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WO2012062718A1 - Mécanisme d'établissement de dose destiné à un dispositif d'administration de médicament, système d'administration de médicaments et dispositif d'administration de médicament - Google Patents

Mécanisme d'établissement de dose destiné à un dispositif d'administration de médicament, système d'administration de médicaments et dispositif d'administration de médicament Download PDF

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Publication number
WO2012062718A1
WO2012062718A1 PCT/EP2011/069583 EP2011069583W WO2012062718A1 WO 2012062718 A1 WO2012062718 A1 WO 2012062718A1 EP 2011069583 W EP2011069583 W EP 2011069583W WO 2012062718 A1 WO2012062718 A1 WO 2012062718A1
Authority
WO
WIPO (PCT)
Prior art keywords
cartridge assembly
dose setting
setting mechanism
protrusions
cartridge
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.)
Ceased
Application number
PCT/EP2011/069583
Other languages
English (en)
Inventor
David Aubrey Plumptre
Richard James Vincent Avery
Aled Meredydd James
Joseph Butler
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi Aventis Deutschland GmbH
Original Assignee
Sanofi Aventis Deutschland GmbH
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 Sanofi Aventis Deutschland GmbH filed Critical Sanofi Aventis Deutschland GmbH
Publication of WO2012062718A1 publication Critical patent/WO2012062718A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • 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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • 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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31543—Means 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
    • 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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • 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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional 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
    • A61M5/31585—Constructional 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 performed by axially moving actuator, e.g. an injection button
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6045—General characteristics of the apparatus with identification means having complementary physical shapes for indexing or registration purposes

Definitions

  • the present patent application is generally directed to reservoirs, particularly reservoirs containing a medicament. More particularly, the present application is generally directed to a drug delivery device that prevents dispensing of a dose when an incorrect reservoir is attached, so as to prevent unwanted reservoir cross use.
  • medicament reservoirs may comprise an ampoule, a cartridge, a vial, or a pouch, and may be used with a medical delivery device.
  • Exemplary medical delivery devices include, but are not limited to syringes, pen type injection syringes, pumps, inhalers, or other similar injection or infusing devices that require at least one reservoir containing at least one medicament.
  • Medicament reservoirs such as ampoules, cartridges, or vials are generally known. Such reservoirs are especially used for medicaments that may be self administered by a patient. For example, with respect to insulin, a patient suffering from diabetes may require a certain amount of insulin to either be injected via a pen type injection syringe or infused via a pump. With respect to certain known reusable pen type drug delivery devices, a patient loads a cartridge containing the insulin into a proximal end of a cartridge holder. After the cartridge has been correctly loaded, the user may then be called upon to select a dose of medicament. Multiple doses may be dosed from the cartridge.
  • the drug delivery device comprises a reusable device
  • the cartridge holder is disconnected from the drug delivery device and the empty cartridge is removed and replaced with a new cartridge.
  • Most suppliers of such cartridges recommend that the user dispose of the empty cartridges properly.
  • the drug delivery device comprises a disposable device, once the cartridge is empty, the user is recommended to dispose of the entire device.
  • Such known self administration systems requiring the removal and reloading of empty cartridges have certain limitations.
  • a user simply loads a new cartridge into the delivery system without the drug delivery device or without the cartridge having any mechanism of preventing cross use of an incorrect cartridge. That is, the drug delivery device does not have a mechanism for determining if the medicament contained in the cartridge is indeed the correct type of medicament to be administered by the patient.
  • certain known drug delivery devices do not present a mechanism for determining if the correct type of medicament within the cartridge should be used with that particular drug delivery system. This potential problem could be exacerbated given that certain elderly patients, such as those suffering from diabetes, may have limited manual dexterity. Identifying an incorrect medicament is quite important, since the administration of a potentially incorrect dose of a medicament such as a short acting insulin in lieu of a long insulin could result in injury or even death.
