HK1173987A - Fluid management system - Google Patents

Description

Fluid management system

Technical Field

The present invention relates generally to fluid management systems and methods for managing the entry of fluid from a multi-dose container into a patient. The FMS according to the present invention is adapted to automatically supply fluid for injection into a patient.

Background

In many medical environments, medical fluids are injected into a patient during diagnosis and treatment. One example is the injection of contrast media into a patient to improve imaging during diagnostic imaging, such as Computed Tomography (CT), angiography, Magnetic Resonance (MR), or ultrasound imaging with a power fluid injection system.

Various manual and automatic injection systems for performing the above procedures are known in the art. As in the systems disclosed in WO 2004/091688 a2 or WO 2007/033103 Al, the container for extraction of the injection fluid must be prepared for manual use, i.e. manually pierced and, after piercing, manually mounted in the withdrawn position.

A typical process of how contrast media is prepared, processed and managed from multi-dose containers is described below:

the multi-dose container with contrast media is preheated prior to use by a heater that is typically positioned near the diagnostic imaging instrument. The temperature of the heater was set to 37 degrees celsius, the normal human body temperature. The container with contrast media is then removed from the multi-dose container by a technician. The plastic safety cap is removed from the end of the multi-dose container to expose the rubber seal. A vented spike (ported spike) is connected to the contrast media injector and then manually driven into a rubber seal on the multi-dose container by a technician to feed the injector line. The nail must be replaced approximately every 6-8 hours for contamination reasons. The multi-dose container is then placed in a container holder suspended in a vertical orientation from an IV pole with the neck end of the container facing downwards. The above steps are then repeated for one salt container. The technician then draws the desired contrast media and saline from the multi-dose container into the syringe reservoir via the syringe user interface. The protective packaging is removed from the new patient connection tube with the cannula connection. The cap used to plug the connector of the syringe patient supply line is manually removed. The patient connection tube and the patient supply line are connected via a cannula connection. The syringe is then manually actuated by the technician to expel air from the tubes, which then pumps the salt and contrast media into the tank. The technician visually inspects the tubing to determine when to purge the lines and then stops the syringe pump. The packaging is then removed from the new cannula connector and the connector is attached to one end of the patient tube. The above described manual process is expensive and less efficient, and it is therefore an object of the present invention to achieve a higher degree of automation. The various medicament injection devices disclosed in WO 2008/076631 a2 show a somewhat higher degree of automation.

However, mere automation causes additional problems. For multi-dose containers, there is always the problem that containers used beyond the recommended time of use or that have previously ceased to be pierced are reused.

Accordingly, it is desirable to have a fluid management system that is safe and effective to use. In particular, it is desirable to have a system that accurately and precisely controls the fluid container and extracts the fluid. It is also important that the fluid source remains uncontaminated throughout the life of the container.

Furthermore, it would be desirable to have a fluid management system that is capable of using a variety of fluids, such as contrast media, saline, and irrigation fluids, and containers of various sizes.

Disclosure of Invention

In view of the foregoing, it is an object of the present invention to provide a Fluid Management System (FMS) that addresses the obstacles and deficiencies associated with conventional fluid injection practices.

An FMS according to the present invention is adapted to automatically supply fluid for injection into a patient. An FMS according to the present invention includes a Fluid Management Device (FMD), a fluid delivery system (FTS), and a syringe.

FMDs are used to store and manage fluids from multi-dose containers, but it is also possible to store and manage fluids from single-dose containers. The term "container" should be understood to also include at least a bottle, pouch, bag, box or capsule. The FTS connects the outlet of the container stored within the FMD to a syringe, which extracts fluid from the container and injects the fluid to a management device at the patient via the FTS. The injector includes at least one pump and is programmed to inject a predetermined amount of fluid at a predetermined flow rate.

The FMD includes: at least one rotating carousel having an axis of rotation in a vertical direction; at least two container holders attached to the carousel, the container holders being adapted to vertically position a container with its neck open end facing downwards; and a staple holder mounted below the carousel and oriented such that the staple holder axially aligns a staple connected thereto with an axis of a container loaded into the container holder and in a piercing position.

