Method, apparatus, and system for measuring intraperitoneal pressure ("IPP")

Abstract

An intraperitoneal pressure ("IPP") measurement device is disclosed herein. In one embodiment, the IPP measurement device includes a transferset or catheter fluidly coupled to a patient's abdominal cavity and a pressure sensor adapted to contact the transferset or catheter. The pressure sensor is configured to transmit output data indicative of IPP within the patient's abdominal cavity. The pressure sensor includes a pressure element configured to measure pressure exerted by fluid in the transferset or catheter. The pressure sensor also includes a pressure amplifier having a first side contacting a portion of the transferset or catheter and a second side contacting the pressure element. The first side has a larger diameter or surface area compared to the second side to amplify the pressure signal for IPP measurement.

Description

Background Art

[0001] Due to various causes, the human renal system can cease to function. Renal failure causes several physiological disorders. For example, it is no longer possible for a human suffering from renal failure to maintain a balance of water and minerals or to excrete the daily metabolic load. In addition, the toxic end products of metabolism, such as urea, creatinine, uric acid, and others, can accumulate in the patient's blood and tissues.

[0002] The decline in kidney function, especially kidney failure, is treated using dialysis. Dialysis removes waste products, toxins, and excess water from the body that a normally functioning kidney would otherwise remove. Dialysis treatment for the replacement of kidney function is important for many people because the treatment can save lives.

[0003] One type of kidney failure therapy is peritoneal dialysis ("PD"), in which a dialysis fluid, also called PD fluid, is injected into the patient's peritoneal cavity via a catheter. The dialysis fluid contacts the peritoneum in the patient's peritoneal cavity. Waste products, toxins, and excess water pass from the patient's bloodstream through the peritoneal capillaries into the dialysis fluid due to diffusion and osmosis (i.e., the osmotic gradient that occurs across the membrane). Osmotic substances in the dialysis fluid provide the osmotic gradient. The used or spent dialysis fluid is drained from the patient, removing waste products, toxins, and excess water from the patient. This cycle is repeated multiple times for the patient.

[0004] Various types of peritoneal dialysis therapies exist, including continuous ambulatory peritoneal dialysis ("CAPD"), automated peritoneal dialysis ("APD"), tidal dialysis, and continuous flow peritoneal dialysis ("CFPD"). CAPD is a manual dialysis treatment. Here, the patient manually connects an implanted catheter to the drainage line, allowing used or depleted dialysis fluid to be drained from the peritoneal cavity. The patient then switches the fluid connection so that the patient catheter communicates with a bag of fresh dialysis fluid and the fresh dialysis fluid is injected into the patient through the catheter. The patient then disconnects the catheter from the bag of fresh dialysis fluid, allowing the dialysis fluid to remain in the peritoneal cavity, where the transfer of waste products, toxins, and excess fluid occurs. After the retention cycle, the patient repeats the manual dialysis procedure, for example, four times per day. Manual peritoneal dialysis requires a significant amount of time and effort from the patient, leaving considerable room for improvement.

[0005] Automated peritoneal dialysis ("APD") is similar to CAPD in that the dialysis treatment includes drainage cycles, replenishment cycles, and retention cycles. However, APD machines typically perform the cycles automatically while the patient sleeps. APD machines relieve patients of the need to manually perform treatment cycles and the need to carry consumables during the day. The APD machine fluidically connects an implanted catheter to a fresh dialysis fluid source or its bag and fluid drainage section. The APD machine pumps fresh dialysis fluid from the dialysis fluid source through the catheter into the patient's abdominal cavity. The APD machine also allows the dialysis fluid to remain in the chamber, resulting in the transfer of waste products, toxins, and excess fluid. The source may contain several liters of dialysis fluid, including several solution bags.

[0006] The APD machine pumps used or depleted dialysate from the patient's abdominal cavity through a catheter to the drainage system. Similar to the manual process, several drainage, refilling, and retention cycles occur during dialysis. A "final refill" may occur at the end of an APD treatment. The final refill fluid may remain in the patient's abdominal cavity until the start of the next treatment, or it may be manually emptied at some point during the day.

[0007] In many cases, clinicians determine certain parameters that define how PD treatment should be administered. For example, a clinician may define a filling volume parameter, which defines the amount of dialysate that should be delivered into the patient's peritoneal cavity during the filling phase of a treatment cycle. A clinician may also define a drainage parameter, which defines the amount of used or depleted dialysate (and ultrafiltrate) that should be recovered during drainage. A clinician may further define a retention parameter, which defines the duration for which the dialysate will remain in the patient's peritoneal cavity. For many treatments, a clinician may also prescribe a certain concentration of glucose for the dialysate to achieve a certain therapeutic objective.

[0008] While all of the above parameters are important for PD treatment, the filling volume parameter can be particularly important. If the filling volume parameter is too high, the patient may become overfilled during treatment, leading to discomfort. If the filling volume parameter is too low, PD treatment may be less effective in removing accumulated toxins. Currently, many clinicians estimate the filling volume parameter using a measurement of the patient's intraperitoneal pressure ("IPP"), which is a measure of the pressure within the patient's abdominal cavity as a result of accumulated fluid and waste products. Generally, a patient's IPP increases as the fluid volume increases. Filling volume can be determined as the amount of PD fluid supplied to the patient's abdominal cavity that brings the pressure to a certain clinically acceptable threshold, which is generally 15–20 centimeters of water column ("cmH2O") (0.213–0.284 pounds per square inch ("psig")). In some cases, the volume of a patient's abdominal cavity is estimated using the patient's height, age, and sex compared to a population mean for similar individuals. The estimated volume may then be adjusted based on IPP measured to determine the filling volume parameter for PD treatment.

[0009] For various reasons, IPP measurements can sometimes be inaccurate. Relatively low peritoneal pressure makes IPP measurement particularly tricky, as many pressure sensors can provide more accurate measurements above 1.0 psig, which may exceed some IPP ranges. In some cases, the patient or measuring device may be moved during the measurement, which affects the IPP measurement. Even slight movement can cause a 20-30% variation in IPP measurements. In addition, the patient's food and beverage intake within 24 hours leading up to the measurement can affect the IPP measurement results.

[0010] Therefore, there is a need for improved IPP measurement systems and methods. [Overview of the Initiative] [Means for solving the problem]

[0011] Exemplary systems, methods, and apparatus for measuring or estimating improved intraperitoneal pressure ("IPP") are disclosed herein. In some embodiments, the systems, methods, and apparatus include a pressure amplifier comprising a pressure sensor connected to or otherwise integrated with a transfer set or catheter. The exemplary pressure amplifier includes a first side in contact with the transfer set or catheter and a second side in contact with a pressure sensor element. The first side has a smaller diameter than the second side. The pressure applied to the first side of the amplifier by the PD fluid located in the transfer set or catheter is amplified in magnitude according to Pascal's law, applying a proportionally larger force to the pressure sensor element. In alternative embodiments, pressure amplification may occur using a different material having higher elasticity than the rest of the transfer set or catheter. The area with higher elasticity applies a proportionally larger pressure to the sensor element. Improved pressure measurement enables clinicians to determine filling volume parameters that are appropriate for the patient.

[0012] In addition, or alternatively, in some embodiments, the systems, methods, and apparatus disclosed herein include a force sensor provided 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 acceleration and / or rotational acceleration in 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 and compensate for any detected patient and / or pressure sensor movement that would otherwise affect the IPP measurement results.

[0013] In addition, or alternatively, in some embodiments, the systems, methods, and apparatus disclosed herein include a spirometer for measuring IPP pressure. The spirometer records the patient's lung volume as an additional amount of PD fluid is delivered to the patient's abdominal cavity. The correlation between the patient's lung volume and IPP for different filling volumes allows the clinician to determine filling volume parameters using the measured lung volume. 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.

