WO2018124983A1 - Dialysis system with thermal radiation means - Google Patents

Dialysis system with thermal radiation means Download PDF

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Publication number
WO2018124983A1
WO2018124983A1 PCT/TR2016/050548 TR2016050548W WO2018124983A1 WO 2018124983 A1 WO2018124983 A1 WO 2018124983A1 TR 2016050548 W TR2016050548 W TR 2016050548W WO 2018124983 A1 WO2018124983 A1 WO 2018124983A1
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WO
WIPO (PCT)
Prior art keywords
dialysis system
fluid
dialysis
medical fluid
heating
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Application number
PCT/TR2016/050548
Other languages
French (fr)
Inventor
Osman Murat Ivegen
Original Assignee
Polifarma Ilac Sanayi Ve Tic As
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Publication date
Application filed by Polifarma Ilac Sanayi Ve Tic As filed Critical Polifarma Ilac Sanayi Ve Tic As
Priority to PCT/TR2016/050548 priority Critical patent/WO2018124983A1/en
Publication of WO2018124983A1 publication Critical patent/WO2018124983A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/166—Heating
    • A61M1/1664—Heating with temperature control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
    • A61M1/153—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit the cassette being adapted for heating or cooling the treating fluid, e.g. the dialysate or the treating gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
    • A61M1/154—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit with sensing means or components thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
    • A61M1/156—Constructional details of the cassette, e.g. specific details on material or shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
    • A61M1/159—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit specially adapted for peritoneal dialysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/287—Dialysates therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/127—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with provisions for heating or cooling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/368—General characteristics of the apparatus related to heating or cooling by electromagnetic radiation, e.g. IR waves

Definitions

  • the present invention relates to fluid heaters for use in dialysis systems, more specifically in peritoneal dialysis.
  • the present invention relates to a dialysis system comprising a heating block for heating a medical fluid, wherein this heating block is equipped with at least one halogen lamp as a heater and at least one fluid cassette. Therefore, the present invention provides a safer heating system along with several of advantages as compared to conventional heaters, such as reduced energy consumption, lower costs and uninterrupted dialysis treatments.
  • Kidney failure and reduced kidney function have been treated with dialysis. Dialysis removes waste, toxins and excess water from the body which is normally the functioning of the kidneys. Dialysis treatment for kidney function replacement is essential for many of the patients because the treatment is crucial. Hemodialysis and peritoneal dialysis are two types of dialysis therapies commonly used to treat toxins caused by loss of kidney function.
  • Peritoneal dialysis utilizes a dialysis solution or dialysate, which is infused into a patient's peritoneal cavity.
  • the dialysate contacts with the peritoneal membrane of the peritoneal cavity. Diffusion and osmosis exchanges take place between the solution and the bloodstream across the peritoneal membrane. Therefore, waste, toxins and excess water pass from the patient's bloodstream, through the peritoneal membrane and into the dialysate.
  • the dialysate consumed in the peritoneal cavity is drained from the abdomen of the patient, removing wastes, toxins and excess water from the blood. This cycle can be repeated during the night in which case an automated dialysis machine is used because the patient falls asleep. This cycle may also be repeated during the day which is generally called a continuous ambulatory peritoneal dialysis.
  • Dialysis solution Prior to infusion into the patient's peritoneal cavity, it is desirable to heat the dialysate to about body temperature.
  • Dialysis solution can be particularly cold when stored in a cold place or exposed to cold weather. Using a dialysate liquid which is colder or warmer relative to patient's body temperature may be harmful, and undesirably causes patient's discomfort during the dialysis procedure.
  • hemodialysis which involves extracorporeal removal of waste products and water by treating patient's blood with a semipermeable membrane outside of the body. Unlike the peritoneal dialysis, this dialysis procedure involves specific steps for extracorporeal treatment of the blood and recirculating the same to the body. In this case, the blood and dialysate solutions which are provided in counter current flow can be heated at any stage of the dialysis.
  • WO 03/061740-A1 discloses a medical heat exchanger which is embodied as a disposable heating cassette, such that the heating of the heating cassette takes place from the outside on the one hand by means of electric light emitter which is coupled to the heating cassette, and on the other hand, additionally with an electric resistance heating plate coupled to the heating cassette on the opposite side of the heating cassette.
  • US 2016/082200 Al discloses a medical heat exchanger for heating a medical fluid by means of light, comprising a fluid chamber, an inlet in the outside wall of the fluid chamber wherein one section of the wall of the fluid chamber configured as a light transmitting section, and a component which is configured as a light absorber inside the fluid chamber.
