WO2023166176A1

WO2023166176A1 - A system for agitating contents of a medical container

Info

Publication number: WO2023166176A1
Application number: PCT/EP2023/055439
Authority: WO
Inventors: Andreas HAAG; Luigi ABRUZZESE; Christian Hermann HENNECKE; Matthias Rau; Nicolai URBAN
Original assignee: Fresenius Kabi Deutschland Gmbh
Priority date: 2022-03-04
Filing date: 2023-03-03
Publication date: 2023-09-07

Abstract

Described herein is a system (100) for agitating contents of at least one medical container (101), preferably a vial. The system comprises a holding device (104) defining at least one receptacle (103) for receiving the medical container, a mount assembly (105) for supporting the holding device. The mount assembly comprises a drive mechanism configured provide agitation motion to the holding device. The system further comprises a control unit (106) configured to control the agitation of the holding device and a gripping ami assembly (200) disposed with the holding device. The gripping arm assembly includes a gripping arm (201) arranged to hold the medical container positioned in the receptacle.

Description

A system for agitating contents of a medical container

Field of invention

The invention relates to a system for agitating contents of at least one medical container. More particularly, the invention relates to a system for agitating contents of a vial for reconstitution of drugs.

Background of the invention

Systems for reconstitution of drugs, in particular, for dissolving a powder form drug with a sterile diluent to reformulate it into liquid form are used, for example, in pharmacies, compounding centers, or hospitals. Preferably, the reconstituted liquid drug is further compounded, for instance diluted, before it is administered to a patient. The manual reconstitution of drugs results into low productivity and may cause repetitive strain injury (RSI).

In order to improve the productivity and prevent repetitive strain injuries, existing automatic reconstitution systems are used. According to one such automatic reconstitution system (provided by Fresenius Kabi under commercial name "PharmaShaker"), the drug and the diluent are filled in medical containers, for example, vials. Said automatic reconstitution system includes provision to shake/agitate contents of one or more vials simultaneously. The system includes a holding device for receiving the vials and the holding device is supported on a mounting unit. The holding device comprises here the housing. The mounting unit comprises a drive assembly pivotally coupled to the holding device. The drive assembly provides agitation motion, in more detail swiveling motion, to the holding device via a shaft of the drive assembly.

The automatic reconstitution system further comprises a control unit configured to control the motion of the holding device. The control unit comprises an electronic control unit (ECU), an input device, and a display. The input device can be used to select a mode of operation of the system. Also, a plurality of speeds and time durations can be selected. For instance, the user may control the swiveling motion on the basis of number of swiveling cycles in a minute. In an embodiment, the number of swiveling or shaking cycles may range from 30 shaking cycles per minute to 240 shaking cycles per minute. Similarly, the user may also select operation time limit of the system within a range of 5 seconds up to approximate 60 minutes. The display shows the information about aforesaid operation modes and other parameters related to operation of the system.

The holding device of the aforesaid reconstitution system includes a plurality of receptacles of the same sizes. The plurality of receptacles is arranged to receive the vials. The one or more vials are first placed in corresponding vial adapters of appropriate size. The vial adapters are provided to securely grip the vials during the motion of the holding device. The system includes five different sizes of vial adaptors. Each of the vial adapters is configured to hold/grip a different size of vial, having different diameters. Thus, the system allows insertion of 5 standard sized vials only. Hence, the system is restricted to be compatible with only a limited types/sized of vials for reconstitution.

CN 111282490 A describes a medicine bottle shaking equipment which includes a clamping mechanism. The clamping mechanism includes three clamping members wherein one end of each clamping member is fixedly arranged on the inner wall of a drive disk. The three clamping members are activated via a drive motor.

CN 106731910 B describes a drug dissolving device. A plurality of clamp modules is fixed to the vibration support module for actively clamping the vial. The clamp modules are driven by a clamping motor.

Therefore, there is well felt requirement for an improved automatic drug reconstitution system which in particular overcomes the aforementioned limitations of the existing systems.

Summary

It is an object of the present invention to provide a system which is compact and compatible with a variety of medical containers having different sizes, in particular, diameters.

The aforesaid are achieved by a system for agitating contents of at least one medical container, in particular by the solution provided in claim 1 of the present invention. Various embodiments of the invention are subject of the dependent claims, of the description and of the drawings.

The present invention relates to a system for agitating contents of at least one medical container, preferably a vial. The system comprises a holding device defining at least one receptacle for receiving the medical container, a mount assembly for supporting the holding device. The mount assembly comprises a drive mechanism configured to provide agitation motion to the holding device. The system further comprises a control unit configured to control the agitation of the holding device and a gripping arm assembly disposed with the holding device. The gripping arm assembly includes a gripping arm arranged to hold the medical container positioned in the receptacle. The gripping arm includes a handle portion. This allows a manual, preferably single-handed, activating or opening of the gripping arm.

