US20070129687A1 - Injection method and apparatus - Google Patents

Injection method and apparatus Download PDF

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Publication number
US20070129687A1
US20070129687A1 US11/598,969 US59896906A US2007129687A1 US 20070129687 A1 US20070129687 A1 US 20070129687A1 US 59896906 A US59896906 A US 59896906A US 2007129687 A1 US2007129687 A1 US 2007129687A1
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United States
Prior art keywords
housing
spring
dose
button
coupled
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
Application number
US11/598,969
Inventor
Jeremy Marshall
Mark Eaton
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Owen Mumford Ltd
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Owen Mumford Ltd
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Publication date
Priority to GBGB0524604.6A priority Critical patent/GB0524604D0/en
Priority to GB0524604.6 priority
Application filed by Owen Mumford Ltd filed Critical Owen Mumford Ltd
Assigned to OWEN MUMFORD, LTD. reassignment OWEN MUMFORD, LTD. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: EATON, MARK, MARSHALL, JEREMY
Publication of US20070129687A1 publication Critical patent/US20070129687A1/en
Application status is Abandoned legal-status Critical

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/3155Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6063Optical identification systems
    • A61M2205/6081Colour codes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31535Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31535Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31543Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose piston rod reset means, i.e. means for causing or facilitating retraction of piston rod to its starting position during cartridge change
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/3155Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31553Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe without axial movement of dose setting member
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/3156Mechanically operated dose setting member using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals

Abstract

A pen-type injector for receiving a medication containing member. The injector comprises a housing 1 and a torsion spring 4 contained within the housing and coupled to a drive member 8. A dose setting knob 2 is coupled to the spring 4, and rotatably coupled to the housing 1 such that rotation of the knob relative to the housing in a first direction results in compression or twisting of the spring. A user actuable trigger 12 is provided for releasing the spring 4 to push the drive member 8 through the housing 1. A user actuable button 6 is coupled to the housing 1 for axial motion relative thereto, said button 6 being coupled to the torsion spring 4 to cause the spring to unwind or expand in discrete steps with each press of the button.

Description

    RELATED APPLICATION DATA
  • This application claims priority to United Kingdom Patent Application No. GB0524604.6 filed on Dec. 2, 2005, the contents of which are incorporated herein by reference.
  • FIELD OF THE INVENTION
  • The present invention relates to an injection method and apparatus, and more particularly to an injection method and apparatus which provides for automatic medication delivery and for variable dose setting.
  • BACKGROUND
  • U.S. Pat. No. 5,104,380 describes a generally pen-like syringe which incorporates a dose metering device provided by a cap or “dose knob” which is rotatable with respect to the pen body to a position related to the dose of medication to be injected. Rotation loads (by twisting) a coil spring which is prevented from unwinding by cooperating teeth. The user disengages the ratchet teeth by means of a sliding trigger coupled to the outside of the pen body, resulting in the unwinding of the spring. This in turn causes rotation of a drive gear which is coupled to a syringe plunger via a quick pitch screw thread. Rotation of the gear results in axial movement of the plunger through the pen body. The plunger acts on a “bung” of a medicament containing cartridge, driving medicament from the cartridge as it travels. The structure of the syringe of U.S. Pat. No. 5,104,380 is such that, once a dose has been set by a user dialing the dose knob to a given position, the user cannot reduce the setting by winding the dose knob in the reverse direction. If the dose has been overset, the user must activate the trigger to expel the set dose, and redial the correct dose.
  • WO02/053214 describes a syringe comprising a similar dose setting mechanism. The design described in this document is claimed to allow the dose knob to be rotated in the reverse direction to allow an overset dose to be reduced.
  • According to a first aspect of the present invention there is provided medication delivery apparatus comprising:
      • a housing for receiving a medication containing member;
      • a drive member mounted within the housing for engaging with the medication containing member and moveable axially within the housing;
      • a spring contained within the housing and coupled to the drive member;
      • a dose setting knob coupled to said spring, and rotatably coupled to the housing such that rotation of the knob relative to the housing in a first direction results in compression or twisting of the spring;
      • a user actuable trigger for releasing the spring to push the drive member through the housing; and
      • a user actuable button coupled to said housing for axial motion relative thereto, said button being coupled to said spring to cause the spring to unwind or expand without causing any substantial movement of said drive member.