  • the subject matter of this disclosure is especially about aforementioned component which is configured as a light absorber suitable for absorbing a predominant portion of the incident light.
  • the light emitter disclosed therein is configured generally in a broad spectrum, comprising for example, the visible light or visible light and the infrared light.
  • the conventional systems for dialysis do not allow freely to move the dialysis assembly with the patient during the day or night, and cables for supplying mains voltage interfere with patient's comfort.
  • conventional light or IR wave emitters usually require use of the complicated arrangements such as light absorbers brought into contact with the medical flluid which would not be feasible and safe enough for use with a medical fluid.
  • the present invention solves these problems with a dialysis system according to claim 1 comprising a hallogen lamp which can be operated independently of the mains voltage in a specific heating block.
  • the present invention provides a dialysis system comprising a heating block (1] for heating of a medical fluid flowing in the said dialysis system, wherein the heating block (1] comprises a fluid cassette (4] accommodating a fluid line (5] and at least one halogen lamp (3] arranged in a position such that the medical fluid flowing through fluid line (5] is heated by way of thermal radiation.
  • the medical fluid described herein can be a dialysate and therefore the system of the invention is particularly useful as a peritoneal dialysis device.
  • the halogen lamp (3] as mentioned hereinabove can be emitting radiation with a wavelength in the range of 400 nm to 1000 nm.
  • the system may further comprise a power supply which is a battery, and a charging unit for recharging said battery by means of mains voltage.
  • a power supply which is a battery
  • a charging unit for recharging said battery by means of mains voltage.
  • the dialysis system may optionally comprise a warning means for informing of the user about a low battery state.
  • the at least one halogen lamp (3] may also be arranged in a position to heat the medical fluid by way of convection in addition to thermal radiation.
  • the fluid line (5] may comprise a fluid conduit provided with a plurality of convolutions. It is also preferable that said fluid conduit is made of a transparent polymer material.
  • the fluid line (5] comprises an inlet and outlet portion inside the cassette (4], wherein the fluid line (5] has an inlet temperature sensor (6] and/or an outlet temperature sensor (7] for measuring temperature of the medical fluid in said inlet and outlet portions, respectively.
  • a warning means generating an alert based on an electrical signal of at least one of the sensors (6, 7] can also be provided.
  • the dialysis system may comprise a control unit configured to receive electrical signals from any of the sensors (6, 7] and producing a control signal for operating at least one halogen lamp (3] when the temperature value is below a threshold value.
  • the system comprises a plurality of halogen lamps (3] and said control means is configured to produce a control signal for some or all of the halogen lamps (3] depending on the temperature difference of the medical fluid from the threshold value.
  • the dialysis system of the present invention may further comprise an interface connected to the control unit, and said control unit in this case is configured to provide display of the information selected from temperature values obtained from at least one of the sensors (6, 7], a warning signal about state of the power supply and a warning signal about temperature value of the medical fluid.
  • the present invention relates to a method for producing a dialysis system comprising the steps of: providing a heating block (1] comprising a fluid cassette (4] accommodating a fluid line (5] and at least one halogen lamp (3] arranged in a position such that the medical fluid flowing through fluid line (5] is heated by way of thermal radiation, and
  • FIG. 1 illustrates a fluid heating block (1] comprising halogen lamps (3] and a fluid cassette (4] according to an embodiment of the present invention.
  • Fig. 2 is a perspective view of a cassette (4] accommodated in the fluid heating block (1], according to an embodiment of the present invention, which comprises a fluid line (5] with a plurality of convolutions and additionally sensors (6, 7] for measuring the inlet and outlet temperatures of the medical fluid.
  • Fig. 3 is the cross-sectional view of the heating block (1] as shown in Fig. 1.
  • the present invention relates to a dialysis system comprising a specific heating arrangement, especially for use in a peritoneal dialysis equipment
  • the present invention relates to a dialysis system comprising a heating block (1] for heating a medical fluid, comprising at least one halogen lamp (3] as a heater and at least one fluid cassette (4]. Therefore, the invention provides a safer, cost effective and simplified heating system, which can also considerably increase patient's comfort by removing dependencies to the mains voltage.
  • the present invention provides a heating block (1] with a halogen lamp (3], which is capable of maintaining an optimum temperature by heating, and reducing energy consumption by emitting light in a unique way.
