Anastomotic leak detection

Abstract

There is provided, in one example aspect, a system comprising: an enclosure portion configured to be removably and at least partially placed within a body, and to permit entry into the enclosure portion of a gas indicative of an anastomotic leak for sensor detection.

Description

ANASTOMOTIC LEAK DETECTIONTECHNICAL FIELD

[0001] The present disclosure generally relates to anastomotic leak detection, more particularly to gastrointestinal anastomotic leak detection.BACKGROUND

[0002] Gastrointestinal surgery carries significant risks, with anastomotic leak being the deadliest complication. This occurs when a surgical join fails, leadingto bowel contents leaking into the abdomen, causing sepsis, multiorgan failure, and high mortality.Current diagnostic methods rely on non-specific signs that emerge days after surgery, resulting in critical delays. These delays exacerbate complications, patient deterioration, and death, highlighting an urgent need for earlier detection to enable timely intervention and patient rescue. While wearable devices for continuous postoperative monitoring exist, they suffer from poor accuracy, high false alarm rates, limited patient adherence, and data transmission issues.SUMMARY

[0003] It is an objective of the present disclosure to ameliorate or overcome at least one problem of existing arrangements, or to provide the public with a useful choice.

[0004] Disclosed in one aspect of the present disclosure is a system comprising: an enclosure portion configured to be removably and at least partially placed within a body, and to permit entry into the enclosure portion of a gas indicative of an anastomotic leak for sensor detection. Advantageously, the enclosure portion can be surgically placed within the body of a human or animal, with a segment exposed proximally to an anastomotic site of the body, to facilitate entry of the gas into the enclosure portion for sensor detection and to thereby provide an early indication of an anastomotic leak.

[0005] Optionally, the enclosure portion may be tubular in shape. A tubular shape facilitates insertion into and extraction from the body.

[0006] The enclosure portion may optionally be gas permeable.

[0007] The system may optionally further comprise: a temperature sensor associated with the enclosure portion and arranged to detect a temperature of the body. The temperature sensor may provide an indication of body inflammation indicative of the leak. Optionally, the temperature sensor may be arranged proximate to a distal segment of the enclosure portion. This further facilitates early provision of the temperature sensor indication.

[0008] Optionally, the system may further comprise: a gas sensor associated with the enclosure portion and arranged to detect the gas therein. The gas sensor may bearranged within the enclosure portion. The gas sensor may be configured to detect a concentration of a methane and hydrogen mixture. The gas sensor may be associated with the enclosure portion either directly or indirectly, as long as the gas sensor is able to detect the gas collected by the enclosure portion.

[0009] The system may optionally further comprise: a blocking portion configured to block escape of the gas from the enclosure portion. Depending on configuration and placement of the enclosure portion within the body, the gas collected by the enclosure portion may escape. The blocking portion may be provided to prevent or reduce such gas escape. The blocking portion may be associated with a proximal segment of the enclosure portion, which may be useful where the proximal segment is otherwise exposed to an external environment of the body.

[0010] Optionally, the system may further comprise: a housing portion associated with the enclosure portion and housing electronics of the system. Through housing the electronics instead in the associated housing portion, the enclosure portion can be implemented to occupy less space within the body, improving wearer comfort.

[0011] The housing portion may be configured to removably attach to the enclosure portion. This may facilitate reuse of the housing portion, reducing wastage. The housing portion may be configured to releasably seal the enclosure portion. Additionally, the housing portion may be provided with an adhesive. Also, the housing portion may be adapted to be arranged proximate to a wound opening of the body, which may reduce interference with wearer movements.

[0012] Optionally, the electronics may be configured to perform at least one of wireless communication and biometric measurement. The housing portion and the enclosure portion may optionally be discrete components. The housing portion may optionally be adapted to be arranged outside of the body, which may facilitate temporary removal by the wearerfor purposes such maintenance. The gas sensor may optionally be housed by the housing portion.

[0013] Optionally, the system may further comprise a flow control arrangement configured to control flow of the gas in the enclosure portion for sensor detection. The flow of the gas can be controlled to facilitate detection. For example, some gases accumulate at such low rates that they are not detectable if diffused and sampled continuously. For such gases, the flow may be controlled to allow the gas to accumulate to a detectable level before being flushed for sensor detection. This arrangement is also useful in scenarios of low-volume leaks.

