WO2021038442A1

WO2021038442A1 - Systems and methods for measuring intra-abdominal cavity pressure

Info

Publication number: WO2021038442A1
Application number: PCT/IB2020/057939
Authority: WO
Inventors: Justin Alexander Long; Christopher Brian Locke
Original assignee: Kci Licensing, Inc.
Priority date: 2019-08-26
Filing date: 2020-08-25
Publication date: 2021-03-04

Abstract

A pressure sensing system for a cavity of a patient can include a tubular member, a pressure sensor, a wound dressing, and a controller. The tubular member can include an inner volume configured to fluidly couple the cavity with an environment outside the cavity. The pressure sensor can be fluidly coupled with the tubular member and configured to measure pressure within the cavity. The wound dressing can be configured to seal the tubular member with exterior skin. The controller can be configured to receive the measured pressure from the pressure sensor, monitor the measured pressure over time, and notify a caregiver regarding the measured pressure.

Description

SYSTEMS AND METHODS FOR MEASURING INTRA- ABDOMINAL CAVITY

PRESSURE

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of priority to U.S. Provisional Application No. 62/891,759, filed on August 26, 2019, which is incorporated herein by reference in its entirety.

BACKGROUND

[0002] The present disclosure relates generally to a pressure sensing system. More particularly, the present disclosure relates to measuring intra-abdominal cavity pressure. Some systems indirectly monitor intra-abdominal cavity pressure by measuring pressure in a patient’s bladder. However, these systems do not measure the intra-abdominal cavity pressure directly and therefore may be inaccurate.

SUMMARY

[0003] One implementation of the present disclosure is a pressure sensing system for a cavity of a patient. The system can includes a tubular member, a pressure sensor, a wound dressing, and a controller. The tubular member can include an inner volume configured to fluidly couple the cavity with an environment outside the cavity. The pressure sensor can be fluidly coupled with the tubular member and configured to measure pressure within the cavity. The wound dressing can be configured to seal the tubular member with exterior skin. The controller can be configured to receive the measured pressure from the pressure sensor, monitor the measured pressure over time, and notify a caregiver regarding the measured pressure.

[0004] Another implementation of the present disclosure is a pressure sensing assembly for a cavity of a patient. The assembly can include a tubular member, a pressure sensor, and a wound dressing. The tubular member may have an inner volume configured to fluidly couple the cavity with an environment outside the cavity. The pressure sensor can be fluidly coupled with the tubular member and can be configured to measure pressure within the cavity. The wound dressing can be configured to seal the tubular member with exterior skin.

[0005] Another implementation of the present disclosure is a method for measuring and monitoring intra-abdominal pressure of an abdominal cavity. The method can include providing a tubular member configured to fluidly couple the abdominal cavity with an environment outside of the abdominal cavity. The method can include providing a pressure sensor configured to fluidly couple with the abdominal cavity and the environment outside of the abdominal cavity through the tubular member. The method can include measuring pressure of the abdominal cavity with the pressure sensor. The method can include comparing the pressure of the abdominal cavity to a threshold value, and notifying a caregiver in response to the pressure of the abdominal cavity exceeding the threshold value.

[0006] Another implementation of the present disclosure is a system for sensing pressure in a cavity of a patient, according to some embodiments. The system can include a conduit, a pressure sensor, a dressing, and a controller. The conduit may include a proximal end and a distal end. The proximal end can be in fluid communication with atmosphere. The distal end can be in fluid communication with the cavity. The pressure sensor can be in fluid communication with the distal end of the conduit. The dressing can be adhered to skin of the patient and is configured to seal the conduit with the exterior skin. The controller is operatively coupled to the pressure sensor.

[0007] Another implementation of the present disclosure is a system for sensing pressure in a cavity of a patient, according to some embodiments. The system can include ab ladder, a conduit, a pressure sensor, a dressing, and a controller. The bladder may be positioned within the cavity. The conduit may include a proximal end and a distal end. The proximal end may be in fluid communication with atmosphere. The distal end may be in fluid communication with the bladder.

The pressure sensor can be in fluid communication with the distal end of the conduit. The dressing can be adhered to skin of the patient and may seal the conduit with the exterior skin. The controller can be operatively coupled to the pressure sensor.

[0008] Another implementation of the present disclosure is a method for measuring pressure in a cavity of a patient, according to some embodiments. The method can include making an incision in a patient’s skin at a bodily cavity and providing an apparatus. The apparatus can include a conduit, a pressure sensor, a dressing, and a controller. The conduit may include a proximal end and a distal end. The proximal end can be in fluid communication with atmosphere. The pressure sensor can be in fluid communication with the distal end of the conduit. The dressing can be adhered to skin of the patient, and may seal the conduit with the exterior skin. The controller can be operatively coupled with the pressure sensor. The method can further include inserting the distal end of the conduit of the apparatus into the incision and the bodily cavity to fluidly couple the distal end with the bodily cavity. The method can further include measuring a pressure at the distal end of the conduit with the pressure sensor.

[0009] Those skilled in the art will appreciate that the summary is illustrative only and is not intended to be in any way limiting. Other aspects, inventive features, and advantages of the devices and/or processes described herein, as defined solely by the claims, will become apparent in the detailed description set forth herein and taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIG. 1 is a diagram of an intra-abdominal pressure sensing system that is topically applied at an area of interest, according to some embodiments.

[0011] FIG. 2 is a diagram of the intra-abdominal pressure sensing system of FIG. 1, according to some embodiments.

[0012] FIG. 3 is a diagram of the intra-abdominal pressure sensing system of FIG. 1 that is positioned within a patient’s abdominal cavity, according to some embodiments.

[0013] FIG. 4 is a diagram of the intra-abdominal pressure sensing system of FIG. 1 with a bladder probe inserted in a patient’s abdominal cavity, according to some embodiments.

[0014] FIG. 5 is a diagram of the intra-abdominal pressure sensing system of FIG. 4, according to some embodiments.

[0015] FIG. 6 is a block diagram of a controller configured to read and monitor the sensor information of an intra-abdominal pressure sensing system, according to some embodiments.

[0016] FIG. 7 is a graph of intra-abdominal pressure over time, according to some embodiments.

[0017] FIG. 8 is a flow diagram of a process for installing an intra-abdominal pressure sensing system and monitoring recorded intra-abdominal pressure, according to some embodiments.

[0018] FIG. 9 is a flow diagram of a process for measuring intra-abdominal pressure, according to some embodiments.

DETAILED DESCRIPTION

Overview

[0019] Referring generally to the FIGURES, systems and methods for directly and indirectly measuring intra-abdominal pressure (IAP) of a patient are shown, according to various embodiments. Monitoring the pressure within a patient’s cavity is important since the IAP can be used to identify the patient’s risk to intra-abdominal hypertension (IAH), and abdominal compartment syndrome (ACS). IAH and ACS are most likely to occur in the setting of a major fluid resuscitation, severe gut edema, intra-peritoneal or retroperitoneal bleeding, or ascites.

[0020] It can be particularly desirable to monitor/measure IAP for trauma patients, bum patients, septic shock patients, and post abdominal surgery patients. IAH and ACS can reduce venous blood return and cardiac output and alter respiratory mechanics. This can result in organ dysfunction, renal failure, impaired hepatic blood flow, respiratory failure, poor splanchic perfusion, and increased intracranial pressure. Early recognition and treatment of IAH and ACS has been shown to significantly aid in patient health and facilitate reducing morbidity and mortality of the patient.

[0021] Some systems and methods for measuring IAP are extremely invasive, and therefore some systems indirectly measure IAP by measuring the pressure in the patient’s bladder (e.g., with a urinary catheter). IAP can be expressed in units of millimeters of mercury (mmHg). However, changes in intra-vesical pressure do not always coincide with current status or dynamic nature of IAP changes.

[0022] The systems and methods described herein provide a minimally invasive way to directly measure IAP, according to some embodiments. Advantageously, directly measuring IAP and monitoring IAP in real-time can reduce the health complications that may arise due to excessively high IAP.

[0023] Advantageously, the systems and methods described herein provide direct measurements of intra-abdominal pressure that is more accurate than other systems that draw inferences of intra abdominal pressure based on bladder pressure measured through indwelling urinary catheters. Additionally, the systems and methods described herein provide a sterile barrier over the abdominal cavity during pressure measurement. Other systems that use urinary indwelling catheters for prolonged use have a high rate of infection and complication. The systems and methods described herein provide a direct measurement system for the intra-abdominal pressure and thereby lower the risk of infection and complication. Additionally, the systems for measuring intra-abdominal pressure described herein may be compatible with minimally invasive/laparoscopic surgical approaches that are sometimes used to treat tears and hernias within the abdominal cavity.

