WO2016049685A1

WO2016049685A1 - An administering device for administering a therapeutic substance

Info

Publication number: WO2016049685A1
Application number: PCT/AU2015/000596
Authority: WO
Inventors: Brendon VAN DEN BERG; Gilman Wong
Original assignee: Sirtex Medical Limited
Priority date: 2014-09-30
Filing date: 2015-09-30
Publication date: 2016-04-07

Abstract

The invention in its first form resides in a administering device for delivering a therapeutic substance in a fluid to a patient, the administering device comprising: (i) a receiving portion arranged to receive a vessel which contains a therapeutic substance and a fluid, the vessel further being configured to be in fluid communication with an outlet in the administering device; (ii) a dispersing mechanism or means to mix or move the vessel to disperse the therapeutic substance and fluid in the vessel; and (iii) at least one infusion line that is in fluid communication with the vessel via the outlet, wherein, in use, the administering device is adapted to deliver to the patient a defined amount of the substance and fluid via the infusion line.

Description

AN ADMINISTERING DEVICE FOR ADMINISTERING A THERAPEUTIC

SUBSTANCE

TECHNICAL FIELD

[0001] The invention relates generally to the field of devices for administering a therapeutic substance.

[0002] A specific embodiment of the invention finds particular, but not exclusive, use in the administration of a therapeutic substance to a patient.

BACKGROUND ART

[0003] In standard use, a syringe is a hand-held device that is operated manually by a person who applies pressure to the plunger, expelling the substance from the syringe outlet. In use, the outlet is connected directly to a needle or cannula, which is inserted into the patient, or indirectly to a needle or cannula via an infusion line.

[0004] Some patients require treatment with a radioactive substance, which is injected from a syringe. In some situations, the person (for example a physician) administering the radioactive substance is required to manually load and operate the syringe, often exposing themselves to radiation. Repeated exposure over numerous administrations can be very harmful to the syringe operator and can lead to radiation poisoning, cancer and in some instances can lead to fatalities. Therefore, eliminating, or substantially reducing, the level of exposure of a physician to radiation is desirable.

[0005] The preceding discussion of the background art is intended to facilitate an understanding of the present invention only. The discussion is not an acknowledgement or admission that any of the material referred to is or was part of the common general knowledge as at the priority date of the application.

SUMMARY OF INVENTION

[0006] It is an object of this invention to provide an administering device for

administering a substance which ameliorates, mitigates or overcomes, at least one disadvantage of the prior art, or which will at least provide the public with a practical choice. [0007] The invention in its first form resides in an administering device for administering a therapeutic substance in a fluid to a patient, the administering device comprising:

(i) a receiving portion arranged to receive a vessel which contains a therapeutic substance and a fluid, the vessel further being configured to be in fluid communication with an outlet in the administering device; and

(ii) at least one infusion line that is in fluid communication with the vessel via the outlet,

wherein, in use, the administering device is adapted to deliver to the patient a defined amount of substance and fluid via the at least one infusion line.

[0008] The invention in its second form resides in an administering device for administering a therapeutic substance in a fluid to a patient, said administering device comprising:

(i) a receiving portion arranged to receive a vessel that is configured to contain the therapeutic substance and the fluid, the vessel further being in fluid communication with an outlet; and

(ii) a dispersing mechanism that is arranged to at least partially disperse the therapeutic substance in the fluid within the vessel prior to or during delivery of the therapeutic substance and the fluid to the outlet; and

(iii) at least one infusion line that is in fluid communication with the outlet, wherein, in use, the device is configured to deliver an amount of the dispersed therapeutic substance in the fluid to the patient via the infusion line.

[0009] In one embodiment, the dispersing mechanism is arranged to rotate, partially rotate or oscillate the vessel to cause the therapeutic substance to disperse in the fluid.

[0010] In an alternate embodiment, the dispersing mechanism is arranged to agitate the vessel.

[001 1] In yet a further embodiment, the dispersing mechanism is further arranged to agitate the fluid within the vessel wherein agitation of the fluid within the vessel causes the therapeutic substance to disperse in the fluid.

[0012] In a further alternate embodiment, the dispersing mechanism is arranged to vibrate the vessel. [0013] In use, the dispersing mechanism is adapted to disperse the therapeutic substance generally evenly or homogeneously within the vessel. This may be achieved, for example, where the dispersing mechanism further includes a motor configured to operate the dispersing mechanism. Said motor preferably operates to rotate the vessel about an axis of the vessel. That axis is desirably the longitudinal axis of the vessel.

[0014] In one embodiment, the vessel is positioned in association with the dispersing mechanism in a manner that substantially prevents contaminant gases in the vessel from entering the at least one infusion line.

[0015] In a second aspect, the invention also includes a swivel mechanism configured to receive the vessel and includes at least one infusion line wherein the swivel mechanism is capable of substantially independent movement of the infusion line relative to the vessel yet is adapted to maintain fluid communication between the infusion line and the vessel. The swivel mechanism, when present in the administering device, is preferably rotatably engaged to, and in fluid communication with, the vessel outlet.

[0016] In an embodiment, the swivel mechanism is interposed between the outlet and the infusion line.

[0017] Preferably a swivel body of the swivel mechanism is capable of substantially independent movement relative to the vessel. Preferably the swivel body receives the at least one infusion line.

[0018] Preferably the swivel mechanism provides a rotatable seal between the vessel and the at least one infusion line.

[0019] In highly preferred form of the second aspect of the invention, the administering device for administering a therapeutic substance in a fluid to a patient comprises:

(i) a receiving portion arranged to receive a vessel configured to contain the therapeutic substance in the fluid, the vessel being in fluid communication with an outlet;

(ii) a dispersing mechanism that is arranged to at least partially disperse the therapeutic substance in the fluid within the vessel prior to or during delivery of the therapeutic substance and the fluid to the outlet;

(iii) at least one infusion line that is in fluid communication with the outlet; and (iv)a swivel mechanism that is interposed between the at least one infusion line and the vessel outlet;

wherein, in use, the dispersing mechanism at least partially disperses the therapeutic substance within the fluid and the swivel mechanism facilitates substantially independent movement of the at least one infusion line relative to the vessel.

[0020] In an alternate form the invention provides an administering device for administering a therapeutic substance in a fluid to a patient, said device comprising:

(ii) a dispensing mechanism that is operable to controllably transfer the therapeutic substance and the fluid from the vessel to the outlet; and

(iii) at least one infusion line that is in fluid communication with the outlet, wherein, in use, the dispensing mechanism operates to controllably deliver an amount of substance and fluid to the patient via the infusion line.

[0021] To the extent that a dispensing mechanism is included in the invention preferably the dispensing mechanism operates via an actuator arranged to transfer the therapeutic substance and the fluid to the outlet. In one embodiment, the actuator is an electrically driven actuator or may be hydraulically operated. Preferably, the actuator is a linear actuator. For example, in the illustrated form of the invention, the linear actuator is operated via a gearing mechanism. In use, one revolution of the gearing mechanism transfers an amount of the therapeutic substance and the fluid from the outlet approximate to the dead volume of the infusion line.

[0022] In one embodiment, the dispensing mechanism in the administering device further includes a scale configured to, in use, display the approximate combined volume of the substance and the fluid in the vessel.

