Systems and devices for measuring intra-abdominal pressure

Abstract

A system or device for determining intra-abdominal pressure (IAP) of a patient based on abdominal wall tension (AWT) of the patient. The system includes a probe, and the probe includes a shield and a spherical tip that is pressed into the patient's abdomen. The probe is connected to a force sensor of the system, and a controller of the system is configured to calculate the IAP of the patient based on the AWT detected by the force sensor. The system may include an accelerometer and a proximity sensor.

Description

SYSTEMS AND DEVICES FOR MEASURING INTRA-ABDOMINAL PRESSURECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to and the benefit of the filing date of U.S. Provisional Patent Application No. 63 / 709,849, filed October 21, 2024, and U.S.Provisional Patent Application No. 63 / 888,558, filed September 26, 2025, the complete disclosures of which are incorporated by reference herein in their entirety.FIELD OF THE INVENTION

[0002] The present disclosure relates generally to monitoring intra-abdominal pressure in a patient and, more particularly, to systems and devices for measuring and determining intra-abdominal pressure in neonatal patients and probes for the sameBACKGROUND OF THE INVENTION

[0003] This section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present invention, which are described and / or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of various aspects of the present invention. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.

[0004] Intra-abdominal pressure (IAP) is the pressure within the abdominal cavity of a patient. IAP is an indicator of intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS). IAH and ACS are comorbid conditions that could resultin low perfusion to the abdominal area, consequently negatively affecting oxygen delivery to organs, and ultimately leading to organ failure. IAH and ACS are indicated primarily by IAP, with IAH defined as IAP greater than 12 mmHg and ACS defined as IAP greater than 20 mmHg. Various complications can result in IAH (i.e., IAP > 12 mmHg), including blunt force abdominal trauma, necrotizing enterocolitis (NEC), etc.

[0005] NEC is the most common gastrointestinal emergency in infants and a common surgical emergency in the neonatal intensive care unit (NICU). NEC occurs in about 1 in 1000 live births, with around 70% of these cases occurring in premature births. NEC is often caused by a bacterial infection of the intestinal wall, leading to cellular destruction and inflammation. As NEC progresses, the infant becomes at risk of intestinal perforation (initially seen as pneumoperitoneum on X-ray), peritonitis, sepsis, and death. With a mortality rate as high as 50%, and the specific cause of the invasion unknown, recognizing NEC indicators and implementing early treatment to mitigate the most severe cases is key.

[0006] Further, while many sources indicate that a normal range of IAP in neonate populations should be between 0-5 mmHg, even a slightly elevated IAP of ~5 mmHg in neonatal populations, well before the threat of ACS, can lead to extreme discomfort and difficulty feeding as additional fluid introduced to the abdominal area from feeding further elevates IAP, dangerously progressing the neonate to ACS. The disruption in regular feeding times in neonatal populations is especially detrimental at this stage in life where regular feeding schedules must be maintained to help babies grow and develop.

[0007] IAP is a key indicator of malfunction in the abdomen, such as low perfusion to the abdominal area, suggesting that IAP could be used as a diagnostic tool for NEC orfor diagnosing other situations where elevated IAP is detrimental. The current gold standard of quantitative IAP measurements is an intravesical catheter; however, catheterization of neonates is difficult, invasive and very risky, and may require sedation or paralysis for an accurate measurement. As a result, physicians rely on a palpation method to monitoring IAP. However, studies have shown that the palpation method is very unreliable, with up to 60% of patients being misdiagnosed when using the palpation method. Given the devastating impact of NEC and / or pneumoperitoneum on IAP, the detrimental impact even slightly elevated IAP in certain populations, the risk associated with using a catheter, and the unreliability of the palpation method, there remains a need for a simple and noninvasive means of measuring IAP in neonatal populations that would increase patent standard of care and improve clinical outcomes.SUMMARY OF THE INVENTION

[0008] Various details of the present disclosure are hereinafter summarized to provide a basic understanding. This summary is not an exhaustive overview of the disclosure and is neither intended to identify certain elements of the disclosure, nor to delineate the scope thereof. Rather, the primary purpose of this summary is to present some concepts of the disclosure in a simplified form prior to the more detailed description that is presented hereinafter.

[0009] According to an embodiment consistent with the present disclosure, a system for monitoring intra-abdominal pressure (IAP) of an abdomen of a person includes a force sensor, a probe operatively connected to the force sensor and configured to contact the abdomen, wherein the force sensor is configured to detect abdominal walltension of the abdomen when the probe is pressed into the abdomen. The system further includes a controller configured to calculate intra-abdominal pressure of the abdomen based on abdominal wall tension readings received from the force sensor.

[0010] In another embodiment, a device for monitoring intra-abdominal pressure (IAP) of an abdomen of a person includes a gauge and a probe. The gauge includes a housing, a display, a force sensor, and a controller in communication with the force sensor and the display. The probe is operatively connected to the force sensor and configured to contact the abdomen, wherein the force sensor is configured to detect abdominal wall tension of the abdomen when the probe is pressed into the abdomen, and wherein the controller is configured to calculate intra-abdominal pressure of the abdomen based on abdominal wall tension readings received from the force sensor, and wherein the display is configured to output calculated intra-abdominal pressure.

[0011] In a further embodiment, a method of determining intra-abdominal pressure within an abdomen of a patient includes pressing a tip of a probe into the abdomen, detecting abdominal wall tension of the abdomen with a force sensor operatively connected to the probe, wherein the force sensor is configured to detect abdominal wall tension of the abdomen when the probe is pressed into the abdomen, and calculating, via a controller, intra-abdominal pressure of the abdomen based on abdominal wall tension readings received from the force sensor.

[0012] Any combinations of the various embodiments and implementations disclosed herein can be used in a further embodiment, consistent with the disclosure. These and other aspects and features can be appreciated from the following description of certainembodiments presented herein in accordance with the disclosure and the accompanying drawings and claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the present invention.

[0014] FIG. 1 depicts a device or system for determining intra-abdominal pressure (IAP), according to one or more embodiments.

[0015] FIG. 2 schematically depicts the system of FIG. 1 , according to one or more embodiments.

[0016] FIGS. 3A-3D depict an alternate probe assembly that may be utilized with the system of FIGS. 1-2, according to various embodiments.

[0017] FIG. 4 depicts another alternate probe assembly that may be utilized with the system of FIGS. 1-2, according to various embodiments.

[0018] FIG. 5 depicts an example contact sensor that may be incorporated into the system of FIGS. 1-2, according to embodiments.

