Intraperitoneal pressure ("IPP") measurement device and system

Abstract

An intraperitoneal pressure ("IPP") measurement device and system are disclosed herein. In an example, an IPP measurement device includes: a transfer kit or catheter fluidly coupled to an abdominal cavity of a patient; and a pressure sensor adapted to contact the transfer kit or the flow guide tube. The pressure sensor is configured to transmit output data indicative of an IPP within a patient's abdominal cavity. The pressure sensor includes a pressure element configured to measure a pressure applied by a fluid within the transfer kit or flow conduit. The pressure sensor also includes a pressure amplifier having a first side that contacts a portion of the transfer kit or flow guide tube and a second side that contacts the pressure element. The first side has a larger diameter or surface area than the second side for amplifying an IPP measured pressure signal.

Description

[0001] This application is a divisional application of Chinese application No. 202180074048.5, filed on November 3, 2021, entitled “Intra-abdominal pressure (“IPP” measurement device and system”). Background Technology

[0002] For various reasons, a person's kidneys can fail. Kidney failure causes several physiological imbalances. For example, a person with kidney failure is no longer able to balance water and minerals or excrete the daily metabolic load. In addition, toxic metabolic byproducts such as urea, creatinine, and uric acid can accumulate in the patient's blood and tissues.

[0003] Decreased kidney function, especially kidney failure, is treated with dialysis. Dialysis removes waste products, toxins, and excess water from the body that would otherwise be cleared by normally functioning kidneys. Dialysis, used to replace kidney function, is crucial for many people because it is a life-saving treatment.

[0004] One type of treatment for kidney failure is peritoneal dialysis (“PD”), in which a dialysis solution (also called dialysis fluid or PD fluid) is injected into the patient’s peritoneal cavity via a catheter. The dialysis fluid comes into contact with the peritoneum within the patient’s abdominal cavity. Waste, toxins, and excess water enter the dialysis fluid from the patient’s bloodstream through capillaries in the peritoneum due to diffusion and osmosis (i.e., the appearance of an osmotic gradient across the membrane). The osmotic agent in the dialysis fluid provides this osmotic gradient. Used or discarded dialysis fluid is drained from the patient to remove waste, toxins, and excess water from the body. This cycle is repeated multiple times for the patient.

[0005] Various types of peritoneal dialysis therapies exist, including continuous ambulatory peritoneal dialysis (“CAPD”), automated peritoneal dialysis (“APD”), flowing dialysis, and continuous flowing peritoneal dialysis (“CFPD”). CAPD is a manual dialysis treatment. Here, the patient manually connects the implanted catheter to the drain line to allow used or waste dialysis fluid to drain from the peritoneum. The patient then switches the fluid connection so that the catheter is connected to a bag of fresh dialysis fluid to allow fresh dialysis fluid to be injected into the patient through the catheter. The patient disconnects the catheter from the fresh dialysis fluid bag, allowing the dialysis fluid to remain in the peritoneum for the removal of waste, toxins, and excess water. After the retention period, the patient repeats the manual dialysis procedure, for example, four times a day. Manual peritoneal dialysis requires a significant investment of time and effort from the patient and has considerable room for improvement.

[0006] Automated peritoneal dialysis (“APD”) is similar to CAPD in that dialysis treatment involves drainage, filling, and retention cycles. However, the APD machine performs this cycle automatically, typically while the patient is asleep. The APD machine eliminates the need for patients to manually perform treatment cycles and to deliver supplies during the day. The APD machine is fluidly connected to an implanted catheter, a source or bag of fresh dialysis fluid, and a fluid drain port. The APD machine pumps fresh dialysis fluid from the dialysis fluid source through the catheter into the patient's peritoneal cavity. The APD machine also allows dialysis fluid to remain in the cavity and allows for the removal of waste, toxins, and excess water. The source may include multiple liters of dialysis fluid, comprising several solution bags.

[0007] An APD machine pumps used or waste dialysate from the patient's peritoneum through a catheter to a drain. Similar to a manual procedure, there are several drain, fill, and retention cycles during dialysis. A "last fill" may occur at the end of an APD treatment. The fluid from this last fill may remain in the patient's peritoneum until the next treatment begins, or it may be manually emptied at some point during the day.

[0008] Typically, clinicians determine certain parameters that specify how PD (dialysis fluid) therapy should be performed. For example, clinicians may specify a fill volume parameter, which limits the amount of dialysis fluid to be delivered to the patient's peritoneum during the fill phase of a treatment cycle. Clinicians may also specify a discharge parameter, which limits how much used or waste dialysis fluid (and ultrafiltrate) will be removed during discharge. Clinicians may also specify a retention parameter, which limits the duration for which dialysis fluid will remain in the patient's peritoneum. For many treatments, clinicians may also prescribe a glucose concentration in the dialysis fluid to achieve a specific therapeutic purpose.

[0009] While all the parameters mentioned above are important for PD treatment, the fill volume parameter can be crucial. If the fill volume parameter is too high, the patient may experience overfilling during treatment, leading to discomfort. If the fill volume parameter is too low, PD treatment may be less effective at clearing accumulated toxins. Currently, many clinicians use measurements of the patient's intraperitoneal pressure (“IPP”) to estimate the fill volume parameter, which is a measure of the pressure within the patient's abdominal cavity caused by the accumulation of fluid and waste. Generally, a patient's IPP increases with increasing fluid volume. Fill volume can be determined as the amount of PD fluid supplied to the patient's abdominal cavity that causes the pressure to reach a clinically permissible threshold, typically between 15 and 20 cm H2O (0.213 to 0.284 psig). In some cases, the patient's abdominal cavity volume is estimated by comparing the patient's height, age, and sex to the population mean for similar individuals. The estimated volume can then be adjusted based on the measured IPP to determine the filler volume parameters for PD treatment.

[0010] IPP measurements can be less accurate for various reasons. The relatively low intra-abdominal pressure makes IPP measurements particularly challenging, as many pressure sensors provide more accurate readings above 1.0 psig, which may exceed some IPP ranges. In some cases, patient or measuring equipment movement during measurement can affect IPP values. Even slight movement can cause a 20% to 30% change in IPP measurements. Furthermore, the patient's food and beverage consumption within the 24 hours prior to measurement can also influence IPP results.

[0011] Therefore, there is a need to improve IPP measurement systems and methods. Summary of the Invention

[0012] This document discloses example systems, methods, and apparatuses for improved measurement or estimation of intraperitoneal pressure (“IPP”). In some embodiments, these systems, methods, and apparatuses include a pressure amplifier with a pressure sensor connected to or otherwise integrated with a transfer kit or tubing. An example pressure amplifier includes a first side and a second side, the first side contacting the transfer kit or tubing and the second side contacting a pressure sensor element. The first side has a smaller diameter compared to the second side. The pressure exerted on the first side of the amplifier by PD fluid located within the transfer kit or tubing is quantitatively increased based on Pascal's law to exert a proportionally larger force on the pressure sensor element. In alternative embodiments, pressure amplification can be accomplished using a different material having greater elasticity than the rest of the transfer kit or tubing. The region with greater elasticity applies a proportionally larger pressure to the sensor element. Improved pressure measurement enables clinicians to determine appropriate filler volume parameters for a patient.

