method of any one of Examples 1 1 to 13, wherein eache simulated surface bleedings is recorded as a video.
  • Example 15 relates to method of preparation of at least a training set of videos comprising the following subsequent steps:
  • Example 16 relates to the method of Example 15, wherein the videos are classified for visualization according an increasing or decreasing order of the corresponding degrees of severity of surface bleeding.
  • Example 1 relates to a method of preparation of at least a testing set of videos comprising the following subsequent steps:
  • Example 18 relates to 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 recorded for instance pursuant to the method of Example 14, wherein a score corresponding to a degree of severity of surface bleeding is affected to each one of the plurality of videos, comprising:
  • Example 19 relates to 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.
  • Example 20 relates to the method of Example 19, wherein the training videos are displayed according to an increasing or decreasing order of the corresponding degrees of severity of surface bleeding.
  • Example 21 relates to the method of any one of Examples 19 or 20, comprising a subsequent step of testing the person in applying the following steps:
  • 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;
  • Example 22 relates to a method of performing a clinical trial to assess hemostatic power of a product against surface bleeding, comprising the following steps:
  • step b) 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, said characterization being for instance based on the training performed according to any one of Examples 19 to 21 ;.
  • Example 23 relates to the method of Example 22, 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.
  • FIG. 1 is a schematic representation of a device for simulating a surface bleeding
  • FIG. 2 is a perspective view of a wound simulator of the device illustrated in figure 1 ;
  • FIG. 3 is a perspective view illustrating a cross section of the wound simulator of figure 2;
  • FIG. 4 is an enlarged perspective view in cross-section of the open chamber and gutter system of the wound simulator of figure 3;
  • FIG. 5 is an enlarged perspective view of one interchangeable plate of the wound simulator of figure 2;
  • FIG. 6a is an upper view of an interchangeable plate according to a first embodiment
  • FIG. 6b is a cross-section view of the interchangeable plate of figure 6a along line A-A;
  • FIG. 7a is an upper view of an interchangeable plate according to a second embodiment
  • FIG. 7b is a cross-section view of the interchangeable plate of figure 7a along line B-B;
  • FIG. 8a is an upper view of an interchangeable plate according to a third embodiment
  • Figure 8b is a cross-section view of the interchangeable plate of figure 8a along line C-C.
  • Reliable and repeatable assessment of a surface bleeding needs establishment of a scale that enables recognition of the severity of the surface bleeding for any target bleeding site (TBS) that can be used similarly for any surgical specialties, i.e. independently from the consequence of the blood loss in such a specific surgical specialty.
  • TBS target bleeding site
  • Such scale - referred to SBSS for Surface Bleeding Severity Scale - will enable a consistent assessment of bleeding that is applicable to any surgical procedure, to be used for instance in a clinical investigation assessing the performance of a medical product, such as a hemostatic agent.
  • the goal is to ensure that the hemostat is applied when control of bleeding by conventional procedures is ineffective or impractical and to allow severity of bleeding to be chosen for designed efficacy of a hemostatic product.
  • TBS target bleeding site
  • this bench-top bleeding model enables simulating several chosen types of bleeding so that a scale of surface bleeding severity is built for later assessment by surgeons of a surface bleeding in a target bleeding site.
  • the specific device to simulate a surface bleeding enables establishing a correspondence between constant blood flow rate (and resulting blood volume in a defined period of time) and the developed surface bleeding severity scale.
  • the surface bleeding simulating device helps people, in particular surgeons, to learn how to assess the severity of surface bleeding in any surgical situation, independently from the individual animal physiology.
  • the proposed device for simulating a surface bleeding comprises a source 1 of a blood liquid.
  • a blood liquid can be a synthetic blood liquid, a blood liquid having been removed from a human body, or any other liquid suitable to mimic blood.
  • a surfactant in the synthetic blood, one can preferably add between 1 % and 30% by weight, and more preferably between 2% and 15% by weight, of a surfactant to adapt surface tension of the synthetic blood and to enable homogeneous flow in the device.
  • a surfactant that can be used is the product commercialized by Procter&Gamble under the trade name "Fairy Original” with the product code PA00168831 .
  • Such surfactant comprises from 20% to 30% of a mixture of Alcohols, C10-16, ethoxylated, sulfates, sodium salts, and from 5% to 10% of a mixture of Amines, C10-16-alkyldimethyl, N- oxides.
  • EDTA Ethylenediaminetetraacetic acid
  • the temperature of the blood liquid is controlled to be at a temperature close to the human body temperature, i.e. around 37°C.
  • the simulation can be done at room temperature, i.e. the blood liquid is at a temperature between 20°C and 25°C.
  • the simulating device further comprises a pump system 2 connected to the source 1 of blood liquid via a specific tubing system 4.
  • This pump system 2 is configured to provide a controlled flow F in of said blood liquid.
  • the pump system 2 is adapted for providing a pulsated flow of blood liquid.
  • the pump system 2 comprises a peristaltic pump 21 provided with the tubing 4 necessary for circulation of the blood liquid from the blood source 1 at the required flow rate F in .
  • the pump system 2 may also preferably include a pump controller 22 for full control of the flow of blood liquid within the tubing 4 of the simulating device, in particular, the volume, flow rate, direction of the blood liquid.
