WO2007130809A2 - An automatic injectable drug mixing device - Google Patents

An automatic injectable drug mixing device Download PDF

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Publication number
WO2007130809A2
WO2007130809A2 PCT/US2007/067162 US2007067162W WO2007130809A2 WO 2007130809 A2 WO2007130809 A2 WO 2007130809A2 US 2007067162 W US2007067162 W US 2007067162W WO 2007130809 A2 WO2007130809 A2 WO 2007130809A2
Authority
WO
WIPO (PCT)
Prior art keywords
syringe
needle
vial
precise
axis
Prior art date
Application number
PCT/US2007/067162
Other languages
French (fr)
Other versions
WO2007130809A3 (en
Inventor
Volodymyr Brodskyy
Original Assignee
Volodymyr Brodskyy
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Volodymyr Brodskyy filed Critical Volodymyr Brodskyy
Publication of WO2007130809A2 publication Critical patent/WO2007130809A2/en
Publication of WO2007130809A3 publication Critical patent/WO2007130809A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/008—Racks for supporting syringes or needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/1782—Devices aiding filling of syringes in situ
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/284—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents

Definitions

  • the present invention relates generally to medical and pharmaceutical equipment, and more particularly, to the devices for mixing of several medications.
  • an automatic injectable 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.
  • the precise positioner includes an element separate from the at least one needle and separate from the at least one vial. Additionally or alternatively, the precise positioner includes an element which is removably positionable with respect to the syringe driver. Preferably, the at least one vial and the at least one needle are removably positionable with respect to the precise positioner. Alternatively, at the at least one vial is fixed with respect to the precise positioner.
  • the syringe driver is fixedly mounted on a base and the precise positioner is removably mounted onto the base.
  • the automatic injectable drug mixing device also includes a base ohentor operative to vary the orientation of the base and thus of the syringe driver with respect to gravity during at least part of the mixing operation.
  • the precise positioner is pivotably mounted with respect to the syringe driver other than during the mixing operation.
  • the at least one vial includes plural vials.
  • the at least one needle includes plural needles.
  • an automatic injectable 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 along a first axis relative to the syringe, 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 tilting mechanism for selectably tilting the syringe, the at least one needle and the at least one vial about at least a second axis.
  • the automatic injectable drug mixing device also includes a rotating mechanism for selectably rotating the syringe driver relative to the at least one needle about the first axis.
  • the syringe driver provides at least some of the series of linear movements at a controlled, generally uniform linear speed.
  • an automatic injectable 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 and for use with 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 and at least one vial containing a substance to be employed in mixing the drug, 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.
  • the precise positioner includes an element separate from the at least one needle and separate from the at least one vial. Additionally or alternatively, the precise positioner is removably positionable with respect to the syringe driver. In accordance with another preferred embodiment of the present invention, the at least one vial and the at least one needle are removably positionable with respect to the precise positioner. Alternatively, the at least one vial is fixed with respect to the precise positioner.
  • the syringe driver is fixedly mounted on a base and the precise positioner is removably mounted onto the base. Additionally or alternatively, the precise positioner is pivotably mounted with respect to the syringe driver other than during the mixing operation.
  • the at least one vial includes plural vials.
  • the at least one needle includes plural needles.
  • an automatic injectable 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 and for use with first and second needles configured to be coupled to the syringe during only part of a mixing operation including the predetermined series of linear movements and at least one vial containing a substance to be employed in mixing the drug, a needle protector assembly for maintaining and removably retaining the first and second needles in non-finger contactable precise mutual orientation with respect to each other during at least part of the mixing operation, the needle protector assembly permitting removal therefrom of the first needle only together with a needle guard.
  • the needle protector assembly also includes first and second needle guards for respective the first and second needles, the first needle guard being removable from the remainder of the needle protector assembly together with the first needle. Additionally, the second needle guard is not removable from the remainder of the needle protector assembly when the second needle is removed therefrom.
  • Fig. 1 is a simplified illustration of an automatic injectable drug mixing device according to the first embodiment
  • Fig. 2 is the device with an open cap
  • Fig. 3 is the device with a disconnected cap
  • Fig. 4 is a base ohentor according to the first embodiment
  • Fig. 5 is a base according to the first embodiment
  • Fig. 6 is the base with a connected vial holder, a needle holder and a syringe driver.
  • the vial holder and the needle holder are constructed in the form of one common element
  • Fig. 7 is the base with the connected vial holder and the needle holder constructed in the form of a precise positioner
  • Fig. 8 is the precise positioner for maintaining needles and vials
  • Fig. 8A is the precise positioner which contains needles and vials
  • Fig. 9 is the syringe driver with a connected syringe
  • Fig. 10 is the base with connected needles and vials;
  • Fig. 11 is the vial holder and needle holder constructed in the form of one common element with connected needles and vials;
  • Fig. 12 is the vial holder and the needle holder constructed in the form of one common element with a connected needle block - a side view;
  • Fig. 13 is a section on A-A of Fig. 12;
  • Fig. 14 is the needle block with connected needles according to the first embodiment
  • Fig. 15 is the needle block in accordance with the first embodiment;
  • Fig. 16 is a section on A-A of Fig. 15;
  • Fig. 17 is a section on B-B of Fig. 15;
  • Fig. 18 is the needle block with the connected needles according to the second embodiment;
  • Fig. 19 is the needle block according to the second embodiment
  • Fig. 20 is a section on A-A of Fig. 19;
  • Fig. 21 are mechanisms for rotating and plunger moving of the syringe driver;
  • Fig. 22 is a section on A-A of Fig. 21 ;
  • Fig. 23 is the rotating mechanism of the syringe driver
  • Fig. 24 is the plunger movement mechanism of the syringe driver
  • Fig. 25 is the mechanism for moving the syringe driver along a first axis
  • Fig. 26 is the mechanism for moving the syringe driver along a second axis
  • Fig. 27 is a titling mechanism for moving the base on a vertical plane
  • Fig. 28 is the titling mechanism for moving the base on a vertical plane, when the base is rotated by "P" degree on a vertical plane;
  • Fig. 29 is a side view of the device
  • Fig. 30 is a top view of the device;
  • Fig. 31 is a section on A-A of Fig. 30;
  • Fig. 32 is a side view of the device; the base is rotated by "P" degree on the vertical plane;
  • Fig. 33 is a top view of the device; the base is rotated by "P" degree on the vertical plane; Fig. 34 is a section on A-A of Fig. 33;
  • Fig. 35 is the device (shown without the cap) with the base orientor according to the second embodiment
  • Fig. 36 is the device (shown without the cap) with the base orientor rotated vertically according to the second embodiment;