[0019] FIG. 6A and FIG. 6B depict an experiment for correlating abdominal wall tension (AWT) and IAP.

[0020] FIG. 7A and FIG. 7B depict the results from the experiment shown in FIGS.DETAILED DESCRIPTION OF THE DRAWINGS

[0021] Various features, aspects, and advantages of the present invention will become better understood when the following detailed description is read with reference to the accompanying figures in which like characters represent like parts throughout the figures. One or more specific embodiments of the present invention will be described below. In an effort to provide a concise description of these embodiments, all features of an actual implementation may not be described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers’ specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.

[0022] Embodiments in accordance with the present disclosure generally relate to measuring or determining intra-abdominal pressure (IAP) within the abdomen of a patient. The IAP of the patient is determined using a measurement of the patient’s abdominal wall tension (AWT), wherein the system / device is configured to calculate the patient’s IAP based on their measured AWT. To help ensure that the device / system is consistently used across all patients and by different users, the probe may have a shield that helps ensure consistent penetration depth of the probe’s tip, or the device / system may include contact sensors or proximity sensors to detect when the probe has beensufficiently pressed into the abdomen. In addition, the device / system may include sensors to help instruct the user / operator to hold the device / system in the proper orientation, for example, to help the user / operator hold the device / system in a vertical orientation. As such, the devices / systems described herein provide an quick and non-invasive means of determining a patient’s IAP.

[0023] FIGS. 1 -2 depict a system or device 100 for monitoring and determining intraabdominal pressure (IAP), according to one or more embodiments. As described herein, the system or device 100 (hereinafter, the system 100) is operable to calculate intra-abdominal pressure (IAP) of a patient, such as an infant or new-born patient, by measuring the abdominal wall tension (AWT) of that patient, wherein the IAP is calculated based on the measured AWT. In practice, the system 100 may be utilized by various different users (i.e., physicians, nurses, etc.) on the same or different patient, and the system 100 is configured to ensure that it is utilized in the same manner regardless of the user or patient. In particular, the system 100 is configured to ensure that the user is holding it at the proper orientation and properly engaging the patient to read the AWT, such that use of the system 100 is standardized across users and patent populations.

[0024] In the illustrated embodiment, the system 100 includes a gauge assembly 102 (or gauge 102), a probe assembly 104 (or probe 104), and a controller 202. In embodiments, the gauge 102 includes a force sensor 204. The probe 104 is operatively connected to the force sensor 204 and configured to contact (i.e., be pressed into) the abdomen of the patient. The force sensor 204 is configured to detect AWT of the patient's abdomen when the probe is pressed into the abdomen. The controller 202 isconfigured to calculate IAP of the patient’s abdomen based on AWT readings received from the force sensor 204. Because the system 100 includes the force sensor 204, in some embodiments the gauge 102 is configured as a force or Newton meter that includes the force sensor 204 and the controller 202 that is configured as described herein, such that the gauge 102 is operable to measure the AWT through the probe 104 when the probe 104 is pressed into the patient’s abdomen and also configured to calculate or determine the IAP based on the measured AWT. In this manner, the system or device 100 is operable to automatically output the patient’s IAP to the user (i.e., to the physician or nurse).

[0025] In the illustrated embodiment, the probe 104 extends along an axis A and includes a tip 106 and a shield 108. As shown, the tip 106 extends or protrudes from the shield 108 and is aligned on the axis A. In particular, the shield 108 includes an upper or proximal surface 110 and a lower or distal surface 112, and the tip 106 is arranged on the lower surface 112 such that the tip 106 protrudes or extends form the lower surface 112 along the axis A, with the tip 106 being centered on the axis A. In embodiments, the lower surface 112 of the shield 108 is a flat surface. When in use, the probe 104 is held in a vertical orientation, where the axis A of the probe 104 is substantially vertical and in alignment with a vertical or normal axis, and the tip 106 is pressed into the abdomen until the lower surface 112 of the shield 108 contacts the abdomen, while the probe 104 is maintained in such vertical orientation. By pressing the tip 106 of the probe 104 into the patient’s abdomen, the probe 104 effectively mimics the palpation method of measuring IAP.

[0026] The probe 104, including both the shield 108 and the tip 106, may be made from a material that is suitable for sterilization. In this manner, the probe 104 may be used multiple times and on different patients, while being sterilized between uses.While various different types of material may be utilized, a material should be selected that is safe to use on human skin (and, in particular, on the skin of an infant), and from a material that permits it to be wiped down with sanitizing wipes. In embodiments, the probe 104 is made from a plastic material and / or a silicone material. In embodiments, the probe 104 is made via additive manufacturing, such as three-dimensional printing.

[0027] Also in the illustrated embodiment, the probe 104 includes a shaft 114 that extends along the axis A and protrudes or extends from the shield 108. Here, the shaft 114 extends or protrudes upward from the upper surface 110. The shaft 114 is configured to be attached to the gauge 102. Here, the gauge 102 includes a housing 116 and a terminal 118 extending from the housing 116, and the shaft 114 is attachable to the terminal 118. The terminal 118 is operatively connected and / or in communication with the one or more components of the gauge 102, such as the force sensor 204 that permit the gauge 102 to detect, measure, or sense the AWT of the patient.

[0028] In embodiments, the probe 104 is removably connected to the gauge 102. In this manner, the probe 104 may be removed and replaced with a different probe. For example, different probes 104 may have differently sized tips 106, such that one probe 104 may be replaced with second probe having a larger or smaller tip 106, or a first probe 104 may be replaced after use with a clean probe 104.

[0029] In embodiments, the probe 104 is threadably attached to the gauge 102. For example, the shaft 114 and the terminal 118 may include corresponding threads thatpermit the probe 104 to be screwed onto and off of the gauge 102, as described with reference to FIG. 3A-3D. In some of these examples, the terminal 118 includes exterior threads and the shaft 114 includes a threaded bore 115 with threads that correspond to the threads on the terminal 118.

[0030] Referring again to FIG. 1 , in embodiments the tip 106 includes a spherical portion 120 that is defined by a diameter d, wherein it is the spherical portion 120 of the probe 104 that contacts and is inserted into the patient’s abdomen when in use. Thus, in the illustrated embodiment, the probe 104 includes a proximal end 122 at which the probe 104 is connected to the gauge 102 and a distal end 124 opposite the proximal end 122, wherein the distal end 124 is an end of the spherical portion 120 that is pressed into the abdomen of the patient. As shown, the tip 106 has a length dimension D (also referred to as the penetration depth D) that is measured between the lower surface 112 of the shield 108 and the distal end 124, and the penetration depth D of the tip 106 defines how far the tip 106 will be inserted into the patient’s abdomen.

