ES2536834T3 - Improved procedure for automatic filling of medical fluid - Google Patents

Abstract

A method for filling at least one interconnectable receptacle with a medical liquid, comprising: establishing a physical interconnection between a disposable element (10) and an automatic actuation system (30), wherein said disposable element includes a member (12 ) tubular, a piston (14) slidably disposed in the tubular member for retraction and advance thereof within a first portion of said tubular member, and a valve (20); wherein said automatic actuation system includes a piston actuating member (32) and a valve actuating member (34) that can selectively interconnect with and disconnect from said piston and said valve, respectively; and wherein said setting step includes interconnecting said piston and said valve with said piston drive member and said valve drive member, respectively; using said piston drive member of said automatic drive system to retract said piston inside a first portion of said tubular member of said disposable element and thereby extract a predetermined volume of a medical liquid into said tubular member; employing said piston drive member of said automatic drive system to cause said piston to advance inside said first portion of said tubular member of said disposable element and, thus, dose at least a portion of said predetermined volume of medical liquid from the tubular member to at least one interconnectable receptacle; using said valve actuation member of said automatic actuation system to automatically and alternately place said valve of said disposable element in a first valve position and in a second valve position, wherein said first valve position is maintained during said use stage, and said second valve position is maintained during said use stage; and, sealing said first portion of said tubular member during said stages of use and use.

Description

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DESCRIPTION

Improved procedure for automatic filling of medical fluid

Related Requests

The present application claims the priority of the provisional US patent application. UU. with Serial No. 5 60 / 742,114, filed on December 2, 2005, entitled "Improved Automated Liquid Filling System and Method", and all disclosure of which is incorporated by reference in its entirety herein.

Field of the Invention

The present invention relates to systems, apparatus and procedures for the automatic filling of medical liquids. More particularly, the embodiments of the present invention relate to systems, apparatus and

10 procedures for the automatic filling of medical liquids using a disposable syringe type apparatus that can be interconnected with an actuation system, a source of medical liquid and a plurality of receptacles. The system, apparatus and procedures may be employed to cause medical liquids to flow to a plurality of receptacles to provide, for example, liquid medication in a desired volume.

Background of the invention

15 The provision of medical fluids in a sterile and accurate manner is, in many cases, desirable. For example, in the production of liquid medications, sterile and precise amounts of medical fluid may be required. An apparatus employable to provide such medical liquids is a peristaltic pump. Peristaltic pumps work to deliver medical fluids by turning a bushing connected with spring-mounted jaws against a flexible tubing line. As the jaws rotate relative to the flexible tube, the

The tube is compressed to occlude a section with respect to another section and to push fluids through the flexible tube. The jaws can be separated from each other by a predetermined distance, which, in relation to a known internal diameter of the flexible tube, enables the displacement and dosing of a calculable amount of fluid.

Although peristaltic pumps can be operated to deliver medical fluids, the pumps

25 peristaltics suffer from the fact that the flexible tube can move and / or twist during operation, the flexible tube can be deformed over time by repeated compression and expansion, a variable inlet and outlet pressure can be experienced, a pulsatile flow can take place with an unwanted flow inversion, and / or the spring forces associated with the jaws can degrade over time. Such factors may, as a result, result in the dosing of an inaccurate volume of medical liquids. In that sense, the

30 systems employing such peristaltic pumps typically require calibration at the beginning of each medical liquid filling procedure. For example, healthcare personnel typically use a peristaltic pump system to fill a first receptacle with a quantity of medical fluid that corresponds to a known degree of pump movement. After filling, such personnel can generally compare such filling amount with a desired filling amount, and can often adjust the peristaltic pump to

35 calibrate the system. Therefore, time and / or materials may be consumed in the calibration of a peristaltic pump. The deformation of the tube can also lead to filtration around the jaws, thereby leading to a transverse flow between the various sections of the tube.

Peristaltic pumps are also limited by the speed of intake rotation. As the peristaltic pump bushing is rotated, a pressure difference is created at both the inlet and the outlet of the pump. 40 These inlet and outlet pressures are generally linked to each other because the bushing's rotation speed is related to both inlet and outlet pressures. As can be seen, the actionable inlet pressure may be limited by the vapor pressure of the liquid being dosed. If the inlet pressure is too high in relation to the vapor pressure of the liquid, a portion of the liquid may evaporate after admission, which is undesirable for many reasons (for example, the dosage of

45 some volumes of liquid not very precise). Correspondingly, the outlet pressure, and thus the dosing rate, is limited by the actionable inlet pressure, which may be substantially less than the actionable outlet pressure, which may not be limited by the vapor pressure of the liquid. Therefore, the maximum speed of fluid flow rate may be substantially less than desired due to the inherent linkage of the inlet pressure with the outlet pressure in the peristaltic pump.

50 Summary of the invention

In view of the foregoing, an objective of the embodiments of the present invention may be to facilitate accurate and repeatable dosing of medical liquids (eg, liquid medications, medical grade solvents, such as pharmaceutical grade water, etc.). A related objective may be to facilitate accurate and repeatable dosing of several free medical fluids of a nominal or significant calibration.

Another objective of the embodiments of the present invention may be to facilitate an optimal flow rate of medical fluid.

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Still another objective of the embodiments of the present invention may be to facilitate automatic or semi-automatic dosing of medical liquids.

Another objective of the embodiments of the present invention may be to facilitate multiple applications of filling of medical liquid with a single apparatus and / or system.

5 Yet another objective of the embodiments of the present invention may be to facilitate the dosing of free medical fluids and / or calibration in relation to the type of medical liquid.

One or more of the above objectives and the additional advantages can be achieved by a medical liquid filling system of the invention comprising a disposable element for use in the automatic filling of at least one receptacle with a medical liquid, a system automatic drive for your

10 use in the automatic filling of at least one receptacle with a medical liquid, a system comprising both a disposable element and an automatic actuation system, and procedures for filling at least one receptacle with a medical liquid (for example , using a disposable element of the invention, an automatic actuation system and / or a combinatorial system).

In the system of the invention, a disposable syringe type element comprising a member is included

15 tubular and a piston slidably disposed in the tubular member for retraction and advance within at least a first portion of the tubular member. The disposable element further includes a sealing member for sealing a distal end of the first portion of the tubular member. The system also includes an automatic drive system comprising a piston drive member that can selectively interconnect with the piston of the disposable element for automatic retraction and advancement.

20 (for example, actuated) inside the tubular member. It should be noted that the use of a disposable element comprising a tubular member and a piston slidably arranged between them facilitates the precise flow of a predetermined amount of medical liquid into and out of the tubular member of the disposable element during use. of the system of the invention. In this regard, the tubular member is preferably of rigid construction, thereby enhancing the accuracy and repeatability of the volumes of

25 extraction / dosing of medical liquid during use. In addition, the tubular member is preferably cylindrical, thereby housing the advance / retraction of the piston and the piston actuating member along a linear path in order to further enhance a precise and repeatable behavior.

In one aspect, the sealing member of the disposable element is interconnected with the piston of the disposable element for its joint movement therewith and a sliding coupling inside a second

30 portion of the tubular member, in which the second portion is located distally with respect to the first portion of the tubular member. In this regard, the sealing member may be separated from the piston a fixed distance that is at least as large as the length of the first portion of the tubular member. In one embodiment, the sealing member is separated from the piston a fixed distance that is larger than the length of the first portion of the tubular member.

In another aspect, the piston of the disposable element may comprise a resilient member (eg, ring-shaped and peripherally arranged), in which, when the piston is in a first position inside the first portion of the tubular member, the resilient member engages in a sealable manner with the tubular member. In addition, the tubular member can be provided with a plurality of portions of different dimensions (for example, cylindrical portions having different diameters) such that the piston can

40 being in a second position inside a different portion of the first portion, in which the resilient member extends when the piston is in the second position in relation to the moment when the piston is in the first position. For example, the tubular member may be provided such that, when the position is in a first position, the resilient member is compressively coupled with the first portion of the tubular member, and such that, when the piston is in the second

In this position, the resilient member is less compressed or free of a compression coupling (for example, inside a second portion of the tubular member). As will be described further, the piston can be in the second position before use (for example, during transport and storage) and then moved to the first position for filling operations, thereby maintaining the integrity of the Resilient member before use.

In a further aspect, the disposable element may include a first connection member interconnected with the sealing member, and the piston drive member may include a second connection member, in which the first and second connection members may interconnect and disconnect selectively. More particularly, the first and second connecting members can be provided such that they are interconnected in a limited way when they are located together inside the tubular member

55 (for example, inside a second portion thereof). By way of example, the first and second connection members can be provided such that, when the piston is in a second position as indicated above, the first and second connection members can be easily disconnected. In turn, when the piston is made to advance in such a way that it is in the first position indicated above, the first and second connecting members interconnect in a limited way in such a way.

60 so that the subsequent advance / retraction of the piston drive member affects the predetermined joint movement of the piston of the disposable element.

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In one embodiment, the first and second connecting members may comprise complementary male and female members. For example, the female connecting member may include a plurality of fingers that defines an opening therebetween to receive a complementary male connecting member when the fingers

5 female connections are placed, at least in part, distally on the outside of the tubular member. In turn, as the male connecting member is received inside the opening of the female connecting member and the female connecting member is driven into the distal end of the tubular member (for example, by the actuating member piston) the fingers of the female connection member may wrap at least a portion of the male connection member (eg, a bulbous end portion).

10 As can be seen, such an interconnection arrangement interacts conveniently with the preferred forward / retract linear path indicated above of the piston drive member and the piston.

In a further aspect, the disposable element may also include a valve that is fluidly interconnected with a proximal end orifice of the tubular member. The valve can be provided with a plurality of 15 holes, in which, in a first valve position, a first valve hole is fluidly interconnected with the tubular member, and in which case, in a second valve position , a second valve orifice is fluidly interconnected with the tubular member (for example, through a proximal end orifice). By way of example, a source of medical liquid may be fluidly interconnected with the first valve portion in which a medical liquid may be drawn into the tubular member when the

The valve is located in the first valve position, and one or more receptacles can be fluidly interconnected with the second valve orifice, in which case at least a portion of the medical liquid extracted into the tubular member can be dosed from the tubular member to the receptacles when the valve is in the second valve position.

The automatic drive system may further include a valve drive member that can

25 selectively interconnect with the valve for an automatic alternative placement (for example, actuated) of the valve between the first and second valve positions. In one embodiment, the valve may include a valve housing and a valve stem slidably disposed inside the valve housing (for example, for a linear and / or rotating movement between them). For interconnection purposes, the valve actuating member may include one of a projection or projections and an opening or openings

30 complementary (for example, to receive the projection or projections) and the valve stem may include the other of the projection or projections and the complementary opening or openings.

The valve stem may include at least some first and second channels, in which the first channel fluidly interconnects the first valve orifice and the tubular member when the valve is in the first valve position, and case in the that the second channel fluidly interconnects the second hole of

35 valve and the tubular member when the valve is in the second valve position. By way of example, the first and second channels may comprise separate precise paths arranged, (for example, displaced), around a perimeter of the valve stem (for example, in which the valve stem can be rotated to control the flow of medical liquid inside / outside the disposable element).

In a further aspect, the automatic drive system may also include at least one motor of

Drive that is interconnected with the piston drive member, a reference member, and a sensor to detect at least a relative degree of motion (eg, a predetermined amount of relative linear motion) between the piston drive member and the reference member and to provide an output signal in corresponding relation thereto. In addition, the drive system may include a controller to receive the output signal from the sensor and to provide a signal from

45 drive motor control. By way of example, the drive system can be provided in such a way that upon detection of a predetermined degree of relative motion corresponding to a desired amount of medical liquid to be dosed into a receptacle, the controller can terminate the operation of the drive motor In addition, in response to the sensor output signal, the controller may be operative to provide a control signal in order to change the valve mentioned.

50 previously from one of the first and second valve positions to the other of the first and second valve positions (for example, in order to facilitate alternate automatic extraction and dosing operations).

In yet another aspect, the drive motor of the automatic drive system can be controlled to automatically provide a predetermined maximum force to the piston drive member in order to produce an internal pressure inside the disposable element that is less than a magnitude

55 desired default. By way of example, the drive system and / or disposable element may include a pressure sensor (for example, to directly detect the pressure applied by the piston drive member or to the piston) that provides an output signal that can be used to control The drive motor. Alternatively, the drive system may comprise a drive motor display that provides an output signal that reflects the magnitude of the indicated force output.

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More particularly, the drive motor may include a mobile output member that can be interconnected with the piston drive member, a magnetic field member to induce movement of the mobile output motor, and a sensor to detect a position of the member of mobile output in relation to the magnetic field member and to provide an output signal to a controller in a corresponding relationship with the

5 same. The output signal may be indicative of, for example, one or more of a force, torque, speed and / or position of the mobile output member. The controller can be operated to compare the output signal with a predetermined operating parameter (for example, a parameter related to filling) and to provide an appropriate control signal to the magnetic field member in relation thereto to drive the motor of drive within a predetermined desired operating range (for example, an operating range corresponding to an apparent force of advance or an apparent force of retraction of the piston). Because the piston drive member can be interconnected with the piston and the mobile operating member, the system can be operated to achieve a predetermined pressure range inside the tubular member through control of the drive motor. Therefore, the system can be operated to achieve a desired predetermined pressure range free of entry in relation to a fluid type parameter.

15 As can be seen, the system of the invention can be provided such that the disposable element further includes a first fluid line that is interconnected or can be interconnected at one end with a first valve orifice of a valve and can be interconnected at another end with at least a first source of medical fluid. In addition, a second fluid line may be interconnected or may be interconnected at one end with a second valve orifice of a valve and may be interconnected at the other end with at least one receptacle, in which case the system is operative to pump a medical liquid from the source of medical liquid through the first fluid line, to the inside / outside of the tubular member, and through the second occlusion-free fluid line of the first and second fluid lines. Such an arrangement facilitates the maintenance of calibration parameters (for example, unlike the use of a peristaltic pump arrangement).

Certain embodiments of the present invention also provide various methodologies in relation to the filling of at least one receptacle that can be interconnected with a medical liquid. In one characterization, the process includes the steps of establishing a physical interconnection between a disposable element and an automatic actuation system, in which case the disposable element includes a tubular member and a piston slidably disposed therein for its retraction and advancement within a first portion, and in which case the automatic drive system includes a piston drive member that can selectively interconnect with the piston of the disposable element. The method further includes the steps of using the piston drive member to retract the piston into the first portion of the tubular member (for example, along a linear path) in order to extract a predetermined volume of a liquid inside the tubular member, and using the actuator member of

35 piston to advance the piston into the first portion of the tubular member (for example, along a linear path) to dose at least a portion of the predetermined volume of medical liquid into at least one interconnectable receptacle. It should be noted that, the process also provides the sealing of a distal end of the first portion of the tubular member during both use and use stages.

In one aspect, the method may further comprise the steps of establishing a fluid interconnection between a source for the medical liquid and the disposable element, and of repeating the steps of using, using and sealing a plurality of times to fill at least in each part of a plurality of receptacles while maintaining the interconnections between the disposable element and the automatic actuation system and between the source of medical liquid and the disposable element. As can be seen, among successive ones of such

In the plurality of times, the method may further include the step of fluidly interconnecting the disposable element with ones different from the plurality of receptacles.

In another aspect, the piston drive member can be used to advance the piston of the disposable element to dose a predetermined portion of the predetermined volume of medical liquid extracted into the tubular member, and repeating such a use step a plurality of times to at least partly fill each of a corresponding plurality of receptacles while maintaining the interconnections indicated above. In other words, a given predetermined volume of medical liquid that is extracted into the tubular member may be sufficient to at least partially fill a plurality of receptacles in the employment stage indicated above.

The procedure may be provided such that, following each advance of the member of

55 piston drive to at least partially fill a given receptacle, the piston drive member can be automatically controlled in order to retract the piston a minimum amount sufficient to reduce or even prevent unwanted dripping downstream of the element disposable (for example, at the end of a tubing line from which the medical liquid is dosed into the receptacles). An optional "recoil" stage of this type is readily facilitated by the piston drive approach of the particular embodiments of the present invention. In this regard, the method may include the steps of causing the medical liquid to flow through an orifice (for example, a valve orifice, a proximal end orifice of the tubular member, a fluid line orifice) during the stage of use, and controlling the piston drive member to retract the piston into the tubular member to extract a predetermined volume of the medical liquid into the tubular member through the hole.

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In another aspect, the method can provide the detection of at least a relative degree of movement between the piston drive member and a reference member of the automatic drive system 5 to provide an output signal for use in at least one of the stages of use (for example, the piston retraction) and of use (for example, the piston feed) indicated above. As can be seen, the degree of relative movement can correspond to a given predetermined amount of medical liquid that is to be dosed into a given receptacle. In addition, the detection step may provide the detection of a plurality of relative degrees of motion between the piston drive member and the reference member in order to provide an output signal in a corresponding relationship with each of the degrees Relative motion detected. In turn, the method may include the step of processing the output signal to obtain at least one speed value indicative of a relative movement speed between the piston drive member and the reference member, and of comparing such value. of speed with at least one predetermined value to identify the occurrence of a predetermined operating condition

15 (for example, an unwanted occlusion and / or unwanted filtration downstream of the disposable element). The procedure can also provide automatic termination and / or provision of a user exit indication upon identification of such an occurrence.

In a further aspect, each of the use stage (for example, the piston retraction) and the use stage (for example, the piston advance) can comprise the step of causing the predetermined volume of medical liquid 20 to flow through a common hole of the tubular member. By way of example, such a common hole can be found at a proximal end of the tubular member. In this regard, additionally, the setting stage may include the step of interconnecting a valve of the disposable element with a valve actuating member of the automatic actuation system. In one embodiment, the valve may comprise a valve housing that is fluidly interconnected with the proximal orifice of the tubular member, and a valve stem

25 placed inside the valve housing.

In conjunction with the present aspect, the method may further include the step of using the valve actuating member of the automatic actuation system to automatically and alternately place the valve in a first valve position and in a second valve position, in which the first valve position is maintained during the use stage and the second valve position is maintained during the

30 employment In one embodiment, the method may provide automatic valve placement in the first valve position before the use stage (e.g., piston retraction), and placement of the valve in the second valve position after the use stage and before the use stage (for example, the piston feed).

In a further aspect, the process of the invention may include the automatic member control step.

Piston drive 35 of the automatic drive system to retract the piston into the tubular member during the use stage (e.g., piston retraction) to achieve the flow of medical fluid within a first speed range, and to cause the piston to advance inside the tubular member during the use stage (for example, the piston advance) to achieve the flow of medical liquid within a second speed range, in which case the first speed range and the second speed range is not

40 overlap at least in part. In other words, the method can be adapted in such a way that the rate of flow of medical liquid into the disposable element is different from the rate of flow of medical liquid to the outside of the disposable element. As can be seen, such a capacity facilitates the optimization of medical liquid filling operations. That is, different maximum flow rates can be achieved inside and outside the disposable element. For example, in applications where medical fluid is removed by

45 inside the disposable element through a relatively large fluid interconnection line (for example, large tube diameter), and is dosed by the disposable element through a relatively small fluid interconnection line (for example, small diameter of tube) and / or inside a relatively small syringe receptacles, can then be accommodated at a higher maximum flow rate into the disposable element.

50 Additional procedural advantages can be achieved when a user interface is connected to an automatic drive system. For example, the procedure may include the step of receiving a user input in the user interface to adjust a filling-related value, which corresponds to, for example, a predetermined volume of medical liquid to be extracted into the interior of the disposable element, for use in the use stage (for example, piston retraction) indicated above. Alternative and / or

In addition, the method may include the steps of fluidly interconnecting the disposable element with at least one of a fluid connection line and a fluid receptacle (for example, a tubing line of a given size of gauge and / or a syringe or vial of a given volume), and receive a user input in a user interface to adjust a filling-related value, which corresponds to, for example, an acceptable maximum flow rate associated with the connection line of fluid and / or fluid receptacle

60 interconnected, for use in the use stage (for example, the piston advance stage). As can be seen, the present functionality allows a user to maximize receptacle filling rates while avoiding unwanted fluid pressure levels inside the disposable element. Additionally and / or alternatively, the method can also provide the selection of the disposable element from a plurality of disposable elements of different sizes employable with the automatic actuation system, and the reception of a user input in the user interface to adjust a size-related value, which corresponds to, for example, the selected disposable element, for use in at least

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5 one of the use stage (for example, the piston retraction) and the use stage (for example, the piston feed). Additionally and / or alternatively, the procedure may also include the step of receiving a user input in the user interface to adjust the parameters in relation to the attributes of or affecting the medical liquid since it is to be extracted inside / dosed by the disposable element (for example, viscosity, density, atmospheric pressure, etc.), for use in at least one of the stages of use and / or use.

In still another aspect, the process of the invention may include the automatic control stage of the piston drive member to automatically adjust a force applied by the piston drive member to the piston of the disposable element for at least a portion of at least one of the stages of use (for example, piston retraction) and of use (for example, piston advance). In turn, the automatic control stage can provide maintenance of the force applied within an interval.

15, in which a predetermined maximum of the predetermined range corresponds to a predetermined maximum desired fluid pressure for the disposable element. In relation to the foregoing, a predetermined minimum of the predetermined range can be set to be within a relatively small given percentage of the predetermined maximum (for example, less than 10%) such that the flow of medical fluid is maximized at inside and / or outside of the disposable element.