In one embodiment, the FMD comprises two rotating carousel. In another embodiment, the FMD further comprises one or more container holders, preferably two container holders, which are not attached to said carousel.

Preferably, each carousel is mounted within a separation chamber, and each container holder not attached to a carousel is also mounted within a separation chamber. In one embodiment, the FMD has a frame to which one or more cavities are mounted.

Preferably, the rotating carousel has a carousel drive shaft positioned at the axis of rotation.

A plate may be attached to the drive shaft, the container holder being mounted vertically to the plate.

In one embodiment, up to ten container holders may be attached to the carousel, preferably five container holders are attached to the carousel. All container holders attached to the same rotary carousel may be adapted to hold containers of the same size. Alternatively, some container holders may be adapted to hold containers of a different size than other container holders. Preferably, one container holder is adapted to hold a container of a smaller size than the other containers. Preferably, the container holders are equally spaced on a circle about the axis of rotation.

At least one chamber, preferably a chamber with a rotating carousel, may be temperature controlled.

Preferably, each cavity is accessible through a separately hinged lid or door. Such a lid or door may be transparent or include a window for visual inspection of the contents of each chamber.

The FMD may also include a carousel drive system for each rotating carousel having a motor and a mechanism for transmitting rotation from the motor axis to the shaft of the rotating carousel. Preferably, the FMD further comprises a mechanism to disconnect the shaft of said carousel from said motor axis when the cover or door of the chamber housing said carousel is being opened.

Each staple holder may be movably mounted to a linear slide, allowing the staple holder to slide in a vertical direction. The FMD may also include an automated piercing system for each staple holder having a motor and a mechanism for moving the staple holder mounted within the linear slide.

The FMD may also include a Central Electronic Control System (CECS) to control the carousel drive system and the automated piercing system. Further, the CECS may be in communication with and adapted to monitor/control:

a. signal output means, such as a display screen;

b. a user input device, such as a touch screen or a keyboard;

c. the temperature is controlled by the temperature in the chamber;

d. a fluid level sensor;

e. a position control sensor for the nail;

f. a position control sensor for rotating the transfer plate;

g. valves in FTS tubing;

h. a bi-directional data transfer system for communicating with the CM injector and/or a computer network;

i. a one-way data transfer system, such as a reader for reading data from a data storage device on a container or Fluid Transfer System (FTS);

j. a data storage device.

A fluid delivery system comprising: a first transfer tube having at least two first ends, each first end connected to a staple, and at least two second ends, each second end corresponding to a first end; a manifold having at least two input openings and one output opening, a second end of the transfer tube being connected to the input opening of the manifold; a second transfer tube connected by its first end to the output opening of the manifold; and a valve mounted between each first and second end of the first transfer tubing. By means of which the fluid can be selectively drawn from one of the pierced containers.

The second end of the second transfer tubing may be adapted to connect to a syringe.

The fluid delivery system may further comprise a data storage mechanism for storing a unique identifier of the fluid delivery system. Upon reading the unique identifier, the CECS is able to record the use of a particular fluid delivery system and alert the user, via an information output device, whether the maximum use time for the spike has been reached.

The bottom of the staple includes a seating and attachment mechanism for connecting the staple to a corresponding seating and attachment mechanism at a staple holder of the FMD. The top of the spike is adapted to enter into the container septum. To allow easy extraction of fluid through the spike, a vented spike is preferably used. The staples are covered by a sheath prior to use to avoid contamination.

The invention also relates to a method for automatically supplying a fluid for injection into a patient, comprising the steps of:

providing a flow management device adapted to receive in a vertical position at least one container with a fluid, the neck open end of the container facing downwards, and having a spike holder mounted and oriented such that it aligns a spike connected thereto axially with the axis of the container loaded in the container holder and in a piercing position;

providing a fluid transfer system having a transfer tubing having a first end connected to the spike and a second end adapted to be connected to a syringe;

loading at least one container into the fluid management device, the open neck end of the container facing downwards, said open neck end being covered by a septum;

attaching the spike to the spike holder and the second end of the transfer tubing to the syringe;

moving a nail into the septum;

extracting fluid from the container.

