Method and system for performing intraoperative organ tissue perfusion assessment and for leak risk assessment

Abstract

This invention concerns asystem for performing organ tissue perfusion assessment and for detecting and / or assessing the risk for a possible post-operative organ leakage, said system comprising at least i) a pressurization module configured to increase pressure inside a target organ in a body cavity, ii) pressure sensor means configured to measure pressure in the target organ and possibly in the body cavity, iii) possibly a dye injection means to introduce dye to the organ though intravenous injection or other means, and iiii) image capturing and processing means comprising a processing unit configured to process captured images of the target organ at different phases or values of pressurization of the target organ, wherein the image processing unit is configured to provide a quantity of perfusion at the organ, possibly at an anastomotic or resection line or site of said organ, by comparing differences in image characteristics of the target organ and correlating them with sensed pressures of said organ, and possibly also with sensed pressure differentials between the target organ and the body cavity.

Description

[0001] METHOD AND SYSTEM FOR PERFORMING INTRAOPERATIVE ORGAN TISSUE PERFUSION ASSESSMENT AND FOR LEAK RISK ASSESSMENT

[0002] The present invention relates to the field of methods, systems and devices in connection with medical procedures, more specifically in relation to minimally invasive surgical procedures, and more specifically to a system and a method to perform realistic organ perfusion examination under variable pressures for an organ located in a body cavity of a human or an animal, in particular a tubular or hollow organ. The invention aims in particular to determine and to compute the probability and measurements, and to compare the changes, in perfusion properties when the considered organ is pressurized by gas / fluid insufflation to various pressures during or after a surgical procedure, as well as to compute measurement indexes or probability values in order to determine the risk of developing a leak post- operatively. Preferably, the system and method of the invention should also be able to perform simultaneously a mechanical leak detection.

[0003] Insufficient blood perfusion at an anastomotic site, at a staple line site, or at a suture line site, is a well-known cause for leaks. For the selection of a well-perfused organ location to perform organ resection or anastomosis and to visualize the perfusion of the selected site, including non- limitatively large bowel / small bowel / colon / rectum / stomach, esophagus, biliary tree, lung or any other hollow organs, techniques using indocyanine green fluorescence angiography (ICG-FA) or near-infrared fluorescence (NIRF), laser based imaging systems (such as Laser Speckle Contrast) and other imaging technologies, including those multi-model modular imaging) to measure blood perfusion intraoperatively, have been developed. These techniques include, but are not limited to, injection of the fluorescent dye (e.g., indocyanine green - ICG) intravenously (systemically), or local evaluation of the organ of interest (such as laser speckle refraction, hyperspectral imaging to measure organ blood properties blood oxygenation..etc...), and the use of special camera filters or other dedicated imaging to visualize and record the ICG fluorescence at the organ level.

[0004] Blood perfusion could also be imaged using Hyperspectral imaging (HSI), which is a relatively new technique that analyzes a wide spectrum of light instead of each pixel. The light is striking at each pixel, and the pixel is then broken down into different spectral bands to provide additional information on what is imaged, compared to normal visible condition. HSI provides color pictures of tissue characterization, such as oxygen saturation (StO2) and Near- Infrared Perfusion Index (NIR-PI), which is used for intraoperative decision-making. Like near-infrared fluorescence (NIRF) imaging, the Hyperspectral imaging (HSI) provides a way to visualize blood perfusion. In addition, Laser Speckle Imaging System is another imaging modality that can be used to evaluate perfusion which does not require injection of a contrast agent.

[0005] Blood flow is generally defined as the movement of blood through the blood vessels: it can be quantified in terms of standard parameters related to “flow”, such as the volumetric flow rate (i.e. the volume of fluid which passes per unit of time), flow speed, or flow velocity. Organ tissue perfusion is defined as the movement of blood flow through blood vessels within a tissue volume. When blood perfusion is sub-optimal, even a well- constructed anastomosis can fail to heal properly, leading to complications like ischemia (inadequate oxygen), tissue necrosis, and ultimately anastomotic leakage. It is known that suture-line blood flow is always reduced compared to normal tissue even under ideal conditions, this means anastomotic tissues are relatively ischemic right after surgery.

[0006] The perfusion pressure of an organ is also an important parameter which can be evaluated as a measure of tissue perfusion. The perfusion pressure of an organ relates to the interaction of the blood pressure and flow rates in the supplying vessels with the resistance to blood flow in the organ. When blood vessels are compressed, the organ tissue perfusion will be disturbed. In particular, the level of pressurization or compression on the blood vessel due to organ tissue compression influences tissue perfusion. In other words, the higher the compression on the local blood vessels, the higher the resistance to blood flow. If the inflow blood pressure remains constant the result will be decreased blood perfusion / perfusion pressure at the site of the compression. The inventors have discovered that this relationship between the pressures on the blood vessel resulting in increased resistance and blood perfusion can be used as a way to assess the quality of the blood perfusion of an organ.

[0007] Importantly, the perfusion-based assessment performed by clinicians during the surgical operations are usually done during the natural or “relaxed” state of the organ. Now, this does not provide a good representation of the blood perfusion activity when the organ is not in a “relaxed” state, such as when it contains digestive contents (such as food or fluid). The introduction of digestive contents after the surgical procedure and during the recovery introduces various changes of pressures in the organ, therefore the blood perfusion quality or behaviour observed for a natural or relaxed state of the organ would be different, and might not resemble the blood perfusion quality or behaviour of a pressurised organ.

[0008] This is particularly sensitive and problematic for parts of the hollow organ subjected to resection procedures, specially around the suture lines, stable lines, generally around the sites of organ closures during surgical procedures. In particular, an organ closure site, for example an colonic anastomotic site (by either sutures or staplers, or other closure technologies) could appear to be well perfused under normal and relaxed state of the organ, but when digestive contents are introduced in the organ (such as colon), the additional pressured caused by the digestive contents will reduce the organ perfusion, which impairs the healing, potentially causing leaks.

[0009] The inventors have discovered that this relationship between the changes (increase or decrease) in pressure in the hallow organ, and the changes (decrease or increase) in tissue perfusion measurements (such as blood oxygenation level or other biological measurable quantifiers... etc) provides a new way to assess and quantify the organ’s tissue perfusion and provide a more realistic representation that mimics the behavior of the organ post-surgery. This allows the assessment of the biomechanical integrity of anastomosis or hollow organ closures in more realistic settings, in particular during the recovering phase after the operation.

[0010] When the perfusion assessment of the same part of the hollow organ is performed under various pressures, it has been noted that the perfusion assessment outputs can be used by clinicians to make preoperative, postoperative or even intraoperative decisions, such as determining the optimal location to perform the anastomosis.

[0011] In addition, such a method / system could be used to assess tissue perfusion and mechanical integrity following the anastomosis. This would allow for assessment of whether or not a repair of the anastomosis is required such as when the anastomosis is 1) mechanically intact (for example, after checked and confirmed by the leak detection device described in US11357932, US2019046742, EP3838119, EP407615), and 2) the standard perfusion imaging quality at the anastomosis site is clinically acceptable, but 3) has impaired perfusion quality at the anastomosis site once the organ is pressurized during apressure perfusion test.

[0012] The blood perfusion intensity (as illustrated by fluorescence intensity from fluorescence imaging, or other tissue oxygenation (StO2), or tissue perfusion (Near-Infrared Perfusion Index, NIR-PI), or other illustration methods that are derived from these principles), is correlated positively with tissue perfusion, the stronger the intensity (usually the brighter) the better the perfusion. This technique is viewed as a quality control technique to identify an adequately perfused organ segment prior to the anastomosis, or as an intraoperative, or post-operative technique to give some indication of anastomotic perfusion.

