WO2022085032A1 - System and method for contactless replacement of medical tubing connections - Google Patents

System and method for contactless replacement of medical tubing connections Download PDF

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Publication number
WO2022085032A1
WO2022085032A1 PCT/IN2021/051008 IN2021051008W WO2022085032A1 WO 2022085032 A1 WO2022085032 A1 WO 2022085032A1 IN 2021051008 W IN2021051008 W IN 2021051008W WO 2022085032 A1 WO2022085032 A1 WO 2022085032A1
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WO
WIPO (PCT)
Prior art keywords
tubing
fluid
drain
flow
fill
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PCT/IN2021/051008
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French (fr)
Inventor
Gowrishankar WUPPULURU
Original Assignee
Wuppuluru Gowrishankar
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Publication date
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Publication of WO2022085032A1 publication Critical patent/WO2022085032A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/285Catheters therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M39/16Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M39/162Tube connectors; Tube couplings having provision for disinfection or sterilisation with antiseptic agent incorporated within the connector
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M39/16Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M39/165Shrouds or protectors for aseptically enclosing the connector
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3306Optical measuring means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • A61M2205/3334Measuring or controlling the flow rate

Definitions

  • the present invention is generally related to a system and method for contactless handling of medical tubing.
  • the present invention is particularly related to a system and method for enabling replacement of a medical tubing apparatus without direct physical contact.
  • the present invention is more particularly related to a system and method for enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer and a system for routing multiple tubing sets to a single catheter line going to patient’s body.
  • the present invention is also related to implementation of a simple mechanism, for identifying and measuring fluid flow and occlusion detection, through a specially designed in-built flow control mechanism.
  • PD Peritoneal Dialysis
  • peritonitis a major risk of infection
  • a major source of infection is the connection-related infections, arising when the patient handles the connections to be made between a catheter and fluid bag(s).
  • a very diligent cleaning procedure is prescribed and the room where the dialysis shall be carried out is to be kept completely clean and sterile. But these conditions are very difficult to be met in the homes of patients.
  • the primary object of the present invention is to provide a system and method for enabling replacement of a medical tubing apparatus without direct physical contact.
  • Another object of the present invention is to provide a system and method for enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer.
  • Yet another object of the present invention is to provide a system for protecting connection-points in a medical tubing and connection system that have a higher potential for infection due to physical contact.
  • Yet another object of the present invention is to provide a system that minimizes the risk of infection due to handling of medical tubing by patients or caregivers in an unsterile environment.
  • Yet another object of the present invention is to provide a system that minimizes the risk of infection in tubing, connections and consumables in medical field, such as IV lines, dialysis connectors or any other connectors where physical contact of hands is required to enablea connection.
  • Yet another object of the present invention is to provide a system for routing of multiple fluid lines/paths into a single patient line/path.
  • Yet another object of the present invention is to provide a mechanism in PD cyclers for managing occlusion detection.
  • Yet another object of the present invention is to provide a mechanism in PD cyclers for managing fluid flow.
  • Yet another object of the present invention is to provide a mechanism in PD cyclers for measuring the volume of fluid transfer.
  • Yet another object of the present invention is to provide a mechanism in PD cyclers for measuring the rate of fluid transfer.
  • the various embodiments of the present invention provide a system and method for enabling replacement of a medical tubing apparatus without direct physical contact.
  • the embodiments also provide a system and method for enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer.
  • a system for replacement of a medical tubing apparatus without direct physical contact and enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer.
  • the system comprises a Peritoneal Dialysis apparatus, a transfer set, a safety bulb, a catheter, a flow sensor, a T-junction, a flow control lever and an occlusion detection system.
  • the peritoneal Dialysis apparatus includes a plurality of Peritoneal Dialysis fluid drain bags, a plurality of fluid bag adaptors, a fill tubing and a drain tubing.
  • the transfer set comprises a cap that is sterile and is opened before connecting the transfer set to the Peritoneal Dialysis apparatus.
  • the safety bulb is a flexible covering provided for the transfer set, wherein the safety bulb is coated with anti-microbial coating on the surface and the safety bulb acts as the interface through which the transfer set is inserted into the connector for connecting to the Peritoneal Dialysis apparatus.
  • the catheter passes through a tight sponge base coated with any prophylactic solution that cleans the surface of the catheter that enters the sterile zone of the Peritoneal Dialysis apparatus.
  • the slit opening of the Peritoneal Dialysis apparatus’ adaptor that comprises the prophylactic covering wipes away the surface from of any contaminant or pathogen when inserted into the sterile bulb portion of the apparatus.
  • the flow sensor is configured to measure the fluid flowing into the Peritoneal Dialysis fluid bags through the catheter coming out from the patient’s body.
  • the T-junction is the meeting point of the fill tubing and the drain tubing.
  • the occlusion detection system is a part of the flow sensor, and the occlusion detection system is configured for occlusion detection, and fluid flow measurement through an opto-electric/magnetic technique, wherein the occlusion detection system is built inside the tubing through which the fluid flows.
  • one end of the transfer set is connected to the body of a patient permanently though a surgical procedure, and the patient removes the cap of the transfer set to perform the dialysis and close the transfer set with a new cap.
  • the cap of the transfer set is designed such that there is no physical contact between the patient’s hands and the cap, which minimizes the risk of infection through physical touch.
  • a plurality of Peritoneal Dialysis fluid bag adaptors connects the Peritoneal Dialysis apparatus to the Peritoneal Dialysis fluid bags, where the Peritoneal Dialysis fluid bag adaptors also comprise a flexible safety covering to minimize chances of infection.