  • Some drug delivery devices or systems may use a color coding scheme to assist a user or care giver in selecting the correct cartridge to be used with a drug delivery device.
  • color coding schemes pose challenges to certain users, especially those users suffering from poor eyesight or color blindness: a situation that can be quite prevalent in patients suffering from diabetes.
  • a first cartridge containing a first medicament from a first supplier may fit a medical delivery device provided by a second supplier.
  • an incorrect medicament such as a rapid or basal type of insulin
  • distal end designates that end of a dose setting mechanism, a drug delivery system or a component thereof which is or is to be arranged closest to a dispensing end
  • proximal end designates that end which is or is to be arranged furthest away from the dispensing end of the device.
  • a dose setting mechanism may include a housing, a spindle, a spindle nut comprising a plurality of protrusions, a lock nut comprising a plurality of corresponding protrusions, and a biasing member operably connected to the lock nut.
  • the spindle nut is engaged with the spindle, fixed axially in the housing, and configured to rotate in the housing.
  • the lock nut is fixed rotationally and is configured to move axially in the housing.
  • a dose setting mechanism includes a housing, a spindle, a spindle nut comprising a plurality of protrusions, a lock nut comprising a plurality of corresponding protrusions, and a biasing member operably connected to the lock nut.
  • the spindle nut is engaged with the spindle, is fixed axially in the housing and is configured to rotate in the housing.
  • the lock nut is fixed rotationally and is configured to move axially in the housing.
  • the lock nut comprises a distal end having a given diameter.
  • the biasing member prevents the plurality of protrusions from interacting with the plurality of corresponding protrusions. Further, when a correct cartridge assembly is inserted in the dose setting mechanism, the cartridge assembly
  • the correct cartridge may comprise a correct length and/or a correct diameter that matches the given diameter, and the interaction prevents the spindle nut from rotating, and so activates the dispensing mechanism.
  • a drug delivery system may include a dose setting mechanism such as the two discussed above and a cartridge assembly.
  • the cartridge assembly may include a connector attached to a proximal end of the cartridge
  • the connector makes the cartridge assembly the correct length and/or diameter.
  • a dose setting mechanism comprises a housing, a spindle, a spindle nut comprising a plurality of protrusions, wherein the spindle nut is engaged with the spindle, and wherein the spindle nut is fixed axially in the housing and is configured to rotate in the housing, a lock nut comprising a plurality of corresponding protrusions, wherein the lock nut is fixed rotationally and is configured to move axially in the housing, and a biasing member operably connected to the lock nut, wherein, when a cartridge assembly is not inserted in the dose setting mechanism, the biasing member prevents the plurality of protrusions from interacting with the plurality of corresponding
  • the spindle nut when an incorrect cartridge assembly that is shorter than a correct cartridge assembly is inserted, the spindle nut is free to rotate, wherein free rotation of the spindle nut prevents the spindle from applying an axial force on the cartridge.
  • the incorrect cartridge assembly when an incorrect cartridge assembly that is longer than a correct cartridge assembly is inserted, the incorrect cartridge assembly is prevented from attaching to the dose setting mechanism.
  • the spindle has a first helical groove extending along an outer surface of the spindle, and the spindle nut has a second helical groove extending along an internal surface of the spindle nut, the first helical groove being engaged with the second helical groove.
  • preventing the spindle nut from rotating allows for dispensing of a dose.
  • preventing the spindle nut from applying an axial force on the cartridge prevents dispensing of a dose.
  • the protrusions and the corresponding protrusions mesh together.
  • the protrusions and corresponding protrusions are axial protrusions.
  • the protrusions and corresponding protrusions are radial protrusions.
  • the corresponding protrusions pass through the radial protrusions.
  • the protrusions and corresponding protrusions line up in a same axial position when a correct cartridge assembly is inserted.