[0031] The shield 108 and the tip 106 of the probe 104 are designed to help standardize the penetration depth D of the tip 106 into the abdomen. During use, the user / operator will press the tip 106 into the abdomen until the shield 108 is in contact with the skin of the patient’s abdomen. In embodiments, the penetration depth D of the tip 106 is greater than zero (0) and lesser than or equal to fifteen (15) millimeters (mm). In some embodiments, penetration depth D of the tip 106 is greater than zero (0) and lesser than or equal to twelve (12) mm. In some embodiments, the penetration depth D of the tip 106 is greater than zero (0) and lesser than or equal to five (5) mm. In some embodiments, the penetration depth D of the tip 106 is five (5) mm. In someembodiments, the penetration depth D is greater than or equal to five (5) mm and lesser than or equal to twelve (12) mm. Different patients have different skin thicknesses, with infants having much thinner skin than older patient’s and premature infants having even thinner skin, and tips 106 having smaller penetration depths D may be utilized on patients having such thin skin, while relatively larger tips 106 may be utilized on populations with thicker skin.

[0032] The tip 106 of the probe 104 may have different spherical shapes. For example, FIG. 1 depicts an embodiment where the tip 106 is comprised entirely of the spherical portion 120 and where the spherical portion 120 is not a full sphere, but rather a spherical cap that is larger than a hemi-sphere (also known as a half sphere) and where a flat surface defined at the top of the spherical cap is in contact with the lower surface 112 of the shield 108. In other embodiments, however, the spherical portion 120 is (i) a full sphere that is in contact with the lower surface 112 of the shield 108 as exemplified in FIG. 4, or (ii) a spherical cap that is smaller than a hemi-sphere and that includes a flat surface defined at the top of the spherical cap that is in contact with the lower surface 112 of the shield 108. Thus, as noted above, FIG. 1 depicts an embodiment where the where the probe tip 106 is embodied by a spherical portion 120 defining a sphere cap that is larger than a hemi-sphere, FIGS. 3A-3D depict an embodiment where the where the probe tip 106 is embodied by a spherical portion 120 defining a hemi-sphere, and FIG. 4 depicts an embodiment where the probe tip 106 is embodied by a spherical portion 120 defining a substantially full sphere that is in contact with the lower surface 112 of the shield 108. Regardless of whether the tip 106 is fully or partially spherical in shape, the sphere may have various diameters d. Inembodiments, the diameter d of the spherical portion 120 is greater than zero (0) and lesser than or equal to fifteen (15) millimeters (mm). In some embodiments, the diameter d of the spherical portion 120 is greater than zero (0) and lesser than or equal to twelve (12) mm. In some embodiments, the diameter d of the spherical portion 120 is greater than zero (0) and lesser than or equal to five (5) mm. In some embodiments, the diameter d of the spherical portion 120 is five (5) mm. Different patients have different skin thicknesses, with infants having much thinner skin than older patient’s and premature infants having even thinner skin, and tips 106 with spherical portions 120 having smaller diameters d may be utilized on patients having such thin skin, while relatively larger tips 106 may be utilized on populations with thicker skin

[0033] Referring to FIGS. 3A-3D, the probe 104 is depicted having an alternately configured tip 106, according to various embodiments. Here, tip 106 includes a shaft 126 extending between the spherical portion 120 and the lower surface 112 of the shield 108. Here, the shaft 126 is a cylindrical shaft having a diameter that is equal to (or the same as) the diameter d of the spherical portion 120. Also in this embodiment, the spherical portion 120 is a hemi-sphere (i.e., half of a sphere) as noted above. In these embodiments, the penetration depth D of the tip 106 includes the length of the shaft portion 126 and the spherical portion 100 and is measured between the lower surface 112 and the distal end 124. Referring again to FIG. 4, which depicts the tip 106 of the probe 104 when configured as a substantially full sphere, the penetration depth D of that tip 106 would be approximately equal to the diameter d thereof.

[0034] In the illustrated embodiment of FIGS. 3A-3D, the upper surface 110 is defined on an upper wall of the shield 108, the lower surface 112 is defined on a lowerwall of the shield 108, and the shield 108 further includes sidewalls 128 extending between the upper wall and the lower wall of the shield 108. The sidewalls 128 may include an individual continuous sidewall, such that the shield 108 has a circular or rounded shape. However, in other embodiments, the sidewalls 128 includes separate sidewall segments that together define the shape of the shield 108. In the illustrated embodiment, the sidewalls 128 includes sidewall segments 128a, 128b, 128c, 128d. Here, the sidewall segments 128a, 128b, 128c, 128d are oriented relative to each other such that the shield 108 is shaped as a square; however, the shield 108 may have other polygonal or rounded shapes, such as a rectangle, triangle, a circle, an oval, etc.

[0035] As best shown in FIG. 1 and FIGS. 3C-3D, upper edges 130 are defined between the upper surface 110 and the sidewalls 128 and lower edges 132 are defined between the lower surface 112 and the sidewalls 128. In embodiments, the upper edges 130 are beveled, rounded, or otherwise blunted so that they do not present a sharp surface that could cause injury to the patient. In embodiments, the lower edges 133 are beveled, rounded, or otherwise blunted so that they do not present a sharp surface that could cause injury to the patient. Also, in embodiments where the sidewalls 128 include multiple sidewall segments, edges are defined between adjacent sidewall segments, and these edges may beveled, rounded, or otherwise blunted so that they do not present a sharp surface that could cause injury to the patient.

[0036] Also, in embodiments where the shield 108 has a polygonal shape, corners 132 are defined between the upper surface 110 and adjacent sidewall segments and between the lower surface 112 and adjacent sidewall segments. Here, for example, upper corners 132 are defined where the upper surface 110 meets a pair of adjacentsidewall segments 128a-128d, and lower corners 132 are defined where the lower surface 112 meets a pair of adjacent sidewall segments 128a-128d. The upper corners 132 and / or the lower corners 134 may be beveled, rounded, or otherwise blunted so that they do not present a sharp surface that could cause injury to the patient.