In one embodiment the gripping arm assembly is disposed inside a, preferably cylindrical, opening adjacent to the receptacle.

For instance, the holding device can be described also as a kind of positioning block or holding block or holding array for the medical containers. The holding device can comprise a housing or can be provided in or as a housing. Preferably the medical container or the vial contains a pharmaceutical substance. Therefore, the medical container or the vial could also be described as a pharmaceutical container. The system could also be described as an arrangement for agitating contents of at least one medical container.

In one further embodiment, the receptacle includes at least a first curved ridge section and a second curved portion ridge section to support the medical container received in the receptacle. The first curved ridge section is defined by a first radius being larger than a second radius of the second curved ridge section. In particular, the receptacle further comprises a platform below or towards a lower end of the second curved ridge section. The platform is arranged to support the base of a second type of containers, which are smaller in height in comparison to a first type of containers.

The gripping arm comprises, in one embodiment, a metal part and a plastic cladding covering at least a portion of the metal part. The plastic cladding preferably has a Shore- A hardness of 40 to 60, preferably 45 to 55 (DIN ISO 7619-1 (3s). In one embodiment the plastic cladding comprises a thermoplastic polymer based on a polyether, polyester and/or polyurethane elastomer.

The gripping arm includes a gripping portion, the handle portion and a mounting portion. The handle portion enables a user for manually, preferably single-handed, activating the gripping arm or opening of the gripping arm, in particular for positioning the medical container in the receptacle and/or for removing the medical container from the receptacle. As an example, the gripping arm could be activated or opened by pushing the handle with the finger, for instance with the thumb.

The gripping arm in particular comprises a vertical section defining the mounting portion, a horizontal section defining the gripping portion, a preferably curved transition section between the vertical section and the horizontal section and a further bent section in the plane of horizontal section connected to the gripping portion and defining the handle portion. The gripping portion of the gripping arm preferably spans over the receptacle. The handle portion in particular extends essentially crosswise to a longitudinal axis of the holding device.

Furthermore, a first type of medical containers is held between the first curved ridge section and the gripping portion of the gripping arm. A second type of medical containers is held between the second curved ridge section and the gripping portion of the gripping arm. The first type of medical container differs from the second type of medical containers, particularly, based on size. More particularly, a diameter of the first type of medical containers is greater than a diameter of the second type of medical containers.

In one embodiment, the gripping arm is covered with the plastic cladding from a tip portion till a top edge of the mounting portion. In a further embodiment, the metal part of the gripping arm comprises a neck portion in a region of the tip portion to retain the plastic cladding to the metal part. An end of the plastic cladding in the region of the mounting portion is preferably a disk-shaped sealing member being installed in a proximal end of the cylindrical opening. In one embodiment, the disk-shaped sealing member comprises a radial shoulder which is installed in a corresponding radial channel in the proximal end of the cylindrical opening, in particular to fix the cladding to the holding device, in particular to the housing of the holding device.

According to one embodiment, the gripping arm assembly includes a carrier unit for mounting the gripping arm and a spring member mounted with the carrier unit to provide resilience to the gripping arm for holding the medical containers. Preferably, the carrier unit includes a disk-shaped head portion and a cylindrical body portion. In an embodiment, the cylindrical body portion extends perpendicular to the horizontal plane of the head portion such that a vertical cross-section of the carrier unit is T-shaped. One embodiment of the head portion includes at least a first hole, and preferably a second hole, to fix the gripping arm to the carrier unit and a further hole to mount the spring member, in particular, a top end portion of the spring member, to the carrier unit. In this example the cylindrical portion of the carrier unit is inserted into a central hollow space of the spring member. In an embodiment, the spring member is a torsion spring. Preferably, the torsion spring is embodied as a helical torsion spring.

According to one embodiment, the gripping arm assembly is pre-tensioned in the initial position. The initial position is the standby or start position in which no medical container is yet positioned in the receptacle. In particular, the pretension of the spring member in the initial position has a torque of about To = 105 Nmm +/- 50 Nmm, preferably To = 105 Nmm +/- 30 Nmm.