  • Fig. 37 and Fig. 39 is the device in the case when the base is also the base orientor;
  • Fig. 38 and Fig. 40 is the device in the case when the base is also the base ohentor (shown without the cap) rotated vertically;
  • Fig. 41 is the device ready to use, the first step - the cap is opened; (herein and hereafter for easy explanation the device is shown without the cap);
  • Fig. 42 the vial and needle holder is rotated towards a loading position for convenience of connection of vials and the needle block;
  • Fig. 44 the vial and needle holder is rotated towards an operating position
  • syringe is connected to the syringe holder, then the cap is closed and the device is switched on by pressing a button;
  • Fig. 46 the syringe driver moves along the axis which is parallel to the axis of the syringe plunger to contact with a needle for mixing;
  • Fig. 47 the syringe holder rotates round the axis of the syringe plunger clockwise until the syringe connects to the needle;
  • Fig. 48 the syringe driver moves along the axis which is parallel to the axis of the syringe plunger to position shown in Fig. 45;
  • Fig. 49 the syringe driver moves across the axis of the syringe plunger until this axis coincides with the axis of a center of a rubber stopper of the vial with fluid;
  • Fig. 50 the syringe driver moves along the axis which is parallel to the axis of the syringe plunger until the needle pierces the rubber stopper of the vial with fluid; Fig. 51 the base rotates round the distal axis in relation to the vial and needle holder;
  • the syringe driver moves the syringe plunger until the syringe is loaded with the prescribed amount of fluid from the vial;
  • Fig. 53 the base rotates round the distal axis in relation to the vial and needle holder to position, as shown in Fig. 50;
  • Fig. 54 the syringe driver moves along the axis parallel to the of the syringe plunger into position, as shown in Fig. 49; Fig. 55 the syringe driver moves across the axis of the syringe plunger until this axis coincides with the axis of a center of a rubber stopper of the vial with powder;
  • Fig. 56 the syringe driver moves along the axis which is parallel to the axis of the syringe plunger until the needle pierces the rubber stopper of the vial with powder;
  • Fig. 57 the base rotates round the proximal axis in relation to the vial and needle holder;
  • Fig. 58 the syringe driver moves the syringe plunger into the position shown in Fig. 51 , making controlled injection of the content into the vial with powder;
  • Fig. 59 and Fig. 60 the base makes repeated cyclic movement round the proximal axis in relation to the vial and needle holder between the positions shown in Fig. 59 and Fig. 60 for better reconstitution of powder;
  • Fig. 61 the base rotates round the proximal axis in relation to the vial and needle holder to the position shown in Fig. 56;
  • Fig. 62 the base rotates round the distal axis in relation to the vial and needle holder
  • syringe driver moves the syringe plunger until the syringe is loaded with the prescribed amount of mixture from the vial;
  • Fig. 64 the base rotates round the distal axis in relation to the vial and needle holder to the position shown in Fig. 61 ;
  • Fig. 65 the syringe driver moves along the axis which is parallel to the axis of the syringe plunger to position shown in Fig. 55;
  • Fig. 66 the syringe driver moves across the axis of the syringe plunger until this axis coincides with the axis of a center of a protector of the needle for mixing;
  • Fig. 67 the syringe driver moves along the axis which is parallel to the axis of the syringe plunger until the needle connects to the protector;
  • Fig. 68 the syringe holder rotates round the axis of the syringe plunger counterclockwise, rotating the syringe to the position where it is disconnected from the needle, as shown in Fig. 46;
  • Fig. 69 the syringe driver moves along the axis parallel to the of axis of the syringe plunger to position shown in Fig. 66;
  • Fig. 70 the syringe driver moves across the axis of the syringe plunger until this axis coincides with the axis of a center of the needle for injection;
  • syringe driver moves along the axis which is parallel to the axis of the syringe plunger to contact with a needle for injection;
  • Fig. 72 the syringe holder rotates round the axis of the syringe plunger clockwise until the syringe connects to the needle;
  • Fig. 73 the syringe driver moves along the axis which is parallel to the axis of the syringe plunger to position shown in Fig. 70;
  • Fig. 75 the syringe holder rotates counterclockwise round the axis of the syringe plunger, rotating the syringe to the position shown in Fig. 71 ;
  • Fig. 76 the cap is opened and the syringe which is prepared for injection is disconnected from the syringe holder;
  • Fig. 80 the cap is closed, the syringe holder moves along the axis parallel to the axis of the syringe plunger to position shown in Fig. 41.
  • the present invention provides an automatic injectable 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.
  • Figs. 1 , 2 and 3 show an automatic injectable drug mixing device with closed, open and disconnected cap 1 , comprising a base ohentor 2, a base
  • Fig. 4 shows the base orientor 2, with four radial grooves 10, which are guiding the movement of the base 3.
  • Fig. 5 shows the base 3 with hinges 11 for attaching the cap 1 , hinges 12 for attaching the vial and needle holder 6, sensors 13 for correct loading of vials and needles, guides 14, a rack 15 for moving the syringe driver
  • Fig. 6 shows the base 3 with the connected the syringe driver 4 and the vial and needle holder 6.
  • Fig. 7 shows the base 3 with the syringe driver 4 and a precise positioner 100.
  • Fig. 8 shows the precise positioner 100.
  • Fig. 8A shows the precise positioner 100 with connected needles 61 and 63 with their protectors 62 and 64, and vials 7 and 8.
  • Fig. 9 shows the syringe driver 4 with the connected syringe 5, comprising a syringe holder 35 with rotating mechanism 30, a plunger movement mechanism 40, a support element 20, guides 21, and a rack 22 for moving the syringe holder 35 perpendicular to the axis of the syringe plunger.
  • Fig. 10 shows the base 3 with a connected needle block 9 and vials 7 and 8.
  • Fig. 11 shows the vial and needle holder 6 with the connected block 9 of needles and vials 7 and 8, including slots 51 and 52 for vials 7 and 8, the slot 53 of the needle block with an orientation cut 54, and a rod of rotation 55.
  • Fig. 12 is a side view of the vial and needle holder 6 with the connected needle block 9.
  • Fig. 13 shows a section on A-A of Fig.12, which shows a moving bottom 56 of the slot 53 of the needle holder 6 and a spring 57.
  • Fig. 14 shows the needle block 9 with the connected needles 61 and 63 with their protectors 62 and 64, and an orientation rib 65.
  • Fig. 15 shows the needle block 9 including two slots 66 and 67 for needles with protectors, the orientation rib 65, a boss 68 and a member 69.
  • the slots 66 and 67 are designed to prevent rotation of the protectors.
  • the boss 68 locks the protector of one of the needles.
  • the member 69 supports the protector of the second needle and allows its effortless disconnecting from the block.
  • the force applied to disconnect the needle protector and the boss 68 is greater than the force needed to disconnect the needle and its protector.
  • the force applied to disconnect the protector of the needle and the member 69 is less than the force needed to disconnect the needle and its protector.
  • Fig. 16 is a section on A-A of Fig.15, which shows the boss 68.
  • Fig. 17 is a section on B-B of Fig.15, which shows the member 69.
  • Fig. 18 shows a needle block 70 with connected needles.
  • the block is also a sterile pouch with a welding a film on a surface 71.
  • Fig. 19 is a side view of the needle bock 70.
  • Fig. 20 is a section A-A of Fig. 19, which shows two slots 72 and 73 for needles with protectors, a boss 75 that locks a protector of one of the needles and a member 76, which supports the protector of the second needle and allows effortless disconnection from a block, and an orientation rib 77.
  • Fig. 21 shows the plunger rotating mechanism 30 and the plunger movement mechanism 40, and the support element 20.