[0037] Referring to FIGS. 3A-3B, the shield may include one or more mounting locations 136, 138. The mounting locations 136, 138 may be surfaces that are recessed below the upper surface 110 and / or the lower surface 112 or elevated surfaces that are elevated above the upper surface 110. In other embodiments, the mounting locations 138, 138 extend through the shield 108 between the upper and lower surfaces 110, 112. The mounting locations 136, 138 may be utilized to attach other components of the system 100, as herein after described. In addition, the shield 108 may include slots 140 that are recessed into the upper surface 110 and extend from the sidewalls 128 (for example, the sidewall segment 128d thereof) into an interior of the shield 108. In embodiments, a sensor 208 is included in the form of an accelerometer, and such sensor 208 is arranged in the slot 140. Moreover, the shield 108 includes through-holes 142 (hereinafter, holes 142) that extend through the shield 108, between the upper surface 110 and the lower surface 112. In the illustrated embodiment, the shield 108 includes four (4) of the holes 142, with each of the four (4) holes 142 being positioned at a location on the shield 108 near where a pair of adjacent sidewall segments 128a-d meet and near the upper and lower corners 132, 134 associated therewith. The holes 142 may be equidistantly spaced from the tip 106 and symmetrically arranged about the shield 108. As further described below, the holes 142 may be utilized to position one or more sensors 144 (see FIGS. 1-2) that the system100 utilizes to determine when the tip 106 is pressed sufficiently into the patient’s abdomen; however, it will be appreciated that FIGS. 3A-3D depict the probe 104 without the sensors 144 (i.e., the sensors 144 are not installed on the probe 104 depicted in FIGS. 3A-3D). As hereinafter described, the sensors 144 may be contact or pressure sensors configured to detect when the shield 108 contacts the abdomen of the patient and when the tip 106 is pressed sufficiently far into the abdomen or the sensor(s) 144 may be a proximity sensor configured to detect a distance between itself and the patient’s abdomen to ascertain how far the tip 106 of the probe 104 has been inserted into the abdomen. The arrangement and orientation of the holes 142 may be provided to help arrange and orient sensors 144 on the shield 108, for example, where the sensors 144 are pressure / contact sensors as described elsewhere herein.

[0038] In embodiments, the sensor(s) 144 may be secured on the probe 104. In some embodiments, the sensor(s) 144 are arranged on the bottom surface 112 of the shield 108 (e.g., when the sensors 144 are contact sensors) or within recesses formed in the shield (e.g., when the sensors 144 are proximity sensors), such as the holes 142; however, the sensor(s) may be arranged elsewhere on the probe 104, such as the shaft 114 thereof. For example, in an embodiment where the probe 104 does not include the shield 108, the sensor(s) 144 may be supported on the shaft 114. In other examples, the sensors 144 may be arranged on the housing 116 of the gauge 102. The sensors 144 may be attached by various means, such as by glue, fasteners (bolts), soldering, etc.

[0039] In embodiments, the tip 106 is removable from the probe 104. FIG. 5 depicts an example of the probe 104 that is configured to allow for removal and replacement ofthe tip 106 from the shield 108, according to embodiments. In particular, FIG. 5 depicts the probe 104 when the tip 106 has been removed from the shield 108. In these embodiments, the probe tip 106 may be threadably attached to the shield 108. Here, for example, the shield 108 includes a threaded stud 146 that extends from the bottom surface 112 of the shield 108, and the tip 106 includes a threaded bore (not shown), wherein the threads of the threaded stud 146 and the threaded bore correspond with each other such that the tip 106 may be screwed into or off of the shield 108. In this manner, the probe 104 may include differently sized tips 106, for example a probe tip having a first diameter d may be removed so that a probe tip having a second diameter d may be installed and utilized to determine a patient’s IAP. The spherical portion 120 of the tip 106 utilized with the probe 104 of FIG. 5 may have various shapes, for example, as described with refence to FIG. 1 , FIGS. 3A-3D, or FIG. 4. In other embodiments, the tip 106 and the spherical portion 120 thereof are integrally formed with the shield 108 such that the tip 106 is not removable.

[0040] Referring again to FIG. 1 , the probe 104 is configured to allow calibration of the system or device 100. In the illustrated embodiment, the tip 106 includes openings 148 formed therein upon and from which weights (not shown) may be hung to help calibrate the gauge 102 to ensure that, when the shield 108 is attached to the terminal 118 or when the tip 106 has been removed and replaced from the shield 108, the addition of the shield 108 and / or the tip 106 do not affect how the force sensor 204 measures the force. Here, the openings 148 are formed in the spherical portion 120. In embodiments, the force sensor 204 is a strain gauge load cell which measures the pull or push on itself, wherein the pulling or pushing applies “strain” on the strain gaugewhich is proportional to the force of the pull or push. By hanging known weights from the openings 148 when the probe 104 is attached to the terminal 118, the user may calibrate the system 100 since the weights would have a known force reading due to the relationship between mass and force where force is equal to mass multiplied by acceleration due to gravity. However, the force sensor 204 may include other types of sensors operable to detect push or pull thereon as described herein.

[0041] As shown in FIG. 2, the system 100 includes a power source 206. In embodiments, the power source 206 is a rechargeable power source, and the power source 206 may comprise various types of power sources. In some embodiments, the power source 206 is a lithium polymer battery. In other embodiments, the power source 206 includes commonly available alkaline or rechargeable AA, AAA, or 9 Volt batteries.

[0042] In embodiments, the system 100 is configured to ensure that it utilized and operated in a standard or standardized manner, regardless of who the particular user (i.e., physician, nurse, etc.) who is actually operating the system 100. Thus, as previously mentioned, in addition to the force sensor 204, the system 100 may include one or more sensors 144 that are utilized to ensure that the tip 106 is pressed a sufficient and consistent distance into the abdomen of each the various patients with which it will be used. Moreover, in addition to the force sensor 204 and the sensor(s) 144, the system 100 may include one or more sensors 208 that ensure the system 100 is being oriented in a manner that its axis A is substantially vertical or normal to a horizontal plane. Thus, it should be appreciated that the sensors 144 and 208 facilitate operation of the system 100 in a standardized and uniform manner across many different uses of the system 100 by different users / operators and with various differentpatients. As shown in at least FIG. 2, all of the sensors 204, 144, and 208 are electrically connected to and in communication with the controller 202.

[0043] Regarding the sensor(s) 144 that is / are utilized to ensure that the tip 106 is pressed a sufficient distance into the patient’s abdomen, the sensor 144 may include one or more sensor units. As previously mentioned, for the force sensor 204 and the probe 104 to obtain accurate readings of AWT, the tip 106 is to be pressed into the abdomen of the patient a certain distance that is generally achieved when the lower surface 112 of the shield 108 comes into contact with the abdomen of the patient.Thus, the sensor(s) 144 may be included in the system 100 to help ensure that the operator / user does not press the probe 104 too far into the abdomen while also ensuring that the operator / user does press the probe 104 far enough into the abdomen, thereby helping to ensure accurate measurements from the force sensor 204.