[0013] Organ perfusion imaging provides information regarding the quality of vascular perfusion and is used in an attempt to minimize the risk of anastomotic leaks or incomplete resection line. However, studies have provided mixed evidence of the clinical benefit of the bowel perfusion imaging in reducing anastomotic leak rates. This is partly due to difficulty in quantifying the intensity of the perfusion which can be related to several factors including: a) the dynamic and time dependent nature of perfusion; b) difficulties in quantifying perfusion as it varies with the distance from the camera to the bowel, that is, for the same test condition, fluorescence will appear to intensify as the camera moves closer to the target organ; and c) contrast between background (florescence intensity noise) vs. organ of interest florescence intensities ratio (florescence intensities of interest).

[0014] Gastrointestinal surgery often requires resection followed by reconstruction of the gastrointestinal tract with a mechanical anastomosis. Unfortunately, leakage from the anastomosis is a relatively frequent occurrence which can be associated with significant patient morbidity, mortality, and overall worse oncologic outcomes. The reasons for anastomotic leakage are largely divided into two main categories.

[0015] The first major cause is the failure to mechanically reapproximate the edges of the resected organ. Such mechanical leak often presents itself early in the postoperative course, often requiring reoperation and is a major contributor to patient morbidity and mortality.

[0016] The second major cause of anastomotic leakage is related to nonhealing or delayed breakdown of the anastomosis. Although this is likely multifactorial, one of the major underlying causes is related to poor anastomotic perfusion. Assessment of anastomotic perfusion can be clinically challenging. Over the last few years evaluation of perfusion using near infrared fluorescence imaging, hyperspectral, laser speckle contras... as well as other perfusion-based imaging technologies has been gaining traction and mainstream acceptance. Some of these methods rely on intravenous injection of fluorescent dye, such as fluorescein dye, followed by evaluation of the anastomosis in the near infrared spectrum. Despite the apparent improvement in the visualization of the perfusion above what regular white light imaging can provide, there is still significant difficulty in objectively identifying areas of relatively poor perfusion. Specifically, areas where perfusion is impaired may still appear relatively normal if some blood flow to the area remains. Efforts at quantifying the perfusion are ongoing. However they continue to suffer from similar limitations where areas of more sluggish perfusion can still appear somewhat normal as long as some blood flow to the area remains. Efforts at quantifying the perfusion continue to suffer from similar limitations whereby areas of more sluggish perfusion can still appear somewhat normal especially when visualized over time or differences in florescence / hyperspectral appearance of the area may be too subtle to be detected with current techniques.

[0017] US11357932, US2019046742, EP3838119, EP4076150 describe methods, technical solutions, systems and devices (herein referred to as the Qaelon device) configured to detect mechanical leaks by precisely creating a pressure differential between the test organ and the surrounding cavity. The described methods, systems and devices are limited to detection of leaks resulting from mechanical causes, more precisely the presence of incomplete organ closures, whereas post-operative leaks can still happen despite complete anastomosis closures. For example, due to sub-optimal blood perfusion that prevents tissue healing. Although these methods and systems represent significant improvement in reducing post-operative leaks by detecting mechanical leaks intraoperatively, they still show shortcomings in that the leak detection provides no or little information to the biomechanical or biological / perfusion properties of the anastomosis, and gives no information on potential post-operative leaks that could be developed due to poor blood perfusion, that could be accessed intraoperatively.

[0018] The present invention aims to overcome the limitations and drawbacks mentioned before and to fill the gaps of the known solutions mentioned herein before. More precisely, the present invention seeks to provide a method and a system for performing a perfusion assessment under a system controlled organ stress test and a gas-based organ leak test to evaluate and assess the organ blood supply, and to provide measures to determine the risk of potential post-operative leak due to impaired blood supply or poor tissue perfusion or oxygenation to the test organ location.

[0019] The method and the system of the invention should bridge the gap between mechanical leak detection and biological leak prevention, by providing a bio-mechanical leak testing method and system.

[0020] The use of the invention should provide an additional quantifiable way to access blood perfusion quality and unique information that can be used for clinical assessment to improve surgical outcomes.

[0021] As stated before in the background, one of the known factors for the risk of anastomotic leaks is related to poor perfusion around the anastomotic site. Adequate blood supply to the anastomosis sites is thought to be crucial for healing and the prevention of leaks. The prior art methods, including perfusion, ICG fluorescence imaging technology, hyperspectral or tissue oxygenation imaging are performed on organ segments at their natural state, namely non-pressurized state. It is a main aim of the invention to overcome these shortcomings of prior art.

[0022] According to a first aspect, the invention concerns a system for performing organ tissue perfusion assessment and for detecting and / or assessing the risk for a possible post-operative organ leakage, said system comprising at least i) a pressurization module configured to increase pressure inside a target organ in a body cavity, ii) pressure sensor means configured to measure pressure in the target organ and possibly in the body cavity, iii) possibly a dye injection means to introduce dye to the organ though intravenous injection or other means, and iiii) image capturing and processing means comprising a processing unit configured to process captured images of the target organ at different phases or values of pressurization of the target organ, wherein the image processing unit is configured to provide a quantity of perfusion at the organ, possibly at an anastomotic or resection line or site of said organ, by comparing differences in image characteristics of the target organ and correlating them with sensed pressures of said organ, and possibly also with sensed pressure differentials between the target organ and the body cavity. Advantageously, the pressurization module includes an injection unit configured to inject a test gas from a gas container into the target organ.

[0023] Preferably, the system comprises a detection module including a gas analyzing component able to perform a real time presence or concentration measurement of the test gas in the taget organ and / or in the cavity.

[0024] Most preferably, the system comprises a leak detection unit for determining mechanical integrity of the considered anastomotic or resection line, said leak detection system preferably comprising the pressurization module, pressure sensor means configured to measure pressure in the target organ and in the body cavity and means to control the pressure in the target organ and in the body cavity, as well as the pressure difference between the organ and the cavity.

[0025] Said leak detection unit may comprise a detection module including the gas analyzing component able to preform a real time presence or concentration measurement of the test gas in the taget organ and / or in the cavity.

[0026] According to an important feature of the invention, the system comprises a processing unit (CPU) hosting a general control software (GCS) configured to communicate with and coordinate the functioning of : the injection unit and the pressure sensor means, which are preferably part of a leak detection unit, possibly the dye injection means, and the image capturing means, said general control software (GCS) unit receiving information / outputs from said means and units and being configured, by processing images of the organ or organ site, to compute and quantify changes in the perfusion quality or characteristics, based on differences in image characteristics of the target organ or organ site, in relation to changes of intraluminal pressure in the organ, and / or in the pressure differential between the organ and the cavity, said general control software (GCS) unit preferably communicating with the leak detection unit, an imaging unit of the image capturing means and possibly a dye injection unit by means of a microcontroller.

[0027] The system may also comprise a user interface, such as a touchscreen, and a remote and / or local data storage associated with said general control software (GCS) unit, which is configured to compute a likelihood of a medically relevant leak based on stored measurement data of previously collected clinical and preclinical data, for different organ pressurisation tests, information entered by a user, and / or gas measurement information.

[0028] In connection with a prefered feature of the invention, the system comprises means to control and / or measure the distance, which can be fixed, adjustable or regulable, between the camera which is part of the image capturing and processing means and the surface of the considered organ or organ site. This distance and its possible variation during a testing sequence will be taken into account and exploited by the general control software when the perfusion image data is computed.

[0029] Advantageously, the previous means to control the distance between the camera and the surface of the considered organ or organ site comprise a spacer or space cap which is mounted or attached onto the camera, preferably onto the tip of said camera (in front of the lens of the endoscopic or laparascopic camera).