  • Fig. 22A and Fig. 22B is a section A-A of Fig. 21 , which shows the rotating mechanism 30 comprising a driving gear wheel 31 , a pair of gears 32 and 33, and a driven gear wheel 34 with a cut 37 for a syringe holder 35 for receiving the syringe 5.
  • a pair of gears 32 and 33 ensures rotation of the driven gear wheel 34. Therefore, when one of gears, for example, the gear 33 of Fig. 22B drops out of engagement with the driven gear wheel 34 within the cut 37 for the syringe holder 35, the second gear wheel 32 will provide the rotation of the gear wheel 34.
  • Fig. 23 shows the plunger rotating mechanism 30 including a motor 36, the driving gear wheel 31 , the pair of gears 32 and 33, and the driven gear wheel 34, with the cut 37 for the syringe holder 35 for receiving the syringe 5.
  • Fig. 24 shows the plunger movement mechanism 40 including a motor 41 , a transfer mechanism 42, a rack 43, a worm 44, and a slot 45 for the plunger of the syringe 5.
  • Fig. 25 shows mechanism of the syringe driver movement along a first axis including motor 46, gear wheel 47, rack 22, guides 21.
  • Fig. 26 shows mechanism of the syringe driver movement along a second axis including motor 48, gear wheel 49, rack 15, guides 14.
  • Fig. 27 shows a titling mechanism of base movement on a vertical plane including motors 81 and 82 disposed at the bottom 80 of the base, rotating elements 18 and 19 able to move within radial grooves 10 of the base orientor 2.
  • Fig. 28 shows the base movement mechanism on a vertical plane, where the base is rotated on a vertical plane.
  • Figs. 29-34 show operation principle of the base movement mechanism on a vertical plane.
  • Figs. 29 and 30 show a side and a top view of the device where the base 3 is not rotated on a vertical plane.
  • Fig. 31 is a section A-A of Fig. 30, which shows radial grooves 10 of the base ohentor 2, and rotating elements 18 and 19 placed therein.
  • Fig. 32 and Fig. 33 show a side and a top view of the device where the base 3 is rotated by "P" degree on a vertical plane.
  • Fig. 34 is a section A-A of Fig. 33, which shows radial grooves 10 of the base orientor 2, and rotating elements 18 and 19 placed therein. Centers of radial grooves 10 of the base orientor 2 are at (M+N)/2 distance, where M and N are radii of inner and outer sides of grooves. Centers of radial grooves 10 of the base orientor 2 coincide with axes E and F, which are axes of the rotation base 3 in relation to the base orientor 2.
  • Rotating elements 18 and 19 in their cross-section have a shape limited by radii M and N on one plane and by two straight lines on other plane, while the distance between these straight lines is larger than (M-N)/2, that allows only moving thereof within grooves 10 along the radius (M+N)/2.
  • Fig. 35 shows the base 3 (without a cap) with the base orientor comprising two parts 91 and 92, where the base 3 is connected in two parallel axes G and H not permitting the disconnection.
  • the base 3 rotates on a vertical plane in relation to one of the axes together with the part of the base orientor connected to the other axis.
  • Fig. 36 shows the base 3 (without a cap) with the base orientor comprising two parts 91 and 92, rotated onto a vertical position in relation to the axis H, while the part 91 of the base orientor rotates together with the base 3.
  • Fig. 37 and Fig. 39 show a variant of the device, when a base 93 is also a base ohentor, and is rotated on a vertical plane by means of an arm 94 shown in Fig. 37 or a double arm 95 shown in Fig. 39, and the arm 94 or the double arm 95 and the base 93 are reciprocally rotating round the axis J, which is moving vertically itself.
  • Fig. 38 and Fig. 40 show the variant the device when the base is also the base ohentor (shown without a cap), rotated onto a vertical position.
  • the device should be loaded with a vial 7 with powder, a vial 8 with fluid, the needle block 9 with a needle 63 designed for the process of reconstituting and its protector 64, and a needle 61 designed for the process of injection and a its protector 62, and the syringe 5.
  • the cap 1 of the device is open.
  • Fig. 41 shows the device before loading the components.
  • the vial and needle holder 6 is turned round the rod 55 into a vertical position for convenient loading, as shown in Fig. 42.
  • the syringe 5 is connected to the syringe holder 35 and the support an element 20. This is shown in Fig. 45.
  • a sensor (not shown) checks whether the cap 1 of the device is closed, sensors 13 check the presence and correctness of loading of vials 7 and 8 and the needle block 9 and also check the presence and correctness of syringe loading 5 (the sensor is not shown).
  • the position sensors check all movements of the device which are not shown in figures.
  • the syringe driver 4 moves along the axis, which is parallel to the axis of movement of the syringe plunger up to the contact with the needle 63. Then the movement continues for the prescribed distance together with the needle block
  • the spring 57 is compressed and exerts a force on a movable bottom 56 of the slot 53 of the needle block 9. Then the syringe driver 4 stops and the said force directed along the axis of movement of the syringe plunger acts to approach the syringe 5 with the needle 63. This is shown in Fig. 46.
  • Fig. 47 shows the rotating mechanism 30 of the syringe driver 4 which rotates the syringe 5 round its axis clockwise up to the prescribed moment for threaded connection of the syringe 5 and the needle 63.
  • Fig. 48 and Fig. 48A show the syringe driver 4 moving along the axis parallel to the axis of movement of the syringe plunger to position shown in
  • the needle 63 is connected to the syringe 5 and disconnected from the protector 64.
  • the boss 68 locks the protector 64.
  • Fig. 49 shows the syringe holder 4 moving perpendicularly to the axis of movement of the syringe plunger until this axis coincides with the axis crossing the center of the rubber stopper of the vial 8 with fluid.
  • Fig. 50 shows the syringe driver 4 moving along the axis parallel to the axis of movement of the syringe plunger until the needle 63 pierces the rubber stopper of the vial 8 with fluid.
  • Fig. 51 shows the base 3 rotating in relation to the base ohentor 2 round the axis E on the prescribed angle.
  • Fig. 52 shows the plunger movement mechanism 40 of the syringe driver 4 moving the syringe plunger to the prescribed distance withdrawing the necessary amount of fluid from the vial 8 into the syringe 5.
  • Fig. 53 shows the base 3 rotating in relation to the base ohentor 2 round the axis E to position shown in Fig. 50.
  • Fig. 54 shows the syringe driver 4 moving along the axis parallel to the axis of movement of the syringe plunger to position shown in Fig. 49, pulling out the needle 63 from the vial 8.
  • Fig. 55 shows the syringe driver 4 moving perpendicularly to the axis of movement of the syringe plunger until this axis coincides with the axis crossing the center of the rubber stopper of the vial 7 with powder.
  • Fig. 56 shows the syringe driver 4 moves along the axis parallel to the axis of movement of the syringe plunger until the needle 63 pierces the rubber stopper of the vial 7 with powder.
  • Fig. 57 shows the base 3 rotating in relation to the base ohentor 2 round the axis F on the prescribed angle.
  • Fig. 58 shows the plunger movement mechanism 40 of the syringe driver 4 moving the syringe plunger to position shown in Fig. 51 making controlled injection of the content of the syringe 5 into the vial 7 with powder.