  • a dialysis system having a heating block (1] comprising at least one halogen lamp (3] and a fluid cassette (4] accommodating a fluid line (5] wherein the halogen lamp (3] is positioned in a way such that the medical fluid passing through the fluid line (5] is sufficiently heated by irradiation of said halogen lamp (3].
  • the desired temperature of the medical fluid would be between 30 °C and 40 °C, more preferably around 36-37 °C ideally close to the body temperature.
  • Halogen lamps As compared to prior art, using a halogen lamp as a heating means is cost effective and efficient Halogen lamps are generally cheap and easily accessible, and they offer a service life of generally more than 3000 hours.
  • Halogen lamps have a well-established technical meaning in state of the art. They are originally incandescent lamps similar to the conventionally known light bulbs, but they differ from the usual bulbs with their halogen (i.e. iodine or bromine] content instead of an inert gas, as well as their filament which is generally made of tungsten. Halogen lamps are known to produce halogen cycles which enable them to be operated at higher temperatures. Their light intensity and color temperature is also higher than the standard bulbs which suggests higher heating capabilities.
  • these halogen lamps can be used in dialysis systems, especially in the equipment for peritoneal dialysis, for heating of a medical fluid recirculated to the patient at a temperature close to 37 °C. More surprising is that this effect can be achieved without utilizing special arrangements such as absorbent materials contacting to the medical fluid. It is also found that a similar heating effect can be obtained without using a mains voltage, i.e. 130-250 V. It is noted that a heating capacity sufficient for heating the medical fluid up to the desired level can be advantageously obtained by using conventional 12 V or 24 V batteries without the need for a higher voltage. In order to obtain this effect, supplying DC from the battery to the halogen lamp (3] would be preferable.
  • the dialysis system as presented herein further comprises a battery (not shown] for the purpose of supplying power to the halogen lamp(s] (3].
  • the lamp(s] (3] are preferably operated with DC supplied from the battery.
  • the batteries can be of the conventional type supplying a 12 V or 24 V voltage.
  • This embodiment is particularly suitable for the devices of peritoneal dialysis which interferes very much with daily life of the patient. In the present form of these systems, patient has to disconnect the tubes from the permanent catheter and stop the fluid flow in order to move.
  • the present system enables the patient freely to move without interruption, by carrying the dialysis system independently from the mains voltage.
  • the dialysis system according to the present invention may further comprise a charging unit (not shown] for recharging of the batteries from the mains voltage whenever it is desired.
  • a warning means generating a voice and/or light as an alert for informing the user about the low battery condition.
  • the patient would have a sufficient time to insert the plug of the charging unit to the mains voltage beforehand.
  • a fluid cassette (4] accommodating a fluid line (5] as shown in Fig. 2 is provided in close proximity with a number of halogen lamps (3] such that the light emitted from the lamps directly impinges upon the fluid line (5] and the medical fluid therein.
  • halogen lamps This is a typical way of heating by radiation, more accurately the "thermal radiation”.
  • a halogen lamp works in a wavelength spectrum typically between 400 nm to 1000 nm which also overlaps with the visible spectrum. However, due to the specific color temperature and higher power efficiency, halogen lamp has higher heating capabilities in terms of the thermal radiation.
  • a halogen lamp also emits a considerable amount of heat intrinsically due to the higher operating temperatures. This provides a further means for heating, namely a "convectional heating" of the fluid line (5] and the medical fluid therein.
  • halogen lamp(s] (3] can be located in a position opposite to the fluid line (5] such that the medical fluid is heated in both ways.
  • the distance between the halogen lamp (3] and fluid line (5] can be arranged in accordance with objectives of the present invention, however the said distance can ideally be arranged inbetween 1 to 5 cm, and more particularly 1 to 3 cm.
  • the halogen lamp(s] (3] are preferably located on a lamp base (2] extending in horizontal axis (x] which can be substantially parallel with the fluid cassette (4] arrangement.
  • Halogen lamps (s] (3] may therefore easily replaced if one or more of them complete their life span.
  • the fluid cassette (4] as mentioned above can be placed into the heating block (1] in an upright position extending also in horizontal axis (x], and it preferably accommodates a conduit through which the medical fluid flows and being heated by the halogen lamp(s] (3].
  • retention time of the medical fluid in the cassette (4] can be increased for heating purposes by providing said fluid conduit with a plurality of convolutions as shown in Fig. 2.
  • a control unit (not shown] is provided to receive electrical signals from these sensors (6, 7] and to produce a control signal.