[0013] Additionally or alternatively, in some embodiments, the systems, methods, and apparatuses disclosed herein include a force sensor disposed within a pressure sensor housing for measuring IPP. The force sensor may include at least one of an inertial sensor, a gyroscope, and / or an accelerometer for sensing at least one of linear and / or rotational accelerations along one or more axes. The force sensor provides indication of patient movement and / or pressure sensor movement during IPP measurement. Data output from the force sensor is used to normalize or adjust the IPP measurement data to compensate for any detected patient movement and / or pressure sensor movement that would otherwise affect the IPP measurement results.

[0014] Additionally or alternatively, in some embodiments, the systems, methods, and apparatuses disclosed herein include a spirometer for measuring IPP pressure. As an additional amount of PD fluid is delivered into the patient's abdominal cavity, the spirometer records the patient's vital capacity. The correlation between the patient's vital capacity and IPP at different filling volumes allows clinicians to use the measured vital capacity to determine filling volume parameters. In some cases, the spirometer is used in conjunction with a pressure sensor to provide a more accurate estimate of IPP and / or filling volume parameters. In other cases, the spirometer is used instead of a pressure sensor to estimate the patient's IPP for determining filling volume parameters for PD treatment.

[0015] Additionally or alternatively, in some embodiments, the systems, methods, and apparatuses disclosed herein include a processor that performs a comparison of IPP measurements with one or more ranges of pressure data to determine whether the drainage tube and / or transfer kit is partially blocked or misaligned. During the filling of a patient's peritoneal cavity with PD fluid, the detected pressure is compared with the one or more ranges. Detecting IPP data within a certain range may result in an alert being provided to prompt a clinician to examine the drainage tube or transfer kit. In some cases, IPP measurements are not accepted until they fall within an acceptable range during PD fluid filling. Furthermore, the processor may be configured to compare measured IPP data with one or more acceptable ranges to confirm that the IPP measurement corresponds to retention rather than PD fluid filling.

[0016] Additionally or alternatively, in some embodiments, the systems, methods, and apparatuses disclosed herein include a processor that receives patient information indicative of a patient's urine output, food / beverage intake, heart rate, and / or blood pressure. The patient information may correspond to time periods before, during, and / or after an IPP measurement. The processor is configured to use the patient information to adjust a fill volume parameter such that the parameter is not solely based on the IPP measurement. The patient information includes factors that may influence the IPP measurement. For example, high levels of beverage consumption and low urine output may indicate abdominal distension or fluid retention in the patient, which could result in a larger IPP measurement compared to a patient with a more normal fluid balance. Taking these factors into account allows for a more accurate fill volume determination for the patient.

[0017] Based on the disclosure set forth herein, and without limiting the scope of this disclosure in any way, in a first aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), an intraperitoneal pressure (“IPP”) measuring device includes: a transfer kit or catheter fluidly coupled to a patient’s abdominal cavity; and a pressure sensor configured to contact the transfer kit or catheter. The pressure sensor is configured to transmit output data indicating the IPP within the patient’s abdominal cavity. The pressure sensor includes: a pressure element configured to measure pressure exerted by fluid within the transfer kit or catheter; and a pressure amplifier having a first side and a second side, the first side contacting a portion of the transfer kit or catheter, and the second side contacting the pressure element. The first side has a larger diameter or surface area than the second side.

[0018] In a second aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the first side comprises a diameter or surface area that is at least twice the diameter or surface area of ​​the second side to provide at least 2 times the pressure amplification.

[0019] In a third aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the pressure element includes at least one of a piezoresistive strain gauge, a pressure-sensing diaphragm, a capacitive diaphragm, a pressure-sensing capsule, or a Boulden tube.

[0020] In the fourth aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the pressure sensor is integrally formed with the transfer kit or guide tube.

[0021] In the fifth aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the pressure sensor is mechanically connected to the transfer kit or the flow guide.

[0022] In a sixth aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), an intraperitoneal pressure (“IPP”) measurement system includes: a fluid container containing peritoneal dialysis (“PD”) fluid; and a transfer kit and a catheter in fluid communication with the fluid container and configured to be in fluid communication with a patient’s peritoneum to enable the PD fluid to be delivered to the patient’s peritoneum. The system also includes a pressure sensor configured to contact the transfer kit or catheter. The pressure sensor is configured to transmit output data indicating IPP within the patient’s peritoneum. The pressure sensor includes: a pressure element configured to measure pressure exerted by fluid within the transfer kit or catheter; and a pressure amplifier having a first side and a second side, the first side contacting a portion of the transfer kit or catheter, and the second side contacting the pressure element. The first side has a larger diameter or surface area than the second side. The system further includes a processor communicatively coupled to the pressure sensor. The processor is configured to: receive output data indicating the intraperitoneal pressure point (IPP) of the patient; and at least one of the following: use the output data indicating the IPP to determine a filling volume parameter for the patient's PD treatment, or cause the output data indicating the IPP to be displayed so that the filling volume parameter can be determined.

[0023] In the seventh aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the output data indicating the patient's intraperitoneal IPP corresponds to a pressure measurement performed by a pressure sensor during the retention interval between the delivery of PD fluid to the patient's intraperitoneal cavity and the removal of PD fluid from the patient's intraperitoneal cavity.

[0024] In the eighth aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the fluid container is positioned at head height, and the system further includes a line clamp that, when closed, blocks the flow of PD fluid through the transfer kit or guide tube.

[0025] In a ninth aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the system further includes a pump configured to move PD fluid from a fluid container through a transfer kit and a catheter to the patient’s abdominal cavity upon activation.

[0026] In the tenth aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the system further includes an automated peritoneal dialysis (“APD”) machine configured to provide PD treatment to a patient using at least the filler volume parameter.

[0027] In the eleventh aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the system further includes a force sensor included on or adapted to contact a transfer kit or a flow channel. The force sensor includes at least one of an inertial sensor, a gyroscope, or an accelerometer for sensing at least one of linear or rotational accelerations along one or more axes. The force sensor is configured to output force data indicating at least one of patient movement or movement of the pressure sensor.

[0028] In the twelfth aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the processor is configured to receive force data and use the force data to adjust output data indicating the IPP to calculate at least one measurement component associated with patient movement or pressure sensor movement.

[0029] In the thirteenth aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the processor is configured to: compare output data indicating the IPP with at least one data range; when the comparison is outside the at least one data range, provide an indication that at least one of the transfer kits or guide tubes is defective; and when the comparison is within the at least one data range, use the output data indicating the IPP to determine a fill volume parameter.

[0030] In the fourteenth aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the processor is configured to: receive second output data from a pressure sensor, the second output data indicating pressure during the filling of a patient's peritoneum with an increased amount of PD fluid; compare the second output data indicating pressure during the filling of the patient's peritoneum with a second data range; when the comparison is outside the second data range, provide an indication that at least one of the transfer kits or drainage tubes is problematic; and when the comparison is within the second data range, use the output data indicating IPP to determine filling volume parameters.