  • the flow F in of the blood liquid can be controlled to vary regularly, preferably with increments of at least 0.1 mL/min.
  • the tubing 4 is adapted to the flow range for which the pump system is intended to be used.
  • the pump system 2 and corresponding tubing 4 are adapted for flow up to 500 mL/min, and most preferably up to 250 mL/min.
  • the tubing 4 is specifically chosen depending on the flow rate that is to be used.
  • a first set of tubing 4 can be used for any flow rate up to 60 mL/min
  • a second set of tubing 4 is used for any flow rate above 60 mL/min.
  • silicon tubes commercialized under the reference “Masterflex® US® 14" could be used for flow rates up to 60 mL/min
  • silicon tubes commercialized under the reference "Masterflex® US® 25" could be used for flow rates above 60 mL/min.
  • the simulating device further comprises a wound simulator 3 having an open chamber 31 connected to the pump system 4 to receive the controlled flow F in of blood liquid
  • the wound simulator 3 comprises a set of interchangeable plates 32 wherein each plate 32 is adapted to be removably mounted on the wound simulator 3 to close the open chamber 31 .
  • each plate 32 has preferably a plurality of holes 321 arranged through said plate 32 according to a specific pattern.
  • the blood liquid entering the chamber 31 via the fluid inlet 31 1 flows out of the chamber 31 through the holes 321 of the plate 32 mounted on the wound simulator 3 (see flow F out on figure 1 ).
  • the blood liquid flowing out of the holes 321 of the plate 32 mimics a surface bleeding, wherein the intensity of the simulated bleeding depends on several parameters as for instance the controlled flow F in of the blood liquid and the arrangement of the holes 321 through the plate 32.
  • the specific pattern of arrangement of the through holes 321 is different for each plate 32 of the set of interchangeable plates. This enables simulating different bleeding surface areas that could correspond to standard target bleeding sites that a surgeon may come across during a surgery.
  • the patterns of arrangement are said to be different from one another for instance if they have different shapes (square, rectangular, circular or any other more complex shape), if they have different sizes, and/or if the through holes 321 that are provided have different dimensions.
  • Figures 6a, 6b, 7a, 7b, 8a and 8b illustrate for instance three different plates 32 included in a set of plates, where the holes 321 are arranged according to three different patterns P1 , P2, and P3 respectively.
  • the patterns differ from one another in that they have different sizes.
  • the density and diameter of the holes 321 provided in each of the interchangeable plates are set to mimic the visual appearance of a bleeding surface.
  • the holes can be provided in each of the interchangeable plates at a density of at least 50 holes/cm 2 , and preferably a density of 100 holes/cm 2 .
  • the diameter of the through holes 321 can be constant, for instance comprised between 0.2 mm and 1 mm, and is most preferably of 0.5 mm.
  • a diameter of 0.5 mm for the hole is indeed preferred as it represents the typical size of small blood vessels.
  • the holes 321 provided may be regularly spaced apart in the corresponding specific pattern, with a pitch preferably comprised between 0.4 mm and 2 mm, and most preferably of 1 mm.
  • the through holes 321 have all the same diameter of 0.5 mm, and are regularly spaced apart (pitch of 1 mm / density of 100 holes/cm 2 ) according to a square pattern.
  • the only difference between the three plates of these embodiments is the size of the area of the square pattern.
  • the plate 32 of figures 6a and 6b corresponds to the plate with the so-called small pattern, the pattern being a square of 1 cm 2 .
  • Such plate comprises 100 holes of a 0.5 mm diameter.
  • the plate 32 of figures 7a and 7b corresponds to the plate with the so-called medium pattern, the pattern being a square of 10 cm 2 .
  • Such plate comprises around 1000holes (more precisely 961 holes) of a 0.5 mm diameter.
  • the plate 32 of figures 8a and 8b corresponds to the plate with the so-called large pattern, the pattern being a square of 50 cm 2 .
  • Such plate comprises around 5000 holes (more precisely 5041 holes) of a 0.5 mm diameter.
  • This specific set of interchangeable plates 32 is especially preferred for the simulation of surface bleeding as it corresponds to the size of several different wounds which will enable having representative data to build a surface bleeding scale.
  • - a plate with a square pattern of 50 cm 2 , comprising around 200 holes of a 0.5 mm diameter.
  • the holes 321 are drilled in the plates 32 according to the required pattern.
  • the plates are preferably made in a material chosen so that the corresponding surface tension participates to the homogeneous surface flow of the blood liquid passing through the holes, thereby simulating an homogeneous bleeding.
  • the quantity thereof is preferably controlled depending on the hydrophobic features of the material, and thus on the surface tension resulting from the chosen material.
  • the plates 32 may for example be made of acrylic, plexiglass, or Polymethylmethacrylate (PMMA).
  • the plates 32 may be formed in a material having a specific porosity so that liquid can pass through the plate.
  • the porosity is chosen so that it opposes a resistance to the passage of fluid, in order to mimic the capillarity of a surface vessel, vein, or artery.
  • the color of the plates is also chosen specifically depending of the surface bleeding which is to be simulated.
  • the plates are preferably colored in red, or made in a material being red.
  • a white plate could be used for simulating a bleeding from a bone.
  • a yellow plate could be used for simulating a bleeding from fat. More generally, the plate could have the color of the targeted tissue.
  • the color of the plates is chosen to mimic the worst case-scenario that could happen in a surgery in terms of contrast between the blood and the bleeding surface (for instance a bleeding from the liver where the contrast is low).