  • a plurality of drain bags is provided to collect the drain fluid from the patient during the drain process. The filling tubing portion and the draining tubing portion are clamped together, and they are opened and closed contextually at suitable times to enable the flow of fluid during the fill and drain process. When the dialysis process is completed, patients withdraw the catheter out and use a new sterile cap provided separately to cover the tip of the catheter.
  • a plurality of Peritoneal Dialysis fluid bags is connected to a single catheter line, performing filling-up and draining operations in a plurality of fluid bags.
  • the fill process and the drain process are complementary in nature, and only one operation is performed at a time by appropriately and contextually opening and closing the flow of fluid.
  • the plurality of fluid bags is connected through fluid bag adaptors on the fill tubing and multiple drain bags through the drain tubing.
  • the catheter line joins in the T-junction and connect to the fill tubing and drain tubing in two separate arms of the T-junction.
  • the flow control lever is designed as a rotatory part, wherein the rotational motion of the flow control lever either opens and/or closes the drain tubing and/or the fill tubing depending on the position and configuration of the flow control lever.
  • the flow control lever is designed to operate in a plurality of preset positions/configurations, including position-A, position-B, position-C and position-D. In position A, both the drain tubing and fill tubing are clamped such that no fluid flow occurs in these any of the tubes. In position-B, the drain tubing is still clamped and the fill tubing is open, which allows fluid to flow from the fluid bags to catheter during the fill process.
  • Position-C the tubing is configured to be placed or removed from the setting, and both the fill tubing and drain tubing are open and free from clamping, and they are freely removed from the setting.
  • Position-D is the complementary position of position-B, wherein the fill tubing is clamped and the drain tubing is open.
  • the drain tuning line is connected to the catheter line while the fill line is blocked, which allows fluid from catheter to flow into the drain bag.
  • the occlusion detection system is configured for identifying occlusion of fluid and measuring fluid flow in a tubing.
  • the occlusion detection system is enabled through a specially designed freely suspended vane.
  • An optical source such as LED, IR and an optical sensor such as LDR (Light Dependent Resistor) are placed on either side of the side of the tubing in the path of the fluid flow in a fluid sensor.
  • the system comprises a circular vane, placed inside a transparent box and allowed to rotate freely whenever there is a fluid flow in the tubing, through a central pivot in the system, allowing a rotation whenever there is a fluid flow.
  • the specially designed vane which comprises cuts in its one or many sectors, is designed to enable a plurality of signals to be perceived by the sensor.
  • the vane blocks the optical path, when its opaque portion is in the line of sensing, and provides a different signal, when the open portion of the vane comes across the line of sensing.
  • a series of pulsed signals from sensor intimates the flow sensor that the fluid is flowing.
  • the occlusion, or blocking of fluid flow in the line is sensed by the system.
  • the system is implemented with mathematical calculation of signals received, to measure the rate of fluid flow, by counting the sensor on and off signals.
  • a flexible and sterile apparatus for covering tubing, connectors and consumables used in external drug-delivery systems.
  • the apparatus protects the connection points in the external drug-delivery system where a patient or a care-giver is required to physically make the connections in the drug-delivery system by making the connection points completely sterile while making the connections.
  • the apparatus is made of flexible material that enables the patient and the caregiver to make the physical connections on the drug delivery mechanism using the covering provided by the apparatus.
  • the apparatus comprises an anti-microbial coating that ensures that prevents the infection of viral spots on the drug-delivery system.
  • a system for flow control for routing multiple fluid lines of drain and fill, or any other tubing lines/path into a single line/path.
  • the system comprises a servo-controlled motor, and a specially designed rotor to facilitate the flow or direction as required by the system.
  • the specially designed servo rotor is placed in between the drain and fill lines that is connected by a T junction, and its four distinct position offers four distinct control points in the fluid flow.
  • a system for identifying occlusion of fluid and measuring fluid flow in a tubing, which is enabled through a specially designed freely suspended vane.
  • An optical source such as LED, IR and an optical sensor such as LDR (Light Dependant Resistor) is placed on either side of the system placed in the path of the fluid flow in a fluid sensor.
  • the system comprises of a circular vane to rotate whenever there is a fluid flow in the tubing. This vane is suspended freely through a central pivot in the system, allowing a rotation whenever there is a fluid flow.
  • the specially designed vane which has cuts in its one or many sectors, is designed to enable a plurality of signals to be perceived by the sensor.
  • the vane blocks the optical path, when its opaque portion is in the line of sensing, and provides a different signal, when the open portion of the vane comes across the line of sensing.
  • a series of pulsed signals from sensor intimates the system that the fluid is flowing. If for any specific duration, there is no change in the sensor signal, it is due the fact that the vane is not rotating, due to lack of fluid flow, and in such a condition, the occlusion, or blocking of fluid flow in the line is sensed by the system.
  • the system is used with mathematical calculation of signals received, to measure the rate of fluid flow, by counting the sensor on and off signals.
  • FIG. 1 illustrates an apparatus for enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer, according to one embodiment of the present invention.
  • FIG. 1 illustrates the line diagram of an apparatus for enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer, according to one embodiment of the present invention.
  • FIG. 3a -3c illustrate a plurality of configurations of the transfer set, according to one embodiment of the present invention.
  • FIG. 4 illustrates a plurality of configurations of the flow control lever, according to one embodiment of the present invention.