  • a drug delivery system comprises a dose setting mechanism and a cartridge assembly, the dose setting mechanism comprising a housing a spindle, a spindle nut comprising a plurality of protrusions, wherein the spindle nut is engaged with the spindle, and wherein the spindle nut is fixed axially in the housing and is configured to rotate in the housing, a lock nut comprising a plurality of corresponding protrusions, wherein the lock nut is fixed rotationally and is configured to move axially in the housing, a biasing member operably connected to the lock nut, wherein, when a cartridge assembly is not inserted in the dose setting mechanism, the biasing member prevents the plurality of protrusions from interacting with the plurality of corresponding
  • the cartridge assembly comprising a connector attached to a proximal end of the cartridge assembly, wherein the connector makes the cartridge assembly the correct length.
  • the cartridge assembly comprises a holder that is detachable.
  • the cartridge assembly comprises a holder that is non-detachable.
  • the connector comprises at least one groove.
  • the connector comprises a plurality of shoulder features.
  • a dose setting mechanism comprises a housing, a spindle, a spindle nut comprising a plurality of protrusions, wherein the spindle nut is engaged with the spindle, and wherein the spindle nut is fixed axially in the housing and is configured to rotate in the housing, a lock nut comprising a plurality of corresponding protrusions, wherein the lock nut is fixed rotationally and is configured to move axially in the housing, and wherein the lock nut comprises a distal end having a given diameter, a biasing member operably connected to the lock nut, wherein, when a cartridge assembly is not inserted in the dose setting mechanism, the biasing member prevents the plurality of protrusions from interacting with the plurality of corresponding protrusions, wherein, when a correct cartridge assembly is inserted in the dose setting mechanism, the cartridge assembly compresses the biasing member and forces the plurality of protrusions to interact with the plurality of corresponding protrusions,
  • the second cartridge assembly when a second cartridge assembly having an internal diameter that is larger than the given the diameter is inserted in the dose setting mechanism, the second cartridge assembly fails to compress the biasing member.
  • the second cartridge assembly when a second cartridge assembly having an external diameter that is smaller than the given the diameter is inserted in the dose setting mechanism, the second cartridge assembly fails to compress the biasing member.
  • a plunger is located on a distal end of the spindle, and a diameter of the plunger is greater than an internal diameter of the second cartridge assembly.
  • a drug delivery system comprises a dose setting mechanism and a cartridge assembly, the dose setting mechanism comprising a housing, a spindle, a spindle nut comprising a plurality of protrusions, wherein the spindle nut is engaged with the spindle, and wherein the spindle nut is fixed axially in the housing and is configured to move rotate in the housing, a lock nut comprising a plurality of corresponding protrusions, wherein the lock nut is fixed rotationally and is configured to move axially in the housing, and wherein the lock nut comprises a distal end having a given diameter, a biasing member operably connected to the lock nut, wherein, when a cartridge assembly is not inserted in the dose setting mechanism, the biasing member prevents the plurality of protrusions from interacting with the plurality of corresponding
  • the cartridge assembly compresses the biasing member and forces the plurality of protrusions to interact with the plurality of corresponding protrusions, wherein the correct cartridge comprises a correct diameter that matches the given diameter, and wherein the interaction prevents the spindle nut from rotating and the cartridge assembly comprising a connector attached to a proximal end of the cartridge assembly, wherein the connector makes the cartridge assembly the correct diameter.
  • the cartridge assembly comprises a holder that is detachable.
  • the cartridge assembly comprises a holder that is non-detachable.
  • the connector comprises at least one groove. In a further example embodiment of the drug delivery system, the connector comprises a plurality of shoulder features.
  • the correct cartridge comprises a correct length and the correct diameter that matches the given diameter.
  • a drug delivery device comprises a dose setting mechanism and a cartridge assembly, wherein, when the cartridge assembly comprises a correct length and is inserted in the dose setting mechanism, the cartridge assembly enables the dose setting mechanism to dispense a dose.