  • the plates are thus preferably colored in red, or made in a material being red.
  • the wound simulator 3 further comprises a gutter system 34 to drain out the blood liquid having passed through the holes 321 of the plate 32.
  • This gutter system can be an overflow gutter 341 as illustrated in figure 4.
  • the gutter system 34 is preferably designed to guide the blood liquid from the plate 32 into a receiving container 33, which is for instance placed in the wound simulator 3 under the open chamber 31 , such that it is fed by gravity (see flow F G on figure 1 ).
  • the gutter system 34 can comprise a funnel-shaped element 342, which is for instance vacuum formed.
  • the receiving container 33 may for example comprise a wide neck return bottle, that can be made in high density polyethylene (HDPE).
  • HDPE high density polyethylene
  • the volume of the receiving container 33 is preferably chosen to be large enough to avoid having to change it during the simulation of one particular surface bleeding.
  • the receiving container 33 has a volume of at least 1 L.
  • the receiving container 33 is connected to the source 1 of blood liquid so as to form a closed loop for the blood liquid to circulate within the simulating device.
  • filter means are preferably interposed between the receiving container 33 and the source 1 of blood liquid to remove any impurities that could have polluted the blood liquid having passed through the holes 321 of the plate 32.
  • most of the elements forming the wound simulator 3 are made in polycarbonate.
  • a support structure manufactured in aluminium can in this case be provided to stabilize the wound simulator.
  • the device for simulating surface bleedings can also include a pressure monitoring system 5 connected to the pump system 2 to measure the pressure of the blood liquid supplied to the open chamber 31 of the wound simulator 3.
  • the pressure monitoring system 5 enables controlling that the flows of blood liquid used for surface bleeding simulations remain at physiologic ranges of pressure.
  • Such device is very advantageous for simulating several types of surface bleedings, and for consequently building a corresponding scale to enable sorting surface bleedings depending on their severity as assessed by surgeons of reference.
  • a plurality of different surface bleedings can be simulated with such device by mounting on the wound simulator 3 a specific plate 32 chosen among the set of interchangeable plates and adjusting the flow of blood liquid provided by the pump system 2 to a specific value.
  • - Class 2 involves 15-30% of total blood volume; patient is often tachycardic with a narrowing of the difference between the systolic and diastolic blood pressures; the body attempts to compensate with peripheral vasoconstriction; skin may start to look pale and be cool to the touch; volume resuscitation with crystalloids is all that is typically required; blood transfusion is not typically required.
  • Class 4 involves loss of more than 40% of circulating blood volume; the limit of the body's compensation is reached and aggressive resuscitation is required to prevent death.
  • the above SBSS scale can be used to define whether or not a bleeding is eligible for an investigation trial, depending on the alleged efficacy of the product to be tested.
  • life-threatening bleeding (score of 4 or 5) is applicable for trauma surgeries or battlefield wounds and would thus usually not be included in clinical investigation of a hemostatic product as an eligible bleeding site.
  • Flow rates for a surface bleeding severity score of 5 do reflect life- threatening bleeding, but it would be highly unlikely that this level of bleeding would ever be seen in elective surgical cases.
  • surgeon key opinion leaders also suggested that surface bleeding severity scores 4 and 5 are infrequent occurrences for elective cases.
  • the simulating device can be used to determine thresholds for the flow rates of the blood liquid corresponding to each one of the scores of the surface bleeding severity scale. This enables building a quantitative definition in addition to the qualitative definition above.
  • TBS target bleeding sites
  • the surgeon will observe a continuous slowly increasing inflow rate and will identify likely targets for thresholds of the surface bleeding scoring system. After these initial thresholds are identified, the surgeon will then refine the definition of the scoring system by observing 10 bleeding scenarios at uniformly distributed increments of flow rate within each initially defined interval.
  • the surgeon may identify the following thresholds as likely candidates for changes in the SBSS: 0, 1 .0 ml/min, 3.0 ml/min, 5.0 ml/min, 15.0 ml/min, and 50.0 ml/min.
  • Step 1 The surgeon begins with a clean surface.
  • Step 2 Blood flow begins at the given flow rate.
  • Step 3 The surface is wiped clean, while the pump continues to flow at the given rate.
  • Step 4 After observing the blood flow from the newly cleaned surface during a certain amount of time (e.g. from 1 second to 60 seconds, and preferably during at least 10 seconds), the surgeon assigns one of the defined score of the surface bleeding severity scale.
  • a certain amount of time e.g. from 1 second to 60 seconds, and preferably during at least 10 seconds
  • Step 5 The surface is wiped clean, while the pump continues to flow at the given rate.
  • Step 6 Immediately following the cleaning, a 4x4 inch stack of pre-weighed gauze is applied to the surface and kept in place for 5 seconds.
  • Step 7 Immediately after the gauze is removed, it is weighed to determine post- bleed weight and determine the out-flow rate.
  • step 7 To check if out-flow rates are well correlated with the in-flow rates, one can then measure, for each in-flow rate and TBS plate combination considered, the out-flow rate obtained from the weighing of the gauze immediately following the time that the surface bleeding severity score was assigned by the surgeon (step 7).
  • weight of blood alone is obtained which when combined with area and time of gauze application will provide a measurement of bleeding out-flow rate.