  • the base 3 makes a repeated cyclic movement in relation to the base ohentor 2 round the axis F between positions shown Fig. 59 and Fig. 60 for better mixing of powder and fluid.
  • Fig. 61 shows the base 3 rotating in relation to the base ohentor 2 round the axis F to position shown in Fig. 56.
  • Fig. 62 shows the base 3 rotating in relation to the base ohentor 2 round the axis E on the prescribed angle.
  • Fig. 63 shows the plunger movement mechanism 40 of the syringe driver 4 moving the syringe plunger for the prescribed distance withdrawing the necessary amount of a mixture from the vial 7 to the syringe 5.
  • Fig. 64 - the base 3 rotates in relation to the base ohentor 2 round the axis F to position shown in Fig. 61.
  • Fig. 65 shows the syringe driver 4 moving along the axis parallel to the axis of movement of the syringe plunger to position shown Fig. 55 pulling out the needle 63 from the vial 7.
  • Fig. 66 shows the syringe driver 4 moving perpendicularly to the axis of movement of the syringe plunger until this axis coincides with the axis crossing of the protector 64 of the needle 63.
  • Fig. 67 shows the syringe driver 4 moving along the axis parallel to the axis of movement of the syringe plunger until the needle 63 connects to the protector 64.
  • Fig. 68 shows the rotating mechanism 30 of the syringe driver 4 rotating the syringe 5 round its axis counterclockwise with the disconnection of threaded connection of the syringe 5 and the needle 63 up to position shown in Fig. 46.
  • Fig. 69 shows the syringe driver 4 moving along the axis of movement of the syringe plunger to position shown in Fig. 66.
  • Fig. 70 shows the syringe driver 4 moving perpendicularly to the axis of movement of the syringe plunger until this axis coincides with the axis crossing the center of the needle 61.
  • the syringe driver 4 moves along the axis, which is parallel to the axis of movement of the syringe plunger up to the contact with the needle 61. Then the movement continues for the prescribed distance together with the needle block
  • Fig. 71 shows the rotating mechanism 30 of the syringe driver 4 which rotates the syringe 5 round its axis clockwise up to the prescribed moment for threaded connection of the syringe 5 and the needle 61.
  • Fig. 73 shows the syringe driver 4 moving along the axis parallel to the axis of movement of the syringe plunger to position shown in Fig. 70.
  • the needle 61 is connected to the syringe 5 together with the protector 62.
  • Fig. 74 shows the syringe driver 4 moving perpendicularly to the axis of movement of the syringe plunger to position shown in Fig.69.
  • Fig. 75 shows the rotating mechanism 30 of the syringe driver 4 rotating the syringe 5 with the connected needle 61 together with its protector 62 round its axis counterclockwise to position shown in Fig. 71.
  • Fig. 76 - the cap 1 is open, and the ready-to-injection syringe 5 with the connected needle 61 and the protector 62 is disconnected from the syringe driver 4.
  • the vial and needle holder 6 is rotated round the rod 55 onto a vertical position to convenient withdrawal, as is shown in Fig. 77.
  • Fig. 78 show vials 7 and 8 taken out of slots 52 and 51, and the needle block 9 is taken out of the slot of the needle block 53.
  • Fig. 80 shows the end of the cycle - the cap 1 is closed, the plunger movement mechanism 40 of the syringe driver 4 is automatically moved along the axis parallel to the axis of movement of the syringe plunger to the starting position shown in Fig. 41.

Abstract

An automatic injectable 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.

Description

AN AUTOMATIC INJECTABLE DRUG MIXING DEVICE
FIELD OF THE INVENTION
The present invention relates generally to medical and pharmaceutical equipment, and more particularly, to the devices for mixing of several medications.
BACKGROUND OF THE INVENTION
The following patent documents are believed to represent the current state of the art:
US 1 ,050,043; US 3,853,158; US 4,219,055; US 4,434,820; US 4,489,766;
US 4,778,454; US 4,998,570; US 5,240,047; US 5,309,959; US 5,431 ,201 ;
US 5,466,220; US 5,487,738; US 5,807,374; US 5,873,859; US 5,885,270;
US 5,894,870; US 5,900,557; US 5,975,470; US 6,006,798; US 6,070,761 ; US 6,159,193; US 6,162,199; US 6,364,866; US 6,439,276; US 6,581 ,648;
US 6,877,530; US 6,915,823; US 2004/0162515 A1 ; US 2005/0045242 A1 ;
US 2005/0171484 A1 ; US 2005/0224137 A1 ; WO 02/24259 A2;
WO 2005/011781 A1 and WO 2005/086587 A3.
SUMMARY OF THE INVENTION
The present invention seeks to provide an improved automatic injectable drug mixing device. There is thus provided in accordance with a preferred embodiment of the present invention an automatic injectable 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.
Preferably, the precise positioner includes an element separate from the at least one needle and separate from the at least one vial. Additionally or alternatively, the precise positioner includes an element which is removably positionable with respect to the syringe driver. Preferably, the at least one vial and the at least one needle are removably positionable with respect to the precise positioner. Alternatively, at the at least one vial is fixed with respect to the precise positioner.
In accordance with another preferred embodiment of the present invention, the syringe driver is fixedly mounted on a base and the precise positioner is removably mounted onto the base. Additionally, the automatic injectable drug mixing device also includes a base ohentor operative to vary the orientation of the base and thus of the syringe driver with respect to gravity during at least part of the mixing operation.
Preferably, the precise positioner is pivotably mounted with respect to the syringe driver other than during the mixing operation.
In accordance with another preferred embodiment of the present invention, the at least one vial includes plural vials. In accordance with another preferred embodiment of the present invention, the at least one needle includes plural needles.
There is also provided in accordance with another preferred embodiment of the present invention an automatic injectable 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 along a first axis relative to the syringe, 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 tilting mechanism for selectably tilting the syringe, the at least one needle and the at least one vial about at least a second axis.
Preferably, the at least a second axis is perpendicular to the first axis. In accordance with another preferred embodiment of the present invention the automatic injectable drug mixing device also includes a rotating mechanism for selectably rotating the syringe driver relative to the at least one needle about the first axis.
Additionally or alternatively, the syringe driver provides at least some of the series of linear movements at a controlled, generally uniform linear speed.
There is further provided in accordance with yet another embodiment of the present invention for use in an automatic injectable 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 and for use with 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 and at least one vial containing a substance to be employed in mixing the drug, 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. Preferably, the precise positioner includes an element separate from the at least one needle and separate from the at least one vial. Additionally or alternatively, the precise positioner is removably positionable with respect to the syringe driver. In accordance with another preferred embodiment of the present invention, the at least one vial and the at least one needle are removably positionable with respect to the precise positioner. Alternatively, the at least one vial is fixed with respect to the precise positioner.
Preferably, the syringe driver is fixedly mounted on a base and the precise positioner is removably mounted onto the base. Additionally or alternatively, the precise positioner is pivotably mounted with respect to the syringe driver other than during the mixing operation.