  • the control unit is preferably adapted to receive the signal of the inlet sensor (6] about the inlet temperature of the medical fluid, and it produces a control signal for operating one or more of the halogen lamps (3]. More preferably, the control unit is adapted to receive the electrical signal of the outlet sensor (7] about outlet temperature of the fluid line (5] and it produces a control signal for operating one or more of the halogen lamps (3] if the temperature measured is below a threshold.
  • control unit is adapted produce a control signal based on the electrical signals of both of the sensors (6, 7].
  • a warning means can be provided in connection with the control unit such that a voice or light signal is triggered in case of a malfunction, and especially of a null or insufficient heat treatment based on the electrical signal of the outlet sensor (7].
  • an interface (not shown] preferably in the form of a display, and more preferably an LCD or LED screen connected to the aforementioned control unit.
  • the inlet and outlet temperatures of the medical fluid can be displayed on the interface for convenience of the patient
  • the control unit is further adapted to generate a warning signal about the state of the battery and heating condition of the medical fluid as mentioned above through the interface visually.
  • the halogen lamp(s] (3] are located at a distance from the fluid line (1] without a contact with the cassette (4] or fluid conduit in order to avoid a conductive heating. This is for safety of the system such that the cassette (4] or fluid conduit would not be damaged due to the elevated surface temperature of the halogen lamp (3].
  • the halogen lamp (3] can be provided in contact with the cassette (4] or fluid conduit if the material thereof is selected to withstand elevated temperatures.
  • an absorbent material can be located in the cassette (4] so as to absorb the heat produced by thermal radiation of the halogen lamp (3] and then for transferring this heat to the medical fluid.
  • fluid conduits made of a transparent polymer such as PVC or silicon.
  • the present invention provides a complete solution for heating of the medical fluids which also renders the dialysis system to be movable with patient without interrupting the dialysis process.

Abstract

The present invention relates to a dialysis system comprising a heating block (1) for heating of a medical fluid flowing in the said dialysis system, wherein the heating block (1) comprises a fluid cassette (4) accommodating a fluid line (5) and at least one halogen lamp (3) arranged in a position such that the medical fluid flowing through fluid line (5) is heated by way of thermal radiation.

Description

DIALYSIS SYSTEM WITH THERMAL RADIATION MEANS
Field of the Invention The present invention relates to fluid heaters for use in dialysis systems, more specifically in peritoneal dialysis. In particular, the present invention relates to a dialysis system comprising a heating block for heating a medical fluid, wherein this heating block is equipped with at least one halogen lamp as a heater and at least one fluid cassette. Therefore, the present invention provides a safer heating system along with several of advantages as compared to conventional heaters, such as reduced energy consumption, lower costs and uninterrupted dialysis treatments.
Background of the Invention
Kidney failure and reduced kidney function have been treated with dialysis. Dialysis removes waste, toxins and excess water from the body which is normally the functioning of the kidneys. Dialysis treatment for kidney function replacement is essential for many of the patients because the treatment is crucial. Hemodialysis and peritoneal dialysis are two types of dialysis therapies commonly used to treat toxins caused by loss of kidney function.
Peritoneal dialysis (PD] utilizes a dialysis solution or dialysate, which is infused into a patient's peritoneal cavity. The dialysate contacts with the peritoneal membrane of the peritoneal cavity. Diffusion and osmosis exchanges take place between the solution and the bloodstream across the peritoneal membrane. Therefore, waste, toxins and excess water pass from the patient's bloodstream, through the peritoneal membrane and into the dialysate. The dialysate consumed in the peritoneal cavity is drained from the abdomen of the patient, removing wastes, toxins and excess water from the blood. This cycle can be repeated during the night in which case an automated dialysis machine is used because the patient falls asleep. This cycle may also be repeated during the day which is generally called a continuous ambulatory peritoneal dialysis.
Prior to infusion into the patient's peritoneal cavity, it is desirable to heat the dialysate to about body temperature. Dialysis solution can be particularly cold when stored in a cold place or exposed to cold weather. Using a dialysate liquid which is colder or warmer relative to patient's body temperature may be harmful, and undesirably causes patient's discomfort during the dialysis procedure. The same is true also for hemodialysis which involves extracorporeal removal of waste products and water by treating patient's blood with a semipermeable membrane outside of the body. Unlike the peritoneal dialysis, this dialysis procedure involves specific steps for extracorporeal treatment of the blood and recirculating the same to the body. In this case, the blood and dialysate solutions which are provided in counter current flow can be heated at any stage of the dialysis.
It is therefore clear that heating of a medical fluid (i.e. blood or dialysate] to a level compatible with body temperature is an important step of dialysis which seriously affects patient's health and comfort.
