Method and system for automatically detecting clinically relevant leaks

Abstract

The invention relates to a method for automatically detecting clinically relevant leaks and / or inadequate closures after a medical procedure in a hollow organ (2) located in an inner volume (4') of a body cavity (4). The test method comprises the following steps: injecting a specific test gas or a gas mixture containing at least one test gas into the organ or organs (2) via a suitable injection device (3), analyzing the gas mixture and measuring the concentration of the test gas in the inner volume (4') of the body cavity (4) via a suitable detection device (5) at least during a measurement window, evaluating the possibility of the presence of a leak and its severity by comparing stored data and real-time data with each other, the test method being characterized in that the pressure difference between the interior of the one or more hollow organs (2) and the inner volume (4') of the body cavity (4) is controlled or mastered at least at a given moment during at least one measurement window, and preferably the pressure difference remains constant during the window.

Description

Technical Field

[0001] The present invention relates to the field of medical procedures, methods, systems and devices, and more particularly to minimally invasive surgical procedures and diagnostic systems for assessing the integrity of organs (particularly tubular or hollow organs) located in body cavities and the size of perforations or incomplete closures during surgical procedures.

[0002] In this context, the present invention more specifically relates to an improved reliable system and corresponding method for detecting leaks and / or verifying adequate closure after a medical procedure. Most preferably, the present invention relates to a method and system for detecting lumen leaks after an endoluminal procedure and / or verifying adequate lumen closure after an endoluminal procedure. Background Art

[0003] When performing a medical procedure (minimally invasive or not) on an organ that is required to be fluid-tight to its local environment under normal circumstances, it is necessary to ensure that there are no discontinuities, nor any channels or openings, in the organ wall defining the relevant lumen or cavity.

[0004] The practice of medicine is moving toward less and less invasive methods to treat diseases and conditions, particularly in surgery. These less invasive procedures advantageously allow for reduced intraoperative and postoperative complication rates, shorter hospital stays, faster return to activity for patients, and lower costs to hospitals and healthcare systems.

[0005] Laparoscopy has become a standard of care that is routinely performed worldwide, and an increasing number of interventional procedures are being performed with an endoscope entering the patient's body through a natural orifice.

[0006] During such procedures, it is also common practice to inject filling gas by means of an insufflator (known per se) which can maintain a determined pressure value of the filling gas within the patient's cavity or organ. Since the injection, aspiration and pressure monitoring of the gas can be finely controlled when using such an insufflator, an accurate internal constant gas pressure value can be maintained.

[0007] Such a filling gas may in particular be present in a cavity containing the organ in question or adjacent to the organ in question.

[0008] As previously mentioned, certain organs in the body need to function in a completely fluid-tight manner compared to their surroundings. Leaking the contents from one of these organs into an adjacent organ or body cavity space can have serious consequences for the subject.

[0009] In several widely performed surgical procedures, this fluid tightness is actively broken (colon resection, Roux-en-Y gastric bypass surgery, etc.) However, physicians may also inadvertently cause accidental leaks by accidentally puncturing an organ while performing a medical procedure.

[0010] The flow of contents or material from the hollow organ in question into the adjacent or surrounding space or spaces or organ or organs is widely referred to in the medical community as a "leak." Leaks may occur at anastomoses, staple lines, or punctures, to name a few reasons.

[0011] Postoperative anastomotic leaks lead to severe complications for patients undergoing surgery, ranging from sepsis, increased risk of cancer recurrence, and even death. This increased rate of postoperative complications also results in a significant economic burden on the healthcare system.

[0012] It is well known that anastomotic leaks occur due to several factors, one of which is incomplete closure of the anastomosis during surgery. Due to the severity of the consequences, several intraoperative "leak testing" methods have been developed and are currently available and commonly used to test for complete closure of the anastomosis (e.g., colored fluids, pressurized air). However, they are not sensitive enough, and many failed anastomoses give negative results to the intraoperative tests used.

[0013] Having reliable intraoperative leak testing is extremely important because it allows the surgeon to repair a failed anastomosis before completing the surgery, sparing the patient possible complications and the hospital increased costs.

[0014] US 2015 / 272499 has shown that the use of a test gas can provide a more sensitive and reliable test method than currently available test methods in the prior art.

[0015] As described herein, a test gas is infused into an organ in a controlled manner, and gas exchange between the organ and the surrounding cavity is monitored and evaluated to determine if a leak is potentially present in the organ.

[0016] However, in this American literature, organs and cavities are considered to be perfect containers, whereas the real environment during intervention is controlled and far from perfect.

[0017] For example, in an imperfect environment, the body cavity in which the organ in question is housed will often leak outwards.

[0018] Furthermore, the measurement result is also influenced by the implementation of the measurement and depends on the parameters used to carry out the measurement.

[0019] In summary, the measurement environment is imperfect in practice, and the measurement process itself affects the environment and, therefore, the reliability of the collected results and data.

[0020] Therefore, even if it represents a significant advance over the prior art, the method and system described in this American document still exhibit several disadvantages which, due to lack of precision and repeatability, prevent any standardization of the measurements and are a key obstacle to the construction of an extensive database that can be used to calculate the presence and size of incomplete closures or leaks and to determine their severity.

[0021] In practice, insufflated gas tends to leak during surgical procedures involving, for example, pneumoperitoneum, a factor not taken into account in US 2015 / 272499 or any other known prior art procedures, and which renders the test less precise and non-standardizable.

[0022] In addition, hollow organs may be open-ended or not, and they are also generally soft. Therefore, it is difficult to predict the pressure rise caused by gas injection at a specific flow rate. When the target pressure difference value is reached by injecting the test gas into the lumen, the lumen pressure safety threshold may be reached or even exceeded because the pressure rise caused by such injection is difficult to predict. If the lumen pressure safety threshold is reached, the obvious solution includes the system triggering a safety measure to quickly reduce the lumen pressure (such as opening a vent valve or starting suction of the lumen contents). This is undesirable because it will stop the measurement, preventing it from drawing a conclusion, and then the user will need to restart the experiment.

[0023] Furthermore, most hollow organs present in the human body have walls with multiple layers. For example, the stomach wall has mucosa, submucosa, muscularis and serosa. Different organs also have different wall thicknesses: from a few millimeters in the colon to several centimeters in certain areas of the stomach. Therefore, when gas is insufflated under similar conditions into different organs with similar incomplete closure, these different organs will behave differently.

[0024] Finally, patients of different BMI and different ages will have different anatomy, with hollow organs and adjacent cavities of different sizes and, depending primarily on age and condition, different compliances. Therefore, the behavior of hollow organs and cavities in different patients will behave differently under similar insufflation parameters (flow rate or target insufflation pressure). For example, in abdominal laparoscopy, it is known that for a peritoneal insufflation of 12 mmHg, the intraperitoneal volume can range from 2-3 liters in a robust young male adult to 8 liters in a postpartum female or morbidly obese patient.

[0025] These anatomical and mechanical differences mean that organs and cavities behave very differently under similar infusion parameters. Summary of the invention

[0026] A main object of the present invention is to overcome at least the main previous disadvantages of the prior art mentioned herein before and, as far as possible, also take into account the previously mentioned situational and anatomical considerations.