[0014] The flow control arrangement may optionally comprise at least one of: a regulating means operable to regulate flow of the gas in the enclosure portion for sensor detection; and a driving means operable to drive flow of the gas in the enclosure portion for sensor detection. The flow control arrangement may optionally further comprise: aconduit means fluidly associated with the at least one of the regulating means and the driving means, and arranged to convey the gas in the enclosure portion for sensor detection.

[0015] Moreover, the conduit means may optionally further be arranged to convey the detected gas back to the enclosure portion, which helps to maintain the gas within the enclosure portion at a level favourable for detection. The conduit means may optionally comprise an inner conduit segment and an outer conduit segment fitted over the inner conduit segment, with one conduit segment conveying the gas from the enclosure portion for sensor detection and with the other conduit segment conveying the detected gas back to the enclosure portion. With the outer conduit segment fitter over the inner conduit segment, the conduit mean occupies less space than otherwise needed.

[0016] Disclosed in another aspect of the present disclosure is a method of using a system of the present disclosure, comprising exposing the enclosure portion to an anastomotic site within the body.

[0017] Optionally, the method may further comprise: fixing the enclosure portion using at least one of a suture means and an adhesive means. This step is useful in reducing the chance of inadvertent displacement or removal of the enclosure portion.

[0018] The method may optionally further comprise associating the housing portion with the enclosure portion. Additionally, the method may optionally further comprise arranging the distal segment of the enclosure portion proximate to the anastomotic site; and arranging the proximal segment of the enclosure portion proximate to a body entry point through which the enclosure portion is inserted into the body.

[0019] Disclosed in another aspect of the present disclosure is a housing portion adapted to be associated with an enclosure portion, and to house electronics in association with a gas sensor for detection of a gas within the enclosure portion and indicative of an anastomotic leak.BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the present disclosure and, together with the description, serve to explain principles of the disclosure. In the drawings:Figure 1 shows a cross-sectional view of a system of the present disclosure according to one example, taken lengthwise and showing an enclosure portion, a gas sensor, a temperature sensor, a housing portion, and a connector with associated wire for electrical communication;Figure 2 shows a housing portion of the system of Figure 1 in association with the enclosure portion, with the housing portion shown to house electronics of the system;Figure 3 shows the system of Figure 1 in association with a body;Figure 4 shows another system in association with a body, with this system further comprising a blocking portionFigure 5 shows a flowchart of a method of using the system of Figure 1 , according to one example of the present disclosure;Figure 6 shows a line chart of redox H2 measurements vs time;Figure 7 shows a housing portion of a system of another example of the present disclosure, showing partially a flow control arrangement; andFigure 8 shows a partial cross-sectional view of a conduit means of the flow control arrangement.DETAILED DESCRIPTION

[0021] Figure 1 shows in one aspect a system 100 of an example of the present disclosure. The system 100 includes an enclosure portion 110, a gas sensor 120, a temperature sensor 125, and a housing portion 130.

[0022] The enclosure portion 110 is configured to be removably and at least partially placed within a body, and to permit entry into the enclosure portion 110 of a gas indicative of an anastomotic leak for sensor detection. The enclosure portion 110 of this example is tubular in shape (e.g., a tubing catheter) and has a closed-ended distal segment 111 and a proximal segment 112 with an open end 113, and is gas permeable (e.g., being made of a gas permeable membrane such as silicone). With such a configuration, the enclosure portion 110 takes the form of a gas permeable tube suitable for extension through a wound opening of the body. The enclosure portion 110 is medical grade in material.

[0023] The gas sensor 120 is arranged within the enclosure portion 110 and proximate to the distal segment 111 of the enclosure portion 110, and is configured in this example to detect a concentration of a methane and hydrogen mixture indicative of a bowel leak. For instance, the concentration of hydrogen gas inside the colon is approximately 30,000 ppm, compared with 0.5 ppm in standard atmospheric levels, and the methane concentration inside the colon is 144,000 ppm, compared with 2 ppm in the atmosphere. The gas sensor may also be configured to detect hydrogen sulphide in some examples. The gas sensor may also be configured to detect a concentration of either one of methane and hydrogen in some examples.

[0024] The temperature sensor 125 is arranged proximate to the distal segment 111 of the enclosure portion 110.

