System and method for an ambulatory peritoneal dialysis cycler apparatus
The portable ambulatory peritoneal dialysis cycler addresses the limitations of bulky and risky manual cyclers by providing automated, sterile, and portable dialysis with real-time monitoring and data sharing, suitable for diverse environments.
Patent Information
- Application Number
- PCT/IN2024/052079
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-07-02
- Filing Date
- 2024-10-17
- Publication Date
- 2026-01-08
AI Technical Summary
Current peritoneal dialysis cyclers are bulky, non-portable, require manual handling, and pose infection risks due to touch, lacking real-time monitoring and control capabilities, and are not suitable for low-resource settings.
A portable ambulatory peritoneal dialysis cycler apparatus with automated control and monitoring, featuring a sterile connection mechanism, fluid management, occlusion detection, and real-time data logging, powered by a computing device, and capable of functioning in any orientation.
Enables safe, automated, and portable peritoneal dialysis with reduced infection risk, real-time monitoring, and data sharing, suitable for various environments, including low-resource settings.
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Figure IN2024052079_08012026_PF_FP_ABST
Abstract
Description
SYSTEM AND METHOD FOR AN AMBULATORY PERITONEAL DIALYSIS CYCLER APPARATUS
[0001] The present invention is generally related to a system for peritoneal dialysis cycler. The present invention is particularly related to a system and method for a portable ambulatory peritoneal dialysis cycler apparatus.
[0002] Peritoneal dialysis cyclers have been in the industry and have evolved over a period of quite a few decades. The currently used cyclers must be carefully handled, usually with the help of caretakers, and many manual processes that are to be carefully implemented for proper dialysis. They also carry a higher risk of infection due to touch, as there are several manual processes needed for the cycler to perform dialysis.
[0003] In current systems, dialysis data such as settings of the apparatus and dialysis volumes are manually noted, and then manually transferred to an electronic storage for further processing and future use by doctors and caregivers. The cyclers are also bulky, non-portable, and work mainly in complex environments that are not suitable for low resource settings.
[0004] Hence, there exists a need for enabling a portable peritoneal dialysis system that is functional in any environment. There also exists a need for providing a portable peritoneal dialysis system that functions in horizontal and vertical orientations. There also exists a need for a system to enable connecting the peritoneal dialysis system to a plurality of computing devices for real-time remote monitoring and control.
[0005] The abovementioned shortcomings, disadvantages and problems are addressed herein, which will be understood by reading and studying the following specification.OBJECT OF THE INVENTION
[0006] The primary object of the present invention is to provide a system and method for a portable ambulatory peritoneal dialysis cycler apparatus.
[0007] Another object of the present invention is to provide a system for automated control and monitoring of a portable peritoneal dialysis.
[0008] Yet another object of the present invention is to provide a portable peritoneal dialysis system that is usable in any environment.
[0009] Yet another object of the present invention is to provide a peritoneal dialysis system that functions as a stationary system and a mobile system depending on the use-case.
[0010] Yet another object of the present invention is to provide a peritoneal dialysis system with a sterile mechanism to connect the catheter and prevent any infections due to touch.
[0011] Yet another object of the present invention is to provide a peritoneal dialysis system that provides a multi-bag system for enabling multiple continuous ambulatory peritoneal dialysis.
[0012] Yet another object of the present invention is to provide a peritoneal dialysis system that comprises an in-built heater mechanism to heat the fluids to appropriate temperature.
[0013] Yet another object of the present invention is to provide a peritoneal dialysis system that comprises an occlusion detection and fluid volume management system for enabling a smooth operation of the system.
[0014] Yet another object of the present invention is to provide a peritoneal dialysis system that comprises a control and monitoring module that is enabled with an embedded system to real-time control and monitoring.
[0015] Yet another object of the present invention is to provide a peritoneal dialysis system that is configured to connect with a plurality of computing devices for real-time data-logging and data-sharing.
[0016] Yet another object of the present invention is to provide a peritoneal dialysis system that is configured to be controlled through an application that runs on a computing device connected to the system through wired or wireless means.
[0017] These and other objects and advantages of the present invention will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings.