[0014] In addition, or alternatively, in some embodiments, the systems, methods, and apparatus disclosed herein include a processor that performs a comparison of IPP measurements with one or more ranges of pressure data during the filling of a patient's peritoneal cavity, determining whether the catheter and / or transfer set is partially blocked or mismatched, and the detected pressure is compared with one or more ranges. Detection of IPP data within a certain range may cause an alarm to be provided and prompt the clinician to check the catheter or transfer set. In some cases, IPP measurement data is not received until the IPP measurement data during PD fluid filling is within an acceptable range. Furthermore, the processor may be configured to compare the measured IPP data with one or more ranges of acceptable ranges to confirm that the IPP measurement corresponds to stagnation rather than PD fluid filling.

[0015] In addition, or alternatively, in some embodiments, the systems, methods, and apparatus disclosed herein include a processor that receives patient information indicating the patient's urinary output, food / beverage intake, heart rate, and / or blood pressure. The patient information may correspond to the pre-, inter-, and / or post-IPP measurement cycles. The processor is configured to use the patient information to adjust the filling volume parameters so that the parameters are not based solely on the IPP measurement. The patient information includes factors that may affect the IPP measurement. For example, high beverage consumption accompanied by low urinary output may indicate that the patient is edema or retaining fluid, which may cause the IPP measurement to be higher than it would be if the patient had a more normal fluid equilibrium state. Taking these factors into account allows for a more accurate filling volume to be determined for the patient.

[0016] In light of the disclosure described herein, and without limiting the disclosure in any way, and in combination with any other aspects or parts thereof described herein, in a first aspect of the disclosure, an intraperitoneal pressure ("IPP") measuring device includes a transfer set or catheter that is fluidically coupled to the patient's abdominal cavity, and a pressure sensor configured to contact the transfer set or catheter. The pressure sensor is configured to transmit output data indicating the IPP in the patient's abdominal cavity. The pressure sensor includes a pressure element configured to measure the pressure imparted by the fluid in the transfer set or catheter, and a pressure amplifier having a first side in contact with a portion of the transfer set or catheter and a second side in contact with the pressure element. The first side has a larger diameter or surface area than the second side.

[0017] In a second aspect of the present disclosure, which may be combined with any other aspects or parts thereof described herein, the first side includes a diameter or surface area which is at least twice the diameter or surface area of ​​the second side, and provides pressure amplification by at least twice.

[0018] In a third aspect of the present disclosure, which may be combined with any other aspects or parts 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 Bourdon tube.

[0019] In a fourth aspect of the present disclosure, which may be combined with any other aspects or parts thereof described herein, the pressure sensor is formed integrally with the transfer set or catheter.

[0020] In a fifth aspect of the present disclosure, which may be combined with any other aspects or parts thereof described herein, the pressure sensor is mechanically connected to a transfer set or catheter.

[0021] In a sixth aspect of the present disclosure, which may be combined with any other aspects or parts thereof described herein, an intraperitoneal pressure ("IPP") measurement system includes a fluid container containing peritoneal dialysis ("PD") fluid, and a transfer set and catheter configured to fluidly communicate with the fluid container and fluidically communicate with the patient's abdominal cavity, enabling the PD fluid to be delivered to the patient's abdominal cavity. The system also includes a pressure sensor configured to contact the transfer set or catheter. The pressure sensor is configured to transmit output data indicating the IPP in the patient's abdominal cavity. The pressure sensor includes a pressure element configured to measure the pressure imparted by the fluid in the transfer set or catheter, and a pressure amplifier having a first side in contact with a portion of the transfer set or catheter and a second side in contact with 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 intraperitoneal pulmonary plaque (IPP) in the patient and to use the output data indicating IPP to determine filling volume parameters for PD treatment for the patient, or to display the output data indicating IPP and enable the determination of filling volume parameters.

[0022] A seventh aspect of this disclosure, which may be combined with any other aspects or parts thereof described herein, shows output data indicating intraperitoneal pulmonary filtration (IPP) in a patient, corresponding to pressure measurements taken by a pressure sensor during the retention interval between when the PD fluid is supplied to the patient's peritoneal cavity and when it is removed therefrom.

[0023] In an eighth aspect of the present disclosure, which may be combined with any other aspects or parts thereof described herein, the fluid container is installed at head height, and the system further includes a line clamp that, when closed, obstructs the flow of PD fluid through a transfer set or catheter.

[0024] In a ninth aspect of the disclosure, which can 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 set and a catheter to a patient's peritoneal cavity when activated.

[0025] In a tenth aspect of the disclosure, which can 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 for a patient using at least a fill volume parameter.

[0026] In an eleventh aspect of the disclosure, which can be combined with any other aspect or part thereof described herein, the system further includes a force sensor included with a pressure sensor or adapted to contact a transfer set or catheter. The force sensor includes at least one of an inertial sensor, a gyroscope, or an accelerometer for sensing at least one of linear acceleration or rotational acceleration about one or more axes. The force sensor is configured to output force data indicative of at least one of patient movement or pressure sensor movement.

[0027] In a twelfth aspect of the disclosure, which can be combined with any other aspect or part thereof described herein, the processor is configured to receive the force data, use the force data, adjust output data indicative of IPP, and account for a measurement component associated with at least one of patient movement or pressure sensor movement.

[0028] In a thirteenth aspect of the disclosure, which may be combined with any other aspect or portion thereof described herein, the processor compares output data indicative of IPP with at least one data range and provides an indication that there is a problem involving at least one of the transfer set or the catheter when the comparison is outside of the at least one data range and is configured to use the output data indicative of IPP to determine a fill volume parameter when the comparison is within the at least one data range.

[0029] In a fourteenth aspect of the disclosure, which may be combined with any other aspect or portion thereof described herein, the processor receives second output data from a pressure sensor indicative of pressure during filling of a patient's abdominal cavity with an increasing amount of PD fluid, compares the second output data indicative of pressure during filling of the patient's abdominal cavity with a second data range, and provides an indication that there is a problem involving at least one of the transfer set or the catheter when the comparison is outside of the second data range and is configured to use the output data indicative of IPP to determine a fill volume parameter when the comparison is within the second data range.

[0030] In a fifteenth aspect of the disclosure, which may be combined with any other aspect or portion thereof described herein, the processor receives patient information including at least one of urine output within a defined period, food / drink intake within a defined period, heart rate, or blood pressure and is configured to use the patient information to adjust output data indicative of IPP or a fill volume parameter.

[0031] In a sixteenth aspect of the disclosure, which may be combined with any other aspect or portion thereof described herein, the defined period includes at least one of 24 hours or 48 hours prior to causing the pressure sensor to provide output data indicative of the patient's IPP.

[0032] In a 17th aspect of the present disclosure, which may be combined with any other aspects or parts thereof described herein, an intraperitoneal pressure ("IPP") measurement system includes a fluid container containing peritoneal dialysis ("PD") fluid, and a transfer set and catheter that are fluidically coupled to the fluid container and the patient's peritoneal cavity, enabling the PD fluid to be delivered to the patient's peritoneal cavity. The system further includes a spirometer for transmitting output data indicating the patient's lung volume, and a processor communicatively coupled to the spirometer. The processor is configured to record output data from the spirometer during the retention interval between when the PD fluid is delivered to and removed from the patient's peritoneal cavity, to use a correlation between lung volume and IPP, and to determine at least one of IPP or filling volume parameters based on at least the output data from the spirometer.

[0033] In an 18th aspect of the present disclosure, which may be combined with any other aspects or parts thereof described herein, the system further includes a pressure sensor adapted to contact a transfer set or catheter. The pressure sensor is configured to transmit a second output data indicating intraperitoneal pulmonary pressure (IPP) in the patient, and a processor is configured to use the output data from the spirometer and the second output data from the pressure sensor to determine a filling volume parameter.