  • a drug delivery device comprises a dose setting mechanisma and a cartridge assembly, wherein, when the cartridge assembly comprises a correct length and a correct diameter and is inserted in the dose setting mechanism, the cartridge assembly enables the dose setting mechanism to dispense a dose.
  • a dose setting mechanism comprises a dispensing mechanism comprising a plurality of protrusions, a lock nut comprising a plurality of corresponding protrusions, and a biasing member operably connected to the lock nut, wherein, when a cartridge assembly is not inserted in the dose setting mechanism, the biasing member prevents the plurality of protrusions from interacting with the plurality of corresponding protrusions, wherein, when a cartridge assembly of a correct length is inserted in the dose setting mechanism, the cartridge assembly compresses the biasing member and forces the plurality of protrusions to interact with the plurality of corresponding protrusions, and wherein the interaction prevents the dispensing mechanism from dispensing a dose.
  • Figure 1 a illustrates an exemplary pen type drug delivery device
  • Figure 1 b illustrates an exemplary drug cartridge
  • Figures 2a and 2b illustrate example drug cartridges of varying lengths
  • Figures 2c and 2d illustrate example drug cartridges having example connector tops
  • Figure 3 illustrates a cross-sectional perspective view of a distal portion of an exemplary dose setting mechanism and a proximal portion of an exemplary cartridge assembly
  • Figure 4a illustrates a cross-sectional perspective view of a distal portion of an exemplary dose setting mechanism and a proximal portion of an exemplary cartridge assembly having a length that is longer than that of a correct cartridge assembly
  • Figure 4b illustrates a cross-sectional perspective view of a distal portion of an exemplary dose setting mechanism and a proximal portion of an exemplary cartridge assembly having a correct length
  • Figure 4c illustrates a cross-sectional perspective view of a distal portion of an exemplary dose setting mechanism and a proximal portion of an exemplary cartridge assembly having a length that is shorter than that of a correct cartridge assembly
  • Figure 5a illustrates a cross-sectional perspective view of a distal portion of an exemplary dose setting mechanism and a proximal portion of an exemplary cartridge assembly having a correct diameter
  • Figure 5b illustrates a cross-sectional perspective view of a distal portion of an exemplary dose setting mechanism and a proximal portion of two exemplary cartridge assemblies having incorrect diameter;
  • Figure 6 illustrates a cross-sectional perspective view of a proximal portion of an exemplary cartridge assembly having an exemplary connector
  • Figure 7 illustrates a cross-sectional perspective view of a proximal portion of an exemplary cartridge assembly having another exemplary connector
  • Figure 8 illustrates a cross-sectional perspective view of a proximal portion of an exemplary cartridge assembly having yet another exemplary connector.
  • a drug delivery device 100 in the form of a pen type syringe that may be used with the disclosed system.
  • This drug delivery device 100 comprises a dose setting mechanism 102, a cartridge holder 104, and a removable cap 106.
  • a proximal end 105 of the cartridge holder 104 and a distal end 103 of the dose setting mechanism 102 are removably secured together.
  • the pen type syringe may comprise a re-usable or a disposable pen type syringe. Where the syringe comprises a re-usable device, the cartridge holder 104 and the dose setting mechanism 102 are removably coupled together. In a disposable device, they are permanently coupled together.
  • the dose setting mechanism 102 may comprise a spindle 109, such as a threaded spindle that rotates when a dose is injected.
  • a double ended needle assembly is attached to a distal end 108 of the cartridge holder 104.
  • the distal end 108 of the cartridge holder 104 comprises a thread 121 (or other suitable connecting mechanism such as a snap lock, snap fit, form fit, or bayonet lock mechanism) so that the needle assembly may be removably attached to the distal end 108 of the cartridge holder 104.
  • the removable cap 106 can be releasably retained over the cartridge holder 104.
  • the spindle 109 may comprise two helical grooves of different pitches, one of which is threaded to a nut, and the other threaded to a part of the dispensing mechanism.