  • Each out-flow measurement is then regressed against the in-flow rate using a linear regression model and the correlation coefficient and corresponding 95% confidence interval is reported.
  • the resulting refined surface bleeding severity scores will reflect a 6-interval partition of the flow rate range with each partition corresponding to a given surface bleeding severity score.
  • - a range noted [x;y] means that both values x and y are included in the range; - a range noted ]x;y[ means that both values x and y are excluded from the range;
  • the surgeon performing the whole procedure can then define a flow rate range for each of the TBS plates, thus establishing a relationship between the input flow rate of the blood liquid (possibly corrected depending on the results of the correlation with the output flow) and each of the scores defining the surface bleeding severity scale (6 discrete scores in the example above).
  • Example A Table 2 below gives a first example (Example A) intervals defined by the expert surgeon performing the procedure, depending on the TBS plates used.
  • Table 3 gives a second example (Example B) of intervals defined by the surgeon performing the procedure, depending on the TBS plates used. Table 3
  • the interval thresholds corresponding to each surface bleeding severity score are averaged across the three TBS scenarios. This enables defining a single relationship between flow rate and the surface bleeding severity score across all TBS scenarios.
  • the resulting flow rate interval corresponding to a surface bleeding severity score of 1 is ]x1 ml/min, y1 ml/min[, ]x2 ml/min, y2 ml/min[, and ]x3 ml/min, y3 ml/min[, within the 1 , 10, and 50 cm 2 TBS scenarios, respectively.
  • the final resulting flow rate interval for a SBSS of 1 will be ](x1 +x2+x3)/3 ml/min, (y1 +y2+y3)/3 ml/min[.
  • the result of this averaging can define a single surface bleeding severity score system that could be applied across all TBS scenarios in subsequent phases of a medical investigation.
  • intervals could also be averaged based on the intervals defined by each expert surgeon for each severity score for each plate.
  • the expert surgeon determines and defines the intervals for one of the TBS plate, those intervals being then processed to derive the corresponding intervals for the other TBS plates depending on the pattern of holes for the TBS plate.
  • the intervals are thus normalized for each of the surface area of the TBS plate used for the experiment.
  • Table 4 below gives an example of normalized intervals assigned to different TBS plates, those normalized intervals being also derived from the intervals defined for the 1 cm 2 TBS plate.
  • the intervals with values rounded to the above superior unit are assigned to the TBS plate of 1 cm 2 and the intervals for the other TBS plates are calculated taking into account the enlargement of the surface area compared to the 1 cm 2 TBS area.
  • the normalization factor is given by the formula 1 +2% * [percentage_of_enlargement] and the final limit of the intervals corresponds to the factorized value rounded to the above superior unit.
  • the simulating device enables simulation of specific surface bleeding at given flow rate in a precise and repeatable manner, which is very advantageous as it will help surgeons/investigators to be trained and tested to learn the specifically defined surface bleeding severity scale.
  • the device for simulating the surface bleeding can be used to create training and/or testing videos of bleeding scenarios across the range of surface bleeding severity values as defined previously for each TBS plate.
  • each TBS scenario two videos are created for each of five flow rates uniformly distributed within the interval partition defining each surface bleeding severity value.
  • the flow rate interval corresponding to a surface bleeding severity value of 3 is defined to be [3.0 ml/min, 5.0 ml/min[, two separate videos of surface bleedings at each flow rates of 3.4, 3.8, 4.2, 4.4, and 4.6 ml/min are made for each TBS scenario.
  • the procedures for recording the video sessions can be similar as the scoring process given above (Step 1 to Step 4). Specifically, the video will begin when blood begins to flow at Step 2 and will continue to run through Step 4. In a preferred embodiment, the video recording of Step 4 following the clean wiping of the TBS surface of Step 3 is done during a period of time between 12 seconds and 20 seconds.
  • the relevant part of the video for assessment of the surface bleeding severity score corresponds in this case to the first 10 seconds following the clean wiping of the TBS surface of Step 3.
  • the videos for the surface bleeding severity score of 0 are made by considering 5 scenarios within each TBS scenarios. The 5 scenarios aim at depicting differing flow rates prior to achieving hemostasis. In particular, the midpoint of the flow rate interval for each surface bleeding severity score ranging from 1 to 5 is considered.
  • the flow rate interval corresponding to a surface bleeding severity score of 3 is defined to be [3.0 ml/min, 5.0 ml/min[, we consider an initial flow rate of 4.0 ml/min.
  • the video begins at Step 2 defined above when blood begins to flow at a flow rate of 4.0 ml/min.
  • the pump Prior to the surface being wiped clean in Step 3, the pump is turned off (flow rate of 0.0 ml/min), and the video continues to run for at least another 10 seconds, preferably between 12 seconds and 20 seconds.
  • the relevant part of the video for assessment of the surface bleeding severity score corresponds to the first 10 seconds following the clean wiping of the TBS surface of Step 3.
  • the first set of replicates can serve as the training pool from which a training sample is created, while the second set of replicates serves as a test pool from which the test sample is created.
  • only one pool of videos is recorded, which will be used both in the training sessions and in the test sessions.
  • 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 2 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 2 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 2 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 2 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 2 to a specific value being chosen superior or equal to 102.0 mL/min.