The gripping of vials of different sizes requires different displacements or opening angle a of the gripping arm assembly. Vials of increased diameter generally owns an increased weight. Therefore, according to one preferred embodiment, the resilient force, also called elastic recoil force, of the spring member is increasing with increasing displacement or opening angle a of the gripping arm assembly. The resilient force is increasing to a torque of about 475 +/- 100 Nmm, preferably 475 +/- 50 Nmm at an opening angle a = 60° - 70°, preferably at a = 70°, in relation to the initial position. In particular, the spring member has a linear or an essential linear characteristic curve, preferably in the range up to a = 70°. In particular, the torques or measured torques of the spring member in the range up to a = 70° can be defined or described by linear regression. Preferably the characteristic curve is defined by T(o) = i* a + To wherein the inclination is defined by i = 5,5 +/- 1,0 Nmm/o, preferably i = 5,5 +/- 0,75 Nmm/o.

According to one embodiment the gripping arm assembly further comprises a fixation member to retain the carrier unit in a predetermined position in the opening. In one example the fixation member is embodied as a ring member, preferably circumferentially disposed over the carrier unit to retain the carrier unit in a predetermined position in the opening. The exemplary ring member is installed to partially overlap with a radial shoulder in the wall section of the cylindrical opening and arranged preferably circumferentially over a top surface of the head portion of the carrier unit.

Furthermore, in one embodiment the carrier unit comprises a receiving area, preferably, a slot for the mounting portion of the gripping arm. In particular, the receiving area conforms with the mounting portion of the gripping arm. More particularly, the mounting portion of the gripping arm is T-shaped and the receiving area of the carrier unit is also T- shaped. A bolt can be inserted in the at least first hole upon insertion of the gripping arm in the receiving area of the carrier unit to fix the gripping arm to the carrier unit. Preferably, a flange of the bolt overlaps with the top edge of the mounting portion of the gripping arm to secure the gripping arm. In this configuration the gripping arm is rotatably moveable along with the carrier unit. The carrier unit is in a biased engagement with the torsion spring such that during a rotation, the carrier unit is biased with the torsion spring. In particular, the torsion spring has a top end portion, protruding axially from the torsion spring. More particular, the top end portion protrudes from the circumference of the torsion spring. More particular, the torsion spring further comprises a bottom end portion bent to form essentially a chord of the torsion spring. In this configuration the top end of the torsion spring is secured inside the further hole of the head portion and the bottom end is secured in a, preferably semi-circular, slot formed at a distal end of the, preferably cylindrical, opening. The bottom end of the torsion spring remains pressed against a horizontal surface of the, preferably semi-circular, slot.

The gripping arm is retractable in the plane of holding device, preferably in the plane of the housing, in particular in the plane of the housing top surface, to allow receiving of the medical container in the receptacle. Preferably, the gripping arm is movable in an anticlockwise motion to receive the medical container in the receptacle. The gripping arm is releasable to move in an opposite direction along with the carrier unit to hold the medical container placed in the receptacle under an action of resilient force provided by the torsion spring. Preferably, the gripping arm is releasable to move in a clockwise motion along with the carrier unit to hold the medical container placed in the receptacle under an action of resilient force provided by the torsion spring. The orientation of clockwise and anticlockwise is related to a displacement of the gripping arm in opposite directions.

Furthermore, in one embodiment the head portion of the carrier unit includes a, preferably curved recessed section, in particular a peripheral recessed section, having a first stop and a second stop. A stopper is guided in the recessed section of the head portion. The stopper contacts with the first stop and second stop to provide a minimum and maximum displacement of the gripping arm. Said stopper can protrude from a surface of a circumferential inner wall of the preferably cylindrical opening. In one configuration, the head portion of the carrier unit rests on a top surface of said inner wall and the stopper lies between the first stop and the second stop. The maximum limit of the preferably anticlockwise displacement of the carrier unit corresponds to a contact between the first stop and the stopper, the maximum limit of the preferably clockwise displacement of the carrier unit corresponds to a contact between the second stop and the stopper. Preferably, the maximum range of said angular displacement is up to 100 degrees and preferably up to a = 70 degrees.

In an embodiment, a plurality of receptacles is positioned inline in the holding device to mount several medical containers simultaneously. In one specific embodiment, the holding device may include three or six receptacles positioned inline.

According to an embodiment, two gripping arms are oppositely mounted between two receptacles wherein one of the two gripping arms is assigned to one adjacent receptacle and the other gripping arm is assigned to the other adjacent receptacle. In an initial position, the gripping portions of the two gripping arms extend in opposite directions, preferably, essentially aligned with a longitudinal axis of the holding device.

According to another embodiment, one single gripping arm is mounted between two receptacles. One gripping arm is assigned to and placed beside one adjacent receptacle. Preferably, all gripping arms are positioned on the same side of the holding device or of the housing. In particular, in an initial position the gripping portions of the gripping arms extend in the same direction, preferably, essentially aligned with a longitudinal axis of the holding device or the housing.

