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JP-2026514546-A - A system featuring optical and electrical sensors for characterizing the outflow from peritoneal dialysis patients.

JP2026514546AJP 2026514546 AJP2026514546 AJP 2026514546AJP-2026514546-A

Abstract

A system is provided for characterizing effluent samples from patients undergoing peritoneal dialysis. The system comprises a container (30) for enclosing the effluent sample, an optical system, an electrical system, and a processor (13). The optical system comprises a light source (18, 24) and a photodetector (14, 54), the light source emitting a beam of radiation that passes through the container and irradiates the effluent sample, and the photodetector detecting the radiation after it has irradiated the effluent sample to generate an optical signal. The electrical system comprises at least a pair of electrodes (38a, 38b) attached to the container and configured to measure the electrical properties of the effluent sample to generate a characteristic signal. The processor collectively processes the optical signal and the characteristic signal to operate an algorithm for characterizing the effluent sample. [Selection Diagram] Figure 2

Inventors

  • マッキャーナ， ジェイムズ
  • タン， エリク
  • ディーロン， マーシャル
  • バネット， マシュー
  • バッキンガム， ジャスティン
  • オッペゴール， ショーン
  • ホルマー， マティアス

Assignees

  • ヴァンティブ ユーエス ヘルスケア エルエルシー
  • ヴァンティブ ヘルス ゲーエムベーハー

Dates

Publication Date
20260511
Application Date
20240327
Priority Date
20230331

Claims (20)

  1. A system for characterizing outflow samples from patients undergoing peritoneal dialysis (PD), A container (30; 80; 108) for sealing the spilled material sample, An optical system comprising a light source (18, 24) and a photodetector (14, 54), wherein the light source (18, 24) is configured to emit a beam of radiation that passes through the container (30; 80; 108) and irradiates the spill sample, and the photodetector (14, 54) is configured to detect the radiation after it has irradiated the spill sample in order to generate an optical signal, An electrical system comprising at least one pair of electrodes (38a, 38b), wherein the at least one pair of electrodes (38a, 38b) are attached to the container (30; 80; 108) and configured to measure the electrical characteristics of the spill sample in order to generate a characteristic signal, A processor (13) that operates an algorithm configured to characterize the spill sample by collectively processing the optical signal and the characteristic signal, A system equipped with these features.
  2. The system according to claim 1, wherein the container (30; 80; 108) is a sample cell having at least two surfaces.
  3. The system according to claim 2, wherein each of the at least two surfaces of the sample cell comprises an optically transparent material.
  4. The system according to claim 3, wherein the optically transparent material is selected from the group consisting of glass, plastic, ceramic, diamond-based material, or derivatives thereof.
  5. The system according to any one of claims 2 to 4, wherein the at least pair of electrodes (38a, 38b) are thin films formed on at least one of the two surfaces.
  6. The system according to claim 5, wherein the thin film is made of a material that is optically transparent and conductive.
  7. The system according to claim 5 or 6, wherein the thin film is mainly composed of gold, In₂O₅Sn , or one of their derivatives.
  8. The system according to any one of claims 1 to 7, wherein the at least pair of electrodes includes a first pair of electrodes (38a) and a second pair of electrodes (38b).
  9. The system according to claim 8, wherein the first surface of the container (30; 80; 108) includes the first pair of electrodes (38a), which is a first optically transparent electrode pair, and the second surface of the container (30; 80; 108) includes the second pair of electrodes (38b), which is a second optically transparent electrode pair.
  10. The system according to claim 9, wherein the light source (18, 24) is configured to emit the beam of radiation that passes through the first optically transparent electrode pair and enters the spill sample, and the photodetector (14, 54) is configured to receive the radiation after it has irradiated the spill sample and passed through the second optically transparent electrode pair.
  11. The electrical system comprises a capacitor having two capacitor electrodes, wherein the first optically transparent electrode pair is the first capacitor electrode pair, and the second optically transparent electrode pair is the second capacitor electrode pair, according to claim 10.
  12. The system according to any one of claims 1 to 8, wherein both the first pair of electrodes (38a) and the second pair of electrodes (38b) have optically transparent apertures.
  13. The system according to claim 12, wherein the light source (18, 24) is configured to emit the beam of radiation that enters the spill sample through a first optically transparent opening in the first pair of electrodes (38a), and the photodetector (14, 54) is configured to receive the radiation after it has irradiated the spill sample and passed through a second optically transparent opening in the second pair of electrodes (38b).
  14. The system according to any one of claims 1 to 8, wherein the optical system is further configured to measure the light absorption of the spilled material sample.
  15. The system according to claim 14, wherein the light sources (18, 24) are configured to emit the beam of radiation entering the spill sample, the photodetectors (14, 54) are configured to receive the radiation after it has irradiated the spill sample, and the processor (13) is configured to analyze the radiation after it has irradiated the spill sample and to determine the amount of radiation absorbed by the spill sample.
  16. The system according to any one of claims 1 to 8, 14, or 15, wherein the optical system is further configured to measure light scattering caused by the spilled sample.
  17. The system according to claim 16, wherein the light sources (18, 24) are configured to emit the beam of radiation entering the spill sample, the photodetectors (14, 54) are configured to receive the radiation after it has irradiated the spill sample, and the processor (13) is configured to analyze the radiation after it has irradiated the spill sample and to determine the amount of light scattering caused by the spill sample.
  18. The system according to any one of claims 1 to 17, wherein the electrical characteristics of the spilled sample are selected from the group consisting of capacitance, resistance, conductivity, complex impedance, impedance, reactance, inductance, dielectric constant, and magnetism.
  19. The system according to claim 18, wherein the at least pair of electrodes (38a, 38b) includes a pair of electrodes (38a; 38b) configured to both induce an electric current in the spill sample and to sense the electrical properties or related parameters of the spill sample.
  20. The system according to claim 18, wherein the at least pair of electrodes (38a, 38b) includes a pair of electrodes (38a; 38b) configured to both generate an electric field within the spill sample and to sense the electrical properties or related parameters of the spill sample.

