WO2013001525A1

WO2013001525A1 - Flow control device for reconstitution and administration of liquid drug dosage, and single use kit and medical apparatus for use therewith

Info

Publication number: WO2013001525A1
Application number: PCT/IL2012/000259
Authority: WO
Inventors: Nimrod Lev
Original assignee: Medimop Medical Projects Ltd
Priority date: 2011-06-27
Filing date: 2012-06-25
Publication date: 2013-01-03
Also published as: IL213783A0

Abstract

Flow control device for reconstituting a liquid drug dosage and administrating same, and single use kits containing a syringe and two or more vials, and medical apparatus for use therewith. The flow control device includes a sleeve member having at least two vial ports disposed along a longitudinal axis for attachment of a vial, a flow control core having an inlet port for sealing connection with a syringe and an outlet port for administration purposes. Flow control devices are designed to ensure an inlet port is in flow communication with a single port at each flow control position of at least three predetermined flow control positions. The medical apparatus includes a housing having a syringe support for horizontally supporting a syringe and a flow control device support for horizontally supporting a flow control device. The medical apparatus can be designed for either manual operation or automatic operation.

Description

FLOW CONTROL DEVICE FOR RECONSTITUTION AND

ADMINISTRATION OF LIQUID DRUG DOSAGE, AND SINGLE USE KIT

AND MEDICAL APPARATUS FOR USE THEREWITH

Field of the Invention The invention pertains to reconstitution and administration of liquid drugs.

Background of the Invention

Commonly owned US Patent No. 6,238,372's Figures 1 1 to 15 illustrate and describe a fluid control device commercially available under the registered trademark MIXJECT^® for liquid drug reconstitution and administration purposes. The fluid control device affords convenient reconstitution with a pre-filled syringe and a single medicament containing vial.

Commonly owned US Patent No. 6,379,340 illustrates and describes a fluid control device including a base member having a generally tubular intermediate portion defining a lumen in which a flow control member is rotatable inserted. The flow control member has a port for receiving a dispensing tool, typically, a syringe. The base member includes a pair of opposite vial adapters adapted for snap fit receiving a first medicinal vial and a second medicinal vial. At least one medicinal vial contains liquid contents for mixing with the contents of the other medicinal vial which can contain powder or liquid contents. The fluid control device allows the preparation of a liquid drug by the initial mixing between the two medicinal vials and the subsequent aspiration of the liquid drug to the dispensing tool.

Commonly owned PCT International Application No.

PCT/IL2010/001077 entitled Medical Apparatus and Single Use Kit including Flow Control Device for use therewith for Reconstitution and Administration of a Liquid Drug Dosage and published under PCT International Publication No. WO 2011/077434 illustrates and describes medical apparatus for use with single use kits containing a flow control device, a syringe, and one or more vials, for reconstituting a liquid drug dosage and administrating same. The flow control devices include a core member having an inlet port and a flow control member rotatably mounted on the core member and having at least one vial port for attachment of a vial and an outlet port. Flow control devices are designed to ensure an inlet port is in flow communication with a single port at each flow control position of at least two predetermined flow control positions of a flow control member relative to a core member. The medical apparatus includes a housing having a syringe support for horizontally supporting a syringe and a flow control device support for horizontally supporting a flow control device. The medical apparatus can be designed for either manual operation or automatic operation.

PCT International Application No. PCT/US2007/067162 entitled An Automatic Injectable Drug Mixing Device and published under PCT international Publication No. WO 2007/130809 illustrates and describes a drug mixing device including a syringe driver configured to receive a syringe in a predetermined syringe orientation and to operate the syringe in a predetermined series of linear movements, at least one needle configured to be coupled to the syringe during only part of a mixing operation including the predetermined series of linear movements, at least one vial containing a substance to be employed in mixing the drug and a precise positioner for maintaining the at least one vial and the at least one needle, when it is not coupled to the syringe, in precise mutual orientation with respect to each other and with respect to the syringe during at least part of the mixing operation.

US Patent No. 7,914,499 to Gonnelli et al illustrates and describes a fluid delivery device for administering a first medicament and a second medicament includes a first fluid reservoir configured to contain the first medicament and a second fluid reservoir configured to contain the second medicament. The fluid delivery device may include one or more basal drive mechanisms to provide a basal delivery of one or more of the first and second medicaments. The fluid delivery device may further include one or more bolus drive mechanisms to provide a bolus delivery of one or more of the first and second medicaments.