[0030] According to an other aspect, the invention also concerns a biomechanical leak testing system, for performing a perfusion assessment and a gas-based leak test on an organ or organ site within a body cavity of a human or an animal, in order to determine the presence of a post-operative leak and the risk of a future potential post-operative leak, wherein said system comprises:

[0031] - a leak detection unit, comprising a pressurization module configured to increase pressure at least inside the target organ, and a pressure sensor means configured to measure pressure in the target organ and in the body cavity, said unit being also configured to control and regulate the pressure differential between the inside of the organ and the inside of the body cavity,

[0032] - an image capturing means comprising a camera unit and a imaging unit, possibly comprising image display means for the user,

[0033] - a possible dye injection means, comprising a dye injection unit,

[0034] - a central processing unit hosting and running a general control software (GCS) and comprising or being associated with a database and a local storage space,

[0035] - a user interface for user input and user display, such as for example a touchscreen, controlled by and communicating with the central processing unit, wherein the general control software (GCS) unit is configured to communicate with and coordinate the functioning of: the leak detection unit, possibly the dye injection means, and the image capturing means, said general control software (GCS) unit receiving information / outputs from said means and unit and being configured, by processing images of the considered organ or organ site, to compute and quantify changes in the perfusion quality or characteristics, based on differences in image characteristics of the target organ or organ site, in relation to changes of intraluminal pressure in the organ, and / or in the pressure differential between the organ and the cavity, said general control software (GCS) unit preferably communicating with the leak detection unit, an imaging unit of the image capturing means and possibly a dye injection unit by means of a microcontroller.

[0036] Of course, the bio-mechanical leak testing system mentioned before may advantageously incorporate the system for performing organ tissue perfusion assessment and for detecting and / or assessing the risk for a possible post-operative organ leakage mentioned previously with its various possible features and aspects.

[0037] According to a still further aspect, the invention concerns a method for performing organ tissue perfusion assessment and for detecting and / or assessing the risk of a possible post-operative organ leakage, said method including at least the steps of : increasing pressure inside a target organ in a body cavity at a site of an anastomosis or resection, measuring pressure in the target organ and possibly in the body cavity, causing if necessary a dye to be present at the organ or an organ site, capturing and processing images of the target organ or organ site at different phases of pressurization of the target organ, and determining a quantity of perfusion at the anastomosis or resection site by comparing differences in image characteristics of images of the organ or organ site taken at different pressure levels and correlating them with the sensed pressures of the target organ and possibly also with the sensed pressure differentials between the target organ and the body cavity.

[0038] According to a possible feature of the inventive method, the images of the target organ or organ site at different phases of pressurization of the target organ are processed and analyzed, possibly together with stored previous or pre-operative measurement data, in order to generate outputs on whether the quality of the perfusion changes according to the pressure in the organ, and whether such changes will likely to be associated with clinical relevant impact, in particular, whether a leak will likely to be developed post- operatively. According to an other possible feature of the inventive method, it may comprise dyeing the site of the organ, anastomotic or resection line with a fluorescent dye, before perfusion is determined.

[0039] In connection with a first alternative, said fluorescent dye is injected prior to pressurization of said target organ.

[0040] In connection with a second alternative, said fluorescent dye is injected while the organ, anastomotic or resection line is insufflated, a time duration to peak fluorescence intensity being then evaluated.

[0041] In connection with a third alternative, said fluorescent dye is injected while said target organ is being pressurized, followed by deflation.

[0042] The perfusion of said target organ may be determined before, during and / or after resection of said target organ.

[0043] The quantity of perfusion at said organ, anastomotic or resection line may be determined by pressurizing said target organ at various pressures without full deflation.

[0044] The quantity of perfusion at said organ, anastomotic or resection line may be determined by evaluating profusion intensity during dynamic variation of intraluminal pressure, cavity pressure and / or pressure differential between organ and cavity.

[0045] According to a preferred embodiment of the invention, a general control software (GCS) unit coordinates and communicates, in parallel, to a leak detection unit, gives instructions to control and regulate organ injection means to coordinate the pressurisation of the organ, and to control and regulate abdomen injection means to coordinate the pressure in the abdomen.

[0046] Advantageously, a dynamic change of pressure is applied to the organ and possibly to the cavity, for example a linear or stepwise increase / decrease of pressure.

[0047] Preferably, the images are taken by a camera (as part of the images capturing means which also comprise the imaging unit), preferably by an endoscopic or laparoscopic camera, and the distance between the camera front lens and the surface of the organ or organ site is controlled, for example by means of a space cap, or a spacer, mounted on the front end of the camera, by means of an automatic estimation based on imaging analysis or positional information such as from magnetic or optical tracking or by means of an automatic estimation based on internal calibration.

[0048] The time series information of the same time period capturing the relationship between the perfusion quality of the organ, the organ pressure, as well as the differential pressure differences between the inside of the organ and the inside of the abdominal cavity in which the organ is located, may be adavntageously used to perform computing, for example in the form of perfusion indexes which represent the perfusion quality of the test period for the specific test sequence, to determine the post-operative perfusion quality and to determine whether a leak is likely to developp after the surgical procedure.

[0049] The measurement noise caused by the distance variation between the camera and the target measurement tissue of the target organ, for example quantified by means of a spacer or a space cap, may be corrected to reveal the unbiased, by space or distance, perfusion index measurements.

[0050] The measurement noise caused by distance variation between the camera and the target measurement tissue, as quantified by the dye injection measurements, may be corrected by taking into account the natural decay or weakening of the dye intensity over time, to reveal the unbiased perfusion index / signal measurements.

[0051] The method described herein before makes advantageously use of the system(s) described herein before.Thus, through its various aspects, the invention proposes first a method and a system for detecting and analyzing blood perfusion imaging in partially hollow organ or mutually fluidly connected hollow organs, within the interior of a body cavity, with system-controlled organ tissue pressurization before, during and / or after a medical procedure to examine the quality of blood perfusion to access the risk, the likelihood, the probability of developing a post-operative leak.

[0052] In contrast to the prior art, the invention is comprised of a general control software (GCS) unit that coordinates, in parallel, the imaging unit (fluorescence perfusion or hyperspectral imaging or other imaging techniques based on perfusion), and the leak detection unit, which preferably incorporates the injection module or unit.

[0053] The general control software (GCS) unit can coordinate the leak detection unit to perform pressurization of both the body abdominal cavity and the target test organ, and to control and regulate the pressure differential between those two spaces in a fully controlled manner. In the case of fluorescence imaging, the general control software (GCS) unit also coordinates the dye injection unit. For other cases of perfusion imaging which do not require dye or other additional medium, such coordination is disactivated. With the parallel control of the above-mentioned sub-units (imaging unit and leak detection unit), the general control software (GCS) unit has the processing capacity to compare, characterise and evaluate the resultant changes in image characteristics of the target organ when different intraluminal pressures are applied, i.e. with or without organ pressurization (baseline measurements), or dynamic change of pressures. Dynamic change of pressure is further defined as a fixed or variable dynamic, or variable stepwise increase / decrease, or linear increase / decrease, or random sequences determined by the systems). In certain embodiments the system may only control the intraluminal pressure without specific control of the fluorescence or hyperspectral imaging. Additionally, in certain embodiments the system may not control the pressure within the body cavity, or the body cavity may be open to the atmosphere. In certain embodiments, dye injection could also be performed independently of the inventive system and not under its direct control. In such cases, the system coordination with the dye unit is disactivated.

[0054] The invention provides an indication of the nature of perfusion and quantitative evaluation of the perfusion pressure in the various areas of the target organ.