  • FIG. 5a , 5b and 5c illustrate occlusion detection system for fluid flow monitoring and occlusion detection in a tubing, according to one embodiment of the present invention.
  • the various embodiments of the present invention provide a system and method for enabling replacement of a medical tubing apparatus without direct physical contact.
  • the embodiments also provide a system and method for enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer.
  • a flexible and sterile apparatus for covering tubing, connectors and consumables used in external drug-delivery systems.
  • the apparatus protects the connection points in the external drug-delivery system where a patient or a care-giver is required to physically make the connections in the drug-delivery system by making the connection points completely sterile while making the connections.
  • the apparatus 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 drug-delivery system.
  • an apparatus for enabling replacement of a medical tubing apparatus without direct physical contact.
  • the connections are made through a flexible anti-microbial coated covering, thus reducing the risk of connection related infections.
  • the apparatus is employed to connect Peritoneal Dialysis fluid bags to a catheter coming out from the patient’s body without physically touching the critical parts of the connector.
  • the apparatus comprises a safety bulb, which acts as a flexible covering, through which a transfer set is inserted into the connector.
  • the transfer set includes a cap, which is highly sterile and opened before connecting the transfer set for dialysis.
  • One end of the transfer set is connected to the body permanently though a surgical procedure, and patients remove the cap to perform the dialysis and close the transfer set with a new cap.
  • a catheter is made to pass through a tight sponge base coated with any prophylactic solution (spirit, betadine etc.), which cleans the surface of the catheter that enters the sterile zone of the apparatus.
  • the slit opening of the apparatus’ adaptor that consists the prophylactic covering wipes away the surface from of any contaminant or pathogen when inserted into the sterile bulb portion of the apparatus.
  • the apparatus to connect Peritoneal Dialysis fluid bags to a catheter coming out from the patient’s body further comprises a flow sensor, which measures the fluid flow in the tubing.
  • a T-junction in the cable acts as the meeting point of drain and fill paths.
  • a plurality of PD fluid bag adaptors connectsthe apparatus to the PD fluid bags, where the PD fluid bag adaptors also comprise a flexible safety covering to minimize chances of infection.
  • a plurality of drain bags is provided to collect the drain fluid from the patient during the drain process.
  • a filling tubing portion and a draining tubing portion are clamped together, where they are opened and closedcontextually at suitable times to enable the flow of fluid during the fill and drain process.
  • the apparatus facilitates a contactless disconnection of catheter without adding any complexity to the system and only providing an anti-microbial covering to avoid direct physical contact.
  • a plurality of PD fluid bags is connected to a single catheter line, performing filling-up and draining operations in a plurality of fluid bags.
  • the fill and drain process are complementary in nature, and only one operation is performed at a time by appropriately and contextually opening and closing the flow of fluid.
  • the plurality of fluid bags is connected through fluid bag adaptors on the fill tubing and multiple drain bags through the drain tubing.
  • the catheter line joins in a T-junction and connect to the Fill tubing and Drain tubing in two separate arms of the T junction.
  • a flow control lever is provided, whose position with respect to the drain tubing and fill tubing is configured such that, it either opens or closes the lines when it rotates.
  • the flow control lever is designed to operate in a plurality of preset positions/configurations, including position-A, position-B, position-C and position-D.
  • position A both the drain tubing and fill tubing are clamped such that no fluid flow occurs in these any of the tubes.
  • position-B the drain tubing is still clamped and the fill tubing is open, which allows fluid to flow from the fluid bags to catheter during the fill process.
  • position-C the tubing is configured to be placed or removed from the setting. Both the fill tubing and drain tubing are open and free from clamping, and they are freely removed from the setting.
  • Position-D is the complementary position of position-B, where the fill tubing is clamped and the drain tubing is open. In this configuration, the drain tuning line is connected to the catheter line while the fill line is blocked, which allows fluid from catheter to flow into the drain bag.
  • the apparatus comprises a Safety Bulb 101, a Flow Sensor 102, a T-junction arrangement 103, a Flow Control Lever 104, a plurality of Fluid Bag Adapters 105, a plurality of Drain Bags 106, a Fill Tubing 107 and a Drain Tubing 108.
  • the apparatus comprises a Safety Bulb 101, a Flow Sensor 102, a T-junction arrangement 103, a plurality of Fluid Bag Adapters 105, a plurality of Drain Bags 106, a Fill Tubing 107, a Drain Tubing 108 and an insertion cavity for Transfer Set 109.
  • FIG. 3a -3c illustrate a plurality of configurations of the transfer set.
  • the transfer set 110 comprises a cap 111 that prevents any infection through physical touch on the surface of the transfer set.
  • FIG. 5a , 5b and 5c illustrate occlusion detection system for fluid flow monitoring and occlusion detection in a tubing.
  • FIG. 5a illustrates the top view of the occlusion detection system
  • FIG. 5b illustrates the front view of the occlusion detection system
  • FIG. 5c illustrates the vane arrangement in the occlusion detection system.
  • the occlusion detection system comprises an Optical Source 102a, an Optical Sensor 102b, a inlet for fluid102c, an outlet for fluid 102d and a vane arrangement 102e.
  • the present invention provides a system and method for enabling replacement of a medical tubing apparatus without direct physical contact.
  • the invention minimizes the risk of infection in tubing, connections and consumables in medical field, such as IV lines, dialysis connectors or any other connectors where physical contact of hands is required to enable a connection.
  • the system comprises an anti-microbial coating that ensures that prevents the infection of viral spots on the drug-delivery system.