  • the nut which is threaded to the spindle 109, has limited axial travel relative to the drug delivery device 100.
  • the nut may or may not rotate relative to the pen body.
  • the nut To dispense a dose of medicament from the cartridge, the nut must be prevented from rotating. A distal movement of the dispensing mechanism then causes the spindle 109 to advance and rotate. One groove rotates in the dispensing mechanism, and the other groove rotates inside the nut, the difference in thread pitches providing a mechanical advantage. To reset the spindle 109 before changing to a new cartridge, the nut must be free to rotate. A proximal force applied on the spindle 109 then causes the spindle 109 to retract in the proximal direction. One groove contacts the nut and the other groove contacts the dispensing mechanism, causing rotation of the spindle 109. Because the groove pitches are different, the nut rotates relative to the pen body.
  • the disclosed coding system may apply to other dispensing mechanisms as well.
  • one type of coding system could be used where the spindle 109 only has one groove and the nut is keyed to it by axial splines, or another where the spindle 109 is a rack driven by a pinion.
  • An inner cartridge cavity 1 1 1 defined by the cartridge holder 104 is dimensioned and configured to securely receive and retain a cartridge, such as glass cartridge.
  • Figure 1 b illustrates a perspective view of a cartridge 120 that may be used with the drug delivery device illustrated in Figure 1 a.
  • the cartridge 120 is manufactured of glass and includes a generally tubular barrel 122 extending from a distal end 130 to a proximal end 132.
  • the cartridge 120 includes a smaller diameter neck 126 and this neck projects distally from the shoulder 131 of the barrel 122.
  • this smaller diameter neck 126 is provided with a large diameter annular bead 124 and this bead 124 extends circumferentially thereabout at the extreme distal end of the neck 126 and defines an opening 127.
  • a pierceable seal or septum 133 is securely held across the opening 127 by a metallic sleeve or a ferrule.
  • the medicament 125 is pre-filled into the cartridge 120 and is retained within this cartridge 120, in part, by the pierceable seal 133, a ferrule, and the stopper 128.
  • the stopper 128 is in sliding fluid-tight engagement with the inner tubular wall of the barrel 122.
  • Axially directed forces acting upon the stopper 128 during dose injection or dose administration urges the medication 125 from the cartridge 120 through a double ended needle mounted onto the distal end 108 of the cartridge holder 104 and into the injection site.
  • Such axial directed forces may be provided by the spindle 109 working in unison with the dose setting member 102.
  • a portion of the cartridge holder 104 defining the cartridge holder cavity 1 1 1 is of substantially uniform diameter represented in Figure 1 by diameter Di 134.
  • This diameter Di 134 is preferably slightly greater than the diameter D 2 136 of the cartridge 120.
  • the interior of the cartridge holder 104 includes an inwardly-extending annular portion or stop that is dimensioned to prevent the cartridge 120 from moving within the cartridge holder 104. In this manner, when the cartridge 120 is loaded into the cavity 1 1 1 of the cartridge holder 104 and the cartridge holder 104 is then connected to the dose setting member 102, the cartridge assembly 120 will be securely held within the cartridge cavity 1 1 1 .
  • a number of doses of a medicament 125 may be dispensed from the cartridge 120. It will be understood that the cartridge 120 may contain a type of medicament 125 that must be administered often, such as one or more times a day. One such medicament 125 is insulin.
  • a movable piston 128 is retained in a first end or proximal end of the cartridge 120 and receives an axial force created by the spindle 109 of the dose setting mechanism 102.
  • the dose setting mechanism 102 comprises a dose setter 1 17 at the proximal end 107 of the dose setting mechanism 102.
  • the dose setter 1 17 may extend along the entire length of the dose setting mechanism 102.
  • the dose setter 1 17 may be rotated by a user so as to set a dose.