[0025] In the example of Figure 1 , the sensors 120, 125 are fixed relative to the enclosure portion 110 by means of any standard adhesive suitable for the materials involved. That is, the enclosure portion 110 is configured with an internal surface at the distal segment 111 suitable for adhesive application. In an alternative arrangement, thesensors 120 and / or 125 may be partially or completely embedded within the material of the enclosure portion 110.

[0026] Referring to Figure 2, the housing portion 130 is associated with the enclosure portion 110 and houses electronics of the system 100. The electronics of this example are configured to perform wireless communication and biometric measurement, and include a wireless communication module 131 (e.g., LTE / 5G, WIFI or Bluetooth), a heart rate sensor 132 (e.g., electrocardiogram with hydrogel), an accelerometer 133, an impedance sensor 134, a respiratory rate sensor 135, and a controller (or processor) 136. The controller 136 is operatively associated with the components 131-135 via a communication bus, and with the components 120, 125 via a wire 141 and a connector 142. The controller 136 is operable to provide sensor data from the components 120, 125 and 132-135 through the wireless communication module 131 to a computing device for processing and storage. The housing portion 130 in this example further houses a battery for powering the components 120, 125 and 131-135. In other examples, the housing portion may comprise any electronics, depending on needs.

[0027] The housing portion 130 of this example is configured to removably attach to the proximal segment 112 of the enclosure portion 110, more particularly to releasably seal the open end 113 of the proximal segment 112. The housing portion 130 of this example is provided with a skin-safe adhesive for removable adhesion to a suitable skin surface, such as one proximate to the wound opening. With such a configuration, the housing portion 130 is adapted to be arranged outside of the body. The housing portion 130 is water resistant, comprises a breathable body made of polyurethane (or other similar materials in other examples), and is formed with at least one receiving space for receiving the electronics. The housing portion 130 depending on arrangements may be referred to as a cap portion. The enclosure portion 110 and the housing portion 130 are discrete components in this example, and may be integrally formed in other examples.

[0028] Figure 3 shows an example application scenario where the system 100 is associated with a human body 900, with the enclosure portion 110 removably and partially placed within (or into) the body 900 via a wound opening 915 thereof. The distal segment 111 of the enclosure portion 110 is arranged proximate to an anastomotic site 905 within the body 900 to facilitate detection by the gas sensor 120 and the temperature sensor 125. Specifically, with the close proximity, the gas sensor 120 can readily detect gas molecules 910 of the methane and hydrogen mixture emanating from the anastomotic site 905. Furthermore, with the close proximity, the temperature sensor 125 can quickly detect an unusual change in the body temperature at the anastomotic site 905 to provide an early indication of inflammation typically associated with a leak. In contrast, the unusual change in the body temperature is conventionally detectable at a skin surface of the body 900 only at a much later time.

[0029] The proximal segment 112 of the enclosure portion 110 is arranged outside of the body 900 in this example, and may be arranged within the body in other examples.

[0030] Figure 4 shows a system 200 of another example of the present disclosure. The system 200 includes an enclosure portion 210, a gas sensor 220, a temperature sensor 225 and a housing portion 230. The components 210, 225 are similar in configuration to those 110, 125 of the system 100. In this example, the housing portion 230 further houses the gas sensor 220 in fluid communication with the enclosure portion 210. Specifically, the housing portion 230 is formed with a sensor recess (not shown) configured for receiving and exposing the gas sensor 220 to the gas from the enclosure portion 210.

[0031] Additionally, the system 200 further includes a blocking portion 240 in the form of a sleeve associated with a proximal segment 212 of the enclosure portion 210 and configured to block escape of the gas from the enclosure portion 210. In particular, the blocking portion 240 is configured to be sleeved onto the proximal segment 212 and to extend along the enclosure portion 210 into the wound opening 915 of the body 900. In this example, the blocking portion 240 is made of a gas impermeable material such as Polytetrafluoroethylene, polyvinyl chloride, or Tygon®.

[0032] The blocking portion 240 serves to block (i.e., prevent or reduce) escape of the collected gas from the enclosure portion 210 via the proximal segment 212 thereof into an external environment of the body 900, such that the collected gas can reach the gas sensor 220 housed by the housing portion 230. With such a configuration, the collected gas diffuses within and along the enclosure portion 210 to reach the gas sensor 220 at the housing portion 230 without inadvertently escaping through the proximal segment 212 into the external environment. An area of overlap between the blocking portion 240 and the enclosure portion 210 may be adjusted to control an overall gas permeability of the enclosure portion 210. The blocking portion may also be extended to cover any intermediate segment of the enclosure portion in other examples.