  • Preferably, actuation of said button causes said spring to unwind or expand in discrete steps with each press of the button
  • In an embodiment of the present invention, the apparatus further comprises a drive shaft extending through the housing, the drive shaft being coupled via a ratchet mechanism to a drive element, and the drive element being coupled to said drive member, whereby rotation of the drive element gives rise to axial movement of the drive member. Said dose setting knob is coupled to the drive shaft for rotation therewith when the user actuable button is in a released position, and is decoupled from the drive shaft when the button is in a depressed position whereupon the dose knob is able to rotate relative to the drive shaft.
  • Said user actuable trigger is configured to release said drive element for rotation by the spring when the trigger is actuated, and to secure the drive element when the trigger is in its resting state.
  • Said ratchet mechanism preferably comprises two complimentary sets of teeth, a first set formed on an end of the drive shaft and a second formed on the drive element. With the trigger in its resting state, the teeth of the drive shaft are able to ride over the teeth of the drive unit to allow rotation of the drive shaft relative to the drive element when the dose knob is rotated in a dose setting direction.
  • Preferably, said user actuable button is coupled to the drive shaft for rotation therewith. The drive shaft comprises means for locking the drive shaft to the dose knob, which means is released when the button is depressed by a user. The locking means may comprise one or more teeth for engaging with teeth of a rack provided around a surface of the dose knob, which teeth are free to flex inwardly when the button is depressed. The button may further comprise means for inducing rotation of the dose knob in a dose reducing direction when the button is depressed, and means for defining the dose reducing steps. These means may be provided by an indexing finger depending from the user actuable button and which engages a rack formed around a surface of the dose knob.
  • In order to assist a user who requires more than one type of medicament, the apparatus may further comprise an annular member that is removably attachable to an outer surface of the main body, the annular member being used to identify a medicament.
  • According to a second aspect of the present invention there is provided medication delivery apparatus for receiving a medication containing member, the apparatus comprising:
      • spring means for storing a force which when released causes ejection of the medication from a received medication containing member;
      • a dose knob which when rotated in a first direction moves the spring to a force storing position, the dose setting knob providing a plurality of discrete setting positions corresponding to respective doses;
      • a user actuable trigger for releasing said stored force to eject medication from said medication containing member; and
      • a user actuable button arranged to reduce a stored force in the spring without causing ejection of medication from said medication containing member.
  • Preferably, the apparatus comprises a drive means for engaging a medication containing chamber, and a drive shaft coupled between the drive means and said spring means. In a resting state, the dose knob is coupled to the drive shaft for rotation therewith. When the button is depressed, the dose knob is at least temporarily uncoupled from the drive shaft to allow the dose knob to rotate relative to the drive shaft.
  • According to a third aspect of the present invention there is provided a method of setting a dose of medication to be ejected from a medication containing member received within a dose delivery apparatus, the method comprising:
      • rotating a dose knob of the apparatus in a first direction to one of a plurality of discrete positions corresponding to respective doses; and
      • changing the set dose to a reduced dose by depressing a button one or more times.
  • According to a fourth aspect of the present invention there is provided medication delivery apparatus comprising:
      • a housing for receiving a medication containing member;
      • a drive member mounted within the housing for engaging with the medication containing member and moveable axially within the housing;
      • a spring contained within the housing and coupled to the drive member;
      • a dose setting knob coupled to said spring, and rotatably coupled to the housing such that rotation of the knob relative to the housing in a first direction results in compression or twisting of the spring;
      • spring retaining means comprising a toothed rack coupled to one of the housing and the dose knob and at least one spring mounted tooth coupled to the other of the housing and the dose knob, the or each tooth engaging the toothed rack to prevent a force stored on the spring from moving the spring to release the force, whilst allowing a user to rotate the dose knob in a second, reverse direction, to reduce a set dose; and
      • a user actuable trigger for releasing the spring to push the drive member through the housing.
  • In a preferred embodiment of the invention, the or each spring mounted tooth has a one piece moulded construction, with a tooth element mounted on an end of a moulded spring.
