WO2017089615A1

WO2017089615A1 - Infusion system

Info

Publication number: WO2017089615A1
Application number: PCT/EP2016/079035
Authority: WO
Inventors: Jean-Pierre Peters
Original assignee: Jean-Pierre Peters
Priority date: 2015-11-27
Filing date: 2016-11-28
Publication date: 2017-06-01

Abstract

The invention relates to the field of medical devices and more in particular to a disposable venous infusion set. The disposable infusion set of the present invention has been specifically adapted to be patient specific and allow reuse with multiple infuses during patient's hospital stay. In said respect the disposable venous infusion set comprises a disposable safety zone and a patient zone, the latter comprising means to monitor and control the fluid rates, and/or volumes to the patient.

Description

INFUSION SYSTEM

FIELD OF THE INVENTION

The invention relates to the field of medical devices and more in particular to a disposable venous infusion set. The infusion set of the present invention has been specifically adapted to be patient specific and allow reuse with multiple infuses during patient's hospital stay. In said respect the disposable venous infusion set comprises a disposable patient line having a safety zone and a patient zone, the former comprising means to monitor and control the fluid rates, and/or volumes to the patient, in a particular embodiment even including means to monitor the localization of the patient and/or one or more health parameters of the patient. As such the system of the present invention allows complete monitoring of a patient and his treatment during hospital's stay. In addition, given the incorporation of protocol control, the system assists the caregiver not only in assuring that prescribed protocols have been completed, but also in fault detection and compatibility of therapies.

BACKGROUND TO THE INVENTION

Intravenous infusion therapy is often necessary to administer medication or other fluids directly into the circulatory system of a patient. In such infusion systems a container acting as a reservoir for holding the liquid to be infused, is connected to the body via a conduit in which pressure supplying the liquid is created by either gravitational pressure or by pressure generating means. With the current infusion sets, and to prevent cross-contamination one set per patient is being used. In certain instances, it may however be beneficial to use the same container with multiple patients, such as for example in the contrast fluid dispensing systems disclosed in US Patent 6,800,072 and US Patent 8,231 ,584 allowing a bulk source of contrast media to be used by multiple patients. To prevent cross-contamination between the patients, these systems include the necessary adaptations, such as intermediate reservoirs, one-way valves and combinations thereof.

In as far these systems address the problems associated with cross-contamination between patients, these systems fail to address the other problems typically encountered with venous infusion sets. In the absence of pressure generating means, e.g. infusion pumping systems such as syringe pumps, the back pressure can create significant changes in the flow rate, and this can be altered almost casually without intention by the patients change in position, e.g. rolling over in bed or changing from sitting to lying in bed. For many infusion therapies it is however necessary to keep the flow rate within selected limits and/or to ensure that a selected quantity of fluid is infused into the patient^'s circulatory system. Where simple in-line fluid flow controllers, such as for example described in US Patent 5,499,968 partly address the aforementioned problem of changes in back pressure they still fail to ensure that a selected quantity of fluid is actually infused. In addition, the current flow controllers are not immediately configured to be wearable by the user with minimal intrusion, see for example the flow controller described in PCT publication WO2014/085395 to control the fluid from a manually administered fluid source. As such said device is adjacent to a syringe used to deliver said fluid to the patient and controls the back-pressure to smoothen liquid flow variation to the infusion set being used. Wear ability being addressed in US 6,290,681 , but being a simple device worn on the wrist of the user and only capable of measuring the actual flow without means to adjust it, this device fails to solve the requisite in many infusion therapies where it is necessary to keep the flow rate within selected limits and/or to ensure that a selected quantity of fluid is infused into the patient's circulatory system. In addition, when to be used with multiple infusates by a single patient the current systems solely rely on the hospitals inventory and the pharmacists experience to track the infusion history of a patient and to prevent incompatible drug administrations.

It would accordingly be desirable to have a single line infusion system capable of being used with multiple different infusates, wherein said single line infusion system is capable of actively monitoring and logging the infusion history and treatment of a patient.

SUMMARY OF THE INVENTION

As will be further detailed in the description hereinafter, numbered embodiments of the present invention include; 1 . A venous infusion set containing a disposable patient line (100), said disposable patient line consisting of a first (1 ) and a second (10) tubing part, wherein; the first tubing part is being provided to establish at a first end (6) a releasable in fluid connection to a dosing device (11 ) adapted to dispense a fluid into a patient's vein, and to establish at the second end (9) a releasable in fluid connection (8, 2) to the second tubing part;

the second tubing part is being provided to establish at a first end (4) a releasable in fluid connection (2,8) to the first tubing part, and to establish at the second end (14) a releasable in fluid connection with a dispensing unit (17);

said second tubing part further comprising one or more one-way valves (3) to permit a unidirectional fluid flow from the dispensing unit (17) towards the dosing device (11 ); and wherein said venous infusion set is characterized in that the first tubing part comprises disposable monitoring means (12) to monitor the administration of said fluid through said first tubing into the patient, said monitoring means comprising:

- a flow meter (22) to measure the fluid (flow) rate,

- means to monitor one or more physiological parameters of the patient,

- a patient tracking system, and

- means for data collection and data transfer;

and wherein said disposable monitoring means (12) are proximal (with respect to the patient) to the one or more one way valves (13) present in the second tubing part of said disposable patient line,

and wherein said second tubing part functions as a safety zone. 2. The disposable venous infusion set according to embodiment 1 ; wherein the monitoring means (12) are integrated with the tubing.

3. The disposable venous infusion set according to any one of embodiments 1 or 2; wherein the flow meter (22) is selected from the group consisting of an electromagnetic flow meter, a Doppler-shift ultrasonic flow meter and a transmit-time ultrasonic flow meter. 4. The disposable venous infusion set according to any one of embodiments 1 to 3; wherein the monitoring means (12) are operable to maintain a record (18) of the total infusion history of the patient.