[0033] Depending on configuration, the enclosure portion 210 and the blocking portion 240 may be regarded as inner and outer tubes, respectively.

[0034] It is worth noting that in arrangements where the enclosure portion is placed substantially within the body, the blocking portion may be omitted.

[0035] The gas sensor 120 and the temperature sensor 125 can advantageously improve safety. For example, a detected temperature below a certain threshold can indicate inadvertent removal of the enclosure portion 110 from the body 900. In comparison, high concentrations of hydrogen and / or methane gas, with or without raised intraabdominal temperatures may indicate the occurrence of an anastomotic leak, facilitating early diagnosis. In other words, detections of the body temperature and thegas concentration within respective abnormal ranges (or outside of respective normal ranges) provide an indication of abnormality.

[0036] Referring to Figure 5, disclosed in another aspect is an example method 500 of using the system 100 of Figure 1 , to be performed in association with a surgical procedure. In the case of a laparoscopic procedure, the method may be partially performed while still under direct laparoscopic vision, as described below.

[0037] In a first step 510, the enclosure portion 110 is exposed to an anastomotic site within the body of a patient. In particular, the sterile enclosure portion 110 is inserted through a small incision (e.g. 5 mm laparoscopic port site) into the abdomen (or any other suitable body part). Under laparoscopic vision, the enclosure portion 110 is placed partially or fully within the body, with the distal segment 111 adjacent (or proximate) and exposed to the completed bowel anastomotic site in the manner of a surgical drain for gas detection. In other arrangements, for example during an open surgery, the enclosure portion 110 may be inserted through any suitable incision. That is, this step includes arranging the distal segment 111 of the enclosure portion 110 proximate or adjacent to the anastomotic site, and arranging the proximal segment 112 of the enclosure portion 110 proximate or distal to a body entry point (e.g., abdomen) through which the enclosure portion 110 is inserted into the body. In other examples of different configurations, any suitable segment of the enclosure portion may instead be exposed to the anastomotic site in a similar manner.

[0038] In a second step 520, the surgical procedure is finalised. That is, the abdomen is deflated to return to a normal state. All other wounds are closed, whether in laparoscopic or open surgery, and dressings placed. In the case of a laparoscopic operation, the laparoscopic camera is also removed.

[0039] In a third step 530, the enclosure portion 110 is securely fixed to a skin area at a point of entry into the abdomen (typically a laparoscopic port site), e.g. using a silk suture, in the common manner of fixing a surgical drain. Othertechniques such as adhesive means may also be used in conjunction or in place of a silk suture. In other words, this step includes fixing, using any suitable techniques, the proximal segment 112 of the enclosure portion 110 with respect to the body entry point through which the enclosure structure 110 is inserted into the body.

[0040] In a fourth step 540, the housing portion 130 is associated with the enclosure portion 110. Specifically, the housing portion 130 is connected to the enclosure portion 110, more particularly to the proximal segment 112, with the electronics of the housing portion 130 forming wired communication with the sensors 120, 125 at the distal segment 111 of the enclosure portion 110. This step may further include powering on the electronics if not already powered on, as well as opening the housing portion 130 (sterilely clean or otherwise) into the sterile field.

[0041] In a fifth step 550, the housing portion 130 is secured with respect to the body. For example, additional adhesives can be used to secure the housing portion 130 to the abdomen to avoid the housing portion 130 from being accidentally pulled on or removed while changing clothes.

[0042] The method of using the system 100 is similarly applicable to the system 200. The blocking portion 240 may be pre-bonded to or otherwise integrally formed with the enclosure portion 210. Alternatively, the blocking portion 240 may be sleeved over and extended along the enclosure portion 210 at any suitable time duringthe performance of the method. In the fourth step for the system 200, however, the electronics do not have any wired connection to any gas sensor in the enclosure portion 210. For arrangements with a temperature sensor in the enclosure portion, the system may still have a wired connection connecting the electronics to the temperature sensor.