  • 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 32 with through holes 321 arranged according to a pattern of 1 cm 2 and by adjusting the flow of the blood liquid provided by the pump system 2 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 32 with through holes 321 arranged according to a pattern of 10 cm 2 and by adjusting the flow of the blood liquid provided by the pump system 2 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 32 with through holes 321 arranged according to a pattern of 50 cm 2 and by adjusting the flow of the blood liquid provided by the pump system 2 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 o at least one surface bleeding being simulated by mounting a plate 32 with through holes 321 arranged according to a pattern of 1 cm 2 and by adjusting the flow of the blood liquid provided by the pump system 2 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 32 with through holes 321 arranged according to a pattern of 10 cm 2 and by adjusting the flow of the blood liquid provided by the pump system 2 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 32 with through holes 321 arranged according to a pattern of 50 cm 2 and by adjusting the flow of the blood liquid provided by the pump system 2 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 32 with through holes 321 arranged according to a pattern of 1 cm 2 and by adjusting the flow of the blood liquid provided by the pump system 2 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 32 with through holes 321 arranged according to a pattern of 10 cm 2 and by adjusting the flow of the blood liquid provided by the pump system 2 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 32 with through holes 321 arranged according to a pattern of 50 cm 2 and by adjusting the flow of the blood liquid provided by the pump system 2 to a specific value being chosen superior or equal to 28.0 mL/min and inferior to 1 17.3 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 32 with through holes 321 arranged according to a pattern of 1 cm 2 and by adjusting the flow of the blood liquid provided by the pump system 2 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 32 with through holes 321 arranged according to a pattern of 10 cm 2 and by adjusting the flow of the blood liquid provided by the pump system 2 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 32 with through holes 321 arranged according to a pattern of 50 cm 2 and by adjusting the flow of the blood liquid provided by the pump system 2 to a specific value being chosen superior or equal to 1 17.3 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
  • o at least one surface bleeding being simulated by mounting a plate 32 with through holes 321 arranged according to a pattern of 1 cm 2 and by adjusting the flow of the blood liquid provided by the pump system 2 to a specific value being chosen superior or equal to 102.0 mL/min; o at least one surface bleeding being simulated by mounting a plate 32 with through holes 321 arranged according to a pattern of 10 cm 2 and by adjusting the flow of the blood liquid provided by the pump system 2 to a specific value being chosen superior or equal to 147.4 mL/min; o at least one surface bleeding being simulated by mounting a plate 32 with through holes 321 arranged according to a pattern of 50 cm 2 and by adjusting the flow of the blood liquid provided by the pump system 2 to a specific value being chosen superior or equal to 192.7 mL/min.
  • At least one set of training videos is made with the pool of training videos and one set of testing videos is made with the pool of testing videos.
  • the set of training videos can be prepared by selecting 36 videos from the pool of training videos, where for instance, within each TBS, two videos are sampled for each surface bleeding severity value. Because the surface bleeding severity score represents a discretization of a continuum of flow rates, videos within each surface bleeding severity value are preferably sampled in order to be representative of bleeds occurring in the flow rate interval corresponding to that value.
  • the two videos for each surface bleeding severity value are sampled such that the three videos of flow rates near the midpoint of the flow rate interval have a 90% chance of being sampled (30% each) while the videos near the endpoints of the flow rate interval have a 10% chance of being sampled (5% each).
  • the flow rate interval corresponding to a surface bleeding severity value of 3 is defined to be [3.0 ml/min, 5.0 ml/min[, videos of bleeding at flow rates of 3.4, 3.8, 4.2, 4.4, and 4.6 ml/min will be available for sampling into the training set.
  • two videos are randomly sampled (without replacement) from these five videos in such a way that the videos corresponding to flow rates 3.8, 4.2, and 4.4 ml/min each have a 30% chance of being chosen, while the videos of bleeding flow rates of 2.4 and 4.6 ml/min will each have a 5% chance of being chosen.
  • This sampling is done for each score within each TBS, resulting in 12 videos for each TBS and 36 training videos in total.
  • the testing videos are sampled from the pool of testing videos created before.
  • the testing videos are preferably sampled in the same manner as that described for the training videos. Specifically, the two videos for each surface bleeding severity value are sampled such that the three videos of flow rates near the midpoint of the flow rate interval have a 90% chance of being sample (30% each) while the videos near the endpoints of the flow rate interval have a 10% chance of being sampled (5% each). Even though the sampling method is the same as for the training videos, the result of the sampling for the testing videos is likely to be different from the result of the sampling for the training videos.
  • Such sampling also enables having a selection of 36 testing videos in total.
  • the 36 training videos are preferably organized as a training set where the videos are presented separately for each TBS setting and in increasing order of flow rates. In this way, surgeons are trained to visual increases in bleeding flow rates and associate them with increases in the surface bleeding severity value.