  • the user To administer a dose that may be set by rotating the dose setter 1 17, the user attaches the needle assembly comprising a double ended needle on the distal end 108 of the cartridge holder 104. In this manner, the needle assembly pierces the seal 133 of the cartridge 120 and is therefore in liquid communication with the medicament 125. The user pushes on the dose setter 1 17 to inject the set dose. The same dose setting and dose administration procedure is followed until the medicament 125 in the cartridge 120 is expended and then a new cartridge 120 must be loaded in the device. To exchange an empty cartridge 120, the user is called upon to remove the cartridge holder 104 from the dose setting mechanism 102.
  • a cartridge assembly (e.g., a cartridge holder holding a cartridge, or a cartridge holder comprising a unitary molded cartridge) may be coded to a delivery device such that when a correct coded assembly is attached to the device, dispensing of a dose is allowed.
  • a holder is attached to a drug delivery device that is not correctly coded for that particular holder, dispensing of a dose is prevented.
  • dispensing of a drug will not be possible.
  • a dose setting mechanism in accordance with an embodiment of the proposed concept may include a housing, a spindle, a spindle nut, a lock nut, and a biasing member.
  • the spindle nut includes a plurality of protrusions and is engaged with the spindle. Further, the spindle nut is fixed axially in the housing and is configured to rotate in the housing.
  • the lock nut includes a plurality of corresponding protrusions. Further, the lock nut is fixed rotationally and is configured to move axially in the housing.
  • the biasing member is operably connected to the lock nut. When a cartridge assembly is not inserted in the dose setting mechanism, the biasing member prevents the plurality of protrusions from interacting with the plurality of corresponding protrusions. Further, when a cartridge assembly of a correct length is inserted in the dose setting
  • the cartridge assembly compresses the biasing member and forces the plurality of protrusions to interact with the plurality of corresponding protrusions, and the interaction prevents the spindle nut from rotating.
  • the spindle nut is prevented from rotating. Preventing rotation of the spindle allows for the spindle to move axially, and this allows for dispensing of a dose.
  • this embodiment only allows a drug delivery device to dispense a drug for a correct cartridge assembly.
  • coding of various drugs or drug types may be accomplished by the length of drug cartridges or cartridge assemblies. Generally, if a user fits a correct cartridge assembly to a dose setting mechanism, the drug delivery device will be capable of dispensing a dose. However, if a user attempts to fit an incorrect cartridge assembly, then the drug delivery device will not be capable of dispensing a dose.
  • the length of a drug reservoir or reservoir assembly may be varied in numerous ways.
  • drug cartridges may be manufactured with various lengths.
  • Figures 2a and 2b depict drug cartridges manufactured with different lengths. Specifically, cartridge 200 has a length l_i 202, whereas cartridge 204 has a length L 2 206.
  • drug cartridges such as a standard sized drug cartridge, may be distinguished in length using a connector.
  • Figure 2c shows a cartridge 220 having a connector 222 having length L 3 224.
  • Figure 2d shows the same cartridge 220 having connector 226 having length L 4 228.
  • the resulting cartridge 220 has a first length L 5 230 that is greater than length L 6 232.
  • Other ways of varying a cartridge length are possible as well.
  • a dose setting mechanism may be configured to only operate correctly if a correct cartridge assembly (e.g., one of a correct length or a correct diameter) is inserted in the dose setting mechanism.
  • a dose setting mechanism is shown in Figure 3.
  • Figure 3 depicts a drug delivery device 300, which includes dose setting mechanism 302 and cartridge assembly 304.
  • the dose setting mechanism 302 includes an outer housing 305 that houses a spindle 306, a spindle nut 308, and a lock nut 309.
  • the spindle 306 has a first helical groove 310 extending along the outer surface 312 of the spindle 306.
  • the spindle nut 308 includes a second helical groove 314 extending along the inner surface 316 of the spindle nut 308.
  • Helical groove 310 is engaged with helical groove 314.
  • the spindle 306 may move axially with respect to the spindle nut 308 when the spindle nut 308 is fixed. Preventing the spindle nut 308 from rotating in the dose setting mechanism 302 therefore allows axial movement of the spindle 306.