The method further comprises the steps of: the spike is withdrawn from the septum of the container. Withdrawal of the spike from the septum may occur in response to a signal triggered by the container being empty or having reached a maximum use time for the container or having reached a maximum use time for the spike. This maximum usage time is recorded by a timer connected to the Central Electronic Control System (CECS) of the fluid management device. The fluid level/volume of the pierced container can be monitored by the CECS via a respective fluid level/volume sensor.

In another embodiment, at least two containers are loaded into the fluid management device. The fluid management device also has a mechanism to subsequently position each container in axial alignment with the staple holder. The method further comprises the steps of: moving the second container to a position in which it is axially aligned with the staple holder; moving the spike into the septum of the second container; and extracting the fluid from the second container.

Drawings

The features of the described embodiments are set forth with particularity in the appended claims. However, embodiments relating to both structure and method of operation are best understood by referring to the following description and accompanying drawings in which like parts are designated by like reference numerals.

FIG. 1 is a first perspective view of a fluid management device;

FIG. 2 is a second perspective view of the fluid management device;

FIG. 3 is a front view of the interior of the fluid management device;

FIG. 4 is a perspective view of the interior of the fluid management device;

FIG. 5 is a perspective view of the nail;

FIG. 6 is a perspective view of a staple having a sheath;

FIG. 7 is a perspective view of a staple holder;

FIG. 8 is a top view of the staple holder;

FIG. 9 is a perspective view of a pierced container and piercing system;

FIG. 10 is a first view of a pierced container and piercing system;

FIG. 11 is a first top view of the fluid management device;

FIG. 12 is a second top view of the fluid management device;

FIG. 13 is a perspective view of the rotating carousel;

FIG. 14 is a perspective view of the rotating carousel with the containers attached;

FIG. 15 is a first perspective view of a second embodiment of a fluid management device; and

fig. 16 is a second perspective view of a second embodiment of a fluid management device.

Detailed Description

First exemplary embodiment of a fluid management device

An FMS according to the first exemplary embodiment described herein is adapted to automatically supply preheated Contrast Media (CM) and unheated salt to a CM injector for injection into a patient from a CM-filled container (CM container) or a salt-filled container (salt container).

According to this embodiment, the Fluid Management Device (FMD) 100 shown in fig. 1 to 4 comprises four separate chambers 20a, 20b, 21a, 21 b. The cavities 20a, 20b are temperature controlled and are assigned to accommodate CM containers 22. The cavities 20a and 20b are positioned above each other in a vertical direction and are mounted to the rack frame 14. The chambers 21a, 21b are non-temperature controlled and are assigned to accommodate salt containers. The chambers 21a, 21b are also mounted on top of each other in the vertical direction and attached to the rack frame 14 adjacent to the two temperature-controlled chambers 20a, 20 b. The FMD 100 is encased in a plastic molding to protect the internal components from the atmosphere. Access to each chamber 20a, 20b, 21a, 21b is provided by individual hinged doors 24a, 24b, 25a, 25b having transparent viewing windows for visual inspection of the contents of each chamber.

A Central Electronic Control System (CECS) (not shown) is positioned in the middle section of the FMD 100 between the two vertically mounted temperature-controlled chambers 20a, 20b and attached to the chassis frame 14.

A rotating carousel, shown in detail in fig. 13 and 14, is secured to each temperature-controlled chamber 20a, 20b, with the carousel drive shaft 27 positioned vertically. The carousel drive shaft 27 is axially mounted to bearings which are fixedly mounted to the frame 14. The carousel drive system is mounted and positioned to enable rotation of the rotating carousel by means of a Central Electronic Control System (CECS). The carousel drive system comprises a motor, a reduction gearbox and supplementary running gears (spur, belt, etc.), the main 2, motor 3 and idler 4 of which can be seen best in figures 4, 11 and 12.