[0018] The various embodiments of the present invention provide a system and method for a portable ambulatory peritoneal dialysis cycler apparatus. The system comprises a one-time safe connection mechanism that minimizes the incidence of infection through touch. The system is designed to work when placed in both horizontal and vertical orientations. The system also includes a peritoneal dialysis cycler along with fluid bags and drain bags. The system is configured to manage power independently, and all the control aspects and tasks of the peritoneal dialysis process are automatically controlled through a computing device connected to the system.
[0019] According to one embodiment of the present invention, the peritoneal dialysis processes that are automated to be controlled through a computing device include scheduling, a plurality of CCPD settings, providing alerts, heating of fill fluid, starting-stopping of the process and tracking and digitally storing a plurality of data.
[0020] According to one embodiment of the present invention, a portable ambulatory peritoneal dialysis cycler apparatus comprises a peritoneal dialysis apparatus including a plurality of fluid fill bags and drain bags, fill tubing, drain tubing, fluid bag adapters, a catheter, and a safety bulb. The apparatus further includes an intelligent peristaltic pump module driven by a geared DC motor for pumping fluid in both directions between the fluid bags and the patient’s peritoneal cavity. A control and monitoring module, comprising an embedded systems controller for real-time control and monitoring of the dialysis process, is communicably coupled with a computing device for scheduling dialysis settings, providing alerts, heating fill fluid, starting-stopping the process, and digitally storing data. The apparatus also includes a sterile connector module designed to cover and protect the connection points of the fill tubing, drain tubing, fluid bag adapters, and the catheter, ensuring sterility during connections and disconnections. A fluid volume management module incorporates a proximity sensor module to measure fluid volume transferred, rate of fluid transfer, and fluid pressure, and communicates this data to the control and monitoring module. Additionally, an occlusion management module with an optical source and detector detects blockages in the fluid pathways and communicates occlusion data to the control and monitoring module. The apparatus also features a heater system for heating the dialysis fluid to a user-defined temperature, with an automatic sensing mechanism controlled by the control and monitoring module. Lastly, the apparatus includes a power management module with a replaceable and rechargeable DC power source and a mechanical switch for powering the system on and off, and a communication module enabling wired and wireless communication between the system components and external computing devices for real-time data logging and remote monitoring.
[0021] According to another embodiment of the present invention, the portable ambulatory peritoneal dialysis cycler apparatus as described above, further comprises a fluid bag servo arm uniquely positioned between the tubings of three different fluid bags, where a predefined rotation of the servo arm opens and closes each tubing individually, together, or in any combination as required to manage the multiple options of allowing fluid from any of these three bags to reach the fill tubing path, thereby enabling the fill process to be carried out in any possible order and volume of fluid as set by the user. Additionally, the apparatus includes a fill / drain path servo arm placed between the fill and drain tubing, which opens up the fill and drain fluid paths during the respective processes. This servo arm can also open and close the fill and drain tubings as per the fill or drain process set by the user. The apparatus features a T-junction in the sterile connector module, which serves as the main junction where the fill and drain fluid paths meet, controlling various combinations of the fill and drain process and establishing pathways for proper implementation. The movable peristaltic arm, fixed permanently at one end and allowed to be opened through a screw by the user, enables the insertion of a fresh sterile connector cable before every PD process. When fastened tightly, the tubing kinks properly for peristaltic action. The peristaltic pump rotor assembly, fixed to a DC motor, rotates in either direction as defined by the fill or drain process set by the user, enabling appropriate fluid transfer. The apparatus also includes a touch screen display, providing an additional user control interface along with the smartphone app, for complete control of the device. The tubings from the three different fill bags, fill tubing, drain tubing, and body catheter tubing are designed to provide flexibility in delivering specific volumes of different PD fluids or dialysates in any prescribed order, ensuring an effective and customized dialysis treatment.
[0022] According to another embodiment of the present invention, the portable ambulatory peritoneal dialysis cycler apparatus as described above, wherein the control and monitoring module is configured to generate and send alerts to the connected computing device in case of abnormal conditions, such as fluid leakage, occlusions, or deviations from preset fluid transfer rates.
[0023] According to another embodiment of the present invention, the portable ambulatory peritoneal dialysis cycler apparatus as described above, wherein the sterile connector module is made of flexible, biocompatible material that allows easy manipulation without compromising sterility during the connection and disconnection of fluid bags and the catheter.