  • each surgeon is then shown a set of testing videos that is different from the one used in the training phase.
  • One or several testing sets of videos can be prepared, based on the 36 testing videos resulting from the sampling as described above, where the selected testing videos are fully randomized.
  • Each video of the selected testing videos can be displayed several times.
  • the testing set of videos is created by displaying, in a random order, 3 times the 36 selected testing videos.
  • Such example of testing set of videos thus comprises a sequence of 108 testing videos displayed randomly.
  • the testing set of videos is created by displaying, in a random order, the 36 selected testing videos and the 6 testing videos selected from the sampling for each TBS corresponding to the score 0.
  • Such example of testing set of videos thus comprises a sequence of 42 testing videos displayed randomly.
  • the testing sets of videos are prepared to comprise the same number of videos for each score of the surface bleeding scale. Possibly, the number of testing videos for the score 0 is larger than for the other scores of the surface bleeding scale.
  • testing sets of videos can be prepared where the order of the selected testing videos to display is different.
  • each surgeon to be enrolled in the investigation as an investigator is trained and tested to be sure that he will be able to assess the severity of a surface bleeding according to the definition of the scores.
  • a preparatory set of videos are displayed to the investigator, where the videos show the plates 32 that have been used for simulating the different surface bleedings used in the training and testing videos without any flow of blood liquid.
  • testing set of videos e.g. a testing set of 42 videos or a testing set of 108 videos. For each videos of the set of testing videos, they are asked to assign a single surface bleeding severity score.
  • Enrollment of the investigators in the clinical investigation depends on their success in the recognition of the surface bleeding severity of the testing videos, which success depends on the degree of knowledge necessary for the clinical investigation.
  • the clinical investigation is indeed always based on the surface bleeding severity scale of reference, on which the investigators have been trained and tested, but the criterion for recognizing the severity of the surface bleeding can differ from a clinical investigation to another.
  • bleeding severities with a surface bleeding severity score of 1 , 2, or 3 will be eligible for inclusion into the clinical trial, whereas bleeding scores of 0, 4, and 5 will not be eligible for inclusion.
  • surface bleeding severity scores will also determine hemostasis (success) versus non-hemostasis (failure).
  • a score of 0 will define hemostasis and a surface bleeding severity score larger than 0 will be equivalent to non-hemostasis (failure).
  • the minimum rate of positive recognitions may be for instance equal to 90%.
  • an investigator fails, re-training and re-testing will be conducted.
  • an investigator has three tries to meet the minimum score for both parameters. The minimum score for both parameters must be achieved within a single test. If the investigator is unable to achieve the minimum score after 3 attempts, he/she will not be permitted to participate in the clinical investigation.
  • the properties of the ideal local hemostatic agent may vary according to the surgical specialty, some properties are universally valued including: rapid and effective control/cessation of bleeding; ability to make effective contact with the bleeding surface; acceptable safety profile; and reliable, easy to handle, quick to prepare.
  • Subjects undergoing any surgical procedure could be eligible for enrolment into the clinical investigation. This could concern subjects undergoing either open or laparoscopic surgeries, like for instance cardiothoracic, abdominal, spinal, soft tissue, breast, or orthopedic lower extremity surgeries.
  • the Investigator will perform the surgery per his or her standard procedures, including conventional methods of hemostasis (pressure, ligature, cautery, etc.). Before the surgical procedure, a hemostatic product to be tested will be prepared per the corresponding instructions for use.
  • a study-specific stopwatch is preferably used to track hemostat application and the times of hemostasis evaluation.
  • Hemostasis is evaluated by the investigator using the specific surface bleeding severity scale that he has learned.
  • a score will be assigned at successive time points until hemostasis is achieved, for instance at the following time points:
  • Bleeding severity assessments can be made by one or more investigators, but has to be done independently. In case of an assessment by two investigators, it is considered that there is hemostasis if both investigators assign a score of 0 at the same assessment time point. All other scores are considered as a failure of hemostasis. The target bleeding site will be assessed at every time point, up until hemostasis is achieved.
  • the investigator may use whatever means necessary in order to control bleeding.
  • the efficacy of the hemostatic product under investigation is then assessed by processing and comparing all the data gathered during the procedure.
  • the device and method for simulation of surface bleedings presented in this document can help the surgeons to establish their diagnostics in respect of the severity of the bleedings, and thus help them making their choice of the hemostatic agent to use in an easier and faster way.
  • the proposed device and method for simulation of surface bleedings also participate to the harmonization in the surface bleedings recognition, and thus to the harmonization of the diagnostic methods and practice among surgeons, which is generally positive for the health of the patient.
  • Another advantage of the proposed device and method for simulation of surface bleedings is that it could prevent performing in vivo studies on animals for testing of an hemostatic product, which has therefore a very positive ethical effect.