20 In conjunction with the present aspect, the automatic control stage may include the step of using an output signal from a pressure sensor that is included either with the disposable element or with the automatic actuation system. By way of example, the pressure sensor may be interconnected with the piston drive member of the automatic drive system to measure the magnitude of the force being applied to the piston of the disposable element. Alternatively and / or additionally, a pressure sensor may be

25 integrated in the disposable element to measure the indicated force and to provide an output signal to the automatic drive system.

In another approach, the automatic control stage may include the step of using an output signal associated with the drive motor comprising the automatic drive system and which is interconnected with the piston drive member, in which the signal of output is indicative of the force being applied to the piston of the disposable element. The method may include the steps of providing a control signal to a magnetic field member of a drive motor and inducing the movement of a moving output member through the magnetic field member in relation to the control signal, being able to The mobile output member is interconnected with a piston drive member. The method may further include the steps of detecting a relative position of the movable exit member in relation to the magnetic field member 35, repeating the steps of providing, inducing and detecting a plurality of times, and determining a pressure inside the member tubular based on the repetition stage. The method may also include the steps of emitting an output signal based on the detection stage, of comparing this output signal with a value related to the predetermined filling, of adjusting the control signal based on the present comparison stage. and of providing a control signal adjusted to the magnetic drive member to adjust

40 the pressure inside the tubular member.

In yet another aspect, the process of the invention may include the steps of packaging the disposable element inside a box before the establishment stage (for example, interconnecting the disposable element with the automatic actuation system), sterilizing the disposable element, and remove the disposable element from the box before the establishment stage. In addition, the procedure may include the steps of

45 completing the packaging step in a first location (for example, a production location and / or assembly of disposable elements), of transporting the disposable element inside the box from the first location to a second location (for example , a hospital pharmacy area or other medical liquid preparation location), and completing the stages of removing, establishing, using and using the second location.

In conjunction with the present aspect, the process of the invention may further comprise the steps of placing the piston of the disposable element inside a second portion of the tubular member before the packaging stage and placing the piston inside the first portion indicated above of the tubular member after the withdrawal stage, in which a resilient member comprising the piston is compressed less or not at all during transport and storage in relation to the degree of

Compression that can be experienced during the use of the disposable element (for example, when the piston and the resilient member meet in the first portion of the tubular member for the extraction / dosing of medical liquid). Similarly, when the disposable element includes a valve, the method of the invention may include the steps of placing a valve stem of the valve inside a first portion of the valve (for example, a first portion of a housing valve valve) before the stage

60 for packing and placing the valve stem inside a second portion of the valve (for example, a second portion of the valve housing of the valve) after the removal stage, in which the valve stem is compresses less or nothing at all during transport and storage in relation to the degree of compression that can be experienced during the use of the disposable element (for example, when the valve stem is in the second portion of the valve for extraction / medical liquid dosage).

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In a related aspect, the process of the invention may comprise advancing linearly a

5 piston drive member to a first point of the linear path, the first point of the linear path corresponding to the reception of a first connection member (eg, a male member) by a second connection member (eg, a member female). The method may further comprise the step of having the piston drive member advance linearly to a second point of the linear path, this second point of the linear path being located proximally with respect to the first

10 point of the linear path, thereby limitably coupling the first connection member and the second connection member. The method can further comprise causing the piston drive member to advance linearly to a third point of the linear path, this third point being of the linear path located proximally with respect to the first and second points of the linear path, the third point of the linear path corresponding to the sealing stage indicated above of the

15 first portion. The method may further comprise the step of moving the piston drive member linearly to a fourth point of the linear path, the fourth point of the path being located proximally with respect to the third, second and first points of the linear path, and to linearly retract the piston drive member to the third point of the linear path. The method may further comprise the step of repeating the steps of moving linearly and of linearly retracting a

20 plurality of times to fill a plurality of receptacles with a medical liquid. The method may further comprise the step of linearly retracting the distal piston drive member from the first point of the linear path, and removing a disposable element from a drive system.

In another aspect, a disposable element is provided for use in a system for automatic filling of at least one receptacle that can be interconnected with a medical liquid. The disposable element may include a housing that includes a tubular member and a valve housing. A piston may be slidably disposed in the tubular member and a valve may be disposed in the valve housing. The valve can be located in a first valve position in which a first valve orifice is fluidly interconnected with the tubular member and the valve can be located in a second valve position in which a second valve orifice is interconnected so fluid with the tubular member. In one embodiment, it can

A sealing member is provided to seal a distal end of the tubular member. The sealing member can be placed at a fixed distance from the piston. A valve stem may be slidably and rotatably arranged inside the valve housing.

In still another aspect, a system for automatic filling of at least one receptacle that can be interconnected with a medical liquid is provided. The system may include a piston drive member, a piston drive motor, a piston drive sensor, a valve drive member, a valve drive motor, a controller and a mount. The piston drive member can selectively interconnect with a piston of a disposable element. The piston drive motor can be interconnected with the piston drive member and can be driven to cause the piston drive member to oscillate. The piston drive sensor can be actuated to detect a position of the piston drive member and to provide an output to the controller. The valve actuating member can be operated to interact with a valve of the disposable element and can be selectively located in at least two positions. The valve drive motor can be interconnected with the valve drive member and can be driven to position the valve drive member. The controller can be operated to determine an outlet pressure of an element

45 disposable that is interconnected with the system based on the input level for the piston drive motor and an output signal from the piston drive sensor. The mount can be operated to selectively engage and fix a disposable element in relation to the piston drive member.

In a further aspect, a procedure for the automatic preparation of at least a predetermined volume of a medical liquid is provided. The method may include establishing an interconnection between a disposable element and an automatic actuation system, extracting a predetermined volume of a medical liquid from a first container through a first hole in the disposable element, through a valve in a first position in the disposable element, and inside a tubular member of the disposable element. The procedure may further include reorienting the valve to a second position after the extraction of the medical liquid into the tubular member of the element.

55 disposable. The method may further include dosing a predetermined volume of the medical liquid into a second container by dosing the liquid from the tubular member, through the valve in the second position, through a second hole in the disposable element , and inside the second container. The process may further include sealing, with a movable seal, a portion of the tubular member during the extraction, reorientation and dosing stages.

In an embodiment of the present aspect, the extraction and dosage procedure can be reversed such that the medical liquid is extracted from the second container and dosed into the first container by mixing

or thereby stirring the medical liquid. By way of example, the first container of the present aspect may be one of a bottle, a bag, or a vial. By way of example, the second container of the present aspect may be one of a bottle, a bag, a vial, a hypodermic syringe, an intravenous syringe, and an oral syringe.

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The present aspect may also include the repetition of the procedure a plurality of times to transfer medical liquid from the first container to the second container. In a related aspect, the method 5 may further include disconnecting the second container and sequentially connecting a plurality of containers while repeating the procedure a plurality of times and thereby filling, at least in part, a plurality of medical liquid containers with medical liquid extracted from the first container. In another related aspect, the procedure may further include disconnecting the first container and sequentially connecting one or more containers while repeating the procedure one or more times. In this regard, the

Medical liquid from multiple sources can be mixed or combined in a single recipient container.

Numerous aspects, features and additional advantages of the present invention will be apparent to those skilled in the art upon consideration of the additional description that follows.

Brief description of the drawings

Figure 1 is a schematic view of an embodiment of an automatic medical liquid filling system

15 of the present invention. Figure 2 is a partial schematic, partial perspective view of an embodiment of the automatic medical liquid filling system of the present invention with a portion of the drive system omitted to show internal characteristics.

Figure 3a is a perspective view of an embodiment of a disposable element of Figures 1–2.

Figure 3b is a perspective view of a portion of the disposable element of Figure 3a with a portion omitted to show internal characteristics. Figure 3c is a side view of the tubular member of Figure 3a. Figure 3d is a side view of the piston of Figure 3a that is interconnected with a sealing member. Figure 4a is a side view of a disposable element illustrating a piston placed in a position.

25 fully retracted.

Figure 4b is a side view of a disposable element illustrating a piston placed in a retracted base position. Figure 4c is a side view of a disposable element illustrating a piston placed in a position.

advanced base.

Figure 4d is a side view of a disposable element illustrating a piston placed in a completely advanced position. Figure 5a is a perspective view of an embodiment of the valve stem of the disposable element of the

figure 3a. Figure 5b is a side view of the valve stem of Figure 5a.

Figure 5c is a top view of the valve stem of Figure 5a. Figure 6 is a perspective view of an embodiment of a mount of Figures 1-2. Figure 7a is a side view of an embodiment of a stage that is used to interconnect the element.

disposable of figure 3a with the mount of figure 6. Figure 7b is a side view of an embodiment of the disposable element of figure 3a that is interconnected with a mount of figure 6.

Figure 8 is a perspective view of an embodiment of a connecting member of the disposable element of Figure 3a with a portion of the distal end of the omitted tubular member. Figure 9 is a perspective view of an embodiment of a position sensor of Figures 1-2. Figure 10 is a schematic view of an embodiment of a controller of Figures 1–2.

Figure 11a is a schematic view of an embodiment of a first screen of a user interface of Figures 1-2.

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Figure 11b is a schematic view of an embodiment of a second screen of a user interface of Figures 1-2.

Figure 12a is a flow chart illustrating an embodiment of a logical system that can be used with the controller and the user interface of Figures 1-2.

5 Figure 12b is a flow chart illustrating particular portions of the flow chart of Figure 12a.

Figure 12c is a flow chart illustrating particular portions of the flow chart of Figure 12a.

Figure 13a is a top view of an embodiment of the disposable element of Figure 3a which is mounted on the drive system illustrating the valve in a shipping position and the piston in a fully retracted position.

Figure 13b is a top view of an embodiment of the disposable element of Figure 3a that is mounted on the drive system illustrating the valve in a second position and the piston in a retracted base position.

Figure 13c is a top view of an embodiment of the disposable element of Figure 3a that is mounted on the drive system illustrating the valve in a second position and the piston in a fully advanced position.

Figure 13d is a top view of an embodiment of the disposable element of Figure 3a that is mounted on the actuation system illustrating the valve in a first position and the piston disposed inside a first portion of the tubular member.

Figure 13e is a top view of an embodiment of the disposable element of Figure 3a that is mounted on the drive system illustrating the valve in the first position and the piston in a retracted base position.

Figure 13f is a top view of an embodiment of the disposable element of Figure 3a that is mounted on the drive system illustrating the valve in the second position and the piston in an advanced base position.

Fig. 14 is a flow chart illustrating one mode of operation of a medical liquid filling system of an embodiment of the present invention.

Figure 15 is a perspective view of an embodiment of a male-female interconnection arrangement.

Figure 16 is an exploded perspective view of an embodiment of a disposable element and a piston drive member that includes a bellows arrangement.

Figure 17 is a side view of an embodiment of a disposable element illustrating an overmoulded piston with a single seal placed in a fully retracted position.

Figure 18 is a perspective view of a distal end of an embodiment of a connecting member 35 inside a tubular member and a retaining ring.

Figure 19 is a partial cross-sectional side view of the embodiment of Figure 18.

Figure 20 is a perspective view of an embodiment of an automatic liquid filling system and an automatic syringe handling system.

Figure 21 is a partial perspective view of an embodiment of an automatic drive system.

40 Detailed Description

Reference is now made to Figures 1 and 2, which illustrate an embodiment of a medical liquid filling system of the present invention. The medical liquid filling system 1 generally includes a disposable element 10, an actuation system 30, one or more sources of medical liquid 60 ("source or sources of medical liquid") and one or more receptacles 62 (" receptacle or receptacles ”). The disposable element 10 can be selectively coupled and decoupled with the drive system 30 through flanges 48 and a mount 40. The source or sources of medical liquid 60 can be fluidly interconnected with the disposable element 10 through a first fluid line 80 and an optional distribution manifold 64 (for example, which is included when multiple sources of medical liquid are provided). Similarly, the receptacle or receptacles 62 can be fluidly interconnected with the disposable element 10 through a second

50 fluid line 82 and optional distribution manifold 64.

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The disposable element 10 may include a housing 21 which may include a valve housing 22 and a tubular member 12. The housing 21 may be a single piece (for example, a part molded into a piece) or may be constructed from multiple parts interconnected individual. The disposable element 10 may include a valve 20 for selective fluid interconnection with the first and second fluid lines 80, 82. A

First filter 201 may be arranged in line with the first fluid line 80. A second filter 202 may be arranged in line with the second fluid line 82. Whether or not a filter is needed and the location of the filter (for example, in the first fluid line 80, in the second fluid line 82, or in the first and second fluid lines 80, 82) it can be determined based on the characteristics of the medical liquid. In turn, the disposable element 10 can include the tubular member 12, which can be fluidly interconnected with the valve 20, and a piston 14 for extracting a medical liquid inside and for dosing a medical liquid outside the tubular member 12 In this regard, the piston 14 may be slidably disposed in the tubular member 12 for retraction and advance within at least a first portion of the tubular member 12. A sealing member 16 can seal a distal portion of the tubular member 12, and in one embodiment the sealing member 16 is interconnected with the piston 14 for joint movement therewith.

15 During operation and as discussed in more detail below, when the valve 20 is located in a first valve position, the piston 14 can be retracted to extract fluids from the source or sources of medical liquid 60 into the tubular member 12 through the first fluid line 80 and the valve 20. When the valve 20 is located in a second valve position, the piston 14 can be made to advance to dose the fluids in the tubular member 12 to the receptacle or receptacles 62 a through the valve 20 and the second fluid line 82. As described in more detail below, because the piston 14 can be retracted and made to advance at different speeds, the filling system 1 can be operated at pressures of different intake and dosage, thus enabling the filling system 1 to dose medical liquids at a materially different velocity of the vel extraction capacity. Additionally, the first fluid line 80 may have an internal diameter different from that of the second fluid line 82. For example, the first fluid line 80

25 may be larger than the second fluid line 82 (for example, the inside diameter of the first fluid line 80 may be twice that of the second fluid line 82) in applications where a relatively high flow rate is desired high inside the disposable element 10 and a relatively high degree of control of the outflow from the disposable element 10 is desired. The relatively higher degree of control of a smaller diameter fluid line may, for example, be due because a smaller flexion of the tube walls results in greater volumetric accuracy. In one embodiment, the ratio of the inside diameter of the first fluid line 80 with respect to that of the second fluid line 82 can be between 2: 1 and 1: 2. The inner diameters of the first fluid line 80 and the second fluid line 82 can also be varied to achieve specific flow parameters, such as flow rate, flow rate and overall pressure at various points throughout the entire system.

35 An accumulator 37 can be fluidly coupled to the second fluid line 82. The accumulator 37 can be operated to soften the pressure pulses inside the second fluid line 82, which can result from the advance of the piston 14 in the inside the tubular member 12 during dosing. The accumulator 37 can also avoid pressure spikes inside the second fluid line 82 that could result in a lack of volumetric accuracy or a higher flow rate than is desired inside the receptacle or receptacles

62

Additionally, the disposable element 10 may comprise one or more relatively rigid materials (for example, substantially non-deformable under normal operating conditions). Therefore, the disposable element 10 may comprise a relatively stable known volume whose deformation is limited, which stabilizes repeatability and dosing accuracy. The filling system 1 can be used in this way to

45 providing medical liquids from the source or sources of medical liquid 60 to the receptacle or receptacles 62 to obtain a contained medical liquid (eg, a liquid medication) of a desired volume. In addition, such an occlusion or deformation-free capacity of the fluid lines 80, 82 can be achieved, thereby producing a filling system 1 that can be used without requiring a dosing calibration operation (for example, a corresponding action with the filling of a first receptacle and cross-checking of the dosed volume in relation to a desired volume).

The source or sources of medical liquid 60 may include any medical liquid, such as a liquid medication (diluted or concentrated), a solvent or other solution. As can be seen, the source or sources of medical liquid 60 can be any container adapted to contain a relatively large amount of a medical liquid (for example, bags or bottles of medical liquid).

55 The receptacle or receptacles 62 may be substantially empty or may include a substance containing medicament (eg, a dry powder or a concentrated suspension), or a solvent. As can be seen, the receptacle or receptacles 62 can be any one of vials, ampoules, syringes, bottles, bags of medical liquid or other containers adapted to receive and contain liquid medications or other medical liquids.

In one embodiment, the source or sources of medical liquid 60 may comprise a solvent (e.g., pharmaceutical grade water) and the receptacle or receptacles 62 may include a substance containing medication (e.g., a dry powder or a concentrated suspension) . A desired amount of the solvent may be provided from the source or sources of medical liquid 60 to one or more of the receptacle or receptacles 62 through the disposable element 10 for mixing with the drug-containing substance to produce liquid medication of the desired volume and concentration. .

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5 In another embodiment, the source or sources of medical liquid 60 may comprise a bulk quantity of liquid medication to be provided in smaller amounts through the receptacle or receptacles 62 and the receptacle or receptacles 62 may be empty (for example , empty of substances that contain medicine and solvents). A desired amount of the liquid medication can be provided from the source or sources of medical liquid 60 to one or more of the receptacle or receptacles 62 through the element

10 disposable 10 to provide a liquid medication in a desired volume.

In yet another embodiment, the source or sources of medical liquid 60 may comprise a bulk quantity of concentrated liquid medication and the receptacle or receptacles 62 may comprise a solvent. A desired amount of the concentrated liquid medication may be provided from the source or sources of medical liquid 60 to one or more of the receptacle or receptacles 62 through the disposable element 10 to produce a medication.

15 liquid in a desired volume and concentration.

In yet another embodiment, the source or sources of medical liquid 60 may comprise a plurality of liquid medications and the receptacle or receptacles 62 may be empty. In conjunction with the optional distribution manifold 64 described above, selected amounts of one or more of the liquid medications at the source or sources of medical liquid 60 may be combined and provided to the

20 receptacle or receptacles 62. Therefore, in the present embodiment, the filling system 1 can be operated as a mixer.

As indicated above, the disposable element 10 can be selectively coupled with the drive system 30. The drive system 30 may include a piston drive member 32, a valve drive member 34, one or more engine or engines 36 ("engine or motors") and a controller 50. The piston drive member 32 can selectively interconnect with the piston 14 of the disposable element 10. More particularly, a first connection member 18 can be provided with the disposable element 10 and a second connection member 31 may be provided with the drive system 30. The first connection member 18 may be interconnected with the sealing member 16, which may be interconnected with the piston 14, and the second connection member 31 may be interconnected with the piston drive member

30 32, wherein the first and second connecting members 18, 31 can be selectively interconnected and disconnected. Therefore, the piston 14 can be selectively engaged and decoupled by the piston drive member 32, thereby facilitating the selective interconnection and disconnection of the disposable element 10 a and from the drive system 30.

The valve actuating member 34 can be interconnected with the valve 20 of the disposable element 10 and the

35 engine or motors 36 to facilitate the placement of the valve 20. In one embodiment, the valve actuating member 34 may include one of at least a first shoulder and a first opening and the valve 20 may include the other of minus the first projection and the first opening, in which the first opening is adapted to receive the first projection to interconnect the valve actuating member 34 with the valve 20. The valve 20 may alternatively be interconnected with the system drive 30 by other means

40 known, such as through one or more gears.

The engine or motors 36 may be interconnected to drive the piston drive member 32 and / or the valve drive member 34 to facilitate the movement of fluids through the system 1. For example, a first engine 36a (Figure 2) it may be interconnected with the piston drive member 32 through one or more belts 39 to facilitate movement of the piston drive member 32 in one or more 45 directions (for example, linearly forward and backward). A second motor 36b (Figure 2) may be interconnected with the valve drive member 34 to facilitate movement of the valve drive member 34 in one or more directions (for example, clockwise and / or counterclockwise) to place valve 20 in at least first and second positions. Therefore, the drive system 30 can be operated to change the position of the piston 14 (by

50, for example, through the piston drive member 34) and / or the valve 20 (for example, through the valve drive member 34) to facilitate the selective movement of medical liquids into and out of the disposable element 10 The motor or motors 36 may also be interconnected with the controller 50 to facilitate automatic filling operations, as discussed in more detail below.

The drive system 30 can also be provided with a sensor and a reference member to detect by

At least a relative degree of movement of the piston drive member 32, the sensor being operable to provide an output signal for use in determining a relative degree of retraction or advance of the piston drive member 32. The amount that the piston drive member 32 is advanced or retracted correlates with the amount of medical fluid extracted into or dosed out of the disposable element 10. Therefore, the sensor and / or reference member can facilitate extraction and

60 the dosing of selected amounts of fluids by detecting a plurality of relative degrees of motion and providing corresponding output signals, relative to each of the degrees of relative motion detected, to controller 50. As discussed in more detail below, the controller 50 can process such output signals to determine a relative degree of movement of the piston drive member 34 and, therefore, in relation to a known internal diameter of the tubular member 12,

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5 the amount of fluid extracted into and / or dosed from the disposable element 10. In the embodiment illustrated, the sensor and reference member are combined and cooperatively illustrated as position sensor 38. The following is provided greater detail with respect to position sensor 38.