Summary of the Invention

The present invention is directed toward medical apparatus for use with single use kits containing a flow control device, a syringe, and two or more vials, for reconstituting a liquid drug dosage and administrating same. Kits include two or more vials depending on an intended quantity of medicament to be administered to a subject. Kits typically include a syringe pre-filled with diluent for reconstitution purposes. Alternatively, some kits may include a vial containing diluent for reconstitution purposes particularly in the case that a greater volume of diluent is required than can be stored in a single pre-filled syringe. The medicament containing vials can contain the same or different medicaments. The present invention is suitable for home users for self administration, professional users at outpatient clinics, hospital departments, and the like.

The flow control device has a longitudinal axis and includes a sleeve member having at least two vial ports disposed along the longitudinal axis for sealed attachment of a vial thereto, a flow control core rotatably inserted in the sleeve member and an outlet port for administration purposes. The outlet port can be formed on either the flow control core or the sleeve member. Flow control devices are designed to ensure an inlet port is in flow communication with a single port of the at least two vial ports and the outlet port at each flow control position of a series of at least three predetermined flow control positions of the flow control device. The flow control device can be operated manually or with a medical apparatus as described hereinbelow.

The medical apparatus includes a housing having a syringe support for horizontally supporting a syringe and a flow control device support for horizontally supporting a flow control device. The medical apparatus can be designed for fully manual operation, fully automatic operation or a combination of manual and automatic operation. The medical apparatus can include a motorized syringe drive unit for reciprocation of a syringe barrel, a motorized flow control core drive unit for rotation of a flow control core relative to a stationary sleeve member, and a motorized sleeve member drive unit for inverting a sleeve member from an initial reconstitution position to a subsequent aspiration position and either a pre-programmed or programmable controller for controlling the motorized drive units. Pre-programmed controllers are intended to reconstitute a liquid drug according to a pre-set liquid drug reconstitution program in terms of an empty or pre-filled syringe, the number and volumetric contents of vials, injection rates and aspiration rates respectively into and from vials, and the like and/or administer a liquid drug dosage according to a pre-set liquid drug administration regime determining administration rate and administration time. Pre-programmed controllers can contain instructions for one more liquid drug reconstitution programs and one or more liquid drug administration regimes. Programmable controllers enable manual input of a liquid drug reconstitution program and/or a liquid drug administration regime. The medical apparatus may include indicators, LCD screen and / or touch panel that combines a graphical user interface.

Brief Description of Drawings

In order to understand the invention and to see how it can be carried out in practice, preferred embodiments will now be described, by way of non- limiting examples only, with reference to the accompanying drawings in which similar parts are likewise numbered, and in which;

Fig. 1 shows a combined front perspective view and block diagram of medical apparatus with a pre-programmed controller for reconstituting and administrating liquid drug dosages;

Fig. 2 shows a combined front perspective view and block diagram of medical apparatus with a programmable controller for reconstituting and administrating liquid drug dosages; Fig. 3 shows a pictorial representation of a single use three vial kit including a 3 vial port flow control device, a syringe, three vial adapters, three vials and an administration line;

Fig. 4 is an exploded view of Figure 3's flow control device having a flow control core with an inlet port and an outlet port, and a sleeve member;

Fig. 5 is a side view of Figure 3's flow control device;

Fig. 6A is a transverse cross section of Figure 3's flow control device along line A-A in Figure 5 at the proximate vial port adjacent the inlet port;

Fig. 6B is a transverse cross section of Figure 3's flow control device along line B-B in Figure 5 at the middle vial port;

Fig. 6C is a transverse cross section of Figure 3's flow control device along line C-C in Figure 5 at the distal vial port remote from the inlet port;

Fig. 6D is a transverse cross section of Figure 3's flow control device along line D-D in Figure 5;

Fig. 6E is a transverse cross section of Figure 3's flow control device along line E-E in Figure 5;

Fig. 7 shows a pictorial representation showing an assemblage of Figure 3's kit with its syringe's plunger in its most backward position ready for mounting in either one of Figures 1 and 2's medical apparatus;

Fig. 8 shows a pictorial representation showing Figure 7's assemblage mounted in Figure l 's medical apparatus;

Fig. 9A shows a longitudinal cross section of Figure 3's flow control device along line F-F in Figure 5 in a first flow control position for injection of diluent into a vial connected to its proximate vial port;