[0027] Therefore, the present invention proposes a method for automatically detecting clinically relevant leaks and / or inadequate closures after a medical procedure in at least partially hollow organs or hollow organs fluidly connected to each other located in the inner volume of a body cavity,

[0028] The test method comprises the following steps:

[0029] injecting a specific test gas or a gas mixture comprising at least one test gas into the one or more organs via a suitable injection device, wherein the test gas is not normally produced or naturally present in the subject's body or is present or produced in a precisely known amount or concentration,

[0030] analyzing the gas mixture and in particular measuring, via suitable detection means and at least during a measurement window, the concentration of the test gas in the inner volume of the body cavity or at least in a space adjacent to said one or more organs, and possibly measuring the gas pressure within said volume or space,

[0031] evaluating, via adapted computing means also managing said injection means and detection means, the probability of the presence of a leak or of a faulty closure and its severity by comparing stored data and real-time data with one another,

[0032] The test method is characterized in that the pressure difference between the interior of one or more hollow organs and the interior volume of its (their) adjacent space or body cavity is controlled or mastered at least at a given moment during the measurement window or at least one measurement window, and

[0033] The pressure difference during the measurement window or a measurement window is set to a predetermined appropriate value, which is automatically set by a computing device based on user input and / or data retrieved from a database, or is set by a practitioner, or the pressure difference is controlled to follow a predetermined value / time curve by providing a progressive injection of a test gas (TG) or a gas mixture containing the test gas.

[0034] A system allowing the method to be carried out is also part of the invention.

[0035] Thus, the present invention provides methods and systems that are capable of providing and / or maintaining a predetermined or known pressure differential between a hollow organ and an adjacent space at least at a point in time during a measurement window. This is accomplished, for example, by simultaneously measuring the pressure within the hollow organ and the adjacent space and creating and maintaining a desired pressure differential between the two, and utilizing it during the assessment process, thereby allowing the integrity of the organ to be assessed. Achieving and / or maintaining such a controlled pressure differential allows for greater accuracy and reliability during the gas analysis and measurement phases. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The invention will be better understood using the following description, which relates to a preferred embodiment given by way of non-limiting example and explained with reference to the accompanying drawings, in which:

[0037] - Figure 1 is a general symbolic and functional representation of a system according to the present invention;

[0038] - Figures 2 to 7 are other symbolic representations of various alternative embodiments of the system according to the present invention;

[0039] - Figure 8 When the application uses Figure 2 and Figure 3 In any one of the detection methods of the present invention shown in the system, a time curve of the profile of the pressure difference between the interior of the hollow organ to be tested and the surrounding space outside the organ;

[0040] - Fig. 9 When the application uses Figure 5 and Figure 6 In any one of the detection methods of the system of the present invention, a time curve of the profile of the pressure difference between the interior of the hollow organ to be tested and the surrounding space outside the organ, and

[0041] - Fig.10 An experimental time curve representing the test gas concentration in the cavity of a gas-tight compliant enclosure in which an isolated hollow organ having a 1 mm hole and infused with the test gas is placed is shown. DETAILED DESCRIPTION

[0042] exist Figures 1 to 7 , continuous or solid lines represent fluid connections, and dotted or dashed lines represent electrical connections (signal or power).

[0043] According to a first aspect, the invention relates to a method for automatically detecting clinically relevant leaks and / or inadequate closure in an at least partially hollow organ 2 or at least two mutually fluidly connected hollow organs located in an inner volume 4 ′ of a body cavity 4 after a medical procedure.

[0044] The test method mainly comprises the following steps:

[0045] injecting a specific test gas TG or a gas mixture comprising at least one test gas TG into the one or more organs 2 via a suitable injection device 3, wherein the test gas TG is not usually produced or naturally present in the subject (e.g. N2O) or is present or produced in a precisely known amount or concentration,

[0046] analyzing the gas mixture GM via suitable detection means 5 and at least during a measurement window and measuring in particular the concentration of the test gas TG in the inner volume 4' of the body cavity 4 or at least in a space adjacent to said one or more organs 2 and possibly measuring the gas pressure GMP within said volume 4' or space,

[0047] Via the adapted computing means 6 which also manage said injection means 3 and detection means 5 , the probability of the presence of a leak or of a faulty closure and its severity are evaluated by comparing the stored data and the real-time data with one another.

[0048] According to the invention, at least at a given moment during the measurement window or at least one measurement window, the pressure difference ΔP between the interior of the hollow organ or organs 2 and the interior volume 4' of its (their) adjacent space or cavity 4 is controlled or known, and

[0049] The pressure difference (ΔP) during the measurement window or a measurement window is set to a predetermined appropriate value, which is automatically set by the computing device (6) based on user input and / or data retrieved from a database, or is set by a practitioner, or the pressure difference is controlled to follow a predetermined value / time curve by providing a progressive injection of a test gas (TG) or a gas mixture containing the test gas.

[0050] The additional pressure differential control provided by the present invention allows to isolate the test gas concentration measurement from the negative influences of the imperfect measurement environment provided by the body cavity 4. Thus, the concentration can be accurately determined, which in turn provides the opportunity to assess the integrity of the tested organ 2 reliably and in a standardized manner and, if this occurs, the severity of the leak or false closure and therefore its clinical relevance (in particular by comparison with stored reference data previously acquired under similar conditions and circumstances).

[0051] The measurement window may comprise only a (preferably repeated) sampling of the gas mixture GM in the adjacent space or inner volume, or also a succession of one or more analysis steps.

[0052] According to a first possible embodiment of the present invention, the pressure difference ΔP is partially or completely grasped by controlling the injection of the test gas TG into one or more hollow organs 2 (preferably while directly or indirectly monitoring the test gas pressure TGP in the one or more organs 2 and the gas pressure GMP in the body cavity 4).

[0053] In order to measure the gas pressure inside the organ 2 and around the outside of the organ 2 (the volume 4' of the cavity 4), sufficient sensors are arranged in the organ 2 and the cavity 4, or in fluid circulation pipelines 9, 9' (pipes) leading to the organ 2 and into the cavity 4 for the purpose of gas entry or exit.

[0054] In the context of said first embodiment or alternatively with respect to said embodiment, the pressure difference ΔP is partially or completely mastered by controlled injection of a filling gas FG via suitable injection means 3' and / or controlled suction of a gas mixture GM via suitable evacuation or suction means 7, 7' from the body cavity 4. Advantageously, the gas pressure GMP in said cavity 4 is monitored directly or indirectly at the same time and the injected filling gas FG is different from the test gas TG.

[0055] Preferably, however, the invention provides for mastering the pressure difference ΔP by combining controlled injection of a test gas TG into one or more hollow organs 2 with controlled injection of a filling gas FG into the inner volume 4 ′ of the body cavity 4 and / or suction of a gas mixture GM from the inner volume 4 ′ of the body cavity 4 .

[0056] Based on the foregoing disclosure and the accompanying drawings, those skilled in the art will understand that the method of the present invention for detecting, evaluating and classifying clinically possible leaks or permeable closures in organs is performed under the management and supervision of a computing device 6 (e.g., a suitably programmed computer with suitable storage and communication devices).

[0057] More specifically, the pressure difference ΔP is automatically and dynamically controlled by the computing device 6, either i) by monitored injection of test gas TG and / or filling gas FG, or ii) by monitoring and deriving at least a portion of the flow rate of test gas TG to be injected into one or more hollow organs 2 and / or at least a portion of the flow rate of filling gas FG to be injected into the body cavity 4 before their actual injection, and / or iii) by monitored suction of some of the test gas TG present in the one or more hollow organs 2 and / or some of the gas mixture GM present in the internal volume 4' of the body cavity 4.

[0058] In order to perform the various tasks in the context of the method of the invention, the computing device 6 must be provided with relevant measurement data (pressure and gas composition - the latter from the detection module 5) in real time.