[0031] In the fifteenth aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the processor is configured to: receive patient information including at least one of urine output over a defined time period, food / drink intake over a defined time period, heart rate, or blood pressure; and use the patient information to adjust output data indicating IPP or fill volume parameters.

[0032] In the sixteenth aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the defined time period includes at least one of twenty-four hours or forty-eight hours prior to the pressure sensor providing output data indicative of the patient's IPP.

[0033] In the seventeenth aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), an intraperitoneal pressure (“IPP”) measurement system includes: a fluid container containing dialysis (“PD”) fluid; and a transfer kit and a catheter fluidly coupled to the fluid container and a patient’s peritoneum to enable the PD fluid to be delivered to the patient’s peritoneum. The system further includes: a spirometer for transmitting output data indicative of the patient’s vital capacity; and a processor communicatively coupled to the spirometer. The processor is configured to: record the output data from the spirometer during a retention interval between the delivery of PD fluid to the patient’s peritoneum and the removal of PD fluid from the patient’s peritoneum; and determine at least one of the IPP or a fill volume parameter, based at least on the output data from the spirometer, using the correlation between vital capacity and IPP.

[0034] In the eighteenth aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the system further includes a pressure sensor adapted to contact the transfer kit or drainage tube. The pressure sensor is configured to transmit second output data indicative of intraperitoneal IPP in the patient, wherein the processor is configured to use output data from the spirometer and the second output data from the pressure sensor to determine filling volume parameters.

[0035] In the nineteenth aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the fluid container is positioned at head height, and the system further includes a line clamp that, when closed, blocks the flow of PD fluid through the transfer kit or guide tube.

[0036] In the twentieth aspect of this disclosure (which may be combined with any other aspect or part thereof described herein), the system further includes a pump configured to move PD fluid from a fluid container through a transfer kit and a catheter into the patient's abdominal cavity.

[0037] In the twenty-first aspect, regarding Figures 2 to 15 Any feature, function, or alternative form described in any one or more of the images may be related to the descriptions of... Figures 2 to 15 Combined with any other features, functions, and alternative forms described in any other diagram.

[0038] In view of this disclosure and the foregoing aspects, the advantage of this disclosure is that it provides improved IPP measurement or estimation.

[0039] Another advantage of this disclosure is that it allows for the determination of more accurate filler volume parameters for PD treatment.

[0040] Another advantage of this disclosure is that patient factors and / or movement are taken into account during IPP measurement to provide adjustments for IPP measurement.

[0041] Additional features and advantages are described in the following detailed description and accompanying drawings, and will become apparent from them. The features and advantages described herein are not exhaustive, and in particular, many additional features and advantages will be apparent to those skilled in the art in light of the drawings and description. Furthermore, any particular embodiment may not necessarily possess all the advantages listed herein, and it is expressly contemplated that individual advantageous embodiments be claimed separately. In addition, it should be noted that the language used in the specification has been chosen primarily for readability and guidance purposes, and not to limit the scope of the subject matter of the invention. Attached Figure Description

[0042] Figure 1 A schematic diagram of a known IPP measurement technique is shown.

[0043] Figure 2 This is a schematic diagram illustrating how the volume of the abdominal cavity changes during inhalation and exhalation.

[0044] Figure 3 and Figure 4 This is a schematic diagram of an example IPP measurement system according to an exemplary embodiment of the present disclosure.

[0045] Figures 5 to 7 This is an example embodiment based on the present disclosure. Figure 3 and Figure 4 A schematic diagram of a pressure sensor.

[0046] Figure 8 This illustrates a connection according to an example embodiment of the present disclosure. Figures 3 to 7 A schematic diagram of a pressure sensor or a force sensor integrated with the pressure sensor in other ways.

[0047] Figure 9 This is a flowchart illustrating an example procedure for combining force output data with IPP measurements to determine filling volume parameters, according to an example embodiment of this disclosure.

[0048] Figure 10 This is a schematic diagram illustrating how a processor and / or portable device according to an example embodiment of the present disclosure calculates the IPP component related to patient movement and / or sensor movement.

[0049] Figure 11 and Figure 12 This is a schematic diagram illustrating a comparison of IPP measurements with one or more ranges and / or thresholds according to an exemplary embodiment of this disclosure.

[0050] Figure 13 This is a schematic diagram illustrating data processing performed by a processor and / or portable device according to an example embodiment of the present disclosure to adjust IPP measurements based on patient information.

[0051] Figure 14 This is a schematic diagram of an example system according to an exemplary embodiment of the present disclosure, in which a spirometer is used to measure vital capacity to determine filler volume parameters for PD treatment.

[0052] Figure 15 This is a schematic diagram of a patient-specific correlation curve between vital capacity and filler volume according to an exemplary embodiment of the present disclosure. Detailed Implementation

[0053] This document discloses methods, systems, and devices for improved measurement or estimation of intraperitoneal pressure (IPP). These methods, systems, and devices provide more accurate IPP measurement and / or filling volume estimation compared to known IPP measurement techniques. As described herein, these methods, systems, and devices include one or more of the following: (i) providing a sensor amplifier to amplify the measurement values ​​of a pressure sensor to correspond to a more sensitive and accurate region of the pressure sensor element; (ii) using a force sensor to adjust for movement of the pressure sensor and / or the patient during IPP measurement; (iii) using a spirometer to correlate vital capacity with IPP and / or patient filling volume; (iv) using known ranges to validate IPP measurement data; and / or (v) using urine output data, food / beverage consumption data, blood pressure data, and / or heart rate data to adjust IPP measurement and / or filling volume estimation.

[0054] The disclosure herein is intended to perform IPP measurements to determine the filling volume parameters for PD treatment. It should be understood that any of the methods, systems, and devices disclosed herein can also be used to measure IPP during PD treatment. IPP measurements during treatment can be used to stop PD fluid filling, prolong PD discharge, and / or switch from continuous circulatory peritoneal pulverization (“CCPD”) therapy to tidal therapy when the detected IPP exceeds a threshold. In some cases, IPP measurements exceeding the threshold can trigger alarms to the patient and / or to the clinician.

[0055] Figure 1 A schematic diagram of a known IPP measurement technique is shown. A known IPP measurement system 100 includes a transfer kit 102 fluidly connected to a catheter 104, which is inserted into or fluidly connected to a patient's abdominal cavity 106. The other end (not shown) of the transfer kit 102 is connected to a fluid source or container, such as PD fluid. The IPP measurement system 100 also includes a measurement or drainage line 108 fluidly connected to the catheter 104 and / or the transfer kit 102.

[0056] IPP measurement provides a measurement of intraperitoneal pressure (IPP) in a patient for a given volume of infused PD fluid. For IPP measurement, the patient is typically in a supine or horizontal position, such as... Figure 1 As shown. Furthermore, the patient is relaxed, and their head is supported to allow their abdominal wall to relax. This patient position avoids pressure on the abdomen. Figure 1 As shown, the drainage bag 112 is held on an elevated support of the drainage tube 108. A ruler or other distance measuring device 114 is placed next to the drainage tube 108, extending upward from the patient to the bag 112, and aligning the 0 mark (i.e., 0 cm) with the mid-axillary line, as shown.