[0044] In embodiments, the sensor(s) 144 may be positioned on the lower surface 112 of the shield 108, as exemplified in FIG. 1 and FIG. 5, and configured to detect when the shield 108 has correctly and sufficiently contacted the abdomen of the patient or when the tip 106 has been inserted sufficiently far into the patient's abdomen. The sensor(s) 144 may be various types of sensing units that are operable to detect when the shield 108 and / or the tip 106 is at the correct position relative to the abdomen, for example, when the shield 108 has contacted the abdomen and / or when the tip 106 has been properly and sufficiently inserted into the abdomen. Thus, the sensor(s) 144 may be referred to as contact sensors 144 that detect contact with the abdomen and / or proximity sensors 144 that detect relative distance between part of the probe 104 and the abdomen. As described below, the sensor(s) 144 may include different types ofsensors that are operable to determine when the part of the probe 104 (e.g., the shield 108) has contacted the abdomen and / or how far the tip 106 has been inserted into the abdomen, including a force sensitive resistor, a proximity and light sensor (referred to simply as a proximity sensor), etc.

[0045] FIG. 5 depicts an example where the sensor(s) 144 includes a plurality of pressure sensors 502, according to an embodiment. Here, there are four (4) of the pressure sensors 502, with at least part of the pressure sensors 502 being arranged on the lower surface 112 of the shield 108. Here, each of the pressure sensors 502 includes a connection portion 504 that is arranged one of the slots 142, and an extension portion 506 that extends form the connection portion 504, where the extension portion is affixed to the lower surface 112 and extends along the lower surface 112 of the shield 108. Here, each of the extension portions 506 extends along one of the lower edges 132 defined between the lower surface 112 and the sidewalls 128. In this embodiment, the connection portion 504 of the pressure sensors 502 is arranged in the slots 142, such that the slots 142 help position the pressure sensors 502 along the edges 132 of the lower surface 112. Also in this embodiment, electrical leads or connectors of the connection portion 504 of the pressure sensors 502 extends upward through the slots 142, such that wires (not shown) from the controller 202 may be connected to the leads of the connection portion 504, such that wires that extend between the pressure sensors 502 and the controller 202.

[0046] In one example, the pressure sensors 502 are force sensitive resistors that change resistance when a force is applied to them. Here, the change in resistance may be used as a binary indicator of whether or not something is in contact with the shield108, meaning even just a light touch of the pressure sensors 502 would register as contact of the shield 108.

[0047] In other embodiments, the sensor(s) 144 includes one or more light proximity sensors that can use light to measure how far part of the probe 104 (e.g., the shield 108) is from the abdomen. In these embodiments, the light proximity sensor(s) may provide resolution in millimeters and are mounted on the shield 108. In some embodiments, only one of the light proximity sensors is utilized. The light proximity sensor is electrically connected to the controller 202 as exemplified in FIG. 2. The light proximity sensor may be simply referred to herein as “the proximity sensor”.

[0048] As mentioned above, the proximity sensor may be mounted at various locations about the probe 104, for example, on the top surface 110 or the bottom surface 112 of the shield 108, in one of the holes 142 of the shield 108, or on the shaft 114 of the probe 104. In embodiments where the probe 104 does not include the shield 108, the proximity sensor may be supported on the shaft 114 of the probe 104 or on the housing 116 of the gauge 102. In an embodiment where the probe 104 includes the shield 108, the proximity sensor 144 may be a proximity sensor 144a that is mounted on the upper surface 110 of the shield 108 and extend over the edges and sidewalls 128, with an emitting end 145 the proximity sensor 144a facing and oriented in a distal direction so that it points towards the patient’s abdomen when in use, as exemplified in FIG. 1. However, FIG. 1 also depicts an example where the proximity sensor 144 is a proximity sensor 144b mounted on the bottom surface 112 of the shield 108. In other embodiments, the proximity sensor is mounted in recessed surface formed in the top surface 110, such as the slot 140 or mounting locations 136, 138, such that theproximity sensor 144 is substantially flush with the top surface 110, wherein an aperture or opening is formed in the bottom surface of the recessed surface through which the emitter portion 145 of the proximity sensor 144 extends. In even other embodiments, the proximity sensor 144 is positioned on the shaft 144 and arranged such that the emitting end 145 thereof points in a distal direction towards the patient’s abdomen and, in these embodiments, the probe 104 need not include the shield 108.

[0049] In some examples, the sensor 144 configured as the proximity sensor is a VCNL4040 sensor, which is a single sensing unit having a proximity sensor (PS), ambient light sensor (ALS), and a high power IRED. In this embodiment, one or more of the VCNL4040 sensor may be arranged and mounted in one or more of the slots 142 or in one or both of the mounting locations 136, 138. The VCNL4040 sensor has contact points to which wires may be connected, and then such wires may be connected to the controller 202. In one example as shown in FIG. 1 , the sensor 144b on the bottom surface 112 is the VCNL4040 sensor. However, the VCNL4040 sensor may be differently installed on the system 100 in various manners that permit it to point and direct light towards the patient's abdomen.

[0050] Regarding the sensor 208, in some embodiments the sensor 208 is an accelerometer configured to measure tilt of the system 100 to ensure that operator / user is holding the system 100 in a level manner during each use. In these embodiments, the accelerometer is electrically connected to the controller 202. This will further help standardize use of the system 100 across many different uses of the system 100 by various different operators / users on various different patients. The system 100 is considered level when the axis A of the system 100 is vertical and normal to ahorizontal plate, or, where either surface 110, 112 of the shield 108 is flat, when the system 100 is oriented such that such flat surface of the shield 108 is co-planar with the horizontal plane. In these embodiments, the accelerometer may be arranged on the shield 108 of the probe 104 or on the housing 116 of the gauge 102. As described below, in some embodiments, the system 100 includes a digital bubble level 152 that is in communication with the controller 202, wherein the digital bubble level 152 provides or outputs, based on readings from the accelerometer (i.e., the sensor 208), visual feedback that is indicative of the tilt of the system 100 and whether the system 100 is being held and used in the correct orientation. For example, the digital bubble level 152 may display a graphical representation of the attitude to the system 100 and whether the axis A thereof is substantially vertical or normal relative to a horizontal plane.