[0059] To this end, the gas pressures TGP, GMP in one or more hollow organs 2 and the body cavity 4 are measured by corresponding sensors 8, 8', which are connected to the computing device 6 and are located somewhere along the gas supply pipelines 9, 9' provided for the injection of the test gas TG and the filling gas FG, or preferably at the outlet tips 9, 9' of the pipelines 8, 8' which are respectively located in one or more hollow organs 2 and the body cavity 4.

[0060] Of course, the pressure values ​​prevailing in the organ 2 and in the body cavity 4 will depend, inter alia, on the type of organ and cavity in question, the nature of previous interventions, the clinical condition and physiological state of the relevant body part and of the patient.

[0061] According to one aspect of the invention, the pressure difference ΔP may be kept constant, advantageously at a set value, at least during the measurement window.

[0062] According to an advantageous feature of the invention in this context, the set value of the pressure difference ΔP used during the measurement window or a measurement window may be an optimized value, advantageously depending at least on the type of the hollow organ 2 concerned, the type of medical procedure previously performed and / or the size and / or number of one or more orifices forming a leak, and possibly on the planned duration of the detection cycle, said set value of the pressure difference ΔP being preferably at least equal to or above a determined minimum value and at most equal to or below a determined maximum value (e.g. set by the practitioner, preprogrammed and / or resulting from a previous similar procedure).

[0063] Thus, the set value for the pressure difference ΔP during the measurement window is a predetermined appropriate value, which is set automatically by the computing device 6 based on user input and / or data retrieved from a database, or is set by a practitioner.

[0064] More specifically, by performing a continuous or stepwise increase of the pressure difference ΔP and monitoring the concentration of the test gas T in the internal volume 4' of the body cavity 4, the optimized value of the pressure difference ΔP used during the measurement window or a measurement window is automatically determined during or after the detection cycle based on the gas mixture pressure (GMP) change and / or based on the measured test gas TG concentration data, preferably during or after the previous or first operating detection or measurement cycle, and then stored in a database.

[0065] According to another aspect of the invention, the pressure difference ΔP follows a predetermined value / time curve generated by the progressive injection of the test gas TG, which is selected by the calculation device 6 at least as a function of the type of hollow organ 2 concerned and of the type of medical procedure previously performed and based on stored data or parameters generated by previous leak detection procedures.

[0066] Therefore, with regard to this second aspect and as a safety precaution, it may advantageously be envisaged that the pressure TGP of the test gas TG in the one or more hollow organs 2 is increased stepwise, advantageously providing a predetermined waiting time (stabilization period) at each successive pressure level.

[0067] For example, during a stepwise increase in injection, the pressure difference ΔP remains stable at different values ​​during the waiting time. During the waiting time, the computing device can evaluate whether the current pressure difference ΔP value reveals the presence of incomplete closure based on pressure monitoring in the adjacent space.

[0068] If it does reveal the presence of an incomplete closure, it can then assess whether the current pressure difference is sufficient by comparing the pressure evolution in the adjacent space with the stored data.

[0069] If the current pressure value difference is sufficient, the computing device may monitor or control the pressure difference value to be equal to the current pressure difference value for a longer period of time (until a conclusive result is reached).

[0070] If the current pressure difference is insufficient, the computing device monitors or controls the pressure difference to increase in the next step according to a predetermined pattern.

[0071] Based on the measurement of the pressure in the adjacent space (as a result of the progressive injection), the computing device identifies the desired ΔP value when it is reached.

[0072] If the user elects to repeat the detection operation cycle, the computing device will select the previously identified ideal ΔP value as the ΔP value for the upcoming detection operation cycle.

[0073] Furthermore, the inventors have found that for different possible sizes of holes there is an ideal or optimized ΔP value. For a given opening size, this optimized ΔP value is considered ideal because it is above the value at which the test gas will leak through the considered opening in the hollow organ and below the value at which an excess of test gas leaks through said opening. An excess is problematic, firstly because it may put the patient at risk and secondly because when the pressure GMP in the adjacent cavity approaches a safety threshold, some of the gas mixture present in the adjacent cavity needs to be immediately evacuated (either by active suction or by triggering the opening of an exhaust valve) in order to ensure patient safety. This emergency evacuation interrupts the controlled measurement and therefore the leak detection cycle, which needs to be restarted again: this is an important limitation.

[0074] The ideal ΔP value for a particular opening size is one that ensures patient safety while avoiding the necessity to restart the experiment with different parameters.

[0075] Furthermore, as mentioned above, detecting a smaller incomplete closure will take more time than detecting a larger hole because the test gas will take more time to diffuse through. This means that at certain ΔP values, the measurement will be conclusive, but will take a significant amount of time. In these specific cases, there are higher ΔP values ​​at which the measurement will also be conclusive, but will take significantly less time.

[0076] Due to the above reasons, the most desired or optimized ΔP value can be determined for each hole or leak size, which ensures that the measurement is safe, decisive and valid in terms of time.

[0077] The following alternatives or additional features are also conceivable in connection with the method, which may be partially combined with one another:

[0078] - the pressure difference (ΔP) can be managed by combining a controlled injection of a test gas (TG) into one or more hollow organs (2) with a controlled injection of a filling gas (FG) into the inner volume (4') of a body cavity (4) and / or a suction of a gas mixture (GM) from the inner volume of the body cavity;

[0079] - before injecting the filling gas (FG) into said volume (4') and therefore before injecting the test gas (TG) into the hollow organ (2), the pressure (GMP) of the gas mixture (GM) in the inner volume (4') of the body cavity (4) can be adjusted to a suitable value, advantageously a selected stored value or a value resulting from a previous leak detection cycle;

[0080] - the leak detection cycle may comprise the progressive injection of a test gas (TG) into the hollow organ (2), determining the optimal value of the pressure difference (ΔP) and using said value to continue and complete said cycle;

[0081] - A leak detection cycle may comprise progressively injecting a test gas (TG) into the hollow organ (2), determining whether more than one leaking orifice is present, and using this information to continue and complete the cycle.

[0082] According to an advantageous embodiment, the method may comprise performing a first leak detection cycle based on a progressive injection of a test gas (TG) and subsequently performing at least one further leak detection cycle, preferably only a second leak detection cycle, advantageously based on a set predetermined appropriate value of the pressure difference (ΔP), preferably determined during the first leak detection cycle.

[0083] From the previously disclosed features and embodiments, a person skilled in the art will recognize that the method of the present invention may be practically implemented according to many alternatives, particularly with regard to the control or mastering of pressure differences.

[0084] In a first alternative, the method may comprise measuring the pressure GMP in the body cavity 4 (previously set by the practitioner) by means of a suitable and adequately arranged sensor 8' and controlling the injection of the test gas TG to achieve, at least at some point during the measurement window, a desired pressure difference ΔP between the organ to be tested 2 and the adjacent space / cavity 4 (see Figure 8 ).

[0085] In a second alternative, the method may comprise measuring the pressure GMP in the body cavity 4 and automatically adjusting it to the most suitable pressure for the test, and then controlling the injection of the test gas TG to obtain the desired pressure difference ΔP at least at a given moment during the measurement window (see Figure 8 ).

[0086] This second alternative is particularly relevant in the case described later, where the system integrates a surgical insufflator (e.g. a laparoscope). Reducing the GMP pressure allows the test cycle to be completed at a given ΔP value and thus reduces the absolute GMP value, thereby reducing the risk of the GMP reaching a safety threshold causing the problems and limitations described previously.

[0087] It is then advantageous to start the detection cycle with the lowest possible GMP value.