[0034] In a 19th aspect of the present disclosure, which may be combined with any other aspects or parts thereof described herein, the fluid container is installed at head height, and the system further comprises a line clamp that, when closed, obstructs the flow of PD fluid through a transfer set or catheter.

[0035] In a 20th aspect of the present disclosure, which may be combined with any other aspects or parts thereof described herein, the system further includes a pump configured to move PD fluid from a fluid container through a transfer set and catheter to the patient's abdominal cavity.

[0036] In the 21st aspect, any feature, functionality, and alternative described in relation to any one or more of the elements in Figure 2-15 may be combined with any other feature, functionality, and alternative described in relation to any other of the elements in Figure 2-15.

[0037] In light of this disclosure and the aspects described above, it is therefore beneficial to this disclosure to provide an improved IPP measurement or estimation.

[0038] Another advantage of this disclosure is the ability to determine more accurate filling volume parameters for PD treatment.

[0039] Another advantage of this disclosure is that it provides adjustments to IPP measurements to account for patient factors and / or changes between IPP measurements.

[0040] Additional features and advantages will be described and will become apparent in the following detailed description and figures. 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 figures and description. Furthermore, no particular embodiment is required to have all of the advantages listed herein, and it is explicitly assumed that individual advantageous embodiments may be claimed separately. It should also be noted that the language used herein has been selected primarily for readability and teaching purposes and is not intended to limit the scope of the subject matter of the invention. The present invention provides, for example, the following: (Item 1) An intraperitoneal pressure ("IPP") measuring device, A transfer set or catheter that is fluidly coupled to the patient's abdominal cavity, A pressure sensor configured to contact the transfer set or catheter, wherein the pressure sensor is configured to transmit output data indicating IPP in the patient's abdominal cavity, and the pressure sensor is configured A pressure element configured to measure the pressure applied by the fluid in the transfer set or catheter, A pressure amplifier having a first side that contacts a portion of the transfer set or catheter and a second side that contacts the pressure element, wherein the first side has a larger diameter or surface area than the second side, and pressure sensors and An intraperitoneal pressure (IPP) measuring device equipped with [specific features]. (Item 2) The apparatus according to item 1, wherein the first side includes a diameter or surface area that is at least twice the diameter or surface area of ​​the second side, and provides pressure amplification by at least twice. (Item 3) The apparatus according to item 1 or 2, wherein 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 Bourdon tube. (Item 4) The apparatus according to item 1, wherein the pressure sensor is integrally formed with the transfer set or catheter. (Item 5) The pressure sensor is mechanically connected to the transfer set or catheter, as described in item 1. (Item 6) An intraperitoneal pressure ("IPP") measurement system, A fluid container containing peritoneal dialysis ("PD") fluid, A transfer set and catheter configured to communicate fluidly with the fluid container and fluidly with the patient's abdominal cavity, enabling the PD fluid to be supplied to the patient's abdominal cavity, A pressure sensor configured to contact the transfer set or the catheter, wherein the pressure sensor is configured to transmit output data indicating IPP in the patient's abdominal cavity, and the pressure sensor is configured A pressure element configured to measure the pressure applied by the fluid in the transfer set or catheter, A pressure amplifier having a first side that contacts a portion of the transfer set or catheter and a second side that contacts the pressure element, wherein the first side has a larger diameter or surface area compared to the first side. A pressure sensor, A processor that is communicatively coupled to the pressure sensor, wherein the processor is Receiving the output data indicating the IPP in the abdominal cavity of the patient, To determine the filling volume parameter for PD treatment for the patient, at least one of the following is performed: using the output data showing the IPP, or displaying the output data showing the IPP, thereby enabling the determination of the filling volume parameter. A processor and An intraperitoneal pressure ("IPP") measurement system equipped with [features / equipment]. (Item 7) The system according to item 6, wherein the output data indicating the IPP in the patient’s abdominal cavity corresponds to pressure measurements taken by the pressure sensor during the retention interval between when the PD fluid is supplied to the patient’s abdominal cavity and when it is removed therefrom. (Item 8) The system according to item 6 or 7, wherein the fluid container is installed at head height, and the system further includes a line clamp that, when closed, obstructs the flow of the PD fluid through the transfer set or catheter. (Item 9) The system according to item 6 or 7, further comprising a pump configured, when activated, to move the PD fluid from the fluid container through the transfer set and catheter to the patient's abdominal cavity. (Item 10) The system according to item 6, 7, or 9, further comprising an automated peritoneal dialysis ("APD") machine configured to provide the PD treatment for the patient using at least the filling volume parameter. (Item 11) A force sensor included with the pressure sensor or adapted to contact the transfer set or catheter, wherein the force sensor includes at least one of an inertial sensor, gyroscope, or accelerometer for sensing at least one of linear acceleration or rotational acceleration in one or more axes. Furthermore, The force sensor is configured to output force data indicating at least one of patient movement or pressure sensor movement. The system described in item 6, 7, 9, or 10. (Item 12) The system according to item 11, wherein the processor is further configured to receive the force data, use the force data, adjust the output data indicating the IPP, and take into account the measured component related to at least one of patient movement or pressure sensor movement. (Item 13) The aforementioned processor further, The output data representing the IPP is compared with at least one data range, When the comparison falls outside the range of at least one of the data, it provides indication that there is a problem relating to at least one of the transfer set or the catheter. When the comparison falls within the range of at least one data, the output data representing the IPP is used to determine the filling volume parameter. A system as described in item 6 or 12, configured to perform the following actions. (Item 14) The aforementioned processor further, The pressure sensor receives second output data indicating the pressure during the filling of the patient's abdominal cavity with an increasing amount of the PD fluid, Comparing the second output data and the second data range, which represent the pressure during the filling of the patient's abdominal cavity, When the comparison falls outside the second data range, it provides indication that there is a problem related to at least one of the transfer set or the catheter. When the comparison is within the second data range, the output data indicating the IPP is used to determine the filling volume parameter. The system described in item 13, configured to perform the following actions. (Item 15) The aforementioned processor further, Receiving patient information including at least one of the following: urine output within a defined period, food / beverage intake within a defined period, heart rate, or blood pressure, Adjusting the output data indicating the IPP or the filling volume parameter using the patient information. The system described in item 6, configured to perform the following actions. (Item 16) The system according to item 15, wherein the defined period includes at least one of 24 hours or 48 hours prior to causing the pressure sensor to provide the output data indicating the patient's IPP. (Item 17) An intraperitoneal pressure ("IPP") measurement system, A fluid container containing peritoneal dialysis ("PD") fluid, A transfer set and catheter are provided, which are fluidically coupled to the fluid container and the patient's abdominal cavity, enabling the PD fluid to be supplied to the patient's abdominal cavity. A spirometer for transmitting output data indicating the patient's lung capacity, A processor that is communicatively coupled to the aforementioned spirometer, Record the output data from the spirometer during the retention interval between when the PD fluid is supplied to the patient's abdominal cavity and when it is removed therefrom. Using the correlation between lung volume and IPP, determine at least one of the IPP or filling volume parameters based on the output data from the spirometer. A processor and An intraperitoneal pressure ("IPP") measurement system equipped with [features / equipment]. (Item 18) A pressure sensor adapted to contact the transfer set or the catheter, wherein the pressure sensor is configured to transmit a second output data indicating the IPP in the patient's abdominal cavity. Furthermore, The processor is further configured to use the output data from the spirometer and the second output data from the pressure sensor to determine the filling volume parameter. The system described in item 17. (Item 19) The system according to item 17 or 18, wherein the fluid container is installed at head height, and the system further comprises a line clamp that, when closed, obstructs the flow of the PD fluid through the transfer set or catheter. (Item 20) The system according to item 17 or 18, further comprising a pump configured to move the PD fluid from the fluid container through the transfer set and catheter to the patient's abdominal cavity. [Brief explanation of the drawing]

[0041] [Figure 1] Figure 1 shows a schematic diagram of a known IPP measurement technique.