[0024] According to another embodiment of the present invention, the portable ambulatory peritoneal dialysis cycler apparatus as described above, wherein the intelligent peristaltic pump module includes a specially designed rotor that calculates the rotation count and rate of fluid flow, providing real-time data to the fluid volume management module for precise fluid control.
[0025] According to another embodiment of the present invention, the portable ambulatory peritoneal dialysis cycler apparatus as described above, wherein the heater system comprises a closed-loop control mechanism that maintains the dialysis fluid at the desired temperature by continuously adjusting the heating element based on real-time temperature feedback.
[0026] According to another embodiment of the present invention, the portable ambulatory peritoneal dialysis cycler apparatus as described above, wherein the power management module includes an energy-efficient design with low-power components and a battery life indicator on the connected computing device to inform the user of the remaining battery capacity.
[0027] According to another embodiment of the present invention, the portable ambulatory peritoneal dialysis cycler apparatus further comprises: fluid bags and the cycler housed in a portable trolley designed in any form factor for anytime, anywhere use; the capability to fill multiple fluid bags in a user-selectable order and volume within a single peritoneal dialysis cycle; and, separate servo paths for the fill and drain processes for each fluid bag, thereby eliminating the need for a cassette mechanism.
[0028] According to one embodiment of the present invention, a method for performing peritoneal dialysis using a portable ambulatory peritoneal dialysis cycler apparatus comprises the steps of powering on the system using a mechanical switch on the power management module, connecting fluid fill bags and drain bags to the sterile connector module ensuring sterility during connections, connecting a catheter to the patient using the sterile connector module, configuring dialysis settings including fluid volumes and compositions through a computing device connected to the control and monitoring module, heating the dialysis fluid to the desired temperature using the heater system controlled by the control and monitoring module, initiating the dialysis process where the intelligent peristaltic pump module pumps fluid from the fill bags to the patient’s peritoneal cavity and from the patient’s cavity to the drain bags under the control of the control and monitoring module, continuously monitoring the dialysis process including fluid flow rates, volumes, and system status using sensors and the fluid volume management module, detecting and managing occlusions using the occlusion management module and sending alerts to the connected computing device in case of blockages, and logging all process data in real-time and storing it on the connected computing device for review and future reference.
[0029] According to another embodiment of the present invention, the method for performing peritoneal dialysis using a portable ambulatory peritoneal dialysis cycler apparatus as described above further comprises the step of generating and sending real-time alerts to the connected computing device in case of abnormal conditions such as fluid leakage, occlusions, or deviations from preset fluid transfer rates.
[0030] According to another embodiment of the present invention, the method for performing peritoneal dialysis using a portable ambulatory peritoneal dialysis cycler apparatus as described above further comprises the step of performing a system cleanup cycle after completing the dialysis session, where the fluid pathways and tubing are flushed to remove any residual fluid and maintain system hygiene.
[0031] According to another embodiment of the present invention, the method for performing peritoneal dialysis using a portable ambulatory peritoneal dialysis cycler apparatus as described above further comprises the step of reviewing the logged process data on the connected computing device, analyzing the dialysis session's effectiveness, and adjusting the settings for future sessions based on medical advice and data analysis.
[0032] These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating the preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications.
[0033] The other objects, features and advantages will occur to those skilled in the art from the following description of the preferred embodiment and the accompanying drawings in which:
[0034] illustrates a system for automated control and monitoring of a portable peritoneal dialysis apparatus, according to one embodiment of the present invention.
[0035] illustrates an ambulatory portable peritoneal dialysis apparatus, according to one embodiment of the present invention.
[0036] illustrates a plurality of configurations of an intelligent peristaltic pump module comprised in an ambulatory portable peritoneal dialysis apparatus, according to one embodiment of the present invention.
[0037] Although the specific features of the present invention are shown in some drawings and not in others. This is done for convenience only as each feature may be combined with any or all of the other features in accordance with the present invention.
[0038] In the following detailed description, a reference is made to the accompanying drawings that form a part hereof, and in which the specific embodiments that may be practiced is shown by way of illustration. These embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments and it is to be understood that other changes may be made without departing from the scope of the embodiments. The following detailed description is therefore not to be taken in a limiting sense.