[0055] To overcome the limitation of little or no control over the dynamic and time dependant nature of perfusion imaging, the following perioperative patient related information linked to variability related to perfusion dye injection (quantify of dye, timing of injection, location of injection, etc.) and patient specific characteristics (age, BMI, height, weight, sex, hydration status, blood pressure, cardiovascular parameters (heart rate, cardiac output), cardiac functions, blood pressure (mean arterial pressure or MAP), pulmonary function (e.g., oxygenation, SpO2, respiratory rate), etc., and biological property such as blood thickness / viscosity, coagulation factors, height, weight, and BMI, medical history (smoking, diabetes, vascular disease, hypertension), are stored in the memory unit of the general control software and contribute as a source of information for later evaluation and computation.

[0056] In one embodiment, the said general control software (GCS) unit coordinates the perfusion dye injection control means (such as the injection quantity, injection flow, concentration of dye, the timing of the injection, the duration of the injection, the brand of the dye,...etc.) according to pre-defined parameters (such as the injection quantity, injection flow, the timing of the injection, the duration of the injection, past injection history of the present procedure... etc.). In another embodiment, the general control software (GCS) unit coordinates the perfusion dye injection control means according to user control (manually, system or robotically controlled) in which the perfusion dye injection means record at least one parameter related to the user control, such as injection volume / quantity, flow, the timing of the injection, the duration of the injection, the concentration of the dye, past injection history of the present procedure, the brand of the dye (differential dissipation or metabolic clearance rates)., etc. The ensemble or set of dye injection information from the dye injection means and the dye injection unit is communicated to the general control software (GCS) unit for further processing.

[0057] The further processing could be based on modeling approaches based on previously available historical clinical data or lab data to simulate dye distribution, metabolism, and excretion; and to generate perfusion dye degradation simulation in real-time or close to real-time for the patient, allowing for dynamic monitoring and to provide processed information to the other units of the system. By integrating patient- specific and dye injection data into predictive / simulation models, the additional processing performed by the system can transform raw clinical measurements that will be used to improve perfusion imaging accuracy, consistency, for the system’s biomechanical perfusion-based leak test.

[0058] In the event that no dye is used for the perfusion-based imaging, the corresponding default parameters for the particular type of perfusion based imaging technology will be used for each type of the perfusion based imaging technology.

[0059] In one embodiment, in which the perfusion imaging is used - to overcome the difficulties in quantifying perfusion as the perfusion intensity varies with the distance between the camera and the test organ tissue, for the same test condition, the invention is comprised of a space cap or a similar spacer element, which can be mounted or attached onto the camera, it allows standardization, or to have a fixed known distance between the camera lens and the surface of the organ tissue when the space cap is in touch of the organ tissue. The space cap mounted camera (the camera unit) can then be used to trace along the region of interest of the organ tissue, to provide standardization of the inspection, assessing the perfusion quality and hence improve the accuracy in quantifying the perfusion with control of distance between the camera lens and the organ tissue.

[0060] The space cap (or spacer) is designed to be mounted onto the tip of a camera, such as a laparoscopic (or endoscopic camera) , aligning with the axis of the camera lens. Each view shows a cylindrical or semi-cylindrical cap fitted over the distal end of the camera shaft.

[0061] The space cap or spacer element can have a fixed known distance, such as a fixed mechanical guide between the camera lens and the organ tissue; or the distance can be adjustable according to the use case and changed by the user; or the distance is regulatable according to a known prefixed and graded distance; or have at least two pre-fixed known distance (such as “far” and “close”) The distance change on the space cap can be done manually by the user or digitally via the central co-ordination unit control. The timing of the distance adjustment is communicated back to the central co-ordination unit via user inputs or digitally determined. The different distance between the space cap and the organ tissue will allow for additional perfusion intensity information and measurement data at the same organ tissue location, to further improve on detection sensitivity. This is particularly important in applications such as: Perfusion imaging (eg, using ICG), and di stance- sensitive fluorescence intensity measurements. It helps standardize optical conditions - especially where signal intensity depends heavily on working distance.

[0062] The spacer element can be made with medical grade plastic materals (transparent or semi-transparent polymer) or metal, with adjustable depth and diameter. The spacer could include calibration markers or embedded fiducials for distance correction. The spacer element may comprise a body (for example a surfacic part) or a tip part which contacts the surface of the organ (and remains in contact with it during the test sequence or period) and a spacing part which determines the distance between camera tip (lens) and surface of the organ (and may be fixed or variable in length). The information on the distance is known to or transmitted to the processing unit and the general control software.

[0063] The spacer can be a retractable with, for example, a collapsible design, to allow flexibility in surgical workflows. A lock mechanisam could be put into place during measurement, to adapt to the need of the procedure.

[0064] The spacer could have embedded sensors, such as pressure sensor or light sensor, or other type of sensor that give similar measurements to signal the distance, at the distal end to detect contact or proximity to organ tissue.

[0065] The space cap or similar spacer element may be an important component or piece of equipment of the inventive system. Indeed, as the pressure changes in the organ, the distance between the camera (front lens) and the target organ (outside surface of the tissues of the organ) changes accordingly. The implication is that the intensity of the perfusion signal changes with said distance, it becomes “less perfused looking” the bigger the distance between the camera and the organ, or the tissues look “more perfused” when the camera is closer to the tissues.

[0066] The space cap or similar spacer element can advantageously ensure that the same distance is maintained during the test sequence (rigid spacer), or, if not, that the variable distance (non rigid spacer) is measured and captured (taken into account) for adjustment to correct the varibility of the measurement signal / index(es) introduced by the variability of the camera distance to the organ.

[0067] In certain embodiments no space cap or spacer is necessary and the distance to the organ is automatically estimated based on imaging analysis or positional information such as from magnetic or optical tracking.

[0068] In certain embodiments no space cap or spacer is necessary and the distance to the organ is automatically estimated based on internal calibration such as from a known distance measurement within the cavity or marked on an instrument.

[0069] As the intensity of the blood perfusion captured by the perfusion imaging is dependent on the interaction of organ pressurisation, and the interaction of the following factors i) dye injection (for Fluorescence imaging at least) and the system processed parameters and information described in paragraph 18, ii) the distance between the camera lens and the organ tissue, and other parameters described in paragraphs 19 and 20 iii) patient specific factors, the measurement data recorded from the perfusion imaging for the same organ tissue location or around similar organ tissue location is compared by varying the organ pressure in a controlled manner. The general control software (GCS) unit coordinates and communicates, in parallel, to the leak detection unit, gives instructions to control and regulate the organ injection means to coordinate the pressurisation of the organ, and to control and regulate the abdomen injection means to coordinate the pressure in the abdomen. The detail of this technology is already described in US 11357932, US2019046742, EP3838119, EP407615.

[0070] The organ pressurisation varies with endoluminal pressurization (in mmHg) such as: no pressurization - natural state prior to organ insufflation; with a known pre-defined pressure; with unknown pressure range insufflate by user control; with dynamic pressure change at a specific pre-defined pressure profile; user control of endoluminal pressure intensity; or with dynamic pressure change at variable pressure profiles dependent on testing conditions and an adoptive learning algorithm.

[0071] The organ pressure control also varies by duration, such as: known pressure changes in a fixed known time interval, i.e. every 3 seconds; pressure change from natural state to a pre-defined pressure at a fixed time interval; with dynamic pressure duration change at variable profiles dependent on testing conditions and an adaptive learning algorithm; user- controlled of pressurisation duration; and / or its interaction by varying dye injection measurements, such as: time from initial injection; change in accumulative injection dosage at the time of imaging; and / or its interaction by varying the distance between the camera lens and the organ tissue; fixed known distance changes in distance between the camera lens and the organ tissue; user manual change in distance between the camera lens and the organ tissue.