There are plenty of studies in prior art which attempt to optimize the heating procedure of the conventional dialysis equipment WO 03/061740-A1, for instance, discloses a medical heat exchanger which is embodied as a disposable heating cassette, such that the heating of the heating cassette takes place from the outside on the one hand by means of electric light emitter which is coupled to the heating cassette, and on the other hand, additionally with an electric resistance heating plate coupled to the heating cassette on the opposite side of the heating cassette.
US 2016/082200 Al discloses a medical heat exchanger for heating a medical fluid by means of light, comprising a fluid chamber, an inlet in the outside wall of the fluid chamber wherein one section of the wall of the fluid chamber configured as a light transmitting section, and a component which is configured as a light absorber inside the fluid chamber. Here, the subject matter of this disclosure is especially about aforementioned component which is configured as a light absorber suitable for absorbing a predominant portion of the incident light. The light emitter disclosed therein is configured generally in a broad spectrum, comprising for example, the visible light or visible light and the infrared light.
The aforementioned attempts to replace the classical resistance heaters with alternative heating means such as light or IR wave emitters still need to be improved as they suffer various drawbacks. First of all, it is generally required to to use a mains voltage in order to expose the necessary energy for heating of the medical fluid, which is mainly because of the lower efficiency of the conventional light emitters in producing the necessary amount of heat. This causes also higher energy consumption and dependence on the mains voltage which can be undesirably interrupted in case of a power cut during the dialysis process. Further, the high voltage may cause serious risks such as fire or electric shock. Furthermore, being dependent on the mains voltage, the conventional systems for dialysis do not allow freely to move the dialysis assembly with the patient during the day or night, and cables for supplying mains voltage interfere with patient's comfort. Irrespective of the kind of power supply, conventional light or IR wave emitters usually require use of the complicated arrangements such as light absorbers brought into contact with the medical flluid which would not be feasible and safe enough for use with a medical fluid.
The present invention solves these problems with a dialysis system according to claim 1 comprising a hallogen lamp which can be operated independently of the mains voltage in a specific heating block.
Brief Description of the Invention
The present invention provides a dialysis system comprising a heating block (1] for heating of a medical fluid flowing in the said dialysis system, wherein the heating block (1] comprises a fluid cassette (4] accommodating a fluid line (5] and at least one halogen lamp (3] arranged in a position such that the medical fluid flowing through fluid line (5] is heated by way of thermal radiation. The medical fluid described herein can be a dialysate and therefore the system of the invention is particularly useful as a peritoneal dialysis device. The halogen lamp (3] as mentioned hereinabove can be emitting radiation with a wavelength in the range of 400 nm to 1000 nm. In preferred embodiments, the system may further comprise a power supply which is a battery, and a charging unit for recharging said battery by means of mains voltage. Accordingly the dialysis system may optionally comprise a warning means for informing of the user about a low battery state.
The at least one halogen lamp (3] may also be arranged in a position to heat the medical fluid by way of convection in addition to thermal radiation. In order to increase retention time of the medical fluid, the fluid line (5] may comprise a fluid conduit provided with a plurality of convolutions. It is also preferable that said fluid conduit is made of a transparent polymer material.
In further embodiments, the fluid line (5] comprises an inlet and outlet portion inside the cassette (4], wherein the fluid line (5] has an inlet temperature sensor (6] and/or an outlet temperature sensor (7] for measuring temperature of the medical fluid in said inlet and outlet portions, respectively. A warning means generating an alert based on an electrical signal of at least one of the sensors (6, 7] can also be provided.
Further the dialysis system according to the present invention may comprise a control unit configured to receive electrical signals from any of the sensors (6, 7] and producing a control signal for operating at least one halogen lamp (3] when the temperature value is below a threshold value. In preferred embodiments, the system comprises a plurality of halogen lamps (3] and said control means is configured to produce a control signal for some or all of the halogen lamps (3] depending on the temperature difference of the medical fluid from the threshold value.
The dialysis system of the present invention may further comprise an interface connected to the control unit, and said control unit in this case is configured to provide display of the information selected from temperature values obtained from at least one of the sensors (6, 7], a warning signal about state of the power supply and a warning signal about temperature value of the medical fluid.
In another aspect, the present invention relates to a method for producing a dialysis system comprising the steps of: providing a heating block (1] comprising a fluid cassette (4] accommodating a fluid line (5] and at least one halogen lamp (3] arranged in a position such that the medical fluid flowing through fluid line (5] is heated by way of thermal radiation, and
mounting said heating block (1] to a dialysis device.