5. The disposable venous infusion set according to any one of embodiments 1 to 4; wherein the monitoring means (12) are operable to maintain a patient's identification record. 6. The disposable venous infusion set according to embodiment 5, wherein the patient's identification record comprises a medical ID of the patient.

7. The disposable venous infusion set according to embodiment 1 ; wherein the one or more physiological parameters of the patient are selected from the group comprising blood pressure, pulse (hearth) rate, respiration rate, body temperature, blood gases, blood sugar levels and the like.

8. The disposable infusion set according to any one of embodiments 1 to 7, wherein the monitoring means are capable of measuring medication of fluid type composition and/or pressure in the fluid channel present within the monitoring means; in particular capable of measuring medication of fluid type composition and pressure in the fluid channel. 9. The disposable infusion set according to embodiment 1 or 8, wherein the monitoring means comprise a fluid delivery sensor; in particular selected from a pressure sensor, a differential pressure sensor, an optical sensor, an ultrasonic sensor, a chemical sensor, a conductivity sensor, a medication composition sensor, a displacement sensor, a fluid flow sensor, or a combination of two or more of these or other fluid delivery sensors. 10. The disposable infusion set according to any one of embodiments 1 to 9, wherein the monitoring means comprise a medication composition sensor.

1 1 . The disposable infusion set according to embodiment 1 , wherein the monitoring means comprise a flow controller to control the rate of fluid flow. 12. The disposable venous infusion set according to embodiment 1 1 wherein the flow controller comprises a system controller and a valve.

13. The disposable venous infusion set according to embodiment 12, wherein the system controller is operable to adjust opening and/or closure of the valve. 14. The disposable venous infusion set according to embodiments 12 or 13, wherein the system controller is operable to maintain a record (18) of total infusion history of the patient.

15. The disposable venous infusion set according to any one of embodiments 1 to 14, wherein the monitoring means comprises an operator interface (13, 18) to operatively control the administration of said fluid through said first tubing, and into the patient. 16. The disposable venous infusion set according to any one of embodiments 1 to 15, wherein the monitoring means (12) comprise patient identification means (15), such as a barcode, name tag, and the like.

17. The disposable venous infusion set according to embodiment 1 , wherein the monitoring means (12) comprise a radiation detector. 18. The disposable venous infusion set according to embodiment 17, wherein the radiation detector is a detector for measuring X-ray radiation.

19. The disposable venous infusion set according to any one of embodiments 1 to 18 wherein the monitoring means are housed in a single housing.

20. A disposable patient line (100) for use in a venous infusion set, said disposable patient line consisting of a first (1 ) and a second (10) tubing part, wherein;

the first tubing part is being provided to establish at a first end (6) a releasable in fluid connection to a dosing device (11 ) adapted to dispense a fluid into a patient's vein, and to establish at the second end (9) a releasable in fluid connection (8, 2) to the second tubing part;

· the second tubing part is being provided to establish at a first end (4) a releasable in fluid connection (2,8) to the first tubing part, and to establish at the second end (14) a releasable in fluid connection with a dispensing unit (17);

said second tubing part further comprising one or more one-way valves (3) to permit a unidirectional fluid flow from the dispensing unit (17) towards the dosing device (11 ); and wherein said venous infusion set is characterized in that the first tubing part comprises monitoring means (12) to monitor the administration of said fluid through said first tubing into the patient, said monitoring means comprising:

- a flow meter (22) to measure the fluid (flow) rate, - means to monitor one or more physiological parameters of the patient,

- a patient tracking system, and

- means for data collection and data transfer;

and wherein said monitoring means (12) are proximal (with respect to the patient) to the one or more one-way valves (13) present in the second tubing part,

and wherein said second tubing part functions as a safety zone.

21 . The disposable patient line according to embodiment 20; wherein the monitoring means (12) are integrated with the tubing. 22. The disposable patient line according to any one of embodiments 20 or 21 ; wherein the flow meter (22) is selected from the group consisting of an electromagnetic flow meter, a Doppler-shift ultrasonic flow meter and a transmit-time ultrasonic flow meter.

23. The disposable patient line according to any one of embodiments 20 to 22; wherein the monitoring means (12) are operable to maintain a record (18) of the total infusion history of the patient.

24. The disposable patient line according to any one of embodiments 20 to 23; wherein the monitoring means (12) are operable to maintain a patient's identification record.

25. The disposable patient line according to embodiment 24, wherein the patient's identification record comprises a medical ID of the patient. 26. The disposable patient line according to embodiment 20; wherein the one or more physiological parameters of the patient are selected from the group comprising blood pressure, pulse (hearth) rate, respiration rate, body temperature, blood gases, blood sugar levels and the like.

27. The disposable patient line according to any one of embodiments 20 to 26, wherein the monitoring means are capable of measuring medication of fluid type composition and/or pressure in the fluid channel present within the monitoring means; in particular capable of measuring medication of fluid type composition and pressure in the fluid channel.

28. The disposable patient line according to embodiment 20 or 27, wherein the monitoring means comprise a fluid delivery sensor; in particular selected from a pressure sensor, a differential pressure sensor, an optical sensor, an ultrasonic sensor, a chemical sensor, a conductivity sensor, a medication composition sensor, a displacement sensor, a fluid flow sensor, or a combination of two or more of these or other fluid delivery sensors.

29. The disposable patient line according to any one of embodiments 20 to 28, wherein the monitoring means comprise a medication composition sensor.

30. The disposable patient line according to embodiment 20, wherein the monitoring means comprise a flow controller to control the rate of fluid flow.

31 . The disposable patient line according to embodiment 30 wherein the flow controller comprises a system controller and a valve.

32. The disposable patient line according to embodiment 31 , wherein the system controller is operable to adjust opening and/or closure of the valve.

33. The disposable patient line according to embodiments 31 or 32, wherein the system controller is operable to maintain a record (18) of total infusion history of the patient.