Preferably, the at least one vial includes plural vials. Additionally or alternatively, the at least one needle includes plural needles. There is further provided in accordance with yet another embodiment of the present invention for use in an automatic injectable 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 and for use with first and second needles configured to be coupled to the syringe during only part of a mixing operation including the predetermined series of linear movements and at least one vial containing a substance to be employed in mixing the drug, a needle protector assembly for maintaining and removably retaining the first and second needles in non-finger contactable precise mutual orientation with respect to each other during at least part of the mixing operation, the needle protector assembly permitting removal therefrom of the first needle only together with a needle guard.
Preferably, the needle protector assembly also includes first and second needle guards for respective the first and second needles, the first needle guard being removable from the remainder of the needle protector assembly together with the first needle. Additionally, the second needle guard is not removable from the remainder of the needle protector assembly when the second needle is removed therefrom. BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will be understood and appreciated more fully from the following detailed description:
Fig. 1 is a simplified illustration of an automatic injectable drug mixing device according to the first embodiment; Fig. 2 is the device with an open cap; Fig. 3 is the device with a disconnected cap; Fig. 4 is a base ohentor according to the first embodiment;
Fig. 5 is a base according to the first embodiment; Fig. 6 is the base with a connected vial holder, a needle holder and a syringe driver. The vial holder and the needle holder are constructed in the form of one common element; Fig. 7 is the base with the connected vial holder and the needle holder constructed in the form of a precise positioner;
Fig. 8 is the precise positioner for maintaining needles and vials; Fig. 8A is the precise positioner which contains needles and vials; Fig. 9 is the syringe driver with a connected syringe; Fig. 10 is the base with connected needles and vials;
Fig. 11 is the vial holder and needle holder constructed in the form of one common element with connected needles and vials;
Fig. 12 is the vial holder and the needle holder constructed in the form of one common element with a connected needle block - a side view; Fig. 13 is a section on A-A of Fig. 12;
Fig. 14 is the needle block with connected needles according to the first embodiment;
Fig. 15 is the needle block in accordance with the first embodiment; Fig. 16 is a section on A-A of Fig. 15;
Fig. 17 is a section on B-B of Fig. 15; Fig. 18 is the needle block with the connected needles according to the second embodiment;
Fig. 19 is the needle block according to the second embodiment;
Fig. 20 is a section on A-A of Fig. 19; Fig. 21 are mechanisms for rotating and plunger moving of the syringe driver;
Fig. 22 is a section on A-A of Fig. 21 ;
Fig. 23 is the rotating mechanism of the syringe driver;
Fig. 24 is the plunger movement mechanism of the syringe driver; Fig. 25 is the mechanism for moving the syringe driver along a first axis;
Fig. 26 is the mechanism for moving the syringe driver along a second axis;
Fig. 27 is a titling mechanism for moving the base on a vertical plane;
Fig. 28 is the titling mechanism for moving the base on a vertical plane, when the base is rotated by "P" degree on a vertical plane;
Fig. 29 is a side view of the device;
Fig. 30 is a top view of the device; Fig. 31 is a section on A-A of Fig. 30;
Fig. 32 is a side view of the device; the base is rotated by "P" degree on the vertical plane;
Fig. 33 is a top view of the device; the base is rotated by "P" degree on the vertical plane; Fig. 34 is a section on A-A of Fig. 33;
Fig. 35 is the device (shown without the cap) with the base orientor according to the second embodiment;
Fig. 36 is the device (shown without the cap) with the base orientor rotated vertically according to the second embodiment; Fig. 37 and Fig. 39 is the device in the case when the base is also the base orientor; Fig. 38 and Fig. 40 is the device in the case when the base is also the base ohentor (shown without the cap) rotated vertically;
Fig. 41 is the device ready to use, the first step - the cap is opened; (herein and hereafter for easy explanation the device is shown without the cap);
Fig. 42 the vial and needle holder is rotated towards a loading position for convenience of connection of vials and the needle block;
Fig. 43 vials and the needle block are connected;
Fig. 44 the vial and needle holder is rotated towards an operating position;
Fig. 45 the syringe is connected to the syringe holder, then the cap is closed and the device is switched on by pressing a button;
Fig. 46 the syringe driver moves along the axis which is parallel to the axis of the syringe plunger to contact with a needle for mixing; Fig. 47 the syringe holder rotates round the axis of the syringe plunger clockwise until the syringe connects to the needle;
Fig. 48 the syringe driver moves along the axis which is parallel to the axis of the syringe plunger to position shown in Fig. 45;
Fig. 49 the syringe driver moves across the axis of the syringe plunger until this axis coincides with the axis of a center of a rubber stopper of the vial with fluid;
Fig. 50 the syringe driver moves along the axis which is parallel to the axis of the syringe plunger until the needle pierces the rubber stopper of the vial with fluid; Fig. 51 the base rotates round the distal axis in relation to the vial and needle holder;
Fig. 52 the syringe driver moves the syringe plunger until the syringe is loaded with the prescribed amount of fluid from the vial;
Fig. 53 the base rotates round the distal axis in relation to the vial and needle holder to position, as shown in Fig. 50;
Fig. 54 the syringe driver moves along the axis parallel to the of the syringe plunger into position, as shown in Fig. 49; Fig. 55 the syringe driver moves across the axis of the syringe plunger until this axis coincides with the axis of a center of a rubber stopper of the vial with powder;
Fig. 56 the syringe driver moves along the axis which is parallel to the axis of the syringe plunger until the needle pierces the rubber stopper of the vial with powder;
Fig. 57 the base rotates round the proximal axis in relation to the vial and needle holder;
Fig. 58 the syringe driver moves the syringe plunger into the position shown in Fig. 51 , making controlled injection of the content into the vial with powder;
Fig. 59 and Fig. 60 the base makes repeated cyclic movement round the proximal axis in relation to the vial and needle holder between the positions shown in Fig. 59 and Fig. 60 for better reconstitution of powder; Fig. 61 the base rotates round the proximal axis in relation to the vial and needle holder to the position shown in Fig. 56;
Fig. 62 the base rotates round the distal axis in relation to the vial and needle holder;
Fig. 63 the syringe driver moves the syringe plunger until the syringe is loaded with the prescribed amount of mixture from the vial;
Fig. 64 the base rotates round the distal axis in relation to the vial and needle holder to the position shown in Fig. 61 ;
Fig. 65 the syringe driver moves along the axis which is parallel to the axis of the syringe plunger to position shown in Fig. 55; Fig. 66 the syringe driver moves across the axis of the syringe plunger until this axis coincides with the axis of a center of a protector of the needle for mixing;
Fig. 67 the syringe driver moves along the axis which is parallel to the axis of the syringe plunger until the needle connects to the protector; Fig. 68 the syringe holder rotates round the axis of the syringe plunger counterclockwise, rotating the syringe to the position where it is disconnected from the needle, as shown in Fig. 46; Fig. 69 the syringe driver moves along the axis parallel to the of axis of the syringe plunger to position shown in Fig. 66;
Fig. 70 the syringe driver moves across the axis of the syringe plunger until this axis coincides with the axis of a center of the needle for injection;
Fig. 71 the syringe driver moves along the axis which is parallel to the axis of the syringe plunger to contact with a needle for injection;
Fig. 72 the syringe holder rotates round the axis of the syringe plunger clockwise until the syringe connects to the needle; Fig. 73 the syringe driver moves along the axis which is parallel to the axis of the syringe plunger to position shown in Fig. 70;
Fig. 74 the syringe driver moves across the axis parallel to the axis of the syringe plunger to position shown in Fig. 69;
Fig. 75 the syringe holder rotates counterclockwise round the axis of the syringe plunger, rotating the syringe to the position shown in Fig. 71 ;
Fig. 76 the cap is opened and the syringe which is prepared for injection is disconnected from the syringe holder;
Fig. 77 the vial and needle holder is turned towards the loading position convenient for the disconnection of vials and needles; Fig. 78 the vials and the needle block are disconnected;
Fig. 79 the vial and needle holder is turned towards operating position; and
Fig. 80 the cap is closed, the syringe holder moves along the axis parallel to the axis of the syringe plunger to position shown in Fig. 41.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENT
The present invention provides an automatic injectable 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.