Fig. 9B shows a longitudinal cross section of Figure 3's flow control device along Figure 5's line F-F in a second flow control position for injection of diluent into a vial connected to its middle vial port;

Fig. 9C shows a longitudinal cross section of Figure 3's flow control device along Figure 5's line F-F in a third flow control position for injection of diluent into a vial connected to its distal vial port; Fig. 9D shows a longitudinal cross section of Figure 3's flow control device along Figure 5's line F-F in a fourth flow control position for aspiration of liquid contents from a vial connected to its proximate vial port;

Fig. 9E shows a longitudinal cross section of Figure 3's flow control device along Figure 5's line F-F in a fifth flow control position for aspiration of liquid contents from a vial connected to its middle vial port;

Fig. 9F shows a longitudinal cross section of Figure 3's flow control device along Figure 5's line F-F in a sixth flow control position for aspiration of liquid contents from a vial connected to its distal vial port;

Fig. 9G shows a longitudinal cross section of Figure 3's flow control device along Figure 5's line F-F with the syringe filled with reconstituted liquid drug contents; and

Fig. 9H shows a longitudinal cross section of Figure 3's flow control device along Figure 5's line F-F in a seventh flow control position for liquid drug administration.

Detailed Description of Preferred Embodiments of the Invention

Figures 1 and 2 show battery or main operated medical apparatus 10 for use with kits containing a Flow Control Device (FCD), a syringe, vial adapters, and vials, for reconstituting and administrating liquid drug dosages. The medical apparatus 10 includes a housing 11 having a syringe support 12 for horizontally supporting a syringe and a flow control device support 13 for horizontally supporting a flow control device. The syringe support 12 includes an open topped slot 12A for supporting a syringe barrel's trailing end. The flow control device support 13 includes a leading stand 14 having an open topped slot 14A for supporting a flow control device's distal end and trailing stands 16 and 17 having open topped slot 16A and 17A for supporting a flow control device's proximal end. The stands 16 and 17 rotatably support a driving cogwheel 18 therebetween.

The medical apparatus 10 has an ON/OFF switch 21 and is under the control of a controller 22A or 22B. The controller 22 has a control panel 23 with three pushbuttons; "RECON" for initiating a reconstitution program, "PURGE" for purging air from an administration line, and "ADMIN" for initiating an administration regime. The control panel 23 can also include indicators 23A and a viewing screen 23B for indicating operational status and progress.

Figure 1 shows medical apparatus 10 with a pre-programmed controller 22 A having one or more pre -set liquid drug reconstitution programs 24 and one or more pre-set liquid drug administration regimes 26. Figure 2 shows medical apparatus 10 with a programmable controller 22B for enable manual input of a liquid drug reconstitution program 27 and/or a liquid drug administration regime 28. Alternatively, the control panel 23 can be a touch-screen with the above functionality.

The housing 11 includes a syringe drive unit 31 under the control of the controller 22 for reciprocating a plunger head drive member 32 forward for injection of liquid contents into a vial and administration purposes and backward for aspiration of liquid contents from a vial. The medical apparatus 10 includes a syringe linear encoder for determining the position of the plunger head drive member 32 for enabling the medical apparatus 10 to be used with syringes containing different volumes of diluent and therefore having plungers at different initial positions relative to their barrels. The controller 22 executes a syringe linear encoder reset procedure to reset the syringe linear encoder for determining the location of a syringe's plunger relative to its barrel for compensating for assembly tolerances, component tolerances, and the like. The syringe linear encoder is set to zero when a syringe's plunger tip abuts against the inside surface of its end wall.

The housing 11 includes a FCD drive unit 33 under the control of the controller 22 for rotating the driving cogwheel 18 for setting a flow control device into a predetermined series of flow control positions for reconstitution and administration purposes.