34. The disposable patient line according to any one of embodiments 20 to 33, wherein the monitoring means comprise an operator interface (13, 18) to operatively control the administration of said fluid through said first tubing, and into the patient.

35. The disposable patient line according to any one of embodiments 20 to 34, wherein the monitoring means (12) comprise patient identification means (15), such as a barcode, name tag, and the like.

36. The disposable patient line according to embodiment 20, wherein the monitoring means (12) comprise a radiation detector.

37. The disposable patient line according to embodiment 36, wherein the radiation detector is a detector for measuring X-ray radiation.

38. The disposable patient line according to any one of embodiments 20 to 37 wherein the monitoring means are housed in a single housing.

39. A disposable venous infusion set comprising a disposable patient line according to any one of embodiments 20 to 38.

DESCRIPTION OF THE INVENTION

The present invention is directed to a venous infusion set containing a particular disposable patient line (100). The disposable patient line consisting of a first (1 ) and a second (10) tubing part, wherein; the first tubing part is being provided to establish at a first end (6) a releasable in fluid connection to a dosing device (11 ) adapted to dispense a fluid into a patient's vein, and to establish at the second end (9) a releasable in fluid connection to the second tubing part;

the second tubing part is being provided to establish at a first end (4) a releasable in fluid connection to the first tubing part, and to establish at the second end (14) an in fluid connection with a dispensing unit (17);

said second tubing part further comprising one or more one-way valves (3) to permit a unidirectional fluid flow from the dispensing unit (17) towards the dosing device (11 ); and wherein said venous infusion set is characterized in that the first tubing part comprises monitoring means (12) to monitor the administration of said fluid through said first tubing into the patient, said monitoring means (12) comprising:

- a flow meter (22) to measure the fluid (flow) rate,

- means to monitor one or more physiological parameters of the patient,

- a patient tracking system, and

- means for data collection and data transfer;

and wherein said monitoring means (12) are present in the first tubing part (1 ) proximal (with respect to the patient) to the one or more one-way valves (3) present in the second tubing part of said disposable patient line,

and wherein the second tubing part functions as a safety zone.

It accordingly differs from the flow monitoring devices directly connected to the dosing device (11 ) adapted to dispense a fluid into a patient's vein, the dosing device typically being an injection needle or a needle holder such as for example shown in Chinese patent application CN 203 075 352. In such devices (see for example the wrist like flow monitor as shown in US 6,290,681 - infra) contamination with bodily fluids of the infusion set cannot be avoided and easy verification of the proper placement of the dosing device is hindered by the presence of such flow meter close to the injection point.

Notable in the present invention is that the second tubing part of the disposable patient line (100) of the infusion set comprises one or more, in particular two one-way valves in a second tubing part releasable connected to a first tubing part comprising means to monitor the administration of a fluid to a patient, wherein said monitoring means (12) are positioned proximal (with respect to the patient) of said valve(s). As such, cross-contamination of the infusion sets between different infuses will be prevented, allowing the first tubing part of the disposable patient line (100) of the venous infusion set to stay with a single patient during hospital stay. The second tubing part functions thus as a safety zone. Being releasable connected to the first tubing part, it allows on the one hand direct control of proper placement of the first part, whilst on the other hand and through the presence of the one or more one way valves, preventing patient contamination at the second (most distal) end (14) of the second tubing part. As such, in-between different infuses there is no need to replace the complete disposable patient line, it suffices to replace the second tubing part, allowing the first tubing part comprising the monitoring means (12) to stay with the patient. In one embodiment said means to monitor the administration of a fluid to the patient could be partly disposable. For example, in one embodiment the fluidic interconnects present within the means to monitor the administration of said fluid, could be integrated with the first tubing and separated from the housing comprising accompanying electronics, display(s), input device(s), and the like. In such embodiment there will be no direct contact between such housing and the fluids, rendering the housing reusable between different patients, with a disposable part consisting of the fluidic interconnects integrated within the first tubing part.

In a further embodiment the disposable patient line (100) of the infusion set is fully disposable. As such, the means to monitor administration of a fluid to the patient are just used in conjunction with a single patient, implying that the current problems associated with the sterilization of such monitoring devices are overcome. Used in combination with the second tubing part comprising one or more one way valves, the disposable venous infusion set of the present invention allows reuse of the first tubing part with multiple infuses during patient's hospital stay. Expressed differently, since the monitoring means are present in the first tubing part and proximal (with respect to the patient) of the one or more (preferably two) valves, the second end (14) of the second tubing part, and in fluid connection with a dispensing unit (17) will never get contaminated and allows this end to be connected with multiple infuses during patient's hospital stay. It actually implies that the disposable first tubing part, comprising the monitoring means is patient specific and worn by the patient.

As evident from the examples herein below, in either embodiment the monitoring means (22) that are to monitor the administration of a fluid to the patient, are present proximal (with respect to the patient) from at least one of said one-way valves in the second tubing part. In a particular embodiment the monitoring means are proximal from at least two one-way valves in the second tubing part. As such the fluidic interconnects (5) of disposable patient line (100) with the dispensing unit are distal of a replaceable safety zone preventing patient contamination of the fluidic interconnects (5) at the second end of the second tubing part.

In order to minimize hindrance to the user, the means to monitor administration, hereinafter also referred to as the 'patient monitor' or the 'monitoring means', will preferably be wearable by the patient. As such, in one embodiment of the present invention the disposable venous infusion set of the present invention is characterized in that the monitoring means (12) are integrated with the first tubing. Integration of the monitoring means with the tubing may for example be realized by encapsulation of the tubing and electronics in a common polymer such as for example epoxy or polystyrene. Integration of the monitoring means with the tubing results in a fixed alignment between the fluidic tubing and the electronics of said means; a low dead volume nature of the fluidic interconnects; a reduction in the manufacturing costs and the ability to shape and polish the look of the means to monitor and control the fluid rates within the disposable venous infusion set according to the invention. In a further embodiment, the monitoring means are housed in a single housing.