  • Preferably, the apparatus comprises an elongate drive shaft coupling said spring to said drive member. An end of the drive shaft is coupled to the dose knob for rotation therewith. The other end of the drive shaft provides part of said spring retaining means, either said at least one sprung tooth or said toothed rack. The other of said at least one sprung tooth and said toothed rack is provided on a drive element which is coupled to the housing via said user actuable trigger. The drive element is in turn coupled to the drive member. Actuation of the trigger releases the drive element to rotate within the housing under the action of the spring via the drive shaft. Rotation of the drive element produces axial movement of the drive member through the housing.
  • According to a fifth aspect of the present invention there is provided medication delivery apparatus comprising:
      • a housing for receiving a medication containing member;
      • a drive member mounted within the housing for engaging with the medication containing member and moveable axially within the housing;
      • a torsion spring contained within the housing and coupled to the drive member;
      • a dose setting knob coupled to said spring, and rotatably coupled to the housing such that rotation of the knob relative to the housing in a first direction results in loading of the spring;
      • a user actuable trigger for releasing the spring to push the drive member through the housing; and
      • a rotatably mounted visual indicator for indicating the dose to be delivered, the rotatably mounted visual indicator being rotatable over at least one complete revolution.
  • According to a sixth aspect of the present invention, there is provided medication delivery apparatus comprising:
      • a housing for receiving a medication containing member;
      • a drive member mounted within the housing for engaging with the medication containing member and moveable axially within the housing;
      • a torsion spring contained within the housing and coupled to the drive member;
      • a dose setting knob coupled to said spring, and rotatably coupled to the housing such that rotation of the knob relative to the housing in a first direction results in loading of the spring;
      • a dial cam configured to co-operate with a dial key, such that upon rotation of the dose setting knob, the dial cam and the dial key co-operate to strain or release the torsion spring, depending upon the direction of rotation of the dose setting knob.
    BRIEF DESCRIPTION OF THE DRAWINGS
  • For a better understanding of the present invention and in order to show how the same may be carried into effect reference will now be made by way of example to the accompanying drawings in which:
  • FIG. 1 shows schematically a pen-type injector;
  • FIG. 2 shows a horizontal cross-section through the injector of FIG. 1;
  • FIG. 2A shows an enlarged view of a retaining and trigger portion of the injector taken at A of FIG. 2;
  • FIG. 3 shows a vertical cross-section through the injector of FIG. 1;
  • FIG. 4 is a perspective exploded view of the injector of FIG. 1;
  • FIG. 5 shows a dose knob of the injector of FIG. 1;
  • FIG. 6 shows a clutch collet of the injector of FIG. 1;
  • FIG. 7 shows in partial cross-section of an end of the injector of FIG. 1;
  • FIG. 8 illustrates an operating sequence of the injector of FIG. 1;
  • FIG. 9 shows a horizontal side elevation view of a dose knob
  • FIG. 10 is a perspective view of a locking bush and a leadscrew;
  • FIG. 11 shows a horizontal cross-section through an alternative internal construction of the injector;
  • FIG. 11A shows an enlarged view of a retaining and trigger portion of the injector taken at A of FIG. 11;
  • FIG. 12 shows a vertical cross-section through the alternative injector of FIG. 9;
  • FIG. 13 is a perspective exploded view of the injector of FIG. 9; and
  • FIG. 14 shows perspective views of an end of a drive shaft of the injector of FIG. 9.
  • DETAILED DESCRIPTION
  • There is illustrated in FIG. 1 a pen-type injector having a user operable dose setting mechanism. With reference to FIGS. 2 to 7, it can be seen that the injector comprises a main body 1 and a cap 20 which snap fit together. Identity ring 19 is colour coded to indicate the type of medicament to be delivered by the injector. A screw thread is provided on an inner surface of the main body 1 at its upper end. This internal screw thread is engaged by an external screw thread 2 a provided on an outer surface of a dose knob 2. The dose knob 2 is illustrated in detail in FIG. 5. Longitudinal movement of the dose knob 2 within the pen body 1 is limited in both directions.