[0042] [Figure 2] Figure 2 is a schematic diagram showing the extent to which the volume of the abdominal cavity changes between inhalation and exhalation during respiration.

[0043] [Figure 3] Figures 3 and 4 are schematic diagrams of an exemplary IPP measurement system according to an exemplary embodiment of the present disclosure. [Figure 4] Figures 3 and 4 are schematic diagrams of an exemplary IPP measurement system according to an exemplary embodiment of the present disclosure.

[0044] [Figure 5] Figure 5-7 is a schematic diagram of the pressure sensor shown in Figures 3 and 4, according to an exemplary embodiment of the present disclosure. [Figure 6] Figure 5-7 is a schematic diagram of the pressure sensor shown in Figures 3 and 4, according to an exemplary embodiment of the present disclosure. [Figure 7] Figure 5-7 is a schematic diagram of the pressure sensor shown in Figures 3 and 4, according to an exemplary embodiment of the present disclosure.

[0045] [Figure 8] Figure 8 is a schematic diagram showing a force sensor connected to, or otherwise integrated with, the pressure sensor of Figure 3-7, according to an exemplary embodiment of the present disclosure.

[0046] [Figure 9] Figure 9 is a flowchart illustrating an exemplary procedure for determining a filling volume parameter using force output data in conjunction with IPP measurements, according to an exemplary embodiment of the present disclosure.

[0047] [Figure 10] Figure 10 is a schematic diagram illustrating how a processor and / or portable device calculates IPP components related to patient and / or sensor movement according to an exemplary embodiment of the present disclosure.

[0048] [Figure 11] Figures 11 and 12 are schematic graphs illustrating a comparison of IPP measurements with one or more ranges and / or thresholds according to exemplary embodiments of the present disclosure. [Figure 12] Figures 11 and 12 are schematic graphs illustrating a comparison of IPP measurements with one or more ranges and / or thresholds according to exemplary embodiments of the present disclosure.

[0049] [Figure 13] Figure 13 is a schematic diagram illustrating data processing by a processor and / or portable device for adjusting IPP measurements based on patient information, according to an exemplary embodiment of the present disclosure.

[0050] [Figure 14] Figure 14 is a schematic diagram of an exemplary system according to an exemplary embodiment of the present disclosure, in which a spirometer is used to measure lung volume for determining filling volume parameters related to PD treatment.

[0051] [Figure 15] Figure 15 is a schematic graph of a patient-specific correlation between lung volume and filling volume according to an exemplary embodiment of the present disclosure. [Modes for carrying out the invention]

[0052] Detailed explanation Methods, systems, and apparatus for improved intraperitoneal pressure (IPP) measurement or estimation are disclosed herein. These methods, systems, and apparatus provide more accurate IPP measurement and / or filling volume estimation compared to known IPP measurement techniques. As described herein, these methods, systems, and apparatus include, or are more than, (i) providing a sensor amplifier for amplifying pressure sensor measurements to match a more sensitive and precise area of ​​the pressure sensor element; (ii) using a force sensor and adjusting for pressure sensor and / or patient movement during IPP measurement; (iii) using a spirometer and correlating lung volume with IPP and / or patient filling volume; (iv) using known ranges to demonstrate 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 measurements and / or filling volume estimates.

[0053] This disclosure, as herein, pertains to performing IPP measurements to determine filling volume parameters in relation to PD treatment. It should be understood that any of the methods, systems, and apparatus disclosed herein may also be used to measure IPP during PD treatment. IPP measurements during treatment may be used to stop PD fluid filling when the detected IPP exceeds a threshold, to prolong PD drainage, and / or to change from continuous periodic peritoneal dialysis ("CCPD") to tidal therapy if the residual volume in the patient's peritoneal cavity exceeds a threshold. In some cases, an IPP measurement exceeding a threshold may trigger an alert for the patient and / or an alert to be communicated to the clinician.

[0054] Figure 1 shows a schematic diagram of a known IPP measurement technique. The known IPP measurement system 100 includes a transfer set 102 which is fluidically connected to a catheter 104 which is inserted into or fluidically connected to the patient's abdominal cavity 106. Another end of the transfer set 102 (not shown) is connected to a source or container of fluid, such as PD fluid. The IPP measurement system 100 also includes a measurement or drainage line 108 which is fluidically connected to the catheter 104 and / or the transfer set 102.

[0055] IPP measurement provides a measurement of the IPP in the patient's abdominal cavity in relation to a given volume of injected PD fluid. For IPP measurement, the patient is typically in a supine or horizontal position, as shown in Figure 1. The patient is also relaxed, and their head is supported to allow their abdominal wall to relax. This patient positioning avoids pressure on the abdomen. As shown in Figure 1, a drainage bag 112 is held within a raised support for the drainage line 108. A graduated ruler or other distance measuring device 114 is positioned next to the drainage line 108, which runs upward from the patient to the bag 112, as shown, aligning level 0 (i.e., 0 cm) with the mid-axillary line.

[0056] To perform the measurement, PD fluid is supplied from the source to the patient's peritoneal cavity 106 through the transfer set 102 and catheter 104. The peritoneal cavity 106 is filled to a certain percentage of its cavity volume. After the desired amount of PD fluid has been supplied to the peritoneal cavity 106, the clamp 110 is closed to prevent further fluid flow from the source. The catheter connection is then opened, allowing at least a portion of the PD fluid from the patient's peritoneal cavity to flow into the drainage line 108. A column of PD fluid rises in the drainage line 108 to a level that stabilizes with a respiratory oscillation of 1-3 cmH2O, which provides the average measurement. Figure 2 is a schematic diagram showing the extent to which the volume of the peritoneal cavity changes between inspiration and expiration of respiration. As shown in this figure, the IPP during inspiration is greater because the peritoneal cavity contracts to become smaller. The IPP difference between inspiration and expiration is averaged to determine the IPP for the patient. In other words, IPP is measured as the midpoint of its oscillation and expressed in centimeters of water column ("cmH2O"). Once the measurement is obtained, the peritoneal cavity is drained, and the volume is recorded as the filling volume in the drainage bag 112. This process is repeated for different amounts of PD fluid, and a correlation between IPP measurements and filling volumes for a particular patient can be determined.

[0057] In stable adult PD patients, an IPP of 10–16 cmH2O at the midaxillary line is generally considered acceptable for PD treatment, corresponding to 1.3–2.8 liters ("L") of injected PD fluid. Patient-to-patient differences between IPP and injected PD fluid volume are due to variations in abdominal volume ("IPV"), body position (associated with standing patients, showing an increase of 2–4 cmH2O compared to supine), physical activity, weight, height, and sex. Clinicians typically prefer to keep IPP below 18–20 cmH2O because higher pressures are associated with symptoms such as discomfort, bloating, sleep disturbances, hemodynamic problems, and respiratory alterations. Higher pressures can also contribute to certain mechanical complications (leakage, hernia, etc.).

[0058] IPP measurements can also be performed while the patient is standing or sitting. In these cases, point "0" is considered to be the midpoint between the patient's xiphoid process and pubic symphysis, on the intermediate axillary line, or within the anterior superior iliac spine. Despite the change in position, IPP measurements are performed in the same manner as described above for patients in a supine position. I. IPP measurement embodiment

[0059] Figures 3 and 4 are schematic diagrams of an exemplary IPP measurement system 300 according to an exemplary embodiment of the present disclosure. The exemplary system 300 includes a transfer set 102 having a first end connected to a fluid container 302. The fluid container 302 may contain any physiologically compatible fluid source. The fluid container 302 may include a bag or other enclosure that is a PD fluid source and is configured to hold a certain volume of fluid, such as 1 to 2 liters of fluid. In some embodiments, the fluid container 302 contains a fresh, pre-prepared PD fluid having a certain formulated glucose concentrate. In some embodiments, the fluid container 302 may include two chambers, one with a dialysis concentrate and the other with purified water. In such embodiments, the container 302 includes a seal that, when ruptured, allows the fluids in the two chambers to mix. Physiologically compatible fluids may include PD fluid, saline solution, renal replacement fluid, etc.