[0043] The system 100, 200 may be worn by a patient in any suitable manner (e.g., under the clothes) for any suitable period (e.g., ranging from 3 days to 7 days). They may be implemented to be resistant to water exposure typical of a shower or rain.

[0044] A gas detection (e.g., H2, CH4or H2S) by the system 100, 200 may be configured to trigger an alarm at the system 100, 200 or otherwise. A cloud-based system may also be configured to register the gas detection (either sudden or progressive) by the system 100, 200 for clinician review or alert.

[0045] The systems 100, 200 is advantageous in several ways. Leak diagnosis can be aided by real-time / continuous or intermittent measurement of supporting vital signs (heart rate, intra-abdominal temperature, respiratory rate, etc.) by the systems 100, 200. An abnormality in the measurement may indicate the onset of systemic inflammatory response syndromes or local changes that increase suspicion of a leak. If a detected gas has a concentration exceeding a safe threshold, medical imaging scans may be ordered and remedial actions may be taken, such as any one or more of formation of defunctioning ileostomy upstream of the anastomosis, take-down of the anastomosis with redo of the anastomosis, or exteriorisation of the bowel ends.

[0046] Put another way, the systems 100, 200 advantageously facilitate early detection of anastomotic leak, which helps reduce subsequent harm and clinical deterioration resulting from an unrecognised complication or delayed recognition. Furthermore, systems 100, 200 may reduce or eliminate the need for routine prophylactic defunctioning ileostomy formation, and may thereby significantly improve patient safety and wellbeing while reducingthe chances of complications, needs for surgeries, and treatment costs.

[0047] Referring to the line chart 600 of Figure 6, the system 200 is shown in a demonstration using an animal model to facilitate anastomotic leak detection within one hour of leak occurrence. The line chart 600 shows results of time versus redox H2 inthe form of a line comprising a region of baseline recordings 610 and a region of creation of anastomotic leak 620. The system 100, 200 is synergetic, enabling rapid diagnosis of leakthrough multimodal sensing capabilities, as explained above. The housing portion 130, 230 can be designed for ambulatory and home use, and can be implemented using adhesive, flexible, breathable, water-resistant materials. Furthermore, the electronics of the housing portion 130, 230 may be recovered and reused to reduce wastage.

[0048] Additionally, with the system 100, the temperature sensor 125 being intra- abdominally arranged together with the gas sensor 120 in the enclosure portion 110 adjacent to the anastomotic site advantageously provides multimodal data. This provides synergistic data to the local (intra-abdominal) measures to inform the diagnosis of a ‘systemic inflammatory response syndrome’.

[0049] Shown in Figures 7 and 8 is a system 300 of another example of the present disclosure. The system 300 includes a gas sensor 320, an associated controller 321 , an associated battery 322, and a housing portion 330 housing the components 320, 321 , 322 as well as other electronics (not shown). The system 300 further includes a flow control arrangement 350 configured to control flow of the gas for sensor detection by the gas sensor 320, and including a regulating means 352, a driving means 354 and a conduit means 356.

[0050] The regulating means 352 is operable to regulate flow of the gas in the enclosure portion 310 for sensor detection by the gas sensor 320. The regulating means 352 of this example includes a one-way entry valve 3522 and a one-way exit valve 3524.

[0051] The driving means 354 is operable to drive flow of the gas in the enclosure portion 310 for sensor detection by the gas sensor 320. The driving means 354 of this example takes the form a pump 354 implemented within the gas sensor 320.

[0052] The conduit means 356 is fluidly associated with the regulating means 352 and the driving means 354, and is arranged to convey the gas in the enclosure portion 310 for sensor detection by the gas sensor 320. Further referring to Figure 8, the conduit means 356 in this example includes an inner conduit segment 3562 and an outer conduit segment 3564 fitted over the inner conduit segment 3562. The outer conduit segment 3564 serves the gas entry and collection function of an enclosure portion in this example.

[0053] The outer conduit segment 3564 is configured to serve the function of an enclosure portion. The outer conduit segment 3564 has a gas permeable distal end in this example, and may be otherwise configured to permit gas entry in other examples.