Pressure Monitoring System

[0024] Referring particularly to FIGS. 1-5, an intra-abdominal cavity pressure system 10 is shown to include a pressure sensing assembly 12 and a controller 100. In some embodiments, pressure sensing assembly 12 is configured to measure or monitor pressure within a cavity 16 (e.g., an abdominal cavity) of a patient 14. Pressure sensing assembly 12 can be configured to provide controller 100 with real-time and/or periodic measurements of IAP (i.e., p_IA) of patient 14. Controller 100 can use any of the received IAP measurements from pressure sensing assembly 12 and report or notify a clinician or a medical professional regarding changes or status of the IAP. In some embodiments, controller 100 is configured to wirelessly communicably connect with pressure sensing assembly 12. For example, pressure sensing assembly 12 and controller 100 can be configured to communicate with each other via near field communication (NFC). Controller 100 can provide any of the measured IAP values to a remote device, a personal computer device (e.g., a smartphone, a tablet, a computer, etc.), a remote or cloud hosted server, or a base station of a medical facility. Controller 100 can notify a caregiver when to intervene based on the received IAP measurements of cavity 16. [0025] A medical professional, doctor, or clinician can be notified regarding undesired changes in the patient’s IAP by controller 100. For example, controller 100 can be configured to provide the notification to any of the cloud server, the base station, the mobile device, etc., in response to detecting that the IAP of patient 14 exceeds a maximum allowable threshold value.

Topical Pressure Sensor

[0026] Referring particularly to FIGS. 1 and 2, system 10 includes a topically applied pressure sensing assembly 12, according to some embodiments. Pressure sensing assembly 12 includes a pressure sensor 22, and a dressing 20. Dressing 20 can be configured to adhere and seal with the patient’s skin 18. In some embodiments, dressing 20 includes an adhesive along substantially an entire surface that is configured to adhere dressing 20 to the patient’s skin 18. Dressing 20 can include a plastic, rubber, or flexible film or layer that substantially covers and fluidly seals external or topically applied components of pressure sensing assembly 12 therewithin.

[0027] In some embodiments, dressing 20 includes a top layer of breathable high moisture vapor transmission rate (MVTR) polymeric film. The polymeric film can be made from a polyurethane material or a polyethylene material. The top layer can be coated with an adhesive layer to maintain adhesion and to create a sterile barrier of an area of interest. In some embodiments, dressing 20 is configured to cover circumferentially around an entire region of interest (e.g., the abdomen).

Dressing 20 can include catheter dressing, a foam, etc., that is adhered to and seals with the patient’s skin 18. The foam or catheter dressing can be disposed between the top layer or dressing 20 and the patient’s skin 18.

[0028] Pressure sensing assembly 12 can be applied topically over the patient’s abdomen, or over any other cavity of interest (e.g., a chest cavity). Pressure sensing assembly 12 can be fluidly coupled with the cavity of interest through a probe, a tubular member, tubing, multilumen tubing, conduit, a pipe, a needle, a trocar, etc., shown as probe 24. In some embodiments, probe 24 includes an inner volume that extends therethrough. Probe 24 can be inserted into an incision, a hole, etc., shown as incision 26 in the patient’s abdomen. Incision 26 extends from an outer surface of the patient’s skin 18 into cavity 16 to fluidly couple cavity 16 with an exterior environment (e.g., the atmosphere). In some embodiments, probe 24 is inserted into incision 26 such that probe 24 establishes a fluid connection between cavity 16 and the outer environment. In some embodiments, probe 24 is fluidly coupled with a valve 28. Valve 28 can transition between an open configuration and a closed configuration. In the open configuration, a fluid flow passage is formed between cavity 16 and the environment. In the closed configuration, the fluid flow passage between cavity 16 and the environment is restricted. [0029] Probe 24 may include a first or proximate end 42 and a second or distal end 40 that is opposite proximate end 42. Distal end 40 can be configured to be inserted into cavity 16 through incision 26. Probe 24 can fluidly couple with cavity 16 through distal end 40 and may fluidly couple with atmosphere through proximate end 42.

[0030] Probe 24 can include a flange, a shoulder, an interfacing portion, a skin engagement portion, a step, etc., shown as flange 36. Flange 36 is configured to engage, abut, directly contact, etc., an exterior surface of the patient’s skin 18. Flange 36 may be positioned near distal end 40 (e.g., an insertable end) of probe 24. Flange 36 may be positioned a distance away from distal end 40 of probe 24 to facilitate a proper insertion depth of distal end 40 of probe 24 into cavity 16. Advantageously, flange 36 can contact the exterior surface of the patient’s skin 18 to ensure that probe 24 is not inserted too far into cavity 16 (e.g., to facilitate preventing the insertable end of probe 24 from making unwanted contact with internal organs).

[0031] Distal end 40 can extend a distance 38 into cavity 16. Distance 38 can be any distance between 20 and 40 millimeters. Flange 36 may be positioned or integrally formed with probe 24 (e.g., protruding radially outwards from probe 24) to facilitate insertion of distal end 40 distance 38 into cavity 16. In other embodiments, flange 36 is positioned such that distal end 40 extends into cavity 16 a negligible distance (e.g., such that distal end 40 is adjacent an interior surface 44 of cavity 16). Advantageously, inserting probe 24 a distance 38 into cavity 16 can facilitate reducing the likelihood that probe 24 contacts internal organs.

[0032] Probe 24 can include a foam end portion, a soft closed cell foam portion, etc., shown as foam portion 46 at distal end 40. Foam portion 46 may be configured to prevent tissue from exiting cavity 16 through probe 24. Probe 24 can also include a load sensor, a force sensor, a strain gage, etc., shown as load sensor 48 at distal end 46. Load sensor 48 can be integrated at distal end 46 of probe 24 (e.g., within a sidewall of probe 24, within foam portion 46, etc.). Load sensor 48 may detect if probe 24 deforms or contacts any internal organs. Load sensor 48 can be communicably coupled with controller 100 such that controller 100 can monitor sensor measurements of load sensor 48.

[0033] Incision 26 can be a 1 cm incision (e.g., 1 cm in diameter) that extends through the patient’s skin 18. Incision 26 can be made by a medical professional with a scalpel. Incision 26 can be sealed with probe 24 (e.g., a trocar) similar to how incisions and trocars are sealed for robotic or laparoscopic surgery systems.

[0034] Pressure sensing assembly 12 includes a pressure sensor 22, according to some embodiments. Pressure sensor 22 can be configured to measure pressure in cavity 16. Pressure sensor 22 may measure gauge pressure or absolute pressure of cavity 16. When valve 28 is in the open configuration, pressure sensor 22 can measure gauge pressure of cavity 16. The gauge pressure of cavity 16 can be referred to as VIA, gauge- When valve 28 is in the closed configuration, pressure sensor 22 can measure absolute pressure of cavity 16. The absolute pressure of cavity 16 can be referred to as p_IA a_bs·

[0035] Pressure sensor 22 can be fluidly coupled with probe 24 such that pressure sensor 22 measures the pressure within cavity 16. In some embodiments, pressure sensor 22 is a sterilizable pressure sensor. In some embodiments, pressure sensor 22 is or includes a TE 1620 pressure sensor.

In other embodiments, pressure sensor 22 is or includes a Merit Sensor BP series pressure sensor. In other embodiments, pressure sensor 22 is or includes an Amphenol NPC-120 pressure sensor.

[0036] Pressure sensor 22 can be positioned outside of dressing 20. For example, pressure sensor 22 can be positioned on top of dressing 20. In other embodiments, pressure sensor 22 is positioned within dressing 20. For example, pressure sensor 22 can be positioned beneath an adhesive seal of dressing 20. Pressure sensor 22 can be fluidly coupled along the fluid flow passage formed by probe 24 between cavity 16 and the environment. Pressure sensor 22 can be fluidly sealed with probe 24.