  • a catheter is made to pass through a tight sponge base coated with any prophylactic solution (spirit, betadine etc.), which cleans the surface of the catheter that enters the sterile zone of the apparatus.
  • the slit opening of the apparatus’ adaptor that consists the prophylactic covering wipes away the surface from of any contaminant or pathogen when inserted into the sterile bulb portion of the apparatus.
  • the invention also comprises a plurality of PD fluid bags connected to a single catheter line and ensure the working of the system by appropriately and contextually opening and closing the flow of fluid.
  • the system enables a patient to have the benefits of home-treatment and therapy with minimum chances of infecting the tubing and medical accessories handled by the patient and/or caregivers during the treatment/therapy.
  • a separate cassette mechanism is used, which is replaced by a single and simple tube in the present invention that is easy for patients to handle.
  • the fluid occlusion control and measuring the rate of fluid flow is also implemented within the tubing itself, thereby replacing complex systems for detecting occlusion and flow monitoring.

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Abstract

The various embodiments of the present invention provide a system and method for enabling replacement of a medical tubing apparatus without direct physical contact. The invention provides a flexible and sterile apparatus for covering connectors, tubing and consumables used in external drug-delivery systems. The apparatus protects the connection points in the external drug-delivery system where a patient or a caregiver is required to physically make the connections in the drug-delivery system by making the connection points completely sterile while making the connections. The apparatus is made of flexible material that enables the patient and the caregiver to make the physical connections on the drug delivery mechanism using the covering provided by the apparatus. The apparatus comprises an anti-microbial coating that ensures that prevents the infection of viral spots on the drug-delivery system.

Description

System and method FOR CONTACTLESS REPLACEMENT OF MEDICAL TUBING CONNECTIONS CROSS-REFERENCE TO RELATED APPLICATIONS
This patent application claims the priority of the Indian Provisional Patent Application filed on October 22, 2020 with the number 202041046034 and titled,"SYSTEM AND METHOD FOR CONTACTLESS REPLACEMENT OF MEDICAL TUBING CONNECTIONS", the contents of which are incorporated herein in its entirety by the way of reference.
  1. TECHNICAL FIELD
The present invention is generally related to a system and method for contactless handling of medical tubing. The present invention is particularly related to a system and method for enabling replacement of a medical tubing apparatus without direct physical contact. The present invention is more particularly related to a system and method for enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer and a system for routing multiple tubing sets to a single catheter line going to patient’s body. The present invention is also related to implementation of a simple mechanism, for identifying and measuring fluid flow and occlusion detection, through a specially designed in-built flow control mechanism.
  1. BACKGROUND ART
Peritoneal Dialysis (PD) is a form of renal therapy, where dialysis is carried out by patients themselves at their homes. Though PD is a simple and natural dialysis process, it carries a major risk of infection, known as peritonitis, when the procedures are not carefully followed by patients. A major source of infection is the connection-related infections, arising when the patient handles the connections to be made between a catheter and fluid bag(s). In order to avoid it, a very diligent cleaning procedure is prescribed and the room where the dialysis shall be carried out is to be kept completely clean and sterile. But these conditions are very difficult to be met in the homes of patients.
Currently, it is totally up to the patient and/or the caregivers to maintain an infection-free replacement of the tubing and accessories during a home-treatment.However, since it is very difficult to track where the patient or the caregiver might have touched, or other types and sources of infections they might be exposed to, the risk of infecting a patient during home therapy is quite high. There are no current solutions that enable a simple but effective system for enabling an infection-free and safe handling of medical tubing and connections.
Therefore, there exists a need for a system that minimizes the risk of infection due to handling of medical tubing by patients or caregivers in an unsterile environment.There is also a need for protecting connection-points in a medical tubing and connection system that have a higher potential for infection due to physical contact. There is also a need for providing a system that enables a patient to have the benefits of home-treatment and therapy with minimum chances of infecting the tubing and medical accessories handled by the patient and/or caregivers during the treatment/therapy.There is also a need for Peritoneal Dialysis (PD) cycler systems that comprise the routing of multiple fluid lines into a single-patient-line implemented in a simple, efficient manner, in conjunction with a flow control system. There is also a need for a simple and in-built system for identifying fluid flow or detect fluid occlusion in a tubing, and for measuring and monitoring fluid flow, in any fluid transfer application.
The above-mentioned shortcomings, disadvantages and problems are addressed herein and which will be understood by reading and studying the following specification.
  1. OBJECTS OF THE INVENTION
The primary object of the present invention is to provide a system and method for enabling replacement of a medical tubing apparatus without direct physical contact.
Another object of the present invention is to provide a system and method for enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer.
Yet another object of the present invention is to provide a system for protecting connection-points in a medical tubing and connection system that have a higher potential for infection due to physical contact.
Yet another object of the present invention is to provide a system that minimizes the risk of infection due to handling of medical tubing by patients or caregivers in an unsterile environment.
Yet another object of the present invention is to provide a system that minimizes the risk of infection in tubing, connections and consumables in medical field, such as IV lines, dialysis connectors or any other connectors where physical contact of hands is required to enablea connection.
Yet another object of the present invention is to provide a system for routing of multiple fluid lines/paths into a single patient line/path.
Yet another object of the present invention is to provide a mechanism in PD cyclers for managing occlusion detection.
Yet another object of the present invention is to provide a mechanism in PD cyclers for managing fluid flow.