The controller 50 may be interconnected with the sensor and / or reference member (for example, through the position sensor 38 or a rotary encoder 2108 discussed below) and / or the motor or motors 36. The controller 50 can be actuated to receive signals from the sensor to help control the position of the piston drive member 32 and / or a speed and / or force of advance and / or retraction of the piston 14. The controller 50 can also be operated to send signals to the motor or motors 36 to control one or more operating parameters of the motor or motors 36 (for example, an address, and / or operating speed). For example, the controller 50 can control the first motor 36a (Figure 2) so that it advances linearly and

15 linearly retract the piston drive member 32. The controller 50 can also control the second motor 36b (Figure 2) to drive the valve drive member 34 clockwise or counterclockwise. clockwise, thereby locating valve 20 in at least one of the first and second valve positions described above. More detail is given below with respect to controller 50.

20 To further facilitate the automatic filling of medical liquids, a user interface 70 may be interconnected with the controller 50, the user interface 70 being able to be operated to receive an input and to provide parameters to the controller 50 to facilitate the automation of the system of filling 1. For example and as described in detail below, the user interface 70 can be operated to accept an input and to communicate parameters associated with a filling-related valve (for example, a

25 desired amount of receptacle or receptacles 62 to be filled and the amount of medical liquid to be dosed to each of the receptacle or receptacles 62). Therefore, the user interface 70 can facilitate the automatic or semi-automatic operation of the filling system 1. Further detail is given below with respect to the user interface 70.

Referring now to Figures 3a-3d, an embodiment of a disposable element 10 useful for

In accordance with the present invention described below. Specifically with reference to Figures 3a and 3c, the disposable element 10 may include a tubular member 12, a piston 14 and a sealing member 16. The tubular member 12 may include first, second and / or third portions, 12a, 12b and 12c, respectively, the first portion 12a having a first internal diameter D1, the second portion 12b being located distally with respect to the first portion 12a and having a second internal diameter D2, and a third being

35 portion 12c located distally with respect to the second portion 12b and having a third internal diameter D3. In the embodiment illustrated, the second diameter D2 is larger than the first diameter D1 and the third diameter D3 is larger than the second diameter D2. As discussed in more detail below, the use of variable diameters may facilitate the increase of the useful life of the disposable element 10.

Referring below to Figures 3c, 3d and 4a – 4d, the piston 14 may include a first member

40 resilient 15 adapted to engage in a sealable manner with an internal surface of the tubular member 12 when it is disposed inside the first portion 12a of the tubular member 12 (for example, ring-shaped and peripherally arranged). That is, the first resilient member 15 can comprise a diameter at least as large as the first diameter D1 of the first portion 12a of the tubular member 12. Therefore, the fluids can be drawn into the tubular member 12 after retraction of the piston 14, and fluids can

45 be dosed from the tubular member 12 with the advance of the piston 14.

The sealing member 16 may be fixedly interconnected with the tubular member or it may be slidably disposed therein for its joint movement with the piston 14. The sealing member 16 may include a second resilient member 17 adapted for engage in a sealable way with an internal surface of the tubular member 12 when disposed inside the second portion 12b of the tubular member

50 12 (for example, ring-shaped and peripherally arranged). That is, the second resilient member 17 may comprise a diameter at least as large as the second diameter D2 of the second portion 12b of the tubular member 12. Therefore, the sealing member 16 can restrict the entry of substances from the outside ( for example, air, particles, etc.) in the tubular member 12 during the operation of the automatic medical liquid filling system 1 by means of distal sealing portions of the tubular member 12.

In addition, because the sealing member 16 can interact with the outside fluids (eg, air), it is not desired for the sealing member 16 to communicate fluidly with the portion of the tubular member 12 communicating from fluid form with medical fluids. Therefore, in one embodiment of the present invention, the sealing member 16 is interconnected with the piston 14 (for example, by the rod 13) and is separated therefrom a fixed distance that is at least as large as a length. of the first portion 12a of

60 tubular member 12. In a particular embodiment and with reference to Figure 4d, the sealing member 16 is separated from the piston 14 a fixed distance 12d that is larger than a length of the first portion

5

10

fifteen

twenty

25

30

35

40

Four. Five

fifty

55

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E12183030

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12a of the tubular member 12. Therefore, it can be restricted that the sealing member 16 be placed inside the first portion 12a of the tubular member 12, thereby reducing the possibility of contamination of the first portion 12a of the tubular member 12 .

As indicated above and with continued reference to Figures 3c, 3d and 4a – 4d, the tubular member 12 may include first, second and third diameters D1, D2, D3. The use of such increasing diameters inside the tubular member 12 can help increase the expected service life of the disposable element 10. In this regard, the first resilient member 15 may comprise a diameter that is at least as large as the first diameter D1 In one embodiment, the diameter of the first resilient member 15 may also not be larger than a diameter of the second portion 12b of the tubular member 12 (for example, the second diameter D2). Therefore, when the first resilient member 15 is located inside the second portion 12b of the tubular member 12, as illustrated in Figure 4a (for example, when the piston is in a fully retracted position), the first resilient member 15 may extend (for example, decompress / be in a less compressed state) in relation to the moment when the first resilient member 15 is located in the first portion 12a of the tubular member 12, as illustrated in the figure 4b. In a particular embodiment, at least a portion of the first resilient member 15 may be free of a compression coupling with the tubular member 12 when the first resilient member 15 is located within the second portion 12b of the tubular member 12. therefore, when the first resilient member 15 is inside the second portion 12b of the tubular member 12 (for example, before use), it can be found only slightly compressed or free of compression. Therefore, the useful life of the first resilient member 15 and thus of the disposable element 10 can be increased.

Similarly, the second resilient member 17 may comprise a diameter that is at least as large as the second diameter D2. In one embodiment, the diameter of the second resilient member 17 may not be larger than a diameter of the third portion 12c of the tubular member 12 (for example, the third diameter D3). Therefore, when the second resilient member 17 is located inside the third portion 12c of the tubular member 12, as illustrated in Figure 4a, the second resilient member 17 may extend (for example, decompress / meet in a less compressed state) in relation to the moment when the second resilient member 17 is located in the second portion 12b of the tubular member 12, as illustrated in Figure 4b. In a particular embodiment, at least a portion of the second resilient member 17 may be free of a compression coupling with the tubular member 12 when the second resilient member 17 is located within the third portion 12c of the tubular member 12. therefore, when the second resilient member 17 is inside the third portion 12c of the tubular member 12 (for example, before use), it can be found only slightly compressed or free of compression. Therefore, the life of the 17 and, thus, of the disposable element 10, can be increased.

Returning to Figure 18, a retaining ring 1801 can be placed above the end of the tubular member

12. The retaining ring 1801 can prevent the piston 14 (not shown in Figure 18) and the sealing member assembly 1804 from leaving the tubular member 12. The retaining ring 1801 may have one or more jaws 1803 that they are coupled with a feature, such as a rib 1802 on the tubular member 12. The one or more jaws 1803 can be operated to provide a relatively low insertion force to place the retaining ring 1801 on the tubular member 12 and to provide a force of relatively high withdrawal to remove the retaining ring 1801 from the tubular member 12. The inner diameter of the retaining ring 1801 may be smaller than the maximum outer diameter of the sealing member 1804, thereby preventing the sealing member 1804 from leaving of tubular member 12. Accordingly, retaining ring 1801 can provide the benefit of preventing piston 14 and sealing member 1804 from leaving unintentionally of the tubular member 12 during, for example, the shipping and handling of the disposable element 10.

The tubular member 12 may include any number of diameters and such diameters may correspond to any shape. For example, the tubular member 12 may comprise a cylinder having a single diameter. The tubular member 12 may comprise two or more adjacent cylinders having different diameters. The tubular member 12 may comprise a cylinder and an ellipsoid and / or other structures, each having different or similar diameters. Additionally, the tubular member 12 may be a unitary structure or may be formed from two or more structures, such as two cylinders having different diameters, which are joined together. Likewise, the size of the diameters may decrease from the distal end to the proximal end of the tubular member 12, as illustrated in Figure 3a, or the size of the diameters may increase from the distal end to the proximal end of the tubular member 12 , or variable diameters may be used, in which case the diameters may increase, then decrease, then increase, as appropriate, and vice versa. Correspondingly, disposable elements of a different size can be used with the filling system 1, depending on the application. For example, a disposable element 10 having a tubular member 12 with a relatively large diameter can be used in low pressure and high volume filling applications. A disposable element 10 having a tubular member 12 with a relatively small diameter can be used in high pressure and low volume filling applications.

Additionally, the first resilient member 15 may comprise a shape that corresponds to the shape of the second portion 12b, in which case at least a portion of the first resilient member extends relative to the time at which that portion of the first resilient member 15 is located in the first portion 12a of the tubular member 12. For example, the second portion 12b may comprise a cylinder shape and the first resilient member may comprise an ellipsoid shape, in which portions of the first resilient member they are free of a compression coupling with the second portion 12b, and other portions of the first resilient member are coupled to compression with such a second portion 12b. The second resilient member 17,

image13

5 the third portion 12c and the second portion 12b may also be arranged similarly.

Another embodiment of the disposable element 10 is illustrated in Figure 17. As illustrated in Figure 17, a piston 1701 may include a single seal portion 1702. The piston 1701 and the unique seal portion 1702 may be a single unitary portion. Composed of a single type of material. The material may, for example, be a thermoplastic material (for example, polyurethane). The piston 1701, which includes the single sealing portion 1702, can be manufactured by overmolding on the rod 1703. For example, the rod 1703 can be placed in a mold for the piston and located inside the mold cavity and can be made Polyurethane then flows into the cavity to form the piston 1701, which includes the single seal portion 1702, directly over the rod 1703. The piston 1701, which includes the unique seal portion 1702, may preferably have a hardness of hardness tester of less than 90 A. More preferably, the hardness hardness can

15 be about 70 A.

The single sealing portion 1702 can undergo compression when the piston 1701 is inside the first portion 12a of the tubular member 12. During dosing, a positive pressure can be created inside the portion of the tubular member 12 containing the liquid being dosed in relation to the portion of the tubular member 12 that does not contain liquid. During the extraction of liquid, a negative pressure 20 can be created inside the portion of the tubular member 12 that contains the liquid that is being drawn in relation to the portion of the tubular member 12 that does not contain liquid. Preferably, the amount of interference between the single seal portion 1702 and the tubular member 12 can be actuated to prevent filtration between the portion of the tubular member 12 containing the liquid and the portion of the tubular member 12 that does not contain the liquid when the difference of pressure between the two portions (i.e. opposite sides of the single seal portion

25 1702) is between 0 and 310.2 kPa. More preferably, the amount of interference can be actuated to prevent filtration when the pressure difference is between 0 and 413.7 kPa.

The ability of the single seal portion 1702 to avoid the filtration mentioned above when a pressure difference is present may be increased or decreased with respect to the values mentioned above. In general, because the capacity of the system for sealing against differences in pressure is increased, the friction forces between the single seal portion 1702 and the tubular member 12 will also increase and because the capacity of the system for its sealing against pressure differences is decreased, the frictional forces between the single sealing portion 1702 and the tubular member 12 will also decrease. A preferred range of interference between the diameter of the single seal portion 1702, constructed from polyurethane with a hardness hardness of approximately 70 A, and the first portion 12a of the member

35 tubular 12 is between 0.3048 mm and 0.6096 mm.

A lubricant can be applied to the disposable element 10. The lubricant can reduce the frictional forces between the valve stem 24 and the valve housing 22. In this regard, the lubricant can initially be applied annularly about an inner diameter in the area 1704 of the transition between the first housing diameter and the second housing diameter of the valve housing 22. The lubricant can reduce the frictional forces between a piston (for example, the piston 14 and the resilient member 15 of Figures 2 , 3b, and 3d, and the piston 1701 and the single sealing portion 1702 of Figure 17) and the tubular member 12. Accordingly, the lubricant may initially be applied annularly about an inner diameter in the area 1705 of the transition between the first portion 12a and the second portion 12b of the tubular member 12. The lubricant can reduce the frictional forces between the second resilient member te 17 and the tubular member 12. In this regard, the lubricant may initially be applied annularly about an inner diameter in the zone 1706 of the transition between the second portion 12b and the third portion 12c of the tubular member 12. Despite that the placement of the lubricant is described with respect to Figure 17, the lubricant may be applied similarly to other embodiments described herein (for example, the embodiments of Figures 4a-4d). The lubricant can also serve to increase the operating life of the various components with which they are

50 in contact.

It may be desired to distribute the lubricant throughout its entire operating range during the initial assembly procedure of the disposable element 10. Accordingly, the lubricant may initially be placed in an annular ring around the inside diameter in the areas mentioned above 1704, 1705, and 1706. The lubricant can be applied pneumatically. The piston 1701, which is interconnected with the rod 1703 and the sealing member 16, can then be inserted into the tubular member 12. The retaining ring 1801, described above, can then be coupled to the tubular member 12. The piston 1701 can then move substantially throughout its entire operating range (for example, between the fully retracted position and the fully advanced position) one or more times to distribute the lubricant. Similarly, the valve stem 24 can be fully inserted into the valve housing 22 and 60 removed from the fully inserted position one or more times to distribute the lubricant inside the valve housing 22. The disposable element 10 can be subjected The following test as described later in this document. After the test, the piston 1701 can move to the

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fully retracted position and remain in such a position, including during storage and shipping periods, until the disposable element 10 is used by an end user. Similarly, the valve stem 24 can move to the area of the second housing diameter of the valve housing 22 and remain in such a position, including during storage and shipping periods, up to

5 that the disposable element 10 is used by an end user.

The lubricant is preferably a lubricant without self-leveling. In a preferred embodiment, the lubricant may have a viscosity of at least 12,500 centistokes (cS). The lubricant may be a silicone grease, such as, for example, Nu-Sil MED-9031 silicone grease, which has a viscosity of approximately one million cS, sold by Nu-Sil Silicone Technology, California, USA. UU.

10 As indicated above and with reference to Figures 3a and 3b, the disposable element 10 may also include a valve 20. The valve 20 may include the valve housing 22 which is interconnected with the tubular member 12 (for example, in a proximal end of the tubular member 12) and a valve stem 24 disposed inside the valve housing 22. The valve 20 may further include a plurality of holes, such as a first valve orifice 26 and a second valve orifice 27 The first valve orifice 26 can

15 be fluidly interconnected with the tubular member 12 when the valve 20 is in a first valve position and the second valve orifice 27 may be fluidly interconnected with the tubular member 12 when the valve 20 is in a second valve position The first valve orifice 26 may be fluidly interconnected with the first fluid line 80, which may be fluidly interconnected with the source or sources of medical liquid 60. The second valve orifice 27 may be

20 fluidly interconnected with the second fluid line 82, which may be fluidly interconnected with the receptacle or receptacles 62. Therefore, when the valve 20 is located and held in the first valve position, fluids can be extracted from the source or sources of medical liquid 60 into the tubular member 12 through the first valve orifice 26 and the first fluid line 80 and, when the valve 20 is located and held in the second valve position, the fluids in the tubular member 12 they can be dosed at

25 receptacle or receptacles 62 through the second valve orifice 27 and the second fluid line 82. Because the first and second orifices 26, 27 are fluidly interconnected with the tubular member 12, they share a common orifice ( for example, a hole that is located at the proximal end of the tubular member 12), and thus medical liquids can flow into and out of a common hole of the tubular member 12.

An embodiment of a valve stem 24 is described below in reference to Figures 3b and 5a-5c. The valve stem 24 may include at least a first opening 23 and the first opening 23 may be adapted to receive a first shoulder 35 of the valve actuating member 34. In one embodiment, the valve stem 24 includes at least about first and second channels 28, 29, the channels 28, 29 being isolated with respect to fluids from one another when the valve stem 24 is disposed inside the

35 valve housing 22. In a particular embodiment, the first and second channels 28, 29 may be arranged in a displaced manner around a perimeter of the valve stem 24. In a related embodiment, the first and second channels 28, 29 may understand separate arched paths. In a further embodiment, the valve stem perimeter can be defined in part by the first and second channels 28, 29.

40 When the valve stem 24 is disposed inside the valve housing 22, the first channel 28 can be fluidly interconnected with the first hole 26 and the second channel 29 can be fluidly interconnected with the second hole 27. More particularly , the first channel 28, the first valve orifice 26 and the tubular member 12 can be fluidly interconnected only when the valve 20 is in the first valve position. The second channel 29, the second valve orifice 27 and the tubular member 12 may be

45 interconnected only fluidly when the valve 20 is in the second valve position. Therefore, in the present embodiment, there is no cross communication between the first and second channels 28, 29 because the tubular member 12 only communicates with a single channel for any given valve position. Restricting cross communication between the channels may restrict contamination of the source or sources of medical liquid 60 and / or the receptacle or receptacles 62 and may restrict the unhindered flow of medical fluids through the

50 system 1.

The valve stem 24 may also include a stop portion 25. When the valve 20 is in a third valve position (eg, a neutral position), the stop portion 25 may restrict fluid communication between the first hole. valve 26 and the tubular member 12. Furthermore, when the valve 20 is in the third valve position, the stop portion 25 can restrict fluid communication between the second

55 valve orifice 27 and the tubular member 12. Therefore, in the third valve position, the flow of the fluids into and out of the tubular member 12 is restricted. As can be seen, this third valve position and a corresponding stop portion 25 may be useful in a variety of circumstances, such as preventing contamination of the tubular member 12 during shipment of the disposable element 10.

The valve stem 24 can also be sent in a less compressed state. Referring to

Next to Figure 3a, the valve housing 22 may include a first housing portion having a first housing diameter H1 and a second housing portion having a second diameter of

image15

housing H2, the first housing diameter H1 being larger than the second housing diameter H2. The valve stem 24 can be placed and shipped inside the first housing portion. After the interconnection of the disposable element 10 with the mount 40, the valve stem 24 can be placed inside the second housing portion (for example, through the valve actuating member 34). Therefore, the valve stem 24 can be sent in a less compressed state to facilitate the increase of the useful life of the disposable element 10. To avoid trapping gas inside the valve housing 22, between the valve stem 24 and the valve housing 22 as the valve stem 24 moves from the first housing portion to the second housing portion, the valve stem may have a vent hole 51 between an upper surface 53 and a lower surface 55 of the valve stem 24. As with the tubular member 12, the valve housing 22 may be of any shape, having any number of diameters, which may increase, decrease or both, through the entire valve housing 22, and may be a unitary structure or may be composed of two or more components. In relation to the foregoing, and as indicated, the valve housing 22 may be integral with the tubular member 12 or may be a separate component adapted for engagement with the tubular member 12. As indicated, the manifold of

15 Optional distribution 64 can be used in conjunction with the valve 20 to distribute fluids in the filling system 1. Therefore, the optional distribution manifold 64 can also be integral with the valve 20 and / or the tubular member 12, or it can be Be a separate component.

The first and second fluid lines 80, 82 can be interconnected immediately before use, such as in the administration facility (for example, a hospital) or can be interconnected during the manufacture of the disposable element 10. In this respect, the disposable element 10 can be sent with the first and second fluid lines 80, 82 interconnected with the disposable element 10. The first and / or second fluid lines 80, 82 can be sent with a connector (for example, a Luer or spigot connector), It can be sealed in a sterile cover or with a plug. The first and / or second fluid lines 80, 82 may be shipped with other devices such as, for example, one or more Y-connectors, fluid bags, valves, nozzles and additional tubes. Further,

25 the disposable element 10 may include the piston 14 oriented in a shipping position (for example, the fully retracted position described above), and the valve 20 oriented in a shipping position (for example, the third valve position which described above) and / or with the valve 20 placed in the first portion of the valve housing 22. Also, the disposable element 10 can be packaged in a sterile condition. For example, the disposable element 10, and any interconnected component, can be assembled, packaged in a heat-sealed box, and sterilized through exposure to gamma radiation in a mounting location. The disposable element 10 can be transferred to another location, remote with respect to the mounting location, where it can be removed from the box and used.

Referring now to Figure 6, a mount 40 may be provided with the drive system 30. The mount 40 may include a coupling surface 44 and a support portion 46. The mount 40 may

35 also include a support portion 42 adapted to receive a portion of the tubular member 12. The disposable element 10 may include a first flange to engage with the support portion 46 and a second flange to engage with the coupling surface 44.

More particularly, and with reference to Figures 3a and 3b, a first flange 48a of the disposable element 10 may include first and second stems 90, 94 interconnected fixedly with the valve housing 22. The first stem 90 may include a first portion 91 interconnected with the valve housing 22 and a second portion 92 interconnected with the first portion 91 and the first valve orifice 26. A passage may be disposed within the first and second portions 91, 92 to facilitate the interconnection of fluid from the first valve orifice 26 with the valve stem 24.

The second stem 94 may include the first and second portions 95, 96. The first portion 95 may be

45 interconnected with the valve housing 22 and the second portion 96 may be interconnected with the first portion 95 and the second valve orifice 27. A passage may be arranged inside the first and second portions 95, 96 to facilitate interconnection of fluid from the second valve orifice 27 with the valve stem

24.

The first portions 91, 95 may be adapted for selective and restrictive coupling with the mount.