A container holder (shown in detail in fig. 13 and 14) for each of the five CM containers 22 is located within each temperature-controlled chamber 20a, 20b to position, orient and secure the CM containers so that they can be properly axially aligned with the spike holder 10 of the automated piercing system. Each CM container holder is equidistantly spaced from an adjacent CM container holder on a circle around the carousel drive shaft 27 and is vertically mounted to a plate 7, which plate 7 is attached to the carousel drive shaft 27. Each container holder comprises two clips 28 and a cable container rack 8. A container holder is located within each non-temperature controlled chamber 21a, 21b in order to position, orient and secure the salt container 23 so that it can be properly axially aligned with the spike holder 10 of the automated piercing system (see, e.g., fig. 4). The container holder is mounted vertically to a plate 18, the plate 18 being attached to the rack frame 14. Each container holder comprises two clips 28 and a cable (wire) container rack 8.

The automatic piercing system as shown in more detail in fig. 9 and 10 comprises: a nail holder 10, a linear slide 9 for the nail holder 10; and a staple driving system 12 including a motor, a reduction gearbox, and a lead screw. The linear slides 9 of the strip nail holder 10 are mounted vertically to the frame 14 and are located under each of the four cavities 20a, 20b and 21a, 21 b. The automatic piercing system is positioned and oriented such that the staple holder 10 is adapted to axially align the staples 11 with the axis of the containers 22, 23 to be pierced.

A bail 31 is mounted to the frame 14 to enable the FMD 100 to be mounted to the top attachment arm 1.

The fluid delivery system (FTS) as shown in fig. 1 and 4 comprises a spike 11 for each chamber, said spike being adapted to be slotted in a spike holder 10 below the chamber. The nail 11 as shown in figures 5 and 6 has a bottom 41 and a top 42. The nail 11 is an open nail. The base 41 has two guide grooves 45 on opposite sides adapted to be retained to respective slide rails 55 (see fig. 7 and 8) of the staple holder 10. The hole 44 in the bottom is adapted to receive the pin 54 of the staple holder 10 when the staple 11 is slotted into the staple holder 10. The nail 11 is preferably provided with a sheath 43 to avoid contamination prior to use. The FTS also comprises tubing 15, 16 connected to each spike 11 and adapted to transfer fluid from the pierced container to the CM syringe (see fig. 1 and 4). The Y-connector 17 is installed between the tube 15 of the nail 11 of the top temperature-controlled chamber 20a and the tube 16 of the nail 11 of the bottom temperature-controlled chamber 20 b. The Y-connector 17 is installed between the tube 15 of the nail 11 of the top non-temperature controlled chamber 21a and the tube 16 of the nail 11 of the bottom non-temperature controlled chamber 21 b. Tubing 18 connects the output end of the Y-connector 17 to the connector plug of the CM injector. A valve (not shown) is mounted between each spike 11 and the Y-connector 17 to control the flow of fluid from the respective pierced container to the Y-connector. With this valve, fluid can be selectively extracted by the CM syringe from a pierced top or bottom container filled with CM or salt.

FMS-functional description

Central electronic control system

A Central Electronic Control System (CECS) with proprietary software is used to communicate with the sensors and control units of the FMD, as further explained below. The CECS may also be connected to a user device interface to output information to the user or to receive input from the user. In particular, the CECS is adapted to communicate with and subsequently drive a rotating carousel and full chamber automated piercing system. The CECS may also allow data storage, unidirectional transfer of data between authorized containers and data storage facilities on authorized FTS, and bidirectional transfer of data with authorized CM injectors.

Preheating and temperature control

Preheating the CM vessel within each temperature-controlled chamber of the FMD to approximately 37 degrees celsius is accomplished by means of forced convection and an internal temperature control system, i.e., the ambient temperature of each temperature-controlled chamber is autonomously controlled. This feature eliminates the need for the user to heat the CM container prior to injecting the CM into the patient. In a preferred embodiment, the temperature control mechanism is adapted to be automatically switched on at the beginning of the day before the treatment for an accelerated start-up.