[0023] In a preferred aspect of this form of the invention the administering device will also include a swivel mechanism arranged to receive at least one infusion line, the swivel mechanism configured to interpose the vessel outlet and the at least one infusion line and wherein, the swivel mechanism facilitates substantially independent movement of the at least one infusion line relative to the vessel. [0024] In highly preferred form, the invention provides an administering device for administering a therapeutic substance in a fluid to a patient, said device comprising:

(i) a receiving portion arranged to receive a vessel configured to contain the therapeutic substance, the vessel being in fluid communication with an outlet;

(iii) at least one infusion line that is in fluid communication with the outlet,

(iv) a swivel mechanism configured to form a fluid communication between the outlet and the at least one infusion line, wherein the swivel mechanism is capable of substantially independent movement of the infusion line relative to the vessel yet is adapted to maintain fluid communication between the infusion line and the vessel; and

(v) a dispensing mechanism that is operable to controllably transfer the therapeutic substance and the fluid from the vessel to the outlet, wherein, in use, the dispensing mechanism operates to controllably deliver an amount of the substance and the fluid to the patient via the infusion line.

[0025] According to the various forms and aspects of the invention the at least one infusion line is arranged to deliver the therapeutic substance from the outlet to the patient.

[0026] In one embodiment, the at least one infusion line further includes at least one one-way valve in fluid communication with the outlet and arranged to prevent backflow of the therapeutic substance and the fluid into the vessel or into another infusion line.

[0027] The present invention is engineered to deliver a wide range of therapeutic substances to a patient. In one embodiment the therapeutic substance is radioactive. Preferably, the radioactive substance is a plurality of radioactive microparticles.

[0028] In the event that the administering device is used to deliver a radioactive substance, the administering device may further include one or more radiation shields. Such a shield may be manufactured from plastic like material. For example, the radiation shield is manufactured from acrylic, Perspex, PVC, polythene, polypropylene, polycarbonate, Bakelite, epoxy resin or melamine. [0029] The vessel used in the administering device of the invention will be of such a configuration that it is capable of retaining a fluid without substantial leakage or loss. Preferably the vessel will be adapted to hold a fluid without substantial leakage or loss. In one embodiment, the vessel is a syringe.

[0030] In the administering device, the vessel is preferably containable within a substantially transparent radiation housing. Such a housing may be manufactured from plastic like material. For example, the radiation shield is manufactured from acrylic, Perspex, PVC, polythene, polypropylene, polycarbonate, Bakelite, epoxy resin or melamine.

[0031] The invention in a further form resides in an administering device for administering a therapeutic substance in a fluid to a patient, the administering device comprising:

(i) a receiving portion arranged to receive and support a vessel, the vessel containing the therapeutic substance and the fluid, the vessel further being configured to be in fluid communication with an outlet in the administering device when received in the receiving portion; and

(ii) a means to mix the therapeutic substance and fluid therein, the vessel being able to move independently of the administering device when supported therein; and wherein, in use, the means to mix the therapeutic substance and fluid is adapted to move the vessel to at least mix the therapeutic substance and the fluid prior to or during delivery of the therapeutic substance and the fluid to the outlet.

[0032] When mixing the therapeutic substance and fluid the resultant substance may be a suspension mixture where the therapeutic substance is dispersed within the fluid, a solution mixture where the therapeutic substance is at least partially dissolved within the fluid, or the mixture may comprise at least a portion of a new product formed from the at least partial reaction of the therapeutic substance with the fluid.

[0033] In one aspect of the invention the means to mix the therapeutic substance and fluid is provided by a means to move the vessel. The means to move the vessel may be in the form of a dispersing mechanism. The dispersing mechanism may be arranged to rotate, partially rotate or oscillate the vessel to cause mixing of the therapeutic substance and the fluid.

[0034] In an alternate embodiment, the dispersing mechanism is arranged to agitate the vessel such that the fluid within the vessel causes the therapeutic substance to disperse in the fluid.

[0035] In another aspect of the invention the means to move the vessel is in the form of a vibration mechanism. The vibration mechanism may be arranged to vibrate the vessel to cause the therapeutic substance to mix with the fluid.

[0036] In another aspect of the invention the means to mix the therapeutic substance and fluid is provided by an excitation mechanism which excites the therapeutic substance and the fluid. The excitation mechanism may be provided by a heat source, a sound source, or a light source.

[0037] The invention in a further form resides in an administering device for administering a substance contained in a vessel to a patient, the administering device comprising: a housing for receiving and supporting the vessel therein, the housing comprising: an outlet through which the substance may pass; a movement means adapted to move the vessel relative to the housing when supported therein; an infusion line in rotatable, fluid communication with the outlet of the housing; wherein, in use, the movement means moves the vessel to mix the substance contained therein prior to or during delivery of the mixed substance, the mixed substance being delivered from the vessel through the at least one infusion line.

[0038] When mixing the substance the resultant mixed substance may be a suspension mixture, where at least one product is dispersed within another product, a solution mixture, where at least one product is at least partially dissolved within another product, or the mixture may comprise a portion of a new product formed from the reaction of the at least one product with another product. [0039] In one aspect of the invention the means to move the vessel is in the form of a dispersing mechanism. The dispersing mechanism may be arranged to rotate, partially rotate or oscillate the vessel to cause mixing of the substance.

[0040] In an alternate embodiment, the dispersing mechanism is arranged to agitate the vessel such that the fluid within the vessel causes the substance to mix.

[0041] In another aspect of the invention the means to mix is in the form of a vibration mechanism. The vibration mechanism may be arranged to vibrate the vessel to cause the substance to mix.

[0042] The invention in a further form resides in an administering device for administering a substance to a patient, the administering device comprising:

(i) a receiving portion arranged to receive a vessel which contains a substance, the vessel being configured to be in fluid communication with an outlet in the administering device once the vessel is received in the receiving portion; and

(ii) at least one infusion line that is in fluid communication with the outlet, wherein the outlet is rotatable relative to the infusion line;

wherein, in use, the administering device is adapted to deliver to the patient a defined amount of substance from the vessel to the at least one infusion line via the outlet.

[0043] The invention in a further form resides in an administering device for administering a therapeutic substance in a fluid to a patient, the administering device comprising:

(iii) a swivel mechanism configured to receive the vessel and includes the at least one infusion line wherein the swivel mechanism is capable of substantially independent movement of the vessel relative to the at least one infusion line yet is adapted to maintain fluid communication between the infusion line and the vessel; wherein, in use, the administering device is adapted to deliver to the patient a defined amount of substance and fluid via the at least one infusion line.