[0060] The second end of the transfer set 102 is connected to a catheter 104, which is fluidly coupled to the patient's abdominal cavity 106. The transfer set 102 and / or catheter 104 may consist of one or more of the following materials: polyvinyl chloride ("PVC"), polyethylene ("PE"), polyurethane ("PU"), polycarbonate, or other non-PVC materials.

[0061] In some embodiments, the system 300 in Figure 3 may include a line clamp 110 for selectively restricting the flow of PD fluid through the transfer set 102. The illustrated embodiment may also include a pump 304. The exemplary pump 304 may include a pump head that is fluidically connected to the transfer set 102. The pump 306 may be any type of fluid pump, such as a peristaltic pump, a gear pump, or a membrane pump. The pump head may be disposable and connected to a reusable actuator controlled by an internal or external control unit. The exemplary pump 304 is configured to pump fresh PD fluid from the container 302 to the patient's peritoneal cavity 106 to perform an IPP measurement. The exemplary pump 304 may also pump the used PD fluid (including the removed toxins and absorbed ultrafiltrate) back from the patient's peritoneal cavity 106 to the container 302 after the IPP measurement has been recorded. In alternative embodiments, a separate pump is provided for (i) pumping fluid to the patient and (ii) pumping or withdrawing fluid from the patient. In some embodiments, the pump 304 is configured to block the fluid flow from the fluid container 302 until the pump head is actuated, thereby preventing free flow of the PD fluid and allowing the clamp 110 to be omitted.

[0062] The IPP measurement system 300 in Figure 3 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 in the transfer set 102. In other embodiments, the pressure sensor 306 may be connected to or comprise a catheter 104. When PD fluid is supplied to or removed from the peritoneal cavity 106, the pressure measurement indicates the fluid pressure being supplied to or removed from the peritoneal cavity 106. When the pump is stopped and the PD fluid is allowed to remain in the peritoneal cavity for a specified duration, the pressure measurement provided by the pressure sensor 306 indicates IPP. The pressure measurement may also be used to detect line blockage (based on an upward positive or negative pressure spike waveform / trend) or fluid leakage (based on a downward positive or negative pressure spike waveform / trend).

[0063] In the illustrated embodiment, the pressure sensor 306 is shown as being aligned with the transfer set 102. It should be understood that the pressure sensor 306 may be aligned with the catheter 104, or integrated with it in a different manner. It should also be understood that the pressure sensor 306 may include a disposable tubular section that comes into contact with the transfer set 102 and the PD fluid, while the remainder of the sensor 306 may be reusable between IPP measurements. Alternatively, the entire pressure sensor 306 may be disposable.

[0064] In some embodiments, the system 300 may also include a flow sensor (not shown) having an output, which is integrated to measure the volume of PD fluid supplied to and / or removed from the patient. It should be understood that one or more pressure sensors 306 may be used, in addition or alternatively, to measure the flow rate or flow rate of fluid delivered to and removed from the abdominal cavity 106. Furthermore, the system 300 may include a heater for warming the PD fluid prior to infusion into the patient. The system 300 may further include a temperature sensor to ensure that the PD fluid is heated to a desired temperature.

[0065] Although not shown, an air trap may be provided within the transfer set 102 to remove air from the PD fluid prior to patient delivery. In other cases, priming of the transfer set 102 may remove air without the need for an air trap. Heating the dialysis fluid tends to separate dissolved air from the dialysis fluid. Therefore, it is conceivable to place the air trap downstream from the heater, for example, upstream of the temperature sensor along the transfer set 102.

[0066] The exemplary system 300 also includes a processor 310 for communicating with a pressure sensor 306. The processor 310 may include any computer, laptop, workstation, server, etc. In some embodiments, the processor 310 is communicatively coupled to the pressure sensor 306 via a wired interface such as a Universal Serial Bus ("USB") connection, or a wireless interface such as Bluetooth®, Zigbee®, or Near Field Communication ("NFC") connection. Furthermore, the processor 310 may also be communicatively coupled to a pump 304.

[0067] As described herein, the exemplary processor 310 executes machine-readable instructions stored in a memory device. These instructions may include applications or software programs. Execution of these instructions causes the processor 310 to perform the operations described herein. For example, the processor 310 receives IPP measurement output data transmitted from the pressure sensor 306. The processor 310 may ensure that the received IPP output data conforms to a defined range. Furthermore, the processor 310 may adjust the output data based on patient information and / or force sensor information.

[0068] The operations performed by the processor 310 provide the determination of fill volume parameters for PD treatment. In some embodiments, the processor 310 uses the received data to calculate or otherwise determine fill volume parameters for the patient under measurement. In addition, or alternatively, the processor 310 may cause a display device to display IPP measurements and / or adjustment information, enabling the clinician to determine fill volume parameters for the patient's PD treatment.

[0069] Figure 4 is a schematic diagram of another embodiment of the IPP measurement system 300. In the embodiment illustrated in Figure 4, the pump 304 is replaced by positioning the fluid container 302 at or above the patient's head height (e.g., 3 to 6 feet above ground level). This allows gravity to draw the PD fluid from the fluid container 302 through the transfer set 102 into the patient's abdominal cavity 106. In the embodiment illustrated, a clamp 110 provides selective flow of the PD fluid.

[0070] In addition, Figure 4 shows that the portable device 402 is communicatively coupled to the pressure sensor 306. The connection may be via a wired interface such as a USB connection, or via a wireless interface such as Bluetooth®, Zigbee®, or NFC. The portable device 402 may include a smartphone, tablet computer, laptop computer, etc. In some cases, the portable device 402 is communicatively coupled to a server or the processor 310 in Figure 3 via a local area connection such as the Internet or Wi-Fi. The portable device 402 is configured to receive IPP output data from the pressure sensor 306 to determine the filling volume parameters for the patient. Similar to the processor 310 in Figure 3, the portable device 402 enables adjustments to be made to the IPP measurement and / or filling volume parameters based on the force sensor output data and / or patient information.

[0071] Figures 5-7 are schematic diagrams of the pressure sensor 306 of Figures 3 and 4 according to exemplary embodiments of the present disclosure. In the illustrated embodiments, the pressure sensor includes an amplifier. Typical IPP values ​​are 15–20 centimeters of water column ("cmH2O") (0.213–0.284 pounds per square inch ("psig")). However, many commercially available pressure sensors for medical applications have a pressure range of 0.0–5.0 psig. As a result, the use of commercially available pressure sensors to measure IPP may only utilize a small portion of the range on the lower end of the detectable pressure. Many known pressure sensors are not very accurate below 0.8 psig and may not have adequate measurement accuracy over the 0.2–0.3 psig pressure range. The disclosed amplifier extends the measurement range, thereby enabling the pressure sensor 306 to provide a more accurate distinction between IPP measurements.

[0072] Figure 5 shows a pressure sensor 306 adapted to contact the transfer set 102. In other cases, the pressure sensor 306 may be connected to or integrated with the catheter 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 pod, a capacitive diaphragm, a pressure-sensing capsule, or a Bourdon tube.

[0073] The pressure sensor 306 also includes an amplifier 504. The amplifier 504 has a first side that contacts a portion of the transfer set 102. The second opposite side of the amplifier 504 contacts the pressure element 502. The first side of the amplifier 504 has a larger diameter or surface area compared to the second side that contacts the pressure element 502. The force difference is illustrated in Figure 5 by the pistons, with the first piston having a larger surface area than the second piston. The force applied from the transfer set 502 to the first area causes the first piston to exert a force on the second piston. The force from the first piston is agglomerated against the smaller surface area of ​​the second piston. This agglomeration of force increases the applied force value, which is sensed by the pressure element 502.