Yet another object of the present invention is to provide a mechanism in PD cyclers for measuring the volume of fluid transfer.
Yet another object of the present invention is to provide a mechanism in PD cyclers for measuring the rate of fluid transfer.
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.
  1. SUMMARY OF INVENTION
The various embodiments of the present invention provide a system and method for enabling replacement of a medical tubing apparatus without direct physical contact. The embodiments also provide a system and method for enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer.
According to one embodiment of the present invention, a system is provided for replacement of a medical tubing apparatus without direct physical contact and enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer. The system comprises a Peritoneal Dialysis apparatus, a transfer set, a safety bulb, a catheter, a flow sensor, a T-junction, a flow control lever and an occlusion detection system. The peritoneal Dialysis apparatus includes a plurality of Peritoneal Dialysis fluid drain bags, a plurality of fluid bag adaptors, a fill tubing and a drain tubing. The transfer set comprises a cap that is sterile and is opened before connecting the transfer set to the Peritoneal Dialysis apparatus. The safety bulb is a flexible covering provided for the transfer set, wherein the safety bulb is coated with anti-microbial coating on the surface and the safety bulb acts as the interface through which the transfer set is inserted into the connector for connecting to the Peritoneal Dialysis apparatus. The catheter passes through a tight sponge base coated with any prophylactic solution that cleans the surface of the catheter that enters the sterile zone of the Peritoneal Dialysis apparatus. The slit opening of the Peritoneal Dialysis apparatus’ adaptor that comprises the prophylactic covering wipes away the surface from of any contaminant or pathogen when inserted into the sterile bulb portion of the apparatus. The flow sensor is configured to measure the fluid flowing into the Peritoneal Dialysis fluid bags through the catheter coming out from the patient’s body. The T-junction is the meeting point of the fill tubing and the drain tubing. The occlusion detection system is a part of the flow sensor, and the occlusion detection system is configured for occlusion detection, and fluid flow measurement through an opto-electric/magnetic technique, wherein the occlusion detection system is built inside the tubing through which the fluid flows.
According to one embodiment of the present invention, one end of the transfer set is connected to the body of a patient permanently though a surgical procedure, and the patient removes the cap of the transfer set to perform the dialysis and close the transfer set with a new cap. The cap of the transfer set is designed such that there is no physical contact between the patient’s hands and the cap, which minimizes the risk of infection through physical touch.
According to one embodiment of the present invention, a plurality of Peritoneal Dialysis fluid bag adaptors connects the Peritoneal Dialysis apparatus to the Peritoneal Dialysis fluid bags, where the Peritoneal Dialysis fluid bag adaptors also comprise a flexible safety covering to minimize chances of infection. A plurality of drain bags is provided to collect the drain fluid from the patient during the drain process. The filling tubing portion and the draining tubing portion are clamped together, and they are opened and closed contextually at suitable times to enable the flow of fluid during the fill and drain process. When the dialysis process is completed, patients withdraw the catheter out and use a new sterile cap provided separately to cover the tip of the catheter.
According to one embodiment of the present invention, a plurality of Peritoneal Dialysis fluid bags is connected to a single catheter line, performing filling-up and draining operations in a plurality of fluid bags. The fill process and the drain process are complementary in nature, and only one operation is performed at a time by appropriately and contextually opening and closing the flow of fluid. The plurality of fluid bags is connected through fluid bag adaptors on the fill tubing and multiple drain bags through the drain tubing. The catheter line joins in the T-junction and connect to the fill tubing and drain tubing in two separate arms of the T-junction.
According to one embodiment of the present invention, the flow control lever is designed as a rotatory part, wherein the rotational motion of the flow control lever either opens and/or closes the drain tubing and/or the fill tubing depending on the position and configuration of the flow control lever. The flow control lever is designed to operate in a plurality of preset positions/configurations, including position-A, position-B, position-C and position-D. In position A, both the drain tubing and fill tubing are clamped such that no fluid flow occurs in these any of the tubes. In position-B, the drain tubing is still clamped and the fill tubing is open, which allows fluid to flow from the fluid bags to catheter during the fill process. In position-C, the tubing is configured to be placed or removed from the setting, and both the fill tubing and drain tubing are open and free from clamping, and they are freely removed from the setting. Position-D is the complementary position of position-B, wherein the fill tubing is clamped and the drain tubing is open. In position-D, the drain tuning line is connected to the catheter line while the fill line is blocked, which allows fluid from catheter to flow into the drain bag.
According to one embodiment of the present invention, the occlusion detection system is configured for identifying occlusion of fluid and measuring fluid flow in a tubing. The occlusion detection system is enabled through a specially designed freely suspended vane. An optical source such as LED, IR and an optical sensor such as LDR (Light Dependent Resistor) are placed on either side of the side of the tubing in the path of the fluid flow in a fluid sensor. The system comprises a circular vane, placed inside a transparent box and allowed to rotate freely whenever there is a fluid flow in the tubing, through a central pivot in the system, allowing a rotation whenever there is a fluid flow. The specially designed vane, which comprises cuts in its one or many sectors, is designed to enable a plurality of signals to be perceived by the sensor. The vane blocks the optical path, when its opaque portion is in the line of sensing, and provides a different signal, when the open portion of the vane comes across the line of sensing. When the vane rotates during the fluid flow, a series of pulsed signals from sensor, intimates the flow sensor that the fluid is flowing. When for any specific duration there is no change in the sensor signal, it is due the fact that the vane is not rotating due to lack of fluid flow, and in such a condition, the occlusion, or blocking of fluid flow in the line is sensed by the system. The system is implemented with mathematical calculation of signals received, to measure the rate of fluid flow, by counting the sensor on and off signals.