40. In this regard and with reference to Figures 3b and 6, the first portions 91, 95 may be adapted to restrictively engage the support surface 46 of the mount 40 (for example, the proximal portion of the surface of support 46). Therefore, the proximal portion of the mount 40 may be adapted to selectively and restrictively engage the disposable element 10 to restrict the movement of the disposable element 10 in at least a first direction (for example, a relative top-down direction ). The support 42 of the mount 40

55 can be further adapted to receive at least a portion of the tubular member 12 to restrict the movement of the disposable element 10 in a second direction (for example, a relative side-to-side direction). Additionally, the second portions 92, 96 may be larger than the first portions 91, 95 in order to facilitate the interconnection of the first and second valve orifices 26, 27 with the first and second fluid lines 80, 82, respectively .

As indicated above, the disposable element 10 may include a second flange portion that can engage the mount 40. More particularly, and with reference to Figures 7a-7b and 8, the mount 40 may include a coupling portion 44 for coupled with the second flange 48b of the disposable element 10, the second flange 48b being fixedly interconnected with the tubular member 12 and located distally with respect to the first flange 48a. In this regard, the coupling surface 44 may be located near a distal end of the mount 40 and include a non-planar (eg, concave) surface adapted for interconnection with the

image16

5 second flange portion 48b. The second flange portion 48b may include a corresponding non-planar portion (eg, a similar concave portion) adapted for engagement with the non-planar portion of the coupling surface 44.

Additionally, the mount 40 may include a proximal face and a distal face separated a first distance from each other. The first and second flanges 48a, 48b may be separated a second distance from each other, such

10 so that, after interconnection with the support portion 46 and the coupling portion 44, the first flange 48a abuts the proximal side of the proximal face and the second flange 48b abuts the distal side of the distal face, thereby restricting the movement of the disposable element in a third direction (for example, a relative front-to-back direction). Therefore, after interconnection with the mount 40, the three-dimensional movement of the tubular member 12 of the disposable element 10 can be restricted.

15 Referring below to Figures 7a – 7b, to interconnect the disposable element 10 with the mount 40, the tubular member 12 may be aligned with the support 42 (not shown), the second flange portion 48b may be aligned with the coupling portion 44, and the proximal end of the disposable element 10 may be in a relative position higher than the distal end of the disposable element 10. The second flange portion 48b can then be interconnected with the coupling portion 44 of the mount 40 for

20 interconnecting the distal end of the disposable element 10 with the mount 40. The proximal end of the disposable element 10 can then be lowered (for example, pressed) in order to engage the first flange portion 48a with the support surface 46. With the application of a sufficient downward force, the first flange portion 48a can slide down and beyond the support surface 46 and the tubular member 12 can come into contact with the support 42 (not shown), engaging thereby restrictively with the

25 disposable element 10. As can be seen, the disposable element 10 can be disengaged from the mount 40 by applying an upward force sufficient for the first flange 48a to slide past the support surface 46. Therefore, the flanges 48a and 48b, the tubular member 12, the support 42, the coupling surface 44 and / or the support surface 46 can enable the selective coupling and uncoupling of the disposable element 10 with the mount 40 (for example, through a pressure and blocking action), facilitating

30 thus placing and removing the disposable element 10 with, and with respect to, the drive system 30. It should be noted that, during the coupling of the proximal end of the disposable element 10 with the mount 40, the first opening of the rod Valve 24 can be coupled with the first shoulder 35 of the valve actuating member 34.

Other methods of restrictively interconnecting the disposable element 10 with the mount 40 may

35 be used as well. For example, a closure, clamp, strip or other mechanical means can be used to restrictively interconnect the disposable element 10 with the mount 40. Also, electromagnetic means can be used to interconnect the disposable element 10 with the mount 40, such as with the use of one or more magnets on the outside of a portion of the disposable element 10 and the mount 40.

Referring again to Figures 1–2, after the interconnection of the disposable element 10 with the mount 40,

40 the piston drive member 32 can be interconnected with the piston 14. As indicated above, the first and second connection members 18, 31 can be used to facilitate the interconnection of the piston drive member 32 and the piston 14. More particularly, when the first and second connecting members 18, 31 are placed inside the tubular member 12 (for example, in or between the retracted base position and the fully advanced position, described below), the piston 14 and the drive member

45 of piston 32 may be interconnected in a limited way to facilitate the joint movement of the piston 14 with the piston drive member 32. When the first and second connecting members 18, 31 are not placed inside the tubular member 12 (by for example, in a fully retracted or transport position, described below), the first connection member 18 can be decoupled from the second connection member 31. Therefore, the first and second connection members 18, 31 can interconnect the piston 14 with

50 the piston drive member 32 to facilitate joint movement when the piston 14 is located inside the proximal portions of the tubular member 12, and the first and second connecting members 18, 31 can be disconnected when the piston 14 is located in the distal portions of the tubular member 12. Therefore, the first and second connecting members 18, 31 can facilitate the selective interconnection of the piston 14 and the piston actuating member 32 and the joint movement thereof.

55 In order to achieve the interconnection between the first and second connection members 18, 31, the piston drive member 32 can be made to advance to push the first and second connection members 18, 31 into the tubular member 12 such that they are placed inside the tubular member 12. To disconnect the first and second connection members 18, 31, the piston drive member 32 can be retracted to remove at least a portion of the first and second connection members 18 , 31 since

60 tubular member 12 such that these are not placed inside the tubular member 12.

In a particular embodiment and with reference to Figures 7a-7b and Figure 8, the first connection member 18 may include a complementary female member and the second connection member 31 may include a complementary male member, the male member may be inserted into , and can be limitedly coupled by means of the female member when the connecting members 18, 31 are placed inside the tubular member 12. In this regard, the female member may comprise a plurality of fingers 18a ("fingers") separated at its ends

image17

5 distal and the male member may comprise a portion of bulbous end shaped / sized in a coincident manner. The fingers 18a of the female portion may be adapted to receive, at least in part, in a defined opening between the fingers 18a, the bulbous end portion of the male member and the fingers 18a may be foldable / articulable / pivotable to wrap and thereby limitably engaging with (for example, holding) the bulbous end portion when the connecting members 18, 31 are in a first position (for example, a first portion of the tubular member 12). The fingers 18a of the female portion may also be resilient enough to release the bulbous end portion when the connecting members 18, 31 are in a second position (for example, outside the tubular member 12 or in another portion of the tubular member 12).

In a particular embodiment, when fingers 18a and the bulbous end portion are not placed inside the

15 Tubular member 12 (for example, in a fully retracted position), the fingers 18a may be in a relaxed position such that the fingers 18a do not limitably engage with the bulbous end portion. Conversely, when the fingers 18a and the bulbous end portion are placed inside the tubular member 12, the fingers 18a may be in a compressed position, in which at least a distal portion of the fingers 18a is engaged in Limitable form with the bulbous end portion of the male member. As can be seen, the first connection member 18 may alternatively comprise the male member and the second connection member 31 may comprise the female member.

The piston drive member 32 may be any member adapted to cause the piston 14 to advance and retract. For example, the piston drive member 32 may comprise a rod, as illustrated in Figure 2. Alternatively , the piston drive member may comprise a

25 spindle of one of the motor or motors 36. The motor or motors 36 may also be one or more of a rotating motor (for example, a brushless DC motor) or a non-rotating motor (for example, a linear motor).

In a particular embodiment and with reference to Figures 18 and 19, the sealing member 1804 may comprise a plurality of fingers 1805 for interconnection with a bulbous end portion of a male member (not shown in Figures 18 and 19 ) similar to those discussed above with reference to Fig. 8. However, in the embodiment illustrated in Figs. 18 and 19, the plurality of fingers 1805 further comprises inward projections 1903 and angled end portions 1904. Inward projections 1903 can be actuated to increase the clamping force (in relation to an embodiment without including the plurality of inward projections 1903) of the plurality of fingers 1805 in the bulbous end portion when the plurality of fingers 1805 and the bulbous end portion are located together in the first portion 1907 of the tubular member

The increase in clamping force may be due to a larger percentage of the surface of the bulbous end portion being surrounded by the plurality of fingers 1805, thereby requiring a larger deformation of the components for the Bulbous end portion is disengaged from the plurality of fingers 1805 while the bulbous end portion and the plurality of fingers 1805 are located together in the first portion 1907 of the tubular member 12.

To decouple the bulbous end portion of the plurality of fingers 1805, the bulbous end portion may be retracted with respect to the tubular member 12. During this retraction, the plurality of fingers 1805 may move to the second portion 1908 of the tubular member 12, case wherein the plurality of fingers 1805 may be in a relaxed position as illustrated in Figure 19. As the bulbous end member is removed outside the tubular member 12, the plurality of fingers 1805 may come into contact with the retaining ring 1801. As the removal of the bulbous end portion with respect to the tubular member 12 is continued, the bulbous end portion can impart a force on the inner side of the plurality of inward projections 1903 which can act to extend out the plurality of fingers 1805, thereby releasing the bulbous end portion with respect to securing the plurality of ded os 1805. To further assist the method of extending the plurality of fingers 1805 to release the bulbous end portion, the plurality of fingers 1805 may comprise angled end portions 1904 and the retaining ring 1801 may comprise an end portion at complementary angle 1905. Accordingly, when the angled end portions 1904 meet the angled portion 1905 of the retaining ring 1801, the angle of the angled end portions 1904 and the angled portion 1905 together with the force imparted on the plurality of fingers 1805 by the bulbous end portion as it is pulled from the

The same outside the tubular member 12 may additionally tend to extend the plurality of fingers 1805. In this regard, the angled end portions 1904 and the angled portion 1905 of the retaining ring 1801 serve to reduce the force required to remove the bulbous end portion with respect to clamping the plurality of fingers 1805.

In order to couple the bulbous end portion with the sealing member 1804, the bulbous end portion can be made to advance to the tubular member 12. During this movement, the sealing member can move towards the second portion 1907 of the custom-made tubular member 12 that the bulbous end portion interacts with the projections in 1903 of the plurality of fingers 1805. Once an O-ring 1906 comes into contact with the first portion 1907 of the tubular member 12, a significant resistive force is present for movement toward inside the bulbous end portion can. At this point, as the bulbous end portion is made to advance further, the bulbous end portion may result in the plurality of fingers 1805 being fully extended, such that the bulbous end portion may

image18

5 then move beyond the projections in 1903 and fully engage with the sealing member 1804. The present sequence can be achieved by configuring the sealing member 1804 such that the resistive force for movement of the sealing member 1804 when the O-ring 1906 of the sealing member 1804 located inside the first portion 1907 of the tubular member 12 is greater than the resistance of the plurality of fingers 1805 to fully extend when the bulbous end portion interacts with the projections in 1903 The present configuration can be achieved by selecting a suitable thickness of the sealing member 1804 at a plurality of articulation points 1901 of the plurality of fingers 1805.

As indicated above and with reference to Figure 2, the actuation system 30 may be provided with a sensor and a reference member to detect at least a relative degree of movement of the member of

15 piston drive 32, the sensor being able to be operated to provide an output signal for use in determining a relative degree of retraction or advance of the piston drive member 32. The sensor and / or reference member can facilitate the extraction and dosing of selected amounts of fluids by detecting a plurality of degrees of relative motion and providing corresponding output signals, relative to each of the degrees of relative motion detected, to controller 50. In the An illustrated embodiment, the sensor and reference member are combined and cooperatively illustrated as the position sensor 38, which is then used to describe various aspects of position and operating speed of the filling system 1.

As indicated, the controller 50 can receive signals periodically from the position sensor 38 at predetermined intervals, such that the controller 50 can determine a relative degree of the movement of the piston 14 For example, the controller can receiving signals from position sensor 38 that correspond to one or more of a fully retracted position, a fully advanced position, a retracted base position and an advanced base position. As used herein, a "fully advanced position" is a position in which the piston 14 is made to advance completely into and in relation to the tubular member 12. A "fully retracted position" is a position wherein the piston 14 retracts in relation to the fully advanced position and the piston drive member 32 can be disconnected from the piston 14. A "base advanced position" is a position that is used to indicate an advanced position of the piston 14 which It can be used during filling operations, which may be different from the fully advanced position. In one embodiment, the advanced base position is near the proximal end of the tubular member, distally with respect to the fully advanced position. A

35 "base retracted position" is a position that is used to indicate an available retracted position of the piston 14 that can be used during filling operations, which may be different from the fully retracted position. In one embodiment, the base retracted position is near the distal end of the tubular member, proximally with respect to the fully retracted position.

The utility can be achieved with the use of base positions that are different from fully retracted and advanced positions. For example, the use of an advanced base position that is distal with respect to a fully advanced position during filling operations may restrict the proximal end of the piston 14 from coming into physical contact with the proximal end of the tubular member 12, restricting from that mode the wear of the piston 14 and, thus, the disposable element 10. Also, the use of a base retracted position that is proximal with respect to a fully retracted position

45 can further prevent wear of the disposable element 10 by limiting the number of times the piston 14 and the piston drive member 32 interconnect and selectively disconnect.

An embodiment of a position sensor 38 is described below in reference to Figure 9, the position sensor includes a reading portion 38a and a reference portion 38b. The reading portion 38a may be interconnected with the piston drive member 32 for directly a corresponding joint movement therewith. The reference portion 38b may be interconnected with a base portion of the drive system 30 that is stationary during use of the filling system 1. The reading portion 38a may be a linear optical encoder adapted to project light from one side of the encoder to another side. The reference portion 38b may include a plurality of demarcations of a predetermined size disposed thereon with a predetermined separation. The reference portion 38b may further include a groove 55 and / or transparent strip disposed between each of the demarcations. Therefore, the slots and / or transparent strips are also of a predetermined size and separation. The reading portion 38a can be mounted in relation to the reference portion 38b such that as the reading portion 38a moves relative to the reference portion 38b, the light from the light projection side of the portion Reading 38a will be absorbed and pass through the demarcations and transparent slots / strips, respectively. The other side of the reading portion 38a will thus receive a light signal for each of the transparent slots / strips through which the reading portion passes. Therefore, the reading portion 38a may be able to communicate output signals to the controller 50, which can be processed to determine a number of transparent demarcations / slots or strips passed to determine a relative degree of movement between the

image19

reading portion 38a and the stationary reference portion 38b and thus a relative degree of movement of the piston drive member 32. In turn and as can be seen, in conjunction with one or more of the base advanced position, base retracted , fully advanced, and / or completely retracted, the system may be able to determine a relative position of the reading portion 38a and, therefore, the relative position of the

5 interconnected piston drive member 32. As can be seen, the transparent demarcations and / or grooves and / or strips may comprise a relatively small width (for example, 30 micrometers) and may be separated from each other a relatively small distance (by for example, every 10 micrometers) to facilitate the provision of precise position coordinates to the controller 50. Therefore, the position sensor 38 can facilitate the calculation and dosing of precise quantities (eg, volumes) of medical liquids at through controller 50. As can be seen, the reference portion 38b and the reading portion 38a can be switched, in which case the reference portion 38a is mounted on a stationary base of the drive system 30 and the reading portion is interconnected with the piston drive member 32.

An embodiment of a position sensor is described below in reference to Figure 21. The position sensor of Figure 21 is a rotary encoder 2108. In general, the rotary encoder 2108 may include a rotating disk 15 inside the encoder. rotating 2108 interconnected with a rotating member such as a first sensor belt bushing 2107. The rotating disk may comprise a series of grooves of a predetermined size arranged with a predetermined spacing. The rotary encoder 2108 may also include a light source and a light sensor placed on opposite sides of the rotating disk. As the rotating disk rotates and the slots move between the light source and the light sensor, alternatively the light sensor is able to detect light from the light source and locks in front of the light detection from The light source. The light sensor may in turn provide an output related to the detection of light by the light sensor, for example, for controller 50, which may be indicative of the speed at which the disc is spinning and the amount of rotation of the disk. This information can be used, for example, by the controller 50, to determine the rotation speed and position of the rotating member such as the first sensor belt bushing 2107 to which the rotary encoder 2108 is

25 interconnected. Other types of rotary encoder known to those skilled in the art can also be used to detect the rotation of the sensor belt bushing 2107.

The first sensor belt bushing 2107 may be interconnected with a second sensor belt bushing 2106 through a sensor belt 2104. The sensor belt 2104 and the first and second sensor belt bushings 2107, 2106 may comprise features , such as projections on the sensor belt 2104 and corresponding recessed areas in the first and second sensor belt bushings 2107, 2106, to prevent slippage between the sensor belt 2104 and the first and second sensor belt bushings 2107, 2106. Additionally, sensor belt 2104 may be interconnected with the piston drive member

32. This interconnection can be accomplished through a piston drive member carriage 2101 and a sensor belt clamp 2105. The sensor belt clamp 2105 can be fixedly held on

35 the sensor belt 2104 such that the movement of the sensor belt clamp 2105 results in the movement of the sensor belt 2104 and the corresponding movement of the rotating disc of the rotary encoder 2108. The sensor belt clamp 2105 it can be rigidly coupled to the piston drive member carriage 2101. Therefore, the movement of the piston drive member 32 can result in a proportional output from the rotary encoder 2108.

The piston drive member carriage 2101 may also be fixedly interconnected with the belt 39 which, as described above, may be interconnected with the engine 36a (as illustrated in Figure 2). The mount 40 can be fixedly interconnected with a stationary base 2103 that can also serve as a mount for several other components (e.g., the first and second sensor belt bushings 2107, 2106, the rotary encoder 2108, and a bushing of drive belt 2102). The car of

The piston drive member 2101 may be interconnected with the stationary base 2103 in a manner, such as a linear slide, which only allows the movement of the piston drive member carriage 2101 along a single axis in relation to the stationary base 2103 corresponding to the longitudinal axis of the piston drive member 32. In an alternative embodiment, the piston drive member carriage 2101 can remain stationary and the mount 40 can be made to oscillate to achieve relative movement between the mount 40 and piston drive member 32.

As illustrated in Figure 21, the sensor belt 2104 is separated from the belt 39 that is used to move the piston drive member carriage 2101 relative to the stationary base 2103. Alternatively, the rotary encoder 2108 it can be directly interconnected with, for example, the drive belt bushing 2102. However, the interconnection of the rotary encoder 2108 with the sensor belt 2104 instead

55 of with the belt 39 that is used to drive the piston drive member carriage 2101 can result in greater precision in determining the position of the carriage of piston drive member 2101 because the sensor belt 2104 It is isolated from deformations and vibrations that may affect the belt 39 due to the operation of the motor 36a to which it is interconnected.

The rotary encoder 2108 may not be able to determine the position of the piston drive member 32 under certain situations. For example, after starting the system the position of the piston drive member 32 may be unknown to the controller 50. Under such circumstances, the controller 50 may direct the motor 36a to drive the piston drive member 32 until it can be established. a position of the piston drive member 32. The position can be established through the use of additional sensors (not shown). For example, additional sensors may be located to provide a signal to the controller 50 when the piston drive member 32 is in a predetermined location, such as when the piston drive member 32 is in a position

image20

5 fully advanced or fully retracted. Such limit switches can be used to verify or establish the position of the piston drive member 32. After the position of the piston drive member 32 is established, the exact position of the piston member can then be monitored. piston drive 32 by monitoring the output of the rotary encoder 2108. Another method of establishing the position of the piston drive member 32 may be to drive the piston drive member 32 to hard stops that are in any one of the ends of the travel range of the piston drive member 32 and then use the output of the rotary encoder 2108 from that point to control the position of the piston drive member 32.

As indicated above and again with reference to Figures 1-2, the controller 50 may be interconnected with the motor or motors 36, the position sensor 38 or the rotary encoder 2108, and / or the interface

15 user 70 to facilitate the operation of the filling system 1. In one approach, the controller 50 may be interconnected with the position sensor 38 or the rotary encoder 2108 to facilitate the control of the position of the piston 14 and thus provide the dosage of precise volumes of medical liquids. More particularly, the controller 50 can use the output signals provided by the position sensor 38 or the rotary encoder 2108 in relation to a known diameter of the tubular member 12 to determine an amount of liquid extracted into and dosed from the tubular member 12.

The controller 50 can be used to move the piston 14 to any one of the fully advanced, fully retracted, advanced base or retracted base positions described above or any position between them (for example, in conjunction with the position sensor 38 or the rotary encoder 2108) to achieve the filling of a desired filling volume. For example, the distance between the base advanced position and

The base retracted position may correspond to a full filling operation stroke, which may correspond to a maximum volume of fluid that can be dosed during normal filling operations. Likewise, the fully advanced position can be used during priming operations, which are analyzed below, or when switching between different medical liquids in order to remove a volume of fluid (for example, air or other gases in relation to the priming operations; residual medical fluid when switching between medical liquids) in the portion of the tubular member located between the fully advanced position and the advanced base position (the "empty volume").

In this regard, and again with reference to Figures 4a – 4d, the piston 14 may include a connector 19 and the tubular member 12 may include a corresponding nozzle portion 11. During various filling operations, the piston 14 may be placed in or between an advanced base position (figure 4c) and a retracted base position

35 (figure 4b). Therefore, a fluid can remain in the vacuum volume of the tubular member 12 during filling operations. In order to remove most or all of the fluid in this vacuum volume, the connector 19 can be made to advance and be placed inside the nozzle portion 11 (for example, to the fully advanced position as illustrated in the figure 4d). For example, the connector 19 can be made to advance to and be placed inside the nozzle portion 11 during priming operations to aid in the removal of gases located inside the tubular member 12. Likewise, it can be done that the connector 19 advances to and is placed inside the nozzle portion 11 when switching between medical liquids in order to facilitate the removal of residual medical liquid. In one embodiment, the connector 19 and the nozzle portion 11 comprise corresponding conformable shapes and lengths to facilitate the removal of fluids with respect to the vacuum volume.