  • A cartridge housing 18 is secured to a lower end of the main body 1 and is arranged to receive a disposable medication filled cartridge (not shown). Such a cartridge has a rubber bung sealing one end of the cartridge, with the other end being arranged to receive a disposable needle. The cartridge is typically multi-use, with a user attaching a new needle for each injection.
  • A torsion spring 4 is located coaxially within the main body 1 and is arranged to provide the drive force for ejecting medication from a loaded cartridge. The spring 4 is fixed at its upper end to the dose knob 5. At its lower end, the spring 4 is fixed to the housing via a retaining ring moulded integrally with the housing 1.
  • A generally cylindrical ratchet drive shaft 3 extends through the centre of the spring 4. An enlarged end portion 3 a of the shaft 3 has three sprung legs 3 b formed around its periphery, the legs being spaced equiangularly around the shaft. At the outermost end of each leg, a tooth 3 c is provided. The teeth 3 c engage teeth of a rack 11 a (not visible in FIG. 4) formed around the inner surface of a generally cylindrical drive gear component 11 which sits within the main body 1 at a fixed axial position. The drive gear 11 has a second toothed rack 11 b formed around a lower outer surface portion. This rack sits within a correspondingly sized rack 12 a formed on an inner surface of a retaining ring 12. The ring 12 is formed integrally with a trigger 12 b, with the component being slidably mounted within a slot formed in the main body 1, separated from the body by a pair of thrust washers 10. A spring 13 urges the trigger 12 b in an upward direction, maintaining the racks 11 b, 12 a in locking engagement in the absence of a user force applied to the trigger. The dose knob 2 and the trigger 12 b may be provided with a soft rubber overmolding. This provides the user with a more comfortable and better grip.
  • Considering further the ratchet drive shaft 3, this is coupled at its upper end to a clutch collet 5. The clutch collet, illustrated in FIG. 6 (viewed from above A and below B) rotates with the drive shaft 3 and is provided with a pair of sprung fingers 5 a. The sprung fingers are shaped in cross-section to provide respective teeth for engaging teeth of a rack 2 c formed around an inner surface of the dose knob 2. The fingers 5 a are biased outwardly.
  • A rewind button 6 is located within the dose knob 2, projecting therefrom. The button 6 is coupled to the ratchet drive shaft 3, rotating with the drive shaft but being able to slide longitudinally within the drive shaft. A spring 7 is coupled between the button 6 and the drive shaft 3 and biases the button outwardly relative to the main body 1. The lower portion of the button 6 is generally cross-shaped, with two opposed arms of the cross opposing the sprung fingers 5 a of the clutch collet 5. These arms taper inwardly such that they prevent any radially inward flexing of the sprung fingers 5 a when the button is in its outer position, whilst allowing inward flexing when the button is fully depressed against the bias of the button spring 7. This arrangement is best illustrated in FIG. 7, where FIG. 7A illustrates the button 6 in situ whilst FIG. 7B illustrates the end of the injector with a cross-section taken through the button 6.
  • A leadscrew 8 has a screw thread formed along the length of its outer surface. The leadscrew is located within the ratchet drive shaft 3, and engages a complimentary screw thread formed on the inner surface of the drive gear 11. The end portion of the leadscrew 8 projecting from the ratchet drive shaft 3 has a leadscrew cap secured thereto. Rotational movement of the leadscrew relative to the drive shaft is prevented by the engagement of recesses formed along the length of the leadscrew with complimentary splines provided on an inner surface of a locking bush 14. The locking bush is held within a mid-body compartment 17 which itself is secured to the end of the main body 1 via a pair of complimentary screw threads. On coupling with a medicament containing cartridge, the cartridge compression cup 16 will compress the spring 15 and transmit the loading onto the locking bush 14. The serrated edge of the locking bush engages with the mating features of the body 1 preventing the locking bush from rotating and ensuring that the leadscrew 8 moves forward when subjected to rotation following release of the drive gear 11.
  • An indexing finger 6 a depends from an inner surface of the button 6. The finger is provided at its end with a ramp shaped tooth 6 b having a vertical, blocking surface and a sloping drive surface. The tooth 6 b engages teeth of an indexing rack 2 b formed around an inner surface of the dose knob 2, when the button is pressed into the dose knob 2.