[0044] The invention in a further form resides in an administering device for administering a therapeutic substance in a fluid to a patient, the administering device comprising:

(iii) a swivel mechanism arranged to receive the at least one infusion line, the swivel mechanism configured to interpose the vessel outlet and the at least one infusion line and wherein, the swivel mechanism facilitates substantially independent movement of the at least one infusion line relative to the vessel;

BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Further features of the present invention are more fully described in the following description of several non-limiting embodiments thereof. This description is included solely for the purposes of exemplifying the present invention. It should not be understood as a restriction on the broad summary, disclosure or description of the invention as set out above. The description will be made with reference to the accompanying drawings in which:

[0046] FIG. 1A is a perspective view of the administering device in accordance with an embodiment of the present invention depicting a receiving portion of the device engaging a syringe and a plunger receiving portion of a dispensing mechanism engaging a syringe plunger;

[0047] FIG. 1 B is a perspective view of the administering device in accordance with the embodiment of the present invention, depicting the receiving portion of the device engaging the syringe but with the plunger disengaged from the plunger receiving portion of the dispensing mechanism; [0048] FIG. 1C is a perspective view of the administering device in accordance with the embodiment of the present invention, depicting the receiving portion of the administering device engaging the syringe and the plunger receiving portion of the dispensing mechanism engaging the syringe plunger;

[0049] FIG. 1 D is a perspective view of the administering device in accordance with the embodiment of the present invention depicting a swivel mechanism. The administering device has not engaged the syringe;

[0050] FIG. 1 E is a cutaway view of the administering device in accordance with the embodiment of the present invention, depicting the components of the mechanism and the dispensing mechanism;

[0051] FIG. 1 F is a perspective view of the administering device in accordance with the embodiment of the present invention, depicting an opaque radiation shield and an opaque radiation housing;

[0052] FIG. 2A is a perspective view of the swivel mechanism in accordance with the embodiment of the present invention;

[0053] FIG. 2B is a side, cutaway view of the swivel mechanism in accordance with the embodiment of the present invention with a gripping portion attached;

[0054] FIG. 2C is a side cut away view of the swivel mechanism in accordance with the embodiment of the present invention; and

[0055] FIG. 2D is an exploded view of the swivel mechanism in accordance with the embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0056] Those skilled in the art will appreciate that the invention described herein is susceptible to variations and modifications other than those specifically described. It is to be understood that the invention includes all such variations and modifications.

[0057] Throughout this specification, unless the context requires otherwise, the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.

[0058] It must also be noted that, as used herein and in the appended claims, the singular forms "a," "or," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a infusion line" includes a plurality of such lines, and so forth.

[0059] Other definitions for selected terms used herein may be found within the detailed description of the invention and apply throughout. Unless otherwise defined, all other scientific and technical terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which the invention belongs.

[0060] No 'gloss' should be taken from any term used, or defined in, the specification, to limit the scope of the embodiments or the broader inventive concept described herein. Other definitions for selected terms used herein may be found within the detailed description of the invention and apply throughout. Unless otherwise defined, all other technical terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which the invention belongs.

[0061] Features of the invention will now be discussed with reference to the following non-limiting description and examples.

[0062] An embodiment of the administering device of the present invention may be used to operate a vessel containing a therapeutic substance and deliver the therapeutic substance to a patient.

[0063] In the following description reference will be made to a "therapeutic substance in a fluid". In a first embodiment the therapeutic substance will be understood to be a radioactive substance or radioactive medical device, such as radioactive microspheres. It is to be understood that the following description is not to be limited to this interpretation of "therapeutic substance in a fluid". The "therapeutic substance in a fluid" could also be, for exemplary purposes only, a different radioactive substance, a chemical compound, a drug, a pharmaceutical substance, fluids for intravenous injection, or a radioactive substance, either dissolved in, or dispersed in, a liquid or gas.

[0064] The term "fluid" is intended to mean a substance that has no fixed shape which yields easily to external pressure, such as a gas or a liquid.

[0065] Briefly, an embodiment of the administering device described herein is an administering device for administering a therapeutic substance in a fluid to a patient, comprising a receiving portion arranged to receive a vessel configured to contain the therapeutic substance and the fluid. The vessel being in fluid communication with an outlet. The administering device also includes a dispensing mechanism that is operable to controllably transfer the therapeutic substance and the fluid from the vessel to the outlet, wherein, in use, an amount of the substance and the fluid is delivered to the patient.

[0066] Referring now in detail to the drawings, in one embodiment of the invention, Figures 1A to 1 F show an administering device (100) as described herein comprising a device body (99), a receiving portion (102), a dispensing mechanism (104), a means to mix the therapeutic substance and the fluid, the means comprising a dispersing mechanism (106), a radiation shield (108), a swivel mechanism (200), a vessel in the form of a syringe (1 12), in this embodiment, the syringe has a plunger (1 14), a patient infusion line (116) and a scale (1 18).

[0067] The dispensing mechanism (104) shown in this embodiment includes a linear actuator including a manual control mechanism (120B) and a translation member (120A) wherein the translation member (120A) further includes a plunger receiving portion (122).

[0068] In this embodiment, the dispersing mechanism (106) is incorporated into a wall of the administering device and is configured to receive the syringe (1 12). In use, the syringe (112) is arranged to receive and dispense the therapeutic substance. In use, the dispensing mechanism (104) engages the plunger (114) of the syringe (1 12) via the plunger-receiving portion (122) and operates the plunger (1 14) via the manual control mechanism and translation member (120B and 120A). When an operator adjusts the manual control mechanism (120B), linear movement of the translation member (120A) operates the plunger (1 14). Movement of the plunger (1 14) along the parallel axis of the syringe (1 12) transfers the substance contained within the syringe (1 12) to a syringe outlet (125) where it is then transferred to the patient infusion line (116). In use, the administering device may be used to deliver the therapeutic substance to a tumour in a patient via the patient infusion line. The scale (1 18) indicates the volume of the substance contained within the syringe (1 12). In this embodiment, the syringe (1 12) is housed within a radiation housing (124), which prevents exposure of the device operator to radiation.

[0069] Figure 1A depicts the administering device with the dispersing mechanism (106), the dispensing mechanism (104) and the swivel mechanism (200). In this figure, the syringe (112) is engaged with the device body (99) via the dispersing mechanism (106) and the syringe plunger (114) is engaged with the plunger receiving portion (122) of the dispensing mechanism (104). In use, the dispensing mechanism (104) operates the syringe (1 12), causing the fluid contained within the syringe (1 12) to move to the outlet. Simultaneously the dispersing mechanism (106) rotates the syringe (1 12) in an oscillating motion, causing the therapeutic substance in the syringe (112) to become dispersed within the fluid. In use, the swivel mechanism (200) moves substantially independently relative to the syringe (1 12) such that as the syringe (112) is oscillating, a swivel body (201 ) of the swivel mechanism (200) remains substantially stationary.

[0070] Figure 1 B depicts the administering device with the radiation shield (108) open for receiving the syringe (1 12). In this figure, the syringe (1 12) is engaged with the device via the dispersing mechanism (106). In this embodiment, the syringe (1 12) is passed through an aperture of the dispersing mechanism (106) to become engaged with the dispersing mechanism (106). In this figure, the syringe plunger (1 14) is not yet engaged with the dispensing mechanism (104). In this figure, the administering device is in the syringe loading position wherein the syringe (112) and administering device are arranged such that the syringe can be loaded with the therapeutic substance via the syringe outlet (125). As the substance fills the syringe (1 12), it forces the plunger (114) through the syringe barrel from a compressed configuration to an extended configuration. Once the syringe is loaded with the desired dose of the therapeutic substance, the plunger receiving portion (122) of the dispensing mechanism (104) may be placed into position in order to receive the plunger (114), as shown in Figure 1 C.

[0071] Figure 1 C depicts the administering device after the dispensing mechanism (104) has been placed into position and has engaged the syringe plunger (1 14) via the plunger receiving portion (122).

[0072] Figure 1 D depicts the administering device prior to receiving the syringe. This embodiment further shows the radiation housing (124).

[0073] Figure 1 E depicts a cut away view of the administering device showing the internal components of the dispersing mechanism (106), and a gearing mechanism comprising the manual control mechanism (120B) and translation member (120B).

[0074] Figure 1 F shows the administering device in with an radiation shield (108) and the radiation housing (124).