[0037] Pressure sensor 22 can be configured to provide controller 100 with any of the measured gauge pressure or the measured absolute pressure of cavity 16. In some embodiments, pressure sensor 22 includes a separate valve configured to transition between an open configuration and a closed configuration. The fluid passageway between cavity 16 and the environment or surroundings can be sealed (e.g., the valve is transitioned into the closed configuration) so that pressure sensor 22 measures absolute pressure of cavity 16. Fikewise, the fluid passageway between cavity 16 and the environment can be formed or defined by transitioning the valve into the open configuration so that pressure sensor 22 measures gauge pressure of cavity 16. In this way, pressure sensor 22 can be configured to measure gauge pressure or absolute pressure of cavity 16.

[0038] In some embodiments, valve 28 and/or the valve of pressure sensor 22 are configured to be operated by an actuator (e.g., an electric solenoid, an electric linear actuator, an electric rotary actuator, etc.). Controller 100 may be configured to operate the actuator to transition valve 28 and/or the valve of pressure sensor 22 between the open configuration and the closed configuration. In this way, controller 100 can transition pressure sensor 22 between the gauge mode (where pressure sensor 22 measures gauge pressure of cavity 16) and the absolute mode (where pressure sensor 22 measures absolute pressure of cavity 16).

[0039] In some embodiments, pressure sensing assembly 12 includes a vent. The vent can be configured to transition between an opened configuration and a closed configuration to relieve pressure within cavity 16. The vent can include a valve and an actuator (e.g., an electrically actuated actuator). The vent can be operated to transition between the opened configuration and the closed configuration by controller 100 or manually. When the vent is opened, a fluid flow passage between cavity 16 and the environment is formed such that the pressure inside of cavity 16 may decrease over time. The vent can be the fluid flow passage defined by probe 24 between cavity 16 and the environment. In other embodiments, the vent is fluidly coupled with cavity 16 through probe 24 but branches off upstream or downstream of pressure sensor 22. An additional incision may be provided through the patient’s skin 18 and a probe or tubing similar to probe 24 is fluidly coupled with cavity 16 and the environment as the vent. The vent can then be opened to relieve pressure within cavity 16, thereby relieving or reducing the pressure applied to the patient’s internal organs. The vent can include a valve similar to valve 28 that can be transitioned between the opened and closed configuration by controller 100 or manually (e.g., with a lever, a snap button, etc.). A sterile filter can be fluidly coupled with the vent (e.g., in-line with the vent) so that the pressure within cavity 16 can be released or relieved but still maintain sterility. In some embodiments, the vent is actuated by a solenoid valve that is operated by controller 100.

[0040] Referring particularly to FIG. 2, system 10 can include electro-active polymer (EAP) sensors or strain gauges, shown as strain sensors 30. Strain sensors 30 are configured to measure deformation in length along the patient’s skin 18. As cavity 16 increases or decreases in pressure, the volume of cavity 16 may also increase or decrease, respectively. As cavity 16 increases or decreases in volume, the patient’s skin 18 may deform. For example, as p_IA increases, the volume V_cavity of cavity 16 increases, and strain sensors 30 can measure deformation (e.g., increases or decreases) that indicate the change in the volume V_cavity. In this way, the pressure within cavity 16 can be related to the deformation measured by strain sensors 30. Strain sensors 30 can be attached to the patient’s skin 18 at the area of interest (e.g., above cavity 16) at two points with a very strong adhesive. Strain sensors 30 can be configured to measure expansion or contraction of exterior girth of the abdomen or the area of interest. Strain sensors 30 may measure expansions and contractions in arc radius of the area of interest (or of cavity 16). Strain sensors 30 can have a length of 30 to 60 millimeters.

[0041] Strain sensors 30 can be topically applied to the patient’s skin and positioned within dressing 20. In other embodiments, strain sensors 30 are topically applied to the patient’s skin 18 outside of dressing 20. Multiple strain sensors 30 can be used to measure and track the deformation of the patient’s skin 18. Multiple strain sensors 30 can be positioned along various axes on the patient’s skin 18 to measure deformation in multiple directions. Strain sensors 30 can provide any of the measured deformation (e.g., increase or decrease in measured length) to controller 100. Controller 100 can use the measured deformations received from strain sensors 30 to indirectly determine the pressure p_IA within cavity 16. Controller 100 can also use the measured deformations received from strain sensors 30 to check or verify the pressure readings measured by pressure sensing assembly 12. Controller 100 can be configured to wiredly or wirelessly communicate with strain sensors 30.

Intra-Abdominal Pressure Sensor

[0042] Referring particularly to FIG. 3, pressure sensing assembly 12 and/or pressure sensor 22 can be positioned within cavity 16. Pressure sensing assembly 12 and/or pressure sensor 22 can be inserted into cavity 16 through an incision in the patient’s skin 18. Pressure sensing assembly 12 and/or pressure sensor 22 can be communicably coupled with controller 100 to provide any measured pressure to controller 100. It should be understood that while the embodiment shown in FIG. 3 includes pressure sensing assembly 12 positioned within cavity 16, pressure sensor 22 may be positioned within cavity 16 without dressing 20. Pressure sensing assembly 12 and/or pressure sensor 22 can be positioned within cavity 16 at an end of probe 24. Probe 24 can extend some distance into cavity 16 to position pressure sensing assembly 12 and/or pressure sensor 22 therewithin.

[0043] The embodiment shown in FIG. 3 can be used in combination with strain sensors 30 as described in greater detail above with reference to FIG. 2. For example, pressure sensing assembly 12 and/or pressure sensor 22 can be positioned within cavity 16 with strain sensors 30 topically applied to the patient’s skin 18. Controller 100 can receive deformation or strain measurements from strain sensors 30 in addition to pressure readings of cavity 16 from pressure sensing assembly 12 and/or pressure sensor 22.

[0044] In some embodiments, pressure sensor 22 is positioned at an end of probe 24 within cavity 16, and dressing 20 is sealed at the patient’s skin 18. If pressure sensor 22 is positioned within cavity 16, a vent hole at the top of pressure sensor 22 can allow pressure sensor 22 to operate in gauge mode and may be fluidly coupled with the environment (e.g., ambient pressure) through a length of tubing appropriate for probing at various depths within cavity 16.

Intra- Abdominal Pressure Sensor with Bladder

[0045] Referring particularly to FIGS. 4 and 5, pressure sensing assembly 12 can include a collapsible, ball-shaped bladder probe 32 that is fluidly coupled and sealed with pressure sensor 22 through probe 24 or a length of tubing that is appropriate for probing at various depths within cavity 16. Bladder probe 32 can be positioned within cavity 16 at an end of probe 24. Bladder probe 32 or any components that are configured to be positioned within cavity 16 (e.g., probe 24) can be manufactured from a material that is radio-opaque so that they can be located by an X-Ray. Bladder probe 32 can be positioned at distal end 40 of probe 24. Bladder probe 32 may extend a distance 38 into cavity 16. Distance 38 can be any distance between 20 and 40mm. In other embodiments, distance 38 is less than 20 mm such that bladder probe 32 is adjacent or proximate interior surface 44 of cavity 16. [0046] Bladder probe 32 can include an inner volume, an inner chamber, a space, etc. The inner volume of bladder probe 32 can include a liquid or a gas, such as air, carbon dioxide, etc., or a sterile saline solution. Pressure sensor 22 is fluidly coupled with the inner volume of bladder probe 32 and is configured to measure the pressure p_bai within bladder probe 32. Pressure sensor 22 can be vented as described in greater detail above to measure gauge pressure of the inner volume of bladder probe 32.

[0047] As the pressure p_IA within cavity 16 increases or decreases, bladder probe 32 increases or decreases in volume (e.g., collapses), thereby increasing the pressure measured by pressure sensor 22. In this way, pressure sensor 22 can indirectly measure the pressure p_IA within cavity 16 by measuring the pressure of bladder probe 32.

Measurement and Reporting System

[0048] Referring now to FIG. 6, system 10 is shown in greater detail, according to some embodiments. Controller 100 can be configured to receive pressure measurements from pressure sensor 22 and deformation measurements from strain sensors 30. The deformation measurements received from strain sensors 30 can be measurements of any stretches or changes in arc length/radius of the patient’s abdomen. Controller 100 can use the deformation measurements as data for a secondary correlation of pressure changes within cavity 16. Controller 100 can receive and track the pressure measured by pressure sensor 22 over time and notify a caregiver if patient 14 requires attention (e.g., if the pressure within cavity 16 exceeds beyond a certain threshold).