As indicated above, the controller 50 can be operated to move the piston 14 to any position between the fully advanced and fully retracted positions (for example, in conjunction with the position sensor 38 or the rotary encoder 2108). In one embodiment, the controller 50 may be operated to move the piston 14 between an advanced base position and another position to facilitate various operations of the filling system 1, the other position being located distally with respect to the advanced base position and shape. proximal with respect to the base retracted position. That is, the controller 50 can be operated to move the piston 14 less than a full-fill operation stroke to facilitate relatively rapid extraction and dosing of fluids. For example, the controller 50 may be operated to move the piston 14 repeatedly between the advanced base position and the other position to facilitate removal of the bubbles inside the tubular member 12, to facilitate the admission and dosing of a relatively small volume of medical fluid (for

55 example, useful during the dosing of expensive medical fluids), or to ensure an adequate discharge of the empty volume described above.

As indicated above, the controller 50 may be interconnected with the motor or motors 36 to control the motor or motors 36. More particularly, the controller 50 may be interconnected with a first motor 36a (for example, a brushless DC motor ) to control one or more operating parameters of the first motor 36a. For example, because the pair of operating forces of the first motor 36a can correspond to the force of the piston drive member 32, the controller 50 can be operated in this way to control the relative retraction and forward force of the piston 14 (for example, through the piston drive member 32). The controller can also control the direction of motor operation

image21

or motors 36 (for example, clockwise or counterclockwise) to control the direction of operation of the piston 14 (eg, advance or retraction) and / or the position of the member valve actuator 34.

5 In one embodiment and with reference to Figure 10, the controller 50 may include a current loop 52, a position loop 54 and a speed loop 56. The current loop 52 may be interconnected with the first motor 36a, the user interface 70, position loop 54 and speed loop 56. Position loop 54 may be further interconnected with position sensor 38 or rotary encoder 2108, speed loop 56 and user interface 70. The speed loop may also be interconnected with the user interface 70.

10 The position loop 54 can be operated to receive output signals from the position sensor 38 or the rotary encoder 2108 to facilitate the determination of at least a relative degree of movement of the piston drive member 32, as analyzed. previously. The position loop 54 may be interconnected with the user interface 70 to receive parameters associated with the positions of the piston drive member (for example, volume unit parameters, source volume parameters, and others

15 values related to filling, which are analyzed below). The position loop 54 may also be interconnected with the user interface 70 to communicate the values associated with the position (for example, a current location of the piston drive member 32). The position loop 54 may be interconnected with the first motor 36a (for example, through the current loop 52) to control the placement of the piston drive member 32 and, correspondingly, the piston 14.

20 The current loop 52 can be operated to control the amount and polarity of the current that is supplied to the first motor 36a to control one or more motor operations (for example, the operating rate, the operating direction). The current loop 52 may be interconnected with the user interface 70 to receive parameters associated with the operation of the first drive motor (for example, pressure parameters, fluid direction parameters, and other filling-related values, which They are analyzed below.) He

25 current loop 52 may also be interconnected with the user interface 70 to communicate the values associated with the engine and / or piston operation (for example, an operation rate, an operation direction, etc.).

The current loop 52 can be operated to control the first motor 36a to thereby control the forward and / or retraction force of the piston 14. In this regard, the current loop 52 can receive parameters at 30 via the interface. of user 70 and driving the first motor 36a in relation thereto to achieve a desired pressure range inside the tubular member 12. More particularly, during the retraction of the piston 14 a negative pressure difference is created between the tubular member 12 and the source or sources of medical liquid 60 to cause fluids to flow from the source or sources of medical liquid 60 into the tubular member 12. If this pressure difference is too high, medical liquids flowing from the source or sources of medical liquid 60 can evaporate, thereby producing unwanted gases inside the filling system 1. Therefore, during retraction of the piston On 14, it is desired to maintain a range of predetermined retraction pressures inside the tubular member 12. In one arrangement, the predetermined retraction pressure may be less than 0 gauge manometers but not less than –82.7 kPa gauge. In another arrangement, the predetermined retraction pressure may be less than 0 gauge pressure but not

40 less than –55.2 kPa manometers.

Additionally, during the advance of the piston 14, a positive pressure is created inside the various fluid-containing components (for example, the tubular member 12, the valve 20, the second fluid line 82 and the associated interconnections). These components may have maximum pressure thresholds. Therefore, during the advance of the piston 14 it is also desired to maintain a predetermined advance pressure range within the interior of the tubular member 12. Preferably, the predetermined feed pressure may be more than 0 kPa manometric but not larger than 310 , 2 kPa gauge. More preferably, the predetermined feed pressure may be more than 0 kPa gauge but not larger than 413.7 kPa gauge. In addition, it may be desired to operate the piston 14 at or near the threshold speeds in relation to the pressure thresholds in order to quickly extract and dose medical liquids. Therefore, it is desired that the speed of the piston 14

50 ascend rapidly to achieve the desired pressure ranges inside the tubular member 12 to achieve a desired extraction and dosing rate without exceeding such threshold pressures.

The amount of pressure created in the tubular member 12 during the advance and retraction of the piston 14 can be a function of a variety of variables, including the viscosity of the fluid being extracted or dosed, the torque and / or the speed of advance of the piston 14 and the cross-sectional area of the internal surfaces 55 of the tubular member 12. As can be seen, the types of medical liquids that can be used in the filling system can be numerous. Correspondingly, the viscosity of the fluids used inside the filling system can vary greatly. Therefore, the use of viscosity in the calculation of the pressure inside the filling system 1 may require compiling a database of known medical liquids and their corresponding viscosities, as well as requiring an entry as regards the type of liquid

60 doctor who is being employed. Therefore, it may not be desirable to use viscosity in the determination of pressure.

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One approach to achieve a desired pressure inside the filling system 1 without using the viscosity information is to use the known internal cross-sectional area of the tubular member 12 in relation to a known force that is being supplied to the piston 14. There are multiple procedures for determining the force that is being supplied to the piston. For example, a fixed force transducer can be used (for example,

5 with the piston drive member 32 and / or the piston 14), and in conjunction with the controller 50 and the first motor 36a, the piston 14 can thus move with a desired force. In another embodiment, a known force that is being supplied by the first engine 36a can be used to the piston drive member 32. More particularly, an engine adapted to determine its operating force (for example, a known torque value) it can be used as the first motor 36a, in which the controller 50 can be used in a closed loop-like manner with the first motor 36a, to drive the first motor 36a within a predetermined range of forces to correspondingly drive the piston 14 within a predetermined range of pressures.

For example, the first motor 36a may include a movable outlet member (for example, a frame) that can be interconnected with the piston drive member 32, a magnetic field member (for example, a stator) to induce movement of the mobile output motor, and a sensor (for example, an optical, electrical and / or magnetic sensor) to detect a position of the mobile output member in relation to the magnetic field member and to provide an output signal to a controller 50 in a corresponding relationship with it. The output signal may be indicative of, for example, one or more of a force, speed and / or position of the mobile output member in relation to the magnetic field member. The controller 50 may be operated to compare the output signal with a predetermined operating parameter (for example, a parameter related to filling, which is discussed below) and to provide an appropriate control signal to the magnetic field member in relation to the same for driving the first motor 36a within a predetermined operating range (for example, an operating range corresponding to a forward force or a retracting force of the piston). In one embodiment, the control signal corresponds to an amount of current that

25 is being supplied to the magnetic field member.

Therefore, the tubular member 12, the piston 14, the first motor 36a, and the controller 50 can be used to drive the filling system 1 at a desirable forward and / or retracting pressure. More particularly, the current loop 52 of the controller 50 may be used in conjunction with the first motor 36a to achieve a predetermined range of motor forces during the advance and / or retraction of the piston 14 to correspondingly move the piston 14 within a desirable range of forces and to thereby create a pressure within a predetermined range inside the tubular member 12. For example, after starting the filling and / or priming operations, the current loop 52 can communicate the supply of a predetermined amount of current to the first motor 36a, after which the first motor 36a can be driven to achieve a desired torque range (for example, according to a preprogrammed / predetermined slope profile). This range of torque can correspond to a desired range of forces and thus with a desired pressure inside the tubular member 12 during the advance and retraction of the piston 14. As discussed in more detail below, the pressure parameter or parameters can be used by the controller 50 (for example, in relation to the predetermined slope profile) to additionally control the pressure inside the tubular member 12. Therefore, the piston 14 can be operated within a range of forces to achieve a desired pressure inside the tubular member 12. Additionally, the filling system 1 can be operated to automatically control the retraction and advance of the piston drive member 32 to achieve fluid flow intervals first and second, respectively, (for example, extraction rates corresponding to the intervals of p predetermined retraction resitions mentioned above, and dosing rates corresponding to the intervals of

45 predetermined feed pressures mentioned above).

In another approach, the known internal cross-sectional area of the tubular member 12, a velocity of the piston 14 and the fluid being dosed can be used to determine the pressure. In this regard, the tubular member 12, the piston 14, the first motor 36a, the position sensor 38 or the rotary encoder 2108, and the controller 50 can be used to move the piston 14 at a desirable forward or retracting speed and The user interface may be adapted for the input of a fluid type parameter, which is analyzed below, in relation to the fluid being used inside the tubular member. More particularly, the position sensor 38 or the rotary encoder 2108 can provide output signals in relation to the degrees of motion relative to the position loop 54, which can be communicated to the speed loop 56. The speed loop 56 can correlate these degrees of relative motion readings over time (for example, every 50 μs) to determine a value

Speed (for example, relative speed) indicative of a relative movement speed of the piston drive member 32 and / or of the piston 14 in relation to a desired speed value (for example, a desired speed). The fluid type parameter (for example, one or more of a viscosity, density or other parameter) can also be communicated to the controller 50 (for example, to the current and / or speed loop) to facilitate the calculation of the mass of the fluid which is being used to further facilitate the calculation of the force. The controller 50 can thus determine and control the first motor 36a to drive the piston 14 at a desired speed in relation to the fluid type parameter.

One of the calculated motor force and the piston speed can be used by the controller 50 as a primary pressure control parameter to control the pressure inside the tubular member 12. In one embodiment, the other of the motor force and The calculated piston speed can be used as a secondary pressure control parameter to help control the pressure inside the tubular member 12. More particularly, a primary pressure control parameter can be used to achieve a desired pressure, in which the first motor 36a can be driven in relation to the present primary pressure control parameter to achieve

image23

5 a desired pressure. A secondary pressure control parameter can be used as a limit for the primary pressure control parameter (for example, an upper limit) to ensure that the pressure inside the tubular member 12 remains within a predetermined range.

For example, the calculated motor force may be the primary pressure control parameter used by the controller 50, in which the controller 50 and the first motor 36a operate in a closed loop-like manner, such as described above, to achieve a predetermined pressure range inside the tubular member 12. The calculated piston speed may be the secondary pressure control parameter, in which case the controller compares the measured piston speed with a predetermined piston speed parameter , so that if the controller 50 determines that the calculated piston speed exceeds the predetermined piston speed parameter, the controller 50 automatically decreases the force that is being supplied by the first motor 36a (for example, through of maintaining or decreasing the amount of current that is being supplied to the first motor 36a) to correspondingly decrease the v piston elocity 14 in relation to the secondary pressure control parameter. In one embodiment, the controller 50 can automatically complete the filling operations if the measured piston speed exceeds a predetermined piston speed parameter, and can provide an indication to a user, through the user interface, that be

20 exceeded the piston speed parameter, as described in more detail below. Therefore, the controller can use the output signals of the position sensor 38 or the rotary encoder 2108 to cross-check the output of the first motor 36a to ensure that the filling system 1 is operating within a range of pressures. predetermined.

Other procedures can also be used to determine the pressure inside the filling system. By

For example, a pressure transducer can be used inside the disposable element (for example, inside the tubular member 12 and / or the valve 20) and interconnected with the controller 50 to determine the operating pressure. A pressure transducer can also be used in conjunction with controller 50 to determine subsequent pressures to extract and dose fluids in order to facilitate the determination of a suitable delay, if any, between extraction and dosing operations. Such a delay may facilitate

30 the compensation of fluid pressures between fluid extraction and dosing operations, which can further facilitate the dosing of precise and repeatable volumes of medical liquids. As can be seen, such a delay and the corresponding pressure compensation can allow any bubble produced to settle, and can restrict the cavitation of the medical liquid. This delay can be rigidly coded in the controller 50 and / or it can be a parameter of the time delay parameters, which are analyzed at

35 continued. A pressure transducer can also be used inside the valve 20 to facilitate recoil operations. As discussed in more detail below, in recoil operations, a recoil parameter (for example, a fixed volume parameter or a pressure reading from the indicated pressure transducer) can be used by the controller 50 to restrict drips between dosing operations, in which case the controller 50 retracts the piston a predetermined amount to extract a volume

40 fixed medical liquid back to the filling system 1.

In another embodiment, the first motor 36a can be used to determine a relative position and / or speed of the piston 14. As indicated above, brushless DC motors and the like can be driven to determine an operating force (for example, a pair of forces). Because the calculation of the operating force of the first motor 36a may comprise the use of the position and speed readings of the first motor

45 36a, such position and speed readings can be output as signals to controller 50 to facilitate the determination of the position and relative speed of the interconnected piston 14. Such readings (for example, force, position, speed, torque, etc.) can also be communicated from controller 50 to user interface 70 for display thereof. Likewise, the use of such readings may obviate the need for position sensor 38.

50 The speed loop 56 can be operated to receive output signals from the position sensor 38 or the rotary encoder 2108 to facilitate the determination of a relative movement rate of the piston drive member 32, as discussed above. The speed loop 56 may be interconnected with the user interface 70 to receive parameters associated with an operating speed of the piston drive member (eg, pressure parameters and other values related to filling, which are

55 discussed below). The speed loop 56 may also be interconnected with the user interface 70 to communicate the values associated with the speed (for example, an operating speed of the piston 14 and / or the piston actuating member 32). The speed loop 56 may be interconnected with the first motor 36a (for example, through the current loop 52) to control the operation rate of the piston drive member 32 and, correspondingly, the piston 14 (for example , as a control parameter of

60 secondary pressure, discussed above).

As indicated above and again with reference to Figures 1–2, the filling system 1 may include a user interface 70. The user interface 70 may include a graphical user interface adapted to accept various parameters, inputs and / or values related to filling ("parameter or parameters related to filling") in relation to the operation of the filling system 1. For example, the user interface 70 may comprise a touch screen display interconnected with a system software operating (for example, WINDOWS, Microsoft Corp., Redmond, Washington, United States of America) using the 50 controller. Such

image24

5 as can be seen, the parameters received through the user interface 70 can thus be communicated to the controller 50 for processing to thereby facilitate the operation of the filling system 1.

An embodiment of a user interface 70 usable with the filling system 1 is described below with reference to Figures 11a-11b. The user interface 70 may include a main screen 71 comprising a plurality of instruction buttons 72a-72h, a configuration button 72i, which may invoke a display of

10 configuration 73, and a variable function button 78, which can be operated to initiate various operations of the filling system 1 through the controller 50.

Each of the instruction buttons 72a – 72h may be associated with one or more parameters or parameters related to the filling and may be communicated to the controller 50 to facilitate the operation and control of the filling system 1. For example and as analyzed in more detail below, a first instruction button 72a may be associated with one or more continuous transfer mode parameters ("continuous transfer mode parameter or parameters"), a second instruction button 72b may be associated with one or more source volume parameters ("source volume parameter or parameters"), a third instruction button 72c may be associated with one or more pressure parameter or parameters ("pressure parameter or parameters"), a fourth button instruction 72d may be associated with one or more fluid address parameters ("fluid address parameter or parameters"), a quint or instruction button 72e may be associated with one or more volume unit parameters ("volume unit parameter or parameters"), a sixth instruction button 72f may be associated with one or more time delay or interval parameters of time ("time delay parameter or parameters"), a seventh instruction button 72g may be associated with one

or more batch size parameters ("batch size parameter or parameters"), and an eighth instruction button

25 72h may be associated with one or more recoil parameters ("parameter or recoil parameters"). The batch size parameters can also be referred to as "batch quantity parameters". Such parameters can be communicated to the controller 50, which can use such communicated parameters to facilitate the operation of the filling system 1. Other instruction buttons (not shown in Figure 11a) may include filling related parameters, such as a instruction button that may be

30 associated with one or more speed parameters ("speed parameter or parameters").

For example, the continuous transfer mode parameter or parameters may be associated with a continuous or non-continuous operation mode of the filling system 1. In one embodiment, the continuous transfer mode parameter or parameters may be activated (for example, they are in the on state) in which the controller 50 controls the filling system 1 for the extraction and complete repeated dosing of medical liquid 35. The present mode is useful, for example, when in the fluid lines a first fluid line is interconnected with a first orifice of the source or sources of medical liquid 60 and a first orifice of the valve 20, and a second fluid line it is interconnected with a second orifice of the source or sources of medical liquid 60 and a second orifice of the valve 20, in which case the medical liquid can be extracted from the source or sources of medical liquid 60 into the disposable element 10 through of the first fluid line and the first 40 holes, and the same medical liquid can be dosed from the disposable element 10 to the same source or sources of medical liquid 60 through the second fluid line and the second holes so that the filling system 1 can repeatedly extract a medical liquid from and dose that same medical liquid back to the source or sources of medical liquid 60 to ensure Chalking that such medical liquid has mixed enough. In a particular embodiment of this continuous transfer mode, the piston 14 is repeatedly retracted from and 45 is advanced to the advanced base and retracted base positions, respectively, in order to extract and dose a relatively large volume of medical fluid. Additionally, one or more of the other filling-related parameter or parameters may be disabled (for example, the source volume parameter or parameters, the volume unit parameter or parameters, the time interval parameter or parameters, the parameter or Batch size parameters and / or the parameter or recoil parameters) when the parameter or

50 continuous transfer mode parameters are activated, because these other parameters may not be required to operate the filling system 1 when the continuous transfer mode parameter or parameters are activated.

When the continuous transfer mode parameter or parameters are not active (for example, they are in the off state), the controller 50 can operate the filling system 1 in a non-continuous manner. For example, the first and second fluid lines 80, 82 may be interconnected with the disposable element 10, the source or sources 60 and the receptacle or receptacles 62 of medical liquid, as described above in relation to Figures 1– 2, in which case the controller 50 can control the filling system 1 to fill the receptacle or receptacles 62 with medical liquid from the source or sources of medical liquid 60 until a desired amount of receptacle or receptacles 62 have been filled (by example, determined using the parameter or 60 batch size parameters). The controller 50 can also control the filling system 1 to fill the receptacle or receptacles 62 until the medical source or sources 60 have drained substantially of a predetermined volume of liquid (for example, determined using a source volume parameter or parameters ), and / or the controller 50 can control the filling system 1 to fill an individual one of the receptacle or

image25

In one embodiment, the controller 50 may be operated to conduct the filling operations without receiving an input in relation to the continuous transfer mode parameter or parameters. In this regard, a default non-continuous transfer mode can be used (for example, the transfer parameter or parameters

5 continuous are not active).

The source volume parameter or parameters may be associated with the volume of medical liquid in the source or sources of medical liquid 60 and may be communicated to the controller 50 to facilitate the operation of the filling system 1 (for example, determining a number of receptacles which can be filled before the source or sources of medical liquid 60 are substantially empty of medical liquid). In one embodiment, the controller 50 10 can be operated to conduct the filling operations without receiving an input in relation to the source volume parameter or parameters. For example, the controller 50 may operate the filling system 1 in the continuous transfer mode described above, the controller 50 may operate the filling system 1 to fill the receptacle or receptacles 62 until a desired amount of receptacle or receptacles 62 have been filled (for example, determined using the batch size parameter or parameters), the controller 50

15 the filling system 1 can be operated to fill an individual one of the receptacle or receptacles 62 until another input is received, or a default source volume parameter or parameters may be used.

The pressure parameter or parameters may correspond to one or more desired operating pressures. As discussed above, the controller 50 and the disposable element 10 can be designed to ensure that the piston 14 achieves a predetermined force or speed to achieve a desired pressure. The pressure parameter or parameters (for example, one or more speed and / or force parameters) may be associated with a particular speed or operating force of the piston 14 and thus with a particular pressure. In this regard, the user interface 70 can communicate the pressure parameter or parameters to the controller 50, which can use such parameter or pressure parameters (for example, through the current loop

or speed 52, 56 described above) to control a pressure of the filling system 1.

In a particular embodiment, the pressure parameter or parameters may include both speed and force parameters, which can be communicated with and that use the controller 50 to control the pressure. For example, the pressure parameter or parameters may include one or more of a maximum or minimum forward speed parameter, a maximum or minimum advance force parameter, a maximum or minimum retraction speed parameter and / or a parameter of maximum or minimum retraction force, which controller 50 can use to

30 maintain a pressure within such thresholds. Therefore, the user interface 70 can be operated to accept a specific parameter of operation of force and piston speed, which can be used by the controller to control a pressure of the filling system 1. In one embodiment, the controller 50 can be operated to conduct the filling operations without receiving an input in relation to the pressure parameter or parameters. In this regard, the maximum and / or minimum speed and / or force values can be used

35 by default.