According to one embodiment of the present invention, a flexible and sterile apparatus is provided for covering tubing, connectors and consumables used in external drug-delivery systems. The apparatus protects the connection points in the external drug-delivery system where a patient or a care-giver is required to physically make the connections in the drug-delivery system by making the connection points completely sterile while making the connections. The apparatus is made of flexible material that enables the patient and the caregiver to make the physical connections on the drug delivery mechanism using the covering provided by the apparatus. The apparatus comprises an anti-microbial coating that ensures that prevents the infection of viral spots on the drug-delivery system.
According to one embodiment, a system is provided for flow control for routing multiple fluid lines of drain and fill, or any other tubing lines/path into a single line/path. The system comprises a servo-controlled motor, and a specially designed rotor to facilitate the flow or direction as required by the system. The specially designed servo rotor, is placed in between the drain and fill lines that is connected by a T junction, and its four distinct position offers four distinct control points in the fluid flow.
According to one embodiment, a system is provided for identifying occlusion of fluid and measuring fluid flow in a tubing, which is enabled through a specially designed freely suspended vane. An optical source such as LED, IR and an optical sensor such as LDR (Light Dependant Resistor) is placed on either side of the system placed in the path of the fluid flow in a fluid sensor. The system comprises of a circular vane to rotate whenever there is a fluid flow in the tubing. This vane is suspended freely through a central pivot in the system, allowing a rotation whenever there is a fluid flow. The specially designed vane, which has cuts in its one or many sectors, is designed to enable a plurality of signals to be perceived by the sensor. The vane blocks the optical path, when its opaque portion is in the line of sensing, and provides a different signal, when the open portion of the vane comes across the line of sensing. As the vane is rotating during the fluid flow, a series of pulsed signals from sensor, intimates the system that the fluid is flowing. If for any specific duration, there is no change in the sensor signal, it is due the fact that the vane is not rotating, due to lack of fluid flow, and in such a condition, the occlusion, or blocking of fluid flow in the line is sensed by the system. The system is used with mathematical calculation of signals received, to measure the rate of fluid flow, by counting the sensor on and off signals.
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.
  1. BRIEF DESCRIPTION OF DRAWINGS
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:
illustrates an apparatus for enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer, according to one embodiment of the present invention.
illustrates the line diagram of an apparatus for enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer, according to one embodiment of the present invention.
FIG. 3a-3c illustrate a plurality of configurations of the transfer set, according to one embodiment of the present invention.
FIG. 4illustrates a plurality of configurations of the flow control lever, according to one embodiment of the present invention.
FIG. 5a, 5b and 5c illustrate occlusion detection system for fluid flow monitoring and occlusion detection in a tubing, according to one embodiment of the present invention.
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.
  1. DESCRIPTION OF EMBODIMENTS
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.
The various embodiments of the present invention provide a system and method for enabling replacement of a medical tubing apparatus without direct physical contact. The embodiments also provide a system and method for enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer.
According to one embodiment of the present invention, a flexible and sterile apparatus is provided for covering tubing, connectors and consumables used in external drug-delivery systems. The apparatus protects the connection points in the external drug-delivery system where a patient or a care-giver is required to physically make the connections in the drug-delivery system by making the connection points completely sterile while making the connections. The apparatus 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 drug-delivery system.
According to one embodiment of the present invention, an apparatus is provided for enabling replacement of a medical tubing apparatus without direct physical contact. The connections are made through a flexible anti-microbial coated covering, thus reducing the risk of connection related infections. According to one exemplary embodiment, the apparatus is employed to connect Peritoneal Dialysis fluid bags to a catheter coming out from the patient’s body without physically touching the critical parts of the connector. The apparatuscomprises a safety bulb, which acts as a flexible covering, through which a transfer set is inserted into the connector.The transfer set includes a cap, which is highly sterile and opened before connecting the transfer set for dialysis. One end of the transfer set is connected to the body permanently though a surgical procedure, and patients remove the cap to perform the dialysis and close the transfer set with a new cap. Using the present apparatus, even if the hands of the patient or the caregiver are not sterile, the risk of infection through touch is minimized as there is no physical contact with the cap of transfer set.A catheter is made to pass through a tight sponge base coated with any prophylactic solution (spirit, betadine etc.), which cleans the surface of the catheter that enters the sterile zone of the apparatus. The slit opening of the apparatus’ adaptor that consists the prophylactic covering wipes away the surface from of any contaminant or pathogen when inserted into the sterile bulb portion of the apparatus.
According to one exemplary embodiment, the apparatus to connect Peritoneal Dialysis fluid bags to a catheter coming out from the patient’s body further comprises a flow sensor, which measures the fluid flow in the tubing. A T-junction in the cable acts as the meeting point of drain and fill paths. A plurality of PD fluid bag adaptorsconnectsthe apparatus to the PD fluid bags, where the PD fluid bag adaptors also comprise a flexible safety covering to minimize chances of infection. A plurality of drain bags is provided to collect the drain fluid from the patient during the drain process. A filling tubing portion and a draining tubing portion are clamped together, where they are opened and closedcontextually at suitable times to enable the flow of fluid during the fill and drain process. After the dialysis process is completed, patients withdraw the catheter out and use a new sterile cap provided separately to cover the catheter tip. The apparatus facilitates a contactless disconnection of catheter without adding any complexity to the system and only providing an anti-microbial covering to avoid direct physical contact.