[0049] Referring still to FIG. 6, controller 100 is shown to include a communications interface 108. Communications interface 108 may facilitate communications between controller 100 and other applications, devices, components, etc. (e.g., pressure sensor 22, strain sensors 30, display screen 116, mobile device 118, base station 120, cloud server 122, etc.) for allowing receiving and sending data. Communications interface 108 may also facilitate communications between controller 100 and a personal computer device such as a tablet, a smartphone, a laptop computer, etc.

[0050] Communications interface 108 can be or include wired or wireless communications interfaces (e.g., jacks, antennas, transmitters, receivers, transceivers, wire terminals, etc.) for conducting data communications with pressure sensor 22 or other external systems or devices. In various embodiments, communications via communications interface 108 can be direct (e.g., local wired or wireless communications) or via a communications network (e.g., a WAN, the Internet, a cellular network, Bluetooth, etc.). For example, communications interface 108 can include an Ethernet card and port for sending and receiving data via an Ethernet-based communications link or network. In another example, communications interface 108 can include a Wi-Fi transceiver, a Bluetooth transceiver, a LoRa transceiver, a Li-Fi transceiver, a Zigbee Transceiver, etc., for communicating via a wireless communications network. In another example, communications interface 108 can include cellular or mobile phone communications transceivers. In one embodiment, communications interface 108 is a power line communications interface. In other embodiments, communications interface 108 is an Ethernet interface.

[0051] Still referring to FIG. 6, controller 100 is shown to include a processing circuit 102 including a processor 104 and memory 106. Processing circuit 102 can be communicably connected to communications interface 108 such that processing circuit 102 and the various components thereof can send and receive data via communications interface 108. Processor 104 can be implemented as a general purpose processor, an application specific integrated circuit (ASIC), one or more field programmable gate arrays (FPGAs), a group of processing components, or other suitable electronic processing components.

[0052] Memory 106 (e.g., memory, memory unit, storage device, etc.) can include one or more devices (e.g., RAM, ROM, Flash memory, hard disk storage, etc.) for storing data and/or computer code for completing or facilitating the various processes, layers and modules described in the present application. Memory 106 can be or include volatile memory or non-volatile memory. Memory 106 can include database components, object code components, script components, or any other type of information structure for supporting the various activities and information structures described in the present application. According to some embodiments, memory 106 is communicably connected to processor 104 via processing circuit 102 and includes computer code for executing (e.g., by processing circuit 102 and/or processor 104) one or more processes described herein.

[0053] In some embodiments, the functionality of controller 100 is implemented within a single computer (e.g., one server, one housing, one computer, etc.). In various other embodiments the functionality of controller 100 can be distributed across multiple servers or computers (e.g., that can exist in distributed locations).

[0054] Referring still to FIG. 6, memory 106 includes a cavity pressure manager 110, according to some embodiments. Cavity pressure manager 110 is configured to receive pressure measurements from pressure sensor 22. The pressure measurements received from pressure sensor 22 can be any of Pi A or Pbai-

[0055] Cavity pressure manager 110 can monitor, record, and track the pressure measurements of cavity 16 (e.g., IAP)s over time. In some embodiments, cavity pressure manager 110 compares currently received pressure measurements received from pressure sensor 22 to a threshold pressure value Pthreshoid- The threshold pressure value p threshold can be a maximum allowable pressure of cavity 16. Cavity pressure manager 110 can compare the currently received pressure measurements received from pressure sensor 22 to the maximum allowable pressure of cavity 16. If the currently received pressure measurements received from pressure sensor 22 exceed the maximum allowable pressure, cavity pressure manager 110 can notify reporting manager 114 that the pressure within cavity 16 has exceeded the maximum allowable pressure.

[0056] In some embodiments, cavity pressure manager 110 collects and stores the pressure measurements received from pressure sensor 22. Cavity pressure manager 110 can store time series data of the pressure measurements received from pressure sensor 22. Cavity pressure manager 110 can store the received pressure measurements in tabular form, graph form, etc. Cavity pressure manager 110 can also generate reports and provide the reports to reporting manager 114. The reports can include previously recorded pressure measurements, a graph of pressure measurements of cavity 16 over time, rate of increase of the pressure in cavity 16, rate of decrease of the pressure in cavity 16, alerts, alarms, notifications, etc. In this way, a clinician or a medical professional can examine the reports and determine if the pressure within cavity 16 is increasing over time or decreasing over time or if the pressure of cavity 16 indicate that patient 14 requires medical attention. In some embodiments, cavity pressure manager 110 is configured to perform a regression (e.g., a linear regression) to determine a rate of change of the pressure of cavity 16 (e.g., to determine that the pressure within cavity 16 is increasing). Cavity pressure manager 110 can provide reporting manager 114 with any of the notifications regarding current pressure conditions in cavity 16, the reports, the rate of change of pressure within cavity 16, etc.

[0057] In some embodiments, cavity pressure manager 110 compares the pressure in cavity 16 (as received from pressure sensors 22) to one or more threshold values to identify if patient 14 requires medical attention. For example, cavity pressure manager 110 can compare the pressure in cavity 16 to a first threshold value Vthreshoid.i (e.g·, 10 mmHg), and a second threshold value p_threshoid,2 (e.g·, 20 mmHg). If the pressure within cavity 16 exceeds the first threshold value Vthreshoid.i, cavity pressure manager 110 may determine that the pressure within cavity 16 indicates abdominal hypertension. Likewise, if the pressure within cavity 16 exceeds the second threshold value Vthreshoid, 2, cavity pressure manager 110 can determine that the pressure within cavity 16 indicates abdominal compartment syndrome. Cavity pressure manager 110 can provide reporting manager 114 with any of the indications of the conditions of the patient’s abdomen (e.g., possible abdominal hypertension, possible abdominal compartment syndrome, etc.) as well as values of the pressure within cavity 16.

[0058] Cavity pressure manager 110 can also determine the pressure p_IA within cavity 16 based on the pressure within bladder probe 32. For example, pressure sensor 22 can be configured to record, measure, monitor, etc., the pressure p_bai within bladder probe 32 and provide the p_bai to controller 100. Cavity pressure manager 110 can receive the pressure p_bai within bladder probe 32 and use a predefined function, relationship, equation, set of equations, curve fit equation, empirical relationship, graph, etc., to determine the pressure p_IA within cavity 16 based on p_bai-

[0059] For example, cavity pressure manager 110 can use a function:

PlA = f(Pbal ) to determine the pressure p_IA within cavity 16 based on the pressure p_bai within bladder probe 32, where / is a function that relates p_bai to p_IA- The function / can be determined using empirical results, established relationships between the volume of bladder probe 32 and the pressure of bladder probe 32 (e.g., the ideal gas law if bladder probe 32 is filled with an ideal or inert gas), relationships between the pressure p_IA within cavity 16 and the volume of bladder probe 32, etc.

[0060] Cavity pressure manager 110 can determine p_IA based on p_bal and proceed to use p_IA to monitor the pressure within cavity 16. In some embodiments, cavity pressure manager 110 monitors the pressure p_bai within bladder probe 32 directly. Since there is a relationship between the pressure Pi_A and p_bai, cavity pressure manager 110 can monitor the pressure p_bai within bladder probe 32 directly to monitor conditions within cavity 16. In some embodiments, cavity pressure manager 110 compares the pressure p_bai to associated threshold values to monitor pressure conditions within cavity 16. For example, cavity pressure manager 110 can identify abdominal hypertension and/or abdominal compartment syndrome based on the pressure p_bai of bladder probe 32.

[0061] Referring still to FIG. 6, memory 106 includes a strain manager 112, according to some embodiments. Strain manager 112 is configured to monitor the deformation measurements of the patient’s abdomen or skin 18 received from strain sensors 30. Strain manager 112 can use a predefined relationship, function, equation, set of equations, etc., to determine an approximation of the pressure p_IA within cavity 16 based on the deformation measurements received from strain sensors 30. For example, strain manager 112 can receive one or more deformation measurements Al from strain sensors 30. Strain manager 112 may determine the approximation of pressure p_IA within cavity 16 using a relationship:

where f deform is a relationship that relates Al to PiA.appr , and PiA.appr is an approximation of the pressure p_IA within cavity 16.