Brief Description of the Figures Fig. 1 illustrates a fluid heating block (1] comprising halogen lamps (3] and a fluid cassette (4] according to an embodiment of the present invention.
Fig. 2 is a perspective view of a cassette (4] accommodated in the fluid heating block (1], according to an embodiment of the present invention, which comprises a fluid line (5] with a plurality of convolutions and additionally sensors (6, 7] for measuring the inlet and outlet temperatures of the medical fluid. Fig. 3 is the cross-sectional view of the heating block (1] as shown in Fig. 1.
Detailed Description of the Invention The present invention relates to a dialysis system comprising a specific heating arrangement, especially for use in a peritoneal dialysis equipment In particular, the present invention relates to a dialysis system comprising a heating block (1] for heating a medical fluid, comprising at least one halogen lamp (3] as a heater and at least one fluid cassette (4]. Therefore, the invention provides a safer, cost effective and simplified heating system, which can also considerably increase patient's comfort by removing dependencies to the mains voltage.
Accordingly, the present invention provides a heating block (1] with a halogen lamp (3], which is capable of maintaining an optimum temperature by heating, and reducing energy consumption by emitting light in a unique way.
In an aspect of the present invention, there is provided a dialysis system having a heating block (1] comprising at least one halogen lamp (3] and a fluid cassette (4] accommodating a fluid line (5] wherein the halogen lamp (3] is positioned in a way such that the medical fluid passing through the fluid line (5] is sufficiently heated by irradiation of said halogen lamp (3]. The desired temperature of the medical fluid would be between 30 °C and 40 °C, more preferably around 36-37 °C ideally close to the body temperature.
As compared to prior art, using a halogen lamp as a heating means is cost effective and efficient Halogen lamps are generally cheap and easily accessible, and they offer a service life of generally more than 3000 hours. Halogen lamps have a well-established technical meaning in state of the art. They are originally incandescent lamps similar to the conventionally known light bulbs, but they differ from the usual bulbs with their halogen (i.e. iodine or bromine] content instead of an inert gas, as well as their filament which is generally made of tungsten. Halogen lamps are known to produce halogen cycles which enable them to be operated at higher temperatures. Their light intensity and color temperature is also higher than the standard bulbs which suggests higher heating capabilities. It is surprisingly found in the present invention that these halogen lamps can be used in dialysis systems, especially in the equipment for peritoneal dialysis, for heating of a medical fluid recirculated to the patient at a temperature close to 37 °C. More surprising is that this effect can be achieved without utilizing special arrangements such as absorbent materials contacting to the medical fluid. It is also found that a similar heating effect can be obtained without using a mains voltage, i.e. 130-250 V. It is noted that a heating capacity sufficient for heating the medical fluid up to the desired level can be advantageously obtained by using conventional 12 V or 24 V batteries without the need for a higher voltage. In order to obtain this effect, supplying DC from the battery to the halogen lamp (3] would be preferable.
Therefore, in another embodiment of the present invention, the dialysis system as presented herein further comprises a battery (not shown] for the purpose of supplying power to the halogen lamp(s] (3]. In this case, the lamp(s] (3] are preferably operated with DC supplied from the battery. This embodiment suggests that a mobile dialysis system can be contemplated independently from the mains voltage while providing sufficiently the heating performance required for heating the medical fluid in the dialysis conditions. As noted above, the batteries can be of the conventional type supplying a 12 V or 24 V voltage. This embodiment is particularly suitable for the devices of peritoneal dialysis which interferes very much with daily life of the patient. In the present form of these systems, patient has to disconnect the tubes from the permanent catheter and stop the fluid flow in order to move. The present system, however enables the patient freely to move without interruption, by carrying the dialysis system independently from the mains voltage. Of course, the dialysis system according to the present invention may further comprise a charging unit (not shown] for recharging of the batteries from the mains voltage whenever it is desired. However, in this embodiment, it is highly desirable to provide a warning means generating a voice and/or light as an alert for informing the user about the low battery condition. In this case, the patient would have a sufficient time to insert the plug of the charging unit to the mains voltage beforehand.