  • In order for a user to set the amount of medicament to be delivered, the dose knob 2 has a barrel 2 d formed integrally with the dose knob 2. The barrel 2 d has a series of numbers printed around its circumference, so that as the dose knob 2 is rotated, the barrel 2 d also rotates. A window in the main body 1 allows the user to see one of the printed numbers, and the printed number relates to the amount of medicament that will be delivered.
  • When the dose knob 2 is rotated, screw thread 2 d ensures that the dose knob moves linearly with respect to the longitudinal axis of the main body 1, and allows the dose knob to be rotated over more than one revolution. This allows both higher loading of the torsion spring, and also allows the barrel 2 d to indicate doses over more than one revolution of the barrel, provided that the printed numbers relating to a medicament dose setting are printed in a helical pattern around the outer surface of the barrel 2 d, as shown in FIG. 13.
  • As shown in FIG. 10, the leadscrew 8 comprises a pair of channels 21 running along its longitudinal axis. At one end of each channel is a ramp 22. The locking bush 14 comprises a pair of fingers 23 that engage with a corresponding leadscrew channel 21. This ensures that when the device is assembled, the leadscrew 8 and the locking bush 14 are located correctly together. The fingers 23 are flexible such that when the leadscrew is passed through the centre of the locking bush 14, the fingers ride up the corresponding ramps 22 and flex outwards. Once the fingers 23 have passed over the ramps 22, they snap into engagement with the channels 21. During resetting, the fingers 23 abut against the corresponding ramps 22 to ensure that the locking bush 14 does not move out of engagement with the leadscrew 8.
  • A full list of injector components with their reference numbers as shown in FIGS. 1 to 8 is contained within Table 1 below.
  • Considering now the operation of the injector, a user sets a dose by rotating the dose knob 2 in a clockwise direction. As the dose knob 2 is rotated, the top of the spring 4 rotates with it creating torsion of the spring. Engagement of the sprung fingers 5 a at the top of the ratchet drive shaft 3 with the rack 2 c formed on the inner surface of the dose knob 2 also causes the ratchet drive shaft 3 to rotate. At the lower end of the ratchet drive shaft 3, the teeth of the sprung legs 5 a “click” around the teeth of the rack 11 a. The engagement of the teeth with the rack 11 a prevents the spring 4 unwinding after each click. Each click corresponds to a predefined angular rotation of the spring and therefore to a predefined ejection dose. It will be readily appreciated that, during the dose setting action, the drive gear 11 is not rotated so no axial movement of the leadscrew 8 is induced. No medication is therefore ejected from the cartridge during the dose setting operation (or indeed air introduced due to back filling).
  • When the user applies a downward force to the trigger 12 b, this disengages the racks of the trigger 12 b and the drive gear 11. This frees the drive gear 11 and the torsion spring 4 to rotate. As the drive gear 11 rotates about the leadscrew 8, the leadscrew is driven down through the drive gear causing the leadscrew cap 9 to push the bung of the cartridge through the cartridge body, expelling medication from the cartridge through the attached syringe.
  • In the event that a user oversets a dose, i.e. over-rotates the dose knob 2, the user fully presses the button 6 into the dose knob 2 against the action of the biasing spring 7. As the button 6 is depressed, the drive surface of the tooth 6 b comes into contact with one of the teeth formed on the indexing rack 2 b (from the starting position of FIG. 8A to the position shown in FIG. 8B). Further pressure induces a rotational force on the dose knob 2 in the counter-clockwise direction until the fully depressed position of FIG. 8C is reached. At substantially the same time, the downward movement of the cross-arms of the button 6 results in the sprung fingers 5 a being free to flex inwardly, freeing the dose knob 2 and the spring 4 to rotate under one or both of the force stored in the spring and the force induced by the tooth. The dose knob 2 is able to rotate until the blocking surface of the tooth engages the next stop surface of the upper rack. Neither the ratchet drive shaft 3 nor the drive gear 11 rotate during this resetting operation. No axial movement of the leadscrew 8 is therefore induced and no medication ejected from the cartridge. The dose resetting mechanism operates by temporarily decoupling the dose knob and the torsion spring from the ratchet drive shaft allowing the former to rotate relative to the drive shaft. Upon removal of the pressure from the button 6, the rewind button spring 7 returns the button to its outermost position, whereupon the teeth of the sprung fingers 5 a reengage with the teeth of the rack 2 c.