Figs. 1 , 2 and 3 show an automatic injectable drug mixing device with closed, open and disconnected cap 1 , comprising a base ohentor 2, a base
3 including a syringe driver 4 with a connected syringe 5, and the vial and needle holder 6 with connected vials 7 and 8, and a needle block 9.
Fig. 4 shows the base orientor 2, with four radial grooves 10, which are guiding the movement of the base 3. Fig. 5 shows the base 3 with hinges 11 for attaching the cap 1 , hinges 12 for attaching the vial and needle holder 6, sensors 13 for correct loading of vials and needles, guides 14, a rack 15 for moving the syringe driver
4 parallel to the axis of the syringe plunger, a stop 16 for fixing vials 7 and 8, a stop 17 for fixing the needle block 9 and rotating elements 18 and 19, which alternatively move the base 3 on a vertical plane round axes E and F.
Fig. 6 shows the base 3 with the connected the syringe driver 4 and the vial and needle holder 6.
Fig. 7 shows the base 3 with the syringe driver 4 and a precise positioner 100. Fig. 8 shows the precise positioner 100.
Fig. 8A shows the precise positioner 100 with connected needles 61 and 63 with their protectors 62 and 64, and vials 7 and 8. Fig. 9 shows the syringe driver 4 with the connected syringe 5, comprising a syringe holder 35 with rotating mechanism 30, a plunger movement mechanism 40, a support element 20, guides 21, and a rack 22 for moving the syringe holder 35 perpendicular to the axis of the syringe plunger. Fig. 10 shows the base 3 with a connected needle block 9 and vials 7 and 8.
Fig. 11 shows the vial and needle holder 6 with the connected block 9 of needles and vials 7 and 8, including slots 51 and 52 for vials 7 and 8, the slot 53 of the needle block with an orientation cut 54, and a rod of rotation 55.
Fig. 12 is a side view of the vial and needle holder 6 with the connected needle block 9.
Fig. 13 shows a section on A-A of Fig.12, which shows a moving bottom 56 of the slot 53 of the needle holder 6 and a spring 57. Fig. 14 shows the needle block 9 with the connected needles 61 and 63 with their protectors 62 and 64, and an orientation rib 65.
Fig. 15 shows the needle block 9 including two slots 66 and 67 for needles with protectors, the orientation rib 65, a boss 68 and a member 69. The slots 66 and 67 are designed to prevent rotation of the protectors. The boss 68 locks the protector of one of the needles. The member 69 supports the protector of the second needle and allows its effortless disconnecting from the block.
The force applied to disconnect the needle protector and the boss 68 is greater than the force needed to disconnect the needle and its protector.
The force applied to disconnect the protector of the needle and the member 69 is less than the force needed to disconnect the needle and its protector.
Fig. 16 is a section on A-A of Fig.15, which shows the boss 68.
Fig. 17 is a section on B-B of Fig.15, which shows the member 69.
Fig. 18 shows a needle block 70 with connected needles. The block is also a sterile pouch with a welding a film on a surface 71.
Fig. 19 is a side view of the needle bock 70. Fig. 20 is a section A-A of Fig. 19, which shows two slots 72 and 73 for needles with protectors, a boss 75 that locks a protector of one of the needles and a member 76, which supports the protector of the second needle and allows effortless disconnection from a block, and an orientation rib 77. Fig. 21 shows the plunger rotating mechanism 30 and the plunger movement mechanism 40, and the support element 20.
Fig. 22A and Fig. 22B is a section A-A of Fig. 21 , which shows the rotating mechanism 30 comprising a driving gear wheel 31 , a pair of gears 32 and 33, and a driven gear wheel 34 with a cut 37 for a syringe holder 35 for receiving the syringe 5. A pair of gears 32 and 33 ensures rotation of the driven gear wheel 34. Therefore, when one of gears, for example, the gear 33 of Fig. 22B drops out of engagement with the driven gear wheel 34 within the cut 37 for the syringe holder 35, the second gear wheel 32 will provide the rotation of the gear wheel 34. Fig. 23 shows the plunger rotating mechanism 30 including a motor 36, the driving gear wheel 31 , the pair of gears 32 and 33, and the driven gear wheel 34, with the cut 37 for the syringe holder 35 for receiving the syringe 5.
Fig. 24 shows the plunger movement mechanism 40 including a motor 41 , a transfer mechanism 42, a rack 43, a worm 44, and a slot 45 for the plunger of the syringe 5.
Fig. 25 shows mechanism of the syringe driver movement along a first axis including motor 46, gear wheel 47, rack 22, guides 21.
Fig. 26 shows mechanism of the syringe driver movement along a second axis including motor 48, gear wheel 49, rack 15, guides 14.
Fig. 27 shows a titling mechanism of base movement on a vertical plane including motors 81 and 82 disposed at the bottom 80 of the base, rotating elements 18 and 19 able to move within radial grooves 10 of the base orientor 2. Fig. 28 shows the base movement mechanism on a vertical plane, where the base is rotated on a vertical plane. Figs. 29-34 show operation principle of the base movement mechanism on a vertical plane.
Figs. 29 and 30 show a side and a top view of the device where the base 3 is not rotated on a vertical plane. Fig. 31 is a section A-A of Fig. 30, which shows radial grooves 10 of the base ohentor 2, and rotating elements 18 and 19 placed therein.
Fig. 32 and Fig. 33 show a side and a top view of the device where the base 3 is rotated by "P" degree on a vertical plane.
Fig. 34 is a section A-A of Fig. 33, which shows radial grooves 10 of the base orientor 2, and rotating elements 18 and 19 placed therein. Centers of radial grooves 10 of the base orientor 2 are at (M+N)/2 distance, where M and N are radii of inner and outer sides of grooves. Centers of radial grooves 10 of the base orientor 2 coincide with axes E and F, which are axes of the rotation base 3 in relation to the base orientor 2. Rotating elements 18 and 19 in their cross-section have a shape limited by radii M and N on one plane and by two straight lines on other plane, while the distance between these straight lines is larger than (M-N)/2, that allows only moving thereof within grooves 10 along the radius (M+N)/2.