Referring now to Fig. 1 which shows a perspective view of the heating block (1] according to the present invention, a fluid cassette (4] accommodating a fluid line (5] as shown in Fig. 2 is provided in close proximity with a number of halogen lamps (3] such that the light emitted from the lamps directly impinges upon the fluid line (5] and the medical fluid therein. This is a typical way of heating by radiation, more accurately the "thermal radiation". A halogen lamp works in a wavelength spectrum typically between 400 nm to 1000 nm which also overlaps with the visible spectrum. However, due to the specific color temperature and higher power efficiency, halogen lamp has higher heating capabilities in terms of the thermal radiation. A halogen lamp also emits a considerable amount of heat intrinsically due to the higher operating temperatures. This provides a further means for heating, namely a "convectional heating" of the fluid line (5] and the medical fluid therein.
Therefore, in the context of the present invention, heating capability with a halogen lamp can be maximized by utilizing both the thermal radiation and convectional heating. For this purpose, halogen lamp(s] (3] can be located in a position opposite to the fluid line (5] such that the medical fluid is heated in both ways. The distance between the halogen lamp (3] and fluid line (5] can be arranged in accordance with objectives of the present invention, however the said distance can ideally be arranged inbetween 1 to 5 cm, and more particularly 1 to 3 cm. The halogen lamp(s] (3] are preferably located on a lamp base (2] extending in horizontal axis (x] which can be substantially parallel with the fluid cassette (4] arrangement. Halogen lamps (s] (3] may therefore easily replaced if one or more of them complete their life span. The fluid cassette (4] as mentioned above can be placed into the heating block (1] in an upright position extending also in horizontal axis (x], and it preferably accommodates a conduit through which the medical fluid flows and being heated by the halogen lamp(s] (3]. In this embodiment, retention time of the medical fluid in the cassette (4] can be increased for heating purposes by providing said fluid conduit with a plurality of convolutions as shown in Fig. 2. Depending on the heat required for the flowing medical fluid, it may be desirable to use a plurality of halogen lamps (3] as a row.
In another preferred embodiment, it is also desirable to provide an inlet sensor (6] located at the inlet of the fluid line (5] and an outlet sensor (7] located at the outlet of the fluid line (5]. In this embodiment, a control unit (not shown] is provided to receive electrical signals from these sensors (6, 7] and to produce a control signal. The control unit is preferably adapted to receive the signal of the inlet sensor (6] about the inlet temperature of the medical fluid, and it produces a control signal for operating one or more of the halogen lamps (3]. More preferably, the control unit is adapted to receive the electrical signal of the outlet sensor (7] about outlet temperature of the fluid line (5] and it produces a control signal for operating one or more of the halogen lamps (3] if the temperature measured is below a threshold. More preferably, the control unit is adapted produce a control signal based on the electrical signals of both of the sensors (6, 7]. Additionally, a warning means can be provided in connection with the control unit such that a voice or light signal is triggered in case of a malfunction, and especially of a null or insufficient heat treatment based on the electrical signal of the outlet sensor (7].
In a further embodiment, there is provided an interface (not shown] preferably in the form of a display, and more preferably an LCD or LED screen connected to the aforementioned control unit. The inlet and outlet temperatures of the medical fluid can be displayed on the interface for convenience of the patient Preferably the control unit is further adapted to generate a warning signal about the state of the battery and heating condition of the medical fluid as mentioned above through the interface visually.
As can be inferred from Fig. 3 showing cross-sectional view of the heating block (1] according to the present invention, the halogen lamp(s] (3] are located at a distance from the fluid line (1] without a contact with the cassette (4] or fluid conduit in order to avoid a conductive heating. This is for safety of the system such that the cassette (4] or fluid conduit would not be damaged due to the elevated surface temperature of the halogen lamp (3]. However, those skilled in the art would appreciate that the halogen lamp (3] can be provided in contact with the cassette (4] or fluid conduit if the material thereof is selected to withstand elevated temperatures. Additionally, an absorbent material can be located in the cassette (4] so as to absorb the heat produced by thermal radiation of the halogen lamp (3] and then for transferring this heat to the medical fluid. However, it is preferred in the current invention to provide fluid conduits made of a transparent polymer such as PVC or silicon.
To this end, the present invention provides a complete solution for heating of the medical fluids which also renders the dialysis system to be movable with patient without interrupting the dialysis process. Such a system would be quite convenient for and a drastic improvement in peritoneal dialysis devices. Therefore, the dialysis system according to the present invention is preferably embodied as a peritoneal dialysis device, and more particularly as a continuous ambulatory peritoneal dialysis.
Further advantages and embodiments of the present invention can be contemplated based upon the appended claims.

Claims

A dialysis system comprising a heating block (1] for heating of a medical fluid flowing in the said dialysis system, wherein the heating block (1] comprises a fluid cassette (4] accommodating a fluid line (5] and at least one halogen lamp (3] arranged in a position such that the medical fluid flowing through fluid line (5] is heated by way of thermal radiation.