The speed parameter or parameters may correspond to one or more desired piston operating speeds. The speed parameter or parameters may be closely related to the pressure parameters parameter, since the speed of the piston 14 may be related to the pressure. As discussed above, the controller 50 and the disposable element 10 can be designed to ensure that the piston

40 14 achieves a predetermined speed. The speed parameter or parameters may be associated with a particular operating speed of the piston 14 and thus with a particular pressure. In this regard, the user interface 70 can communicate the speed parameter or parameters to the controller 50, which can use such speed parameter or parameters to control a pressure of the filling system 1.

The fluid direction parameter or parameters may be associated with a first fluid direction and a

45 second fluid direction. As described in more detail below, the filling system 1 can be operated to dose medical liquids from the source or sources of medical liquid 60 to the receptacle or receptacles 62 and vice versa. The first fluid direction may be associated with the transfer of medical liquids from the source or sources of medical liquid 60 to the receptacle or receptacles 62. The second fluid direction may be associated with the transfer of medical liquids from the receptacle or

50 receptacles 62 to the source or sources of medical liquid 60. As can be seen, the first fluid direction can be useful when it is desired to dose a large amount of fluid into a single container (for example, the medical liquid at the source or sources of medical liquid 60) to a plurality of other containers (for example, the receptacle or receptacles 62), such as in the production of liquid medication of a desired volume and concentration. The second direction may be useful when it is desired to collect a small amount of fluid contained

55 in a plurality of containers (for example, the receptacle or receptacles 62) in a single container (for example, the source or sources of medical liquid 60), such as when it is desired to collect a liquid medication contained in a plurality of ampoules in A single deposit. In one embodiment, the controller 50 may be operated to conduct the filling operations without receiving an input in relation to the fluid direction parameter or parameters. In this regard, the first fluid direction described above can be used as a value.

60 by default.

image26

The volume unit parameter or parameters may be associated with the volume of liquid to be provided to each of the receptacle or receptacles 62, which can be communicated to the controller 50 to facilitate the operation of the filling system 1 (for example, by calculating the amount that should be made for the piston drive member 32 to advance to fill one or more of the receptacle or receptacles 62). For the

Thus, the controller can be operated to dose a predetermined volume of medical liquid from the tubular member 12 to the receptacle or receptacles 62. In one embodiment, the controller 50 can be operated to conduct the filling operations without receiving an input corresponding to the volume unit parameter or parameters. In this regard, the controller 50 may operate the filling system 1 in the continuous transfer mode described above or the default volume unit parameter or parameters may be used.

The time delay parameter or parameters may be associated with a delay time between the dosing of medical liquids inside the receptacle or receptacles 62. For example, a time delay of 2 seconds can be used between the dosing operations to provide time sufficient for the receptacle or receptacles 62 to move to an appropriate position. In one embodiment, controller 50 may

15 actuated to conduct the filling operations without receiving an input in relation to the time delay parameter or parameters. In this regard, the controller 50 may operate the filling system 1 in the continuous transfer mode described above or the default time delay parameter or parameters may be used.

The batch size parameter or parameters may be associated with the receptacle number or receptacles 62 to be filled, which can be communicated to the controller 50 to facilitate the operation of the filling system 1 (for example, by calculating if sufficient medical liquid is found at the source or sources of medical liquid 60 and / or the tubular member 12 to fill one or more of the remaining receptacle (s) 62; calculating the remaining number of receptacle or receptacles 62 to be filled before the end of the filling operations). In one embodiment, the controller 50 may be operated to conduct the filling operations without receiving an input in relation to the batch size parameter or parameters. In this regard, the controller 50 can operate the filling system 1 in the continuous transfer mode, the controller 50 described above can operate the filling system 1 to fill an individual one of the receptacle or receptacles 62 until another input is received , the controller 50 can operate the filling system 1 to fill the receptacle

or receptacles 62 until the source or sources of medical liquid 60 have been substantially emptied of a predetermined volume of liquid (for example, determined using a source volume parameter or parameters) or the batch size parameter or parameters may be used by default.

The recoil parameter or parameters may be associated with the retraction of the piston 14 after a dosing operation has been completed. In one embodiment, the recoil parameter or parameters may be activated (for example, they are in the on state) in which case the piston 14 will retract in relation to another parameter (for example, a pressure parameter or recoil volume) at the end of a dosing operation. Retraction of the piston 14 after a dosing operation may be useful to facilitate the dosing of a desired amount of medical liquid and limit contamination of the receptacle or incoming receptacles 62. For example and as discussed below, the second line of fluid 82 may be interconnected with a second dosing apparatus (for example, a needle). After completion of a dosing operation, the medical liquid may be suspended outside of the present second dosing apparatus (for example, in the form of droplets). In some cases, it may be desirable to extract this suspended medical liquid back to the second dosing apparatus. Therefore, the recoil parameter or parameters can be used by the controller 50 to retract the piston 14 a predetermined amount (for example, equivalent to a specific volume), or in relation to the pressure readings from a pressure transducer , after a

45 Dosing operation to facilitate the removal of the suspended liquid back to the filling system 1. In this regard, the position sensor 38 or the rotary encoder 2108, as described above, can be used to facilitate the retraction of the piston 14 to The desired position. Because the suspended liquid can be removed back to the filling system 1, there is a reduced risk of contamination of the receptacle or incoming receptacles 62. In one embodiment, the recoil parameter or parameters can be deactivated, in which the piston 14 is not will retract slightly after a dosing operation.

Other parameters can also be used. For example, one or more fluid type parameters or parameters ("fluid type parameters or parameters") can be used to facilitate the entry of various fluid parameters (for example, physical properties of the medical liquid, such as density, viscosity, pressure of steam, etc.) and / or environmental conditions (for example, temperature, atmospheric pressure, elevation, etc.) In one approach, the fluid type parameter or parameters may be the name or name of the liquid or medical liquids that are being used, and the controller 50 may comprise a database that relates various physical properties of the medical liquid with the names of the liquid or medical liquids. In one embodiment, the fluid type parameter or parameters may be used in conjunction with other parameters to facilitate the operation of the filling system. For example, the fluid type parameter or parameters can be used with the pressure parameter or parameters to facilitate the operation of the piston 14 within a predetermined force and / or speed range to restrict unwanted results (e.g., foaming, bubbles, cavitation, etc.) In a particular embodiment, after the input of the fluid type parameter or parameters, the controller 50 can automatically select the pressure parameter or parameters and / or the appropriate recoil parameter or parameters.

image27

recommended, you can ask a user for the pressure parameter or parameters and / or the recommended recommended return parameter or parameters, or you can request an entry in relation to the pressure parameter or parameters and / or the recommended recommended return parameter or parameters .

One or more values related to size can also be used. As a primary example, they can

5 one or more disposable element size parameter or parameters ("disposable element size parameter or parameters") may be used and may correspond to one or more sizes associated with the disposable element (eg, one or more diameters of the tubular member 12 ; the length of the tubular member 12). In a particular embodiment, the disposable element size parameter or parameters may be used to facilitate the determination of one or more suitable pressure parameter or parameters or recoil parameter or parameters.

10 recommended. For example, a disposable element can be selected from a plurality of disposable elements of different sizes and a corresponding disposable element size parameter or parameters can be entered through the user interface, after which the controller can select so automatic the pressure parameter or parameters and / or the recommended setback parameter or parameters, ask a user for the pressure parameter or parameters and / or the parameter or

15 recommended suitable setback parameters, or you can request an entry in relation to the pressure parameter or parameters and / or the recommended recommended setback parameter or parameters.

As a secondary example, one or more fluid line parameters or parameters can be used (“parameter

or fluid line parameters ”) and may correspond to an inside diameter of one or more interconnected fluid lines and the fluid line parameter or parameters can be used to facilitate the determination of one or more pressure parameters or parameters or parameters or recommended recommended recoil parameters. For example, a tubing line can be selected from a plurality of tubing lines and the corresponding fluid line parameter or parameters can be entered through the user interface, after which the controller can automatically select the pressure parameter or parameters and / or the recommended recommended return parameter or parameters, you can ask a user for the parameter or

25 recommended pressure parameters and / or the recommended recoil parameter or parameters, or you can request an entry in relation to the pressure parameter or parameters and / or the appropriate recommended recoil parameter or parameters.

By way of a tertiary example, one or more receptacle type parameters or parameters can also be used, in which the parameter or parameters can be entered in relation to the receptacle type. In one embodiment, the receptacle type parameter or parameters may correspond to one or more of a vial, ampoule, or syringe of a specific size. For example, the receptacle type parameter or parameters may correspond to a specific syringe size. In a particular embodiment, the receptacle size parameter or parameters may be used to facilitate the determination of one or more suitable pressure parameters or parameters or recommended recoil parameters or parameters. For example, after the input of the receptacle type parameter or parameters, the controller 50 can automatically select the pressure parameter or parameters and / or the recommended recommended return parameter or parameters, you can ask a user for the parameter or pressure parameters and / or the recommended recommended return parameter or parameters, or you can request an entry in relation to the pressure parameter or parameters and / or the parameter

or recommended recommended recoil parameters.

In another embodiment, a sensor can be used to facilitate the determination of any of the parameter or parameters related to the size detected above. For example, an operable sensor for determining a size of a fluid line and / or interconnected disposable element can be used by the drive system 30 (for example, in mount 40). The sensor may be further operated to provide output signals to controller 50 that correspond to such fluid line size and / or element size.

45 disposable set. The controller 50 can then automatically select the pressure parameter or parameters and / or the recommended recommended return parameter or parameters, you can ask a user for the pressure parameter or parameters and / or the recommended recommended return parameter or parameters , or you can request an entry in relation to the pressure parameter or parameters and / or the parameter

or suitable recoil parameters recommended based on such parameter or parameters related to the size detected.

As can be seen, many of the above parameters can be used alone or in conjunction with one or more other parameters. Additionally, in addition to the examples provided above, the controller 50 can automatically select one or more suitable filling related parameters or parameters based on the input of one or more other filling related parameters or parameters, you can ask a

A user or parameter related to filling is recommended based on the input of one or more of another parameter or parameters related to filling, and / or can request an entry in relation to a suitable parameter or parameters related to filling in based on the input of one or more other parameters or parameters related to filling.

As indicated above, the user interface may include a configuration screen 73, which may

60 can be invoked from the main screen using the configuration button 72i. An embodiment of a configuration screen 73 is illustrated in Figure 11b. The configuration screen 74 may include configuration buttons 74a – 74f, which may be associated with particular configuration functions of the filling system 1. For example, the configuration screen may include a first configuration button 74a corresponding to one or more parameters or shutdown parameters, which can turn off the user interface 70 and / or several other components of the filling system 1. A second configuration button 74b may correspond

image28

5 with one or more decoupling parameters ("decoupling parameter or parameters"), which can be communicated to the controller 50 to facilitate decoupling of the disposable element from the drive system 30. In a particular embodiment, when the parameter or decoupling parameters, the controller 50 can fully retract the piston drive member 32 and / or can rotate the valve drive member 34 to the third position described above (eg, a neutral position) to facilitate removal of the disposable element 10 with respect to the drive system 30.

In one embodiment, upon activation of the decoupling parameter or parameters, the valve 20 may be placed in the third valve position before the complete retraction of the piston 14. As indicated above, the third valve position may restrict the communication of fluids between the valve holes 26, 27 and the tubular member 12 thereby sealing a proximal end of the tubular member. The sealing member 16 seals a distal end of the tubular member 12, and thus the tubular member 12 can be sealed substantially tightly when the valve 20 is in this third valve position. Therefore, as the piston 14 retracts, a negative pressure will be created inside the tubular member 12, and upon decoupling of the piston drive member 32 from the piston 14, the piston 14 can be made due to such negative pressure, advance inside the tubular member 12. The present advanced position may be different from a shipping position, which may thus indicate to a user that the disposable element 10 has been used previously, thereby restricting involuntary subsequent use of the disposable element 10 previously used. Correspondingly and as indicated above, the valve stem 24 can be sent in a first position inside the valve housing 22 (for example, inside the valve

25 first portion of the valve housing 22 corresponding to the diameter H1) and used in a second position inside the valve housing (for example, inside the second portion of the valve housing 22 corresponding to the diameter H2). The negative pressure difference described above may also keep the valve stem 24 in the second position, which may also indicate to a user that the disposable element has been used. Additionally, the diameter of the valve housing 22 may be such that the movement of the valve stem 24 is restricted back to the first position after use, thereby indicating to a user that the disposable element has been used without using a negative pressure

A third configuration button 74c may correspond to one or more statistics parameter or parameters, which may invoke a statistics display screen.

A fourth configuration button 74d may correspond to one or more priming parameters ("parameter or

35 priming parameters ”). As discussed in more detail below, priming operations are used to fill the various components of the filling system 1 with liquid before filling the receptacle or receptacles 62. In this regard, the priming parameter or parameters can be communicated to the controller 50 to initiate automatic or semi-automatic priming operations (for example, priming of the filling system 1 with a predetermined amount of medical fluid).

A fifth configuration button 74e may correspond to one or more default parameters ("default parameter or parameters"). The default parameter or parameters may include default, minimum and / or maximum values associated with any of the filling-related parameters described above, such as one or more of the continuous transfer mode parameter or parameters, the parameter. or source volume parameters, the pressure parameter or parameters, the unit parameter or parameters of

45 volume, the time delay parameter or parameters, the batch size parameter or parameters and the recoil parameter or parameters, to name a few.

A sixth configuration button 74f may correspond to one or more other adjustment parameters ("parameter or adjustment parameters)", such as an amount of liquid to be used in relation to the priming parameter or parameters, and / or a pressure to be achieved or a volume of liquid to be extracted in relation to the parameter or recoil parameters.

As also indicated above and referring again to Figure 11a, the main screen 71 may include a variable function button 78, which can be used to initiate various operations of the filling system 1 through the controller 50. For example, The various functions button 78 may correspond to one of an instruction for starting, pausing, resuming, stopping or hitching the disposable element. The start instruction can tell the controller 50 to start the filling operations according to the parameter variety

or parameters related to filling, which are discussed above, until another input is received. The pause instruction can tell the controller 50 to pause the operation of the filling system 1. The resume instruction can tell the controller 50 to resume the operation of the filling system 1 (for example, after a pause instruction was received ). The stop instruction may tell the controller to stop filling operations 1 (for example, in relation to an active continuous transfer mode). As can be seen, the stop instruction can stop and completely reset the filling system 1 such that another parameter or parameters related to the filling can be entered and / or new filling operations can begin, while a pause instruction pauses. The filling sequence and the parameters of the filling operations cannot be changed. The insert instruction of the disposable element may instruct the controller to move the piston drive member 32 to engage with the element

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5 disposable 14 (for example, moving from a fully retracted position to a retracted base position).

A tag can be used to tag the variable function button 78 to indicate a currently available instruction (for example, a "Start" tag that corresponds to a start instruction), and / or the tag can indicate a necessary operation that has to take place so that the filling system 1 can

10 be activated (for example, a text label of "Load Disposable Element" to indicate that a disposable element 10 must be interconnected with the filling system 1 to enable filling operations). The variable function button can also be disabled according to the status of the filling system 1 (for example, when a disposable element is not interconnected with the filling system 1). The label can include any character and / or graphic needed to convey the desired message.

15 As indicated above, a label can be used in conjunction with the variable function button to illustrate various instructions, an action to be taken, the status of the filling system 1, etc. To further facilitate indicating such instructions and / or an action to be taken and / or the status of the filling system 1, an optional graphics portion 79 may be included in the main screen 71. The graphics portion 79 may be used to illustrate such instructions, actions to be taken or the status of the system

20 Filling 1. For example, the animated graphics portion 79 may illustrate graphics and / or text that correspond to the interconnection of the disposable element 10 with the filling system 1 (eg, graphics illustrating how to interconnect the disposable element 10 with the mount 40 and / or that a disposable element 10 needs to be interconnected with the filling system 1 to enable the filling operations). The graphics portion 79 may illustrate a piston coupling status 14 / piston drive member 32 (for example, if the

25 piston 14 and the piston drive member 32 are coupled and / or how to couple the piston and the piston drive member), a priming status of the system (for example, if the system is primed and / or how to prime the system), an operation direction (for example, the advance of the piston 14, the retraction of the piston 14), a relative position of the piston 14 and / or the piston actuating member 32 (for example, the static position and / or dynamic of the piston 14), the volume of medical liquid contained in the disposable element 10 (for example, the

30 volume of medical liquid contained in the tubular, static or dynamic member), a status of speed and / or torque (for example, the speed and / or torque of current and / or current retraction of the piston 14 , static or dynamic), a pressure status (for example, the current pressure inside the tubular member 12 during the advance and / or retraction of the piston), an estimated amount of liquid contained in the source or sources of medical liquid 60 and / or an amount of receptacle or receptacles 62 that can be filled before an estimated emptying of the

35 medical liquid in the source or sources of medical liquid 60, and / or a remaining number of receptacle or receptacles 62 to be filled. Other instructions and / or status information may also be illustrated by the graphics portion 79. For example, a recommended disposable element size 10 and / or tube size may be illustrated based on the fluid type parameter or parameters. Therefore, the user interface 70 can be operated to indicate an instruction, to indicate an action to be taken to enable system operation.

40 of filling 1 and / or to indicate a current status of the filling system 1 and, therefore, the user interface 70 can be interconnected with the controller 50 and actuated to display various parameters, instructions and / or statistics.

An embodiment of a logical system employable with the user interface 70 and the controller 50 is described below in relation to Figures 12a-12c. Referring next to Figure 12a, the logical system 45 begins with the determination of whether the disposable element 10 is interconnected with the mount 40. For example, the controller 50 may be interconnected with one or more switches on the mount 40 (by for example, one or more mechanical, optical and / or electrical switches) and when the disposable element 10 is interconnected with the mount 40, the switches can be switched (for example, through a physical coupling with the disposable element 10), after which switches send one or more signals to the

50 controller 50 indicating that the disposable element 10 is interconnected with the mount 40.

If the disposable element is not interconnected with the mount 40, the controller 50 can disable one or more operations of the filling system 1 and / or disable one or more buttons of the user interface 70 (for example, the various functions button 78 from main screen 71). Subsequent to the determination that a disposable element 10 is not interconnected with the mount 40, the controller 50 can additionally display an instruction on the main screen 71 indicating a necessary action to be taken for the filling system 1 to be become operational In one embodiment, the variable function button 78 may be disabled and may include a label, such as "Load Disposable Element", to indicate that the disposable element 10 should be interconnected with the mount 40. The graphics portion 79 described above. It can also be used to indicate that the disposable element 10 should be interconnected with the mount 40.

60 After the disposable element 10 is interconnected with the mount 40, a signal from the one or more switches on the mount 40 can be sent to the controller 50.

After establishing a physical interconnection between the disposable element and the mount 40, the controller 50 can determine if the piston 14 is engaged by the piston drive member 32. In this regard, the controller 50 can receive signals from the position sensor 38 or the rotary encoder 2108 such that the controller 50 can determine the relative position of the piston drive member 32 relative to the piston 14, as described above.

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5 If the piston 14 is not engaged by the piston drive member 32, the controller 50 may display an instruction indicating a necessary action to be taken so that the filling system 1 becomes operable (for example, through the variable function button 78 / graphics portion 79). In one embodiment, the variable function button 78 may be enabled and may include a label, such as "Attach Disposable Element", to indicate that the variable function button 78 should be used (for example, pressed) of such

10 so that the controller 50 can make the piston drive member 32 advance to engage the same with the piston 14 of the disposable element 10. In one embodiment, the piston drive member 32 and the piston 14 are advanced to an advanced position based upon activation of the variable function button 7

The controller 50 may be aware that the piston 14 is not engaged by the drive member of

15 piston 32 without communicating with position sensor 38 or rotary encoder 2108 (for example, after the disposable element interconnects with mount 40). In one embodiment, the controller 50 may cause the piston drive member 32 to automatically advance to engage with the piston 14 after the disposable element 10 interconnects with the mount 40, as illustrated through the dashed line 120a. For example, controller 50 may cause the member of the

20 piston drive 32 and piston 14 to an advanced base position a predetermined time after reception of the signals from the one or more switches indicating that the disposable element 10 is interconnected with the mount 40.

After the piston 14 interconnects with the piston drive member 32, the controller 50 can determine whether to prime the filling system 1 with fluid. In one embodiment, the controller 50 can wait for an entry in relation to the priming parameter or parameters described above through the user interface 70 before priming the filling system 1. For example, after the element disposable interconnect with mount 40, a user can activate the configuration screen button 72i (figure 11a), which invokes the configuration screen 73 (figure 11b). A user can then activate priming button 74d, which can activate one or more priming parameters or parameters, which can be provided to controller 50. After

30 upon receipt of the priming parameter or parameters, the controller 50 can prime the filling system 1, as described in more detail below.