According to one embodiment of the present invention, a plurality of PD fluid bags is connected to a single catheter line, performing filling-up and draining operations in a plurality of fluid bags. The fill and drain process are complementary in nature, and only one operation is performed at a time by appropriately and contextually opening and closing the flow of fluid. The plurality of fluid bags is connected through fluid bag adaptors on the fill tubing and multiple drain bags through the drain tubing. The catheter line joins in a T-junction and connect to the Fill tubing and Drain tubing in two separate arms of the T junction. A flow control lever is provided, whose position with respect to the drain tubing and fill tubing is configured such that, it either opens or closes the lines when it rotates. The flow control lever is designed to operate in a plurality of preset positions/configurations, including position-A, position-B, position-C and position-D.In position A, both the drain tubing and fill tubing are clamped such that no fluid flow occurs in these any of the tubes. In position-B, the drain tubing is still clamped and the fill tubing is open, which allows fluid to flow from the fluid bags to catheter during the fill process. In position-C, the tubing is configured to be placed or removed from the setting. Both the fill tubing and drain tubing are open and free from clamping, and they are freely removed from the setting. Position-D is the complementary position of position-B, where the fill tubing is clamped and the drain tubing is open. In this configuration, the drain tuning line is connected to the catheter line while the fill line is blocked, which allows fluid from catheter to flow into the drain bag.
illustrates an apparatus for enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer. The apparatus comprises a Safety Bulb 101, a Flow Sensor 102, a T-junction arrangement 103, a Flow Control Lever 104, a plurality of Fluid Bag Adapters 105, a plurality of Drain Bags 106, a Fill Tubing 107 and a Drain Tubing 108.
illustrates the line diagram of an apparatus for enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer. The apparatus comprises a Safety Bulb 101, a Flow Sensor 102, a T-junction arrangement 103, a plurality of Fluid Bag Adapters 105, a plurality of Drain Bags 106, a Fill Tubing 107, a Drain Tubing 108 and an insertion cavity for Transfer Set 109.
FIG. 3a-3c illustrate a plurality of configurations of the transfer set. The transfer set 110 comprises a cap 111 that prevents any infection through physical touch on the surface of the transfer set.
illustrates a plurality of configurations of the flow control lever.
FIG. 5a, 5b and 5c illustrate occlusion detection system for fluid flow monitoring and occlusion detection in a tubing.FIG. 5a illustrates the top view of the occlusion detection system, FIG. 5b illustrates the front view of the occlusion detection system, and FIG. 5c illustrates the vane arrangement in the occlusion detection system. The occlusion detection system comprises an Optical Source 102a, an Optical Sensor 102b, a inlet for fluid102c, an outlet for fluid 102d and a vane arrangement 102e.
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.
  1. ADVANTAGEOUS EFFECTS OF INVENTION
The present invention provides a system and method for enabling replacement of a medical tubing apparatus without direct physical contact. The invention minimizes the risk of infection in tubing, connections and consumables in medical field, such as IV lines, dialysis connectors or any other connectors where physical contact of hands is required to enable a connection. The system comprises an anti-microbial coating that ensures that prevents the infection of viral spots on the drug-delivery system. A catheter is made to pass through a tight sponge base coated with any prophylactic solution (spirit, betadine etc.), which cleans the surface of the catheter that enters the sterile zone of the apparatus. The slit opening of the apparatus’ adaptor that consists the prophylactic covering wipes away the surface from of any contaminant or pathogen when inserted into the sterile bulb portion of the apparatus. The invention also comprises a plurality of PD fluid bags connected to a single catheter line and ensure the working of the system by appropriately and contextually opening and closing the flow of fluid. The system enables a patient to have the benefits of home-treatment and therapy with minimum chances of infecting the tubing and medical accessories handled by the patient and/or caregivers during the treatment/therapy. Currently, a separate cassette mechanism is used, which is replaced by a single and simple tube in the present invention that is easy for patients to handle. The fluid occlusion control and measuring the rate of fluid flow is also implemented within the tubing itself, thereby replacing complex systems for detecting occlusion and flow monitoring.
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 (6)

  1. A system for replacement of a medical tubing apparatus without direct physical contact and enabling a contactless replacement of medical tubing and related connections through an anti-microbial protective layer, the system comprising:
    a peritoneal Dialysis apparatus, including a plurality of Peritoneal Dialysis fluid drain bags, a plurality of fluid bag adaptors, a fill tubing and a drain tubing;
    a transfer set, wherein the transfer set comprises a cap that is sterile and is opened before connecting the transfer set to the Peritoneal Dialysis apparatus.
    a safety bulb, wherein the safety bulb is a flexible covering provided for the transfer set, and wherein the safety bulb is coated with anti-microbial coating on the surface and the safety bulb acts as the interface through which the transfer set is inserted into the connector for connecting to the Peritoneal Dialysis apparatus;
    a catheter, wherein a catheter passes through a tight sponge base coated with any prophylactic solution that cleans the surface of the catheter that enters the sterile zone of the Peritoneal Dialysis apparatus, and wherein, the slit opening of the Peritoneal Dialysis apparatus’ adaptor that comprises the prophylactic covering wipes away the surface from of any contaminant or pathogen when inserted into the sterile bulb portion of the apparatus.
    a flow sensor, wherein the flow sensor is configured to measure the fluid flowing into the Peritoneal Dialysis fluid bags through the catheter coming out from the patient’s body;
    a T-junction, wherein the T-junction is the meeting point of the fill tubing and the drain tubing;
    a flow control lever; and,
    an occlusion detection system, wherein the occlusion detection system is a part of the flow sensor, and wherein the occlusion detection system is configured for occlusion detection, and fluid flow measurement through an opto-electric/magnetic technique, wherein the occlusion detection system is built inside the tubing through which the fluid flows.