[0074] In one embodiment, the pressure amplifier 504 uses Pascal's law to amplify the fluid pressure in the transfer set 102. Pressure amplification allows the medical-grade pressure sensor to be used in this low IPP measurement application. According to Pascal's law, force or pressure is proportional to the surface area to which the force is applied. In one embodiment, 2 cm 2 A force with a value of 1 psig applied to the first surface area is 1 cm 2 A force of approximately 2 psig is applied to a second surface that is pneumatically and / or mechanically coupled, having a surface area of ​​. In the illustrated embodiment, the first side of amplifier 504 has an area (A1) which is at least twice the area (A2) of the second side, thereby providing an amplification factor of at least 2. In other embodiments, the areas of the first and second sides may be selected to provide amplification factors such as 3, 4, 5, 10, and 20.

[0075] In the illustrated embodiment, the processor 310 and / or portable device 402 are configured to normalize the IPP measurement to account for amplification. For example, if amplification is provided by amplifier 504, the processor 310 and / or portable device 402 may reduce the IPP measurement by an amplification factor. In other embodiments, a packing volume parameter may be correlated with the amplified IPP measurement.

[0076] Figure 6 shows an alternative embodiment of the pressure sensor 306. In the illustrated embodiment, section 602 of the transfer set 102 comprises a material having higher elasticity compared to the other sections. The higher elasticity allows section 602 to amplify the pressure applied on the pressure element 502 as the pressure increases within the transfer set 102. Similar to the embodiment discussed in relation to Figure 5, the embodiment in Figure 6 provides an increased IPP measurement range, thereby improving the accuracy of IPP measurement detection. In some embodiments, the elastic expansion of the material in section 602 is linear. If the material in section 602 exhibits nonlinear expansion, the processor 310 and / or portable device 402 are configured to account for the nonlinearity of the material. This consideration may include providing a nonlinear calibration curve for section 602 that corresponds to a linear pressure change within the transfer set 102.

[0077] Figure 7 shows a further embodiment of the pressure sensor 306. In this embodiment, at least a portion of the transfer set 102 includes a double lumen with a fluid path side 702 and a non-fluid path side 704. The double lumen may extend through the transfer set 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 a known volume and / or pressure, thereby providing a reference pressure. A diaphragm 706 separates the sides 702 and 704 of the transfer set 102. The diaphragm 706 moves toward the fluid path side 702 when the reference side 704 has a higher pressure, and vice versa. The sensor element 710 may be located adjacent to the reference side 704. As the diaphragm 706 moves, the volume within the side 704 changes, thereby changing the internal pressure. The sensor element 710 senses the internal pressure, which is transmitted to the processor 310 and / or portable device 402 as an IPP measurement. II. Embodiment of force sensing

[0078] Figure 8 is a schematic diagram showing a force sensor 802 connected to, or otherwise integrated with, the pressure sensor 306 of Figure 3-7, according to an exemplary embodiment of the present disclosure. 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 may cause an increase or decrease in IPP pressure readings due to changes in head height and / or stress applied to the abdominal cavity.

[0079] To reduce IPP measurement errors, the exemplary force sensor 802 provides force output data indicating the pressure sensor 306 and / or patient movement. The force output data is received by the processor 310 and / or portable device 402 and modifies the IPP measurement and / or filling volume parameters. In some cases, force values ​​above a certain threshold may cause the processor 310 and / or portable device 402 to ignore the IPP measurement. For example, since movement is likely to contribute to a significant error in the measurement, detection of a significant change in patient position may cause the processor 310 and / or portable device 402 to remove IPP measurements recorded during that movement.

[0080] The force sensor 802 may include an inertial sensor, a gyroscope, and / or an accelerometer. Sensing may be provided within at least one axis, including the x, y, z, yaw, pitch, and / or roll axes. In some embodiments, the force sensor 802 and / or pressure sensor 306 are positioned midline of the patient (if supine) or on or in line with the pelvic cavity (if seated / standing). The force sensor 802 detects the relative change in the orientation / angle of the pressure sensor 306 and / or the patient from the initial position.

[0081] The force sensor 802 transmits force output data to the processor 310 and / or the portable device 402. In some cases, the force sensor 802 may use the same transceiver or transmitter as the pressure sensor 306. In other cases, the force sensor 802 may have its own transceiver or transmitter. The processor 310 and / or the portable device 402 use the force output data to determine whether the IPP measurement should be processed and, if applicable, provide adjustments to the IPP measurement and / or filling volume parameters.

[0082] Figure 9 is a flowchart of an exemplary procedure 900 for determining a patient's filling volume parameter using force output data in conjunction with IPP measurements, according to an exemplary embodiment of the present disclosure. While procedure 900 is described with reference to the flowchart illustrated in Figure 9, it should be understood that many other ways of performing the steps associated with procedure 900 may also be used. For example, the order of many of the blocks may be changed, some blocks may be combined with others, and many of the blocks described may be arbitrary. In some embodiments, the number of blocks may be changed. For example, force output data may be used to correct the filling volume parameter rather than IPP measurements. The actions described in procedure 900 may be defined by one or more instructions and performed across multiple devices, for example, including a force sensor 802, a pressure sensor 306, a processor 310, and / or a portable device 402.

[0083] Exemplary procedure 900 begins when the patient is connected to the transport set 102 and catheter 104. After the transport set 102 is placed in position, the force sensor 802 is zeroed out or reset (block 902) while it is positioned in the patient's midline or lower pelvis. Such a reset provides the zero point for the inertial sensor and / or accelerometer. In some cases, the clinician may manually zero out the force sensor 802 by pressing a reset button on the sensor. Alternatively, the clinician may input an input to the processor 310 and / or portable device 402, which transmits a command to the force sensor 802 to zero it out or reset it.

[0084] The clinician then begins filling the patient's abdominal cavity. After a certain percentage of the cavity is filled, the flow of PD fluid is stopped and the pressure sensor 306 transmits IPP measurement data 903 indicating IPP in the abdominal cavity (block 904). The processor 310 and / or portable device 402 receive force output data 905 from the force sensor 802 (block 906). The processor 310 and / or portable device 402 compare the force output data 905 with one or more force limits (block 908). If the force output data 905 exceeds one or more force limits, the processor 310 and / or portable device 402 ignore the corresponding IPP measurement data 903 (block 910). Force output data exceeding one or more limits may indicate a changing position of the patient that causes a greater amount of movement or drops the pressure sensor 306 or the transport line 102. In these cases, the IPP measurement data may be inaccurate or not represent the actual IPP pressure.

[0085] When the force output data is within one or more limit values, the processor 310 and / or portable device 402 proceed to process the IPP measurement data 903 (block 912). This includes determining the IPP measurement component attributable to the measured force (block 914). Figure 10 is a schematic diagram illustrating how the processor 310 and / or portable device 402 calculate the IPP component related to patient and / or sensor movement according to an exemplary embodiment of the present disclosure. In the illustrated embodiment, sensors 306, 802 may be moved to a different or more convenient location for the clinician or patient, such as a higher or lower location. This may be due to a patient having a higher exit site for its catheter, or to allow the sensors 306, 802 to be in the most comfortable or convenient location for the clinician / patient. The processor 310 and / or portable device 402 calculate the change in position of sensors 306, 802 using the raw force output data 1002. A change in position provides, for example, a change in head height, which correlates to a change in pressure within the transport set 102 based on the degree of the change. Changes in lateral position and / or rotation also correspond to changes in pressure. The pressure changes are aggregated as an IPP component (i.e., Δh) associated with sensors 306, 802 and / or patient movement. As shown in Figure 10, the processor 310 and / or portable device 402 adjust the IPP measurements based on the IPP component associated with the force output data. This may include updating the adjustment value or subtraction based on the IPP component (block 916 in Figure 9).