In another embodiment, the controller 50 may be aware that the filling system 1 is not primed without receiving an additional input. For example, the controller 50 may be aware that the disposable element 10 was recently interconnected with the mount 40 and / or aware that the piston drive member 32 has not been made to advance and / or still retract in relation to with a predetermined disposable element 10, and thus the controller 50 can determine that the filling system 1 is not primed. In turn, the controller 50 may request a user to enter a priming parameter or parameters through the user interface 70 such that the controller 50 can determine whether it is necessary to prime the filling system 1. In another approach, the controller 50 can automatically prime the filling system 1 after

40 the determination that the filling system 1 is not primed (for example, a predetermined amount of time after the interconnection of the piston 14 and the piston drive member 32), as illustrated through the dashed line discontinuous 120b.

After priming the filling system 1, the filling system 1 can be used for filling operations. In this regard, the controller 50 can display an instruction by indicating the user interface 70 that the filling system 45 can be operated to start the filling operations (for example, via the variable function button 78 / graphics portion 79) . In one embodiment, the variable function button 78 may be enabled and may include a label, such as "Start," indicating that the variable function button 78 can be used to signal the controller 50 to begin filling operations. In this regard, the default parameter or parameters, discussed above, can be used by controller 50 to drive the

50 filling operations. In one embodiment, the controller 50 can begin the filling operations without receiving an input from a user, as illustrated by the dashed line 120c.

Before starting the filling operations, one or more parameters or parameters related to the filling can be provided to the controller 50. Referring now to Figure 12b and as indicated above, the user interface 70 can be operated to accept one or more. more parameter or parameters related to filling. For example, the user interface 70 may include the continuous transfer mode parameter or parameters discussed above. If the continuous transfer mode parameter or parameters are activated (for example, they are in the "on" state), the controller 50 may disable one or more other parameters or parameters related to filling (for example, by displaying one or plus corresponding button or buttons on the user interface 70). For example, controller 50 may disable one or 60 more of the source volume parameter or parameters, the volume unit parameter or parameters, the time delay parameter or parameters, the batch size parameter or parameters and the parameter or

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recoil parameters described above because such parameter or parameters may not be necessary to operate the filling system 1 in the continuous transfer mode. The controller 50 may additionally enable one or more other parameters or parameters related to filling. For example, controller 50 may enable one or more of the pressure parameter or parameters and the parameter or parameters of

5 fluid direction because such parameters can be useful in the continuous transfer mode. As can be seen, the filling system 1 can be operated in the continuous transfer mode without inputs from the other parameter or parameters mentioned above (for example, through the default operation parameter or parameters). After any entry in relation to the other parameter or parameters referred to above, the filling operations can be initiated (for example, via the variable functions button 78).

When the continuous transfer mode parameter or parameters is not activated / not designated, the controller 50 may enable the selection of a variety of other parameters or parameters related to filling. For example and with reference to Figure 12c, the controller 50 may enable the selection / designation of one or more of the source volume parameter or parameters, the pressure parameter or parameters, the parameter or

15 fluid address parameters, the volume unit parameter or parameters, the time delay parameter or parameters, the batch size parameter or parameters and the recoil mode parameter or parameters described above, to name a few few. As can be seen, the filling system 1 can be operated to conduct the filling operations without receiving an input related to any of the parameter or parameters related to the filling mentioned above. After entering any of the indicated parameter or parameters related to filling, the filling operations can be initiated (for example, via the variable function button 78).

Referring again to FIGS. 1–2, an operation mode of the automatic medical liquid filling system 1 is described. First, preliminary configuration procedures are completed, such as establishing interconnections between the disposable element 10 and the mount 40, 25 between the disposable element 10 and the source or sources of medical liquid 60 (for example, through the first fluid line 80), and between the second fluid line 82 and the element disposable 10. In this regard, any one of the first and second fluid lines 80, 82 may be fixedly interconnected with the disposable element 10 before configuration (for example, with a shipping interconnect with the disposable element 10) . In addition, any one of the first and second fluid lines 80, 82 may include connectors 81, 83 for interconnection with the source or sources 60 and the receptacle or receptacles 62 of medical liquid, respectively. For example, any one of the connectors 81, 83 may be a pin connector or a complementary Luer connector. The interconnection of spigot connectors and Luer connectors with various devices is described in US Pat. UU. No. 6,953,450, the contents of which are incorporated herein by reference in their entirety. Additionally, the valve 20 may be in the third position (for example, a

35 neutral position) after the interconnection of the disposable element 10 with the mount 40. As can be seen, when the valve 20 is in this third position, the entry of the fluids from the first and second valve holes 26 is restricted. , 27 in the disposable element 10.

Next, the filling system 1 is primed with medical liquid from the source or sources of medical liquid

60. More particularly, and with reference to Figures 1–2 and 13a – 13b, priming operations can be initiated using the user interface 70 (for example, through the priming parameter or parameters) described above in the that the controller 50 can automatically or semi-automatically control the priming of the filling system 1. In one embodiment, the controller 50 can control the valve 20 to rotate it from the third position described above, as illustrated in the Figure 13a, to the second position described above as illustrated in Figure 13b, for fluidly interconnecting the second line of

45 fluid 82 with the tubular member 12 (for example, through the second valve orifice 27). Therefore, fluids located inside the tubular member 12 (for example, sterile air and / or gases used during shipping) can be removed from the tubular member 12 through the second fluid line 82 through the advance of the piston 14.

Concomitantly, the controller 50 can control the piston drive member 32 to engage the same with the piston 14 of the disposable element 10 as illustrated in Figure 13b. More particularly, it is possible for the piston drive member 32 to advance to interconnect with the piston 14 of the disposable element 10 (for example, through the first connection member 18 and the second connection member 31) to facilitate the advance and the piston retraction 14.

With the advance of the piston 14 to the fully advanced position, as illustrated in Figure 13c and which doses the delivery fluids indicated above to the outside of the disposable element 10 through the

55 second fluid line 82, the controller 50 can control the valve 20 to place it in the first valve position described above to fluidly interconnect the tubular member 12 and the source or sources of medical liquid 60 (for example , through the first fluid line 80 and the first valve hole 26). The controller 50 can then control the piston drive member 32 to retract the piston 14 to extract medical fluids from the source or sources of medical liquid 60 into the first fluid line 80 and the tubular member 12, as illustrated in figures 13d – 13e.

After a desired amount of medical liquids has been removed inside the tubular member 12, an embodiment of which is illustrated in Figure 13e, which illustrates the piston 14 retracted to the retracted base position to fill the tubular member 12 with a relatively large amount of fluid, the controller 50 can control the valve 20 to place it in the second valve position, as illustrated in Figure 13f, to fluidly interconnect the tubular member 12 with the second fluid line 82 (for example, through

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5 second valve hole 27). The controller 50 can then control the piston drive member 32 to advance the piston 14 to dose medical liquids contained in a tubular member 12 through the second fluid line 82. The above procedures may be repeated as necessary until necessary. the tubular member 12, the first fluid line 80 and the second fluid line 82 are "primed" (eg, substantially filled with medical liquid). Therefore, the filling system 1 can be operated a plurality of times (for example, the piston drive member 32 can be made to advance and retract relative to the tubular member 12 a plurality of times) while simultaneously they maintain the interconnections between the disposable element 10 and the actuation system 30, while maintaining the interconnections between the source or sources of medical liquid 60 and the disposable element 10 and at the same time maintaining the seal of the tubular member through of the sealing member 16.

15 Although the priming operation discussed above and in Figure 13e describes the piston 14 retracted to the retracted base position to fill the tubular member 12, shorter piston strokes can be used during the priming operation. Shorter piston strokes, unlike the movement of the piston 14 towards the retracted base position, during priming may result in the use of less medical fluid during the priming operation. For example, if full strokes are used (for example, between the retracted base and advanced base positions) during the priming operation, it is possible that the medical liquid may begin to enter the tubular member 12 while the piston 14 is relatively near the valve

20. If the piston 14 continues to move back to a situation of this type, the entire volume of medical liquid that is extracted into the tubular member 12 may be unusable because it is mixed with the gas that is was inside the tubular member 12 before the entrance of the medical liquid

25 in the tubular member 12. On the contrary, if relatively short strokes are used (for example, between the base advanced position and a second position between the base advanced position and the base retracted position) during the priming operation, when the Medical liquid first enters the tubular member 12, the additional amount of liquid extracted into the tubular member 12 will be less than the amount removed if the piston 14 had to be pulled all the way to the base retracted position. Similarly, the use of piston strokes shorter than the entire distance between the base advanced position and the base retracted position may be beneficial when the automatic fluid filling system 1 is discharged, for example, when changing the source or sources of medical fluid 60.

After priming, the second fluid line 82 can be fluidly interconnected with the receptacle or receptacles 62. More particularly, the second fluid line 82 can be interconnected with a second apparatus

Dosage 35 designed for the dosing of medical liquids to the receptacle or receptacles 62. For example, the second fluid line 82 can be interconnected with one or more of a nozzle, needle, Luer connector or other apparatus adapted to dose medical liquid into the interior of a receptacle

In one embodiment, the second dosing apparatus may comprise a support and a corresponding Luer connector adapted to receive and interconnect with the receptacle or receptacles 62, and such receptacle or receptacles 62 may comprise syringes. In this respect, the Luer connector (for example, a RAPID-FILL connector, available from Baxa Corporation, Englewood, Colorado, USA) can be interconnected in a restricted way with the support (for example, Syringe Filling Fixture, available from Baxa Corporation, Englewood, Colorado, USA) the second fluid line 82 being fluidly interconnected with a first end of the Luer connector. A syringe can be fluidly interconnected with a second end of the Luer connector,

After which the filling operations can be performed, as described below, to dose a predetermined amount of a medical liquid into the syringe. The syringe can then be fluidly disconnected from the Luer connector and a rear syringe can be interconnected with the filling system 1 through the Luer connector. Filling operations can be repeated as desired until a desired / predetermined amount of syringes is filled.

After the second fluid line 82 is interconnected with the receptacle or receptacles 62 and any necessary filling related parameters or parameters have been entered (for example, through the main screen 71 of the user interface 70), the Medical filling system 1 can be used to conduct filling operations.

Referring again to Figures 1–2, the automatic medical liquid filling system 1 may include

55 self-calibration and self-diagnosis capabilities. These capabilities may include calibration and diagnostic routines that can be executed several times, including before, or in conjunction with, the priming operations. Self-calibration and diagnostic capabilities may also include the ability to monitor the behavior of the automatic medical fluid filling system 1 during any or all of the operations to determine whether the behavior of the automatic medical liquid filling system 1 is outside. of acceptable parameters. Self-calibration and diagnostic capabilities may also include the ability to monitor the behavior of the automatic medical liquid filling system 1 to detect trends that could indicate future degradation of the functionality of the system or components.

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An embodiment of the autocalibration and diagnostic capabilities of the automatic medical liquid filling system 1 that can be performed before any filling operation will be described below. After the interconnection of the disposable element 10 with the mount 40, the piston drive member 32 and the valve drive member 34, the valve drive member 34 can be positioned to fluidly interconnect the tubular member 12 or with the first valve orifice 26 or with the second valve orifice 27. The piston 14 can then be made to fully advance (as illustrated in Figure 4d) inside the tubular member 12. The valve stem 24 it can then be placed in the third valve position (for example, the neutral position). The piston 14 can then be removed from the fully advanced position to a first reference point between the fully advanced position and the base retracted position. If the piston 14 and the valve 20 are functioning properly, a reference vacuum can be created when the piston 14 is at the first reference point. The next step may be to cause the piston 14 to move back to a second reference point between the first reference point and the base retracted position. The automatic liquid filling system 1 can measure a parameter (for example, the average current that is supplied to the motor 36a) related to the movement of the piston 14 between the first point

15 reference and the second reference point. This measurement can be used to calibrate the automatic liquid filling system 1 for the particular atmospheric pressure of the environment in which the automatic liquid filling system is operating 1. Because of the level of vacuum that is occurring inside the Tubular member 12 is known and the force used to move the piston 14 from the first reference point to the second reference point is known, the atmospheric pressure exerted on the system can be determined. Another calibration procedure may include the use of the engine 36a to impart a constant retraction force on the piston 14 for a predetermined amount of time and the measurement of the amount of displacement of the piston 14 during that predetermined amount of time. The amount of displacement can then be correlated with the atmospheric pressure surrounding the automatic liquid filling system 1.

The automatic liquid filling system 1 can also be operated to determine the friction forces

25 associated with the movement of the piston 14 inside the first portion 12a of the tubular member 12. This can be achieved by fluidly interconnecting the tubular member 12 either with the first valve orifice 26 or with the second valve orifice 27 and causing the valve orifice to which the tubular member is fluidly interconnected is open to the local atmosphere. The drive system 30 can then move the piston 14 inside the first portion 12a of the tubular member 12 and measure the current required by the motor 36a to move the piston 14 along a given distance. This current measurement can be correlated with the frictional force associated with the movement of the piston inside the first portion 12a of the tubular member 12.

Therefore, as described, the automatic liquid filling system 1 can be calibrated in relation to the local atmospheric pressure and the frictional forces related to the movement of the piston 14. If during the calibration procedure a measured parameter ( for example, the average current that is supplied to the motor 36a) is outside acceptable values, an alarm may sound or an alert can be displayed to inform a user of the unacceptable results. For example, if the average current supplied to the motor 36a while moving from the first reference point to the second reference point falls below a predetermined value, it can be deduced that either the valve stem 24, Either the piston 14 or a combination thereof does not have a suitable seal. An alert can then be displayed for the user to replace the disposable element 10. Similarly, if the average current supplied is above a predetermined value, it can be deduced that the friction forces are higher than acceptable and the user to replace the disposable element 10. In another example, if the average current supply to the motor 36a while moving the piston 14 during the

The friction force calibration falls below a predetermined value, it can be deduced that the resilient piston member 15 is not properly coupled with the wall of the tubular member 12 and, therefore, the user can be alerted to replace the disposable element 10.

The atmospheric and friction conditions determined in the calibration steps described above may be used for the partial determination of operating parameters of the automatic liquid filling system 1. For example, it may be desired to maximize the speed of the piston 14 while simultaneously it draws medical liquid from the source or sources of medical liquid 60. However, it may also be desired to avoid foaming, bubbles or cavitation inside the tubular member 12 that may be caused by the relatively low pressure inside the tubular member 12 while piston 14 is being pulled back. Because cavitation is partially determined by pressure and the source or sources of medical fluid 60

55 may be under local atmospheric pressure, the point at which a particular medical liquid can cavitate may be related to local atmospheric pressure. Because the procedure described above can determine the local atmospheric pressure, the automatic liquid filling system 1 can be operated to determine a maximum piston speed that can be achieved without significant cavitation inside the medical liquid.

The automatic liquid filling system 1 may also have other diagnostic capabilities. The automatic liquid filling system 1 can be operated to detect leaks inside the disposable element 10 and the coupled tube. For example, before fluidly interconnecting the first fluid line 80 with a source or sources of medical liquid 60 and before fluidly interconnecting the second fluid line 82 with a

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medical fluid receptacle or receptacles 62, the first and second fluid lines 80, 82 can be plugged

or seal. The valve stem 24 can be positioned to fluidly interconnect with the tubular member 12 with the first fluid line 80. The piston 14 can then move inside the tubular member 12 and the current required by the motor 36a to move the piston 14 can be measured. Because the first fluid line 80 is sealed, there should be a resistance to the movement of the piston 14 due to a vacuum (if the piston 14 is made to recede) or a pressure build-up (if the piston 14 moves forward ) that should be reflected in the amount of current required by the motor 36a. The present procedure may be repeated with the valve stem 24 positioned to fluidly interconnect the tubular member 12 with the second fluid line 82. The present procedure may be repeated with the valve stem 24 placed in the neutral position. Any errors detected, and when those errors were detected, can be used to determine possible locations of system leaks. For example, if an error is detected when the first fluid line 80 is fluidly interconnected with the tubular member 12 but not when the second fluid line 82 is fluidly interconnected with the tubular member 12, it can be deduced that the filtration it is related to the first fluid line 80. Conversely, if an error is detected when the second fluid line 82 is fluidly interconnected with the tubular member 15 but not when the first fluid line 80 is interconnected so fluid with the tubular member 12, it can be deduced that the filtration is related to the second fluid line 82. If an error occurs under all situations, it can be deduced that the error is related to the tubular member 12 or the valve 20. The Previous procedures can be used to determine probable locations of system leaks. However, other system leaks or sources of error may be present. When any error is detected or any reading is outside a predetermined interval, an alarm or alert can be provided to inform a user of a system failure. In addition, the system can direct the user to the most likely location of the problem. The alarm or alert may be presented in the automatic liquid filling system 1 and may be in the form of a visual indication, an audible signal or a combination thereof. The alarm or alert can also occur on any device, such as a PC (including remote PCs), which is

25 interconnected with the automatic liquid filling system 1.

Additionally, the system diagnostics can also be operative during the operation of the automatic liquid filling system 1. For example, during the operation the automatic liquid filling system 1 can monitor the current required by motor 36a to move the piston 14 during several extraction and dosing operations. If a gradual increase in the current required to cause the piston 14 to recede is detected, but no change is detected in the current required to move the piston 14 forward, it can be deduced that an obstruction in the first fluid line may be developing 80 or in a member, such as filter 201, which is interconnected with the first fluid line 80. Once such a situation is detected, an alarm or alert can be generated to inform the user of the potential obstruction. Similarly, if a gradual increase in the current required to move the piston 14 forward is detected

35 but no change is detected in the current required to cause the piston 14 to recede, it can be deduced that an obstruction may have developed in the second fluid line 82 or in a member that is interconnected with the second fluid line 82.

A sudden increase in the current required to move the piston 14 inside the first portion 12a of the tubular member 12 may indicate a sudden blockage, such as a torsional fold in a fluid line. The probable location of the sudden block can be determined in a manner similar to that described above and an alarm or alert can be issued to inform the user of the situation and the probable location of the problem.

A gradual decrease in the current required to move the piston 14 inside the first portion 12a of the tubular member 12 may indicate increased filtration in the automatic liquid filling system 1. A

A sudden decrease in the current required to move the piston 14 may indicate rapid growth filtration or that a component has been disconnected. The probable location of the problem can be determined and communicated to a user in a manner similar to that described above.

A filling operation procedure is described below in relation to Figure 14. After a physical interconnection between the disposable element 10 and the mount 40 has been established, as described above, the source or sources of medical liquid 60 they can be interconnected with the disposable element 10, as described above (for example, through the first fluid line 80). The piston 14 can then be interconnected with the piston drive member 32, after which the system can be primed, as described above. After the system is primed, the disposable element 10 can be interconnected with a second dosing apparatus, as described above.

55 (for example, a needle). After the second dosing apparatus is interconnected with the disposable element 10, it can be primed, as described above. Next, a first receptacle receptacle or receptacles 62 (for example, a vial containing a dry powder) can be interconnected with the second dosing apparatus, and thus fluidly interconnected with the disposable element 10, after which The medical liquid (for example, pharmaceutical grade water) contained in the tubular member 12 can be dosed to the first receptacle, as described above (for example, through the rotation of the valve to the second position and the advance of the piston 14). Before dosing medical liquid to the first receptacle, the tubular member 12 can be refilled, as described above (for example, through the rotation of the valve 20 to the first position and the retraction of the piston 14).

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After the first receptacle is filled, the piston 14 can be retracted (which is not illustrated) in accordance with the recoil parameter or parameters, to extract the non-dosed liquid back to the filling system 1, as described above. . Additionally, the piston 14 can be retracted and advanced (for example, using the piston drive member 32) any number of times (which is not illustrated) to mix

5 the solution contained in the first receptacle. Subsequently, a second receptacle can be interconnected with the second dosing apparatus, and thus fluidly interconnected with the disposable element 10, after which a medical liquid can be dosed to the second receptacle. Before dosing medical liquid to the second receptacle, the tubular member 12 can be refilled, as described above. These procedures can be repeated, as desired, for any number of receptacles to provide receptacles containing a desired volume of a medical liquid.

Other optional filling operations can also be performed after a desired number of receptacles have been filled. For example and with additional reference to Figure 14, the filled receptacles may comprise a first medical liquid. After a desired number of receptacles have been filled, the source or sources of medical liquid 60 can be disconnected from the disposable element (for example, through the

15 disconnection of the first fluid line 80 with respect to the source of medical liquid) and the disposable element can be interconnected with a collection container (for example, through the first fluid line 80). Then, the fluid flow direction can be changed, in which case the disposable element 10 removes the first medical liquid from the receptacles into the tubular member. This first medical liquid in the tubular member 12 can then be dosed into the collection container. The present procedure can be repeated for any number of receptacles containing the first medical liquid. Therefore, the collection container can be filled with a first medical liquid.

Additional optional filling operations can also be performed. For example, and with additional reference to Figure 14, after the collection container is filled, the receptacles can be disconnected from the disposable element (for example, by disconnecting the second fluid line 82 with respect to

25 a needle) and other receptacles can be interconnected with the disposable element 10 (for example, through the second fluid line 82 and a second dosing apparatus, such as a support and a corresponding Luer connector). The fluid flow direction can be changed again, in which case the first medical liquid contained in the collection container can be removed inside the disposable element and subsequently dosed into these other receptacles (eg syringes) to provide a receptacle that It contains a pre-selected volume of the first medical liquid.