For example, when the rotating element 18 rotates round the axis E in relation to the base 3 by "P" degrees it remains non-rotatable in relation to the base orientor 2. The rotating element 19 does not rotate and remains non- rotatable in relation to the base 3, while it rotates together with the base 3 round the axis E by "P" degrees in relation to the base orientor 2 moving along the radial groove 10. Fig. 35 shows the base 3 (without a cap) with the base orientor comprising two parts 91 and 92, where the base 3 is connected in two parallel axes G and H not permitting the disconnection. In this case the base 3 rotates on a vertical plane in relation to one of the axes together with the part of the base orientor connected to the other axis. Fig. 36 shows the base 3 (without a cap) with the base orientor comprising two parts 91 and 92, rotated onto a vertical position in relation to the axis H, while the part 91 of the base orientor rotates together with the base 3. Fig. 37 and Fig. 39 show a variant of the device, when a base 93 is also a base ohentor, and is rotated on a vertical plane by means of an arm 94 shown in Fig. 37 or a double arm 95 shown in Fig. 39, and the arm 94 or the double arm 95 and the base 93 are reciprocally rotating round the axis J, which is moving vertically itself.
Fig. 38 and Fig. 40 show the variant the device when the base is also the base ohentor (shown without a cap), rotated onto a vertical position.
The operation of the device is now described with reference to Figs. 41 -80. The device is shown without the cap 1 in all figures for an easy explanation.
The device should be loaded with a vial 7 with powder, a vial 8 with fluid, the needle block 9 with a needle 63 designed for the process of reconstituting and its protector 64, and a needle 61 designed for the process of injection and a its protector 62, and the syringe 5. For this purpose the cap 1 of the device is open. Fig. 41 shows the device before loading the components.
The vial and needle holder 6 is turned round the rod 55 into a vertical position for convenient loading, as shown in Fig. 42.
Then, as is shown in Fig. 43 vials 7 and 8 are inserted into the vial slots 52 and 51, while the needle block 9 is inserted into a needle block slot 53, so that the orientation rib 65 of the needle block 9 goes into the orientation cut
54 of the slot of the needle block 53. Therefore, there is only one way to attach the needle block 9 to the needle and vial holder 6.
Then the vial and needle holder 6 is turned into a horizontal position, as is shown in Fig. 44. The stop 16 fixes vials 7 and 8, and the stop 17 fixes the needle block 9.
The syringe 5 is connected to the syringe holder 35 and the support an element 20. This is shown in Fig. 45.
Then the cap 1 is closed and start button of the device is pressed
(not shown).The automated cycle of the device begins. A sensor (not shown) checks whether the cap 1 of the device is closed, sensors 13 check the presence and correctness of loading of vials 7 and 8 and the needle block 9 and also check the presence and correctness of syringe loading 5 (the sensor is not shown).
The position sensors check all movements of the device which are not shown in figures. The syringe driver 4 moves along the axis, which is parallel to the axis of movement of the syringe plunger up to the contact with the needle 63. Then the movement continues for the prescribed distance together with the needle block
9. The spring 57 is compressed and exerts a force on a movable bottom 56 of the slot 53 of the needle block 9. Then the syringe driver 4 stops and the said force directed along the axis of movement of the syringe plunger acts to approach the syringe 5 with the needle 63. This is shown in Fig. 46.
Fig. 47 shows the rotating mechanism 30 of the syringe driver 4 which rotates the syringe 5 round its axis clockwise up to the prescribed moment for threaded connection of the syringe 5 and the needle 63. Fig. 48 and Fig. 48A show the syringe driver 4 moving along the axis parallel to the axis of movement of the syringe plunger to position shown in
Fig.45. The needle 63 is connected to the syringe 5 and disconnected from the protector 64. The boss 68 locks the protector 64.
Fig. 49 shows the syringe holder 4 moving perpendicularly to the axis of movement of the syringe plunger until this axis coincides with the axis crossing the center of the rubber stopper of the vial 8 with fluid.
Fig. 50 shows the syringe driver 4 moving along the axis parallel to the axis of movement of the syringe plunger until the needle 63 pierces the rubber stopper of the vial 8 with fluid. Fig. 51 shows the base 3 rotating in relation to the base ohentor 2 round the axis E on the prescribed angle.
Fig. 52 shows the plunger movement mechanism 40 of the syringe driver 4 moving the syringe plunger to the prescribed distance withdrawing the necessary amount of fluid from the vial 8 into the syringe 5. Fig. 53 shows the base 3 rotating in relation to the base ohentor 2 round the axis E to position shown in Fig. 50. Fig. 54 shows the syringe driver 4 moving along the axis parallel to the axis of movement of the syringe plunger to position shown in Fig. 49, pulling out the needle 63 from the vial 8.
Fig. 55 shows the syringe driver 4 moving perpendicularly to the axis of movement of the syringe plunger until this axis coincides with the axis crossing the center of the rubber stopper of the vial 7 with powder.
Fig. 56 shows the syringe driver 4 moves along the axis parallel to the axis of movement of the syringe plunger until the needle 63 pierces the rubber stopper of the vial 7 with powder. Fig. 57 shows the base 3 rotating in relation to the base ohentor 2 round the axis F on the prescribed angle.
Fig. 58 shows the plunger movement mechanism 40 of the syringe driver 4 moving the syringe plunger to position shown in Fig. 51 making controlled injection of the content of the syringe 5 into the vial 7 with powder. The next step - the base 3 makes a repeated cyclic movement in relation to the base ohentor 2 round the axis F between positions shown Fig. 59 and Fig. 60 for better mixing of powder and fluid.
Fig. 61 shows the base 3 rotating in relation to the base ohentor 2 round the axis F to position shown in Fig. 56. Fig. 62 shows the base 3 rotating in relation to the base ohentor 2 round the axis E on the prescribed angle.
Fig. 63 shows the plunger movement mechanism 40 of the syringe driver 4 moving the syringe plunger for the prescribed distance withdrawing the necessary amount of a mixture from the vial 7 to the syringe 5. Fig. 64 - the base 3 rotates in relation to the base ohentor 2 round the axis F to position shown in Fig. 61.
Fig. 65 shows the syringe driver 4 moving along the axis parallel to the axis of movement of the syringe plunger to position shown Fig. 55 pulling out the needle 63 from the vial 7. Fig. 66 shows the syringe driver 4 moving perpendicularly to the axis of movement of the syringe plunger until this axis coincides with the axis crossing of the protector 64 of the needle 63. Fig. 67 shows the syringe driver 4 moving along the axis parallel to the axis of movement of the syringe plunger until the needle 63 connects to the protector 64.
Fig. 68 shows the rotating mechanism 30 of the syringe driver 4 rotating the syringe 5 round its axis counterclockwise with the disconnection of threaded connection of the syringe 5 and the needle 63 up to position shown in Fig. 46.
Fig. 69 shows the syringe driver 4 moving along the axis of movement of the syringe plunger to position shown in Fig. 66. Fig. 70 shows the syringe driver 4 moving perpendicularly to the axis of movement of the syringe plunger until this axis coincides with the axis crossing the center of the needle 61.