[0086] Returning to Figure 9, the processor 310 and / or portable device 402 then output the adjusted IPP measurement 917, or have it displayed otherwise (block 918). In some cases, the steps in blocks 902–918 are repeated at least once to obtain a sample set of IPP measurements over one or more respiratory cycles, allowing the IPP measurements to be averaged. In some embodiments, the processor 310 and / or portable device 402 displays a graph showing the IPP measurements over time, thereby allowing the average to be calculated or otherwise determined. The processor 310 and / or portable device 402 then determines the filling volume parameter based on the adjusted IPP measurement (block 920). The filling volume may be determined by correlating the filling volume with the IPP measurement for a patient with similar body mass / height to the patient under measurement. In other cases, the volume of PD fluid to be injected into the patient may be measured using either a fluid sensor or by draining and measuring the PD fluid.

[0087] In some embodiments, if the IPP measurement falls below a threshold for performing appropriate PD filling, additional PD fluid may be added to the patient. Steps 902–918 may be repeated until the adjusted IPP measurement reaches 16–19 cmH2O or 0.25–0.28 psig, indicating an appropriate filling volume for PD treatment. The filling volume parameter is then determined from patient characteristics and / or the detected amount of PD fluid injected into the patient's peritoneal cavity. The filling volume parameter may then be used for subsequent PD treatment using a PD machine for continuous ambulatory peritoneal dialysis ("CAPD") treatment, or manually. Exemplary procedure 900 is then completed.

[0088] In some embodiments, the patient may wear a force sensor. For example, the force sensor may be connected to the patient's wrist or abdomen. Output data from the sensor provides further data indicating patient movement. The force sensor worn by the patient may be used in conjunction with a force sensor 802 comprising a pressure sensor 306. Alternatively, only a force sensor connected to the patient is provided. In some cases, data from a force sensor connected to the patient is tracked over time in conjunction with IPP measurements. For example, the patient may experience a set of daily routines or activities with the transport set 102 connected. IPP measurements may be correlated with force data (allowing for the removal of force-related components) to identify the extent to which IPP changes with respect to the patient due to different orientations and / or activities. The clinician may use this correlation to ensure that the filling volume does not exceed the clinically recommended limit for the patient's IPP, regardless of the position or activity performed by the patient, thereby improving patient comfort during treatment. The filling volume determined by the clinician may then be set in the patient's treatment or device prescription and downloaded locally or remotely to the patient's cyclo or peritoneal dialysis machine. III. IPP measurement demonstration implementation

[0089] In some embodiments, the processor 310 and / or portable device 402 are configured to demonstrate the IPP measurement data prior to processing the data. For example, as shown in block 908 of Figure 9, the processor 310 and / or portable device 402 compare the received IPP measurement data with one or more ranges or thresholds that indicate substantial patient and / or sensor movement. This operation may also include a comparison with one or more ranges and / or limits that correspond to normal filling pressure and / or expected IPP measurements. IPP measurements outside the ranges and / or limits may indicate catheter connection, catheter occlusion, leakage within the transfer set, or other fluid connectivity issues.

[0090] Figure 11 shows Graph 1100 illustrating a comparison of IPP measurements with one or more ranges and / or thresholds according to exemplary embodiments of the present disclosure. Graph 1100 includes a first range 1102 corresponding to acceptable pressure measurements when PD fluid is being injected into the patient's peritoneal cavity. During PD fluid filling, a force is applied to the sensor element (e.g., transducer membrane) as a result of the fluid flow. The first range 1102 may correlate with fluid filling for gravity-fed administration, while a second range may be used when a pump is supplying the PD fluid.

[0091] Graph 1100 also includes a second range 1104 corresponding to pressure reductions resulting from partial occlusion of the transfer set or catheter. During the filling phase, the processor 310 and / or portable device 402 receive IPP measurement data and compare the data 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 may generate a warning or other message / indication indicating that a problem exists with the catheter and / or transfer set. Furthermore, the processor 310 and / or portable device 402 may prevent subsequent IPP measurements from being processed until it is confirmed that the patient is properly filled with PD fluid.

[0092] Graph 1100 shows that the pressure measurement data decreases over time. This decrease is a result of the lower flow rate as the gravity-supplied PD fluid bag becomes empty inside 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. The pressure values ​​on the y-axis have been normalized for brevity.

[0093] Graph 1100 also includes a third range 1106, which applies after the flow of PD fluid has been stopped and the fluid has been allowed to remain in the patient's abdominal cavity. The processor 310 and / or portable device 402 may use the third range 1106 to identify IPP measurements that exceed an acceptable pressure threshold, which may indicate patient movement, transfer set movement, or patient overfilling. IPP measurements exceeding this third range 1106 may be ignored by the processor 310 and / or portable device 402. In addition, or alternatively, the processor 310 and / or portable device 402 may generate an alarm. It should be noted that IPP measurements increase over time because the PD fluid absorbs waste products or other toxins from the patient, which increases the volume of fluid in the abdominal cavity and thereby increases the pressure being measured. The processor 310 and / or portable device 402 may be configured to log IPP measurements over time and ensure that the PD filling volume does not exceed an acceptable IPP during the retention phase, which could cause patient discomfort during PD treatment.

[0094] Figure 12 shows a graph 1200 of an alternative embodiment in which the processor 310 and / or portable device 402 uses recorded head high values ​​and bag solution volume of bag filling to determine a threshold 1202 corresponding to the expected filling pressure. If a pump is provided, the expected pump pressure value may be used instead. In this embodiment, the processor 310 and / or portable device 402 estimates the threshold based on the actual filling conditions to more accurately determine whether there is a problem in injecting PD fluid into the patient's peritoneal cavity. Graphs 1100 and 1200 may be displayed to the clinician by the processor 310 and / or portable device 402. IV. Implementation of IPP measurement adjustment using patient information

[0095] During IPP measurement, the processor 310 and / or portable device 402 may adjust the IPP measurement or filling volume parameter based on the received patient information. In some situations, the patient's fluid retention may affect the abdominal volume or pressure provided over the cavity, which affects the IPP measurement. In addition, the patient's blood pressure or heart rate may indicate whether the patient is under stress or exertion, which may also affect the IPP measurement.

[0096] Figure 13 is a schematic diagram 1300 illustrating data processing by the processor 310 and / or portable device 402 for adjusting IPP measurements based on patient information, according to an exemplary embodiment of the present 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 the patient's urine output within a specified time period prior to the IPP measurement, such as 24 or 48 hours. The urine output may be self-reported by the patient and entered into the processor 310 and / or portable device 402. In other cases, the urine output may be measured in a container and entered into the processor 310 and / or portable device 402.

[0097] The processor 310 and / or portable device 402 also receive food and beverage consumption information 1304. This information provides indications regarding the amount of food and beverage consumed by the patient during the period leading up to or during the IPP measurement. Together, the urine data 1302 and food / beverage data 1304 provide fluid equilibrium state information. The processor 310 and / or portable device 402 is configured to calculate the patient's fluid equilibrium state by summing the food / beverage data 1304, subtracting the urine data 1302, and considering the metabolic combustion of the fluid based on a patient population of similar age, sex, height, and weight. The processor 310 and / or portable device 402 then determines whether the patient's fluid equilibrium state contributes to the IPP measurement component by comparing the calculated equilibrium state information with the correlation of equilibrium state information and IPP measurement values ​​for patients with similar height, sex, weight, etc. The processor 310 and / or portable device 402 then modulate the IPP measurement data 903 by taking into account the IPP component related to the fluid equilibrium state. In cases where the fluid equilibrium state is negative, such as in the case of dehydration, the modulation may result in an increase in the IPP measurement value.

[0098] The processor 310 and / or portable device 402 also receive heart rate and blood pressure data 1306. The processor 310 and / or portable device 402 correlate the data 1306 with IPP measurement components based on a patient population with similar height, weight, sex, age, etc. The processor 310 and / or portable device 402 then adjust the IPP measurement by the identified IPP measurement components.