[0072] The ensemble of information and all measurement data described above, related to organ pressure, timing, duration, distance, and perfusion intensity, are communicated from the imaging unit, the leak detection unit, and the dye injection unit, to the general control software (GCS) unit for further processing.

[0073] When the pressure test is ready to be performed, after dye has been injected via user control, or via the control through the general control software (GCS) unit, with the real-time processing mode of the pressure test, which can be activated by the user; the general control software (GCS) unit coordinates in parallel: the injection unit (for example as part of the leak detection unit ) to control the organ pressure to activate insufflation controls that will result in variable organ pressures composes of with, or without, or dynamics pressures (shown in Fig. IE), or by manual user organ insufflation control (with pressure and flow control within the safety measures according to clinical usage of organ and abdomen insufflation), then compare the perfusion imaging information, at different organ pressurization, for the same organ location, the imaging unit to display and record information from the camera lens.

[0074] The general control software (GCS) unit, has the data processing capacity, when activated by the user to start the pressure test, to compute and to compare, in real-time, the perfusion changes (in quality / quantity) at different pressure levels and with the organ insufflation flow provided by the leak injection unit (and usually at the same organ location which is controlled by the manual control of the user via the control / positioning / handling of the camera).

[0075] The above computation outputs, together with the measurement data housed in the database of the general control software (GCS) unit, will be processed and analyzed further by the data processing capacity of the general control software (GCS) unit to generate outputs on whether the quality of the perfusion changes according to the pressure in the organ, and whether such changes will likely to be associated with clinical relevant impact, in particular, whether a leak will likely to be developed post- operatively. More specifically, if the perfusion quality of the target test organ remains relatively unchanged under pressure, it represents good blood perfusion under pressure. In contrast, if the perfusion quality of the target test organ changes relative to changes in pressure, more specifically, the perfusion quality reduces under increased pressures, it represents poor blood perfusion under pressure, signaling highly risk of post-operative leak. The time series information of the same time period capturing the relationship between the perfusion quality of the organ, the organ pressure, as well as the differential pressure differences between the inside of the organ and the inside of the abdominal cavity in which the organ is located, are used to perform computing, for example in the form of perfusion indexes which represent the perfusion quality of the test period for the specific test sequence, to determine the post-operative perfusion quality and to determine whether a leak is likely to developp after the surgical procedure.

[0076] The above-described computation and data-processing could be done close to real-time, or at any time points during the operation.

[0077] The invention proposes a method and a system for accessing and quantifying organ perfusion in intact hollow organ, or at anastomosis sites around the organ closure, to access, to evaluate, and to compute the risk, the probability, and the likelihood of a post-operative leak due to impaired blood supply.

[0078] The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which:

[0079] Figs. 1A-1D are illustrations of perfusion imaging of the same portion of organ tissues (site of an anastomosis or resection line) at natural endoluminal pressure state (Fig. 1A and Fig. 1C which is a close-up of Fig. 1A) vs. positive endoluminal pressure state (Fig. IB and Fig. ID which is a close-up of Fig. IB).

[0080] Fig. IE are simplified graphical illustrations of two types of dynamic pressure changes showing regular intervals with insufflation and without insufflation (top illustration: consecutive square / rectangular pressure slots; bottom illustration: consecutive triangular pressure slots).

[0081] Fig. 2 is a simplified block diagram of a system for detection of organ or anastomosis leakage, in accordance with a non-limiting embodiment of the present invention (the hardware components are indicated in CAPITAL letters and the software components are indicated in small letters).

[0082] Fig. 3 is a schematic mixed diagram of “pressure test” - system flow and methods, in accordance with a non-limiting embodiment of the present invention.

[0083] Figs. 4, 5 and 6 are simplified block diagrams of a system for detection of organ or anastomosis leakage, in accordance with three other non-limiting embodiments of the present invention, as alternatives to the system shown in figure 2 (the hardware components are indicated in CAPITAL letters and the software components are indicated in small letters).

[0084] Eigs. 7A, 7B and 7C are simplified representations of different arrangements of a space cap or a spacer, mounted or attached to the camera lens of the camera unit shown in figures 4 to 6, according to three non limiting embodiments of the invention, said arrangements showing at least one point of connection, between the tip of the camera lens and the body of the space cap or the spacer.

[0085] Eig. 8A and Fig. 8B are schematic mixed diagrams of “pressure test” - system flow and methods, similar to the diagram of figure 3, in accordance with two other non-limiting embodiments of the present invention. Fig. 9A and Fig. 9B show each simplified graphical illustrations (in the form of four time curves) of one type of dynamic pressure changes showing a relatively regular intervals with organ pressure with organ insufflation (top illustration); a relatively regular intervals with Delta pressure differences between the organ and the abdominal cavity (middle illustration); and the perfusion measurement of the target test organ (bottom illustration). These graphical illustrations have the same start time X, and illustrate the same period of the procedure. Fig. 9A represents an organ with a relatively good perfusion, as the bottom illustration shows the max-min perfusion indexes, or the variation of the perfusion indexes / signals are relatively small throughout the test sequence with the pressure changes in the organ (top illustration), signaling relatively good perfusion quality relatively independent of organ pressure changes. Fig. 9B represents an organ with a relatively poor perfusion, as the bottom illustration shows the max-min perfusion indexes, or the variation of the perfusion indexes / signals are relatively large throughout the test sequence with the pressure changes in the organ (top illustration), signaling relatively poor perfusion quality subject to organ pressure changes.

[0086] Fig. 10A are simplified graphical illustrations - the top two illustrations are identical to the ones of Fig. 9 A and Fig. 9B. The top bottom half of the illustration shows - (see third illustration from the top named “Space Cap”) - the distance changes between the camera and the measurement tissue over time during the course of the test sequence and the bottom half of the bottom illustration (fourth illustration from the top) shows the “Original Uncorrected Perfusion Signal” max-min perfusion indexes, or the variation of the perfusion indexes; as well as the “Corrected Perfusion Signal”. In this latter time curve, the measurement noise caused by the distance variation between the camera and the target measurement tissue of the target organ (surface of the organ), for example quantified by means of a spacer or a space cap, is corrected to reveal the unbiased (by space / distance) perfusion index / signal measurements.. The same logic may be applied to the inputs from the dye injection measurements.

[0087] Fig. 10B are simplified graphical illustrations - the top two illustrations are identical to Fig. 9A and Fig. 9B. The top bottom half of the illustration contains - Dye injection measurement information overtime - showing the change perfusion signal due to natural degrade / changes of dye intensity over time, based on estimation, known dye injection time, injection dosage, at the time of imaging. The bottom half of the bottom illustration shows the “Original Uncorrected Perfusion Signal” max-min perfusion indexes, or the variation of the perfusion indexes; as well as the “Corrected Perfusion Signal”, in which the measurement noise caused by variation between the camera and the target measurement tissue, as quantified by the dye injection measurements, are corrected to reveal the unbiased (accounted for natural decay or weakening of the dye intensity over time) perfusion index / signal measurements.

[0088] Further description is provided hereinafter, with reference to the attached figures, in particular to figures 2 and 4 to 6.

[0089] The invention comprises of a processing unit, in which the general control software (GCS) is stored and located. Said processing unit is also configured to run / execute said general control software. The general control software (GCS) contains the graphical user interface (GUI) software, which receives user inputs through the user control interface on exterior of the housing of the system. The general control software (GCS) also communicates to the embedded software housed in the microcontroller(s) (MCU), for instructions, and inputs / outputs signals to the leak detection unit, the dye injection unit (present in figures 2 and 4, not present in figures 5 and 6), and the imaging unit.