  • An alternative pen-type injector will now be described with reference to FIGS. 11 to 14. Externally, this injector has a similar external appearance to the injector illustrated in FIG. 1. The operating principle of the alternative injector is similar to that of the injector of FIGS. 2 to 10 in terms of both the dose setting and firing functionality. However, the dose resetting mechanism differs.
  • The injector comprises a dose setting knob 2′ which is coupled to the main body 1′ via complimentary screw threads. The end of the dose knob 2′ is closed by a dose knob cap 7′ which rotates with the dose knob. Considering now the ratchet drive shaft 3′, this has an end collar 3 a′ having three radial extending slots formed therein (FIG. 14, where FIG. 14A shows the knob 2 with a ratchet retainer removed, FIG. 14B shows the knob with the retainer in situ, and FIG. 14C shows the knob with the retainer in place but shown transparent). These slots receive respective arms (also referred to as a dial key) 5 a′ of a ratchet plunger component 5′ having a cylindrical body. The body sits tightly within the circular opening in the end of the collar 3 a′. Each arm 5 a′ comprises a moulded spring body and an end tooth, the surfaces of the tooth sloping at the same angle. A ratchet retainer 6′ snaps over the end of the collar 3 a′ to secure the ratchet plungers in place. The teeth of the ratchet plunger project from the ends of their respective slots by approximately 0.5 mm, and can be deflected radially inwards (by approximately 0.25 mm) as a result of the moulded springs.
  • In the assembled injector, the teeth of the ratchet plunger 5′ engage the rack (also referred to as a dial cam) formed around the inner surface of the drive gear 11′. The teeth surfaces of the rack are also equiangular, corresponding to the teeth of the ratchet plunger.
  • A full list of injector components with their reference numbers as shown in FIGS. 11 to 14 is contained within Table 2 below.
  • In use, a user dials up a dose by rotating the dose knob 2′ in a clockwise direction. The user applied force is sufficient to overcome the resistance between the teeth of the ratchet plunger 11′ and those of the rack of the drive gear 11′, the drive gear being held in place against rotation by the trigger 12′. During this action, the teeth of the ratchet plunger are pushed inward into the end collar of the ratchet drive shaft to allow them to ride over the teeth of the rack within the drive gear. In the same way, if a user wishes to reduce a set dose, he or she rotates the dose knob in an anti-clockwise direction. The shape of the ratchet plunger teeth permits this. Thus according to this design, there is no need for a rewind button separate from the dose knob in order to facilitate resetting of the dose.
  • It will be appreciated by the person of skill in the art that various modifications may be made to the above described embodiments without departing from the scope of the present invention. TABLE 1 Reference numeral Description 1 Main Body 2 Dose Knob - Rewind Button 3 Ratchet Drive Shaft - No Rewind 4 Torsion Spring - Rewind Button 5 Clutch Collet 6 Rewind Button 7 Rewind Button Spring 8 Leadscrew 9 Leadscrew Cap 10 Thrust Washer 11 Drive Gear - No Rewind (1 Unit) 12 Trigger 13 Trigger Spring 14 Locking Bush 15 Compression Cup Spring 16 Cartridge Compression Cup 17 Mid-Body 18 Cartridge Housing 19 Identity Ring 20 Cap 21 Leadscrew channel 22 Leadscrew ramp 23 Locking bush finger
  • TABLE 2 Reference numeral Description 1 Main Body 2 Dose Knob 3 Ratchet Drive Shaft 4 Torsion Spring 5 Ratchet Plungers 6 Ratchet Retainer 7 Dose Knob Cap 8 Leadscrew 9 Leadscrew Cap 10 Thrust Washer 11 Drive Gear 12 Trigger 13 Trigger Spring 14 Locking Bush 15 Compression Cup Spring 16 Cartridge Compression Cup 17 Mid-Body 18 Cartridge Housing 19 Identity Ring 20 Cap

Claims (23)

1. A medication delivery apparatus comprising:
a housing for receiving a medication containing member;
a drive member mounted within the housing for engaging with the medication containing member and moveable axially within the housing;
a spring contained within the housing and coupled to the drive member;
a dose setting knob coupled to said spring, and rotatably coupled to the housing such that rotation of the knob relative to the housing in a first direction results in compression or twisting of the spring;
a user actuable trigger for releasing the spring to push the drive member through the housing; and
a user actuable button coupled to said housing for axial motion relative thereto, said button being coupled to said spring to cause the spring to unwind or expand without causing any substantial movement of said drive member.