[0062] Strain manager 112 can also use a function, relationship, equation, set of equations, etc., to determine an expected deformation of the patient’s skin 18 based on the pressure p_IA of cavity 16. For example, strain manager 112 can use the relationship: Al expected ^~ fpress(PlA ) where Al_expected is an expected amount of deformation or stretch of the patient’s skin 18 based on the pressure p_IA within cavity 16, and f_press is a function that relates p_IA to Al _ex_pected

[0063] Strain manager 112 and cavity pressure manager 110 can communicate with each other to verify pressure measurements received from pressure sensor 22. For example, cavity pressure manager 110 can provide strain manager 112 with the pressure p_IA as measured by pressure sensor 22. Strain manager 112 can use the deformation measurements Al and/or the approximate pressure PiA.appr within cavity 16 to check or verify that the pressure measurements p_IA within cavity 16 are realistic. Strain manager 112 and/or cavity pressure manager 110 can compare the measured pressure p_IA to the approximate pressure Pi_{A CLpp}r °f cavity 16 to verify that the measured pressure p_IA of cavity 16 is realistic.

[0064] For example, if the pressure p_IA increases, it is expected that the deformation measurements received from strain sensors 30 will also increase some expected amount. If the deformation measurements received from strain sensors 30 does not increase, or does not increase the expected amount, cavity pressure manager 110 and/or strain manager 112 may determine that the pressure measured by pressure sensor 22 may be inaccurate (e.g., that pressure sensor 22 is malfunctioning). Strain manager 112 and cavity pressure manager 110 can cooperatively function to verify the pressure p_IA as measured by pressure sensor 22 and can provide reporting manager 114 with verification results.

[0065] In some embodiments, cavity pressure manager 110 provides strain manager 112 with the measured pressure p_IA of pressure sensor 22. Strain manager 112 can use the measured pressure p_IA to determine the expected amount of deformation or stretch Al of the patient’s skin 18. Strain manager 112 can then compare the expected amount of deformation or stretch Al to the deformation measurements received from strain sensors 30 to verify or check that the pressure measured by pressure sensor 22 is accurate.

[0066] Strain manager 112 can also record, track, monitor, etc., any of the deformation measurements received from strain sensors 30. In some embodiments, strain manager 112 is configured to generate reports or to track the deformation measurements received from strain sensors 30 over time. Strain manager 112 can construct time series data and provide any of the time series data and the reports to reporting manager 114.

[0067] Referring still to FIG. 6, memory 106 is shown to include probe load manager 126. Probe load manager 126 may receive probe loads from load sensor 48 at the distal end of probe 24. Probe load manager 126 can be configured to monitor the probe load to determine if probe 24 has contacted internal organs. For example, probe load manager 126 can receive the probe load from load sensor 48 and compare the probe load to a corresponding threshold value. If the load at probe 24 exceeds the threshold value (e.g., thereby indicating that probe 24 has deformed or contacted something), probe load manager 126 may provide a load alert or a notification to reporting manager 114. Reporting manager 114 can notify a caregiver that a load has occurred at probe 24. For example, reporting manager 114 can operate or provide a notification using display screen 116, mobile device 118, base station 120, and/or cloud server 122.S

[0068] Reporting manager 114 is configured to receive any of the measured pressure p_IA, the approximate pressure Pi_A.appr , the deformation Al. the expected deformation Al_expected. reports, notifications, time series data, graphs, tabular information, trends, etc., from cavity pressure manager 110 and/or strain manager 112. Reporting manager 114 can be communicably coupled with one or more external devices. For example, reporting manager 114 can be communicably coupled with a display screen 116, a mobile device 118, a base station 120, a cloud server 122, etc. Reporting manager 114 can provide any of the calculated, determined, received, sensor, etc., information of controller 100 to any of display screen 116, mobile device 118, base station 120, and cloud server 122.

[0069] Reporting manager 114 can track the pressure p_IA within cavity 16 over time and provide reports, notifications, alerts, alarms, messages, etc., to display screen 116, mobile device 118, base station 120, and cloud server 122. For example, reporting manager 114 can operate display screen 116 to display real-time notifications or values of pressure p_IA . Reporting manager 114 can periodically record pressure p_IA of cavity 16 and operate display screen 116 to show the recorded pressure p_IA. Display screen 116 can be any LCD, LED, etc., screen configured to provide visual and/or aural alerts or information.

[0070] Reporting manager 114 can also be configured to provide mobile device 118 with notifications regarding changing conditions in cavity 16. For example, reporting manager 114 can provide mobile device 118 with real-time pressure information (e.g., real time values of p_IA) and/or notifications if the pressure p_IA in cavity 16 exceeds one or more predefined threshold values or if patient 14 requires medical attention. Reporting manager 114 can provide mobile device 118 with any of the sensor information of pressure sensor 22, strain sensors 30, reports, trends of the pressure Pi_A within cavity 16, etc. Reporting manager 114 can notify mobile device 118 when the pressure of cavity 16 indicates abdominal hypertension and/or abdominal compartment syndrome. Reporting manager 114 can also notify mobile device 118 if the pressure within cavity 16 begins to increase at a rapid rate. Mobile device 118 can be a caregiver’s mobile device (e.g., a nurse’s smartphone) so that the caregiver can be notified of current, historical, or changing conditions (e.g., pressure) of cavity 16.

[0071] Reporting manager 114 can also provide real-time information or periodic information to base station 120. Base station 120 can be a monitoring device, a main computer, a server, a system, etc., of a medical facility where the patient is located. In some embodiments, a caregiver can remotely monitor the pressure of cavity 16 at base station 120 and can be notified of changing or excessively high pressures in cavity 16.

[0072] Reporting manager 114 can also provide cloud server 122 with periodic or real-time information regarding cavity 16. For example, reporting manager 114 can provide reports, values of p_IA, values of the deformation on the patient’s skin 18, etc., to cloud server 122. Controller 100 can wirelessly and/or wiredly provide cloud server 122 with any of the received sensor measurements. In some embodiments, cloud server 122 is configured to perform any of the functionality of controller 100 to identify changes or current values of the pressure p_IA that indicate that the patient requires attention or will require attention in the near future (e.g., to determine if abdominal hypertension conditions are present or likely to occur). Cloud server 122 can be a medical facility database or server and can notify caregivers if patient 14 requires medical attention based on the received pressure p_IA of cavity 16.

[0073] Referring still to FIG. 6, controller 100 includes a control signal generator 124, according to some embodiments. Control signal generator 124 can be configured to generate control signals for a venting valve 34 to vent cavity 16 to ambient, thereby relieving pressure buildup within cavity 16. Venting valve 34 can be valve 28, or any other valve that is positioned along a fluid path between cavity 16 and the environment. Control signal generator 124 can receive an indication from reporting manager 114 that the pressure p_IA within cavity 16 exceeds a maximum allowable threshold value. Control signal generator 124 can operate venting valve 34 to relieve the pressure within cavity 16 in response to the pressure p_IA exceeding the maximum allowable threshold value. Advantageously, control signal generator 124 can operate venting valve 34 to facilitate relieving pressure buildup in cavity 16. In other embodiments, reporting manager 114 provides any of the communicably connected devices with a notification that venting valve 34 should be opened to relieve pressure within cavity 16. A caregiver may receive the notification from controller 100 and manually open venting valve 34 to relieve pressure within cavity 16. Control signal generator 124 can also operate valve 28 and/or pressure sensor 22 to transition between the open and the closed configuration to transition pressure sensor 22 between the gauge and the absolute mode, respectively.

[0074] Reporting manager 114 can also transmit any of the sensor information to a negative pressure wound therapy (NPWT) unit for the purpose of controlling and regulating the pressure within cavity 16. The NPWT unit can operate to reduce the pressure within cavity 16 down to or equalized to a pressure of 0 mmHg based on the sensor information received from controller 100.

[0075] Controller 100 can be wirelessly communicably coupled with any of display screen 116, mobile device 118, base station 120, and cloud server 122 through communications interface 108. Controller 100 can be configured to communicate with mobile device 118, base station 120, cloud server 122, etc., through wireless cellular communications, Bluetooth communications, near field communications (NFC), two or one-way radio frequency identification (RFID), etc.

[0076] Controller 100 can also be configured to wirelessly communicate with pressure sensor 22 and/or strain sensors 30. In some embodiments, controller 100 communicates with pressure sensor 22 and/or strain sensors 30 through wireless cellular communications, Bluetooth communications, NFC, two or one-way RFID, etc. Controller 100 can periodically interrogate the pressure p_IA within cavity 16 on a set time interval in real time and can track the longitudinal change in pressure p_IA over time.