[0057] To perform the measurement, PD fluid is supplied from a source to the patient's peritoneal cavity 106 via transfer kit 102 and drainage tube 104. The peritoneal cavity 106 is filled to a certain percentage of its volume. After the desired amount of PD fluid has been supplied to the peritoneal cavity 106, clamp 110 is closed to prevent further flow of fluid from the source. Next, the drainage tube connection is opened to allow at least some PD fluid to flow from the patient's peritoneal cavity into drainage line 108. The column of PD fluid rises in drainage line 108 to a level at which it stabilizes with respiratory oscillations of 1 to 3 cm H2O, providing an average measurement. Figure 2 This is a schematic diagram illustrating how abdominal cavity volume changes during inhalation and exhalation. As shown in the diagram, the IPP is larger during inspiration and decreases due to abdominal cavity contraction. The increment of IPP change between inspiration and exhalation is averaged to determine the patient's IPP. In other words, IPP is measured as the midpoint of this oscillation and expressed in centimeters (“cm” H2O). Once the measurement is obtained, the abdominal cavity is drained, and the volume in drainage bag 112 is recorded as the filling volume. This process can be repeated for different amounts of PD fluid to determine the correlation between IPP measurement and filling volume for a particular patient.

[0058] In stable adult patients with Parkinson's disease (PD), an intraperitoneal pressure (IPP) of 10 to 16 cm H2O at the mid-axillary line is considered acceptable for PD treatment, which typically corresponds to 1.3 to 2.8 liters ("L") of infused PD fluid. Differences in IPP and infused PD fluid volume among patients are attributed to intraperitoneal volume ("IPV"), body position (standing patients show an increase of 2 to 4 cm H2O compared to lying down), physical activity, weight, height, and sex. Clinicians generally prefer to keep IPP below 18 to 20 cm H2O, as higher pressure is associated with symptoms such as discomfort, fullness, sleep disturbances, hemodynamic problems, and respiratory changes. Higher pressure may also lead to certain mechanical complications (leakage, hernia, etc.).

[0059] IPP measurement can also be performed while the patient is standing or sitting. In these cases, the "0" point is considered to be on the midaxillary line, that is, at the midpoint between the xiphoid process and the pubic symphysis, or in the patient's anterior superior iliac spine. Despite the change in location, IPP measurement is performed in the same manner as described above for lying patients.

[0060] I. IPP Measurement Example

[0061] Figure 3 and Figure 4This is a schematic diagram of an example IPP measurement system 300 according to an exemplary embodiment of the present disclosure. The example system 300 includes a transfer kit 102 having a first end connected to a fluid container 302. The fluid container 302 may include any physiologically compatible fluid source. The fluid container 302 is a PD fluid source and may include a bag or other housing constructed to contain a volume of fluid, such as one to two liters. In some embodiments, the fluid container 302 includes fresh, pre-prepared PD fluid with a predetermined glucose concentration. In some embodiments, the fluid container 302 may include two chambers, one containing dialysis concentrate and the other containing purified water. In such embodiments, the container 302 includes a seal that, when broken, allows the fluids in the two chambers to mix. Physiologically compatible fluids may include PD fluid, saline, renal replacement fluid, etc.

[0062] The second end of the transfer kit 102 is connected to the drainage tube 104, which is fluidly connected to the patient's abdominal cavity 106. The transfer kit 102 and / or the drainage tube 104 may be made of any one or more of the following: polyvinyl chloride (“PVC”), polyethylene (“PE”), polyurethane (“PU”), polycarbonate or other non-PVC materials.

[0063] In some embodiments, Figure 3 System 300 may include line clamps 110 to selectively restrict the flow of PD fluid through transfer kit 102. The illustrated embodiment may also include pump 304. Example pump 304 may include a pump head fluidly connected to transfer kit 102. Pump 306 may be any type of fluid pump, such as a peristaltic pump, gear pump, or membrane pump. The pump head may be disposable and connected to a reusable actuator controlled by an internal or external control unit. Example pump 304 is configured to pump fresh PD fluid from container 302 into the patient's peritoneal cavity 106 to perform IPP measurements. Example pump 304 may also pump used PD fluid (including cleared toxins and absorbed ultrafiltrate) back from the patient's peritoneal cavity 106 to container 302 after an IPP measurement has been recorded. In alternative embodiments, separate pumps are provided for (i) pumping fluid into the patient and (ii) pumping or pulling fluid out of the patient. In some embodiments, pump 304 is configured to block the flow of fluid from fluid container 302 until the pump head is actuated, thereby preventing free flow of PD fluid and allowing clamp 110 to be omitted.

[0064] Figure 3The IPP measurement system 300 also includes a pressure sensor 306 for performing IPP measurements. In the illustrated embodiment, the pressure sensor 306 is positioned to measure the fluid pressure within the transfer kit 102. In other embodiments, the pressure sensor 306 may be connected to or have a flow channel 104 provided with it. The pressure measurement indicates the pressure of the fluid being delivered to or removed from the abdominal cavity 106 when PD fluid is supplied to or removed from the abdominal cavity. When pumping stops and PD fluid is allowed to remain in the abdominal cavity for a specific duration, the pressure measurement provided by the pressure sensor 306 is an indication of IPP. The pressure measurement can also be used to detect line blockages (based on upward positive pressure or negative pressure spikes / trends) or fluid leaks (based on downward positive pressure or negative pressure spikes / trends).

[0065] In the illustrated example, pressure sensor 306 is shown aligned with transfer kit 102. It should be understood that pressure sensor 306 may be aligned with or otherwise integrated with flow guide 104. It should also be understood that pressure sensor 306 may include a disposable section contacting transfer kit 102 and the PD fluid, while the remainder of sensor 306 may be reusable between IPP measurements. Alternatively, the entire pressure sensor 306 may be disposable.

[0066] In some embodiments, system 300 may further include a flow sensor (not shown) with an output section, which is integrated to measure the volume of PD fluid supplied to and / or removed from the patient. It should be understood that, additionally or alternatively, one or more pressure sensors 306 may be used to measure the flow rate or velocity of fluid delivered to or removed from the peritoneal cavity 106. Furthermore, system 300 may include a heater for heating the PD fluid prior to infusion to the patient. System 300 may further include a temperature sensor to ensure that the PD fluid is heated to a desired temperature.

[0067] Although not shown, an air trap may be provided in transfer kit 102 to purge air from the PD fluid before delivery to the patient. In other cases, air can be purged by filling transfer kit 102 without the need for an air trap. Heating the dialysate tends to separate dissolved air from the dialysate. Therefore, it is envisioned to place the air trap downstream of the heater (e.g., along transfer kit 102) and upstream of the temperature sensor.

[0068] Example system 300 also includes a processor 310 for communicating with pressure sensor 306. Processor 310 may include any computer, laptop, workstation, server, etc. In some embodiments, processor 310 is communicatively coupled to pressure sensor 306 via a wired interface (such as Universal Serial Bus (“USB”) connection) or a wireless interface (such as Bluetooth®, Zigbee®, or Near Field Communication (“NFC”) connection). Additionally, processor 310 may also be communicatively coupled to pump 304.