Storage of CM and salt fluids

Storing up to five CM containers in each temperature controlled chamber allows the FMD to service up to about 1 entire day of treatment to the patient. The CM container (as well as the salt container) may be of various sizes. The container holder is adapted to the size of the container to be used therewith. Preferably, four CM containers filled with 500ml CM and one container filled with 100ml CM are installed in each temperature-controlled chamber. The proximity of the smaller size of the CM container reduces unnecessary waste of CM fluid at the end of the work day or between pauses in treatment that are longer than the recommended usage time for the CM container. After piercing the CM container, the CM fluid stored therein has a limited useful life, which results in a recommended use time of typically about 10 hours for the established CM. Thus, if a new 500ml CM container is used for the last treatment of a day, the remaining fluid must be discarded before the next morning. The ability to more effectively control the waste of CM fluid is facilitated. Storing salt containers filled with 500ml of salt in each non-temperature controlled chamber allows up to one day to treat about half of the supply.

The storage of multiple containers filled with CM or saline eliminates the need for the user to constantly replenish the CM syringe with fluid supply throughout the day.

Automatic piercing of container septum

In order for the FMD to supply CM and saline fluid to the CM syringe, the spike 11 of the FTS is inserted into the septum of the respective container. To do this, the user must fit the FTS nail 11 to the nail holder 10 on the FMD 100 by means of the seating and attachment features (guide groove 45, slide rail 55, pin 54 and hole 44). The spike holder 10 is designed such that a good axial alignment of the spike 11 with respect to the container septum can be achieved. Once the FMS is started, the container is replenished in the chamber and the temperature is determined by the temperature of the control chamber, the Central Electronic Control System (CECS) communicating with the automatic piercing system 12 to drive the staple holder 10 with the staple 11 vertically upwards, so that the staple enters the relevant chamber through the entry point and reaches the container septum. As this occurs, the silicone rubber crimp sheath 43 is crushed to allow the spike tip 42 to fully enter the container septum. In the case of a position control sensor, the CECS drives the spike 11 a prescribed distance into the container septum. Once the prescribed distance is reached, the CECS deactivates the automatic piercing system 12 to maintain the staple holder 10 in a set vertical position relative to the container septum.

The fluid level or volume within each pierced container is monitored by means of a sensor having feedback to the CECS. Once the container is emptied to a specified height, referred to as "empty", the CECS communicates with the automated piercing system 12 to drive the staple holder 10 vertically downward, thereby releasing the piercing of the associated container. This position of the container holder 8 is then marked "empty" by the CECS. By recording the empty/full status of the container, the CECS is able to send a signal to the user via the user device interface, for example, when the last container in the CM cavity is being punctured or when all containers in the cavity are empty.

The FMD also incorporates a button that allows the user to override the automatic piercing feature in order to prevent the system from piercing another container. In addition, the button also has the function of allowing the user to manually select a small CM container for ending the one day treatment in order to minimize CM fluid waste.

Automatic rotation of a rotating carousel with free-wheeling option

Automatic rotation of the rotating carousel within each temperature-controlled chamber is used to index a new CM container so that it can be accessed and punctured. The CECS is used to drive a geared motor, which in turn rotates (indexes) the rotating carousel to a desired position. The angular position of the rotating carousel is monitored by means of a position sensor and the CECS. Thus, at any given time, the CECS identifies the location of each CM container. It is thus possible to determine how much the rotating carousel should rotate through in order to puncture a particular CM container.

In the event that the user opens the door of the temperature-controlled chamber, the sensor triggers feedback to the CECS. The CECS then turns off (mechanically, electrically, electronically, or otherwise) the carousel drive system so that the rotating carousel can no longer spin automatically. This then allows the user to "spin around" the rotating carousel, thereby providing the user with a means to easily rotate the rotating carousel to access each individual CM container in the fastest manner possible.

In one embodiment as shown in fig. 11, 12 and 13, the rotation of the motor is transmitted to the main gear 2 via the motor gear 2 and the idler gear 4. The idler pulley 4 is mounted to a first end of a pivoted attachment 61, the second end of which is movably connected to an idler pin 6. Idler pin 6 is attached to the door of the temperature controlled chamber. After opening the temperature controlled chamber door as shown in fig. 12, the idler pin 6 moves with the door and rotates the attachment 61 so that the idler gear 4 disengages from the motor gear 3 and the main gear 2.