[0051] The system 100 is configured to communicate information and provide output or feedback to the user / operate. In embodiments, the system 100 is configured to output I PA to the user / operator, such that at least some of the information communicated to the user / operator is indicative of the IAP. In the illustrated embodiment, the system 100 includes a display 150 that is connected to and in communication with the controller 202, wherein the display 150 is operable to output data and information, such as the IAP values calculated / determined by the controller 202. In some embodiments, the display 150 outputs other types of data as well, such as the AWT from which the IAP was correlated. Here, the display 150 is provided on the gauge 102 and, in particular on the housing 116 thereof. In embodiments, the display 150 also displays information based on data from the sensor 144 (i.e., the contact or proximity sensor) and the sensor 208 (i.e., accelerometer).

[0052] The system 100 may also be configured to provide user feedback or output information to the user that is indicative of whether the system 100 is being properly used. Thus, the system 100 may include components that can output or provide information to the user that is based on data captured by the sensors 144 and / or the sensor 208. In embodiments, the display 150 also displays information based on data from the sensor 144 (i.e. , the contact or proximity sensor) and the sensor 208 (i.e. , accelerometer). For example, the display 150 could be configured to display a visual representation of whether the system 100 is being oriented in a vertical orientation, as described with regard to the digital bubble level 152 and / or the display 150 may provide indication of when the probe 104 is pressed sufficiently far into the patient.

[0053] In embodiments, the system 100 includes the digital bubble level 152. The digital bubble level 152 is in communication with the controller 202 and is a display that provides a visual indication of the orientation or attitude of the system 100, based on data from the sensor 208 (e.g., the accelerometer). In the illustrated embodiments, the digital bubble level 152 provides a real-time visual indication as to the attitude of the system 100, such that the user / operator of the system 100 can ensure that they are holding the system 100 in an orientation where the axis A is vertical (i.e., whether the probe 104 and the gauge 102 are being held in a substantially vertical orientation). Also in the illustrated embodiment, the digital bubble level 152 is provided on the gauge 102 and, in particular on the housing 116 thereof; however, the digital bubble level 152 may be provided elsewhere, such as on the shield 108 and, in some examples, on the upper surface 110 of the shield 108. In other embodiments, in addition to outputting / displaying information as detailed elsewhere herein (such as the IAP), the display 150 is alsoconfigured to also display similar information or graphics as described with regard to the digital bubble level 152, such that the system 100 may simply include just the display 150 and not have a separate digital bubble level 152.

[0054] Also in the illustrated embodiment, the system 100 includes an indicator 154. The indicator 154 may be an LED light configured to emit light and / or a speaker that is configured to emit a sound. The indicator 154 is in communication with the controller 202 and is operable to emit a light and / or sound based on data from the sensors 144. In the illustrated embodiment, the indicator 154 is provided on the gauge 102 and, in particular on the housing 116 thereof; however, the indicator 154 may be provided elsewhere, such as on the shield 108 and, in some examples, on the upper surface 110 of the shield 108.

[0055] In embodiments, the indicator 154 may output a certain color light (e.g., a green light) when the probe 104 has been sufficiently pressed into the abdomen, based on data from the sensors 144 which would indicate when the shield 108 has made sufficient and appropriate contact with the abdomen. In some examples, the indicator 154 may output a different color light (e.g., a red light) if the probe 104 has been pressed to far into the abdomen and / or if the probe 104 has not been pressed far enough into the abdomen. In embodiments, the indicator 154 may flash at different colors, flash at speeds, and / or flash for different lengths of time, and these different colors, speeds or lengths of time at which the indicator 154 flashes light may be indicative of operation of the system 100. In embodiments, the indicator 154 is configured to emit a sound (such as an audible alarm or buzzer) if the probe 104 is pressed too far or not far enough into the abdomen. In embodiments, the indicator 154is configured to provide haptic feedback based on data from the sensor 144 such that the user feels vibration that may indicate that the probe 104 is or is not pressed sufficiently far into the patient.

[0056] In embodiments, the indicator 154 may also output user feedback (e.g., light and / or sound) based on data received from the sensor 208 (e.g., the accelerometer). For example, the indicator 154 may output a certain color light (e.g., a green light) when system 100 is oriented in the proper orientation (i.e., when held vertically), and / or may emit a different color light (e.g., a red light) or output an audible alarm when not held in a vertical orientation.

[0057] Thus, the digital bubble level 152 and the indicator 154 are configured to provide visual and / or audible user feedback that is indicative of whether the system 100 is being properly utilized.

[0058] In the illustrated embodiment, the system 100 also includes a user input or user interface 156. Here, the user interface 156 includes a plurality of buttons, knobs, switches, etc. that control the various features of the system 100, and which are positioned on the housing 116 of the gauge 102. However, at least a portion of the user interface 156 may be arranged elsewhere about the system 100, for example, on the shield 108. As will be appreciated, the user interface 156 may be utilized by the user / operator to turn the interface 156100 on and off, for initiating a measurement, for changing units that the information is displayed on the display 150, for zeroing or calibrating the system 100, etc.

[0059] The controller 202 may include a microcontroller or processor and memory. The controller 202 may be embodied by a printed circuit board, on which the processorand memory are arranged, and one or more of the sensors of the system 100 (e.g., the sensor 208 and / or the force sensor 204) may also be arranged on the printed circuit board. The force sensor 204, the sensor(s) 144 and the sensor 208 are read and controlled by the controller 202 (i.e., by the microcontroller or processor thereof). Data from these sensors is captured by the memory of the controller 202 (e.g., by an internal memory of microcontroller or processor thereof), and this data will be utilized by the controller 202 to determine if the operator / user correctly using the system 100, for example, if they are holding the system 100 in a vertical orientation and / or properly inserting the probe 104 into the abdomen; and the controller 202 will instruct the indicator 154 to output feedback (i.e., lights or sound) that is indicative of whether they are or are not using the system properly. In embodiments, the controller 202 may also or instead instruct the display 150 to output information that is indicative of whether they are or are not using the system properly.

[0060] The controller 202 is configured to determine IAP. In particular, the controller 202 is configured to calculate or correlate a value of the IAP of a particular patent based the AWT of that particular patient that was sensed by the force sensor 204. Data or readings indicative of the patient’s AWT (i.e., AWT data or AWT readings) from the force sensor 204 are received at the controller 202 and used by the controller 202 to determine the patient’s IAP. To make this determination, the controller 202 includes (or is programmed with) an algorithm that correlates AWT to IAP, and this algorithm is stored in the memory of the controller 202.