[0088] The first alternative improves the prior art by measuring the pressure GMP in the body cavity 4, which allows taking into account the insufflation or filling gas FG leaking from the body cavity 4 when processing the measurement data, running calculations and evaluating the situation, thus achieving greater accuracy during the test. In addition, the second alternative makes it possible to set the most appropriate pressure for the test, thereby improving resolution and minimizing the risk of unclear tests.

[0089] In a third alternative, the method may comprise: measuring the pressure GMP in the body cavity 4 (set by the practitioner) by means of the sensor 8′ and controlling the injection of the test gas TG so as to achieve the desired pressure difference ΔP between the organ 2 to be tested and the adjacent body cavity 4, and repeatedly measuring the pressure TGP in the organ 2 to be tested by means of the pressure sensor 8 present at the distal tip 10 of the injection line or tube 9 and repeatedly regulating the injection of the test gas TG accordingly, maintaining its value throughout the duration of the test (see Fig. 9 ).

[0090] In a fourth alternative, the method may comprise: measuring the pressure TGP in the body cavity 4 and adjusting it to the most suitable pressure for the test, then controlling the injection of the test gas TG to obtain the desired pressure difference ΔP, and repeatedly measuring the pressure TGP in the organ 2 by means of the pressure sensor 8 present at the distal tip 10 of the injection line 9 and repeatedly adjusting the injection of the test gas TG accordingly, maintaining this pressure difference throughout the duration of the test (see Fig. 9).

[0091] The third alternative improves upon the prior art by maintaining the desired pressure difference ΔP for the duration of the test by controlled injection of the test gas TG in addition to measuring the pressure in the body cavity 4. This is very beneficial for the detection of smaller incomplete closures, as the gas may take more time to diffuse and pass through the holes or orifices in the organ 2 to reach the body cavity 4. Therefore, maintaining a constant pressure difference ΔP throughout the experiment will fulfill this need. In addition, the fourth alternative can set the most appropriate pressures for the test and maintain them, thereby improving resolution and minimizing the risk of ambiguous tests.

[0092] In a fifth alternative, the method may include measuring the pressure in the body cavity 4 set by the physician and injecting a test gas TG so as to achieve a desired pressure difference ΔP between the organ 2 to be tested and the adjacent space 4' / cavity 4, and maintaining this pressure difference throughout the duration of the leak test (or at least during the measurement phase of the test) by repeatedly measuring the pressures TGP, GMP in the organ 2 and the body cavity 4 and correspondingly aspirating or blowing the filling gas FG (i.e., CO2) into the body cavity 4.

[0093] In a sixth alternative, the method may include measuring the pressure GMP in the body cavity 4 and adjusting it to the most suitable pressure for the test, then injecting the test gas TG into the organ 2 to obtain the desired pressure difference ΔP, and maintaining this pressure difference throughout the duration of the test (or at least during the measurement phase of the test) by repeatedly measuring the pressure TGP in the organ 2 and the pressure GMP in the body cavity 4 and correspondingly aspirating or blowing the filling gas FG (i.e., CO2) in the body cavity 4.

[0094] The fifth alternative improves upon the prior art by maintaining the desired pressure difference ΔP for the duration of the test (or at least during the measurement phase of the test) by suctioning and / or insufflating the body cavity 4 in addition to measuring the pressure in the body cavity 4. This is very beneficial for the detection of smaller incomplete closures, since the test gas TG may take more time to diffuse and pass through one or more holes or one or more orifices in one or more organs 2 to reach the body cavity 4. Therefore, maintaining a constant pressure difference ΔP throughout the experiment will fulfill this need. In addition, the sixth alternative can set the most appropriate pressure for the test and maintain that pressure, thereby improving resolution and minimizing the risk of ambiguous tests.

[0095] All the above-mentioned alternative methods preferably allow controlling the pressure difference ΔP during the measurement window or a measurement window by providing a progressive injection of the test gas TG or a gas mixture containing the test gas so as to follow a predetermined value / time curve. The curve may be specific and adapted to the organ under consideration and / or to a previously implemented surgical procedure. According to an advantageous embodiment, the method according to the invention may allow the test gas pressure TGP in the organ 2 to be tested to be increased in a stepwise manner by increasing to a certain percentage (i.e. 20%) of a set, optimal or maximum value, and maintaining this pressure for a given amount of time until another percentage increase (i.e. 40%), and continuing the process until the desired pressure difference ΔP is achieved between the body cavity 4 and the organ 2 to be tested. This stepwise increase may be applicable to different organs, which in turn will increase the accuracy of the testing of said organs.

[0096] In order to further improve the accuracy level and reliability of the method of the present invention, the composition sequence of its operating steps can be repeated at least once, or even several times.

[0097] Thus, the method may comprise performing at least two consecutive operational detection cycles, each comprising the respective injection, analysis and evaluation steps under consideration and at least one measurement window. Between two consecutive detection cycles, a venting step is inserted, wherein the one or more hollow organs 2 are substantially emptied of at least the test gas TG, and preferably substantially emptied of all gases.

[0098] Of course, the test gas TG may be injected as a pure (ie, single-component) gas, and may be a specific regulatory clinical gas, such as N2O.

[0099] However, and according to an advantageous embodiment of the invention, the test gas is injected as part of a gas mixture, and preferably, the injected gas mixture is ambient air, preferably filtered and sterilized, and the test gas TG used is one of its gaseous components, such as O2 or N2.

[0100] One way is to at least partially control the pressure and / or the pressure difference ΔP in the hollow organ 2 by controlled suction of the interior of said hollow organ 2 .

[0101] When considering the features and alternatives of the method according to the present invention, the following supplementary description and additional explanations may be considered.

[0102] For the reasons stated above, it is advantageous that the calculation means dynamically controls the pressure difference and also advantageously causes it to vary during the detection. This variation can be performed, for example, after a gradual increase or a stepwise increase.

[0103] Thus, the pressure difference ΔP may vary throughout the measurement process: for example, after a gradual injection or a specific time profile set by the computing device based on user input and / or data retrieved or set by the practitioner.

[0104] Due to the above, the parameters of the tested organ can be found during the gradual increase or stepwise increase. In particular, the volume, compliance and presence of pores can be identified or made more precise.

[0105] It may happen that there are multiple incomplete closures in the organ to be tested. For a given pressure difference, the size or behavior of these pores may not be the same. As mentioned before, different pore sizes have different ideal ΔP values, and at a given ΔP value, larger pores may allow significant TG to flow through, while smaller pores may simply not allow any gas to pass.

[0106] This method is suitable for identifying the presence of multiple incomplete closures by analyzing the pressures (and potentially TG concentrations) measured in adjacent cavities.

[0107] As described above and in more detail below, the progressive filling curve can be used to understand the characteristics of the organ to be tested and the presence of one or more pores and, in each case, to identify the ideal pressure difference ΔP value for a dedicated measurement cycle, thereby allowing confirmation of the presence of incomplete closure and assessment of the likelihood of the presence of a leak and its potential severity.

[0108] For example, a system performing the detection method of the present invention may perform a first detection cycle in which ΔP follows an asymptotic injection curve. The computing device may assess whether there are one or more incomplete closures in the hollow organ being tested based on the pressure (and potential TG concentration) monitored in the adjacent space, and the computing device also identifies the most appropriate ΔP value associated with each of the one or more incomplete closures identified.

[0109] The system can then continuously:

[0110] - output information to the user informing him that one or more leaks are suspected,

[0111] - completing a draining step, wherein the hollow organ is emptied of its TG content, and potentially wherein adjacent cavities are emptied and filled with FG up to the desired pressure value,

[0112] - completing a new detection cycle using the ΔP value identified during a previous detection cycle completed with a ΔP value following the progressive injection curve,

[0113] - Potentially completing a further detection cycle with another ideal ΔP value previously identified.