[0054] The conduit means 356 further includes intermediate conduit segments 3566, 3568, 3570, 3572. The intermediate conduit segment 3566 fluidly communicates an exit port 3564b of the outer conduit segment 3564 to an entry port of the entry valve 3522.The intermediate conduit segment 3568 fluidly communicates an exit port of the entry valve 3522 to an entry port of the pump 354 at the gas sensor 320. The intermediate conduit segment 3570 fluidly communicates an exit port of the pump 354 to an entry port of the exit valve 3524. The intermediate conduit segment 3572 fluidly communicates an exit port of the exit valve 3524 to an entry port 3562a of the inner conduit segment 3562. The inner conduit segment 3562 fluidly communicates at an open distal exit port 3562b thereof with an entry distal end 3564a of the outer conduit segment 3564.

[0055] In this example, the controller 321 is configured to control operations of the valves 3522, 3524 and the pump 354 to cause intermittent circulation of the gas for detection by the gas sensor 320. Specifically, in a first control state, the controller 321 controls the valves 3522, 3524 to permit gas flow therethrough and activates the pump 354 to drive the gas flow through the conduit means 356; and in a second control state, the controller 321 controls the valves 3522, 3524 to block gas flow therethrough and deactivate the pump 354 to stop the gas flow through the conduit means 356. Through alternating between the control states in a predetermined matter (e.g., at predetermined times), the controller 321 can cause intermittent circulation of the gas for detection by the gas sensor 320.

[0056] With such an operation, collected gas molecules are intermittently driven from the entry distal end 3564a via the exit port 3564b of the outer conduit segment 3564 through the intermediate conduit segment 3566 via the entry valve 3522 through the intermediate conduit segment 3568 for detection by the gas sensor 320. Detected gas modules (i.e., those sampled by the gas sensor 320) are intermittently driven from the gas sensor 320 via the intermediate conduit segment 3570 through the exit valve 3524 via the intermediate conduit segment 3572 through the entry port 3562a via the distal exit port 3562b of the inner conduit segment 3562 back into the entry distal end 3564a of the outer conduit segment 3564. That is, the conduit means 356 is further arranged to convey the detected gas back to the outer conduit segment 3564, which serves the gas entry and collection function of an enclosure portion in this example.

[0057] In practice, depending on sensor sensitivity, the gas sensor may not be able to detect the gas if the gas accumulation rate is too low, and the accumulated gas is continuously sampled and consumed duringthe sensing process. With the system 300, the flow control arrangement 350 is controllable to allow the gas to accumulate intermittently within the outer conduit segment 3564 to a detectable level prior to sampling by the gas sensor 320. Moreover, the sampled gas is discharged back into the outer conduit segment 3564 via a return path formed by the components 3570, 3524, 3572, 3562 to facilitate a next sampling operation, which can advantageously shorten the duration of accumulation to facilitate relatively frequent sampling operations.

[0058] In other arrangements, the conduit means may be arranged instead to discharge the sampled gas from the system into an external environment of the system. That is, in such arrangements, the gas is not circulated. For instance, in place of a return path provided by components such as those 3570, 3524, 3572, 3562 of the system 300, the conduit means may include a discharge conduit segment for dischargingthe gas from the system once fed through and sampled by the gas sensor.

[0059] In other examples with a system similar to the system 200, the gas sensor housed by the housing portion may be provided with a return path (e.g., a return conduit segment) to return the sampled gas to the enclosure portion to facilitate a next sampling operation. Such a system may be regarded as a modification of the system 200, modified with an additional return path.

[0060] In other arrangements, the conduit segments may not be fitted or sleeved over each other. They may instead be placed next to each other, provided that they fluidly communicate with each other in a manner similar to that of system 300.

[0061] In addition to those described above, additional alternative arrangements are provided below.

[0062] The system may be configured for use with any animals other than humans. For example, the enclosure portion may be adapted to anatomically match an animal. That is, the techniques and systems disclosed herein may be applicable to any animals, in addition to humans.

[0063] In some arrangements, the gas sensor may be arranged within the enclosure portion toward the proximal segment to meet a different need. In practice, the gas sensor may be arranged anywhere along the enclosure portion to facilitate gas detection. In some arrangements, the gas sensor may even be housed by the housing portion, and the housing portion may be arranged to communicate fluidly with the enclosure portion. In some arrangements, the gas sensor may be configured to detect different gases.

[0064] In some arrangements, the electronics may be associated instead with the enclosure portion. For example, the electronics may be placed and fixed proximate within the enclosure portion proximate to the proximal end. Where the housing portion does not house any electronics, the enclosure portion may be provided with a cap in place of the housing portion. Furthermore, the electronics may be configured to locally process sensor data, and the processed sensor data may be wirelessly transmitted.