[0061] In embodiments, the system 100 is embodied as a handheld instrument, wherein the controller 202, the force sensor 204, and the accelerometer 208 arearranged inside of or on the housing 116, and the sensor(s) 144 (i.e., the proximity sensor and / or the contact sensor(s)) are arranged outside of or exterior to the housing 116.

[0062] Testing may be conducted to ascertain this algorithm. FIGS. 6A and 6B depict an example test that was conducted to validate correlation between AWT and IAP. Here, an endotracheal tube (ETT) 602 was as an abdominal phantom that simulated the abdomen of a patient. The ETT 602 was used as a tissue phantom due to its ability to inflate like a balloon to physiologically relevant pressures, and pressure within the ETT 602 was measured with a digital manometer 604 (or pressure transducer) and regulated / controlled with a syringe 606. The ETT 602, the manometer 604, and the syringe 606 were connected together at a T-pressure relief valve 608. In this manner, the balloon defined by the ETT 602 could be filled with fluid via the syringe 606, and the digital manometer 604 would continuously monitor and display the pressure experienced within the balloon via the injected fluid in real time, wherein the pressure within the balloon simulates the IAP of the patient’s abdomen. Then, a digital force gauge (or newton meter / gauge) (not shown) outfitted with the probe 104 was utilized to take readings of the force when the tip 106 of the probe 104 was pressed / inserted into the balloon defined by the ETT 602 until the shield 108 lightly touched the ballon 602, and the force readings obtained by the force meter (or Newton meter) simulated the AWT of the patient’s abdomen. In this test, the probe 104 was configured such that the penetration depth D of the tip 106 thereof was five (5) millimeters.

[0063] FIG. 7A is graph showing the relationship between pressure within and wall tension of the ETT 602 of FIG. 6A. Here, the wall tension of the balloon defined by the ETT 602 was measured by the digital force meter while the pressure within the balloon of the ETT 602 was measured by the manometer 604. As shown in FIG. 7A, wall tension measured by the digital force meter had a positive linear correlation with the internal pressure of the ETT 602 as measured by the manometer 602, thereby demonstrating a relationship or correlation between AWT and AIP.

[0064] To simulate the effects of skin and fat tissue at the abdomen of the patient, a second experiment was conducted. This second experiment is depicted in FIG. 6B and the results are shown in FIG. 7B. In this second experiment, medical-grade gel 610 was placed on top of the ETT 602 to simulate the effect of skin and fat tissue on the measurements, as shown in FIG. 6B which shows a cross-section of the ETT 602 with medical-grade gel 610 arranged thereon. In this second experiment, four (4) different thicknesses of the medical-grade gel 610 were applied to the ETT 602, and with measurements being conducted when each of the different thicknesses of the gel 610 were applied. Here, the medical-grade gel 610 was sequentially applied on top of the balloon defined by the ETT 602 in thicknesses of five (5) mm, six (6) mm, seven (7) mm, and eight (8) mm to evaluate the effect of skin and fat tissue on AWT and IAP at each of those thicknesses, and measurements were taken for each of the four (4) different thickness of the medical-grade gel 610. As shown in Fig. 7B, even in the presence of different amounts of medical-grade gel 610 which imitated different amounts of subcutaneous tissue, wall tension of the ETT 602 measured by the digitalforce meter correlates to the internal pressure of the ETT 602 measured by the manometer 604.

[0065] Embodiments disclosed herein include:

[0066] A. A system for monitoring intra-abdominal pressure (IAP) of an abdomen of a person, the system comprising: a force sensor; a probe operatively connected to the force sensor and configured to contact the abdomen, wherein the force sensor is configured to detect abdominal wall tension of the abdomen when the probe is pressed into the abdomen; and a controller configured to calculate intra-abdominal pressure of the abdomen based on abdominal wall tension readings received from the force sensor.

[0067] B. A device for monitoring intra-abdominal pressure (IAP) of an abdomen of a person, the system comprising: a gauge comprising: a housing, a display, a force sensor, and a controller in communication with the force sensor and the display; and a probe operatively connected to the force sensor and configured to contact the abdomen, wherein the force sensor is configured to detect abdominal wall tension of the abdomen when the probe is pressed into the abdomen, and wherein the controller is configured to calculate intra-abdominal pressure of the abdomen based on abdominal wall tension readings received from the force sensor, and wherein the display is configured to output calculated intra-abdominal pressure.

[0068] C. A method of determining intra-abdominal pressure within an abdomen of a patient, comprising: pressing a tip of a probe into the abdomen; detecting abdominal wall tension of the abdomen with a force sensor operatively connected to the probe, wherein the force sensor is configured to detect abdominal wall tension of the abdomen when the probe is pressed into the abdomen; and calculating, via a controller, intra-abdominal pressure of the abdomen based on abdominal wall tension readings received from the force sensor.

[0069] Each of embodiments A through C may have one or more of the following additional elements in any combination: Element 1 : further comprising a display in communication with the controller that outputs calculated intra-abdominal pressure. Element 2: further comprising a contact sensor and / or a proximity sensor in communication with the controller. Element 3: further comprising an indicator in communication with the controller that provides an indication based on data from the contact sensor and / or the proximity sensor. Element 4: further comprising a display in communication with the controller that outputs calculated intra-abdominal pressure, wherein the display is also configured to output information associated with the contact sensor and / or the proximity sensor. Element 5: further comprising an accelerometer in communication with the controller, wherein the accelerometer detects an attitude of the system. Element 6: further comprising an indicator in communication with the controller that provides indication of the attitude of the system. Element 7: wherein the indicator is a digital bubble level. Element 8: further comprising a display in communication with the controller that outputs calculated intra-abdominal pressure, wherein the display is also configured to output information associated with accelerometer. Element 9: wherein the probe includes a tip. Element 10: wherein the tip at least partially spherical. Element 11 : wherein the tip has a penetration depth that is greater than or equal to five millimeters and less than or equal to twelve millimeters. Element 12: wherein the probefurther includes a shield from which the tip protrudes, wherein the penetration depth is measured between a distal end of the tip and a lower surface of the shield. Element 13: wherein the tip is removable from the shield. Element 14: wherein the system includes a gauge having a housing within which the force sensor and the controller are provided. Element 15: wherein the system includes a terminal operatively connected to the force sensor and extending from the housing, wherein the probe is removably connected to the terminal. Element 16: further comprising: a proximity sensor in communication with the controller, wherein the proximity sensor is configured to detect when the shield contacts the abdomen; and an accelerometer in communication with the controller, wherein the accelerometer detects an attitude of the system; and wherein the display is configured to output information associated with proximity sensor and / or the accelerometer. Element 17: wherein the probe includes a shield and a tip protruding from the shield. Element 18: wherein the probe includes a tip having a penetration depth that is greater than or equal to five millimeters and less than or equal to twelve millimeters.