[0090] The communication between the processing unit CPU and the MCU, is done through the general control software, and from the MCU to the leak detection unit through the embedded software to coordinate the leak detection unit. The role of the computation unit / the general control software (GCS) is described in US11357932, US2019046742, EP3838119, EP4076150, the computation unit / the general control software (GCS) receives information from all sensors (such as pressure sensing means, flow sensing means, open / close of valves, on / off pumps) of the leak detection unit. The leak detection unit insufflate the organ to the pre-defined target pressure based on the instruction received from the general control software (GCS) and defined by user inputs or automatically defined by the general software control (GSC) based on user selection on the detection program (such as type of surgery, type of organs, etc.).

[0091] The communication between the CPU and the MCU is done through the general control software, and from the MCU to the dye injection unit (when present) through the embedded software to coordinate the dye injection means of the dye injection unit. The dye injection means control and record the injection time, the injection quantity, the injection flow, etc.

[0092] In some embodiments the system may instruct the user when to inject the dye (if necessary) but would not directly control dye injection.

[0093] The communication between the CPU and the MCU is done through the general control software, and from the MCU to the imaging unit through the embedded software to coordinate the imaging unit, which further consists of a camera and image display. The imaging unit allows for display of perfusion imaging. This imaging unit is for example advantageously a standard surgical imaging or perfusion imaging unit or hyperspectral imaging unit, using known knowledge and technology in the domain. The outputs from the imaging unit are communicated to the CPU.

[0094] In parallel or close to parallel control, the general control software (GCS) coordinates the lumen pressure (inside the organ) through the lumen injection means (injection unit) of the leak detection unit (part of the pressurization means), and the general control software (GCS) controls image capturing during the course of test / inspection spanning multiple time points, from prior to, during, and after organ insufflation by said lumen injection means, as well as at various organ pressures. The general control software (GCS) receives information / outputs from the injection unit, imaging unit, and leak detection unit, and, based on the received information, the general control software (GCS) computes and quantifies changes in the perfusion quality or characteristics in relation to the change of intraluminal pressure (pressure change inside the organ), and / or the change of pressure differential between the organ and the cavity, with reference to the dye injection property (such as time from the initial dye injection), when present. Computation comparison between the change of perfusion property or characteristics in relation to the different level of organ pressurisation is used to compute and to predict, based on computational means, with / without reference to stored database (in the GCS) - which contains measurement data of previously collected clinical and preclinical data, for different organ pressurisation tests(under perfusion / endoscopic / hyperspectral imaging, for different patient ages, BMI, types of surgery, types of organ, surgical history, blood thickness properties, and clinical outcomes for each of the associated dataset) -, the risk, the likelihood, the probability of future post-operative leak. The computation output is displayed on the graphical user interface, and the user can use the computation outputs to input his / her clinical judgment and / or comments to determine the course of follow up actions, if any.

[0095] In certain embodiments of the invention, the pre- and postpressurization images can be displayed to the user without significant image processing for their own evaluation and judgement of the degree of change of perfusion.

[0096] There is thus provided in accordance with a non-limiting embodiment of the invention a system for detection of organ leakage including a pressurization module configured to increase pressure inside a target organ in a body cavity, a pressure sensor configured to measure pressure in the target organ and in the body cavity, a dye introduced to the organ though intravenous injection or other means, and an image processor configured to capture and process images of the target organ at different phases of pressurization of the target organ, wherein the image processor is configured to provide a quantity of perfusion at the organ by comparing differences in image characteristics and correlating them with sensed pressure of the target organ and with a sensed pressure differential between the target organ and the body cavity.

[0097] In accordance with a non-limiting embodiment of the invention the pressurization module includes an injection module configured to inject a test gas from a gas container into the target organ. The pressurization module may include an inflatable balloon.

[0098] In accordance with a non-limiting embodiment of the invention the system further includes a leak detect system for determining mechanical integrity of the anastomosis.

[0099] In accordance with a non-limiting embodiment of the invention, the pressurization module includes an injection module configured to inject a test gas from a gas container into the target organ and the leak detect system includes a detection module including a gas analyzing component that makes a real time presence or concentration measurement of the test gas.

[0100] In accordance with a non-limiting embodiment of the invention the system includes a processor or processing unit with a user interface and a remote and / or local data storage, wherein the processor communicates with the injection module and the leak detection unit, and is configured to compute a likelihood of a medically relevant leak based on stored data, information entered by a user, or gas measurement information. There is also provided in accordance with a non-limiting embodiment of the invention a method for detection of organ leakage including increasing pressure inside a target organ in a body cavity at a site of an anastomosis, measuring pressure in the target organ and in the body cavity, causing a dye to be at the site of the organ or anastomosis (only for imaging that requires a dye; the invention can also be carried out with imaging that does not require a dye), and capturing and processing images of the target organ at different phases of pressurization of the target organ, and determining a quantity of perfusion at the anastomosis by comparing differences in image characteristics (of images taken at different pressures) and correlating them with (respectively) sensed pressure of the target organ and with a sensed pressure differential between the target organ and the body cavity.

[0101] Reference is now made to Figure 3, which illustrates in a combined way a method and a system for detection of organ or anastomosis leakage, in accordance with a non-limiting embodiment of the present invention.

[0102] Similar to US Patent 11357932, the system may include an injection module that can inject a test gas from a gas container to a hollow body part, cavity, organ or lumen (the terms being used interchangeably). The injection module has a pressure sensor. The test gas may be a gas that is not naturally present within the body cavity, or a gas which is naturally present within the body cavity in a known amount or concentration. The injection module can control injection or insufflation of the test gas, and can measure any one of, or a combination of, the volume, the concentration, the detected test gas pressure in the hollow organ, and / or the rate of injection of the test gas delivered from the gas container. The pressure sensor can measure the pressure within an injection tubing of the injection module and / or inside the hollow organ.

[0103] The system may include a detection module including a gas analyzing component that makes a real time presence or concentration measurement of the test gas within a gaseous sample. The system may include a transferring component that transfers the gas or gas mixture from the internal free volume inside the body cavity to the gas analyzing component.

[0104] The injection module and the detection module are advantageously part of a leak detection unit or device, as described for example in US11357932, US2019046742, EP3838119 or EP4076150, which may be physically mounted within the housing of the inventive system as shown in figures 2 and 4 to 6.

[0105] Reference is now made to figures 2, 4, 5, 6. The system may include a general software control (also called a processor or controller) with a user interface and a remote and / or local data storage for computing the likelihood of a medically relevant leak based on stored data, information entered by the user, and gas measurement information, among other parameters. The computational module communicates with both the injection module and the detection module. The injection module, the detection module, and the computational module may all be located outside the patient.

[0106] When performing the surgical procedure, the surgeon may wish to evaluate the target organ perfusion either before, during or after resection of the target organ.

[0107] The body cavity and / or the target organ to be evaluated are pressurized using the (gas) injection module, the detection unit, and the processing unit.

[0108] A fluorescent dye, such as fluorescein dye, may be injected intravenously, if needed by the used imaging technology. Dye injection can be performed prior to pressurization of the target organ. Alternatively, dye may be injected while the target organ is already pressurized, and the anastomosis is inspected as the pressure is relieved. As stated before, imaging techniques that do not require a dye, such as hyperspectral imaging can also be used to carry out the invention (no dye injection unit or device are needed then- see figures 5 and 6).