[0075] Figures 1A, 1 D and 1 F show an embodiment wherein the swivel mechanism (200) is engaged with the administering device. In use, the dispensing mechanism (104) operates the syringe (112), causing the fluid contained within the syringe (1 12) to move to the outlet. Simultaneously the dispersing mechanism (106) rotates the syringe (1 12) in an oscillating motion, causing the therapeutic substance in the syringe (112) to become dispersed within the fluid therein. In use, the swivel mechanism (200) moves substantially independently relative to the syringe (1 12) such that as the syringe (1 12) is oscillating, the swivel body (201 ) remains substantially stationary.

[0076] Figures 1A to 1 F show the dispersing mechanism (106) incorporated into a wall of the administering device, when supporting the syringe (Figures 1A to 1 C) and when not supporting the syringe (Figures 1 D to 1 F). In this embodiment of the invention, the dispersing mechanism (106) also functions as the receiving portion (102). That is, the dispersing mechanism (106) is arranged to receive the syringe (1 12). In use, the syringe (1 12) is passed through the aperture of the dispersing mechanism (106) and engages the dispersing mechanism (106). The dispersing mechanism (106) is operated by a motor (126) which causes a rotational motion of the dispersing mechanism (106) and the syringe (1 12). The dispersing mechanism (106) rotates the syringe (1 12) about its longitudinal axis. In some embodiments, the rotational motion alternates between a clockwise and anticlockwise direction.

[0077] It would be readily understood by the skilled address that the manual control mechanism and translation member can be substituted with an alternative gearing mechanism.

[0078] It will also be understood by the skilled addressee that the vessel may have any suitable structure able to contain and dispense a therapeutic substance. In one embodiment, the vessel may be a compressible vessel wherein in use, the dispensing mechanism causes the vessel to compress which in turn causes the volume of the vessel to become reduced. This reduction in volume size forces the therapeutic substance and fluid contained within the vessel to flow to the vessel outlet wherein, in use, the therapeutic substance and the fluid are delivered to the patient via the infusion line.

[0079] In another embodiment, the vessel may be a syringe or other suitable vessel, adapted to receive a dosage cartridge containing a therapeutic substance and a fluid therein. In use, the vessel may engage the dosage cartridge such that the vessel outlet is in fluid communication with the substance contained within the cartridge. In this embodiment, the therapeutic substance is dispersed within the fluid inside the dosage cartridge which, in turn, may be housed within the vessel.

[0080] Figures 2A to 2D show a full (Figure 2A), cutaway (Figures 2B and 2C) and deconstructed (Figure 2D) view of the swivel mechanism (200). The swivel mechanism (200) comprises the swivel body (201 ), a swivel portion (202), a gripping portion (204), a fastening mechanism (206) extending from the swivel body (201 ), a substance mixing portion (208), the patient infusion line (1 16), in the form of a first patient infusion line (1 16'), and a second infusion line (210). One or both of the second infusion line (210) and the swivel mechanism (200) may further include one-way valves (212). In some embodiments, the first infusion line may include a one-way valve.

[0081] In use, the swivel mechanism (200) is rotatably engagable to, and in fluid communication with the outlet (125) of the syringe (1 12) via the swivel portion (202). The gripping portion (204) provides the user with a portion to grip to facilitate attachment of the swivel portion (202) to the syringe (1 12). The fastening mechanism (206) assists in securing the swivel body (201 ) relative to the device body (99).

[0082] The swivel portion (202) comprises a luer lock arrangement for engaging the syringe outlet (125). Upon engagement of the syringe outlet (125) and the swivel portion (202), the syringe outlet (125) is in fluid communication with the mixing portion (208) through a fluid passage (207) whereby the fluid passage is rotatably sealed relative to the mixing portion (208). This enables the syringe (1 12) to rotate relative to the swivel body (201 ). In alternative embodiments the swivel portion (202) may comprise a rotatable coupling to allow the syringe outlet to rotatably and sealingly engage the fluid passage, such that the fluid passage is fixed.

[0083] In use, the swivel portion (202) engages both the gripping portion (204) and the syringe outlet (125). Due to the swivel capacity of the swivel portion (202), the swivel body (201 ) is able to move substantially independently relative to the swivel portion (202) and gripping portion (204). Following on from this, the swivel body (201 ) is able to move substantially independently from the syringe (1 12) as the syringe (1 12) is rotated by the dispersing mechanism (106).

[0084] When the swivel mechanism (200) is secured relative to the device body (99), movement of the swivel body (201 ) relative to the device body (99)is substantially inhibited by the fastening mechanism (206). In use, rotation of the syringe (1 12) by the dispersing mechanism (106) causes the swivel portion (202) and the gripping portion (204) to rotate, while the swivel body (201 ) will remain substantially stationary. Thus, in use, the swivel mechanism (200) prevents the patient infusion lines (1 16) from moving and become disengaged from the patient or from shifting to an off-target position as a result of the rotation of the syringe (1 12).

[0085] In use, the second infusion line (210) may be used to co-administer at least one additional therapeutic substance to a patient other than the substance contained within the syringe (1 12). In this embodiment, the additional substance is injected into the second infusion line (210) where the substance travels to the mixing portion (208). In this figure, there is only a single patient infusion line. Therefore, in use, the substance being administered from the syringe (1 12) and the co-administered substance both enter the mixing portion (208) before being delivered to the patient via the patient infusion line.

[0086] In this particular embodiment, the mixing of the two therapeutic substances occurs only through the physical movement of the substances as they meet at the mixing portion (208) and travel through the patient infusion line, however it will be understood that this embodiment of the invention may be used in conjunction with a mixing device to ensure a more thorough mixing of the two substances. Furthermore, it will be understood that any number of therapeutic substances can be administered to the patient simultaneously using the administering device of the present invention.

[0087] In one embodiment, the dispensing mechanism (104) may be a syringe pump (104'), wherein the administering device is arranged to receive the syringe (112).

[0088] The syringe pump (104') may be manually operated such that when in use, the syringe pump operates the syringe (1 12).

[0089] In this embodiment, the syringe (1 12) received by the administering device may be any standard or custom made syringe. The syringe may include a chamber or barrel with an outlet at a first end, and an open second end arranged to receive the plunger (1 14). The plunger (1 14) can be inserted into the second end of the barrel and may slidably move through the barrel. The plunger (1 14) further includes a rubber piston arranged to create a fluid seal between the plunger (1 14) and the barrel of the syringe. When pressure is applied by the pump (104') to the plunger (1 14), the plunger (1 14) slidably extends parallel to the longitudinal axis of the syringe (1 12), through the barrel. The piston creates a seal such that movement of the plunger (1 14) transfers the substance contained with the barrel to the outlet. In use, the syringe (1 12) may be connected at its outlet to the at least one patient infusion line (1 16) leading to the patient such that when the pump (104') is operated, the contents of the syringe (112) are transferred from the syringe (1 12), along the infusion line (116), into a patient. The syringe outlet may have a slip tip, a luer lock or any other suitable form of outlet.

[0090] In one embodiment, the dispensing mechanism (104) operates an actuator arranged to transfer the therapeutic substance and the fluid to the outlet. In this embodiment, the actuator may be a linear actuator such as a gear mechanism including a manual control mechanism (120B) and translation member (120A).