As presented, the means to monitor administration of a fluid to a patient or monitoring means do not automatically imply that said means have the capability of both monitoring (measuring) the fluid rates and the capability in actively controlling the fluid rates. In a simple embodiment the means are only capable of monitoring the fluid rates. In another embodiment the means are capable of monitoring and controlling the fluid rates. In each and all of said embodiments the monitoring means comprise means to measure the fluid (flow) rates of the fluidics through the second tubing. Possible methods to measure fluidic flow rates include an electromagnetic flow measurement, a doppler-shift ultrasonic flow measurement, a transmit- time ultrasonic flow measurement and the like. It is accordingly an object of the present invention to provide a disposable venous infusion set wherein the patient monitor comprises a flow meter (22) selected from the group consisting of; an electromagnetic flow meter, a Doppler-shift ultrasonic flow meter and a transmit-time ultrasonic flow meter. Evidently, the flow meter as used herein is operable to perform any one of the aforementioned fluidic flow measurement methods, and accordingly comprises all technical elements, including a processing unit (also referred to as 'the flow meter cpu'), minimally required to perform a fluidic flow measurement selected from an electromagnetic flow measurement, a Doppler-shift ultrasonic flow measurement and a transmit-time ultrasonic flow measurement. In a particular embodiment the flow meter comprises an output interface, such as for example a display (16), to present the flow measurement to the operator. Being an objective of the present invention to provide an infusion set capable to monitor a patient during his hospital stay, the functionality of the monitoring means preferably goes beyond the mere measurement of the fluidic flow rates. Such further functionalities could for example include; the possibility of measuring the total volume of a given infusate; the possibility of maintaining a total infusion history of the patient; the possibility of performing an error detection in therapy given to the patient, the possibility of localization monitoring of the patient, the possibility of maintaining general health parameters of the patient, the possibility of actively controlling the flow rate of the fluid through the second tubing, and the like. Therefore, the monitoring means also comprise means to monitor one or more physiological parameters of the patient. In a further embodiment, the monitoring means comprise one or more sensors to monitor a physiological parameter selected from the group comprising blood pressure, pulse (heart) rate, respiration rate, body temperature, blood gases, blood sugar levels and the like. In an embodiment the monitoring means also comprise means to monitor at least two physiological parameters of the patient, including blood pressure, pulse (heart) rate, respiration rate, body temperature, blood gases, blood sugar levels and the like. In particular the monitoring means comprise combinations of sensors to monitor the following combinations of physiological parameters; blood pressure and pulse (heart) rate; blood pressure and respiration rate; Blood pressure and body temperature; blood pressure and blood gases; blood pressure and blood sugar levels; blood pressure, pulse (heart) rate, and respiration rate; blood pressure, pulse (heart) rate, and body temperature; blood pressure, pulse (heart) rate, and blood gases; blood pressure, pulse (heart) rate, and blood sugar levels; blood pressure, pulse (heart) rate, respiration rate, and body temperature; blood pressure, pulse (heart) rate, respiration rate, and blood gases; blood pressure, pulse (heart) rate, respiration rate, and blood sugar levels; blood pressure, pulse (heart) rate, respiration rate, body temperature, and blood gases; blood pressure, pulse (heart) rate, respiration rate, body temperature, and blood sugar levels; blood pressure, pulse (heart) rate, respiration rate, body temperature, blood gases and blood sugar levels; pulse (heart) rate and respiration rate; pulse (heart) rate and body temperature; pulse (heart) rate and blood gases. For the nursing staff and doctors the combination of a set of physiological parameters, provides a more complete picture than the sum of the individual measurements. In having these further functionalities, the patient monitoring means of the present invention provide an instant record of the patient's therapy during hospital stay. At each instance, nursing staff and doctors will be able to consult the patient monitoring means to get an indication of the patient's treatment history and eventual health parameters. In conjunction with the hospital administration system, the patient monitoring means may for example be used to check compliance with the prescribed therapy. Even more in particular, real-time clinical surveillance, either in the hospital or at home, can be done by combining all clinical data. Thus in one embodiment the monitoring means is operable to combine the physiological parameters and maintain an instant record of the patient's general health parameters