[0069] As described herein, example processor 310 executes machine-readable instructions stored in a memory device. These instructions may include an application program or software program. Execution of the instructions causes processor 310 to perform the operations described herein. For example, processor 310 receives IPP measurement output data transmitted from pressure sensor 306. Processor 310 can ensure that the received IPP output data conforms to a specified range. Furthermore, processor 310 can adjust the output data based on patient information and / or force sensor information.

[0070] The operations performed by processor 310 provide for the determination of filler volume parameters for PD treatment. In some embodiments, processor 310 uses received data to calculate or otherwise determine filler volume parameters for the patient being measured. Additionally or alternatively, processor 310 may enable a display device to display IPP measurements and / or adjustment information to enable clinicians to determine filler volume parameters for PD treatment of the patient.

[0071] Figure 4 This is a schematic diagram of another embodiment of the IPP measurement system 300. Figure 4 In the illustrated example, the pump 304 is replaced by positioning the fluid container 302 at or above the patient's head height (e.g., three to six feet above the ground). This allows gravity to pull the PD fluid from the fluid container 302 through the transfer kit 102 into the patient's abdominal cavity 106. In the illustrated example, the clamp 110 provides selective flow of the PD fluid.

[0072] also, Figure 4 A portable device 402 is shown communicatively connected to a pressure sensor 306. This connection can be via a wired interface (such as a USB connection) or a wireless interface (such as Bluetooth®, Zigbee®, NFC, etc.). The portable device 402 may include a smartphone, tablet, laptop, etc. In some cases, the portable device 402 communicatively connects to a server or... Figure 3 The processor 310. The portable device 402 is configured to receive IPP output data from the pressure sensor 306 for determining the patient's filling volume parameters. Figure 3 Similar to the processor 310, the portable device 402 is capable of adjusting IPP measurements and / or filling volume parameters based on force sensor output data and / or patient information.

[0073] Figures 5 to 7 This is an example embodiment based on the present disclosure. Figure 3 and Figure 4 A schematic diagram of pressure sensor 306 is shown. In the illustrated embodiment, the pressure sensor includes an amplifier. Typical IPP values ​​are between 15 and 20 cm² H₂O (0.213 to 0.284 psig). However, many commercial pressure sensors used in medical applications have a pressure range of 0.0 to 5.0 psig. Therefore, using a commercial pressure sensor to measure IPP may only utilize a small portion of the lower side of the detectable pressure. Many known pressure sensors have low accuracy below 0.8 psig and may not have sufficient measurement accuracy for the pressure range between 0.2 and 0.3 psig. The disclosed amplifier increases the measurement range, thereby enabling pressure sensor 306 to provide a more accurate distinction between IPP measurements.

[0074] Figure 5 A pressure sensor 306 is shown, which is adapted to contact the transfer kit 102. In other cases, the pressure sensor 306 may be connected to or integrated with the flow guide 104. The pressure sensor 306 includes a pressure element 502 that converts the measured pressure into a digital and / or analog signal. The pressure element 502 includes at least one of a piezoresistive strain gauge, a pressure-sensing diaphragm, a pressure chamber, a capacitive diaphragm, a pressure-sensing capsule, or a Boulden tube.

[0075] The pressure sensor 306 also includes an amplifier 504. The amplifier 504 includes a first side that is a portion of the contact transfer assembly 102. A second, opposing side of the amplifier 504 contacts the pressure element 502. Compared to the second side of the pressure element 502, the first side of the amplifier 504 has a larger diameter or surface area. The difference in force... Figure 5 The image shows pistons, with the first piston having a larger surface area than the second piston. A force applied to the first piston from the transfer assembly 502 causes the first piston to exert a force on the second piston. The force from the first piston concentrates on the smaller surface area of ​​the second piston. This concentration of force results in an increase in the applied force, which is sensed by the pressure element 502.

[0076] In one embodiment, pressure amplifier 504 uses Pascal's law to amplify the fluid pressure in transfer kit 102. Pressure amplification enables medical-grade pressure sensors to be used in this low IPP measurement application. According to Pascal's law, force or pressure is proportional to the surface area on which it is applied. In the example, pressure is applied to a surface area of ​​2 cm. 2 The first surface area is 1 psig, and a force of 1 cm² makes the surface area 1 cm². 2 A force of approximately 2 psig is applied to the second surface of the pneumatically and / or mechanically coupled amplifier. In the illustrated example, the area (A1) of the first side of amplifier 504 is at least twice the area (A2) of the second side, thereby providing a gain of at least two. In other embodiments, the areas of the first and second sides can be selected to provide a gain of three, four, five, ten, twenty, etc.

[0077] In the illustrated example, processor 310 and / or portable device 402 are configured to normalize the IPP measurement for amplification. For example, if amplification is provided by amplifier 504, processor 310 and / or portable device 402 can reduce the IPP measurement value by an amplification factor. In other embodiments, a fill volume parameter may be associated with the amplified IPP measurement value.

[0078] Figure 6 An alternative embodiment of the pressure sensor 306 is shown. In the illustrated embodiment, segment 602 of the transfer kit 102 comprises a material with greater elasticity compared to other segments. This greater elasticity allows segment 602 to amplify the pressure applied to the pressure element 502 as pressure increases within the transfer kit 102. Figure 5 The examples discussed are similar. Figure 6 The example provides an increased IPP measurement range, thereby improving the accuracy of IPP measurement detection. In some embodiments, the elastic expansion of the material in segment 602 is linear. If the material in segment 602 exhibits nonlinear expansion, the processor 310 and / or the portable device 402 are configured to calculate the nonlinearity of the material. This calculation may include providing a nonlinear calibration curve for segment 602 corresponding to the linear pressure change within transfer kit 102.

[0079] Figure 7Another embodiment of the pressure sensor 306 is shown. In this example, at least a portion of the transfer kit 102 includes a dual cavity having a fluid path side 702 and a non-fluid path side 704. This dual cavity may extend through the transfer kit 102 or be located in a section adjacent to the sensor element. The non-fluid path side 704 may be filled with air or fluid of known volume and / or pressure to provide a reference pressure. A diaphragm 706 separates the two sides 702 and 704 of the transfer kit 102. When the reference side 704 has a greater pressure, the diaphragm 706 moves toward the fluid path side 702, and vice versa. The sensor element 710 may be positioned adjacent to the reference side 704. As the diaphragm 706 moves, the volume within that side 704 changes, thereby changing the internal pressure. The sensor element 710 senses this internal pressure, which is transmitted as an IPP measurement to the processor 310 and / or the portable device 402.

[0080] II. Force sensing embodiment

[0081] Figure 8 This illustrates a connection according to an example embodiment of the present disclosure. Figures 3 to 7 A schematic diagram of a pressure sensor 306 or a force sensor 802 otherwise integrated with the pressure sensor. In some cases, IPP measurements performed by the pressure sensor 306 may be inaccurate due to changes in the orientation of the patient or the sensor itself. Changes in orientation or position can cause increases or decreases in IPP pressure readings due to changes in head height and / or changes in stress on the abdominal cavity.