[0114] During the gradual increase of injection, the pressure difference ΔP value gradually increases, so dynamic control may involve stopping the gradual increase at a pressure value that appears sufficient for detection and keeping the pressure difference at this sufficient value for a period of time.

[0115] Furthermore, during the step-wise increase of the injection, the pressure difference remains stable at different values ​​during the waiting time, and the dynamic control may involve stopping the step-by-step increase at one of the steps that appears to be sufficient for the ongoing detection.

[0116] In the following, several practical aspects and problems related to the detection method will be explained in more detail below with respect to a practical preferred embodiment of the invention mainly based on the inventors' conclusions following experimental results.

[0117] In the context of the present invention, there is a known maximum safe insufflation pressure for adjacent cavities. Exposing patients to excessive pressures can lead to various complications and comorbidities that are well documented for common technical approaches such as laparoscopy and thoracoscopy.

[0118] For example, in abdominal laparoscopic surgery, the surgeon operates by setting the pneumoperitoneum with a FG insufflation target pressure typically between 10 mmHg and 15 mmHg, depending on the patient's characteristics. Most commercially available surgical insufflator systems allow the surgeon to set a target pressure for cavity insufflation (typically 12 mmHg), but also set a maximum pressure threshold in the cavity that should not be exceeded (typically 15 mmHg). Depending on the surgical insufflator system, once the threshold is reached, it will activate an alarm and stop insufflation, with more advanced systems typically automatically reducing the pressure by valve opening (passive or active).

[0119] In an advantageous embodiment, the detection method is based on the analysis of GM sampled from a single point in an adjacent cavity. For example, in the case of a laparoscope, the GM will be sampled from a surgical access port in the wall of the adjacent cavity. If the cavity is the peritoneum, the cavity is typically 2 to 6 liters large, depending on the patient and the insufflation pressure. In any case, if during a leak test performed according to the method of the invention, only a few cc of TG mixture leaks into the adjacent cavity through an incomplete closure of the test organ, an irregular signal may not be detected or may be generated. Because the circulation and mixing of the gas is uncontrolled, the TG detection signal may be irregular. Because the detection method is based on measuring the TG concentration, the TG irregular signal does not allow the detection to be decisive.

[0120] The inventors have observed that during their experiments it is necessary that at least 10% of adjacent cavities are filled with TG (or a TG mixture) to achieve consistent and standardized measurements.

[0121] Another object of the claimed method and system is to allow detection within a time frame that is acceptable to the user / practitioner and compatible with operating room use.

[0122] This leads to the fact that, given certain characteristics and properties of the incomplete closure, the system will work best at a specific pressure difference ΔP that produces a flow that allows adjacent cavities to be filled with at least 10% TG in less than a minute.

[0123] The optimum pressure difference ΔP value mentioned will vary greatly, depending on the size of the imperfect closure (which can vary from a few millimeters to a few centimeters), and on its shape, which can sometimes be approximated by a slit and sometimes by a "hole". Obviously, the characteristics of an imperfect closure of a hole or other shape are unknown at the beginning of a leak test.

[0124] In order to provide the leak detection in accordance with the present invention desired by the clinician, a minimum value of ΔP should be used.

[0125] Of course, the flow and pressure change behavior and pressure difference will be different when considering different types of adjacent cavities.

[0126] As described above, the detection method is based on the measurement of TG leaking from a hollow organ through an incomplete closure and subsequent sampling at a distant point in the cavity. In order for this principle to work in practice, it is necessary to inject enough FG (filling gas) into the adjacent cavities before the TG (test gas) injection begins, so that the organs are well spaced from each other. Organ spacing ensures that the incomplete closure is not blocked by adjacent tissue and is in free fluid communication with the cavity created by the FG injection: this allows the TG to leak freely through. If not enough FG is injected, the incomplete closure may remain blocked by adjacent tissue, or the TG bag may remain trapped under the tissue and will not be detected.

[0127] Using again the example of abdominal laparoscopic surgery, surgeons typically consider complete organ separation to be achieved from a 10 mmHg peritoneal insufflation.

[0128] The inventors have observed that during controlled testing, 7 mmHg is an effective value for the adjacent cavity insufflation pressure at the start of the detection cycle. If there is an incomplete closure, the TG mixture will leak into the adjacent cavity during the injection of TG into the organ to be tested, thereby increasing the GMP pressure. If the GMP pressure reaches the above-mentioned maximum safe pressure (typically 15 mmHg), it is necessary to stop the TG injection in the organ, thereby interrupting the detection process. Of course, for certain injection parameters - TG flow rate and target organ pressure - depending on the size of the incomplete closure, the injection may produce an unexpected and very rapid pressure rise in the cavity, which may be dangerous to the patient.

[0129] By considering Fig.10 The figure will better understand the previous comments.

[0130] Fig.10 Depicted are the results of a controlled experiment in which a 1 mm hole was created in an isolated organ, which was then placed in an airtight compliant enclosure. According to the detection method of the present invention, TG was then injected into the organ in a controlled manner, while GM was sampled from the enclosure (cavity), and the concentration of TG was measured. For different pressure differences, the concentration of TG in adjacent cavities was plotted as a function of time, providing Fig.10 curve.

[0131] like Fig.10 As shown, to ensure that a TG concentration of 10% is measured in the shell in less than one minute for a 1 mm pore, a minimum pressure difference ΔP of 6 mmHg should be used. This accounts for the fact that for a specific configuration of organ, cavity and pore properties there is a minimum ΔP value for which detection within an acceptable time frame will be decisive.

[0132] As described above, the pressure value will depend on the type of organ and cavity, the nature of the intervention, and the patient and organ clinical and physiological status. Some of this information is known before the leak detection procedure begins and will be used by the system computing device to identify and set the most appropriate ΔP value.

[0133] Advantageously, based on this patient and procedural information, the system computing device will also identify and set the most appropriate adjacent cavity FG pressure value prior to initiating a leak detection cycle.

[0134] However, the leakage rate of the TG in the adjacent cavity will depend greatly on parameters that are unknown at the time of initiating the test.

[0135] First, the exact properties of the patient's anatomy and organs are often unknown: the volume of organs and their compliance are mostly only derived statistically.

[0136] Second, and most importantly, the nature of the incomplete closure, hole, slit, orifice or other gas leakage opening is unknown: its location, size and shape are unknown.

[0137] Consider Again Fig.10 The example given in , for the same organ and cavity, using the same insufflation parameters, i.e., a pressure difference ΔP of 6 mmHg, but with an incomplete closure of 10 mm, would almost immediately cause the pressure to exceed the safe pressure threshold and potentially injure the patient.

[0138] The inventors have observed in controlled settings during ex vivo experiments that for exactly the same organ and settings (position and shape of incomplete closure, cavity volume), you need to increase the pressure difference ΔP value between the 1 mm hole and the 8 mm hole by 4 times to achieve a 10% TG volume in the adjacent cavity in less than a minute.

[0139] These examples illustrate the fact that for certain patients and procedure characteristics, the same ΔP cannot be used to ensure safe and rapid leak detection. This means that, in this illustrative example, there may not be a single appropriate pressure differential value that can be predetermined by the system that would allow rapid and decisive detection of incomplete closures between 1 mm and 10 mm in the organ model of the above experiments.