Container and FTS identification

Containers suitable for use with FMDs (referred to as authorized containers) have RFID tags (or other data storage mechanisms) attached thereto. This allows the CECS to identify when and where to replenish the container by interrogation with an RFID reader (or a reader corresponding to other data storage mechanisms) connected to the CECS. This also allows the CECS to determine whether an unauthorized container is disposed in one of the container holders by interrogating the RFID tag. If no RFID tag is present on the container, the CECS will recognize the situation by attempting to interrogate the container as no communication will be effected. If this is the case, the CECS will give visual and/or audible error feedback to the user and then lock the associated container position from use so that the container cannot be pierced. This is an important safety feature to ensure that only the correct fluid and authorized container are stored within the FMD for supply to the CM syringe.

Similarly, an RFID tag is also attached to each FTS. The CECS can then interrogate each FTS present to ensure that the FTS is authorized for use.

In addition, once the FTS spike is pierced into the container septum, the CECS records the FTS being used and begins a countdown of the specified time, which is the recommended time of use for the spike. After the recommended use time for the nail (i.e., 24 hours) has elapsed, the CECS then issues an error feedback via visual or audible means to alert the user that the FTS must be replaced before the FMS can be used further.

Fluid data

The data (e.g., date of manufacture, fluid formulation, etc.) stored on the RFID tag of each container can be interrogated and stored by means of an RFID reader and the CECS. This data can then be transferred to the CM injector or stored on a removable storage mechanism (i.e., USB stick). This feature improves trackability.

Locking timer

Once a CM container is spiked, a countdown timer is actuated via the CECS and the corresponding CM container is recorded by the CECS as being spiked. After the recommended use time for the CM container has elapsed, and assuming the respective CM container has not been defined as "empty," the CECS locks the respective CM and communicates with the automatic piercing system to stop piercing the CM container. When the unique code stored on the RFID tag of the CM container is recorded in the CECS as used and/or a defined useful life has elapsed when punctured, then the user is prevented from reusing the CM container in either of the temperature-controlled chambers and from refilling the CM container at a later date.

User device interface

In one embodiment, information related to the CM injector (remaining fluid source height/volume, temperature) is displayed on the main user interface screen of the CM injector. This is accomplished by direct data transfer between the FMD and the CM injector. The information for each temperature controlled chamber (e.g., temperature, which container is empty/has been subjected to a recommended usage time, etc.) is intended to be displayed via LEDs or a display screen on the FMD. This feature allows the user to directly monitor the fluid level within the FMD relative to the associated chamber. A viewing window is also positioned on each chamber door as a second mechanism for the user to visually check the fluid level and which containers need replenishment. The chamber door allows the user access to replenish the fluid source as long as the container in the chamber is not pierced at this time. Once the door on the temperature-controlled chamber is opened, the carousel drive system is disconnected to prevent the rotating carousel from being automatically driven while the user is replenishing the fluid source. The disconnection of the carousel drive system also allows the carousel to spin freely so that the user can easily rotate the carousel to access each individual container in the fastest manner. After closing the door of the temperature controlled chamber, the carousel drive system is reengaged to automatically drive the rotating carousel for use.

Data transfer

The two-way communication between the FMS and the CM injector is achieved by means of a proprietary software communication platform. This enables the user to directly control and observe several functions of the FMD from the CM injector interface. Data transfer between the FMD and CM injectors may be accomplished by several means of transfer including, but not limited to, the following:

wired cable-USB, LAN or other mode-bluetooth-wireless network.

Diaphragm spill protection

A manually removable drip tray 13 is positioned below the rotating transfer tray and above the automatic piercing system of each temperature controlled chamber so that any CM fluid spillage from the previously pierced CM container septum is trapped within the area of the machine.