[0109] The target organ tissue is then inspected using a laparoscopic camera with / without a space cap or using a dedicated imaging device, or any other useful method. The target organ can be evaluated using fluorescence imaging, hyperspectral imaging or any other imaging technique, with or without dye injection.

[0110] The imaging characteristics of the target organ are evaluated at various phases of pressurization. An image processor, advantageously the processing unit of the system (CPU), using known image processing algorithms, compares the differences in image characteristics (of various images of the organ or organ site taken at different pressure conditions / levels) and correlates them with the known intraluminal pressure (for each considered image) as well as the pressure differential between the lumen and the body cavity. The image processor uses the known pressures to provide a quantitative evaluation of the degree of perfusion.

[0111] Additional perfusion characteristics may be evaluated by injecting the dye while the anastomosis is insufflated and then evaluate the time to peak intensity.

[0112] The perfusion evaluation can also be performed by first injecting the dye while the target organ is pressurized followed by deflation.

[0113] Additional evaluation can be performed by assessing the target organ at various pressures without full deflation or by evaluating profusion intensity during dynamic variation of the intraluminal and / or cavity pressures and pressure differentials.

[0114] The perfusion characteristics can be displayed to the operator in various manners such as overlay on the existing laparoscopic monitor (associated with the imaging unit) or through a separate monitor or on the monitor display of the main insufflator unit.

[0115] Once the system indicates that there is no mechanical leak and the perfusion based images appears to be intact / satisfatory, the leak testing is completed (positively for the patient). Of course, such leak testing can be repeated as needed.

[0116] Testing for mechanical integrity as well as evaluation of perfusion can be performed independently from each other or simultaneously.

[0117] The present invention provides several advantages over the prior art. For example, with respect to the perfusion-based imaging, pressurization of the lumen during the injection can highlight areas of relative perfusion defects that may otherwise not be detected. The perfusion pressure may be related to the difference between the local blood pressure in the supplying vessels and the intraluminal pressure resisting the flow. By artificially increasing the intraluminal pressure temporarily, areas of relatively poor blood supply (for example, from vascular injury in the mesentery) are better highlighted as compared to perfusion assessment in a decompressed loop of bowel. Alternatively, if the perfusion pressure is uniform, no relative perfusion abnormalities would be identified.

[0118] Furthermore, by controlling the intraluminal pressure, the invention can be used to perform a stress test of the perfusion pressure of the anastomosis to make sure it is adequate. This could be potentially useful in the areas where the global perfusion of the anastomosis may be compromised even though it appears uniform, such as in areas of watershed perfusion of the colon or any areas of more central vascular compromise, such as from atherosclerotic disease.

[0119] Additionally, the method of the invention can serve to create an internal control for the perfusion pressure assessment which would make it easier to quantify the perfusion of the target organ. Specifically, the perfusion intensity, or other imaging representation of perfusion, of the anastomosis could be compared with and without luminal pressure. Since the degree of luminal pressure would be known, the difference in fluorescence intensity, or other imaging representation of perfusion, could be used to help quantify the perfusion pressure and thus the vascular health of the anastomosis.

[0120] Furthermore, in accordance with a preferred embodiment of the invention, the combination of testing both the vascular perfusion of the organ as well as its mechanical integrity provides a much more holistic evaluation of the anastomosis than can be performed by the prior art.

[0121] It is noted that the invention does not require the intraluminal and intracavitary pressures to be coordinated through a central system. The invention can be carried out whether pressurizing the lumen is coordinated with the cavity pressure or not.

[0122] It is noted that the lumen can be pressurized by other means, for example, with an intraluminal balloon.

[0123] In one embodiment, the imaging unit is outside of the central housing of the system, with a communication connection between the embedded software, and the general control software (figure 4).

[0124] In one embodiment, the invention does not contain the dye injection unit, see figure 5.

[0125] In one embodiment, the invention does not contain the dye injection unit, and the imaging unit is outside of the central housing of the system, with a communication connection between the embedded software, and the general control software (figure 6).

[0126] The space cap or the spacer can be mounted or attached to the camera lens, having at least one point of connection, between the tip of the camera lens and body of the space cap or the spacer (see Figures 7).

[0127] The various embodiments described herein before and represented in a non-limitative way in the attached figures, do all concern, despite showing alternative features or options between them, a system for the evaluation of organ perfusion alone or in combination with mechanical leak assessment.

[0128] This system advantageously includes : a pressurization module configured to increase pressure inside a target organ in a body cavity (mimic natural physiological conditions during postoperative recovery), or a pressurization module configured to controllably increase or decrease the internal pressure of a target organ, such as colon, and the pressure within the body cavity; a pressure sensing assembly that includes sensors configured to accurately measure internal pressure within the target organ, as well as preferably pressure within the surrounding body cavity, thereby enabling precise detection of pressure differentials indicative of potential anastomotic vulnerabilities; an optional fluorescent dye injection component positioned at or near the site of the anastomosis; and image capturing and processing means configured to capture, process and analyse images of the target organ during different phases of controlled pressurization of the target organ. The image processing means, which are part of a general control software unit, are configured to provide quantitative perfusion based matrices of the target anastomotic sites by comparing differences in image characteristics such as intensity, perfusion patterns, or other relevant optical characteristics, and correlating these changes directly or indirectly to the real-time internal organ pressure, and possibly to the differential pressure between the organ and the surrounding cavity. According to the invention, a general control software (GCS) unit is provided that integrates the intensity of blood perfusion captured by imaging, considering interactions between organ pressurization, dye injection parameters, camera-organ distance, and patient- specific factors. This unit coordinates the leak detection module and simultaneously regulates the organ and abdomen pressurization systems to systematically vary organ pressure in a controlled manner, thereby facilitating and generating robust comparative perfusion analysis and accurate assessment of tissue viability in the form of measurement indexes.

[0129] A space cap or spacer may be mounted at the tip of the camera which is part of the image capturing and means, in order to provide a fixed known distance between the camera lens and the organ tissue or an adjustable distance configured according to specific use cases or user preferences. For example, at least two predefined known distances (e.g., "far" and "close") may be set, and manual or digital adjustment capabilities controlled through a central coordination unit, with distance adjustments communicated digitally or via user inputs to the central unit for enhanced detection sensitivity, may be provided.

[0130] In some embodiments, no space cap is necessary, with the distance to the organ automatically estimated via imaging analysis, positional information (e.g., magnetic or optical tracking), or internal calibration from known distances within the cavity or markings on surgical instruments.

[0131] Of course, the invention is not limited to the embodiments described herein before and represented in the accompanying drawings. Modifications remain possible, particularly from the viewpoint of the composition of the various elements or by substitution of technical equivalents without thereby exceeding the field of protection of the invention.

Claims

CLAIMS1. System for performing organ tissue perfusion assessment and for detecting and / or assessing the risk for a possible post-operative organ leakage, said system comprising at least i) a pressurization module configured to increase pressure inside a target organ in a body cavity, ii) pressure sensor means configured to measure pressure in the target organ and possibly in the body cavity, iii) possibly a dye injection means to introduce dye to the organ though intravenous injection or other means, and iiii) image capturing and processing means comprising a processing unit configured to process captured images of the target organ at different phases or values of pressurization of the target organ, wherein the image processing unit is configured to provide a quantity of perfusion at the organ, possibly at an anastomotic or resection line or site of said organ, by comparing differences in image characteristics of the target organ and correlating them with sensed pressures of said organ, and possibly also with sensed pressure differentials between the target organ and the body cavity.

2. System according to claim 1, wherein the pressurization module includes an injection unit configured to inject a test gas from a gas container into the target organ.

3. System according to claim 2, wherein it comprises a detection module including a gas analyzing component able to perform a real time presence or concentration measurement of the test gas in the taget organ and / or in the cavity.