The invention is also related to a gripping arm assembly as such. It is a gripping arm assembly for a system for agitating contents of at least one medical container, preferably as illustrated in the above description, wherein the gripping arm assembly is mountable to or can be arranged on a holding device of said system and wherein the gripping arm assembly includes a gripping arm to hold a medical container positioned in a receptacle of holding device of said system.

Brief description of drawings

The idea underlying the invention shall be explained in greater detail below with reference to the illustrative embodiments represented in the figures, wherein:

Figure 1 shows a schematic view of a system for agitating contents of at least one medical container;

Figure 2 shows a perspective view of a holding device of said system;

Figure 3 shows a perspective view of a holding device for receiving medical containers in accordance with an embodiment;

Figure 4A shows a perspective view of said holding device showing at least one receptacle and at least one gripping arm assembly;

Figure 4B shows a top view of the holding device in accordance with Figure 4A;

Figure 5A shows a perspective view of the holding device exposing the gripping arm assembly;

Figure 5B shows an exploded view of the gripping arm assembly with respect to the holding device;

Figure 6 shows a perspective view of the gripping arm;

Figure 7A shows a cross-sectional view of the gripping arm assembly in an embodiment;

Figure 7B shows a cross-sectional view of the gripping arm assembly of figure 7A in a different perspective;

Figure 8 shows a perspective view of a carrier unit;

Figure 9A shows a perspective of the gripping arm assembly in accordance with an embodiment;

Figure 9B shows a perspective view of the gripping arm assembly in accordance with Figure 9A;

Figure 10A shows a top view of the gripping arm assembly in accordance with an embodiment;

Figure 10B shows another perspective view of the gripping arm assembly;

Figured 11 shows a perspective view of a spring member; Figure 12A shows a perspective view of an opening formed adjacent to the receptacle;

Figure 12B shows a cross section view of said opening exposing internal components of the gripping arm assembly;

Figure 12C shows a top view of said opening and the spring member inserted in the opening;

Figure 13A shows a top view of a portion of the holding device wherein the gripping arm is in its initial position;

Figure 13B shows a top view of a portion of the holding device in a relation to Figure 13A wherein the gripping arm is in its maximum displaced position;

Figures 14A to 14C show a perspective view of the holding device wherein vials of different sizes are held in the receptacle by the gripping arm assembly.

Detailed description of drawings

Figure 1 shows a schematic view of one example of a system 100 for agitating contents of at least one medical container 101, preferably a vial. More particularly, the system 100 is a drug reconstitution system used to dissolve powdered drugs into fluids inside a vial.

The system 100 comprises a holding device 102 defining a plurality of receptacles 103 for receiving the medical containers 101. However, the holding device 102 may comprise lesser number of receptacles 103 than shown in Figure 1, for example, even one receptacle for holding one single medical container only. The system 100 further comprises a mount assembly 104 for supporting the holding device 102. In this example the holding device 102 is preferably pivotally supported on to the mount assembly 104 through a pivot coupling 105. The mount assembly 104 comprises a drive mechanism (not illustrated) configured to provide agitation to the holding device 102. In an embodiment, the drive mechanism may comprise a motor assembly and a shaft coupled with the holding device to provide a rotary motion about a first axis of rotation A-A and preferably, a to-and-fro swiveling motion about said first axis of rotation A-A. However, the drive assembly may be configured to provide other types of motion to the holding device, for example, vibratory or oscillatory motion. Furthermore, the system 100 comprises a control unit 106 configured to control agitation of the holding device 102 and a gripping arm assembly 200 disposed with the holding device 102.

In an embodiment, the control unit 106 may comprise an electronic control unit (ECU), an input device 107, preferably a rotatable knob and/or button and a display 108. A user may access the input device to select a mode of operation of the system 100, for example, a manual mode and an automatic mode. Also, the user may select from a plurality of speeds and time duration options. For instance, the user may control the swiveling motion on the basis of number of swiveling or shaking cycles in a minute. In an embodiment, the number of swiveling or shaking cycles may range from 30 shaking cycles per minute to 480 shaking cycles per minute and preferably from 30 shaking cycles per minute to 360 shaking cycles per minute. The shaking cycle could also be described as a shake. Similarly, the user may also select operation time limit of the system 100, preferably ranging from 1 minute to 10 minutes. The display shows the information about aforesaid operation modes and other parameters related to operation of the system.

Figure 2 illustrates the holding device 102 according to an embodiment of the present invention. In the embodiment, the holding device 102 comprises six in-line receptacles 103. The holding device 102 also comprises six gripping arm assemblies, one gripping arm assembly 200, corresponding to each of the receptacle 103 for holding six medical containers 101 simultaneously. The gripping arm assembly 200 includes a gripping arm

201 wherein two gripping arms 201 are oppositely mounted between two receptacles 103.