[0082] To reduce IPP measurement errors, example force sensor 802 provides force output data indicating movement of pressure sensor 306 and / or patient movement. This force output data is received by processor 310 and / or portable device 402 to adjust IPP measurements and / or fill volume parameters. In some cases, force values ​​above a certain threshold may cause processor 310 and / or portable device 402 to ignore IPP measurements. For example, detecting a significant change in patient position may cause IPP measurements recorded during that movement to be cleared from processor 310 and / or portable device 402, as the movement may contribute significantly to the measurement error.

[0083] Force sensor 802 may include an inertial sensor, a gyroscope, and / or an accelerometer. Sensing may be provided on at least one axis, including the x-axis, y-axis, z-axis, yaw axis, pitch axis, and / or roll axis. In some embodiments, force sensor 802 and / or pressure sensor 306 are positioned on or in line with the patient's midline (if supine) or pelvic cup (if sitting / standing). Force sensor 802 detects relative changes in the orientation / angle of pressure sensor 306 and / or the patient relative to the initial placement position.

[0084] Force sensor 802 transmits force output data to processor 310 and / or portable device 402. In some cases, force sensor 802 may use the same transceiver or transmitter as pressure sensor 306. In other cases, force sensor 802 may have its own transceiver or transmitter. Processor 310 and / or portable device 402 use the force output data to determine whether the IPP measurement should be processed, and if so, to provide adjustments to the IPP measurement and / or fill volume parameters.

[0085] Figure 9 This is a flowchart of an example procedure 900 for combining force output data with IPP measurements to determine a patient's filling volume parameters, according to an exemplary embodiment of this disclosure. Although referenced... Figure 9 The flowchart shown describes procedure 900, but it should be understood that many other methods can be used to perform the steps associated with procedure 900. For example, the order of the blocks can be changed, some blocks can be combined with other blocks, and the blocks described can be optional. In one embodiment, the number of blocks can be varied. For example, force output data can be used to correct for fill volume parameters instead of IPP measurements. The actions described in procedure 900 are specified by one or more instructions and can be performed among multiple devices, including, for example, force sensor 802, pressure sensor 306, processor 310, and / or portable device 402.

[0086] Example procedure 900 begins when the patient is connected to transfer kit 102 and drainage tube 104. After transfer kit 102 is in place, force sensor 802 is zeroed or reset (box 902) while positioned at the patient's midline or low pelvis. This reset provides the zero point for the inertial sensor and / or accelerometer. In some cases, the clinician can manually zero force sensor 802 by pressing a reset button on the sensor. Alternatively, the clinician can type input into processor 310 and / or portable device 402, which transmits instructions to force sensor 802 to zero or reset it.

[0087] The clinician then begins filling the patient's abdominal cavity. After the abdominal cavity is filled to a certain percentage, the flow of PD fluid is stopped, and pressure sensor 306 transmits IPP measurement data 903, indicating the IPP within the abdominal cavity (box 904). Processor 310 and / or portable device 402 receive force output data 905 from force sensor 802 (box 906). Processor 310 and / or portable device 402 compares the force output data 905 to one or more force limits (box 908). If the force output data 905 exceeds the one or more force limits, processor 310 and / or portable device 402 ignores the corresponding IPP measurement data 903 (box 910). Force output data exceeding the one or more limits may indicate a change in patient position, further significant movement, or dislodgement of pressure sensor 306 or transfer tubing 102. In these cases, the IPP measurement data will be inaccurate or not represent the actual IPP pressure.

[0088] When the force output data is within one or more of the stated limits, the processor 310 and / or the portable device 402 continue to process the IPP measurement data 903 (block 912). This includes determining the IPP measurement component resulting from the measured force (block 914). Figure 10 This is a schematic diagram illustrating how the processor 310 and / or portable device 402, according to an exemplary embodiment of this disclosure, calculates the IPP component associated with patient movement and / or sensor movement. In the illustrated example, sensors 306, 802 can be moved to different or more convenient positions for the clinician or patient, such as higher or lower. This could be due to a higher patient drainage tube outlet or to position sensors 306, 802 in the most comfortable or convenient position for the clinician / patient. The processor 310 and / or portable device 402 uses raw force output data 1002 to calculate the positional change of sensors 306, 802. This positional change provides, for example, a change in head height, which, based on the degree of the change, is associated with a change in pressure within the transfer kit 102. Changes in lateral position and / or rotation also correspond to changes in pressure. This pressure change is summarized as an IPP component (i.e., Δh) associated with the movement of sensors 306, 802 and / or the patient. Figure 10 As shown, processor 310 and / or portable device 402 adjust the IPP measurement based on the IPP components associated with the force output data. This may include updating adjustments based on the IPP components or performing subtraction. Figure 9 (Box 916).

[0089] Back Figure 9The processor 310 and / or portable device 402 then outputs or otherwise causes the adjusted IPP measurement 917 to be displayed (block 918). In some cases, steps 902 through 918 are repeated at least once to obtain a sample set of IPP measurements for one or more respiratory cycles, allowing the IPP measurements to be averaged. In some embodiments, the processor 310 and / or portable device 402 causes a graph to be displayed showing the change of IPP measurements over time, thereby enabling the calculation or otherwise determination of the mean. The processor 310 and / or portable device 402 then determines a filling volume parameter based on the adjusted IPP measurement (block 920). The filling volume can be determined by relating the IPP measurement to the filling volume of a patient with a similar body mass / height to the patient being measured. In other cases, a flow sensor or discharging and measuring PD fluid can be used to measure the volume of PD fluid infused to the patient.

[0090] In some embodiments, if the IPP measurement is below a threshold for performing adequate PD filling, additional PD fluid may be added to the patient. Steps 902 to 918 may be repeated until the adjusted IPP measurement is between 16 and 19 cm H2O or between 0.25 and 0.28 psig, indicating an adequate filling volume for PD treatment. The filling volume parameters are then determined based on the patient's characteristics and / or the amount of PD fluid infused into the patient's peritoneal cavity as detected. The filling volume parameters can then be used for subsequent PD treatment, i.e., continuous ambulatory peritoneal dialysis (“CAPD”) treatment using a PD machine or manually. This example procedure 900 then concludes.

[0091] In some embodiments, the patient may wear a force sensor. For example, the force sensor may be attached to the patient's wrist or abdomen. Output data from this sensor provides additional data indicating patient movement. The force sensor worn by the patient may be used in conjunction with a force sensor 802 equipped with a pressure sensor 306. Alternatively, only a force sensor attached to the patient may be provided. In some cases, data from the force sensor attached to the patient is tracked over time along with IPP measurements. For example, the patient may be performing routine work or a set of activities while connected to the transfer kit 102. IPP measurements may be correlated with the force data (so that force-related components are cleared) to identify how the patient's IPP changes with different orientations and / or activities. Clinicians can use this correlation to ensure that the fill volume does not cause the patient's IPP to exceed clinically recommended limits regardless of the patient's position or activity, thereby improving patient comfort during treatment. The fill volume determined by the clinician can then be set in the patient's treatment or device prescription and downloaded locally or remotely to the patient's circulatory system or peritoneal dialysis machine.