2. The apparatus according to claim 1, wherein actuation of said button causes said spring to unwind or expand in discrete steps with each press of the button.
3. The apparatus according to claim 1 further comprising a drive shaft extending through the housing, the drive shaft being coupled via a ratchet mechanism to a drive element where the drive element is prevented from moving axially within the housing, and the drive element being coupled to said drive member, whereby rotation of the drive element gives rise to axial movement of the drive member.
4. The apparatus according to claim 1, comprising a drive shaft extending through the housing, the drive shaft being coupled via a ratchet mechanism to a drive element where the drive element is prevented from moving axially within the housing, and the drive element being coupled to said drive member, whereby rotation of the drive element gives rise to axial movement of the drive member, wherein said dose setting knob is coupled to the drive shaft for rotation therewith when the user actuable button is in a released position, and is decoupled from the drive shaft when the button is in a depressed position whereupon the dose knob is able to rotate relative to the drive shaft.
5. The apparatus according to claim 1 and comprising a drive shaft extending through the housing, the drive shaft being coupled via a ratchet mechanism to a drive element where the drive element is prevented from moving axially within the housing, and the drive element being coupled to said drive member, whereby rotation of the drive element gives rise to axial movement of the drive member, wherein said user actuable trigger is configured to release said drive element for rotation by the spring when the trigger is actuated, and to secure the drive element when the trigger is in its resting state.
6. The apparatus according to claim 1, wherein actuation of said button causes said spring to unwind or expand in discrete steps with each press of the button, said ratchet mechanism comprising two complimentary sets of teeth, a first set formed on an end of the drive shaft and a second formed on the drive element, wherein with the trigger in its resting state, the teeth of the drive shaft are able to ride over the teeth of the drive unit to allow rotation of the drive shaft relative to the drive element when the dose knob is rotated in a dose setting direction.
7. The apparatus according to claim 1, wherein actuation of said button causes said spring to unwind or expand in discrete steps with each press of the button, said user actuable button being coupled to the drive shaft for rotation therewith.
8. The apparatus according to claim 1, wherein actuation of said button causes said spring to unwind or expand in discrete steps with each press of the button, said user actuable button being coupled to the drive shaft for rotation therewith, and the drive shaft comprising means for locking the drive shaft to the dose knob, which means is released when the button is depressed by a user.
9. The apparatus according to claim 1, wherein actuation of said button causes said spring to unwind or expand in discrete steps with each press of the button, said user actuable button being coupled to the drive shaft for rotation therewith; and
the drive shaft comprising means for locking the drive shaft to the dose knob, which means is released when the button is depressed by a user; and
the locking means comprising one or more teeth for engaging with teeth of a rack provided around a surface of the dose knob, which teeth are free to flex inwardly when the button is depressed.
10. The apparatus according to claim 1, the button comprising means for inducing rotation of the dose knob in a dose reducing direction when the button is depressed, and means for defining the dose reducing steps.
11. The apparatus according to claim 1, the button comprising means for inducing rotation of the dose knob in a dose reducing direction when the button is depressed, and means for defining the dose reducing steps, said means for inducing rotation and for defining the dose reducing steps comprising an indexing finger depending from the user actuable button and which engages a rack formed around a surface of the dose knob.
12. The apparatus according to claim 1, further comprising an annular member that is removably attachable to an outer surface of the main body, the annular member being used to identify a medicament.
13. A medication delivery apparatus for receiving a medication containing member, the apparatus comprising:
spring means for storing a force which when released causes ejection of the medication from a received medication containing member;
a dose knob which when rotated in a first direction moves the spring to a force storing position, the dose setting knob providing a plurality of discrete setting positions corresponding to respective doses;
a user actuable trigger for releasing said stored force to eject medication from said medication containing member; and
a user actuable button arranged to reduce a stored force in the spring with each press of the button without causing ejection of medication from said medication containing member.