In another embodiment, as shown in Figure 3, the holding device 102 comprises three inline receptacles 103. The holding device 102 also comprises three gripping arm assemblies, one gripping arm assembly 200, corresponding to each of the receptacle 103 for holding three medical containers 101 simultaneously. The gripping arm assembly 200 includes a gripping arm 201 wherein each gripping arm 201 is arranged adjacent to each receptacle 103 and preferably next to each receptacle 103.

Figure 6 shows a perspective view of the gripping arm 201. The gripping arm 201 comprises a metal part, preferably, a laser-cut metal part and a plastic cladding 300 (as shown in Figure 5B) covering at least a portion of the metal part. In an embodiment, the plastic cladding has a Shore-A hardness of 40 to 60, preferably 45 to 55 (DIN ISO 7619- 1 (3s). In an embodiment, the plastic cladding may comprise a thermoplastic polymer based on a polyether, polyester and polyurethane elastomer.

Furthermore, the gripping arm 201 includes a first gripping portion 202, a handle portion 203, and a mounting portion 204, wherein the mounting portion is preferably T-shaped. The gripping arm 201 comprises an essentially vertical section defining the mounting portion 204, an essentially horizontal section defining the gripping portion 202, a curved transition section 205 between the vertical section and the horizontal section, and a further bent section in the plane of horizontal section connected to the gripping portion 202 and defining the handle portion 203. The gripping portion 202 of the gripping arm 201 spans over the receptacle 103 and the handle portion 203 extends essentially crosswise to a longitudinal axis of the holding device 102. The bent portion between the gripping portion

202 and the handle portion 203 preferably comprises a curved section. In the shown embodiment the gripping portion 202 and the handle portion 203 enclose an angle of 95° to 135°.

In an embodiment the gripping arm 201 is covered with the plastic cladding 300 from a tip portion 206 till a top edge 207 of the mounting portion 204. The metal part of the gripping arm 201 comprises a neck portion 208 in a region of the tip portion 206 to retain the plastic cladding 200 to the metal part of the gripping arm 201.

Referring to Figures 4A and 4B, the receptacle 103 includes at least a first curved ridge section 109 and a second curved ridge section 110 to support the medical container 101 received in the receptacle 103. The first curved ridge section 109 is defined by a first radius being larger than a second radius of the second curved ridge section 110. In operation, the gripping portion 202 faces the first curved ridge section 109 or the second curved ridge section 110 so as to hold the medical container 101 between the gripping portion 202 and the first curved ridge section 109 or between the gripping portion 202 and the second curved ridge section 110 respectively. A first type of medical containers is held between the first curved ridge section 109 and the gripping portion 202. A second type of medical container is held between the second curved ridge section 110 and the gripping portion 202. The first and the second type of containers are categorized on the basis of size, preferably, diameter such that a diameter of the first type of medical container is greater than a diameter of the second type of medical containers. Also, height of the first type of containers is more than the height of the second type of containers. The receptacle 103 further comprises a platform 112 below or towards lower end of the second curved ridge section. The platform 112 is arranged to support base of the second type of containers, which are smaller in height in comparison to the first type of containers. The platform 112 is provided above the bottom area of the receptacle 103. Preferably, the platform 112 is provided as a recess in the wall of the receptacle 103.

The receptacle 103 comprises a further curved section 111 having a radius larger than the first curved ridge section 109 and the second curved ridge section 110. In a preferred embodiment, radius of the first curved ridge section 109 may vary from 18 mm to 25mm, preferably from 21 mm to 22 mm, and/or the radius of the second curved ridge section 110 may vary from 10 mm to 18 mm, preferably from 15 mm to 16 mm and/or the radius of the further curved section 111 may vary from 25 mm to 30 mm, preferably from 26 mm to 27 mm.

As shown in Figures 4A and 4B, two gripping arms 201 are oppositely mounted between the two receptacles 103 in a way that one of the two gripping arms 201 is assigned to one adjacent receptacle 103 and the other of the two gripping arms 201 is assigned to the other adjacent receptacle 103 such that the two gripping arms 201 hold the medical containers 101 in opposite directions with respect to each other. Furthermore, in the initial position, the gripping portions 202 of the two gripping arms 201 extend in opposite directions, preferably aligned with a longitudinal axis of the holding device 102.