The medical apparatus 10 preferably includes a cover safety mechanism for preventing operation in the case the cover is not fully closed. Figure 3 shows a three vial kit 100 includes a flow control device (FCD) 101. a syringe 40 containing diluent, three vial adapters 50, three vials 60A, 60B and 60C, and an administration line 70, for example, an IV set. The syringe 40 includes a syringe barrel 41, a plunger 42 with a plunger head 43 and an elastomer plunger tip 44 for sealing the syringe barrel 41, and a male connector 46. The male connector 46 is preferably in the form of a male Luer lock connector. The three vial adapters 50 are conventional vial adapters including connectors 51, for example, commercially available from the Medimop Medical Projects Ltd, Ra'anana, Israel. The connectors 51 can be female Luer connectors as shown, male Luer connectors, and the like. Alternatively, the flow control device 101 can be integrally formed with vial adapters 50 for snap fit receiving vials, thereby simplifying assembly of the kit 100 by precluding the need to attach vial adapters to a flow control device. The three vial kit 100 includes a syringe 40 pre-filled with diluent and three medicament containing vials 60A-60C. Alternatively, the three vial kit 100 could include an empty syringe, one diluent containing vial and two medicament containing vials. In the latter case, the diluent containing vial necessarily undergoes aspiration at the start of the serial reconstitution of the remaining vials.

Figures 3 to 7 show the flow control device 101 has a horizontal longitudinal axis 102, a proximate end 103, and a distal end 104. The proximate end 103 includes an inlet port 106 with a female connector 107 for sealing engagement with the syringe's male connector 46. The female connector 107 is preferably in the form of a female Luer connector for screw thread engagement with a syringe's male Luer connector 46. The distal end 104 includes an outlet port 108 with a connector 109 for fluid connection, for example, with an IV set, and the like. The connector 109 can be a male Luer lock connector as shown, a female connector, and the like.

The flow control device 101 includes a solid flow control core 111 co- directional with the longitudinal axis Ϊ02 and a generally tubular sleeve member 112 rotatably and sealingly mounted on the flow control core 111. The flow control core 111 includes the inlet port 106 and the outlet port 109 and a cylindrical peripheral surface 113. The flow control core 111 includes a head 114 at the proximate end 103 for sliding insertion into the slot 17A for mounting the flow control core 111 at a stationary predetermined orientation relative to the housing 11. The flow control core 111 includes a driven cogwheel 116 at the proximate end 103 for engaging the driving cogwheel 18 thereby enabling rotation of the flow control core 111 relative to the housing 11. The flow control core 111 has a longitudinal directed bore 117 including a proximate major bore section 118 having a proximate end 118A and a distal end 118B and a distal minor bore section 119 having a proximate end 119A and a distal end 119B. The distal end 118B and the proximate end 119A are spaced apart by solid core material 121 such that the bore sections 118 and 119 are not in direct longitudinal continuous flow communication. The flow control core 111 includes five radial directed lumens as follows: a first lumen 122A terminating at a first opening 123A on the cylindrical peripheral surface 113, a second lumen 122B terminating at a second opening 123B on the cylindrical peripheral surface 113, a third lumen 122C terminating at a third opening 123C on the cylindrical peripheral surface 113, a fourth lumen 122D terminating at a fourth opening 123D on the cylindrical peripheral surface 113 and a fifth lumen 122E terminating at a fifth opening 123E on the cylindrical peripheral surface 113. The fourth lumen 122D radial extends from the distal end 118B. The fifth lumen 122E radial extends from the proximate end 119A. The lumens 122B and 122C are preferably radial spaced at 120° and 240° relative to the lumen 122A defined at 0°. The lumens 122D and 122E are preferably radial spaced at the same 100° relative to the lumen 122A defined at 0°.

The sleeve member 112 has a cylindrical peripheral surface 124 and a cylindrical internal surface 126. The sleeve member 112 is formed with a proximate vial port 127 adjacent the inlet port 106, a middle vial port 128 and a distal vial port 129 remote from the inlet port 106 for corresponding registration with the lumen 122A, the lumen 122B and the lumen 122C at particular flow control positions of the flow control core 111 relative to the sleeve member 112. The internal surface 126 is formed with a longitudinal directed administration flow channel 131 for connecting the lumens 122D and 122E at a particular flow control position of the flow control core 111 relative to the sleeve member 112.

Figure 7 shows an assemblage 140 of a diluent filled syringe 40, the flow control device 101, and the three vials 60A, 60B and 60C.

Figure 8 shows the assemblage 140 mounted in Figure l 's medical apparatus ready for operation.

The flow control device 101 has seven Flow Control Positions (FCPs) as now described with reference to Figures 9A to 9H as follows:

Figure 9 A shows a first flow control position in which the lumen 122 A is in registration with the proximate vial port 127 in the sleeve member 112's initial reconstitution position ready for injection of diluent from the syringe 40 to the vial 60 A connected to the proximate vial port 127.