14. The apparatus according to claim 13, wherein said user actuable button is arranged to reduce a stored force in the spring by a discrete step with each press of the button.
15. The apparatus according to claim 13 and comprising a drive means for engaging a medication containing chamber, and a drive shaft coupled between the drive means and said spring means, wherein, in a resting state, the dose knob is coupled to the drive shaft for rotation therewith and, when the button is depressed, the dose knob is at least temporarily uncoupled from the drive shaft to allow the dose knob to rotate relative to the drive shaft.
16. A method of setting a dose of medication to be ejected from a medication containing member received within a dose delivery apparatus, the method comprising:
rotating a dose knob of the apparatus in a first direction to one of a plurality of discrete positions corresponding to respective doses; and
changing the set dose to a reduced dose by depressing a button one or more times.
17. A method according to claim 16, where each press of the button reduces the dose by a discrete step.
18. A medication delivery apparatus comprising:
a housing for receiving a medication containing member;
a drive member mounted within the housing for engaging with the medication containing member and moveable axially within the housing;
a spring contained within the housing and coupled to the drive member;
a dose setting knob coupled to said spring, and rotatably coupled to the housing such that rotation of the knob relative to the housing in a first direction results in compression or twisting of the spring;
spring retaining means comprising a toothed rack coupled to one of the housing and the dose knob and at least one spring mounted tooth coupled to the other of the housing and the dose knob, the or each tooth engaging the toothed rack to prevent a force stored on the spring from moving the spring to release the force, whilst allowing a user to rotate the dose knob in a second, reverse direction, to reduce a set dose; and
a user actuable trigger for releasing the spring to push the drive member through the housing.
19. The apparatus according to claim 18, wherein the or each spring mounted tooth has a one piece moulded construction, with a tooth element mounted on an end of a moulded spring.
20. The apparatus according to claim 18 and comprising an elongate drive shaft coupling said spring to said drive member, wherein an end of the drive shaft is coupled to the dose knob for rotation therewith.
21. The apparatus according to claim 18 and comprising an elongate drive shaft coupling said spring to said drive member, wherein an end of the drive shaft is coupled to the dose knob for rotation therewith, and wherein the other end of the drive shaft provides part of said spring retaining means, either said at least one sprung tooth or said toothed rack, and the other of said at least one sprung tooth and said toothed rack is provided on a drive element which is coupled to the housing via said user actuable trigger, the drive element in turn being coupled to the drive member, wherein actuation of the trigger releases the drive element to rotate within the housing under the action of the spring via the drive shaft, and rotation of the drive element produces axial movement of the drive member through the housing.
22. A medication delivery apparatus comprising:
a housing for receiving a medication containing member;
a drive member mounted within the housing for engaging with the medication containing member and moveable axially within the housing;
a torsion spring contained within the housing and coupled to the drive member;
a dose setting knob coupled to said spring, and rotatably coupled to the housing such that rotation of the knob relative to the housing in a first direction results in loading of the spring;
a user actuable trigger for releasing the spring to push the drive member through the housing; and
a rotatably mounted visual indicator for indicating the dose to be delivered, the rotatably mounted visual indicator being rotatable over at least one complete revolution.
23. A medication delivery apparatus comprising:
a housing for receiving a medication containing member;
a drive member mounted within the housing for engaging with the medication containing member and moveable axially within the housing;
a torsion spring contained within the housing and coupled to the drive member;
a dose setting knob coupled to said spring, and rotatably coupled to the housing such that rotation of the knob relative to the housing in a first direction results in loading of the spring;
a dial cam configured to co-operate with a dial key, such that upon rotation of the dose setting knob, the dial cam and the dial key co-operate to strain or release the torsion spring, depending upon the direction of rotation of the dose setting knob.
US11/598,969 2005-12-02 2006-11-14 Injection method and apparatus Abandoned US20070129687A1 (en)

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WO2007063342A1 (en) 2007-06-07
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CN101321550B (en) 2013-03-13
EP1954337A1 (en) 2008-08-13

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