[0092] III. IPP Measurement Verification Example

[0093] In some embodiments, the processor 310 and / or portable device 402 are configured to verify IPP measurement data before processing the data. For example, such as Figure 9 As shown in block 908, processor 310 and / or portable device 402 compare received IPP measurement data with one or more ranges or thresholds that indicate significant patient and / or sensor movement. This operation may also include comparisons with one or more ranges and / or limits corresponding to normal filling pressure and / or expected IPP measurements. IPP measurements outside these ranges and / or limits may indicate problems with tubing connections, tubing blockage, leaks in the transfer kit, or other fluid connectivity issues.

[0094] Figure 11 A graph 1100 is shown comparing illustrated IPP measurements to one or more ranges and / or thresholds according to an example embodiment of this disclosure. Graph 1100 includes a first range 1102 corresponding to an acceptable pressure measurement when PD fluid is injected into a patient's peritoneal cavity. During PD fluid filling, forces are applied to sensor elements (e.g., transducer membranes) due to fluid flow. The first range 1102 may be associated with gravity-fed fluid filling, while a second range may be used if a pump supplies PD fluid.

[0095] The graph 1100 also includes a second range 1104, which corresponds to a pressure drop due to partial blockage of the transfer kit or tubing. During the filling phase, the processor 310 and / or portable device 402 receives IPP measurement data and compares it to the first range 1102 and the second range 1104. If the IPP measurement data corresponds to the second range 1104, the processor 310 and / or portable device 402 can generate an alarm or other message / indication indicating a problem with the tubing and / or transfer kit. Furthermore, the processor 310 and / or portable device 402 can prevent processing of subsequent IPP measurements until it is confirmed that the patient has been correctly filled with PD fluid.

[0096] Graph 1100 shows that pressure measurements decrease over time. This decrease is a result of the reduced flow rate as the gravity-fed PD fluid bag empties into the patient. In some cases, ranges 1102 and 1104 may have corresponding decreases over time to account for the expected pressure drop during PD fluid infusion. For simplicity, pressure values ​​on the y-axis are normalized.

[0097] The graph 1100 also includes a third range 1106, which applies after the flow of the PD fluid has ceased and the fluid is allowed to remain in the patient's abdominal cavity. The processor 310 and / or portable device 402 can use the third range 1106 to identify IPP measurements exceeding the permissible pressure threshold, which may indicate patient movement, transfer kit movement, or overfilling of the patient. IPP measurements exceeding the third range 1106 can be ignored by the processor 310 and / or portable device 402. Additionally or alternatively, the processor 310 and / or portable device 402 can generate an alarm. It should be noted that IPP measurements increase over time as the PD fluid absorbs waste and other toxins from the patient, increasing the volume of fluid within the abdominal cavity and thus increasing the measured pressure. The processor 310 and / or portable device 402 can be configured to record IPP measurements over time to ensure that the PD filling volume does not exceed the permissible IPP during the retention phase, which may cause patient discomfort during PD treatment.

[0098] Figure 12 An alternative embodiment, graph 1200, is shown where the processor 310 and / or portable device 402 uses recorded bag filling head height values ​​and bag solution volumes to determine a threshold 1202 corresponding to the expected filling pressure. When a pump is provided, the expected pump pressure value can be used instead. In this example, the processor 310 and / or portable device 402 estimates the threshold based on actual filling conditions to more accurately determine if there are problems with injecting PD fluid into the patient's peritoneum. Graphs 1100 and 1200 can be displayed to the clinician by the processor 310 and / or portable device 402.

[0099] IV. Adjusting the Implementation Example Using IPP Measurements from Patient Information

[0100] During IPP measurement, the processor 310 and / or portable device 402 can adjust the IPP measurement or fill volume parameters based on received patient information. In some cases, a patient's fluid retention can affect abdominal cavity volume or the pressure exerted on the abdominal cavity, which can influence the IPP measurement. Furthermore, a patient's blood pressure or heart rate may indicate whether the patient is under stress or fatigue, which can also affect the IPP measurement.

[0101] Figure 13This is a schematic diagram 1300 illustrating data processing by a processor 310 and / or portable device 402 to adjust IPP measurements based on patient information, according to an exemplary embodiment of this disclosure. As shown, the processor 310 and / or portable device 402 receives IPP measurement data 903. The processor 310 and / or portable device 402 may also receive urine data 1302, indicating urine output from a patient at a specific time prior to the IPP measurement, such as urine output from 24 or 48 hours prior. Urine output may be self-reported by the patient and entered into the processor 310 and / or portable device 402. In other cases, urine output may be measured in a container and entered into the processor 310 and / or portable device 402.

[0102] The processor 310 and / or portable device 402 also receive food and beverage consumption information 1304. This information provides an indication of how much food and beverage the patient consumed before or between IPP measurements. Urine data 1302 and food / beverage data 1304 together provide fluid balance information. The processor 310 and / or portable device 402 are configured to calculate the patient's fluid balance by adding food / beverage data 1304 and subtracting urine data 1302, and to calculate metabolic combustion of fluids based on a patient group with similar age, sex, height, and weight. The processor 310 and / or portable device 402 then determines whether the patient's fluid balance is subject to an IPP measurement component by comparing the calculated balance information with the correlation between the IPP measurement value and the balance information of patients with similar height, sex, weight, etc. The processor 310 and / or portable device 402 then adjusts the IPP measurement data 903 by calculating the IPP component associated with fluid balance. In cases of negative fluid balance (such as dehydration), this adjustment may result in an increase in the IPP measurement value.

[0103] The processor 310 and / or portable device 402 also receive heart rate and blood pressure data 1306. Based on a patient group with similar height, weight, sex, age, etc., the processor 310 and / or portable device 402 correlate the data 1306 with IPP measurement components. The processor 310 and / or portable device 402 then adjusts the IPP measurement values ​​by identifying the obtained IPP measurement components.

[0104] After adjusting the IPP measurement, the processor 310 and / or portable device 402 determine the filling volume parameter 917. As discussed above, this may include comparing the adjusted IPP measurement (or a trend of the adjusted IPP measurement) to the filling IPP limit for PD therapy. Once the IPP measurement approaches but does not exceed the limit, the processor 310 and / or portable device 402 determines the filling volume as the PD fluid volume within the patient's abdominal cavity, using the patient's body mass or by determining the PD fluid volume through fluid drainage and / or using a flow sensor. The filling volume parameter 917 can then be used for subsequent PD treatment.

[0105] V. Vital Capacity Example for Determining Filling Volume

[0106] In the example discussed above, pressure sensor 306 was used for IPP measurement. In some embodiments, pressure sensor 306 can be replaced by a spirometer (such as a spirometer). Lung capacity has been shown to decrease with increasing IPP. Processor 310 and / or portable device 402 can use the known correlation between spirometer and IPP measurements to determine the patient's fill volume parameters without using a pressure sensor.