In one embodiment the monitoring means, and in particular the flow meter, is operable to maintain a record of the total infusion history of the patient. The latter eventually comprising a further output interface (19) to present the cumulative flow measurement to the operator. As will be evident to the skilled artisan, in being enabled to maintain a record of the total infusion history of the patient, the monitoring means will equally be operable to maintain a patient's identification tag. Such patient identification tag can be present as a barcode, name tag, and the like (15), and are preferably found on the means to monitor the administration of a fluid to the patient. A patient identification tag may equally be present in a patient's record stored in the memory of the device. Within the context of the present invention the flow meter cpu is operable in performing one of the aforementioned fluidic flow measurements. In one embodiment the flow meter is operable in maintaining a patient's identification record. Such an identification record, typically maintained in an appropriate data storage means in the monitoring means, will minimally comprise information like the name and surname of the patient, but could equally comprise a medical ID of the patient. Further to the patient identification record the flow meter may be operable to maintain a record of the patient's prescribed treatment. Being part of a disposable infusion set, the record of the patient's prescribed treatment will minimally comprise identification of the drug or drugs to be infused, the infusion regimen. Based on the measurements and sensors (infra) present within the monitoring means, this record of the patient's prescribed treatment preferably further comprises identification of the drug or drugs being administered, the amount of drug or drugs being administered, the duration of administration for the drug or drugs being administered, information on the caregiver administering an infusate, drug or drugs to the patient, and the like. Being able to maintain a record of the patients prescribed treatment, the monitoring means may optionally be operable to perform a compatibility check of said treatment, on the one hand based on incompatibility data for the medication being administered, on the other hand based on incompatibility with the medical ID of the patient, and even in a further aspect based on the information related to the caregiver administering a given infusate, drug or drugs to the patient. In a first aspect the latter allows subsequent identification of the caregivers treating the patient and could in a further aspect be used to prevent unauthorized administration of therapies / treatments to a patient. In said embodiment the monitoring means will be operable to receive a caregiver ID, such as for example from a barcode tag, magnetic strip, RFID and the like. In performing a compatibility check of the treatment the monitoring means will be capable of interrogating a drug table either locally or remotely, said drug table comprising a list of all drugs used or prescribed for patients in the hospital . The drugs may be stored by drug name, mnemonic, and identification number. The drug table may also include incompatibility data for the drugs. For example, if a solution containing a mixture of two drugs were to cause particles to precipitate, the drugs would be incompatible, since a solution with precipitates would not be suitable for infusion into a patient. The system checks the drug table upon entering new prescriptions for each patient, and in case an incompatibility is detected with either the treatment history and/or the medical ID of the patient, alerts this to the user. The medical ID of the patient used in this incompatibility check could for example include information on disease indications, chronic therapies, allergies, and the like; but could equally include health parameters such as body weight, blood type, blood pressure, heart rate and the like. Health parameters of the patient could be entered by the operator as part of the medical ID data, or through sensors monitoring the physiological condition of the patient such as blood pressure, pulse rate, respiration rate, temperature, blood gases, blood sugar levels and the like. Thus expressed differently, in another embodiment the flow meter is operable to perform an automatic error detection , comprising means to monitor one or more health parameters of the patient. In a particular embodiment the monitoring means comprise one or more sensors, preferably at least two, even more in particular a combination of sensors (supra) to monitor a physiological parameter selected from the group comprising blood pressure, pulse (hearth) rate, respiration rate, body temperature, blood gases, blood sugar levels and the like.

As evident from the foregoing, in performing the compatibility check, it may be desired that the monitoring means are not only capable of determining fluid flow, volume and cumulated volume but also capable of measuring medication of fluid type composition and/or pressure in the fluid channel present within the monitoring means. To said extent the monitoring means may further or alternatively to the flow meter comprise a fluid delivery sensor. This sensor can either be a pressure sensor, a differential pressure sensor, an optical sensor, an ultrasonic sensor, a chemical sensor, a conductivity sensor, a medication composition sensor, a displacement sensor, or a fluid flow sensor or a combination of two or more of these or other fluid delivery sensors. In some implementations, the monitoring means include a medication composition sensor in order to verify and/or determine the contents of the medication container. The medication composition sensor can automatically determine the composition of the medication administered from the medication container. This can be a sensor or plurality of sensors that determine the fluid type being administered. This can be compared to the medication type indicated by the medication ID Code, if present. The sensor can be any one or more of a pH detector, a viscosity indicator, an optical density indicator, a chemical indicator, a drug molecule indicator, a drug sensor, a spectrophotometer, an HPLC detector, a UV detector, a fluid density sensor, a specific gravity fluid sensor, a medication identification sensor, etc. A medication identification sensor is operable to receive information on the medication from an information source. The medication information source is typically present on the medication container, the medication packaging, the medication leaflet, or the like. Such information source can be, for example, mechanically encoded information, magnetically encoded information, and radio frequency readable information. The information source can also or alternatively comprise optically encoded information and the identification sensor can comprise an optical emitter and an optical detector to read the optically encoded information, such as for example by means of an integrated barcode reader (23). The identification sensor can include an optical emitter LED to illuminate the information source and an optical detector such as a camera (charge coupled device-CCD). The identification sensor can read information from the information source, for example as a result of relative motion of the fluid outlet of the medication container relative to the medication port.

As already mentioned hereinbefore, in a further aspect the means (12) to monitor the administration of said fluid through said first tubing have the capability of both monitoring (measuring) and actively controlling the fluid rates. In said embodiment, and further to aforementioned flow meter, the means to monitoring means comprise a flow controller configured to control the rate of fluid flow there through and into the patient's vein. Independent of the flow meter, the flow controller enables the operator to program the venous infusion set for administering multiple infusates at individually rates, and/or volumes to the circulatory system of the patient. The flow controller accordingly comprises a processor unit, hereinafter also referred to as system controller with the requisite interfaces and memory units to accept and perform the instructions provided by the operator, including actuators to actively control the further means, such as a valve, present that enable adjustment of the fluidic flow through the second tubing, hereinafter also referred to as fluidic flow adjustment means. It is accordingly an object of the present invention to provide an embodiment wherein the flow controller of a disposable infusion set according to the present invention comprises a system controller and fluidic flow adjustment means, such as a valve. Said system controller is operable to adjust opening and/or closure of the valve and comprises an operator interface to operatively control the system controller. In another embodiment, said system controller is operable based on programmed algorithms to adjust opening and/or closure of the valve. For example, automatic opening and/or closure of the valve can be programmed in case an alarm signal from sensors monitoring the patient's physiological health parameters is detected or in case an error in the fluid delivery sensors is detected. The system controller may equally include the processing unit of the flow meter. In said embodiment the flow controller may even include an automatic error detection, such as an incompatibility check in infusates, an incompatibility check of infusates with the patient, logging of infusion stops, and the like. In said embodiment the system controller is operable to perform a fluidic flow measurement selected from an electromagnetic flow measurement, a Doppler-shift ultrasonic flow measurement and a transmit-time ultrasonic flow measurement. Optionally further comprising an output interface, such as for example a display, to present the flow measurement to the operator. In an even further embodiment the system controller is operable to maintain a record of the total infusion history of the patient. The latter eventually comprising a further output interface (19) to present the cumulative flow measurement and/or an identification code for the infusate to the operator.