Figure 9B shows a second flow control position in which the lumen 122B is aligned with the middle vial port 128 in the sleeve member 112's initial reconstitution position ready for injection of diluent from the syringe 40 to the vial 60B connected to the middle vial port 128.

Figure 9C shows a third flow control position in which the lumen 122C is aligned with the distal vial port 129 in the sleeve member 112's initial reconstitution position ready for injection of diluent from the syringe 40 to the vial 60C connected to the distal vial port 129.

Figure 9D shows a fourth flow control position in which the lumen 122 A is in registration with the proximate vial port 127 in the sleeve member 112's final aspiration position ready for aspiration of reconstituted liquid drug contents from the vial 60 A connected to the vial port 127 to the syringe 40.

Figure 9E shows a fifth flow control position in which the lumen 122B is aligned with the middle vial port 128 in the sleeve member 112's final aspiration position ready for aspiration of reconstituted liquid drug contents from the vial 60B connected to the middle vial port 128 to the syringe 40. Figure 9F shows a sixth flow control position in which the lumen 122C is aligned with the distal vial port 129 in the sleeve member 112's final aspiration position ready for aspiration of reconstituted liquid drug contents from the vial 60C connected to the distal vial port 129 to the syringe 40.

Figure 9G shows the sixth flow control position subsequent to aspiration of liquid drug contents from the vial 60C to the syringe 40 which is now filled with reconstituted liquid drug contents.

Figure 9H shows a seventh flow control position in which the inlet port 106 is in flow communication with the outlet port 108 via the major bore section 118, the lumen 122D, the longitudinal directed administration flow channel 131, the lumen 122E and the minor bore section 119.

Figures 8 and 9D show two operative positions of the plunger head drive member 32 with the plunger 42 in its most rearward and forward positions, respectively.

The operation of the medical apparatus 10 with the pre-programmed controller 22A and a three vial kit 100 including a pre-filled syringe 40 and three medicament containing vials 60A, 60B and 60C includes the following steps:

Step 1: The kit 100 is supplied with its flow control device 101 in its first flow control position for setting flow connection between the inlet port 106 and the proximate vial port 127

Step 2: User attaches the vials 60A-60C to the vial adapters 50

Step 3: User attaches the vials 60A-60C to the proximate vial port 127, the middle vial port 128 and the distal vial port 129, respectively

Step 4: User attaches the syringe 40 onto the flow control device 101

Step 5: User sets the medical apparatus 10 such that its plunger head drive member 32 is in its most backward position and inverts the assembled three vial kit 100 on the medical apparatus 10 with the sleeve member 112 in its initial reconstitution position such that its vials 60A, 60B and 60C are below the horizontal longitudinal axis 102

Step 6: User presses the "RECON" pushbutton Step 7: Medical apparatus 10 depresses the plunger 42 a first third of its inward stroke to inject a first third of the diluent contents into the vial 60A as shown in Figure 9A

Step 8: Medical apparatus 10 rotates the flow control core 111 to set the flow control device 101 to its second flow control position ready for injection of a second third of the diluent contents into the vial 60B as shown in Figure 9B

Step 9: Medical apparatus 10 depresses the plunger 42 a second third of its inward stroke to inject the second third of the diluent contents into the vial 60B

Step 10: Medical apparatus 10 rotates the flow control core 111 to set the flow control device 101 to its third flow control position ready for injection of a last third of the diluent contents into the vial 60C as shown in Figure 9C

Step 1: Medical apparatus 10 depresses the plunger 42 a last third of its inward stroke to inject the last third of the diluent contents into the vial 60C Step 12: User inverts the sleeve member 112 such that the vials 60A, 60B and 60C are above the horizontal longitudinal axis 102

Step 13: Medical apparatus 10 rotates the flow control core 111 to set the flow control device 101 to its fourth flow control position ready for aspiration of the liquid drug contents from the vial 60A as shown in Figure 9D

Step 14: Medical apparatus 10 withdraws the plunger 42 a first third of its outward stroke to aspirate the vial 60A's liquid drug contents into the syringe 40

Step 15: Medical apparatus 10 rotates the flow control core 111 to set the flow control device 101 to its fifth flow control position ready for aspiration of the liquid drug contents from the vial 60B as shown in Figure 9E