[0077] For example, controller 100 can be configured to communicate with pressure sensor 22 and/or strain sensors 30 using NFC. Controller 100 can include any inductors, resistors, etc., for providing wireless power to pressure sensor 22 and/or strain sensors 30. Controller 100 can be a mobile unit that can wirelessly transfer power to pressure sensor 22 and/or strain sensors 30. When controller 100 is placed within range of pressure sensor 22 and/or strain sensors 30, controller 100 may operate to provide wireless power to pressure sensor and/or strain sensors 30. Pressure sensor 22 and/or strain sensors 30 can use the wirelessly transmitted power to record measurements (e.g., pressure and deformation/strain measurements) and provide controller 100 with the recorded measurements or data. Controller 100 can wirelessly receive the recorded measurements or data from pressure sensor 22 and/or strain sensors 30. In some embodiments, any of the functionality of controller 100 can be performed by a mobile computing device (e.g., a smartphone, a tablet, etc.) that is configured to communicate with pressure sensor 22 and/or strain sensors 30 using NFC. In some embodiments, pressure sensor 22 and/or strain sensors 30 receive wireless power from controller 100 via the NFC connection, and respond with current values of pressure and deformation.

[0078] The period of time over which pressure sensing assembly 12 is applied and controller 100 records and monitors pressure p_IA within cavity 16 can be relatively short or minimal and provides real, direct, and accurate automated logging and recordation of the pressure p_IA of cavity 16. Advantageously, system 10 is more accurate than other systems or methods (e.g., systems that indirectly measure the pressure of cavity 16 through a urinary catheter).

[0079] When pressure sensing of cavity 16 is no longer required, pressure sensing assembly 12 can be removed and incision 26 can be closed. Incision 26 can then be covered with a standard dressing. If patient 14 requires open abdomen surgery, pressure sensing assembly 12 can be removed at this time.

Sample Graph

[0080] Referring particularly to FIG. 7, a graph 700 that controller 100 can generate based on collected pressure p_IA information is shown, according to some embodiments. In some embodiments, controller 100 is configured to collect values of the pressure p_IA over time and generate graph 700 based on the collected values. Graph 700 includes scatter data 704. Scatter data 704 indicates corresponding pressure p_IA of cavity 16 (e.g., IAP), and the time at which the each scatter data point was recorded by controller 100. In some embodiments, controller 100 is configured to use scatter data 704 to generate a trendline 702. Trendline 702 can indicate rate of change of the pressure p_IA of cavity 16. For example, controller 100 can use trendline 702 to determine if the pressure p_IA of cavity 16 is increasing or decreasing. Controller 100 can use trendline 702 to determine a slope 706 of trendline 702. Controller 100 can provide slope 706 to any of the communicably coupled devices (e.g., mobile device 118, base station 120, cloud server 122, etc.). Controller 100 can re-generate trendline 702 and re-calculate slope 706 as new pressure values of cavity 16 are recorded. Controller 100 can also generate a graph similar to graph 700 for the deformation values recorded by strain sensors 30. Controller 100 can use trendline 702 to predict when the pressure p_IA within cavity 16 will exceed a predetermined threshold value (e.g., 10 mmHg). In this way, controller 100 can notify a caregiver regarding the rate of change of pressure p_IA within cavity 16 and can notify the caregiver if patient 14 requires medical attention (e.g., if the pressure within cavity 16 is increasing rapidly or faster than a predetermined threshold value).

Process

[0081] Referring particularly to FIG. 8, a process 800 for installing a pressure sensing system and monitoring IAP of a patient’s cavity is shown. Process 800 includes steps for installing pressure sensing assembly 12, monitoring and tracking longitudinal changes in the pressure p_IA (e.g., IAP) and notifying a caregiver regarding changes in the pressure p_IA of the patient’s cavity (e.g., the patient’s abdomen). Process 800 can be used to directly measure pressure within the patient’s cavity and to track changes in the patient’s IAP.

[0082] Process 800 includes providing an incision at an area of interest that fluidly couples ambient (e.g., surroundings) with a patient’s cavity (step 802), according to some embodiments. Step 802 can be performed by a medical professional. The incision can be a 1 cm diameter incision that extends into the cavity of interest.

[0083] Process 800 includes fluidly coupling a probe and a pressure sensor with the patient’s cavity through the incision (step 804), according to some embodiments. Step 802 can be performed by a medical professional to fluidly couple pressure sensor 22 with the cavity of interest (e.g., cavity 16). This enables pressure sensor 22 to measure the pressure p_IA within cavity 16.

[0084] Process 800 includes providing a dressing over any external components of the probe and the pressure sensor (step 806), according to some embodiments. The dressing can be dressing 20.

The dressing (e.g., dressing 20) can be an absorbent, anti-microbial dressing to reduce risks of infection at the incision (e.g., incision 26). Step 806 can be performed by a medical professional. It should be understood that the dressing can be placed over the pressure sensor after the pressure sensor is installed, or can be placed over the incision and the probe with the pressure sensor being installed on top of the dressing.

[0085] Process 800 includes providing strain sensors at the area of interest (step 808), according to some embodiments. The strain sensors can be strain sensors 30 and can be topically applied to the patient’s skin at the area of interest. The strain sensors can be strain gauges and/or EAP sensors. Step 808 can be performed by the medical professional.

[0086] Process 800 includes tracking pressure values recorded by the pressure sensor and strain values recorded by the strain sensors over time (step 810), according to some embodiments.

Controller 100 can be configured to communicably couple with the pressure sensor and the strain sensors to receive the pressure values and the strain values. Step 810 can be performed by controller 100. Step 810 can include generating reports, comparing the pressure values recorded by the pressure sensor to threshold values, generating alerts, etc.

[0087] Process 800 includes providing a notification to a caregiver regarding changes in pressure values or changes in strain values (step 812), according to some embodiments. The notification can be a message, a visual indication, an aural alert, etc. Step 812 can be performed in response to determining that the pressure within the cavity of interest exceeds a predetermined threshold value or that a rate of change of the pressure within the cavity exceeds a predetermined threshold value. Step 812 can include providing the notification (or an alert) to the caregiver through display screen 116, mobile device 118, base station 120, cloud server 122, etc. Step 812 can be performed by controller 100 and any of display screen 116, mobile device 118, base station 120, and cloud server 122.

[0088] Referring particularly to FIG. 9, a process 900 for measuring intra-abdominal pressure or for measuring pressure within a bodily cavity is shown, according to some embodiments. Process 900 include steps 902-912 and can be performed by a caregiver and/or controller 100.

[0089] Process 900 includes making an incision in a patient’s skin at a bodily cavity (step 902), according to some embodiments. The incision can be made by the caregiver, a surgeon, etc., using any appropriate and sterile cutting tool. The incision may be incision 26. The incision can extend through the patient’s skin at the bodily cavity to fluidly couple the bodily cavity with atmosphere.

[0090] Process 900 includes providing a pressure sensing assembly to measure pressure within the bodily cavity (step 904), according to some embodiments. The pressure sensing assembly can be pressure sensing assembly 12 and may include any of the components thereof for measuring pressure within the bodily cavity.

[0091] Process 900 includes inserting a distal end of a conduit of the pressure sensing assembly into the bodily cavity through the incision produced in step 902 (step 906), according to some embodiments. The distal end of the conduit may be inserted into the bodily cavity until a flange on the conduit engages or abuts an exterior surface of skin at the bodily cavity. Step 906 may be performed to fluidly couple the conduit (e.g., probe 24) with the bodily cavity (e.g., cavity 16). Step 906 can be performed by a caregiver or a surgeon to configure the pressure sensing assembly to measure pressure within the bodily cavity.

[0092] Process 900 includes providing strain sensors to an area of interest (e.g., the exterior surface of the skin at the bodily cavity) for measuring strain (step 908), according to some embodiments. The strain sensors can be operatively coupled with controller 100. The strain sensors measure strain at the exterior surface (e.g., the skin) of the bodily cavity. The measured strain can be used to estimate or verify pressure within the bodily cavity.