Being an objective of the present invention to provide a disposable venous infusion set that allows reuse with different infusates for the same patient, the disposable venous infusion sets according to the different embodiments of the present invention, preferably comprise patient identification means. Such patient identification means can be present as a barcode, name tag, and the like, and are preferably found on the means to monitor and control the fluid rates. A patient identification record may equally be present in the patient's record stored in the RAM of the system controller and/or in the RAM of the Flow meter. Thus in one embodiment of the present invention the disposable venous infusion set is characterized in that the system controller is operable to maintain a patient identification record. In the different embodiments the system is characterized in being capable of maintaining a record of the patient's treatment, as such the monitoring means comprise a memory element that can store information obtained from the different sensors present within the system. A timing element can be coupled to the memory element to enable recordation of events corresponding to what medication is administered, where the medication is administered, when the medication is administered, the volume of medication administration, the duration of medication administration, who administered the medication, etc. The patient record logged within said memory element can at all times be interrogated by the operator. The operator may transfer the record directly through a communication port, including wireless transmission to a remote data collection system, such as the hospital administration system. The data collection can equally be part of a cellular phone or other mobile computing system (e.g. tablet computer, IPAD, etc.), within said embodiment the data collection system can provide collected data to other systems (medical information systems, emergency medical services, hospital information systems, remote monitoring systems, home health care systems, telemedicine systems, and the like.). An important advantage of the presence of means for data collection and data transfer in the disposable infusion set according to the present invention is that the patient can be fully monitored during its stay in the hospital but also when the patient is back home or in a nursing home. Information on patient parameters can be easily transmitted to the medical staff for follow-up of the patient. The transfer can be done using WIFI or an internal data transfer network in the hospital.

In one embodiment the infusion set will be operable to monitor the localization of the patient, i.e. comprises a patient tracking system. The presence of such patient tracking systems not only allows subsequent confirmation of patient attending hospital tests and/or therapies; but also allows recovery of wandering patients. The technology used by the patient tracking system may be any of a variety of known tracking technology, including global positioning technology (GPS) and telemetric broadcast technology such as Radio Frequency (RF), e.g. RFID, Bluetooth; Infrared (IR); Ultrasound technology; and the like. In case of telemetric broadcast technology, the monitoring means will comprise an appropriate transmitter broadcasting a location signal associated with a particular patient. In conjunction with a plurality of telemetric receivers disposed throughout the telemetry coverage area, it will be possible to track the location of the patient within said coverage area. Throughout the telemetry coverage area, the strength of the location signals received at each of the telemetry receivers can be used to triangulate the patient tracking system as the varying signal strength from a plurality of telemetry receivers may be used to determine the patient location with reference to each of the telemetry receivers receiving the location signal. In one embodiment the patient tracking system comprises a wireless transceiver for communication over a public communications network, a GPS receiver for receiving location related information from a global positioning system, a microprocessor for performing on board calculations and transferring data from said GPS receiver to said transceiver, and firmware in said microprocessor for processing instructions for operation of said transceiver, said GPS receiver and said microprocessor communicating with the communications network, and a FLASH memory for tracking the location of the article over a period of time and delivering corresponding information through the transceiver to the communication network. In another embodiment this GPS based patient tracking system is combined with telemetric broadcast technology, in particular with RFID. When in a building, and within range of a telemetry coverage area, the telemetric broadcast technology will be used to track the patient and not the GPS, which is less effective indoor and would draw power uselessly.

When in use the second end (14) of the second tubing part will be connected to a fluid dispensing system. Within the context of the present invention such fluid dispensing system is not meant to be limited to a single fluid dispensing unit. The infusion set may equally be connected to a manifold with multiple liquid input lines, such as for example used in contrast fluid delivery systems. The fluid dispensing system may equally comprise an injection port distal to the monitoring means allowing direct injection of medication into the fluid administered to the patient. If present, each of the fluids will be identifiable to the monitoring means using the medication information source(s) and the medication identification sensor present within the monitoring means.

The automated record keeping of the infusion set of the present invention, provides accurate records of the patient (treatment, health parameters, position) and frees up health care provider's time, improving patient care. In addition, the compact nature and the safety zone, enable use of the device at al times during patient's hospital stay, and through its communication with the hospital administration system provides the medical staff with a realtime record of the patient treatment history, optionally including a real time record of one or more health parameters and location of the patient. If present, the flow controller additionally provides the medical staff real-time control of the fluidic flow to the patient.

In a particular embodiment, the monitoring means of the present invention also comprise a radiation detector. In an even further embodiment, said radiation detector is a detector for measuring X-ray radiation. In a further embodiment, this radiation detector is a Geiger counter. After all, during their hospital stays, patients are often exposed to X-ray examinations since these take part in a more accurate diagnosis or follow-up of the disease. Authorized regulatory bodies emphasize the importance of keeping the dose to patients as low as reasonably achievable (ALARA). Therefore, it is crucial that the cumulative dose of radiation to which a patient is exposed during his hospital stay(s) is measured.

As the infusion set is patient specific and allows reuse with multiple infuses during the patient's hospital stay, the presence of the radiation detector will automatically measure the cumulative dose of radiation that is collected during the stay in the hospital. Further, since the radiation detector is integrated in the infusion set, there is no need to wear a separate radiation detector and thus the chance to forget to wear said radiation detector, e.g. after redressing the patient, is eliminated. ln a further embodiment, the present invention also discloses a disposable venous infusion set comprising a disposable patient line as outlined herein above.

BRIEF DESCRIPTION OF THE DRAWINGS

With specific reference now to the figures, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the different embodiments of the present invention only. They are presented in the cause of providing what is believed to be the most useful and readily description of the principles and conceptual aspects of the invention. In this regard no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention. The description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

Fig. 1 : Perspective top view of a venous infusion set according to the present invention. Fig. 2 and 3: Perspective top view of the distal fragment of the first tubing part.