Step 16: Medical apparatus 10 withdraws the plunger 42 a second third of its outward stroke to aspirate the vial 60B's liquid drug contents into the syringe 40 Step 17: Medical apparatus 10 rotates the flow control core 111 to set the flow control device 101 to its sixth flow control position ready for aspiration of the liquid drug contents from the vial 60C as shown in Figure 9F

Step 18: Medical apparatus 10 withdraws the plunger 42 a final third of its outward stroke to aspirate the vial 60C's liquid drug contents into the syringe 40 as shown in Figure 9G

Step 19: Medical apparatus 10 rotates the flow control core 111 to set the flow control device 101 to its seventh flow control position ready for dosage administration as shown in Figure 9H

Step 20: User attaches the administration line 70 to the outlet port 108 Step 21: User presses "PURGE" pushbutton

Step 22: Medical apparatus 10 depresses the plunger 42 to purge air from the administration line 70

Step 23: User attaches the administration line 70 to patient's vein via an administration device, for example, a needle, and the like

Step 24: User presses the "ADMIN" pushbutton to start dosage administration to patient

Step 25: Medical apparatus 10 fully depresses the plunger 42 for dosage administration While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications, and other applications of the invention can be made within the scope of the appended claims.

Claims

CLAIMS:

1. A flow control device for use with a syringe and at least two vials for reconstituting and administering a liquid drug dosage, the syringe having a reciprocal plunger with a proximal plunger head, the flow control device having a horizontal longitudinal axis and comprising:

(a) a sleeve member co-directional with the longitudinal axis and having at least two peripheral located vial ports disposed along the longitudinal axis for sealed attachment of a vial thereto and a cylindrical internal surface formed with a longitudinal directed administration flow channel;

(b) a flow control core rotatably inserted in said sleeve member and having an inlet port for sealing fluid connection with the syringe and at least two radial directed lumens perpendicular to the longitudinal axis and in flow communication with said inlet port; and

(c) an outlet port in selective flow communication with said inlet port for administrating the liquid drug dosage;

the flow control device being operative such that said inlet port is in flow communication with a single port of said at least two vial ports and said outlet port at each flow control position of at least three predetermined flow control positions of said sleeve member relative to said flow control core for initially establishing a liquid drug reconstitution flow path between the syringe and each vial of the at least two vials for enabling initial reconstitution of the liquid drug dosage according to a liquid drug reconstitution program and subsequently establishing a liquid drug administration flow path between the syringe and said outlet port for administration of the liquid drug dosage according to a liquid drug administration regime.

2. The device according to claim 1 wherein said flow control core includes a driven cogwheel for rotating said flow control core about said longitudinal axis.

3. The device according to either claim 1 or 2 wherein said flow control core includes said outlet port.

4. The device according to any one of claims 1 to 3 wherein each vial port of said at least one vial port is integrally formed with a vial adapter for snap fit receiving a vial.

5. A kit for reconstituting and administrating a liquid drug dosage, the kit comprising a flow control device according to any one of claims 1 to 4, a syringe and at least two vials.

6. Medical apparatus for reconstituting and administrating a liquid drug dosage, the medical apparatus intended for use with a flow control device according to any one of claims 1 to 4, a syringe having a reciprocal plunger with a proximal plunger head, and at least two vials, the medical apparatus comprising a housing including a syringe support for horizontally supporting a syringe and a flow control device support for horizontally supporting a flow control device.

7. Medical apparatus according to claim 6 and further comprising a controller for controlling the operation of:

i) a motorized syringe drive unit for selectively reciprocating a plunger head drive member engaging the plunger head for reciprocating the plunger relative to the flow control device, and

ii) a motorized flow control device drive unit for selectively rotating the flow control member relative to the core member to a series of predetermined flow control positions for initially establishing a liquid drug reconstitution flow path between the syringe and each vial of the at least one vial for enabling initial reconstitution of the liquid drug dosage according to a liquid drug reconstitution program and subsequently establishing a liquid drug administration flow path between the syringe and the outlet port for administration of the liquid drug dosage according to a liquid drug administration regime.

8. Medical apparatus according to claim 7 wherein said controller reciprocates the flow control member back and forth relative to the core member for agitating a vial for reconstituting its powder contents.

9. Medical apparatus according to claim 7 wherein said controller is programmable for enabling manual input of said liquid drug reconstitution program.

10. Medical apparatus according to claim 7 wherein said controller is programmable for enabling manual input of said liquid drug reconstitution regime.