[0039] The various embodiments of the present invention provide a system and method for a portable ambulatory peritoneal dialysis cycler apparatus. The system comprises a one-time safe connection mechanism that minimizes the incidence of infection through touch. The system is designed to work when placed in both horizontal and vertical orientations. The system also includes a peritoneal dialysis cycler along with fluid bags and drain bags. The system is configured to manage power independently, and all the control aspects and tasks of the peritoneal dialysis process are automatically controlled through a computing device connected to the system.
[0040] According to one embodiment of the present invention, the peritoneal dialysis processes that are automated to be controlled through a computing device include scheduling, a plurality of CCPD settings, providing alerts, heating of fill fluid, starting-stopping of the process and tracking and digitally storing a plurality of data.
[0041] According to one embodiment of the present invention, a system is provided for automated control and monitoring of a portable peritoneal dialysis apparatus. The system comprises a peritoneal dialysis apparatus, an intelligent peristaltic pump module, a sterile connector module, a fluid flow management module, a control and monitoring module, a geared DC motor, an occlusion management module, a fluid volume management module, a heater system, a fluid priming system, a power management module and a communication module. A plurality of computing devices is configured to communicably couple with the system for automated control and monitoring of a portable peritoneal dialysis apparatus.
[0042] According to one embodiment of the present invention, the peritoneal dialysis apparatus comprises a plurality of fill bags, a plurality of drain bags, a fill tubing and a drain tubing, a plurality of fluid bag adapters, a catheter, a flow control lever, a flow sensor and a safety bulb. The peritoneal dialysis apparatus is connected to the sterile connector module that is designed for covering the layers of fill tubing and a drain tubing, the plurality of fluid bag adapters and the flow control lever. The sterile connector protects the fluid connection points in the peritoneal dialysis apparatus by making the connection points completely sterile when a patient or a care-giver physically makes the connections between the fluid bags in the peritoneal dialysis apparatus. The sterile connector module is made of flexible material that enables the patient and the caregiver to make the physical connections without having to come in contact with the surface of the critical and sensitive parts of the peritoneal dialysis apparatus.
[0043] According to one embodiment of the present invention, the peritoneal dialysis apparatus comprises portable fluid bags connected through a specially designed tubing mechanism. The bag filled with fluid comprises a stopper that is designed to open and close by a human user to fill-in the fluid in the bag. The empty bag comprises a second stopper that facilitates a device to open and close automatically as per the programmed sequence enable the draining of fluid into the empty bag. The fluid flow management module comprises DC servomotors, a weight measurement system, servomotors with stopcocks and plastic connecting components. The DC servomotors are designed to control the flow of liquid between a plurality of fluid bags and the patient. The weight measurement system is configured to measure the quantity of fluid exchanged between a plurality of fluid bags and the quantity of fluids in the plurality of fluid bags. The servomotors with stopcocks are designed to control the flow of fluid from fluid bags to the catheter connected to the patient in one direction and from the catheter connected to the patient to the drain bag in another direction.
[0044] According to one embodiment of the present invention, the intelligent peristaltic pump module is enabled through the geared DC motor. A motor controller drives the peristaltic pump, which pumps fluid in two directions, namely, fluid from fluid bags to the catheter connected to the patient in one direction and from the catheter connected to the patient to the drain bag in another direction. The intelligent peristaltic pump module is designed to provide a contactless pumping system, which comprises a specially designed rotor that is designed calculate and measure the count of rotation and rate of fluid flow. The calculated and measured information is communicated to the control and monitoring module.
[0045] According to one embodiment of the present invention, the fluid volume management module comprises a proximity sensor module that is designed and positioned in an assembly with the specially designed rotor of the intelligent peristaltic pump module. The rate of rotation of the rotor is captured by the proximity sensor module through a plurality of identifiers in the rotor design. The rate of rotation provides data on multiple parameters, including the fluid volume transferred, rate of fluid transfer and pressure of the fluid, to the control and monitoring module.
[0046] According to one embodiment of the present invention, the fluid volume management module is configured to connect with the occlusion management module and the fluid priming system. The occlusion management module further comprises an optical source and an optical detector placed at exactly opposite directions of the specially designed rotor of the occlusion management module that lies in the path of fluid. The optical detector in the occlusion management module is connected to the control and monitoring module for communicating the measurements and data. The fluid priming system is configured to utilize the readings from the optical detector in identifying the colour of the fluid flowing. The fluid priming system is configured to connect with the control and monitoring module for verifying whether the flow of fluid satisfies the pre-set conditions.