Abstract

L'invention concerne un dispositif pour simuler un saignement en surface, comprenant : - une source de liquide sanguin, en particulier un liquide sanguin synthétique ou un liquide sanguin ayant été retiré d'un corps humain ; un système de pompe relié à la source de liquide sanguin et conçu pour permettre un écoulement régulé dudit liquide sanguin ; un simulateur de plaie comportant une chambre ouverte reliée au système de pompe pour recevoir l'écoulement régulé de liquide sanguin, le simulateur de plaie comprenant un ensemble de plaques interchangeables, chaque plaque ayant une pluralité de trous disposés dans ladite plaque selon un motif spécifique, le motif spécifique étant différente pour chaque plaque de l'ensemble de plaques interchangeables, et chaque plaque étant conçue pour être montée amovible sur le simulateur de plaie afin de fermer la chambre ouverte, de telle sorte que le liquide sanguin s'écoule à l'extérieur de la chambre par les trous de la plaque montée sur le simulateur de plaie. L'invention concerne également des procédés d'utilisation d'un tel dispositif de simulation.
PCT/EP2016/057611 2015-04-08 2016-04-07 Dispositif et procédé pour simulation de saignements en surface WO2016162415A1 (fr)

Priority Applications (8)

Application Number Priority Date Filing Date Title
US15/565,024 US20180102067A1 (en) 2015-04-08 2016-04-07 Device and Method for Simulation of Surface Bleedings
CA2981909A CA2981909A1 (fr) 2015-04-08 2016-04-07 Dispositif et procede pour simulation de saignements en surface
EP16717295.6A EP3281187A1 (fr) 2015-04-08 2016-04-07 Dispositif et procédé pour simulation de saignements en surface
JP2017552945A JP6655630B2 (ja) 2015-04-08 2016-04-07 表面出血のシミュレーションのための装置および方法
BR112017021331-1A BR112017021331B1 (pt) 2015-04-08 2016-04-07 Dispositivo para estimular um sangramento de superfície e método para simular uma pluralidade de diferentes sangramentos de superfície
CN201680032755.7A CN107851402B (zh) 2015-04-08 2016-04-07 用于模拟表面出血的装置和方法
AU2016245924A AU2016245924B2 (en) 2015-04-08 2016-04-07 Device and method for simulation of surface bleedings
HK18109347.1A HK1249959A1 (zh) 2015-04-08 2018-07-19 用於模擬表面出血的裝置和方法

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP15305517.3 2015-04-08
US14/681,305 2015-04-08
EP15305517.3A EP3079139B1 (fr) 2015-04-08 2015-04-08 Dispositif et procédé pour une simulation d'hémorragies superficielles
US14/681,305 US10283015B2 (en) 2015-04-08 2015-04-08 Device and method for simulation of surface bleedings

Publications (1)

Publication Number Publication Date
WO2016162415A1 true WO2016162415A1 (fr) 2016-10-13

Family

ID=55794945

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2016/057611 WO2016162415A1 (fr) 2015-04-08 2016-04-07 Dispositif et procédé pour simulation de saignements en surface

Country Status (7)

Country Link
EP (1) EP3281187A1 (fr)
JP (1) JP6655630B2 (fr)
CN (1) CN107851402B (fr)
AU (1) AU2016245924B2 (fr)
CA (1) CA2981909A1 (fr)
HK (1) HK1249959A1 (fr)
WO (1) WO2016162415A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021144047A1 (fr) * 2020-01-16 2021-07-22 Limbs & Things Ltd Appareil de simulation de fluide

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109470822B (zh) * 2018-10-24 2024-02-06 苏州大学 一种大动脉创伤止血材料与器械封堵性能的测试装置及其评价方法
CN110136559B (zh) * 2019-05-16 2020-12-01 解涛 一种基于vr技术的液体模拟出血点的模拟手术装置

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3027655A (en) * 1959-09-17 1962-04-03 Alderson Res Lab Inc Synthetic casualty
US5316730A (en) * 1992-12-07 1994-05-31 Xylum Corporation Disposable cartridge for investigating physical properties of blood
WO2000051485A2 (fr) * 1999-03-02 2000-09-08 Peter Yong Modele thoracique d'entrainement pour la chirurgie cardiaque endoscopique
US20070292829A1 (en) * 2004-12-02 2007-12-20 King Lynn R Intravenous (iv) training system

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0417138D0 (en) * 2004-07-31 2004-09-01 Bradford Teaching Hospitals Nh Wound simulation device
US7887330B2 (en) * 2004-12-02 2011-02-15 The United States Of America As Represented By The Secretary Of The Army Trauma training system
US20080145829A1 (en) * 2006-12-15 2008-06-19 Atellis, Inc. Synchronous multi-media recording and playback with end user control of time, data, and event visualization for playback control over a network
US8647327B2 (en) * 2007-11-08 2014-02-11 Medela Holding Ag Test unit for wound drainage dressings
CN201229701Y (zh) * 2008-08-01 2009-04-29 天津市天堰医教科技开发有限公司 控制出血手臂模型
CN201946199U (zh) * 2011-02-23 2011-08-24 陶磊 外科止血模型
CN202749005U (zh) * 2011-12-14 2013-02-20 爱惜康公司 缝合练习及测试模型
CN202976650U (zh) * 2012-12-28 2013-06-05 北京医模科技有限公司 伤口止血缝合模型
US8926333B2 (en) * 2013-03-15 2015-01-06 Simnext, Llc Device, system, and method for simulating blood flow

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3027655A (en) * 1959-09-17 1962-04-03 Alderson Res Lab Inc Synthetic casualty
US5316730A (en) * 1992-12-07 1994-05-31 Xylum Corporation Disposable cartridge for investigating physical properties of blood
WO2000051485A2 (fr) * 1999-03-02 2000-09-08 Peter Yong Modele thoracique d'entrainement pour la chirurgie cardiaque endoscopique
US20070292829A1 (en) * 2004-12-02 2007-12-20 King Lynn R Intravenous (iv) training system