[0070] Element 19: further comprising a contact sensor in communication with the controller. Element 20: further comprising a display in communication with the controller that outputs calculated intra-abdominal pressure, wherein the display is also configured to output information associated with the contact sensor. Element 21 : further comprising a proximity sensor in communication with the controller. Element 22: further comprising a display in communication with the controller that outputs calculated intra-abdominal pressure, wherein the display is also configured to output information associated with the contact sensor and / or the proximity sensor.

[0071] By way of non-limiting example, exemplary combination applicable to A through B include: Element 3 with Element 2; Element 4 with Element 2; Element 6 with Element 5; Element 8 with Element 5; Element 13 with Element 10 and Element 9. Element 19 with Element 20; Element 21 with Element 22.

[0072] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, for example, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “contains”, “containing”, “includes”, “including,” “comprises”, and / or “comprising,” and variations thereof, when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0073] Terms of orientation used herein are merely for purposes of convention and referencing and are not to be construed as limiting. However, it is recognized these terms could be used with reference to an operator or user. Accordingly, no limitations are implied or to be inferred. In addition, the use of ordinal numbers (e.g., first, second, third, etc.) is for distinction and not counting. For example, the use of “third” does not imply there must be a corresponding “first” or “second.” Also, if used herein, the terms “coupled” or “coupled to” or “connected” or “connected to” or “attached” or “attached to” may indicate establishing either a direct or indirect connection, and is not limited to either unless expressly referenced as such.

[0074] The use of directional terms such as above, below, upper, lower, upward, downward, left, right, proximal, distal and the like are used in relation to the illustrative embodiments as they are depicted in the figures, the upward direction being toward the top of the corresponding figure and the downward direction being toward the bottom of the corresponding figure, the proximal direction being toward the user or operator of the medical device / system and the distal direction being toward the patient or the abdomen of the patient.

[0075] While the disclosure has described several exemplary embodiments, it will be understood by those skilled in the art that various changes can be made, and equivalents can be substituted for elements thereof, without departing from the spirit and scope of the invention. In addition, many modifications will be appreciated by those skilled in the art to adapt a particular instrument, situation, or material to embodiments of the disclosure without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed, or to the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims. Moreover, reference in the appended claims to an apparatus or system or a component of an apparatus or system being adapted to, arranged to, capable of, configured to, enabled to, operable to, or operative to perform a particular function encompasses that apparatus, system, or component, whether or not it or that particular function is activated, turned on, or unlocked, as long as that apparatus, system, or component is so adapted, arranged, capable, configured, enabled, operable, or operative.

Claims

WHAT IS CLAIMED IS:

1. A system for monitoring intra-abdominal pressure (IAP) of an abdomen of a person, the system comprising:a force sensor;a probe operatively connected to the force sensor and configured to contact the abdomen, wherein the force sensor is configured to detect abdominal wall tension of the abdomen when the probe is pressed into the abdomen; anda controller configured to calculate intra-abdominal pressure of the abdomen based on abdominal wall tension readings received from the force sensor.

2. The system of claim 1 , further comprising a display in communication with the controller that outputs calculated intra-abdominal pressure.

3. The system of claim 1 , further comprising a contact sensor and / or a proximity sensor in communication with the controller.

4. The system of claim 3, further comprising an indicator in communication with the controller that provides an indication based on data from the contact sensor and / or the proximity sensor.

5. The system of claim 3, further comprising a display in communication with the controller that outputs calculated intra-abdominal pressure, wherein the display is alsoconfigured to output information associated with the contact sensor and / or the proximity sensor.

6. The system of claim 1, further comprising an accelerometer in communication with the controller, wherein the accelerometer detects an attitude of the system.

7. The system of claim 6, further comprising an indicator in communication with the controller that provides indication of the attitude of the system.

8. The system of claim 7, wherein the indicator is a digital bubble level.

9. The system of claim 6, further comprising a display in communication with the controller that outputs calculated intra-abdominal pressure, wherein the display is also configured to output information associated with accelerometer.

10. The system of claim 1 , wherein the probe includes a tip that is at least partially spherical.

11. The system of claim 10, wherein the tip has a penetration depth that is greater than or equal to five millimeters and less than or equal to twelve millimeters.

12. The system of claim 10, wherein the probe further includes a shield from which the tip protrudes, wherein the penetration depth is measured between a distal end of the tip and a lower surface of the shield.

13. The system of claim 12, wherein the tip is removable from the shield.

14. The system of claim 1 , wherein the system includes a gauge having a housing within which the force sensor and the controller are provided.

15. The system of claim 1 , wherein the system includes a terminal operatively connected to the force sensor and extending from the housing, wherein the probe is removably connected to the terminal.

16. A device for monitoring intra-abdominal pressure (IAP) of an abdomen of a person, the system comprising:a gauge comprising:a housing,a display,a force sensor, anda controller in communication with the force sensor and the display; anda probe operatively connected to the force sensor and configured to contact the abdomen,wherein the force sensor is configured to detect abdominal wall tension of the abdomen when the probe is pressed into the abdomen, and wherein the controller is configured to calculate intra-abdominal pressure of the abdomen based on abdominal wall tension readings received from the force sensor, andwherein the display is configured to output calculated intra- abdominal pressure.

17. The device of claim 16, further comprising:a proximity sensor in communication with the controller, wherein the proximity sensor is configured to detect when the shield contacts the abdomen; andan accelerometer in communication with the controller, wherein the accelerometer detects an attitude of the system; andwherein the display is configured to output information associated with proximity sensor and / or the accelerometer.

18. The device of claim 16, wherein the probe includes a shield and a tip protruding from the shield.

19. The device of claim 16, wherein the probe includes a tip having a penetration depth that is greater than or equal to five millimeters and less than or equal to twelve millimeters.

20. A method of determining intra-abdominal pressure within an abdomen of a patient, comprising:pressing a tip of a probe into the abdomen;detecting abdominal wall tension of the abdomen with a force sensor operatively connected to the probe, wherein the force sensor is configured to detect abdominal wall tension of the abdomen when the probe is pressed into the abdomen; and calculating, via a controller, intra-abdominal pressure of the abdomen based on abdominal wall tension readings received from the force sensor.

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