[0140] The optimized value of ΔP is one that allows fast and decisive leak detection consistent with defined measurement parameter targets: i.e., allows a defined minimum TG concentration threshold to be reached in the cavity in less than a defined maximum detection timing when measurements are done at the optimized ΔP value.

[0141] The optimal value of the pressure difference ΔP can be determined by the calculation means of the system only during or after a first operation detection performed with a continuous or stepwise increase of the pressure difference. As previously mentioned, the determination of the optimal value of the pressure difference ΔP can be determined based on the evolution of the pressure GMP and / or TG concentration measurements in the body cavity.

[0142] The computing means of the system will identify whether the optimized ΔP value is reached by evaluating whether the evolution of the pressure GMP and / or TG concentration at a given pressure difference is sufficient to complete the measurement in compliance with the measurement parameter target.

[0143] In a first possible practical embodiment of the invention, a first leak detection cycle is completed following an appropriate [ΔP value vs. time] curve selected by the system, and the evolution of the pressure GMP and / or TG concentration is analyzed by a computing device to identify an optimized pressure difference ΔP value. The gas content of the organ and cavity is then purged to reduce the TG concentration. Next, an injection of FG can be performed in the organ cavity to reach an appropriate pressure GMP.

[0144] Subsequently, a second leak detection cycle is performed using the previously identified optimized pressure differential value as the appropriate value set by the system.

[0145] In a second practical embodiment of the invention, a leak detection cycle is started following a [ΔP value-time curve] deemed appropriate by the computing device, based on data input by the user or retrieved from a database. For example, this value / time curve can be a step function, according to which, starting from a value of 1 mmHg, it increases in steps of 2 mmHg. As the injection of TG in the organ begins, the analysis of the TG concentration in the adjacent organ cavity also begins. The computing device analyzes the evolution of the TG concentration and / or the pressure GMP in the adjacent cavity to identify if and when the optimized ΔP value is reached.

[0146] As mentioned above, the optimized value of ΔP is a value that allows fast and decisive leak detection, relying on an adequate TG flow through the leak. A flow will be considered adequate when it allows reaching a defined minimum TG concentration threshold in the chamber in a time less than a defined maximum detection time. The flow through an incomplete closure can be easily evaluated from the TG concentration and / or pressure GMP evolution in the chamber.

[0147] During the increase of ΔP, the computing device of the system may then identify when the optimized ΔP value is reached as the first / lowest ΔP value at which the flow through the leakage reaches the appropriate flow value.

[0148] When such an optimized ΔP value is identified, the computing device will stop the ΔP value increment to maintain a detection loop in which the identified optimized ΔP value occurs.

[0149] In other words, the computing device will stop the pressure increase when the flow through the incomplete closure is sufficient for rapid and decisive leak detection.

[0150] As will be appreciated, the optimized ΔP value (or value range) depends heavily on parameters such as the location and size of the incomplete closure and cannot be derived before injection begins. Leak detection without an optimized ΔP value may result in inconclusive detection, lengthy detection cycles or safety-related interruptions requiring restarting the measurement.

[0151] The method and associated system described in more detail below allow in a preferred embodiment of the invention to circumvent this limitation by providing for identification and adjustment of an optimized ΔP value during the measurement process, thereby ensuring a safe, fast and decisive leak detection cycle.

[0152] like Figure 1 and Figures 2 to 7 As shown in various illustrative embodiments and alternatives, the present invention also specifically includes a system 1 for automatically detecting clinically relevant leaks and / or inadequate closures in at least a portion of a hollow organ 2 or hollow organs fluidly connected to each other located in an interior volume 4' of a body cavity 4 after a medical procedure. The system 1 includes at least:

[0153] an injection device 3, designed for controlled injection of a specific test gas TG or a gas mixture containing at least one test gas TG into the one or more organs 2, the injection device 3 comprising a first gas pressure measuring device 8 or being associated with the first gas pressure measuring device 8,

[0154] detection means 5 designed to analyse the gas mixture GM and in particular to measure the concentration of the test gas TG in the internal volume 4' of the body cavity 4 or at least in the space adjacent to the organ or organs 2, and possibly the gas pressure GMP in said volume 4' or space, and

[0155] The computing means 6 are designed to manage the injection means 3 and the detection means 5, to store and retrieve data from an integrated local or remote database and to analyze the data and to assess the possibility of the presence of a leak or a faulty closure and its severity by comparing the stored data with the real-time data.

[0156] According to the present invention, the computing device 6 is connected to a sensor device 8, 8', which allows determining a pressure difference ΔP between the interior of one or more hollow organs 2 and an adjacent space or internal volume 4' of a body cavity 4, and the computing device 6 controls or grasps the pressure difference ΔP by correspondingly driving the associated injection and / or suction device 3, 3', 7, 7', which injection and / or suction device 3, 3', 7, 7' includes the test gas TG injection device 3.

[0157] Thus, the system 1 is designed, configured and adapted to be able to carry out the method previously described herein, ie at least some of the previous alternatives of said method.

[0158] According to a first and simplest embodiment, the system 1 makes it possible to control the pressure difference ΔP only by controlling the test gas TG injection device 3 and thus by acting only on the test gas TG pressure in the organ 2 .

[0159] However, in addition to the test gas TG injection means 3 , the system 1 advantageously also comprises a filling gas FG injection means 3 ′ designed to inject a filling gas FG into the inner volume 4 ′ of the body cavity 4 in a controlled manner.

[0160] Thus, the system 1 can set the most appropriate pressure GMP in the body cavity 4 by bypassing and / or by dispersing the filling gas FG insufflation flow, and can regulate and measure the injection of the test gas TG so as to achieve the desired pressure difference ΔP between the organ 2 to be tested and the adjacent space / cavity 4 at least at some point during the measurement window.

[0161] Alternatively, the system 1 may comprise a surgical insufflator 16 and set the most appropriate pressure in the body cavity 4 and then regulate and measure the injection of the test gas TG so as to achieve the desired pressure difference ΔP between the organ 2 to be tested and the adjacent space / cavity 4 at least at that moment during the measurement window.

[0162] The pressure sensors 8, 8' may be arranged and positioned in various ways.

[0163] According to a preferred feature of the invention, in particular Figures 5 to 7 As shown in the figure, each of the gas supply pipelines 9, 9' which are part of one of the test gas TG injection device 3 and the filling gas FG injection device 3', respectively, comprises a pressure sensor 8, 8' or is associated with the pressure sensor 8, 8', which is preferably located at or near the outlet tip 10, 10' of the pipeline 9, 9' under consideration.

[0164] In this case, it is conceivable that the system 1 measures the pressure in the body cavity 4 (set by the physician) by means of a pressure sensor 8' present at the tip 10' of a line or tube 9' connecting the system 1 to the subject, and regulates and measures the injection of the test gas TG to achieve the desired pressure difference ΔP between the organ 2 to be tested and the adjacent space / body cavity 4, and repeatedly measures the pressure in the organ 2 by means of another pressure sensor 8 present at the distal tip 10 of the test gas TG injection pipe or line 9 and repeatedly regulates the injection of the test gas TG accordingly, maintaining this pressure difference throughout the duration of the leak test (or at least during the measurement phase) (see Figure 5 ).

[0165] It is also conceivable that the system 1 measures and sets the most appropriate pressure in the body cavity 4 by bypassing and / or by diverting the insufflation flow of the filling gas FG, and regulates and measures the injection of the test gas TG to achieve the desired pressure difference ΔP between the organ 2 to be tested and the adjacent space / body cavity 4, by means of a sensor 8' present at the tip 10' of a tube or line 9' connecting the system 1 to the subject, and maintains this pressure difference throughout the duration of the leak test (or at least during the measurement phase) by repeatedly measuring the pressure in the organ 2 and repeatedly regulating the injection of the test gas TG accordingly, by means of the pressure sensor 8 present at the distal tip 10 of the injection tube or line 9 (see Figure 2 , Figure 3 , Figure 5 and Figure 7 ).