[0091] It is to be understood that the actuator may use an alternative means to a gearing mechanism, such as an electric motor driven actuator, hydraulically driven actuator, pneumatically driven actuator, screw actuator, rack and pinion or any other mechanical actuator as would be understood by the skilled addressee.

[0092] In this embodiment, the interface between the manual control mechanism and translation member (120A and 120B) includes gears which convert rotational motion of an operator switch, into linear motion. Rotational motion applied to the manual control mechanism (120B) causes the translation member (120A) to move, thereby translating the rotational motion of the manual control mechanism (120B) into the linear motion of the translation member (120A). In this embodiment, the pump (104') is adapted such that the translation member (120A) is movable from an extreme position at a first end of the device allowing the syringe (1 12) and plunger (1 14) to take a fully extended configuration, to an opposite extreme position at the opposite (second) end of the device. When in use, the pump (104') forcibly moves the plunger (1 14) along the barrel of the syringe (1 12), arranging the syringe (1 12) into a fully compressed configuration.

[0093] In this embodiment, one revolution of the control mechanism (120B) may transfer an amount of the therapeutic substance and the fluid from the outlet approximate to the dead volume of the at least one infusion line (1 16).

[0094] In one embodiment, the dispersing mechanism sits within the radiation housing (124). On the end of the radiation housing, proximal to the dispensing mechanism, is a flange (128) within which the dispensing mechanism sits. The dispensing mechanism (106) is adapted to freely rotate within the flange (128) and the radiation housing (124).

[0095] In this embodiment, the motor (126) may be enclosed within an outer casing

(130) and may further include a drive belt (132) configured to engage the dispensing mechanism (106). In one embodiment, the motor (126) may drive a rotating motion which causes the drive belt to rotate clockwise or anti-clockwise. When the drive belt (132) has engaged the dispensing mechanism (106), the dispensing mechanism (106) is rotated by the drive belt (132).

[0096] In one embodiment, the motor (126) may drive an oscillating motion which causes the drive belt (132) to rotate in alternating clockwise and anti-clockwise directions. When the drive belt (132) has engaged the dispensing mechanism (106), the dispensing mechanism (106) is oscillated by the drive belt (132).

[0097] In one embodiment, the oscillating motion may be driven by a stepper motor.

[0098] It is also within the scope of the present invention for the motor to require cogs, teeth or other components as understood by the skilled addressee.

[0099] In use, rotation or oscillation of the syringe caused by the dispersing mechanism may cause the therapeutic substance to disperse in the fluid. The motor (126) may operate the dispersing mechanism (106) to rotate the syringe (1 12) about an axis of the syringe (112).

[00100] In alternative embodiments, rotation of the syringe (1 12) may occur in a clockwise direction or an anti-clockwise direction. The motor (126) may also operate to oscillate the syringe (1 12) such that the rotation of the syringe (1 12) is alternated between a clockwise direction and an anti-clockwise direction.

[00101] In some embodiments, the dispersing mechanism (106) is arranged to controllably rotate the syringe (1 12) about its own axis such that the contents of the syringe (1 12) are dispersed inside the syringe (1 12) prior to, and at the same time as, the substance is being transferred to the outlet where it may be administered to the patient via the patient infusion line (1 16). In use, the dispersing mechanism (106) at least partially disperses the substance contained within the syringe (1 12), allowing for the substance to be more uniformly administered to the patient. In this embodiment, the rate of oscillation of the syringe (1 12) may be manually adjusted by adjusting the settings of the dispersing mechanism (106).

[00102] The dispersing mechanism (106) may be operated by a driving mechanism, such as a motor (126), which may be associated with the device, or external to the device. The dispersing mechanism (106) may be programmed to operate at a plurality of speeds and oscillate at a plurality of angles. When in use, the syringe (1 12) may be removably engagable with the dispersing mechanism (1 12).

[00103] In one embodiment, the syringe (1 12) may be positioned in a manner that substantially prevents gases in the syringe (1 12), other than the therapeutic substance or the fluid, from entering the at least one infusion line (1 16). In one embodiment the device may include the syringe (1 12) being positioned at an angle relative to the device such that air bubbles present in the syringe (1 12) travel to the end of the syringe barrel distal to the outlet and the patient infusion line (116).

[00104] In one embodiment, the device may further include a swivel mechanism (200) interposing the outlet (125) and the at least one infusion line (1 16). In this embodiment, the swivel mechanism (200) may be rotatably engagable to, and in fluid communication with, the outlet (125) of the syringe (1 12), via the swivel portion (202). In use, the swivel mechanism (200) facilitates substantially independent movement of the at least one infusion line (1 16) relative to the syringe (1 12). In use, the dispersing mechanism (106) causes the syringe (1 12) to rotate about its axis. Therefore, as the syringe (1 12) is moving, the physical exertion of the movement of the syringe (1 12) on the patient infusion line (1 16) may otherwise cause the patient infusion line (116) to move. In this situation, movement of the infusion line (116) may pull on a cannula inserted into the patient and as such may cause pain or dislodge the cannula. If the cannula shifts or becomes disengaged from the patient, the therapeutic substance may be spilled or not delivered to the target treatment area. If the therapeutic substance is harmful, any substance expelled off-target may damage healthy tissue or may spill onto the operator, or the floor, which may be potentially hazardous. In this embodiment, the patient infusion line (1 16) is connected to the syringe (1 12) via a swivel mechanism

(200) such that the patient infusion line (1 16) may move substantially independently relative to the syringe (1 12) and the dispersing mechanism (106).

[00105] In this embodiment, the swivel portion (202) is in fluid communication with the syringe outlet (125). In use, the syringe outlet (125) engages the swivel portion (202) and the gripping portion (204) which in turn, are rotatably about the swivel body

(201 ) via a bearing (214). When the therapeutic substance and the fluid are delivered to the outlet (125), they are expelled into the swivel mechanism (200) at the swivel portion

(202) . As the syringe (1 12) rotates about its axis, the swivel portion (202) and the gripping portion (204) are also rotated. The bearing (214), being rotatable about the swivel body (201 ) allows the swivel body (201 ) to move substantially independently from the rotating parts, that being the syringe (1 12), the swivel portion (202) and the gripping portion (204).

[00106] Therefore, in use, this embodiment prevents the infusion line (116), which is engaged with the swivel body (201 ) from disengaging from the patient due to forces imparted on it by the dispersing mechanism (106) and the rotating syringe (1 12).

[00107] In one embodiment, the swivel mechanism (200) may be arranged to comprise multiple patient infusion lines (1 16) such that when in use, the therapeutic substance may be delivered to multiple sites in the patient during the same delivery.

[00108] In one embodiment, the swivel mechanism is arranged to receive at least one additional substance infusion line (210) such that the swivel mechanism (200) is arranged to co-deliver at least one additional therapeutic substance not contained within the syringe (1 12) to the patient. In this embodiment, the swivel mechanism (200) includes a substance mixing portion (208) configured to mix the co-administered substances before they are transferred to the patient via the patient transfusion line (166).

[00109] The at least one infusion line (1 16) may further include at least one oneway valve (212) configured to prevent backflow of the therapeutic substance and the fluid into the syringe (1 12) or into another infusion line (210).