[0047] According to one embodiment of the present invention, the heater system is designed to heat the fluid in the fill bag and enable the human user to control the temperature of the fluid in the bag. The heater system comprises an automatic sensing mechanism that maintains the fluid at the temperature set by the user by heating the fluid. The heater system is communicably coupled with the control and monitoring module which is configured to control the heater system through a closed loop control system mechanism.
[0048] According to one embodiment of the present invention, the control and monitoring module is an electronic module that comprises an embedded systems controller, a plurality of integrated circuits and other circuitry to control and monitor the functioning of a plurality of modules in the system for automated control and monitoring of a portable peritoneal dialysis apparatus. The control and monitoring module comprises a complete firmware apparatus to enable the functioning of the system. The control and monitoring module is enabled to communicably couple with a plurality of computing devices, where the computing devices are configured with applications that provide a user interface that enables human users to control and monitor the working of the system for automated control and monitoring of portable peritoneal dialysis apparatus. The computing devices are configured to connect with the control and monitoring module through wired and wireless means, and the computing devices are also configured to store a log of all the processes in the system, create databases of the information on performance of the plurality of modules in the system and render the information through infographics to human users accessing the computing device.
[0049] According to one embodiment of the present invention, the power management module comprises a DC power source that powers the entire system and a mechanical switch for powering the system ON and OFF. The DC power source in the power management module is replaceable and rechargeable.
[0050] According to one embodiment of the present invention, the communication module enables the digital communication between the plurality of modules in the system. The communication module also enables communication between a plurality of computing devices and the system through wired and wireless means.
[0051] illustrates a system for automated control and monitoring of a portable peritoneal dialysis apparatus. The system 100 comprises a peritoneal dialysis apparatus 101, an intelligent peristaltic pump module 102, a sterile connector module 103, a fluid flow management module 104, a control and monitoring module 105, a DC motor 106, an occlusion management module 107, a fluid volume management module 108, a heater system 109, a fluid priming system 110, a power management module 111 and a communication module 112. The system is configured to connect with a computing device 113 that is configured with a user interface 114 and dialysis data archiving module 115 for remote control, monitoring and storage of data on performance of the system 100.
[0052] illustrates an ambulatory portable peritoneal dialysis apparatus. The apparatus includes Fluid Bag Servo Arm 201, Fill / Drain Path Servo Arm 202, T-Junction of Stericon 203, Movable Peristaltic Arm 204, Peristaltic Pump Rotor Assembly 205, Touch Screen Display 206, Tubings 207a, 207b, 207c, Fill Tubing 208, Drain Tubing 209 and Body Catheter Tubing 210.
[0053] Fluid Bag Servo Arm: The fluid bag servo arm is uniquely shaped and strategically positioned between the tubings of three different fluid bags (7a, 7b, and 7c). This servo arm is designed to rotate in a predefined manner, enabling it to open and close each of the tubings individually, together, or in any combination. This allows the system to manage fluid from any of the three bags to reach the fill tubing path (8), thus facilitating the fill process according to the user’s set order and volume of fluid.
[0054] Fill / Drain Path Servo Arm: This servo arm is placed between the fill and drain tubings. It operates by opening the fill and drain fluid paths during their respective processes. The servo arm can open and close these tubings based on the fill or drain process set by the user, ensuring controlled fluid transfer during the peritoneal dialysis procedure.
[0055] T-Junction of Stericon: The T-junction is a critical component where the fill and drain fluid paths meet. It controls various combinations of the fill and drain processes, establishing proper pathways for the implementation of these processes by the device. This junction ensures that the fluid flows correctly between the different paths during the dialysis cycle.
[0056] Movable Peristaltic Arm: The peristaltic pump arm has a unique movement, being fixed permanently at one end while allowing the other end to be opened through a screw mechanism by the user. This enables the insertion of a fresh sterile connector cable (stericon) before each PD process. Once the screw is fastened tightly, the tubing kinks properly, enabling the peristaltic pump to carry out its action efficiently.