[0093] Process 900 includes measuring pressure at the distal end of the conduit with a pressure sensor (e.g., pressure sensor 22) of the pressure sensing assembly (step 910), according to some embodiments. The pressure measured at the distal end of the conduit can be the pressure within the bodily cavity (e.g., if the distal end of the conduit is directly fluidly coupled with the bodily cavity) or may be pressure that is related or proportional to the pressure within the bodily cavity (e.g., if the distal end of the conduit is fluidly coupled with a bladder or balloon inserted in the bodily cavity).

Step 910 can be performed by a controller (e.g., controller 100) of the pressure sensing assembly. The controller of the pressure sensing assembly can be operatively coupled with the pressure sensor and/or the strain sensors.

[0094] Process 900 can include estimating or verifying bodily cavity pressure (e.g., pressure within the bodily cavity) based on strain measured by the strain sensors (step 912), according to some embodiments. Step 912 may be optional. The controller of the pressure sensing assembly may use strain values as measured by the strain sensors to estimate the pressure within the bodily cavity, or to check or verify the pressure within the bodily cavity as measured by the pressure sensor 22. [0095] Process 900 includes providing a notification to a caregiver regarding changes in pressure values or changes in strain values (step 914), according to some embodiments. In some embodiments, step 914 is the same as or similar to step 812 of process 800. Deviations (e.g., increases) of the pressure in the bodily cavity or the strain values may indicate that the patient requires medical attention. The notifications can be provided to the caregiver to prompt the caregiver to administer medical attention to the patient.

[0096] Process 900 includes automatically operating a vent of the pressure sensing assembly to relieve pressure within the bodily cavity in response to the pressure within the cavity exceeding a threshold or maximum allowable value (step 916), according to some embodiments. Step 916 may be performed by controller 100 in response to pressure within the bodily cavity exceeding the maximum allowable value. Controller 100 may generate control signals for venting valve 34 to relieve pressure within the cavity.

Configuration of Exemplary Embodiments

[0097] The construction and arrangement of the systems and methods as shown in the various exemplary embodiments are illustrative only. Although only a few embodiments have been described in detail in this disclosure, many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.). For example, the position of elements can be reversed or otherwise varied and the nature or number of discrete elements or positions can be altered or varied. Accordingly, all such modifications are intended to be included within the scope of the present disclosure. The order or sequence of any process or method steps can be varied or re sequenced according to alternative embodiments. Other substitutions, modifications, changes, and omissions can be made in the design, operating conditions and arrangement of the exemplary embodiments without departing from the scope of the present disclosure.

[0098] The present disclosure contemplates methods, systems and program products on any machine-readable media for accomplishing various operations. The embodiments of the present disclosure can be implemented using existing computer processors, or by a special purpose computer processor for an appropriate system, incorporated for this or another purpose, or by a hardwired system. Embodiments within the scope of the present disclosure include program products comprising machine -readable media for carrying or having machine -executable instructions or data structures stored thereon. Such machine-readable media can be any available media that can be accessed by a general purpose or special purpose computer or other machine with a processor. By way of example, such machine-readable media can comprise RAM, ROM, EPROM, EEPROM, CD- ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to carry or store desired program code in the form of machine- executable instructions or data structures and which can be accessed by a general purpose or special purpose computer or other machine with a processor. Combinations of the above are also included within the scope of machine-readable media. Machine-executable instructions include, for example, instructions and data which cause a general purpose computer, special purpose computer, or special purpose processing machines to perform a certain function or group of functions.

[0099] Although the figures show a specific order of method steps, the order of the steps may differ from what is depicted. Also two or more steps can be performed concurrently or with partial concurrence. Such variation will depend on the software and hardware systems chosen and on designer choice. All such variations are within the scope of the disclosure. Likewise, software implementations could be accomplished with standard programming techniques with rule based logic and other logic to accomplish the various connection steps, processing steps, comparison steps and decision steps.

Claims

WHAT IS CLAIMED IS:

1. A pressure sensing system for a cavity of a patient, the system comprising: a tubular member comprising an inner volume configured to fluidly couple the cavity with an environment outside the cavity; a pressure sensor fluidly coupled with the tubular member and configured to measure pressure within the cavity; a wound dressing configured to seal the tubular member with exterior skin; and a controller configured to: receive the measured pressure from the pressure sensor; monitor the measured pressure overtime; and notify a caregiver regarding the measured pressure.

2. The system of Claim 1, wherein the tubular member extends through and seals with an incision that extends between the cavity and the environment outside the cavity.

3. The system of Claim 1, wherein the wound dressing comprises an adhesive layer configured to seal with the exterior skin.

4. The system of Claim 1, wherein the pressure sensor is positioned outside of the cavity and fluidly coupled with both the cavity and the environment outside of the cavity through the tubular member.

5. The system of Claim 1, wherein the pressure sensor is positioned at least partially within the cavity and is fluidly coupled with the environment outside of the cavity through the tubular member.

6. The system of Claim 1, further comprising a valve positioned in line with the tubular member and configured to transition between an open configuration and a closed configuration, wherein transitioning the valve into the open configuration configures the pressure sensor to measure gauge pressure of the cavity, and transitioning the valve into the closed configuration configures the pressure sensor to measure absolute pressure of the cavity.

7. The system of Claim 1, further comprising a flexible bladder positioned at an end of the tubular member that is within the cavity, wherein the flexible bladder is filled with a fluid and the pressure sensor is configured to measure pressure of the flexible bladder.

8 The system of Claim 7, wherein the bladder comprises a radio opaque material.

9. The system of Claim 1, wherein the controller is configured to communicate with the pressure sensor using near field communications.

10. The system of Claim 9, wherein the pressure sensor is configured to wirelessly receive power from the controller when the controller is within range of the pressure sensor and respond with the measured pressure of the cavity.

11. The system of Claim 1, further comprising a vent, wherein the secondary vent comprises a second tubular member that includes a second valve, wherein the second valve is configured to transition between an open configuration and a closed configuration to vent the cavity to atmospheric pressure.

12. The system of Claim 1, wherein the system further comprises one or more strain gauges topically applied to the exterior skin and configured to measure deformation of the exterior skin, wherein the controller is configured to receive the measured deformation of the exterior skin and verify the measured pressure based on the measured deformation.

13. The system of Claim 1, wherein the system further comprises one or more electro-active polymer sensors topically applied to the exterior skin and configured to measure deformation of the exterior skin, wherein the controller is configured to receive the measured deformation of the exterior skin and verify the measured pressure based on the measured deformation.

14. The system of Claim 1, wherein the controller is configured to notify the caregiver regarding the measured pressure by providing a notification to a mobile device.

15. The system of Claim 1, wherein the controller is configured to compare the measured pressure of the cavity to a threshold value to determine if the measured pressure of the cavity exceeds the threshold value and, in response to the measured pressure of the cavity exceeding the threshold value, notify the caregiver that the measured pressure exceeds the threshold value.

16. The system of Claim 1, wherein the controller is configured to wirelessly provide the measured pressure of the cavity to any of a mobile device, a base station, and a cloud server.

17. The system of Claim 1, wherein the cavity is an abdominal cavity and the pressure sensor is configured to measure intra-abdominal pressure of the abdominal cavity.

18. A pressure sensing assembly for a cavity of a patient, the assembly comprising: a tubular member comprising an inner volume configured to fluidly couple the cavity with an environment outside the cavity; a pressure sensor fluidly coupled with the tubular member and configured to measure pressure within the cavity; and a wound dressing configured to seal the tubular member with exterior skin.

19. The assembly of Claim 18, wherein the tubular member extends through and seals with an incision that extends between the cavity and the environment outside the cavity.

20. The assembly of Claim 18, wherein the wound dressing comprises an adhesive layer configured to seal with the exterior skin.

21. The assembly of Claim 18, wherein the pressure sensor is positioned outside of the cavity and fluidly coupled with both the cavity and the environment outside of the cavity through the tubular member.

22. The assembly of Claim 18, wherein the pressure sensor is positioned at least partially within the cavity and is fluidly coupled with the environment outside of the cavity through the tubular member.

23. The assembly of Claim 18, further comprising a valve positioned in line with the tubular member and configured to transition between an open configuration and a closed configuration, wherein transitioning the valve into the open configuration configures the pressure sensor to measure gauge pressure of the cavity, and transitioning the valve into the closed configuration configures the pressure sensor to measure absolute pressure of the cavity.

24. The assembly of Claim 18, further comprising a flexible bladder positioned at an end of the tubular member that is within the cavity, wherein the flexible bladder is filled with a fluid and the pressure sensor is configured to measure pressure of the flexible bladder.