[0065] In some arrangements, the wireless communication capability of the electronics may include, in addition to or in place of that of the system 100, 200, any suitable protocol such as WiFi or Bluetooth. Alternatively, in some arrangements, the electronicsof the housing portion may be self-sufficient, i.e., providing sufficient storage and computation capabilities.

[0066] In some arrangements, the enclosure portion may assume any suitable shape, tubular or otherwise. Where the enclosure portion is non-tubular in shape, the blocking portion may assume any corresponding shape provided that the blocking portion serves to prevent or reduce unintended exit or escape of the collected gas between the gas sensor and the exposed portion of the enclosure portion. Additionally, the enclosure portion may comprise a non-membrane mechanism configured to permit gas entry into the body. For example, a valve mechanism may be implemented with the enclosure portion or the housing portion to permit controlled intermittent gas entry.

[0067] Furthermore, in some arrangements, the enclosure portion may instead be implemented with a closed-ended proximal segment, provided that the gas collected by the enclosure portion can reach the gas sensor. Where the gas sensor is housed by the housing portion, the gas sensor can be exposed to the collected gas via a conduit extending from the enclosure portion through the proximal segment to the housing portion.

[0068] In some arrangements, the enclosure portion is or can be sealed on its own (i.e., no proximal opening). In such a case, the housing portion does not close any opening of the enclosure portion.

[0069] In some arrangements, the housing portion may be associated with the wound opening by any suitable means. Moreover, the housing portion may be arranged partially or wholly inside of the body. The housing portion may be provided with an adhesive suitable for adhesion to a non-skin surface, e.g., a clothing surface. Further, the housing portion may be configured to be detached from and reattached to the enclosure portion before and after shower.

[0070] In some arrangements, the housing portion may be otherwise associated with the wound opening. For example, the housing portion may also be designed to be carried on any suitable body part (e.g., the hip) for convenience. For example, the housing portion may be provided with a releasable fastening mechanism adapted for fastening to a pocket, or a strap for carrying.

[0071] In some arrangements, the housing portion may not be arranged proximate to the wound opening. For example, the housing portion may be arranged a few inches away from the wound opening while remaining connected to the enclosure portion.

[0072] In some arrangements, the temperature sensor may be arranged anywhere in the enclosure portion.

[0073] In some arrangements, the biometric measurement capability may include heart rate, heart rate variability, respiratory rate, impedance, and any combination thereof. Any other biometric sensors may also be employed by the system.

[0074] In some arrangements, the enclosure portion may have no proximal opening. Further, the enclosure portion may house the electronics otherwise housed in the housing portion.

[0075] In some arrangements, the enclosure portion and the housing portion may be integrally formed.

[0076] In some arrangements, the gas sensor may instead be arranged outside of and in fluid communication with the enclosure portion. For example, the gas sensor may be housed by the housing portion. In such a scenario, the detection of a gas in or within the enclosure portion means the detection of a gas entering and subsequently exiting the enclosure portion.

[0077] The housing portion and the enclosure portion may be configured to be removably fastened with each other by any suitable means. For example, the enclosure portion may be removably plugged into a corresponding port formed in the housing portion. For example, the enclosure portion may be removably adhered to the housing portion byway of adhesives.

[0078] In some arrangements, the enclosure portion may comprise multiple lumens to allow for active or passive circulation of gas through one or more channels past the gas sensor. In some arrangements, gas flow may occur passively via diffusion or be facilitated by active means.

[0079] In some arrangements, an additional lumen may be incorporated into the enclosure portion to allow for continuous or intermittent sampling or drainage of peritoneal fluid. Specific sensors for the monitoring of peritoneal fluid biomarkers (for example pH, amylase, or impedance) may also be incorporated into the housing portion in this instance.

[0080] In some embodiments, the device may be introduced percutaneously with or without radiological guidance, rather than intra operatively at the time of surgery.

[0081] In some arrangements, the blocking portion may take the form of an extension of the enclosure portion arranged at the proximal side to fluidly connect the enclosure portion to the housing portion. In some other arrangements, the distal segment of the enclosure portion may be configured to be gas impermeable.