In the embodiment of the FMS described in this example, the CECS may identify the location of each container within the FMD, how long the containers were seated within the FMD, whether the containers were previously pierced, and whether the fluid in a particular container has passed its useful life. In theory, this eliminates safety issues such as the user re-piercing a used container or a container whose useful life has elapsed.

Second exemplary embodiment of a fluid management System

An FMS according to a second exemplary embodiment described herein is adapted to automatically supply preheated Contrast Media (CM) and preheated salt to a CM injector for injection into a patient from a CM-filled container (CM container) or a salt-filled container (salt container).

In fig. 15 and 16, a second embodiment of the FMD is shown. The FMD 200 of this embodiment includes two cavities 201 and 202 attached to the chassis frame. Both chambers 201, 202 are temperature controlled. Each cavity 201, 202 houses a rotating carousel 205, 206. Five container holders are mounted to each carousel 205, 206 for holding up to five CM containers 22 and up to five salt containers 23. Each chamber 201, 202 has a lid 203, 204 and is adapted to be loaded from the top. Between the two chambers 201, 202, a housing 215 for the CECS is mounted to the chassis frame, along with a display screen 217 and printer 220.

A vertically movable staple holder 210 is mounted vertically to the frame and is located below each of the two cavities 201 and 202. The automatic piercing system is positioned and oriented such that each staple holder 210 is adapted to axially align a staple 211 with the axis of a container 22, 23 to be pierced. Tubing 218 connected to each spike 211 is adapted to transfer fluid from the pierced container to the CM syringe.

The functional description of the first exemplary embodiment of the invention described above applies mutatis mutandis to this second exemplary embodiment of the invention.

Abbreviations and reference numerals

FMS fluid management system

FMD, 100 fluid management device, 100

FTS fluid delivery system

CM contrast medium

CECS central electronic control system

1 Top arm attachment

31 handle

5 Heater for temperature controlled Chamber

14 frame

2 main gear

3 Motor gear

4 idler pulley

6 Idle wheel Pin

20a, b temperature controlled chamber

21a, b non-temperature controlled chamber

22 CM container

23 salt container

24a, b temperature controlled chamber door

25a, b doors not having temperature-controlled chambers

26 window

27 transfer disc drive shaft

7 board (conveying plate)

18 board (salt holder)

8 cable container rack

28 clip

13 drip plate

15 to Top Cavity nail pipe

16 to lower cavity nail

17Y-type connector

18 to CM Syringe tubing

9 Linear slide block

10 nail holder

11 nail

12 automatic piercing system

43 sheath of nail

41 bottom part

42 top of the container

44 holes

45 guide groove

54 pin

55 sliding guide rail

200 FMD second embodiment

201 first temperature controlled chamber

202 second temperature controlled chamber

203 cover for a first temperature controlled chamber

204 cover for a second temperature-controlled chamber

205, 206 rotating carousel

210 nail holder

211 nail

215 housing for a CECS

217 display screen

220 Printer

Claims (25)

1. A fluid management device (100) for automatically supplying a fluid for injection into a patient, the fluid management device comprising:

at least one rotating carousel having an axis of rotation in a vertical direction;

at least two container holders attached to the carousel and adapted to vertically position containers (22, 23) having a neck open end facing downwards; and

a staple holder (10) mounted below the carousel and oriented such that the staple holder (10) axially aligns a staple (11) with the axis of a container (22, 23) loaded into the container holder and in a piercing position.

2. The fluid management device (100) of claim 1, comprising two rotating carousel.

3. The fluid management device (100) according to claim 1 or 2, further comprising one or more container holders, preferably two container holders, which are not attached to the carousel.

4. The fluid management device (100) of claim 1 comprising two carousel disks and two container holders that are not attached to the carousel disks.

5. The fluid management device (100) according to one of claims 1 to 4, wherein up to ten container holders, preferably five container holders, are attached to the carousel.

6. The fluid management device (100) of one of claims 1 to 5, wherein all container holders attached to the carousel are adapted to hold containers (22, 23) of the same size, or alternatively some container holders are adapted to hold containers (22, 23) of a different size than others.