[0099] After adjusting the IPP measurements, the processor 310 and / or portable device 402 determine the filling volume parameter 917. As discussed above, this may include comparing the adjusted IPP measurements (or the trend of the adjusted IPP measurements) with the filling IPP limit for PD therapy. Once the IPP measurements are complete but do not exceed the limit, the processor 310 and / or portable device 402 determine the filling volume as the volume of PD fluid in the patient's abdominal cavity, using either the patient's body mass or determining the PD fluid volume by draining the fluid and / or using a fluid sensor. The filling volume parameter 917 may then be used for subsequent PD treatment. V. Lung volume embodiment for determining filling volume

[0100] In the embodiments discussed above, IPP measurement is performed using a pressure sensor 306. In some embodiments, the pressure sensor 306 may be replaced with a lung volume sensor, such as a spirometer. It has been shown that lung volume decreases as IPP increases. The processor 310 and / or portable device 402 may use a known correlation between lung volume and IPP measurements to determine a filling volume parameter for the patient, without the use of a pressure sensor.

[0101] Figure 14 shows an exemplary system 1400 according to an exemplary embodiment of the present disclosure, in which a spirometer 1402 is used to perform lung volume measurement and determine filling volume parameters. Such lung volume measurement allows for higher efficiency for IPP measurement, which otherwise may result in the errors discussed above. Furthermore, the use of the spirometer 1402 allows for the use of standard transfer sets and catheters, in contrast to transfer sets or catheters equipped with pressure sensors.

[0102] As shown in Figure 14, the spirometer 1402 measures the patient's respiratory volume at different filling levels, indicated as M0 (dry state), M1 (10% of filled volume), M2 (20% of filled volume), M3 (50% of filled volume), etc. After the patient has filled to the estimated desired percentage of the cavity volume, the spirometer 1402 records the patient's lung volume. The spirometer 1402 may record the lung volume over one or more respiratory cycles to determine the average lung volume.

[0103] An exemplary processor 310 and / or portable device 402 receives lung volume data from a spirometer 1402. The processor 310 and / or portable device 402 uses known correlations between lung volume and IPP to adjust the IPP measurement to provide a more accurate measurement. The identified IPP value may then be used to determine the filling volume and / or to identify when the PD fluid reaches a desired percentage of the volume so that it is effective for PD treatment. This filling volume is stored by the processor 310 and / or portable device 402 as a filling volume parameter for use in PD treatment for the patient.

[0104] A patient-specific correlation between filling volume and lung volume can be determined and subsequently used for PD treatment. In these embodiments, the PD machine may use periodic lung volume measurements to estimate the patient's IPP or filling volume during different stages of PD treatment. Figure 15 shows a graph 1500 of a patient-specific correlation between lung volume and filling volume according to an exemplary embodiment of the present disclosure. Graph 1500 shows that lung volume decreases as PD filling volume increases. Such a correlation may be useful in PD treatment, where lung volume measurements may be used to attempt to estimate the patient's IPP, or to use them instead of directly measuring it. VI. conclusion

[0105] It should be understood that various changes and modifications to the preferred embodiments described herein will be obvious to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the subject matter and without diminishing the intended advantages. Accordingly, such changes and modifications are intended to be covered by the appended claims.

Claims

1. A system for measuring intraperitoneal pressure ("IPP"), wherein the system is A fluid container containing peritoneal dialysis ("PD") fluid, A transfer set and catheter having fluid communication with the fluid container, wherein the transfer set and catheter are configured to enable the delivery of PD fluid to the patient's abdominal cavity by fluid communication with the patient's abdominal cavity, A pressure sensor configured to contact the transfer set or the catheter, wherein the pressure sensor is configured to transmit output data indicating IPP in the patient's abdominal cavity, A processor that is communicatively coupled to the pressure sensor and Equipped with, The aforementioned pressure sensor is A pressure element configured to measure the pressure applied by the fluid in the transfer set or catheter, A pressure amplifier having a first side that contacts a portion of the transfer set or the catheter, and a second side that contacts the pressure element, wherein the first side has a diameter or surface area larger than the diameter or surface area of ​​the second side. Includes, The aforementioned processor, Receiving the output data indicating the IPP in the abdominal cavity of the patient, Receiving force data indicating at least one of patient movement and pressure sensor movement, vital capacity measurement data indicating the patient's lung capacity, and patient information, wherein the patient information includes at least one of urine output during a defined period, food / beverage intake during a defined period, heart rate, and blood pressure. Adjusting the output data indicating the IPP using the force data or the vital capacity measurement data or the patient information, To use the adjusted output data showing the IPP to determine the filling volume parameter for PD treatment for the patient, and to enable the determination of the filling volume parameter by making the adjusted output data showing the IPP visible. A system configured to perform the following actions.

2. The system according to claim 1, wherein the first side includes a diameter or surface area that is at least twice the diameter or surface area of ​​the second side, thereby providing at least twice the pressure amplification.

3. The system according to claim 1, wherein the pressure element includes at least one of a piezoresistive strain gauge, a pressure-sensing diaphragm, a capacitive diaphragm, a pressure-sensing capsule, and a Bourdon tube.

4. The system according to claim 1, wherein the pressure sensor is integrally formed with the transfer set or the catheter.

5. The system according to claim 1, wherein the pressure sensor is mechanically connected to the transfer set or the catheter.

6. The system according to claim 1, wherein the output data indicating the IPP in the patient’s abdominal cavity corresponds to pressure measurements performed by the pressure sensor during the retention interval between when the PD fluid is supplied to the patient’s abdominal cavity and when it is removed from the patient’s abdominal cavity.

7. The system according to claim 1 or 6, wherein the fluid container is installed at head height, and the system further includes a line clamp, which, when closed, obstructs the flow of the PD fluid through the transfer set or the catheter.

8. The system according to claim 1 or 6, further comprising a pump, which, when activated, moves the PD fluid from the fluid container through the transfer set and the catheter to the patient's abdominal cavity.

9. The system according to claim 1, claim 6, or claim 8, further comprising an automated peritoneal dialysis ("APD") machine, the APD machine configured to provide the PD treatment for the patient using at least the filling volume parameter.

10. The system further comprises a force sensor, the force sensor being included together with the pressure sensor or adapted to contact the transfer set or the catheter, the force sensor including at least one of an inertial sensor, a gyroscope and an accelerometer for sensing at least one of linear acceleration and rotational acceleration in one or more axes, The system according to claim 1, claim 6, claim 8, or claim 9, wherein the force sensor is configured to output the force data.

11. The system according to claim 10, wherein the processor is further configured to receive force data and to consider a measurement component related to at least one of patient movement and pressure sensor movement by adjusting the output data indicating the IPP using the force data.

12. The aforementioned processor, The output data representing the IPP is compared with at least one data range, When the comparison falls outside the range of at least one of the data, it provides an indication that there is a problem relating to at least one of the transport set and the catheter. When the comparison is within the range of at least one data, the filling volume parameter is determined using the output data indicating the IPP. The system according to claim 1 or claim 11, further configured to perform the following:

13. The aforementioned processor, The pressure sensor receives second output data indicating the pressure during the filling of the patient's abdominal cavity with an increasing amount of the PD fluid. Comparing the second output data and the second data range, which represent the pressure during the filling of the patient's abdominal cavity, When the comparison falls outside the second data range, it provides indication that there is a problem related to at least one of the transport set and the catheter. When the comparison is within the second data range, the filling volume parameter is determined using the output data indicating the IPP. The system according to claim 12, further configured to perform the following:

14. The system according to claim 1, wherein the defined period includes at least one of 24 hours and 48 hours prior to causing the pressure sensor to provide the output data indicating the patient's IPP.

15. The system according to claim 1, further comprising a spirometer for transmitting the spirometry data.

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