The syringe driver 4 moves along the axis, which is parallel to the axis of movement of the syringe plunger up to the contact with the needle 61. Then the movement continues for the prescribed distance together with the needle block
9. The spring 57 is compressed and exerts a force on a movable bottom 56 of the slot 53 of the needle block 9. Then the syringe driver 4 stops and the said force directed along the axis of movement of the syringe plunger acts to approach the syringe 5 with the needle 61. This is shown in Fig. 71. Fig. 72 shows the rotating mechanism 30 of the syringe driver 4 which rotates the syringe 5 round its axis clockwise up to the prescribed moment for threaded connection of the syringe 5 and the needle 61.
Fig. 73 shows the syringe driver 4 moving along the axis parallel to the axis of movement of the syringe plunger to position shown in Fig. 70. The needle 61 is connected to the syringe 5 together with the protector 62.
Fig. 74 shows the syringe driver 4 moving perpendicularly to the axis of movement of the syringe plunger to position shown in Fig.69.
Fig. 75 shows the rotating mechanism 30 of the syringe driver 4 rotating the syringe 5 with the connected needle 61 together with its protector 62 round its axis counterclockwise to position shown in Fig. 71. Fig. 76 - the cap 1 is open, and the ready-to-injection syringe 5 with the connected needle 61 and the protector 62 is disconnected from the syringe driver 4.
The vial and needle holder 6 is rotated round the rod 55 onto a vertical position to convenient withdrawal, as is shown in Fig. 77.
Fig. 78 show vials 7 and 8 taken out of slots 52 and 51, and the needle block 9 is taken out of the slot of the needle block 53.
The vial and needle holder 6 is rotated onto a horizontal position, as shown in Fig. 79. Fig. 80 shows the end of the cycle - the cap 1 is closed, the plunger movement mechanism 40 of the syringe driver 4 is automatically moved along the axis parallel to the axis of movement of the syringe plunger to the starting position shown in Fig. 41.

Claims

C L A I M S
1. An automatic injectable drug mixing device comprising: a syringe driver configured to receive a syringe in a predetermined syringe orientation and to operate said syringe in a predetermined series of linear movements; at least one needle configured to be coupled to said syringe during only part of a mixing operation including said predetermined series of linear movements; at least one vial containing a substance to be employed in mixing said drug; and a precise positioner for maintaining said at least one vial and said at least one needle, when it is not coupled to said syringe, in precise mutual orientation with respect to each other and with respect to said syringe during at least part of said mixing operation.
2. An automatic injectable drug mixing device according to claim 1 and wherein said precise positioner comprises an element separate from said at least one needle and separate from said at least one vial.
3. An automatic injectable drug mixing device according to claim 1 or claim 2 and wherein said precise positioner comprises an element which is removably positionable with respect to said syringe driver.
4. An automatic injectable drug mixing device according to any of the preceding claims and wherein said at least one vial and said at least one needle are removably positionable with respect to said precise positioner.
5. An automatic injectable drug mixing device according to any of claims 1 - 3 and wherein at said at least one vial is fixed with respect to said precise positioner.
6. An automatic injectable drug mixing device according to any of the preceding claims and wherein said syringe driver is fixedly mounted on a base and said precise positioner is removably mounted onto said base.
7. An automatic injectable drug mixing device according to claim 6 and also comprising a base ohentor operative to vary the orientation of said base and thus of said syringe driver with respect to gravity during at least part of said mixing operation.
8. An automatic injectable drug mixing device according to any of the preceding claims and wherein said precise positioner is pivotably mounted with respect to said syringe driver other than during said mixing operation.
9. An automatic injectable drug mixing device according to any of the preceding claims wherein said at least one vial comprises plural vials.
10. An automatic injectable drug mixing device according to any of the preceding claims wherein said at least one needle comprises plural needles.
11. An automatic injectable drug mixing device comprising: a syringe driver configured to receive a syringe in a predetermined syringe orientation and to operate said syringe in a predetermined series of linear movements along a first axis relative to said syringe; at least one needle configured to be coupled to said syringe during only part of a mixing operation including said predetermined series of linear movements; at least one vial containing a substance to be employed in mixing said drug; and a tilting mechanism for selectably tilting said syringe, said at least one needle and said at least one vial about at least a second axis.
12. An automatic injectable drug mixing device according to claim 11 and wherein said at least a second axis is perpendicular to said first axis.
13. An automatic injectable drug mixing device according to claim 11 and also comprising: a rotating mechanism for selectably rotating said syringe driver relative to said at least one needle about said first axis.
14. An automatic injectable drug mixing device according to any of the preceding claims and wherein said syringe driver provides at least some of said series of linear movements at a controlled, generally uniform linear speed.
15. For use in an automatic injectable drug mixing device including a syringe driver configured to receive a syringe in a predetermined syringe orientation and to operate said syringe in a predetermined series of linear movements and for use with at least one needle configured to be coupled to said syringe during only part of a mixing operation including said predetermined series of linear movements and at least one vial containing a substance to be employed in mixing said drug, a precise positioner for maintaining said at least one vial and said at least one needle, when it is not coupled to said syringe, in precise mutual orientation with respect to each other and with respect to said syringe during at least part of said mixing operation.
16. A precise positioner according to claim 15 and wherein said precise positioner comprises an element separate from said at least one needle and separate from said at least one vial.
17. A precise positioner according to claim 15 or claim 16 and wherein said precise positioner is removably positionable with respect to said syringe driver.
18. A precise positioner according to any of claims 15 - 17 and wherein said at least one vial and said at least one needle are removably positionable with respect to said precise positioner.
19. A precise positioner according to any of claims 15 - 17 and wherein said at least one vial is fixed with respect to said precise positioner.
20. A precise positioner according to any of claims 15 - 19 and wherein said syringe driver is fixedly mounted on a base and said precise positioner is removably mounted onto said base.
21 . A precise positioner according to any of claims 15 - 20 and wherein said precise positioner is pivotably mounted with respect to said syringe driver other than during said mixing operation.
22. A precise positioner according to any of claims 15 -21 and wherein said at least one vial comprises plural vials.
23. A precise positioner according to any of claims 15 - 22 and wherein said at least one needle comprises plural needles.
24. For use in an automatic injectable drug mixing device including a syringe driver configured to receive a syringe in a predetermined syringe orientation and to operate said syringe in a predetermined series of linear movements and for use with first and second needles configured to be coupled to said syringe during only part of a mixing operation including said predetermined series of linear movements and at least one vial containing a substance to be employed in mixing said drug, a needle protector assembly for maintaining and removably retaining said first and second needles in non- finger contactable precise mutual orientation with respect to each other during at least part of said mixing operation, said needle protector assembly permitting removal therefrom of said first needle only together with a needle guard.
25. A needle protector assembly according to claim 24 and comprising first and second needle guards for respective said first and second needles, said first needle guard being removable from the remainder of said needle protector assembly together with said first needle.
26. A needle protector assembly according to claim 25 and wherein said second needle guard is not removable from the remainder of said needle protector assembly when said second needle is removed therefrom.
PCT/US2007/067162 2006-05-06 2007-04-21 An automatic injectable drug mixing device WO2007130809A2 (en)

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