25. The assembly of Claim 24, wherein the bladder comprises a radio opaque material.

26. The assembly of Claim 18, further comprising a vent, wherein the secondary vent comprises a second tubular member that includes a second valve, wherein the second valve is configured to transition between an open configuration and a closed configuration to vent the cavity to atmospheric pressure.

27. The assembly of Claim 18, wherein the assembly further comprises one or more strain gauges topically applied to the exterior skin and configured to measure deformation of the exterior skin.

28. The assembly of Claim 18, wherein the system further comprises one or more electro-active polymer sensors topically applied to the exterior skin and configured to measure deformation of the exterior skin.

29. The assembly of Claim 18, wherein the cavity is an abdominal cavity and the pressure sensor is configured to measure intra-abdominal pressure of the abdominal cavity.

30. A method for measuring and monitoring intra-abdominal pressure of an abdominal cavity, the method comprising: providing a tubular member configured to fluidly couple the abdominal cavity with an environment outside of the abdominal cavity; providing a pressure sensor configured to fluidly couple with the abdominal cavity and the environment outside of the abdominal cavity through the tubular member; measuring pressure of the abdominal cavity with the pressure sensor; comparing the pressure of the abdominal cavity to a threshold value; and notifying a caregiver in response to the pressure of the abdominal cavity exceeding the threshold value.

31. A system for sensing pressure in a cavity of a patient, comprising: a conduit comprising a proximal end and a distal end, the proximal end in fluid communication with atmosphere, the distal end in fluid communication with the cavity; a pressure sensor in fluid communication with the distal end of the conduit; a dressing adhered to skin of the patient, the dressing configured to seal the conduit with the exterior skin; and a controller operatively coupled to the pressure sensor.

32. The system of Claim 31, wherein the conduit comprises a flange positioned a distance from the distal end, the flange configured to engage an exterior surface of skin of the patient, wherein the flange facilitates a desired insertion depth of the distal end of the conduit into the cavity.

33. The system of Claim 32, wherein the flange is configured to abut the skin of the patient.

34. The system of Claim 32, further comprising a drape, wherein the drape is configured to seal the flange with the skin of the patient.

35. The system of Claim 31, wherein the distal end of the conduit is configured to extend a distance into the cavity of the patient.

36. The system of Claim 35, wherein the distal end of the conduit extends a distance between 20 and 40 millimeters into the cavity of the patient.

37. The system of Claim 31, further comprising a venting valve in fluid communications with the conduit, wherein the venting valve is configured to vent the cavity to the atmosphere to relieve pressure within the cavity.

38. The system of Claim 37, wherein the controller is configured to receive pressure measurements of the cavity from the pressure sensor and operate the venting valve to relieve the pressure within the cavity in response to the pressure measurements of the cavity exceeding a predetermined amount.

39. The system of Claim 31, further comprising a strain sensor, wherein the strain sensor is disposed on an exterior surface of the skin of the patient and is operatively coupled with the controller.

40. The system of Claim 39, wherein the controller is configured to receive strain measurements of the exterior surface of the skin of the patient from the strain sensor and estimate a pressure within the cavity based on the strain measurements.

41. The system of Claim 40, wherein the controller is configured to estimate the pressure within the cavity using correlation data that relates the strain measurements to estimated pressure within the cavity.

42. The system of Claim 31, wherein the controller is configured to alert a caregiver in response to pressure within the cavity increasing or exceeding a predetermined threshold.

43. The system of Claim 31 , further comprising a load sensor at the distal end of the conduit.

44. The system of Claim 43, wherein the load sensor is operatively coupled with the controller, wherein the controller is configured to alert a caregiver in response to detecting a load at the probe.

45. The system of Claim 31, wherein the probe further comprises a foam end portion.

46. The system of Claim 45, wherein the foam end portion is a soft closed cell foam material.

47. A system for sensing pressure in a cavity of a patient, comprising: a bladder positioned within the cavity; a conduit comprising a proximal end and a distal end, the proximal end in fluid communication with atmosphere, the distal end in fluid communication with the bladder; a pressure sensor in fluid communication with the distal end of the conduit; a dressing adhered to skin of the patient, the dressing configured to seal the conduit with the exterior skin; and a controller operatively coupled to the pressure sensor.

48. The system of Claim 47, wherein the bladder is a flexible balloon filled with a fluid.

49. The system of Claim 47, wherein the conduit comprises a flange positioned a distance from the distal end, the flange configured to engage an exterior surface of the skin of the patient, wherein the flange facilitates a desired insertion depth of the distal end of the conduit and the bladder into the cavity.

50. The system of Claim 49, wherein the flange is configured to abut the skin of the patient.

51. The system of Claim 49, further comprising a drape, wherein the drape is configured to seal the flange with the skin of the patient.

52. The system of Claim 47, further comprising a venting valve in fluid communications with the conduit, wherein the venting valve is configured to vent the cavity to the atmosphere to relieve pressure within the cavity.

53. The system of Claim 52, wherein the controller is configured to receive pressure measurements of the bladder from the pressure sensor and estimate a pressure within the cavity based on the pressure measurements of the bladder received from the pressure sensor.

54. The system of Claim 47, further comprising a strain sensor, wherein the strain sensor is disposed on an exterior surface of the skin of the patient and is operatively coupled with the controller.

55. The system of Claim 54, wherein the controller is configured to receive strain measurements of the exterior surface of the skin of the patient from the strain sensor and estimate a pressure within the cavity based on the strain measurements.

56. The system of Claim 55, wherein the controller is configured to estimate the pressure within the cavity using correlation data that relates the strain measurements to estimated pressure within the cavity.

57. The system of Claim 47, wherein the controller is configured to alert a caregiver in response to pressure within the cavity increasing or exceeding a predetermined threshold.

58. The system of Claim 47, wherein the bladder is positioned a distance within the cavity.

59. The system of Claim 58, wherein the bladder is positioned a distance between 20 and 40 millimeters within the cavity.

60. A method for measuring pressure in a cavity of a patient, comprising: making an incision in a patient’s skin at a bodily cavity; providing an apparatus comprising: a conduit comprising a proximal end and a distal end, the proximal end in fluid communication with atmosphere; a pressure sensor in fluid communication with the distal end of the conduit; a dressing adhered to skin of the patient, the dressing configured to seal the conduit with the exterior skin; and a controller operatively coupled with the pressure sensor; inserting the distal end of the conduit of the apparatus into the incision and the bodily cavity to fluidly couple the distal end with the bodily cavity; and measuring a pressure at the distal end of the conduit with the pressure sensor.

61. The method of Claim 60, further comprising: comparing the pressure at the distal end of the conduit to a threshold value; and notifying a caregiver in response to the pressure at the distal end of the conduit exceeding the threshold value.

62. The method of Claim 60, further comprising: providing one or more strain sensors at an exterior surface of skin of the bodily cavity, wherein the one or more strain sensors are operatively coupled with the controller.

63. The method of Claim 62, further comprising: measuring a deformation of the exterior surface of the skin of the bodily cavity using the one or more strain sensors; correlating the deformation of the exterior surface of the skin of the bodily cavity to a pressure of the bodily cavity; and estimating the pressure of the bodily cavity based on the deformation of the exterior surface of the skin of the bodily cavity.

64. The method of Claim 63, further comprising: verifying the pressure at the distal end of the conduit measured with the pressure sensor using the pressure estimated based on the deformation of the exterior surface of the skin of the bodily cavity.

65. The method of Claim 60, further comprising: comparing the pressure at the distal end of the conduit as measured by the pressure sensor to one or more threshold values; and determining if the patient requires medical attention in response to the pressure exceeding one or more of the threshold values.

66. The method of Claim 65, further comprising: alerting a caregiver in response to determining that the patient requires medical attention.

67. The method of Claim 60, wherein the apparatus further comprises: a vent fluidly coupled with the atmosphere and the bodily cavity; wherein the vent is operatively coupled with the controller and is selectably transitionable between an open or venting state and a closed or sealed state.

68. The method of Claim 67, further comprising: operating the vent to transition at least partially into the open state to relieve pressure within the bodily cavity in response to the pressure at the distal end of the conduit exceeding a threshold pressure value.

69. The method of Claim 68, wherein the controller is configured to automatically operate the vent to relieve pressure within the bodily cavity in response to the pressure at the distal end of the conduit exceeding the threshold pressure value.