DETAILED DESCRIPTION OF THE INVENTION

Figure 1 shows the two tubings (1 ) and (10) making up the disposable infusion set, wherein set tubings are releasable connected to one another through the interconnecting elements (2) and (8) at respectively ending (4) and ending (9) of the second and first tubing. At the other end (6) this first tubing is provided with a further element (7) to allow releasable connection with a dosing device (11 ) adapted to dispense a fluid into a patient's vein. Analogously the second tubing (10) is provided at its other ending with an element (5) to allow releasable connection with a dispensing unit (17). This second tubing further comprises one or more one- way valves (3) to realize a unidirectional flow from the dispensing unit to the patient. The first tubing further comprises means (12) to monitor and control the fluid rates and amounts of dispensed fluids through the tubing.

The one way valve may be mounted at any position in the second tubing part. To facilitate manipulation, the one way valve is preferably mounted in the proximity of the first end part (4) of the second tubing part (10), preferably at the end part. Manipulation is further facilitated in that the first connector part (2) of the releasable connection is mounted to an end part of the one-way valve (3a), it accordingly appears as if integrated with the releasable in fluid connection (2) at the first end part of the second tubing part. The connector can be made of any suitable connector known to the person skilled in the art, which permits to releasably connect two parts of a tubing, for example a luer connector or a bayonet coupling or any other coupling known to the person skilled in the art. The second connector part (8) is mounted to a second end part (9) of the first tubing part (1 ). The first and second connector part (2), (8) are releasable connectible to each other in a liquid tight manner and permit a fluid flow from the fluid dispensing unit towards the patient as well as the reverse.

The presence of the one-way valve(s) in the second tubing prevents a backward flow from the patients dosing device (11 ) towards the fluid dispensing unit, and accordingly prevents contamination of the fixed part of the fluid dispensing unit. As presented in Figure 1 , the second tubing comprises a second one-way valve (3b). The second one-way valve may be mounted at any position in the second tubing part, i.e. at any distance from the first and second connector part, respectively. However, to obtain the best results, each valve, in particular a first and second valve, should be mounted about 3 cm or more from each other. If the valves are mounted too close to each other the beneficial effect on the reduction of the contamination is decreased. Preferably, the second one-way valve is mounted at a distance about halfway the second tubing part, i.e. on about an equal distance from the first and second connector part, respectively. The second one-way valve may be mounted either unreleasably or releasably attached to the tubing, using any combination of commonly known attachment means such as, for instance, glueing, pressing, clamping, or the use of any suitable connector known to the person skilled in the art, which permits to releasably connect two parts of a tubing, for example a luer connector or a bayonet coupling or any other coupling known to the person skilled in the art. Within the scope of the present invention any one-way valve considered suitable by the person skilled in the art may be used. Often the use of a one-way valve made of a transparent material will be used as it assists in facilitating the control of the dispensing of the fluid.

The first and second tubing part may also contain one or more clips (20) to temporarily close off the tubing part onto which the clip has been attached, such as by pressing or squeezing the elastic tubing together such that the inner flow is blocked. Advantageously, such clip (20) may be mounted in the first tubing part to close off the blood reflux, for example when the first and second tubing parts are disconnected. In this way, the patient's veins are not exposed to possible contaminants entering the open second end of the first tubing part. Advantageously, such clip (20) may be mounted in the first tubing part, between the second end (8) of the first tubing part (1 ) and the means (12) to monitor and control the fluid rates further reducing the risk of contamination. Alternatively, such clip (20) is mounted in the second tubing part. Being releasably connected to the second tubing, the first tubing part can for example be kept connected to the dosing device where a patient is moved from one fluid dispensing unit to another, whilst temporarily closing the tubing using the clip mounted thereon.

Again per reference to Figure 1 , the disposable venous infusion set of the present invention comprises at the second end (14) of the second tubing part a connector (5) for establishing a fluid connection towards the dispensing unit (17), that is re-used with every patient. Also at the first end (6) of the first tubing a connector (7) is present to establish a releasable in fluid connection with the dosing device (11 ) adapted to dispense a fluid in the patient's vein. The connector can be made of any suitable connector known to the person skilled in the art, which permits to realize a releasably in fluid connection between two parts of a tubing, for example a luer connector or a bayonet coupling or any other coupling known to the person skilled in the art. As a dosing device any suitable device known to a person skilled in the art may be used. A suitable example of a dosing device is a syringe or injection needle. The possibility to disconnect the first tubing part form the second tubing part also allows to verify whether the dosing device has been correctly inserted into the patient's vein. The releasable connection with the second tubing part is opened to permit a back flow from the patient's vein into the first tubing part and the releasable connection is re-established after the back flow of blood into the first tubing part has occurred and has been observed.

As follows from the foregoing description of the connections of the two tubing parts of the infusion set of the invention, the first tubing part is located proximal to the patient. This first tubing part allows to take samples from or make direct injections into the patient's circulatory system, independent of the infusion set upon simple opening of the first and second connector part (2), (8) with closure of the clips (20) present on the first tubing part. As such this first tubing part represents the sample or patient's line. It typically stays with the patient during his stay at the hospital but may equally be replaced between different infusates. The second tubing part is located distal from the patient. Comprising the one or more, and in particular two one-way valves it prevents eventual cross-contamination to the remaining part of the infusion set. As it ensures safe use of the same infusion set between different patients, this second tubing part represents the safety zone within the infusion set according to the present invention. It is evidently a disposable part that can be replaced between different infuses.

Enabling patient specific reuse of the same infusion set between different infusions, allows infusion of the same container with multiple patients. This approach not only reduces the waste of infusates liquids, but also saves time otherwise consumed by assembling injectors and insertion of the dosing device into the patient's vein. Where such reuse reduces waste and simplified patients' handling, it requires proper recording by the hospitals^' personal of the kind and amounts of infusates administered to a patient. To assist and prevent erroneous administration of either kind (incompatibility issues within infusates or with a patient's medical file) and amount of infusates, the infusion set of the present invention is further characterized in comprising means (12) to monitor and control the liquid delivered to the patient.