[001 10] In one embodiment, the device further includes a scale (1 18) configured to, in use, display the approximate combined volume of the substance and the fluid in the vessel. The scale may include a graduated structure, or ruler, such that as the dispensing mechanism (104) operates the plunger (1 14), moving it along the barrel of the syringe (1 12), the operator of the dispensing mechanism (104) is able to determine from the scale (118), the volume of the substance which has been administered into the patient. In use, the graduations on the scale (1 18) may be identical to those on the syringe (1 12) so that a quantitative measure can be determined. In addition, the scale (1 18) may be easily removed from the device and replaced with an alternate scale (118) corresponding to a different sized syringe (1 12) such that different sized syringes (1 12) may be employed with the same device to accommodate different doses which may be required to be administered to the patient.

[001 11] In one embodiment of the present invention, where the therapeutic substance is a radioactive substance, the administering device may further include the radiation shield (108) which may encapsulate the device. When the substance contained within the syringe is radioactive, the radiation is attenuated by the radiation shield (108), providing a reduction in radiation exposure experienced by the device operator. In further embodiments, the radiation shield (108) may only encapsulate the syringe (1 12) containing the radioactive substance, forming the radiation housing (124) for the syringe (112).

[001 12] In this embodiment, the radiation shield (108) and/or the radiation housing

(124) may be manufactured from lead, ceramic, a composite material or plastic suitable to shield the type of radiation emission. Where the radiation shield and/or housing are manufactured from plastic, any suitable plastic may be used such as acrylic, Perspex, PVC, polythene, polypropylene, polycarbonate, Bakelite, epoxy resin or melamine. In further embodiments, the radiation shield (108) and/or radiation housing (124) may be made from a substantially transparent plastic to allow the device operator to observe the syringe (1 12) as the substance is being administered and as such can visually assess the volume of substance contained within the syringe. Any suitable plastic may be used such as acrylic, Perspex, polypropylene, or polycarbonate.

[001 13] Also described herein, is a dispersing device for dispersing a therapeutic substance in a fluid comprising a receiving portion (102) arranged to receive a vessel, such as a syringe (1 12), configured to contain the therapeutic substance and the fluid. The device further includes a dispersing mechanism (106), wherein, in use, the dispersing mechanism (106) at least partially disperses the therapeutic substance within the fluid.

[001 14] In one embodiment, the device is in fluid communication with an outlet

(125) , such as provided by a syringe (1 12), arranged to receive at least one infusion line (1 16). The device may be configured to transfer the therapeutic substance and the fluid from the syringe to the outlet, wherein, in use, an amount of the therapeutic substance and the fluid is delivered to a patient via the at least one infusion line (1 16).

[001 15] In one embodiment, the device may further include a dispensing mechanism (104) that is operable to controllably transfer the therapeutic substance and the fluid from the syringe (1 12) to the outlet. [001 16] The dispensing mechanism (104) may be a syringe pump. The pump (104') being manually operated such than when in use, the pump (104') operates the syringe (1 12).

[001 17] The syringe (1 12) received by the device may be any standard or custom made syringe. The syringe (1 12) may include a chamber or barrel with an outlet at a first end, and an open second end further arranged to receive a plunger (1 14), wherein a plunger (1 14) is inserted into the second end of the barrel such that the plunger (114) slidably moves through the barrel. The plunger (1 14) further includes a piston arranged to create a fluid seal between the plunger (1 14) and the barrel of the syringe (112). When pressure is applied by the pump (104) to the plunger (1 14), the plunger (1 14) slidably extends parallel to the longitudinal axis of the syringe (1 12), through the barrel. The piston creates a seal such that movement of the plunger (1 14) transfers the substance contained with the barrel to the outlet. In use, the syringe (1 12) may be connected at its outlet to at least one infusion line (1 16) leading to a patient. When the pump (104') is operated the contents of the syringe (1 12) are transferred from the syringe, along the infusion line (1 16), into the patient. The syringe (1 12) outlet may have a slip tip, a luer lock or any other suitable form of outlet.

[001 18] In one embodiment, the dispensing mechanism (104) operates an actuator arranged to transfer the therapeutic substance and the fluid to the outlet. In this embodiment, the actuator may be a linear actuator powered in a manner such as with a gear mechanism including a manual control mechanism (120B) and translation member (120A).

[001 19] In this embodiment, the manual control mechanism and translation member (120B and 120A) includes gears which convert rotational motion of the control mechanism (120B), into linear motion. The circular gear (control mechanism; 120B), engages teeth on an internal gear. Rotational motion applied to the control mechanism (120B) causes the translation member (120A) to move, thereby translating the rotational motion of the control mechanism (120B) (into the linear motion of the translation member (120A). In this embodiment, the dispensing mechanism (104) is adapted such that the translation member (120A) is movable from an extreme position at a first end of the device allowing the syringe (1 12) and plunger (114) to take a fully extended configuration, to an opposite extreme position at the opposite (second) end of the device. The dispensing mechanism (104) forcibly moves the plunger (1 14) along the barrel of the syringe (1 12), arranging the syringe (1 12) into a fully compressed configuration.

[00120] In one embodiment, one revolution of the control mechanism (120B) causes the gearing mechanism to operate and transfer an amount of the therapeutic substance and the fluid from the outlet approximate to the dead volume of the at least one infusion line (1 16).

[00121] In one embodiment, the device may include a dispersing mechanism (106) for dispersing the therapeutic substance in the fluid. The dispersing mechanism (106) may further include a motor (126) configured to rotate a vessel, such as a syringe (112). Rotation of the syringe causes the therapeutic substance to disperse in the fluid. The motor (126) operates the dispersing mechanism (106) to rotate the syringe (112) about an axis of the syringe (1 12).

[00122] In this embodiment, rotation of the syringe (112) may occur in a clockwise direction or an anti-clockwise direction. The motor (126) may also operate to oscillate the syringe (1 12) such that the rotation of the syringe (112) is alternated between a clockwise direction and an anti-clockwise direction.

[00123] In some embodiments, the dispersing mechanism (106) is arranged to controllably rotate the syringe (1 12) about its own longitudinal axis such that the contents of the syringe (1 12) are dispersed inside the syringe (1 12) prior to, and at the same time as, the substance is being transferred to the outlet where it may be administered to a patient via the patient infusion line (1 16). In use, the dispersing mechanism (106) at least partially disperses the substance contained within the syringe (1 12), allowing for the substance to be more uniformly administered to the patient. In this embodiment, the rate of oscillation of the syringe (1 12) may be manually adjusted by adjusting the settings of the dispersing mechanism (106).

[00124] The dispersing mechanism (106) may be operated by a driving mechanism, such as a motor (126). The dispersing mechanism (106) may be programmed to operate at a plurality of speeds and oscillate at a plurality of angles. The syringe (112) may be removably engagable with the dispersing mechanism (112).

[00125] In one embodiment, the syringe (1 12) may be positioned in a manner that substantially prevents gases in the syringe (1 12), other than the therapeutic substance or the fluid, from entering the at least one infusion line (1 16). An example of this embodiment may include the syringe (1 12) being positioned at an angle relative to the device such that air bubbles present in the syringe (112) travel to the end of the syringe barrel distal to the outlet and the patient infusion line (116).

[00126] In one embodiment, the device further includes a scale (1 18) configured to, in use, display the approximate combined volume of the substance and the fluid in the vessel. The scale may include a graduated structure, or ruler, such that as the dispensing mechanism (104) operates the plunger (1 14), moving it along the barrel of the syringe (1 12), the operator of the dispensing mechanism (104) is able to determine from the scale (118), the volume of the substance which has been administered into the patient. In use, the graduations on the scale (1 18) may be identical to those on the syringe (112) so that a quantitative measure can be determined. In addition, the scale (1 18) may be easily removed from the device and replaced with an alternate scale (1 18) corresponding to a different sized syringe (1 12) such that different sized syringes (112) may be employed with the same device to accommodate different doses which may be required to be administered to the patient.