In one approach, the filling system 1 can be used to fill the receptacle or receptacles 62 with a medical liquid from the source or sources of medical liquid 60 to produce a liquid medication of a desired volume in each of the receptacle or receptacles 62 That is, the filling system 1 can be used to produce a desired volume of liquid medication in each of the receptacle or receptacles 62. To achieve filling of the receptacle or receptacles 62, the tubular member 12 can be filled with various volumes of liquid doctor. In one approach, the tubular member 12 can be filled with a sufficient volume of medical liquid to fill a plurality of the receptacle or receptacles 62 without refilling the tubular member 12. For example, the tubular member 12 can be filled with a relatively large amount of medical fluid through the retraction of the piston 14 and the piston drive member 32 (for example, the retraction from the advanced base position to the retracted base position). Subsequently, the piston 14 can be made to advance to dose a quantity of medical liquid to a first receptacle (for example, through the advance from the retracted base position to a first position). After a second receptacle is in position for filling, it can be made again for the piston 14 to dose an amount of medical liquid to this second receptacle (for example, through the advance from the first position to a second position). Such as

45 can be appreciated, these procedures can be repeated until a desired amount of receptacle or receptacles 62 is filled or the tubular member 12 no longer contains enough medical liquid to fill the next receptacle with a desired amount of medical liquid. The piston 14 can then be retracted to fill the tubular member 12 with a desired amount of medical liquid. As can be seen, the piston 14 can be advanced and retracted any number of times to fill the tubular member 12 until a desired amount of receptacle or receptacles 62 is filled or until the source or sources of medical liquid 60 are empty of a sufficient amount of medical fluid.

In another approach, the tubular member 12 can be filled with a sufficient volume of medical liquid to fill a single receptacle. For example, the tubular member 12 can be filled with a predetermined amount of medical liquid through the retraction of the piston 14 (for example, the retraction from the advanced base position to another

55 position). Subsequently, this predetermined amount of medical liquid can be dosed into a receptacle (for example, through the advance from the other position to the advanced base position). As can be seen, the present procedure can be repeated as necessary until a desired amount of receptacle or receptacles 62 is filled or until the source or sources of medical liquid 60 are empty of a sufficient amount of medical liquid.

During the filling operations, the controller 50 can be actuated to determine if a sufficient volume of medical liquid is contained inside the tubular member 12 to fill a next one of the receptacle or receptacles 62. The partial filling of one of the receptacle or receptacles 62, the new subsequent filling of the medical member 5 to a next one of the receptacle or receptacles 62.

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Any number of medical liquids may move to and from any source number or sources 60 and the receptacle or receptacles 62 of medical liquid. In this regard, the optional distribution manifold 64 can be used to facilitate filling operations. Additionally, the valve 20 can include any number of holes, passages and / or channels and any number of fluid lines can be interconnected with the valve 20 and / or the optional distribution manifold 64 to facilitate filling operations. Additionally, the first and second fluid lines 80, 82 may be a single line or may comprise a plurality of lines, such as a set of bifurcated and / or trifurcated tubes, which can be interconnected with any source number or sources 60 and / or receptacle or receptacles 62 of medical liquid. Also, the user interface 70 and / or the controller 50 can be used to initiate, control and / or conduct any of the filling operations described

15 above.

So far in this document, the filling system 1 has been described in general in relation to the flow of fluids through a first flow path (for example, from the source or sources of medical liquid 60 through the element disposable 10 and to receptacle or receptacles 62). Additionally, the filling operations can be conducted by the filling system 1 to cause medical liquids to flow in another flow path. In one approach, the receptacle or receptacles 62 may contain a substance that contains medicament (eg, a dry powder) and the source or sources of medical liquid 60 may contain a solvent. After the addition of a desired amount of solvent to the receptacle or receptacles 62, it may be useful to mix the composition contained within the receptacle or receptacles 62 to achieve a desired liquid medication. Therefore, the piston 14 can be retracted and made to advance one or more times to achieve a

25 desired mixture, after which the piston 14 can be made to advance to dose the composition to the receptacle or receptacles 62.

As indicated above, the controller 50 can be operated to automatically or semi-automatically control several operations of the filling system 1. The controller 50 can also be operated to aid in the detection of leaks or occlusion inside the filling system. As can be seen, the back pressure applied to the piston 14 during the dosing operations (for example, the advance of the piston 14) is, in general, related to the viscosity of the medical liquid used as well as to the hydraulic nature of the interconnections. Correspondingly, the extraction pressure created during the extraction operations (for example, the retraction of the piston 14) is also related, in general, with the viscosity of the medical liquid used as well as with the hydraulic nature of the interconnections. If the interconnections of the filling system 1 are properly connected and no appreciable leaks are present inside the system, a particular extraction back pressure / pressure will be created. However, if one or more interconnections are not properly connected and / or appreciable filtration is present inside the filling system 1, a smaller back pressure / larger extraction pressure will take place. Correspondingly, if one or more components are clogged, a larger back pressure / pressure of

40 smaller extraction. Because the speed of the piston 14 is related to this back pressure / extraction pressure and since the speed of the piston 14 can be calculable (for example, through the position sensor 38 or the rotary encoder 2108), the controller 50 can actuated to determine if an appropriate back pressure / extraction pressure is taking place and, therefore, can be operated to determine if a filtration or occlusion is present inside the filling system 1.

More particularly, the controller 50 may be operated to receive (for example, through the user interface 70) one or more detection parameters ("detection parameter or parameters"), such as parameters associated with one or more of the viscosity of the medical liquid, the diameter or diameters of one or more interconnected components (for example, the first and second fluid lines 80, 82, a second apparatus connected to the second fluid line 82, the source or sources of medical liquid 60 ) and / or a diameter of the tubular member 12. Such

50 as can be seen, such a parameter or detection parameters may correspond to, or be equivalent to, one or more parameters related to filling. Using such parameter or detection parameters and parameter

or pressure parameters described above, the controller 50 can be operated to calculate a normal back pressure in relation to the dosing operations and a normal extraction pressure in relation to the extraction operations. The controller 50 can also be operated to calculate a current operating pressure, as described above, and can be operated to compare the normal back pressure / extraction pressure calculated with the current operating pressure. If the current operating pressure is not within a desired range of normal back pressure / extraction pressure, as appropriate, controller 50 may be operated to indicate such status and controller 50 may take appropriate action. For example, controller 50 may automatically cease priming and / or filling operations and / or may

60 indicate that a leak or occlusion has been detected (for example, through the user interface 70).

As indicated above, the piston 14 and a piston drive member 32 can be interconnected by first and second connecting members 18, 31, respectively. As also indicated above, one of the first and second connection members 18, 31 may comprise a complementary female member, and the other of the first and second connection members may comprise a complementary male member. Another embodiment of a female member / male member interconnection arrangement is provided in Figure 15. In the embodiment illustrated, the piston drive member 32 is

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5 interconnected with a female member 1531, the female member including a plurality of grooves 1531a, each of the plurality of grooves adapted to receive a corresponding one from a plurality of discs 1518a of the male member 1518. The male member 1518 can also interconnect with a sealing member 1516 and / or a rod 13, and the rod 13 can interconnect the male member 1518 with the piston 14 (which is not illustrated). Because the disposable element 10 is interconnected with the mount 40 (for example, through a quick-fit and pressing action), the discs 1518a of the male member 1518 can move towards and slide into the corresponding grooves 1531a of the member female 1531, thereby restrictively interconnecting the piston 14 with the piston drive member 32. To disconnect the connecting members 1518, 5131, the discs 1518a can move away from the grooves 1531a (for example, through a force upwards).

In another embodiment, the female member may comprise a spring portion that acts as a unidirectional jaw to facilitate interconnection between the female and male members. In this regard, the female member may be inside the tubular member 12. As the male member (for example, a bulbous end portion) is advanced to the female member, the spring portion is compressed allowing the male member enters, and couples with, the female member. When the male member is caused to advance a predetermined amount, the spring member can no longer engage with the male portion and can elastically return to its original position. As the male member retracts, the spring portion engages restrictively with one end of the male portion, thereby restricting the removal of the male portion from the female portion and facilitating the joint movement of the portions female and male. To disconnect the female and male portions, the female portion may be placed in another diameter of the

25 tubular member 12 or withdraw from the tubular diameter, after which the female member may extend allowing the male member to withdraw from the female member. In another embodiment, the male member may comprise a screw and the female member may comprise corresponding threads.

As can be seen, the female and male connection members may comprise a tolerance size to facilitate interconnection. These tolerance sizes can be known by the controller 50 (for example, they can be rigidly encoded or through an input through the user interface 70) to facilitate the determination of the proper movement of the piston 14 and / or the member of piston drive 32. Also, the piston drive member 32 can thus move a small amount before physically interconnecting with the piston 14 for joint movement therewith.

As also indicated above, it is desired to restrict the communication of the portions of the tubular member

35 12 that communicate fluidly with medical liquids with outside air and / or with other contaminating substances (eg particles). In one embodiment, and as indicated above, the piston 14 and the sealing member 16 may be separated a fixed distance from each other to restrict fluid communication of such materials from the outside with the portions of the tubular member 12 which They communicate fluidly with medical fluids. In another embodiment and as illustrated in Figure 16, a bellows 1630 can be used to restrict contamination of the tubular member 12. In the present embodiment, the piston 1614 can be interconnected with a bellows 1630 through a first connecting member 1618 and a coupling bellows connection member 1632. The piston drive member 32 can be interconnected with the piston 1614 through a second connection member 31 and the coupling bellows connection member 1632. In this regard, the member 1632 coupling bellows connection can be one of a first member

45 male or female connection, the second connection member 1631 may be the same as the male or female connection member, but of a smaller proportionate size, and the first connection member 1618 may be the other of a first connection member male or female. A sealing member 1616 may be provided on the distal end of the bellows 1630 to seal a distal end of the tubular member when such a bellows 1630 and piston 14 are disposed inside the tubular member 12. In this regard, the sealing member 1616 may be a closed cell foam material adapted to engage in a sealable manner with the inner surfaces of the tubular member 12 to restrict the entry of contaminating substances into the tubular member 12 when such a sealing member 1616 is disposed inside the tubular member 12.

Figure 20 is a perspective view of an embodiment of an automatic liquid filling system 2000 that is interconnected with an automatic syringe handling system 2001. The liquid filling system

Automatic 55 is illustrated with the disposable element 10 installed in the mount 40 with the piston drive member 32 coupled with the disposable element 10. Other components of the drive system 30 are located inside a housing 2002 of the filling system of automatic liquid 2000. A user interface display 2003 is located in a front portion of the automatic liquid filling system 2000. The user interface display 2003 can be a touch screen interface that displays menus and functions as it is described above with respect to figures 11a-11b.

The first fluid line 80 may be interconnected with any source of medical liquid (not shown in Figure 20) that is analyzed herein. As illustrated, the second fluid line 82 is interconnected with the disposable element 10 and with the automatic syringe handling system 2001. The automatic syringe handling system 2001 can automatically take syringes, such as the syringe 2004, that have been loaded into a 2005 hopper, and transfer them to a filling position inside a housing 2006. In the filling position inside the housing 2006, the handling system

image38

5 of automatic syringes 2001 can fluidly interconnect a syringe with the second fluid line 82. Once interconnected, the automatic liquid filling system 2000 can proceed to pump a medical liquid through the second fluid line 82 and inside the syringe inside the housing 2006. Once the syringe inside the housing 2006 is filled to a predetermined level with the medical liquid, the filled syringe, such as filled syringes 2008, can be transferred to a syringe. 2007 output tray.

To coordinate the interconnection of the second fluid line 82 with a syringe located in a filling position inside the automatic syringe handling system 2001 with the pumping action of the automatic liquid filling system 2000, the filling system of automatic liquid 2000 can be found in communication with the automatic syringe handling system 2001. This communication can be done at

15 via a wireless link, an Ethernet connection, a Universal Serial Bus (USB) connection, or through any other communication procedure known to those skilled in the art.

The automatic liquid filling system 2000 can also be found in communication with other devices (for example, personal computers (PC), labeling devices, and one or more distribution manifolds 64). This communication can be done through a direct link or through a network connection. The user interface functions described above in connection with the user interface 70 can also be performed remotely on a PC or other device. The remote device may be located distally with respect to the automatic liquid filling system 2000. For example, it is well known that some chemotherapy drugs have a high level of toxicity and fortuitous contact should be minimized. Therefore, if the 2000 automatic liquid filling system is being used to process such chemotherapy medicine, the

The remote device, such as a PC, can be found in a different room or on the other side of a barrier with respect to the automatic liquid filling system 2000. This would allow a user to adjust parameters and monitor the automatic liquid filling system. 2000 while minimizing potential contact with the fluids that are being handled by the 2000 automatic liquid filling system.

The automatic liquid filling system 2000 can also be interconnected with more sophisticated medical container handling systems than those of the automatic syringe handling system 2001 illustrated in Figure 20. For example, the automatic liquid filling system 2000 can interconnect with a syringe management system capable of handling, fluidly interconnecting and labeling medical containers (for example the RAPID-FILL ASF produced by Baxa Corporation of Englewood, Colorado, USA). In such interconnected systems, a user may only need to enter information once (for example in the system of

35 automatic liquid filling 2000, the syringe handling system, or a PC), and the system can automatically fill and label a plurality of medical containers.

The 2000 automatic liquid filling system can also be interconnected with the Internet. Through such an interconnection, the software of the automatic liquid filling system 2000 can be altered or updated remotely. These updates can, for example, improve functionality, improve self-diagnostic capabilities, or improve the user interface.

The 2000 automatic liquid filling system may also include the ability to read Radio Frequency Identification (RFID) tags. For example, medical liquid containers that are interconnected with the first fluid line 80 may contain RFID tags. The 2000 automatic liquid filling system can read the RFID tags and verify that the correct medical liquid container is interconnected. 45 Once the medical liquid has been identified by reading the RFID tags, the 2000 automatic liquid filling system can also be operated to determine or consult characteristics of the medical liquid (eg, viscosity) and to use those characteristics for determining operating parameters or for detecting badly labeled medical liquid containers (for example, detecting if the viscosity of the liquid is different from that expected for the medical liquid indicated by the RFID tag). In addition, the automatic liquid filling system 2000 may relay the information regarding the medical liquid to other interconnected devices, such as the automatic syringe handling system 2001 or an automatic labeling device. If an incorrect medical liquid is interconnected with the 2000 automatic liquid filling system, the system can be operated to read the RFID labels of the incorrect medical liquid and to sound an alarm to inform a user of the error. The 2000 automatic liquid filling system can

55 also be operated to avoid any operation while an incorrect medical fluid interconnection is detected.

The functionality described in conjunction with RFID tags can also be achieved with a barcode system in which the 2000 automatic liquid filling system can include a barcode reader for reading barcodes coupled with a container. or medical liquid containers to be interconnected with the first fluid line 80. Other medical liquid container verification systems known to those skilled in the art can also be incorporated into the automatic liquid filling system 2000.

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As can be seen, the use of first, second and other numerical indicators in relation to the component, the positions and other descriptions described above previously provided, is not intended to indicate any particular order of use of the filling system. , because such use is, in

In general, for descriptive purposes and is not intended to limit the scope of the present invention. Additionally, the aspects, approaches and / or embodiments described above are for exemplary purposes only and are not intended to limit the scope of the present invention. Various adaptations, modifications and extensions of the procedure / system described will be apparent to those skilled in the art and are designed to be within the scope of the invention as defined by the following claims.

10

Claims (19)

image 1 1. A method for filling at least one interconnectable receptacle with a medical liquid, comprising: establishing a physical interconnection between a disposable element (10) and an automatic actuation system (30), wherein said disposable element includes a tubular member (12), a piston (14) disposed of 5 Sliding form in the tubular member for retraction and advancing thereof within a first portion of said tubular member, and a valve (20); wherein said automatic actuation system includes a piston actuating member (32) and a valve actuating member (34) that can selectively interconnect with and disconnect from said piston and said valve, respectively; and wherein said establishment step includes interconnecting said piston and said valve with said member 10 piston drive and said valve drive member, respectively; using said piston drive member of said automatic drive system to retract said piston inside a first portion of said tubular member of said disposable element and thereby extract a predetermined volume of a medical liquid into said tubular member; employing said piston drive member of said automatic drive system to make 15 advancing said piston inside said first portion of said tubular member of said disposable element and, thus, dosing at least a portion of said predetermined volume of medical liquid from the tubular member to at least one interconnectable receptacle ; using said valve drive member of said automatic drive system to automatically and alternately place said valve of said disposable element in a first position of 20 valve and in a second valve position, wherein said first valve position is maintained during said use stage, and said second valve position is maintained during said use stage; and, sealing said first portion of said tubular member during said stages of use and use. 2. A method according to claim 1, further comprising: establishing a fluid interconnection between a source for said medical liquid and said disposable element; 25 and, repeating said stages of use, use and sealing a plurality of times to at least partially fill each of a plurality of receptacles while maintaining said interconnections between said disposable element and said automatic actuation system and between said source of medical liquid and said disposable element. A method according to claim 2, wherein between successive ones of said plurality of times, the method further comprises: fluidly interconnecting said disposable element with different receptacles of said plurality of receptacles. 4. A method according to claim 1, wherein at least a portion of said step of use comprises: advancing one end of said piston drive member inside said tubular member. 5. A method according to claim 1, further comprising: detecting at least a relative degree of movement between said piston drive member and a reference member of said automatic drive system to provide an output signal 40 for use in at least one of said use and use stages . 6. A method according to claim 5, wherein said detection step comprises: detecting a plurality of degrees of relative motion between said piston drive member and said reference member of said automatic drive system to provide said output signal in corresponding relation to each of said detected degrees of relative motion.

A method according to claim 6, further comprising:

processing said output signal to obtain at least a speed value indicative of a relative movement speed between said piston drive member and said reference member; and, comparing said at least one speed value with at least one predetermined value to identify an occurrence of a predetermined operating condition.

A method according to claim 7, further comprising:

automatically terminate said at least one of said stages of use and use after identification of said occurrence of said predetermined operating condition. 42 image2 9. A method according to claim 6, further comprising: providing a user exit indication upon identification of said occurrence of said predetermined operating condition. 10. A method according to claim 1, wherein each of said stages of use and use 5 comprises: flowing said predetermined volume of medical liquid through a common orifice of said tubular member. 11. A method according to claim 1, further comprising: automatically placing said valve in a first valve position before said use stage; and, 10 placing said valve in a second valve position after said use stage and before said use stage. 12. A method according to claim 1, further comprising: receiving a user input in a user interface interconnected with said automatic actuation system to establish a value related to filling, which corresponds to said predetermined volume of medical liquid, for use in said use stage. 13. A method according to claim 1, further comprising: fluidly interconnecting said disposable element with at least one of a fluid connection line and a fluid receptacle; and receiving a user input in a user interface of said automatic drive system for 20 adjusting a value related to filling, which corresponds to said at least one of a fluid connection line and a fluid receptacle, for use in said employment stage. 14. A method according to claim 1, further comprising: automatically controlling said piston drive member of said automatic drive system to automatically adjust a force applied by said piston drive member 25 to said piston of said disposable element for at least a portion of at least one of these stages of use and employment. 15. A method according to claim 14, wherein the automatic control step comprises: maintaining said force within a predetermined range, in which a predetermined maximum of said predetermined range corresponds to a predetermined maximum desired fluid pressure for said disposable element. 16. A method according to claim 14, wherein said automatic control step comprises: maintaining said force within a predetermined range, in which a predetermined minimum of said predetermined range corresponds to a predetermined minimum desired fluid pressure for said disposable element. A method according to claim 14, wherein said automatic control step comprises: using an output signal from a pressure sensor included in one of said disposable element and said automatic actuation system. 18. A method according to claim 14, wherein said automatic control step comprises: using an output signal associated with a drive motor included in said automatic drive system 40 and interconnected with said piston drive member, wherein said output signal is indicative of said force. 19. A method according to claim 1, further comprising: packaging said disposable element inside a box before said establishment stage; sterilizing said disposable element; and 45 removing said disposable element from said box before said establishment stage. 43 image3 20. A method according to claim 19, further comprising: complete said packaging stage in a first location; transporting said disposable element inside said box from said first location to a second location; Y, 5 complete said withdrawal, establishment, use and employment stages in said second location. 21. A method according to claim 19, further comprising: placing said piston inside a second portion of said tubular member before said packing stage; and placing said piston inside said first portion of said tubular member after said step of 10 removed, in which at least a portion of said piston extends when it is placed in said second portion of said tubular member in relation to the moment in which said piston is placed in said first portion of said tubular member. 22. A method according to claim 19, further comprising: placing a valve of said disposable element inside a first portion of a housing of 15 valve of said disposable element before said packing stage; and placing said valve inside a second portion of said valve housing after said withdrawal stage, in which at least a portion of said valve extends when it is placed in said first portion of said valve housing in relation to with the moment in which said valve is placed in said second portion of said valve housing. 23. A method according to claim 1, wherein a sealing member of said disposable element is interconnected with said piston of said disposable element for joint movement therewith, and wherein said sealing step comprises: slidingly coupling said sealing member inside a second portion of said tubular member during said stages of use and use, wherein said second portion is located distally 25 with respect to said first portion of said tubular member . 24. A method according to claim 23, wherein said sealing member is separated from said piston from said disposable element a fixed distance that is at least as large as a length of the first portion of the tubular member. 44