[0057] Peristaltic Pump Rotor Assembly: This rotor assembly is connected to a DC motor that can rotate in either direction as required by the fill or drain process set by the user. This assembly ensures the appropriate fluid transfer during the fill and drain phases of the dialysis process, controlled by the user’s settings.
[0058] Touch Screen Display: The touch screen display serves as an additional user control interface alongside the smartphone app interface. It provides users with complete control over the device, allowing them to monitor and adjust settings directly on the device.
[0059] Tubings: These tubings connect the three different fill bags to the system. They allow the inclusion or exclusion of any fluid bag in the fill process in various combinations as set by the user. This setup provides flexibility in delivering different dialysate fluids such as Dextrose PD Fluid bags or Bicarbonate, as prescribed by the healthcare provider.
[0060] Fill Tubing: This is a single tubing path connected from the multiple fluid bags, which can be controlled during the fill process of peritoneal dialysis. It ensures the proper delivery of the dialysate to the patient.
[0061] Drain Tubing: This is a single tubing path connected to one or multiple drain (empty) bags. It is controlled during the drain process of peritoneal dialysis, ensuring the removal of used dialysate from the patient’s peritoneal cavity.
[0062] Body Catheter Tubing: This tubing path connects from the peristaltic pump assembly to the catheter coming from the patient’s body. It serves as the conduit through which the peritoneal dialysis process is performed, ensuring the dialysate is correctly infused into and drained from the patient’s peritoneal cavity.
[0063] illustrates a plurality of configurations of an intelligent peristaltic pump module comprised in an ambulatory portable peritoneal dialysis apparatus.
[0064] Although the embodiments herein are described with various specific embodiments, it will be obvious for a person skilled in the art to practice the embodiments herein with modifications.ADVANTAGEOUS EFFECTS OF INVENTION
[0065] The various embodiments of the present invention provide a system and method for a portable ambulatory peritoneal dialysis cycler apparatus. The system comprises a one-time safe connection mechanism that minimizes the incidence of infection through touch. The system is designed to work when placed in both horizontal and vertical orientations. The system also includes a peritoneal dialysis cycler along with fluid bags and drain bags. The system is configured to manage power independently, and all the control aspects and tasks of the peritoneal dialysis process are automatically controlled through a computing device connected to the system. The peritoneal dialysis processes that are automated to be controlled through a computing device include scheduling, a plurality of CCPD settings, providing alerts, heating of fill fluid, starting-stopping of the process and tracking and digitally storing a plurality of data.
[0066] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and / or adapt for various applications such as specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modifications. However, all such modifications are deemed to be within the scope of the claims.
Claims
A system for performing peritoneal dialysis using a portable ambulatory peritoneal dialysis cycler apparatus, the system comprising:a peritoneal dialysis apparatus including a plurality of fluid fill bags and drain bags, fill tubing, drain tubing, fluid bag adapters, a catheter, and a safety bulb;an intelligent peristaltic pump module driven by a geared DC motor for pumping fluid in both directions between the fluid bags and the patient’s peritoneal cavity;a control and monitoring module comprising an embedded systems controller for real-time control and monitoring of the dialysis process, communicably coupled with a computing device for scheduling dialysis settings, providing alerts, heating fill fluid, starting-stopping the process, and digitally storing data;a sterile connector module designed to cover and protect the connection points of the fill tubing, drain tubing, fluid bag adapters, and the catheter, ensuring sterility during connections and disconnections;a fluid volume management module incorporating a proximity sensor module to measure fluid volume transferred, rate of fluid transfer, and fluid pressure, and communicate this data to the control and monitoring module;an occlusion management module with an optical source and detector to detect blockages in the fluid pathways and communicate occlusion data to the control and monitoring module;a heater system for heating the dialysis fluid to a user-defined temperature, with an automatic sensing mechanism controlled by the control and monitoring module;a power management module with a replaceable and rechargeable DC power source and a mechanical switch for powering the system on and off; and,a communication module enabling wired and wireless communication between the system components and external computing devices for real-time data logging and remote monitoring.The system as claimed in claim 1, wherein portable ambulatory peritoneal dialysis cycler apparatus further comprises : a fluid bag servo arm uniquely positioned between the tubings of three different fluid bags, wherein a predefined rotation of the servo arm opens and closes each tubing individually, together, or in any combination as required to manage the multiple options of allowing fluid from any of these three bags to reach the fill tubing path, thereby enabling