[0107] Figure 14 An example system 1400 according to an exemplary embodiment of the present disclosure is shown, in which a spirometer 1402 is used to measure vital capacity to determine fill volume parameters. Such vital capacity measurement makes IPP measurement more efficient, which would otherwise lead to the errors discussed above. Furthermore, the use of the spirometer 1402 enables the use of standard transfer kits and tubing, instead of transfer kits or tubing equipped with pressure sensors.

[0108] like Figure 14 As shown, the spirometer 1402 measures a patient's respiratory capacity at different filling levels, indicated as M0 (dry state), M1 (10% of filling capacity), M2 (20% of filling capacity), M3 (50% of filling capacity), etc. After the patient is filled to an estimated desired percentage of cavity volume, the spirometer 1402 records the patient's vital capacity. The spirometer 1402 can record vital capacity for one or more respiratory cycles to determine mean vital capacity.

[0109] Example processor 310 and / or portable device 402 receive vital capacity data from spirometer 1402. Processor 310 and / or portable device 402 use the known correlation between vital capacity and IPP to adjust the IPP measurement to provide a more accurate measurement. The obtained IPP value can then be used to determine the filling volume and / or identify when the PD fluid filling reaches the desired percentage of capacity for effective PD treatment. This filling volume is stored by processor 310 and / or portable device 402 as a filling volume parameter for use in the patient's PD treatment.

[0110] Patient-specific correlations between filler volume and vital capacity can be determined and subsequently used in PD treatment. In these embodiments, the PD machine can use periodic vital capacity measurements to estimate the patient's IPP or filler volume during different phases of PD treatment. Figure 15 A graph 1500 illustrating a patient-specific correlation between vital capacity and filler volume according to an example embodiment of this disclosure is shown. The graph 1500 shows that vital capacity decreases as PD filler volume increases. Such a correlation may be useful for PD treatment, where vital capacity measurements can be used instead of attempting to estimate or directly measure the patient's IPP.

[0111] VI. in conclusion

[0112] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the subject matter or diminishing its intended advantages. Therefore, it is intended that such changes and modifications be covered by the appended claims.

Claims

1. An intra-abdominal pressure ("IPP") measurement system, comprising: A fluid container that contains peritoneal dialysis ("PD") fluid; A transfer kit and a catheter fluidly connected to the fluid container and the patient's peritoneum to enable PD fluid to be delivered to the patient's peritoneum; A spirometer, the spirometer being used to transmit output data indicating the patient's vital capacity; as well as A processor, communicatively coupled to and configured to use the spirometer During the retention interval between delivering the PD fluid into the patient's peritoneum and removing the PD fluid from the patient's peritoneum, the output data from the spirometer is recorded, and The filling volume parameter is determined by using the correlation between vital capacity and IPP, based at least on the output data from the spirometer.

2. The system of claim 1, further comprising a pressure sensor adapted to contact the transfer kit or the drainage tube, the pressure sensor being configured to transmit second output data indicating intraperitoneal IPP in the patient. The processor is further configured to determine the filling volume parameter using the output data from the spirometer and the second output data from the pressure sensor.

3. The system according to claim 1, wherein, The fluid container is positioned at head height, and the system further includes a line clamp that, when closed, blocks the flow of the PD fluid through the transfer kit or guide tube.

4. The system of claim 1, further comprising a pump configured to move the PD fluid from the fluid container through the transfer kit and the tubing into the patient's abdominal cavity.

5. The system of claim 1, further comprising an automated peritoneal dialysis ("APD") machine configured to provide PD treatment to the patient using the filling volume parameter.

6. The system of claim 1, further comprising a force sensor adapted to contact the transfer kit or guide tube, the force sensor comprising at least one of an inertial sensor, a gyroscope, or an accelerometer for sensing at least one of linear or rotational accelerations on one or more axes. in, The force sensor is configured to output force data indicating at least one of patient movement or spirometer movement.

7. The system according to claim 6, wherein, The processor is further configured to receive the force data and use the force data to adjust the output data to calculate at least one measurement component associated with patient movement or spirometer movement.

8. The system according to claim 1, wherein, The processor is further configured to: The output data is compared with at least one data range; When the comparison is outside the at least one data range, it provides an indication that at least one of the transfer kit or the guide tube has a problem; as well as When the comparison is within the at least one data range, the output data is used to determine the fill volume parameter.

9. The system according to claim 1, wherein, The processor is further configured to: Receive patient information, which includes at least one of urine output within a defined time period, food / drink intake within a defined time period, and heart rate or blood pressure; and The patient information is used to adjust the output data or the fill volume parameters.

10. The system according to claim 9, wherein, The defined time period includes at least one of twenty-four hours or forty-eight hours prior to the time the spirometer provides the output data.

11. An intra-abdominal pressure ("IPP") measurement system, comprising: A fluid container that contains peritoneal dialysis ("PD") fluid; A transfer kit and a catheter fluidly connected to the fluid container and the patient's peritoneum to enable PD fluid to be delivered to the patient's peritoneum; A spirometer, the spirometer being used to transmit output data indicating the patient's vital capacity; as well as A processor, communicatively coupled to and configured to use the spirometer During the retention interval between delivering the PD fluid into the patient's peritoneum and removing the PD fluid from the patient's peritoneum, the output data from the spirometer is recorded, and The patient's IPP is determined by using the correlation between vital capacity and IPP, based at least on the output data from the spirometer.

12. The system of claim 11, further comprising a pressure sensor adapted to contact the transfer kit or the drainage tube, the pressure sensor being configured to transmit second output data indicating intraperitoneal IPP in the patient. The processor is further configured to determine the IPP using the output data from the spirometer and the second output data from the pressure sensor.

13. The system according to claim 11, wherein, The fluid container is positioned at head height, and the system further includes a line clamp that, when closed, blocks the flow of the PD fluid through the transfer kit or guide tube.

14. The system of claim 11, further comprising a pump configured to move the PD fluid from the fluid container through the transfer kit and the tubing into the patient's abdominal cavity.

15. The system of claim 11, further comprising an automated peritoneal dialysis ("APD") machine configured to provide PD treatment to the patient using the patient's IPP.

16. The system of claim 11, further comprising a force sensor adapted to contact the transfer kit or guide tube, the force sensor comprising at least one of an inertial sensor, a gyroscope, or an accelerometer for sensing at least one of linear or rotational accelerations on one or more axes. in, The force sensor is configured to output force data indicating at least one of patient movement or spirometer movement.

17. The system according to claim 16, wherein, The processor is further configured to receive the force data and use the force data to adjust the output data to calculate at least one measurement component associated with patient movement or spirometer movement.

18. The system according to claim 11, wherein, The processor is further configured to: The output data is compared with at least one data range; When the comparison is outside the at least one data range, it provides an indication that at least one of the transfer kit or the guide tube has a problem; as well as When the comparison is within the at least one data range, the output data is used to determine the patient's IPP.

19. The system according to claim 11, wherein, The processor is further configured to: Receive patient information, which includes at least one of urine output within a defined time period, food / drink intake within a defined time period, and heart rate or blood pressure; and Use the patient information to adjust the output data or the patient's IPP.

20. The system according to claim 19, wherein, The defined time period includes at least one of twenty-four hours or forty-eight hours prior to the time the spirometer provides the output data.

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