7. The fluid management device (100) of claim 6, wherein one container holder is adapted to hold a container (22, 23) of a smaller size than the other containers (22, 23).

8. The fluid management device (100) of one of claims 1 to 7, wherein each rotating carousel is mounted into a separate chamber (20 a, 20 b).

9. The fluid management device (100) of claim 3 or 4, wherein each container holder not attached to the carousel is mounted into a separate cavity (21 a, 21 b).

10. The fluid management device (100) of claim 8 or 9, wherein all chambers (20 a, 20b, 21a, 21 b) are mounted to a chassis frame (14).

11. The fluid management device (100) according to one of claims 8 to 10, wherein at least some of the cavities (20 a, 20b, 21a, 21 b) are temperature controlled.

12. The fluid management device (100) of one of claims 8 to 11, wherein each chamber (20 a, 20b, 21a, 21 b) is accessible through a separately hinged lid or door (24 a, 24b, 25a, 25 b).

13. The fluid management device (100) of one of claims 1 to 12, wherein the staple holder (10) is movably mounted to a linear slide (9) allowing the staple holder (10) to slide in a vertical direction.

14. The fluid management device (100) of claim 13 further comprising a central electronic control system adapted to control the rotation of the carousel and the movement of the staple holder (10).

15. A fluid transfer system, the fluid transfer system comprising:

a first transfer tube (15, 16) having at least two first ends, each connected to a nail (11), and at least two second ends, each corresponding to a first end;

a manifold (17) having at least two input openings and one output opening, the second ends of the transfer tubes (15, 16) being connected to the input openings of the manifold (17);

a second conveying duct (18) connected by a first end thereof to the output opening of the manifold (17); and

a valve mounted between each first and second end of the first transfer duct (15, 16).

16. The fluid transfer system of claim 15, wherein the second end of the second transfer tubing (18) is adapted to be connected to a syringe.

17. The fluid transfer system of claim 15 or 16, wherein the spike (10) is an open spike.

18. The fluid delivery system of one of claims 15 to 17, wherein the spike (10) is covered by a sheath (43).

19. The fluid delivery system of any one of claims 15 to 18, wherein said fluid delivery system further comprises a data storage mechanism for storing a unique identifier of said fluid delivery system.

20. A fluid management system for automatically supplying a fluid for injection into a patient, the fluid management system comprising a fluid management device (100) according to claims 1 to 14, a fluid delivery system according to claims 15 to 19, and a fluid injector.

21. A method for automatically supplying a fluid for injection into a patient, the method comprising the steps of:

-providing a fluid management device (100) adapted to receive in a vertical position at least one container (22, 23) with a neck open end facing downwards with a fluid, and having a spike holder (10) mounted and oriented such that the spike holder (10) aligns axially a spike (11) connected thereto with the axis of a container loaded in the container holder and in a piercing position;

-providing a fluid transfer system having a transfer tube (15, 16, 18) having a first end connected to the spike (11) and a second end adapted to be connected to a syringe;

-loading at least one container (22, 23) with a neck open end facing downwards into the fluid management device (100), the neck open end being covered by a septum;

-attaching the spike (11) to the spike holder (10) and the second end of the transfer tubing (15, 16, 18) to a syringe;

-moving the spike (11) into the septum;

-extracting fluid from the container (22, 23).

22. The method of claim 21, further comprising the step of: withdrawing the spike (11) from the septum of the container (22, 23).

23. Method according to claim 22, the withdrawal of the spike (11) from the septum occurring in response to a signal triggered by the pierced container (22, 23) being empty or having reached a maximum time of use of the container (22, 23) or having reached a maximum time of use of the spike (11).

24. The method according to one of claims 21 to 23, wherein at least two containers (22, 23) are loaded into the fluid management device (100).

25. The method of claim 24, wherein the fluid management device (100) further comprises a mechanism to subsequently position each container (22) in axial alignment with the staple holder (10), and further comprising the steps of:

-moving the second container (22) to a position in which it is axially aligned with the staple holder (20);

-moving the spike (11) into the septum of the second container (22); and

-extracting fluid from the second container (22).