Figure 2 shows a perspective top view of the distal fragment of the first tubing part, comprising the means (12) to monitor and control the fluid rates through the tubing. An alternative embodiment with an integrated barcode reader at the side of the monitoring means (12) is shown in Figure 3.

As already outlined hereinbefore and per reference to Figure 2, these means are preferably positioned into the first tubing part and proximal of the one-way valve(s) when compared to the second tubing part, i.e. when compared to the patient. As presented, these monitoring means are operable not only to measure the liquid flow through the tubing but also comprises means (18) to maintain a record of the total infusion history. Through an operator interface, in the exemplified embodiment including the power button (13) and the scroll buttons (21 ), the operator is able to consult the patient's infusion record as maintained in the memory of the flow meter or of the system controller present within the monitoring means (12). The latter may further comprise a stored drug table wherein the operator interface can also be used to operatively control the means (12) to monitor the administration of said fluid through said first tubing, and into the patient. Programming mode, in particular of the flow meter cpu and/or the system controller, may for example be activated by a press and hold input from the power button, a long pressure of the power button or the like. Within the programming mode the scroll buttons (21 ) can be used to select and adjust the requisite flow rate, volume and drug to be administered. Evidently, the system is operable to maintain a patient identification record. In as far this may be interrogated through an appropriate interface in the monitoring means (12), in a preferred embodiment the means further comprise patient identification means (15), such as a barcode, name tag, and the like, visible to the user/operator. Interrogation of the patient's infusion record and/or corresponding patient identification record may occur through any art know interfaces allowing communication with the hospital administration system, including network interfaces as well as direct bus connections, such as USB, Firewire, and Serial ATA; and wireless connections such as Bluetooth. Feedback to the operator may accordingly be remote, but to allow direct monitoring of the means (12) during operation and without accessing the hospital administration system, the means (12) to monitor the administration of said fluid through said first tubing, preferably comprise one or more displays, such as a first display (16), to present the flow measurement to the operator; and an optional display (19) to present the cumulative flow measurement and/or an identification code of the infusate to the operator.

The invention is not to be limited by what has been particularly shown and described, expect as indicated in the appended claims.

Claims

C LAI MS

1 . A disposable patient line (100) for use in a venous infusion set, said disposable patient line consisting of a first (1 ) and a second (10) tubing part, wherein;

· the first tubing part is being provided to establish at a first end (6) a releasable in fluid connection to a dosing device (11 ) adapted to dispense a fluid into a patient's vein, and to establish at the second end (9) a releasable in fluid connection (8, 2) to the second tubing part;

said second tubing part further comprising one or more one-way valves (3) to permit a unidirectional fluid flow from the dispensing unit (17) towards the dosing device (11 ); and wherein said venous infusion set is characterized in that the first tubing part comprises:

monitoring means (12) to monitor the administration of said fluid through said first tubing into the patient, said monitoring means comprising:

- a flow meter (22) to measure the fluid (flow) rate,

- means to monitor one or more physiological parameters of the patient, - a patient tracking system, and

- means for data collection and data transfer;

and wherein said monitoring means are located proximal to the one or more one-way valves of the second tubing part,

and wherein said second tubing part functions as a safety zone.

2. The disposable patient line according to claim 1 ; wherein the flow meter (22) is selected from the group consisting of an electromagnetic flow meter, a Doppler-shift ultrasonic flow meter and a transmit-time ultrasonic flow meter.

3. The disposable patient line according to any one of claims 1 or 2; wherein the monitoring means (12) comprise means to maintain a record (18) of the total infusion history of the patient.

4. The disposable patient line according to any one of the preceding claims; wherein the monitoring means (12) are operable to maintain a patient's identification record.

5. The disposable patient line according to claim 1 , wherein the one or more physiological parameters of the patient are selected from the group comprising blood pressure, pulse (heart) rate, respiration rate, body temperature, blood gases, blood sugar levels and the like.

6. The disposable patient line according to any one of claims 1 to 5, wherein the monitoring means measure medication of fluid type composition and/or pressure in the fluid channel present within the monitoring means; in particular capable of measuring medication of fluid type composition and pressure in the fluid channel.

7. The disposable patient line according to claim 1 , wherein the monitoring means comprise a fluid delivery sensor; in particular selected from a pressure sensor, a differential pressure sensor, an optical sensor, an ultrasonic sensor, a chemical sensor, a conductivity sensor, a medication composition sensor, a displacement sensor, a fluid flow sensor, or a combination of two or more of these or other fluid delivery sensors.

8. The disposable patient line according to claim 1 , wherein the monitoring means comprises a flow controller to control the fluid flow rate.

9. The disposable patient line according to claim 8, wherein the flow controller comprises a system controller and a valve.

10. The disposable patient line according to claim 9, wherein the system controller is operable to adjust opening and/or closure of the valve.

1 1 . The disposable patient line according to claims 9 or 10, wherein the system controller is operable to maintain a record (18) of total infusion history of the patient.

12. The disposable patient line according to any one of claims 1 to 1 1 , wherein the monitoring means comprise an operator interface (13, 18) to operatively control the administration of said fluid through said second tubing, and into the patient.

13. The disposable patient line according to any one of claims 1 to 12, wherein the monitoring means (12) comprise patient identification means (15), such as a barcode, name tag, and the like.

14. The disposable patient line according to claim 1 , wherein the monitoring means (22) comprise a radiation detector.

15. The disposable patient line according to claim 14; wherein the radiation detector is a detector for measuring X-ray radiation.

16. The disposable patient line according to any one of claims 1 to 15 wherein the monitor means are housed in a single housing.

17. A disposable venous infusion set comprising a disposable patient line according to any one of claims 1 to 16.