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
"Acute in-vivo evaluation of bleeding with Gelfoam plus saline and Gelfoam plus human thrombin using a liver square lesion model in swine", J THROMB THROMBOLYSIS., vol. 28, no. 1, 16 July 2008 (2008-07-16), pages 1 - 5
"Acute in-vivo evaluation of bleeding with Gelfoam plus saline and Gelfoam plus human thrombin using a liver square lesion model in swine", J THROMB THROMBOLYSIS., vol. 28, no. 1, July 2009 (2009-07-01), pages 1 - 5
GEORGE L ADAMS ET AL: "Acute in-vivo evaluation of bleeding with GelfoamTM plus saline and Gelfoam plus human thrombin using a liver square lesion model in swine", JOURNAL OF THROMBOSIS AND THROMBOLYSIS, KLUWER ACADEMIC PUBLISHERS, BO, vol. 28, no. 1, 16 July 2008 (2008-07-16), pages 1 - 5, XP019689308, ISSN: 1573-742X *
MYLAN CORP.: "ACYCLOVIR-acyclovir ointment Mylan Pharmaceuticals Inc", 1 February 2013 (2013-02-01), XP055297261, Retrieved from the Internet <URL:http://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=ce3d5e8b-9401-40be-8ce7-4ea42113f4ab&type=pdf&name=ce3d5e8b-9401-40be-8ce7-4ea42113f4ab> [retrieved on 20160824] *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021144047A1 (fr) * 2020-01-16 2021-07-22 Limbs & Things Ltd Appareil de simulation de fluide

Also Published As

Publication number Publication date
CA2981909A1 (fr) 2016-10-13
AU2016245924B2 (en) 2021-03-04
JP6655630B2 (ja) 2020-02-26
EP3281187A1 (fr) 2018-02-14
BR112017021331A2 (pt) 2018-06-26
CN107851402B (zh) 2020-01-17
CN107851402A (zh) 2018-03-27
JP2018526660A (ja) 2018-09-13
AU2016245924A1 (en) 2017-10-26
HK1249959A1 (zh) 2018-11-16

Similar Documents

Publication Publication Date Title
US10283015B2 (en) Device and method for simulation of surface bleedings
Chan et al. Validation of microsurgical models in microsurgery training and competence: a review
De Oliveira et al. Learning brain aneurysm microsurgical skills in a human placenta model: predictive validity
Olasky et al. Effects of sleep hours and fatigue on performance in laparoscopic surgery simulators
AU2016245924B2 (en) Device and method for simulation of surface bleedings
Di Stasi et al. Quantifying the cognitive cost of laparo-endoscopic single-site surgeries: Gaze-based indices
Seidenstuecker et al. Myosonographic study of abdominal wall dynamics to assess donor site morbidity after microsurgical breast reconstruction with a DIEP or an ms-2 TRAM flap
EP3830813B1 (fr) Système de validation et d&#39;entraînement d&#39;interventions invasives
Rooney et al. Simulator and 2 tools: validation of performance measures from a novel neurosurgery simulation model using the current Standards framework
Mattavelli et al. Development and validation of a preclinical model for training and assessment of cerebrospinal fluid leak repair in endoscopic skull base surgery
EP3079139B1 (fr) Dispositif et procédé pour une simulation d&#39;hémorragies superficielles
Amirian et al. Admission medical records made at night time have the same quality as day and evening time records
Yang et al. Portable fluid circuit device containing printed silicone microvessels as a training aid for arterial microanastomosis
BR112017021331B1 (pt) Dispositivo para estimular um sangramento de superfície e método para simular uma pluralidade de diferentes sangramentos de superfície
Sevdalis et al. Surgical Decision-Making: A Multimodal Approach
Mohamed et al. The effect of Nursing Intervention Protocol About Laparoscopic Urological Surgery on Nurse’s Performance and Patient Outcome
Salaminia et al. Evaluating success rate in clinical skills learning and its related factors among medical students of the Yasuj University of Medical Sciences during the lastthree years of medical training course in 2016-2017
Schröder The Influence of time pressure on MIS simulation tasks
Norasi et al. Intraoperative teamwork and workload among surgeons and surgical trainees during DIEP flap surgery
Guldal et al. Comparison of clinical skills of 3rd-year students who completed structured clinical skills program with 6th-year students who acquired clinical skills in unsystematic way
Berthelot et al. A New Tool for Microsurgical Training and Skill Assessment
Jonathan Examining surgeon’s eye-hand coordination during microsurgery
Mayooran et al. Reliability and validity of an objective assessment instrument of laparoscopic skill
Abou-Raya et al. AB0627 A randomized controlled trial of early initiation of osteoporosis assessment and management in the acute setting of the fracture clinic
Fluegel et al. The Effect of Interruptions on Novices Learning a Challenging Surgical Skill

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16717295

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2981909

Country of ref document: CA

ENP Entry into the national phase

Ref document number: 2017552945

Country of ref document: JP

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: 15565024

Country of ref document: US

NENP Non-entry into the national phase

Ref country code: DE

REG Reference to national code

Ref country code: BR

Ref legal event code: B01A

Ref document number: 112017021331

Country of ref document: BR

ENP Entry into the national phase

Ref document number: 2016245924

Country of ref document: AU

Date of ref document: 20160407

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 112017021331

Country of ref document: BR

Kind code of ref document: A2

Effective date: 20171004