[00127] In one embodiment, the therapeutic substance may be radioactive such as a plurality of radioactive microparticles. When the device is used to administer a radioactive substance, the device may further include a radiation shield (108) which may encapsulate the device. When the substance contained within the syringe is radioactive, the radiation attenuated by the radiation shield (108), providing a reduction in radiation exposure experienced by the device operator. In further embodiments, the radiation shield (108) encapsulates the syringe (1 12) containing the radioactive substance, forming a radiation housing (124) for the syringe (1 12).

[00128] In this embodiment, the radiation shield (108) and/or the radiation housing(124) may be manufactured from lead, ceramic, a composite material or plastic. Where the radiation shield and/or housing are manufactured from plastic, any suitable plastic may be used such as acrylic, Perspex, PVC, polythene, polypropylene, polycarbonate, Bakelite, epoxy resin or melamine. In further embodiments, the radiation shield (108) and/or housing (124) is substantially transparent to allow the device operator to observe the syringe (1 12) as the substance is being administered and as such can visually assess the volume of substance contained within the syringe. Any suitable transparent material may be used such as acrylic, Perspex, polypropylene, or polycarbonate. [00129] The device of the present invention finds particular, but not exclusive use, in the delivery of radioactive microparticles to a patient having a tumour to be treated via selective internal radiation therapy (SIRT).

Selective internal radiation therapy (SIRT)

[00130] Selective internal radiation therapy (SIRT) is the intra-arterial delivery of radioactive microparticles to tumours, which has an established therapeutic role in the management of inoperable primary and metastatic liver tumours.

Microparticles

[00131] The terms "microparticle" and "microsphere" are used interchangeably and are used in the ensuing description as an example of a particulate material. However they are not intended to limit the embodiments and broader invention described herein to the administration of microspheres. A person skilled in the art will appreciate that the shape of the particulate material while preferably without sharp edges or points that could damage the patients arteries or catch in unintended locations, is not limited to spheres. Nor should the term microsphere be limited to spheres. Preferably the particulate material is substantially spherical, but need not be regular or symmetrical in shape.

[00132] The microspheres also need not be limited to any particular form or type of microparticle. Any microparticle may be administered using the embodiments and broader invention described herein. An example of a suitable microparticle may include the type capable of receiving a radionuclide such as through impregnation, absorbing, coating or more generally bonding the particles together. An example of a suitable radionuclide includes yttrium-90 (Y-90).

[00133] In some embodiments, the microparticles are prepared as polymeric particles or as ceramic particles (including glass).

[00134] When microparticles or other small particles are administered into the arterial blood supply of a target organ, it is desirable to have them of a size, shape and density that results in the optimal homogeneous distribution within the target organ. If the microparticles or small particles do not distribute evenly, and as a function of the absolute arterial blood flow, then they may accumulate in excessive numbers in some areas and cause focal areas of excessive radiation. Dispersing Microparticles

[00135] SIR-Spheres® microspheres are a trademarked product and are an example of a radioactive microparticle. SIR-Spheres® microspheres are polymeric particles usually dispersed in water for administration to the patient. Thus the SIR- Spheres® are not in a solution and as such, due to their weight, the SIR-Spheres® settle by gravity in the syringe as they are being administered to the patient. Consequently, uniform administration of SIR-Spheres® to the target site in the patient presents significant challenges to the clinician.

[00136] More specifically, the administration of SIR-Spheres® to a patient requires extreme care as the SIR-Spheres® must be administered uniformly and at a constant rate in order that the SIR-Spheres® distribute themselves evenly throughout the tumour. If the radioactive SIR-Spheres® congregate in a small area of the tumour, this portion of the tumour will receive a higher dose of radiation compared to other parts of the tumour where distribution of SIR-Spheres® is sparse. This uneven distribution of radiation may lower the effectiveness of the dose as the areas of the tumour with fewer SIR-Spheres® may not receive the full radiation dose required to eliminate the tumour. In this situation, the patient may require subsequent treatment or in extreme cases, may not survive the cancer.

[00137] Furthermore, if the SIR-Spheres® are not uniformly distributed within the fluid during administration, they may form pockets of high density areas which may clog the syringe or patient infusion lines, causing complications during the procedure.

[00138] Furthermore, it is desirable that the rate of administration of the SIR- Spheres® to the patient is controlled by the treating physician.

[00139] Therefore, the devices as described herein assist in controllably and uniformly administering radioactive microparticles such as SIR-Spheres® to a tumour in a patient, while limiting unnecessary exposure of radiation to the physician.

[00140] Embodiments of the device of the present invention find particular, but not exclusive use, in the delivery of radioactive microparticles to a tumour in a patient. In this example of use, the radioactive microparticles are delivered to a physician in an ampule (dispensing vessel; 330) contained within a protective lead pot (328). The physician transfers the radioactive substance from the ampule (330) to a syringe (112) which is engaged with the administration device (100). The physician then activates the dispensing mechanism (104) of the administration device (100) to controllably deliver the radioactive microspheres to the patient. In practice, the physician may use the administration device (100), in conjunction with the dispersing mechanism (106) to ensure a more even dispersion of the radioactive microparticles is administered to the patient. In order to prevent the patient infusion line (1 16) from disengaging the patient, the physician may also use the swivel mechanism (200) in conjunction with the dispersing mechanism (106) and the administration device (100).

[00141] Although the exemplified specific use of the device described herein involves the administration of radioactive microparticles to a patient, a person skilled in the art will understand that the present invention can be used to deliver any type of fluid substance to a patient or target such as, but not limited to, saline, blood or other fluids for intra venous injection, a pharmaceutical substance or chemotherapy.

[00142] A person skilled in the art will also appreciate that the device may be configured to receive any sized syringe, including but not limited to, syringes ranging in size from less than 1 ml to more than 60ml. The device may also be configured to receive a bag containing fluids, for example a bag containing blood or any other fluid for intra venous injection, ranging in size from less than 100ml to more than 1 L.

[00143] The present invention is not to be limited in scope by any of the specific embodiments described herein. These embodiments are intended for the purpose of exemplification only. Functionally equivalent products are clearly within the scope of the invention as described herein.

Claims

1 . An administering device for delivering a therapeutic substance in a fluid to a patient, the administering device comprising:

(ii) a dispersing mechanism that is arranged to at least partially disperse the therapeutic substance and fluid in the vessel prior to or during delivery of the therapeutic substance and the fluid to the outlet; and

(iii) at least one infusion line that is in fluid communication with the outlet, wherein, in use, the administering device is configured to deliver an amount of the dispersed therapeutic substance and the fluid to the patient via the infusion line.

2. The administering device according to claim 1 wherein the dispersing mechanism is arranged to rotate, partially rotate or oscillate the vessel to cause the therapeutic substance to disperse in the fluid.

3. The administering device according to claim 1 or 2 wherein the dispersing mechanism is arranged to agitate the vessel.

4. The administering device according to any one of claims 1 to 3 wherein the dispersing mechanism is arranged to agitate the fluid within the vessel wherein agitation of the fluid within the vessel causes the therapeutic substance to disperse in the fluid.