A dialysis system according to claim 1 wherein medical fluid is a dialysate.
A dialysis system according to claim 1 wherein the system is a peritoneal dialysis device.
A dialysis system according to claim 1 wherein the halogen lamp (3] emits radiation with a wavelength in the range of 400 nm to 1000 nm.
A dialysis system according to claim 1 wherein the system further comprises a power supply which is a battery, and a charging unit for recharging said battery by means of mains voltage.
A dialysis system according to claim 1 wherein the system further comprises a warning means for informing of the user about a low battery state.
A dialysis system according to claim 1 wherein at least one halogen lamp (3] is arranged in a position to heat the medical fluid by way of convection.
A dialysis system according to claim 1 wherein the fluid line (5] comprises a fluid conduit provided with a plurality of convolutions.
A dialysis system according to claim 8 wherein said fluid conduit is made of a transparent polymer material.
A dialysis system according to claim 1 wherein the fluid line (5] comprises an inlet and outlet portion inside the cassette (4], said fluid line (5] having an inlet temperature sensor (6] and/or an outlet temperature sensor (7] for measuring temperature of the medical fluid in said inlet and outlet portions, respectively.
11. A dialysis system according to claim 10 wherein the system further comprises a warning means generating an alert based on an electrical signal of at least one of the sensors (6, 7).
12. A dialysis system according to claim 10 wherein the system comprises a control unit configured to receive electrical signals from any of the sensors (6, 7] and producing a control signal for operating at least one halogen lamp (3] when the temperature value is below a threshold value.
13. A dialysis system according to claim 12 wherein the system comprises a plurality of halogen lamps (3] and said control means is configured to produce a control signal for some or all of the halogen lamps (3] depending on the temperature difference of the medical fluid from the threshold value.
14. A dialysis system according to claim 12 wherein the system further comprises an interface connected to the control unit, and said control unit is configured to provide display of the information selected from temperature values obtained from at least one of the sensors (6, 7], a warning signal about state of the power supply and a warning signal about temperature value of the medical fluid.
15. A method for producing a dialysis system comprising the steps of: providing heating block (1] comprising a fluid cassette (4] accommodating a fluid line (5] and at least one halogen lamp (3] arranged in a position such that the medical fluid flowing through fluid line (5] is heated by way of thermal radiation, and
mounting said heating block (1] to a dialysis device.
PCT/TR2016/050548 2016-12-28 2016-12-28 Dialysis system with thermal radiation means WO2018124983A1 (en)

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Citations (6)

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GB2265697A (en) * 1992-03-20 1993-10-06 Christopher Langley Heating apparatus
US5559924A (en) * 1991-02-08 1996-09-24 Kabushiki Kaisha Komatsu Seisakusho Radiant fluid heater encased by inner transparent wall and radiation absorbing/reflecting outer wall for fluid flow there between
WO2003061740A1 (en) * 2002-01-17 2003-07-31 Baxter International Inc. Medical fluid heater using radiant energy
US20100228222A1 (en) * 2009-03-09 2010-09-09 Williams Jeffrey B Surgical fluid management system with pressure and/or flow control
US20130174842A1 (en) * 2010-09-22 2013-07-11 Clovershield, Inc. Therapeutic vaporizer
US20160082200A1 (en) * 2013-06-18 2016-03-24 Fresenius Medical Care Deutschland Gmbh Medical heat exchanger for heating medical fluids by means of a light emitter and medical fluid treatment device having a light emitter

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5559924A (en) * 1991-02-08 1996-09-24 Kabushiki Kaisha Komatsu Seisakusho Radiant fluid heater encased by inner transparent wall and radiation absorbing/reflecting outer wall for fluid flow there between
GB2265697A (en) * 1992-03-20 1993-10-06 Christopher Langley Heating apparatus
WO2003061740A1 (en) * 2002-01-17 2003-07-31 Baxter International Inc. Medical fluid heater using radiant energy
US20100228222A1 (en) * 2009-03-09 2010-09-09 Williams Jeffrey B Surgical fluid management system with pressure and/or flow control
US20130174842A1 (en) * 2010-09-22 2013-07-11 Clovershield, Inc. Therapeutic vaporizer
US20160082200A1 (en) * 2013-06-18 2016-03-24 Fresenius Medical Care Deutschland Gmbh Medical heat exchanger for heating medical fluids by means of a light emitter and medical fluid treatment device having a light emitter

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