Description

This disclosure relates to a system for monitoring patients, particularly those with end-stage renal disease (ESRD) and undergoing peritoneal dialysis (PD), in both hospital and home settings. PD (Peripheral Dialysis) is a type of dialysis that uses the peritoneum in the patient's abdomen as a membrane, through which fluids and dissolved substances are exchanged with blood. Typically, PD is used to remove excess fluid, correct electrolyte imbalances, and remove toxins from patients suffering from ESRD (Edible Subcutaneous Fat Reduction). PD is typically less efficient at removing waste from the body than hemodialysis (hereinafter referred to as "HD"). However, PD typically shows better results than HD during the first few years of treatment. Compared to HD, PD allows for greater patient mobility, results in less symptom variability due to its continuous nature, and is superior in removing phosphate compounds. However, PD also typically removes large amounts of albumin, requiring constant monitoring of the patient's nutritional status. The costs associated with PD are generally lower than those associated with HD in most parts of the world, and this is most pronounced in developed countries. Other advantages of PD include greater flexibility and better tolerability for patients with significant heart disease. Peritoneal dialysis (PD) can be performed at regular intervals throughout the day, either as continuous portable peritoneal dialysis (known herein as "CAPD") or at night with the assistance of a machine known as an automated peritoneal dialysis machine (known herein as "APD") or "Cycla." The solution is typically prepared from osmotic agents such as sodium chloride, bicarbonate, and glucose. During PD, dialysate (also referred to herein as dialysate or dialysate fluid) is introduced through a permanent catheter placed in the patient's lower abdomen during the surgical procedure. One end of the catheter is inserted into the abdomen, and the other end protrudes from the skin. Naturally, the presence of the catheter carries a risk of peritonitis, as it can introduce bacteria into the abdomen. Typically, 2 to 3 liters of dialysate are introduced into the abdomen at the start of PD treatment. This volume, called the "filling volume," can be as much as 3 liters, and medications can be added to the solution immediately before infusion. This volume remains in the abdomen, and waste diffuses from the underlying blood vessels into the peritoneum. After a variable period, the "residence time" (usually 2 to 6 hours depending on the procedure), the fluid is removed, and the removed fluid is called "fluid." Removal of fluid can be done automatically while the patient is sleeping (e.g., during APD) or during the day by maintaining 2 liters of fluid in the abdomen at all times, with fluid changes 4 to 6 times daily (CAPD). APD involves 3 to 10 stool respirations per night, while CAPD involves 4 stool respirations per day, each containing 2 to 3 liters, and each remains in the abdomen for 4 to 8 hours. PD effusion can be monitored to determine whether a patient is experiencing early onset of peritonitis or suffering from any other adverse condition that may affect the color of the effusion. For example, pink effusion may suggest internal abdominal bleeding or menstruation, while the presence of brown or yellowish hues in the effusion may suggest feces, which could indicate bowel perforation. Cloudy effusion typically suggests infection. Often, the test to determine this condition involves holding the waste bag containing the effusion against normally legible documents (e.g., magazines or newspapers) and determining whether the text is legible. Documents that are not clearly legible indicate cloudy effusion, which could indicate the presence of leukocytes (e.g., white blood cells) or other biological material, and thus peritonitis. Therefore, the evaluation of PD effusion is a manual process that is difficult to repeat with meaningful accuracy. The subjectivity of the process, particularly the need for individual visual evaluation, further affects the overall accuracy of this process. Several automated systems have been developed to evaluate PD effluent. These include, for example, optical systems based on light absorption, scattering, or fluorescence to characterize PD effluent, while others describe the measurement of chemical properties of the effluent, such as pH. In yet another example, conventional systems measure physiological properties from patients (e.g., blood pressure, glucose) to estimate their condition, such as the presence of peritonitis. Patents issued in this field include, for example, U.S. Patent No. 11,013,843, U.S. Patent No. 10,983,124, U.S. Patent No. 10,925,549, U.S. Patent No. 10,758,659, U.S. Patent No. 10,744,253, U.S. Patent No. 10,537,673, U.S. Patent No. 10,155,081, U.S. Patent No. 10,010,289, U.S. Patent No. 9,518,914, U.S. Patent No. 9,215,985, U.S. Patent No. 9,125,989, U.S. Patent No. 8