[0166] Alternatively, the sensor means 8 , 8 ′ associated with the test gas TG and filling gas FG injection means 3 , 3 ′ are located within the unit 15 .

[0167] Advantageously, the system 1 further comprises a surgical insufflator 16 (ie, a separate external insufflator or an integrated internal insufflator) which measures and sets the most appropriate pressure in the body cavity 4 and is used by the system 1 to help achieve pressure differential ΔP control (in addition to the TG insufflation device).

[0168] According to another embodiment, Figure 4 As shown, each of the gas supply lines 9, 9', which are part of one of the test gas TG injection device 3 and the filling gas FG injection device 3', respectively, may include a corresponding volume control device 11 and flow control device 11'.

[0169] like Figures 1 to 3 and Figures 5 to 7 As shown, in order to control both the injection of test gas TG and the injection of filling gas FG, the system 1 may alternatively include a gas evacuation device 7, which is designed to limit the amount of test gas TG injected into one or more hollow organs 2 and / or the amount of filling gas FG injected into the body cavity 4, for example by controlledly conducting a portion of the flow in the gas supply lines 9, 9'.

[0170] As an alternative or supplement to the gas evacuation device 7, the system 1 may also include a gas suction device 7', which is designed to perform controlled suction of the test gas TG from one or more hollow organs 2 and / or the gas mixture GM from the body cavity 4 at or near the outlet tip 10, 10' of the gas supply pipeline 9, 9'.

[0171] like Figure 2 , Figure 3 and Figures 5 to 7 As shown, the gas evacuation device 7 and the gas suction device 7' include valves 12, 12' controlled by the computing device 6, and the valves include: an outlet valve 12, which is designed and configured to selectively connect the gas supply pipeline 9, 9' to the main collective evacuation and suction duct 13; and a suction valve 12', which is designed and configured to selectively connect specific suction line sections 14, 14' to the main collective duct 13, and an overpressure valve 12" is advantageously associated with each suction valve 12'.

[0172] like Figures 2 to 7 As shown, an additional valve 12 can be arranged to control the fluid connection between the gas supply line 9' (delivering the filling gas FG) and the inlet of the detection device 5 (e.g. a combination of a pump and a gas analyzer known per se). In particular, if no detection is required, the valve 12 can be used when the detection device 5 is isolated from the FG gas flow.

[0173] In a preferred embodiment, the system 1 comprises filling, insufflation, evacuation and aspiration capabilities for both the organ of interest 2 and the body cavity 4. After the pressure measurement, the system 1 decides whether the result lies between its confidence intervals by comparing it with the results stored in its local or remote database and, if necessary, repeats the measurement after aspirating some test gas TG from the organ 2 to be tested and / or some gas mixture GM from the adjacent body cavity 4 (see Figure 7 ).

[0174] All embodiments and alternative configurations of the system 1 may perform the test gas pressure increase in the organ to be tested in a stepwise manner, by increasing to a certain percentage (i.e. 20%) and maintaining that pressure for a given amount of time, until another percentage increase (i.e. 40%), and continuing until the desired pressure difference ΔP is achieved between the body cavity 4 and the one or more organs 2 to be tested. This stepwise increase may be applicable to different organs, which in turn will increase the accuracy of the testing of the one or more organs 2.

[0175] According to another feature of the invention, the system 1 may also include a pressure chamber 12'' connecting the filling gas FG supply line 9' connected to the insufflator 16 with the main manifold 13 and containing a control valve configured to open intermittently to avoid flow alarms from the insufflator (see Figure 3 and Figure 6 ).

[0176] According to the previously described embodiments or alternatives considered, the system 1 according to the invention exhibits the following improvements over the prior art:

[0177] - Adding a means of measuring the pressure in the body cavity 4 , which allows taking into account the gas leaking from the body cavity 4 when measuring and running calculations, and achieving greater accuracy during testing;

[0178] - Setting the most appropriate pressure for the test, thereby improving resolution and minimizing the risk of unclear tests. The most appropriate cavity pressure and pressure differential may be different for different types of surgeries or organs, and the system 1 may take this into account based on data retrieved from a local or remote database;

[0179] - Adding means to maintain the desired pressure difference ΔP during the test, by controlled injection of test gas TG and / or by suction and / or insufflation into the body cavity 4. This is necessary or at least beneficial for detecting smaller incomplete closures, since the gas may take more time to diffuse and pass through the hole to the body cavity.

[0180] Preferably, all main operating components of the system 1 (including injection devices 3, 3', detection devices 5, calculation devices 6, volume control devices and flow control devices 11, 11' and at least part of various valves 12, 12', 12", 12'") are included in a physical and functional unit 15, which is preferably equipped with a user interface 15'.

[0181] This unit 15 may be connected at least to an electrical power source and to sources of test gas TG and filling gas FG.

[0182] The test gas TG source may be an external insufflator 16, such as Figure 2 , Figure 3 , Figure 5 and Figure 6 shown.

[0183] However, the invention can also provide that the system comprises a laparoscope or surgical insufflator 16 ( Figure 4 and Figure 7 ).

[0184] Of course, a person skilled in the art will understand that the system according to the invention is configured and comprises all the operational and functional means necessary to carry out the test method, including one, two or several detection cycles, as described above.

[0185] More specifically, at least part of the operating and functional means 3, 5, 6, 7, 7', 8, 8', 11, 11' of the system is configured to perform the various method steps and alternatives set forth, for example under the control of management software or expert or trained AI software.

[0186] Of course, the invention is not limited to the embodiments described and represented in the drawings. Modifications are still possible, in particular from the point of view of the composition of the various elements or by replacing technical equivalents, without exceeding the scope of protection of the invention.

Claims

1. A system (1) for automatically detecting clinically relevant leaks and / or inadequate closure in at least part of a hollow organ (2) located in an inner volume (4') of a body cavity (4) or hollow organs fluidly connected to each other after a medical procedure, wherein: The system (1) at least comprises: an injection device (3) designed for controlled injection of a specific test gas (TG) or a gas mixture comprising at least one test gas (TG) into the one or more hollow organs (2), the injection device (3) comprising a first gas pressure measuring device or being associated with the first gas pressure measuring device; a detection device (5) designed to analyse the gas mixture (GM) and to measure the concentration of a test gas (TG) in the inner volume (4') of the body cavity (4) or at least in a space adjacent to the one or more hollow organs (2), and to measure the gas pressure (GMP) in the inner volume (4') or space; computing means (6) designed to manage the injection means (3) and the detection means (5), for storing and retrieving data from an integrated local or remote database and for analyzing the data and assessing the likelihood of the presence of a leak or a faulty closure and its severity by comparing the stored data with real-time data, The system (1) is characterized in that the computing device (6) is connected to a sensor device (8, 8'), which allows the determination of a pressure difference (ΔP) between the interior of the one or more hollow organs (2) and an adjacent space or internal volume (4') of the body cavity (4), and the computing device (6) controls or grasps the pressure difference (ΔP) by correspondingly driving an associated injection and / or suction device, which injection and / or suction device includes the test gas (TG) injection device (3).