Referring to Figures 5A, 5B and 8 the gripping arm assembly 200 is disposed inside an opening 113 adjacent to the receptacle 103. In a preferred embodiment, the opening 113 is a cylindrical opening. The gripping arm assembly 200 includes a carrier unit 209 for mounting the gripping arm 201 and a spring member 210 mounted with the carrier unit 209 to provide holding resilience to the gripping arm 201. The carrier unit 209 includes a disk-shaped head portion 211 and a cylindrical body portion 212. In a preferred embodiment, the cylindrical body portion 212 extends perpendicular to the horizontal plane of the head portion. According to the embodiment, a vertical cross-section of the carrier unit 209 is T-shaped. As shown in Figures 10A, 10B and 11, the head portion 211 includes at least a first hole 213, and preferably a second hole 214, to fix the gripping arm 201 to the carrier unit 209. The head portion 211 comprises a further hole 215 to mount the spring member 210, in particular, a top end portion 216 of the spring member 210, to the carrier unit 209. In a preferred embodiment, the first hole 213 and the second hole 214 are threaded holes, formed to receive bolts 217. The bolts are arranged in said holes to secure the gripping arm 201.

As shown in Figures 9A and 9B, the body portion 212 of the carrier unit 209 is inserted into a central hollow space of the spring member 210. Preferably, the spring member 210 is a torsion spring and more preferably, the spring member 210 is a helical torsion spring, as shown in Figure 11. The top end portion 216 of the torsion spring 210 protrudes axially from the torsion spring 210. The further hole 215 receives the top end portion 216 such that the torsion spring 210 is coupled with the carrier unit 209, preferably, via form fit. The gripping arm 201 is rotatably moveable along with the carrier unit 209 and the carrier unit 209 is in biased engagement with the torsion spring 210.

Referring to Figure 12A to 12C, the torsion spring 210 further comprises a bottom end portion 220 bent to essentially form a chord of the circular space of the torsion spring 210. In other words, the bottom end portion 220 overlaps with the imaginary chord of the circular space or helical space of the torsion spring 210. Said bottom end portion 220 is secured in a, preferably, semi-circular slot 116 formed at a distal end of the cylindrical opening 113. The bottom end of the torsion spring 210 being pressed against a horizontal surface 117 of the semi-circular slot 116.

Referring to Figures 5B, 7A and 9B, the gripping arm assembly 200 further comprises a ring member 218 circumferentially disposed over the carrier unit 209 to retain the carrier unit 209 in a predetermined position in the opening 113. The ring member 218 is installed to partially overlap with a radial shoulder 114 in the wall section of the cylindrical opening 113. Moreover, the ring member 218 is arranged circumferentially over a top surface of the head portion 211 of the carrier unit 209.

Referring to Figures 7A, 7B and 8, the carrier unit 209 comprises a receiving area 221, preferably a slot, for the mounting portion of the gripping arm 201. The receiving area 221 conforms with the mounting portion 204 of the gripping arm 201. In the shown embodiment, the mounting portion 204 of the gripping arm 201 is T-shaped and the conforming receiving area 221 of the carrier unit 209 is also T-shaped. The bolts 217 are inserted in the first hole 213 and the second hole 214 upon insertion of mounting portion 204 in the receiving area 221. The bolts 217 are arranged such that a flange of the bolts 217 overlaps with a top edge 207 of the mounting portion 204 of the gripping arm 201.

The plastic cladding 300 conforms with the shape of metal part of the gripping arm 201 from the tip portion 206 till the top edge 207. An end of the plastic cladding 300 in the region of the mounting portion 204 is a disk-shaped sealing member 301. Said disk-shaped sealing member 301 is installed in a proximal end of the opening 113. The sealing member 301 comprises a radial shoulder 302 which is installed in a corresponding radial channel 115 in the proximal end of the cylindrical opening 113. Said sealing member 301 prevents ingress of liquid, dust, dirt and the like in the cylindrical opening 113.

The gripping arm 201 is retractable in the plane of housing 102 or the top surface of the housing to allow receiving of the medical container 101 in the receptacle 103. In the shown embodiment, the gripping arm 201 is movable in an anti-clockwise motion. The gripping arm 201 moves along with the carrier unit 209 which is in a biased engagement with the torsion spring 210. Furthermore, the shown gripping arm 201 is releasable to move in a clockwise motion along with the carrier unit 209 to hold the medical container 101 placed in the receptacle 103 under an action of holding resilient force provided by the torsion spring 210.

Referring to Figures 9A, 9B and 10A to 10B, the head portion 211 of the carrier unit 209 includes a, preferably curved recessed section 222. In particular, the head portion comprises a peripheral curved recessed section 222, having a first stop 223 and a second stop 224. A stopper 225 is affixed vertically inside a hole 118 with the cylindrical opening 113. In the shown embodiment, the first stop 223, the second stop 224 are curved inwards and the stopper 225 has a cylindrical shape. The shown stopper 225 is arranged to protrude from a top surface of a circumferential inner wall 119 of the cylindrical opening 113. The head portion 211 rests on a top surface of said inner wall 119 and the stopper 225 lies between the first stop 223 and the second stop.