5. The administering device according to any one of claims 1 to 4 wherein the dispersing mechanism is arranged to vibrate the vessel.

6. The administering device according to any one of claims 1 to 5 wherein the dispersing mechanism is adapted to disperse the therapeutic substance generally evenly or homogeneously within the vessel.

7. The administering device according to any one of the preceding claims wherein the vessel is positioned in association with the dispersing mechanism in a manner that substantially prevents contaminant gases in the vessel from entering the at least one infusion line.

8. The administering device according to any one of the preceding claims further including a swivel mechanism configured to receive the vessel and includes at least one infusion line wherein the swivel mechanism is capable of substantially independent movement of the infusion line relative to the vessel yet is adapted to maintain fluid communication between the infusion line and the vessel.

9. The administering device according to claim 8 wherein the swivel mechanism is rotatably engaged to, and in fluid communication with, the vessel outlet.

10. The administering device according to claims 8 or 9 wherein the swivel mechanism is interposed between the outlet and the infusion line.

1 1 . The administering device according to claims 8, 9 or 10 wherein the swivel mechanism further includes a swivel body capable of substantial independent movement relative to the vessel.

12. The administering device according to claim 1 1 wherein the swivel body receives the at least one infusion line.

13. An administering device for administering a therapeutic substance in a fluid to a patient comprising:

(ii) a dispersing mechanism that is arranged to at least partially disperse the therapeutic substance and fluid in the vessel prior to or during delivery of the therapeutic substance and the fluid to the outlet;

(iii) at least one infusion line that is in fluid communication with the outlet; and

(iv) a swivel mechanism that is interposed between the at least one infusion line and the vessel outlet;

14. An administering device for administering a therapeutic substance in a fluid to a patient, the administering device comprising:

(i) a receiving portion arranged to receive a vessel configured to contain the therapeutic substance and the fluid, the vessel being in fluid communication with an outlet;

15. The administering device according to claim 14 wherein the dispensing mechanism operates via an actuator arranged to transfer the therapeutic substance and the fluid to the outlet.

16. The administering device according to claim 15 wherein the actuator is an electrically driven actuator or is hydraulically operated

17. The administering device according to claim 15 wherein the actuator is a linear actuator.

18. The administering device according to any one of claims 14 to 17 wherein the dispensing mechanism in the administering device further includes a scale configured to display the approximate combined volume of the substance and the fluid in the vessel.

19. The administering device according to anyone of claims 14 to 18 wherein the administering device includes a swivel mechanism arranged to receive at least one infusion line, the swivel mechanism configured to interpose the vessel outlet and the at least one infusion line and wherein, the swivel mechanism facilitates substantially independent movement of the at least one infusion line relative to the vessel.

20. An administering device for administering a therapeutic substance in a fluid to a patient, the administering device comprising:

(i) a receiving portion arranged to receive a vessel configured to contain a therapeutic substance, the vessel being in fluid communication with an outlet;

21 . An administering device for delivering a therapeutic substance in a fluid to a patient, the administering device comprising:

22. The administering device according to claim 21 further comprising a dispersing mechanism that is arranged to at least partially disperse the therapeutic substance and fluid in the vessel prior to or during delivery of the therapeutic substance and the fluid to the outlet.

3. An administering device for administering a therapeutic substance in a fluid to a patient, the administering device comprising:

24. The administering device according to claim 23 wherein the means to mix the therapeutic substance and fluid is provided by a means to move the vessel.

25. The administering device according to claim 24 wherein the means to move the vessel is in the form of a dispersing mechanism to cause the therapeutic substance to disperse in the fluid.

26. The administering device according to claim 24 wherein the means to move the vessel is in the form of an agitation mechanism arranged to agitate the vessel to cause the therapeutic substance to mix with the fluid.

27. The administering device according to claim 24 wherein the means to move the vessel is in the form of a vibration mechanism arranged to vibrate the vessel to cause the therapeutic substance to mix with the fluid.

28. The administering device according to claim 23 wherein the means to mix the therapeutic substance and fluid is provided by an excitation mechanism which excites the therapeutic substance and the fluid, the excitation mechanism is provided by one or a combination of a heat source, a sound source, or a light source.

29. An administering device for administering a substance contained in a vessel to a patient, the administering device comprising:

(i) a housing for receiving and supporting the vessel therein, the housing comprising:

(ii) an outlet through which the substance may pass;

(iii) a movement means adapted to move the vessel relative to the housing when supported therein;

(iv) an infusion line in rotatable, fluid communication with the outlet of the housing; wherein, in use, the movement means moves the vessel to mix the substance contained therein prior to or during delivery of the mixed substance, the mixed substance being delivered from the vessel through the at least one infusion line.

30. The administering device according to claim 29 wherein the means to move the vessel is in the form of a dispersing mechanism to cause mixing of the substance.

31 . The administering device according to claim 29 wherein the means to move the vessel is in the form of a agitation mechanism arranged to agitate the vessel to cause the substance to mix.

32. The administering device according to claim 29 wherein the means to move the vessel is in the form of a vibration mechanism arranged to vibrate the vessel to cause the substance to mix.

33. An administering device for administering a substance to a patient, the administering device comprising:

(i) a receiving portion arranged to receive a vessel which contains a substance, the vessel being configured to be in fluid communication with an outlet in the administering device once the vessel is received in the receiving portion; and (ii) at least one infusion line that is in fluid communication with the outlet, wherein the outlet is rotatable relative to the infusion line; wherein, in use, the administering device is adapted to deliver to the patient a defined amount of substance from the vessel to the at least one infusion line via the outlet.

34. The administering device according to any one of claims 23 to 33 further comprising a swivel mechanism arranged to receive the at least one infusion line, the swivel mechanism configured to interpose the vessel outlet and the at least one infusion line and wherein, the swivel mechanism facilitates substantially independent movement of the at least one infusion line relative to the vessel;

35. An administering device for administering a therapeutic substance in a fluid to a patient, the administering device comprising:

36. An administering device for administering a therapeutic substance in a fluid to a patient, the administering device comprising:

(i) a receiving portion arranged to receive a vessel which contains a therapeutic substance and a fluid, the vessel further being configured to be in fluid communication with an outlet in the administering device; and (ii) at least one infusion line that is in fluid communication with the vessel via the outlet,

(iii) a swivel mechanism arranged to receive the at least one infusion line, the swivel mechanism configured to interpose the vessel outlet and the at least one infusion line and wherein, the swivel mechanism facilitates substantially independent movement of the at least one infusion line relative to the vessel; wherein, in use, the administering device is adapted to deliver to the patient a defined amount of substance and fluid via the at least one infusion line.

37. The administering device according to any one of the preceding claims wherein the at least one infusion line is arranged to deliver the therapeutic substance from the outlet to the patient.

38. The administering device according to any one of the preceding claims wherein the at least one infusion line further includes at least one one-way valve in fluid communication with the outlet and arranged to prevent backflow of the therapeutic substance and the fluid into the vessel or into another infusion line.

39. The administering device according to any one of the preceding claims wherein, the administering device includes one or more radiation shields.

40. The administering device according to any one of the preceding claims wherein the vessel is adapted to hold a fluid without substantial leakage or loss.

41 . The administering device according to claim 40 wherein the vessel is a syringe.

42. The administering device according to any one of the preceding claims wherein the therapeutic substance is radioactive.

43. The administering device according to any one of the preceding claims wherein the radioactive substance is a plurality of radioactive microparticles.