2. The system according to claim 1, characterized in that In addition to the test gas (TG) injection device (3), the system also includes a filling gas (FG) injection device (3'), which is designed to inject filling gas (FG) into the internal volume (4') of the body cavity (4) in a controlled manner.

3. The system according to claim 2, characterized in that Each of the gas supply lines (9, 9') being part of one of the test gas (TG) injection device (3) and the filling gas (FG) injection device (3'), respectively, comprises or is associated with a pressure sensor.

4. The system according to claim 3, characterized in that The pressure sensor is located at or near the outlet tip (10, 10') of the gas supply line (9, 9').

5. The system according to claim 2, characterized in that Each of the gas supply lines (9, 9') which are part of one of the test gas (TG) injection device (3) and the filling gas (FG) injection device (3') respectively comprises a corresponding volume control device (11) and flow control device (11').

6. The system according to any one of claims 3 to 5, characterized in that The system comprises a gas evacuation device (7) designed to limit the amount of test gas (TG) injected into the one or more hollow organs (2) and / or the amount of filling gas (FG) injected into the body cavity (4) by controlled diversion of a portion of the flow in the gas supply line (9, 9').

7. The system according to claim 6, characterized in that The system further comprises a gas suction device (7') designed to perform controlled suction of the test gas (TG) from the one or more hollow organs (2) and / or the gas mixture (GM) from the body cavity (4) at or near the outlet tip (10, 10') of the gas supply line (9, 9').

8. The system according to claim 7, characterized in that The gas evacuation device (7) and the gas suction device (7') include valves (12, 12') controlled by the computing device (6), and the valves include: an outlet valve (12), which is designed and configured to selectively connect the gas supply pipeline (9, 9') to the main collective evacuation and suction duct (13); and a suction valve (12'), which is designed and configured to selectively connect a specific suction pipeline section (14, 14') to the main collective evacuation and suction duct (13).

9. The system according to claim 8, characterized in that An overpressure valve (12") is associated with each of said suction valves (12').

10. The system according to claim 8, characterized in that The system further comprises a pressure chamber (12'") connecting the gas supply line (9') of the filling gas (FG) connected to the insufflator (16) with the main collective evacuation and aspiration conduit (13) and containing a control valve configured to be opened intermittently to avoid flow alarms from the insufflator (16).

11. The system according to claim 5, characterized in that All the main operating and functional components of the system are included in the physical and functional unit (15), including the injection device (3, 3'), the detection device (5), the calculation device (6), the volume control device (11) and the flow control device (11') and at least part of the various valves (12, 12', 12", 12'").

12. The system according to claim 11, characterized in that The physical and functional unit (15) is provided with a user interface (15').

13. The system according to claim 11 or 12, characterized in that The sensor means (8, 8') associated with the test gas (TG) injection means (3) and the filling gas (FG) injection means (3') are located within the physical and functional unit (15).

14. The system according to claim 11 or 12, characterized in that: The system comprises a laparoscope or surgical insufflator (16) mounted within the physical and functional unit (15).

15. The system according to claim 5, characterized in that The operating and functional devices of the system include an injection device (3), a detection device (5), a calculation device (6), a gas evacuation device (7), a gas suction device (7'), a sensor device (8, 8'), a volume control device (11) and a flow control device (11').

16. The system according to claim 15, characterized in that At least a portion of the operational and functional means of the system is configured such that the pressure difference (ΔP) remains constant during a measurement window.

17. The system according to claim 16, characterized in that At least a portion of the operational and functional means of the system is configured such that the pressure difference (ΔP) is maintained at a set value during the measurement window.

18. The system according to claim 17, characterized in that At least part of the operating and functional means of the system is configured so that the set value of the pressure difference (ΔP) used during the measurement window or a measurement window of a detection cycle is an optimized value depending on the type of hollow organ (2) concerned.

19. The system according to claim 17, characterized in that At least part of the operating and functional means of the system is configured so that the set value of the pressure difference (ΔP) used during the measurement window or a measurement window of a detection cycle is an optimized value that depends on the type of medical procedure previously performed and / or the size and / or number of one or more orifices forming the leak.

20. The system according to claim 17, characterized in that At least part of the operating and functional means of the system is configured so that the set value of the pressure difference (ΔP) used during the measurement window or a measurement window of a detection cycle is an optimized value depending on the planned duration of the detection cycle.

21. A system according to any one of claims 18 to 20, characterized in that At least part of the operating and functional means of the system is configured such that the optimized value of the pressure difference (ΔP) used during the measurement window or a measurement window is automatically determined during or after a detection cycle based on changes in the gas mixture pressure (GMP) and / or based on measured test gas (TG) concentration data by performing a continuous or stepwise increase of the pressure difference (ΔP) and monitoring the concentration of the test gas (TG) in the internal volume (4') of the body cavity (4).

22. The system according to claim 21, characterized in that The optimized value of the pressure difference (ΔP) used during the measurement window or a measurement window is determined during or after a previous or first operational detection or measurement cycle and then stored in a database.

23. The system according to claim 15, characterized in that At least part of the operating and functional means of the system is configured so that the pressure difference (ΔP) follows a predetermined value / time curve generated by the progressive injection of the test gas (TG), the predetermined value / time curve being selected by the calculation means (6) at least as a function of the type of hollow organ (2) concerned and of the type of medical procedure previously performed and based on stored data or parameters generated by previous leak detection procedures.

24. The system according to claim 15, characterized in that At least part of the operating and functional means of the system is configured to cause a stepwise increase in the pressure (TGP) of the test gas (TG) in the one or more hollow organs (2) and to provide a predetermined waiting time at each successive pressure level.

25. The system according to claim 15, characterized in that At least part of the operating and functional means of the system is configured so that the pressure difference (ΔP) is managed by combining the controlled injection of a test gas (TG) into the one or more hollow organs (2) with the controlled injection of a filling gas (FG) into the internal volume (4') of the body cavity (4) and / or the suction of a gas mixture (GM) from the internal volume of the body cavity.

26. The system according to claim 15, characterized in that At least part of the operating and functional means of the system is configured so that the pressure (GMP) of the gas mixture (GM) in the internal volume (4') of the body cavity (4) is adjusted to a selected stored value or to a value resulting from a previous leak detection cycle before the filling gas (FG) is injected into the internal volume (4') and therefore before the test gas (TG) is injected into the hollow organ (2).

27. The system according to claim 15, characterized in that At least part of the operating and functional means of the system is configured so that a leak detection cycle comprises the progressive injection of a test gas (TG) into the hollow organ (2), determining an optimal value for the pressure difference (ΔP), and continuing and completing the cycle using the optimal value, or performing a continuous cycle.

28. The system according to claim 15, characterized in that At least a portion of the system's operational and functional means is configured such that a leak detection cycle comprises progressively injecting a test gas (TG) into the hollow organ (2), determining whether more than one leak orifice is present, and using this information to continue and complete the cycle.

29. The system according to claim 15, characterized in that At least part of the operating and functional means of the system is configured such that it performs a first leak detection cycle based on a progressive injection of a test gas (TG) and subsequently performs at least one other leak detection cycle based on a set predetermined appropriate value of the pressure difference (ΔP).

30. The system according to claim 29, characterized in that The performing of at least one other leak detection cycle is performing only the second leak detection cycle.

31. The system according to claim 29 or 30, characterized in that The set predetermined value of the pressure difference (ΔP) is determined during the first leak detection cycle.

32. The system according to claim 15, characterized in that At least a part of the operating and functional means of the system is configured such that it at least partially controls the pressure and / or the pressure difference (ΔP) in the hollow organ (2) by controlled suction of the interior of the hollow organ (2).

Images