Referring to Figures 13A and 13B, the stopper 225 is guided in the recessed section 222 of the head portion 211. The stopper 225 is engageable with the first stop 223 and the second stop 224 during angular motion of the carrier unit 209. The stopper 225 contacts with the first stop 223 and second stop 224 to provide a minimum and maximum displacement of the gripping arm 201. In particular, the maximum limit of anti-clockwise displacement of the carrier unit 209 corresponds to a contact between the first stop 223 and the stopper 225. The maximum limit of clockwise displacement of the carrier unit 209 corresponds to a contact between the second stop 224 and the stopper 225. The maximum range of aforesaid angular displacement is up to a ?100 degrees and preferably up to a = 70 degrees.

Figures 14A to 14C show a perspective view of the holding device 102 wherein vials 101 of different sizes are held in one receptacle 103 by the gripping arm 201. For illustration purposes the corresponding features of the receptacle 103 are also indicated in the empty receptacles 103.

Figure 14A shows a vial 101 of small diameter which is fixed by the gripping arm 201. The vial 101 is in contact with the gripping portion 202 of the gripping arm 201. The gripping arm 201 presses the vial 101 via the spring member 210 (not shown in the figure) into contact with the second curved ridge section 110. The second curved ridge section 110 extends into the opening of the receptacle 103 and merges into the platform 112. The platform 112 is formed in the wall of the receptacle 103. The small sized vial rests with its bottom or with a part of its bottom on the platform 112 of the receptacle 103. This enables a contact, preferably a plane contact, of the gripping portion 202 with the body of the vial 101. A contact with the neck or head of the vial 101 is prevented. The curvature of the second curved ridge section 110 is essentially in accordance or adapted to the size or circumference of the vial 101.

Figure 14B shows a vial 101 of medium diameter which is fixed by the gripping arm 201. The vial 101 is also in contact with the gripping portion 202 of the gripping arm 201. The gripping arm 201 presses the vial 101 into contact with the first curved ridge section 109. The first curved ridge section 109 extends into the opening of the receptacle 103 and merges into or extends to the bottom of the receptacle 103. The curvature of the first curved ridge section 109 is essentially in accordance or adapted to the size or circumference of the medium sized vial 101. Preferably, a radius of the segment of the first curved ridge section 109 is larger than a radius of the segment of the second curved ridge section 110.

Figure 14C shows a vial 101 of larger diameter which is fixed by the gripping arm 201. The vial 101 is also in contact with the gripping portion 202 of the gripping arm 201. The gripping arm 201 presses the vial into contact with the wall of the receptacle 103. The curvature of the wall is essentially in accordance or adapted to the size or circumference of the larger vial 101. Preferably, a radius of the receptacle 103 is larger than a radius of the segment of the first curved ridge section 109. The form or curvature of the gripping portion 202 of the griping arm 201 is adapted such that the gripping portion 202 is essentially always, preferably at least partially, in contact with the body of the vial 101 for all vial sizes which can be received in the receptacles 103. For instance, in figure 14C the body of the larger vial 101 is in contact with a central area of the gripping portion 202. This enables a safe positioning of vials 101, even of different sizes, in the receptacles 103 of the holding device 102 during a common shaking operation for the reconstitution of drugs, particularly for dissolving a powder form drug with a sterile diluent to reformulate it into liquid form.

It will be understood that the invention may be embodied in other specific forms without departing from the spirit or central characteristics thereof. The present examples and embodiments, therefore, are to be considered in all respects as illustrative and not restrictive, and the invention is not to be limited to the details given herein. Accordingly, features of the above-described specific embodiments can be combined with one another. Further, features described in the summary of the invention can be combined with one another. Furthermore, features of the above-described specific embodiments and features described in the summary of the invention can be combined with one another.

Reference list:

100 System for agitating

101 Medical container or vial

102 Holding device

103 Receptacle

104 Mount assembly

105 Pivot coupling

106 Control unit

107 Input device

108 Display

109 First curved ridge section

110 Second curved ridge section

111 Further curved ridge section

112 Platform

113 Opening

114 Radial shoulder in wall

115 Radial channel

116 Slot

117 Horizontal surface

118 Hole

200 Gripping arm assembly

201 Gripping arm

202 Gripping portion

203 Handle portion

204 Mounting portion

205 Curved transition section

206 Tip portion

207 Top edge

208 Neck portion

209 Carrier unit

210 Spring member

211 Head portion

212 Cylindrical body portion

213 First hole

214 Second hole

215 Further hole

216 Top end portion

217 Bolts

218 Ring member

220 Bottom end portion

221 Receiving area

222 Curved recessed section

223 First stop

224 Second stop

225 Stopper

300 Plastic cladding

301 Disk-shaped sealing member

302 Shoulder

Claims

1. A system (100) for agitating contents of at least one medical container (101), the system (100) comprising: a holding device (104) defining at least one receptacle (103) for receiving the medical container (101); a mount assembly (105) for supporting the holding device (104), the mount assembly (105) comprising a drive mechanism configured to provide agitation to the holding device (104); a control unit (106) configured to control the agitation of the holding device (104); and at least one gripping arm assembly (200) disposed with the holding device (104), wherein the gripping arm assembly (200) includes a gripping arm (201) arranged to hold the medical container (101) positioned in the receptacle (103), wherein the gripping arm (201) includes a handle portion (203).

2. The system as claimed in claim 1, wherein the gripping arm assembly (200) is disposed inside a, preferably cylindrical, opening (113) adjacent to the receptacle (103).

3. The system as claimed in claims 1 to 2, wherein the receptacle (103) includes at least a first curved ridge section (109) and/or a second curved ridge section (110) and/or a platform (112) towards a lower end of the second curved ridge section (110) to support the medical container (101) received in the receptacle (103), preferably wherein the first curved ridge section (109) is defined by a first radius being larger than a second radius of the second curved ridge section (110).

4. The system as claimed in of the preceding claims, wherein the gripping arm (201) comprises a metal part and a plastic cladding (300) covering at least a portion of the metal part.

5. The system as claimed in one of the preceding claims, wherein the gripping arm (201) includes a gripping portion (202), the handle portion (203) and a mounting portion (204).

6. The system as claimed in the preceding claim, wherein the gripping arm (201) comprises a vertical section defining the mounting portion (204), a horizontal section defining the gripping portion (202), a curved transition section (205) between the vertical section and the horizontal section, and a further bent section in the plane of horizontal section connected to the gripping portion (202) and defining the handle portion (203).

7. The system as claimed in claim 4, wherein the metal part of the gripping arm (201) comprises a neck portion (208) in a region of the tip portion (206) to retain the plastic cladding (300) to the metal part. The system as claimed in one of the preceding claims, wherein the gripping arm assembly (200) includes: a carrier unit (209) for mounting the gripping arm (201); and a spring member (210) mounted with the carrier unit (209) to provide holding resilience to the gripping arm (201). The system as claimed in claim 8, wherein the spring member (210) is a torsion spring, preferably wherein the torsion spring is embodied as a helical torsion spring. The system as claimed in one of the preceding claims 8 to 9, wherein the carrier unit (209) comprises a receiving area (221), preferably a slot, for the mounting portion of the gripping arm (201), preferably the receiving area (221) conforming with the mounting portion (204) of the gripping arm (201). The system as claimed in one of the preceding claims 8 to 10, wherein the gripping arm (201) is rotatably moveable along with the carrier unit (209), the carrier unit (209) being in a biased engagement with the torsion spring (210). The system as claimed in of the preceding claims, wherein the gripping arm (201) is retractable, preferably in the plane of holding device (102), to allow receiving of the medical container (101) in the receptacle (103), preferably wherein the gripping arm (201) being movable in an anti-clockwise motion and/or wherein the gripping arm (201) is releasable to move in an opposite direction, preferably a clockwise motion, to hold the medical container placed in the receptacle under an action of resilient force provided by a spring member (210). The system as claimed in one of the preceding claims 8 to 12, wherein a stopper (225) is provided in the receptacle and wherein the maximum limit of an angular, preferably anti-clockwise, displacement of the carrier unit (209) corresponds to a contact between a first stop (223) provided on the carrier unit and the stopper (225), and/or the maximum limit of an opposite angular, preferably clockwise, displacement of the carrier unit (209) corresponds to a contact between a second stop (224) provided on the carrier unit and the stopper (225) and/or wherein the maximum range of an angular displacement is up to a = 100 degrees, preferably up to a = 70 degrees. The system as claimed in one of the preceding claims, wherein the gripping arm assembly (200) is pre-tensioned in an initial position, in particular wherein the pretension of the spring member (210) in the initial position has a torque of about To = 105 Nmm +/- 50 Nmm, preferably To = 105 Nmm +/- 30 Nmm. The system as claimed in one of the preceding claims, wherein the resilient force of the spring member (210) increases with increasing angular displacement a of the gripping arm assembly (200), in particular wherein the resilient force increases to a torque of about 475 +/- 100 Nmm, preferably 475 +/- 50 Nmm, at an opening angle a = 60° - 70°, preferably at a = 70°, in relation to the initial position and/or wherein the spring member (210) comprises an essentially linear characteristic curve in the region up to a = 70°.