the fill process to be carried out in any possible order and volume of fluid as set by the user; a fill / drain path servo arm placed between the fill and drain tubing, wherein the servo arm opens up the fill and drain fluid paths during the respective processes, and can also open and close the fill and drain tubings as per the fill or drain process set by the user; a T-junction in the sterile connector module, which serves as the main junction where the fill and drain fluid paths meet, controlling various combinations of the fill and drain process and establishing pathways for proper implementation; a movable peristaltic arm, fixed permanently at one end and allowed to be opened through a screw by the user, enabling the insertion of a fresh sterile connector cable before every peritoneal dialysis process, wherein, when fastened tightly, the tubing kinks properly for peristaltic action; a peristaltic pump rotor assembly, fixed to a DC motor, configured to rotate in either direction as defined by the fill or drain process set by the user, thereby enabling appropriate fluid transfer during the fill and drain processes; a touch screen display providing an additional user control interface along with a smartphone app, for complete control of the device; and, tubings from three different fill bags, fill tubing, drain tubing, and body catheter tubing designed to provide flexibility in delivering specific volumes of different peritoneal dialysis fluids or dialysates in any prescribed order, ensuring an effective and customized dialysis treatment.The system as claimed in claim 1, wherein the control and monitoring module is configured to generate and send alerts to the connected computing device in case of abnormal conditions, such as fluid leakage, occlusions, or deviations from preset fluid transfer rates.The system as claimed in claim 1, wherein the sterile connector module is made of flexible, biocompatible material that allows easy manipulation without compromising sterility during the connection and disconnection of fluid bags and the catheter.The system as claimed in claim 1, wherein the intelligent peristaltic pump module includes a specially designed rotor that calculates the rotation count and rate of fluid flow, providing real-time data to the fluid volume management module for precise fluid control.The system as claimed in claim 1, wherein the heater system comprises a closed-loop control mechanism that maintains the dialysis fluid at the desired temperature by continuously adjusting the heating element based on real-time temperature feedback.The system as claimed in claim 1, wherein the power management module includes an energy-efficient design with low-power components and a battery life indicator on the connected computing device to inform the user of the remaining battery capacity.The system as claimed in claim 1, wherein the portable ambulatory peritoneal dialysis cycler apparatus further comprises: fluid bags and the cycler housed in a portable trolley designed in any form factor for anytime, anywhere use; the capability to fill multiple fluid bags in a user-selectable order and volume within a single peritoneal dialysis cycle; and, separate servo paths for the fill and drain processes for each fluid bag, thereby eliminating the need for a cassette mechanism.A method for performing peritoneal dialysis using a portable ambulatory peritoneal dialysis cycler apparatus, the method comprising:powering on the system using a mechanical switch on the power management module;connecting fluid fill bags and drain bags to the sterile connector module, ensuring sterility during connections;connecting a catheter to the patient using the sterile connector module;configuring dialysis settings, including fluid volumes and compositions, through a computing device connected to the control and monitoring module;heating the dialysis fluid to the desired temperature using the heater system, controlled by the control and monitoring module;initiating the dialysis process, where the intelligent peristaltic pump module pumps fluid from the fill bags to the patient’s peritoneal cavity and from the patient’s cavity to the drain bags, under the control of the control and monitoring module;continuously monitoring the dialysis process, including fluid flow rates, volumes, and system status, using sensors and the fluid volume management module;detecting and managing occlusions using the occlusion management module, and sending alerts to the connected computing device in case of blockages; and,logging all process data in real-time and storing it on the connected computing device for review and future reference.The method as claimed in claim 9, further comprising the step of generating and sending real-time alerts to the connected computing device in case of abnormal conditions such as fluid leakage, occlusions, or deviations from preset fluid transfer rates.The method as claimed in claim 9, further comprising the step of performing a system cleanup cycle after completing the dialysis session, where the fluid pathways and tubing are flushed to remove any residual fluid and maintain system hygiene.The method as claimed in claim 9, further comprising the step of reviewing the logged process data on the connected computing device, analyzing the dialysis session's effectiveness, and adjusting the settings for future sessions based on medical advice and data analysis.
Citation Information
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Automated peritoneal dialysis system using a peristaltic pump and non-contact sensors
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