  2. The system according to claim 1, wherein one-end of the transfer set is connected to the body of a patient permanently though a surgical procedure, and the patient removes the cap of the transfer set to perform the dialysis and close the transfer set with a new cap, and wherein the cap of the transfer set is designed such that there is no physical contact between the patient’s hands and the cap, which minimizes the risk of infection through physical touch.
  3. The system according to claim 1, wherein a plurality of Peritoneal Dialysis fluid bag adaptors connects the Peritoneal Dialysis apparatus to the Peritoneal Dialysis fluid bags, where the Peritoneal Dialysis fluid bag adaptors also comprise a flexible safety covering to minimize chances of infection, and wherein a plurality of drain bags is provided to collect the drain fluid from the patient during the drain process, and whereinthe filling tubing portion and the draining tubing portion are clamped together, and wherein they are opened and closed contextually at suitable times to enable the flow of fluid during the fill and drain process, and whereinafter the dialysis process is completed, patients withdraw the catheter out and use a new sterile cap provided separately to cover the tip of the catheter.
  4. The system according to claim 1, wherein a plurality of Peritoneal Dialysis fluid bags is connected to a single catheter line, performing filling-up and draining operations in a plurality of fluid bags, and wherein the fill process and the drain process are complementary in nature, and only one operation is performed at a time by appropriately and contextually opening and closing the flow of fluid, and whereinthe plurality of fluid bags is connected through fluid bag adaptors on the fill tubing and multiple drain bags through the drain tubing, and whereinthe catheter line joins in the T-junction and connect to the fill tubing and drain tubing in two separate arms of the T-junction.
  5. The system according to claim 1, whereinthe flow control lever is designed as a rotatory part, wherein the rotational motion of the flow control lever either opens and/or closes the drain tubing and/or the fill tubing depending on the position and configuration of the flow control lever, and wherein, the flow control lever is designed to operate in a plurality of preset positions/configurations, including position-A, position-B, position-C and position-D, and whereinin position A, both the drain tubing and fill tubing are clamped such that no fluid flow occurs in these any of the tubes, and wherein, in position-B, the drain tubing is still clamped and the fill tubing is open, which allows fluid to flow from the fluid bags to catheter during the fill process, and wherein,in position-C, the tubing is configured to be placed or removed from the setting, and whereinboth the fill tubing and drain tubing are open and free from clamping, and they are freely removed from the setting, and wherein, position-D is the complementary position of position-B, wherein the fill tubing is clamped and the drain tubing is open, and wherein, In position-D, the drain tuning line is connected to the catheter line while the fill line is blocked, which allows fluid from catheter to flow into the drain bag.
  6. The system according to claim 1, wherein the occlusion detection system is configured for identifying occlusion of fluid and measuring fluid flow in a tubing, and wherein the occlusion detection system is enabled through a specially designed freely suspended vane, and wherein an optical source such as LED, IR and an optical sensor such as LDR (Light Dependant Resistor) are placed on either side of the side of the tubing in the path of the fluid flow in a fluid sensor, and wherein the system comprises a circular vane, placed inside a transparent box and allowed to rotate freely whenever there is a fluid flow in the tubing, through a central pivot in the system, allowing a rotation whenever there is a fluid flow, and wherein the specially designed vane, which comprises cuts in its one or many sectors, is designed to enable a plurality of signals to be perceived by the sensor, and wherein the vane blocks the optical path, when its opaque portion is in the line of sensing, and provides a different signal, when the open portion of the vane comes across the line of sensing, and wherein, when the vane rotates during the fluid flow, a series of pulsed signals from sensor, intimates the flow sensor that the fluid is flowing, and wherein when for any specific duration there is no change in the sensor signal, it is due the fact that the vane is not rotatingdue to lack of fluid flow, and in such a condition, the occlusion, or blocking of fluid flow in the line is sensed by the system, and wherein,the system is implemented with mathematical calculation of signals received, to measure the rate of fluid flow, by counting the sensor on and off signals.
PCT/IN2021/051008 2020-10-22 2021-10-22 System and method for contactless replacement of medical tubing connections WO2022085032A1 (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11507285A (en) * 1996-03-05 1999-06-29 メディケイション デリバリー デバイシーズ,インコーポレイテッド Apparatus and method for limiting free flow in an injection system
WO2000002617A1 (en) * 1998-07-13 2000-01-20 Jms Co., Ltd. Medical tube connector device
US20130237903A1 (en) * 2012-03-12 2013-09-12 Fresenius Medical Care Deutschland Gmbh Tubing adapter for influencing the pressure inside a tubing section during a medical treatment

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11507285A (en) * 1996-03-05 1999-06-29 メディケイション デリバリー デバイシーズ,インコーポレイテッド Apparatus and method for limiting free flow in an injection system
WO2000002617A1 (en) * 1998-07-13 2000-01-20 Jms Co., Ltd. Medical tube connector device
US20130237903A1 (en) * 2012-03-12 2013-09-12 Fresenius Medical Care Deutschland Gmbh Tubing adapter for influencing the pressure inside a tubing section during a medical treatment

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