4. System according to anyone of claims 1 to 3, wherein it comprises a leak detection unit for determining mechanical integrity of the considered anastomotic or resection line, said leak detection system preferably comprising the pressurization module, pressure sensor means configured to measure pressure in the target organ and in the body cavity and means to control the pressure in the target organ and in the body cavity, as well as the pressure difference between the organ and the cavity.

5. System according to claim 4, wherein said leak detection unit comprises a detection module including a gas analyzing component able to preform a real time presence or concentration measurement of the test gas in the taget organ and / or in the cavity.

6. System according to anyone of claims 1 to 5, wherein it comprises a processing unit hosting a general control software (GCS) configured to communicate with and coordinate the functioning of : the injection unit and the pressure sensor means, which are preferably part of a leak detection unit, possibly the dye injection means, and the image capturing means, said general control software (GCS) unit receiving information / outputs from said means and units and being configured, by processing images of the organ or organ site, to compute and quantify changes in the perfusion quality or characteristics, based on differences in image characteristics of the target organ or organ site, in relation to changes of intraluminal pressure in the organ, and / or in the pressure differential between the organ and the cavity, said general control software (GCS) unit preferably communicating with the leak detection unit, an imaging unit of the image capturing means and possibly a dye injection unit by means of a microcontroller.

7. System according to claim 6, wherein it comprises a user interface, such as a touchscreen, and a remote and / or local data storage associated with said general control software (GCS) unit, which is configured to compute a likelihood of a medically relevant leak based on stored measurement data of previously collected clinical and preclinical data, for different organ pressurisation tests, information entered by a user, and / or gas measurement information.

8. System according to anyone of claims 1 to 7, wherein it comprises means to control and / or measure the distance, which can be fixed, adjustable or regulable, between a camera which is part of the image capturing and processing means and the surface of the considered organ or organ site.

9. System according to claim 8, wherein the means to control the distance between the camera and the surface of the considered organ or organ site comprise a spacer or space cap which is mounted or attached onto the camera, preferably onto the tip of the lens of said camera.

10. Bio-mechanical leak testing system, for performing a perfusion assessment and a gas-based leak test on an organ or organ site within a body cavity of a human or an animal, in order to determine the presence of a post-operative leak and the risk of a future potential postoperative leak, wherein said system comprises:- a leak detection unit, comprising a pressurization module configured to increase pressure at least inside the target organ, and a pressure sensor means configured to measure pressure in the target organ and in the body cavity, said unit being also configured to control and regulate the pressure differential between the inside of the organ and the inside of the body cavity,- an image capturing means comprising a camera unit and a imaging unit, possibly comprising image display means for the user,- a possible dye injection means, comprising a dye injection unit,- a central processing unit hosting and running a general control software (GCS) and comprising or being associated with a database and a local storage space,- a user interface for user input and user display, such as for example a touchscreen, controlled by and communicating with the central processing unit, wherein the general control software (GCS) unit is configured to communicate with and coordinate the functioning of : the leak detection unit, possibly the dye injection means, and the image capturing means, said general control software (GCS) unit receiving information / outputs from said means and unit and being configured, by processing images of the considered organ or organ site, to compute and quantify changes in the perfusion quality or characteristics, based on differences in image characteristics of the target organ or organ site, in relation to changes of intraluminal pressure in the organ, and / or in the pressure differential between the organ and the cavity, said general control software (GCS) unit preferably communicating with the leak detection unit, an imaging unit of the image capturing means and possibly a dye injection unit by means of a microcontroller.

11. Method for performing organ tissue perfusion assessment and for detecting and / or assessing the risk of a possible post-operative organ leakage, said method including at least the steps of: increasing pressure inside a target organ in a body cavity at a site of an anastomosis or resection, measuring pressure in the target organ and possibly in the body cavity, causing if necessary a dye to be present at the organ or an organ site, capturing and processing images of the target organ or organ site at different phases of pressurization of the target organ, and determining a quantity of perfusion at the anastomosis or resection site by comparing differences in image characteristics of images of the organ or organ site taken at differentpressure levels and correlating them with the sensed pressures of the target organ and possibly also with the sensed pressure differentials between the target organ and the body cavity.

12. Method according to claim 11, wherein the images of the target organ or organ site at different phases of pressurization of the target organ are processed and analyzed, possibly together with stored previous or pre- operative measurement data, in order to generate outputs on whether the quality of the perfusion changes according to the pressure in the organ, and whether such changes will likely to be associated with clinical relevant impact, in particular, whether a leak will likely to be developed post- operatively.

13. Method according to claim 11 or 12, wherein comprising dyeing the site of the organ, anastomotic or resection line with a fluorescent dye, before perfusion is determined.

14. Method according to claim 13, wherein said fluorescent dye is injected prior to pressurization of said target organ.

15. Method according to claim 13, wherein said fluorescent dye is injected while the organ, anastomotic or resection line is insufflated, a time duration to peak fluorescence intensity being then evaluated.

16. Method according to claim 13, wherein said fluorescent dye is injected while said target organ is being pressurized, followed by deflation.

17. Method according to anyone of claims 11 to 16, wherein perfusion of said target organ is determined before resection of said target organ.

18. Method according to anyone of claims 11 to 16, wherein perfusion of said target organ is determined during resection of said target organ.

19. Method according to anyone of claims 11 to 16, wherein perfusion of said target organ is determined after resection of said target organ.

20. Method according to anyone of claims 11 to 19, wherein the quantity of perfusion at said organ, anastomotic or resection line is determined by pressurizing said target organ at various pressures without full deflation.

21. Method according to anyone of claims 11 to 19, wherein the quantity of perfusion at said organ, anastomotic or resection line is determined by evaluating profusion intensity during dynamic variation ofintraluminal pressure, cavity pressure and / or pressure differential between organ and cavity.

22. Method according to anyone of claims 11 to 21, wherein a general control software (GCS) unit coordinates and communicates, in parallel, to a leak detection unit, gives instructions to control and regulate organ injection means to coordinate the pressurisation of the organ, and to control and regulate abdomen injection means to coordinate the pressure in the abdomen.

23. Method according to anyone of claims 11 to 22, wherein dynamic change of pressure is applied to the organ and possibly to the cavity, for example a linear or stepwise increase / decrease of pressure.

24. Method according to anyone of claims 11 to 23, wherein the images are taken by a camera, preferably an endoscopic or laparoscopic camera, and wherein the distance between the camera front lens and the surface of the organ or organ site is controlled, for example by means of a space cap, or a spacer, mounted on the front end of the camera, by means of an automatic estimation based on imaging analysis or positional information such as from magnetic or optical tracking or by means of an automatic estimation based on internal calibration.

25. Method according to anyone of claim 11 to 24, wherein the time series information of the same time period capturing the relationship between the perfusion quality of the organ, the organ pressure, as well as the differential pressure differences between the inside of the organ and the inside of the abdominal cavity in which the organ is located, are used to perform computing, for example in the form of perfusion indexes which represent the perfusion quality of the test period for the specific test sequence, to determine the post-operative perfusion quality and to determine whether a leak is likely to developp after the surgical procedure.

26. Method according to claim 25, wherein the measurement noise caused by the distance variation between the camera and the target measurement tissue of the target organ, for example quantified by means of a spacer or a space cap, is corrected to reveal the unbiased, by space or distance, perfusion index measurements.

27. Method according to claim 25 or 26, wherein the measurement noise caused by distance variation between the camera and the target measurement tissue, as quantified by the dye injection measurements, are corrected by taking into account the natural decay or weakening of thedye intensity over time, to reveal the unbiased perfusion index / signal measurements.

Images