[0082] In some arrangements, the proximal segment of the enclosure portion may be exposed to the external environment of the body, with the gas sensor housed in fluid communication with the enclosure portion by the housing portion. In such a configuration without the effect of the blocking portion, the collected gas can stillsufficiently reach the gas sensor at the housing portion via the proximal segment for gas detection.

[0083] In some arrangements, the enclosure portion may be provided with a first engaging part and the housing portion with a second engaging part for engagement with the first engaging part.

Claims

CLAIMS1 . A system comprising: an enclosure portion configured to be removably and at least partially placed within a body, and to permit entry into the enclosure portion of a gas indicative of an anastomotic leak for sensor detection.

2. The system of claim 1 , wherein the enclosure portion is tubular in shape.

3. The system of claim 1 or 2. wherein the enclosure portion is gas permeable.

4. The system of any one of the preceding claims, further comprising: a temperature sensor associated with the enclosure portion and arranged to detect a temperature of the body.

5. The system of claim 4, wherein the temperature sensor is arranged proximate to a distal segment of the enclosure portion.

6. The system of any one of the preceding claims, further comprising: a gas sensor associated with the enclosure portion and arranged to detect the gas therein.

7. The system of claim 6, wherein the gas sensor is arranged within the enclosure portion.

8. The system of claim 6 or 7, wherein the gas sensor is configured to detect a concentration of a methane and hydrogen mixture.

9. The system of any one of the preceding claims, further comprising: a blocking portion configured to block escape of the gas from the enclosure portion.

10. The system of claim 9, wherein the blocking portion is associated with a proximal segment of the enclosure portion.11 . The system of any one of the preceding claims, further comprising: a housing portion associated with the enclosure portion and housing electronics of the system.

12. The system of claim 11 , wherein the housing portion is configured to removably attach to the enclosure portion.

13. The system of claim 11 or 12, wherein the housing portion is configured to releasably seal the enclosure portion.

14. The system of any one of claims 11 to 13, wherein the housing portion is provided with an adhesive.

15. The system of any one of claims 11 to 14, wherein the housing portion is adapted to be arranged proximate to a wound opening of the body.

16. The system of any one of claims 11 to 15, wherein the electronics are configured to perform at least one of wireless communication and biometric measurement.

17. The system of any one of claims 11 to 16, wherein the housing portion and the enclosure portion are discrete components.

18. The system of any one of claims 11 to 17, wherein the housing portion is adapted to be arranged outside of the body.

19. The system of any one of claims 11 to 18 when not dependent on claim 7, wherein the gas sensor is housed by the housing portion.

20. The system of any one of the preceding claims, further comprising: a flow control arrangement configured to control flow of the gas in the enclosure portion for sensor detection.21 . The system of claim 20, wherein the flow control arrangement comprises at least one of: a regulating means operable to regulate flow of the gas in the enclosure portion for sensor detection; and a driving means operable to drive flow of the gas in the enclosure portion for sensor detection.

22. The system of claim 21 , wherein the flow control arrangement further comprises: a conduit means fluidly associated with the at least one of the regulating means and the driving means, and arranged to convey the gas in the enclosure portion for sensor detection.

23. The system of claim 22, wherein the conduit means is further arranged to convey the detected gas back to the enclosure portion.

24. The system of claim 23, wherein the conduit means comprises an inner conduit segment and an outer conduit segment fitted over the inner conduit segment, with one conduit segment conveying the gas from the enclosure portion for sensor detection and with the other conduit segment conveying the detected gas back to the enclosure portion.

25. A method of using a system of any one of claims 1 to 24, the method comprising: exposing the enclosure portion to an anastomotic site within the body.

26. The method of claim 25, further comprising: fixing the enclosure portion using at least one of a suture means and an adhesive means.

27. The method of claim 25 or 26 when dependent on any one of claims 11 to 19, further comprising: associating the housing portion with the enclosure portion.

28. The method of any one of claims 25 to 27 when dependent on claims 5 and 10, further comprising: arranging the distal segment of the enclosure portion proximate to the anastomotic site; and arranging the proximal segment of the enclosure portion proximate to a body entry point through which the enclosure portion is inserted into the body.

29. A housing portion adapted to be associated with an enclosure portion, and to house electronics in association with a gas sensor for detection of a gas within the enclosure portion and indicative of an anastomotic leak.

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