  • the axial movement of the spindle 306 allows the spindle 306 to advance forward, and the plunger 318 may provide an axially directed force upon a stopper in a drug cartridge to urge medication from the cartridge through an attached double ended needle mounted on the distal end of cartridge assembly 304.
  • spindle nut 308 when the spindle nut 308 is free to rotate, the spindle 306 is prevented or substantially prevented from applying an axial force on the cartridge, which prevents dispensing of a dose.
  • Spindle nut 308 is fixed axially in the housing 305 and is configured to rotate in the housing 305.
  • the lock nut 309 is fixed rotationally and is configured to move axially in the housing 305.
  • Splines such as spline 340 (i) prevent the lock nut 309 from rotating while (ii) allowing the lock nut 309 to move axially.
  • spindle nut 308 includes a plurality of protrusions 320.
  • the protrusions 320 include a plurality of protrusions disposed along the lower surface of the spindle nut 308.
  • the protrusions 320 may be pentagon-shaped protrusions.
  • protrusions 320 of alternative shapes e.g., any polygon-shape
  • the lock nut 309 includes a plurality of corresponding protrusions 322.
  • corresponding coding feature includes a plurality of protrusions 322 (and thus a plurality of indentations).
  • the protrusions 322 are a similar pentagon-shape to the protrusions 320 of the spindle nut 308.
  • the protrusions 320 and 322 mesh together. It should be appreciated, given the pentagon-type shape, the protrusions 320, 322 may mesh together even when the protrusions and indentations are not originally perfectly aligned.
  • the dose setting mechanism 302 also includes a biasing member 324, such as spring 324, that is operably connected to lock nut 309.
  • biasing members 324 are also possible, such as a wave washer, or a flexible feature formed as part of the housing 305 or lock nut 309.
  • biasing member 324 is in communication with an inside surface 330 and a proximal end 332 of the lock nut 309.
  • the biasing member 324 prevents the plurality of protrusions 320 from interacting with (e.g., meshing with) the plurality of corresponding protrusions 322.
  • the cartridge assembly 304 compresses the spring 324 and forces the plurality of protrusions 320 to interact with the plurality of corresponding protrusions 322.
  • the lock nut 309 would be pushed axially in direction 334. This would force the lock nut 309 to move axially in direction 334 a length of 336, which causes the protrusions 320, 322 to mesh.
  • the protrusions 320, 322 may take the form of a pentagon-shape with a triangle-shaped top.
  • the dose setting mechanism 302 may prevent an incorrect cartridge from being used with the dose setting mechanism 302 in at least two ways. First, the dose setting mechanism 302 may prevent an incorrect cartridge that is too short from being used with the dose setting mechanism 302. Second, the dose setting mechanism 302 may prevent an incorrect cartridge that is too long from being attached or fastened to the dose setting mechanism 302.
  • FIG. 4a-c Another example of a dose setting mechanism that prevents dispensing of a dose when an incorrect cartridge assembly is attached is shown in Figures 4a-c.
  • This example is similar to the example described with respect to Figure 3; however, the lock nut and spindle nut are slightly modified.
  • the lock nut and spindle nut are configured so that when incorrect cartridges that are either too short or too long are inserted, the spindle nut is free to rotate.
  • dose setting mechanism 402 is connected to a cartridge assembly 404.
  • dose setting mechanism 402 is connected to a cartridge assembly 404a that is too long; in Figure 4b, dose setting mechanism 402 is connected to a cartridge assembly 404b that is of a correct size; and in Figure 4c, dose setting mechanism 402 is connected to a cartridge assembly 404c that is too short.
  • Dose setting mechanism 402 includes a spindle 406, a spindle nut 408, and a lock nut 409.
  • the spindle nut 408 includes radial protrusions 420 that extend radially from a distal end 430 of the spindle nut 408.
  • the protrusions 420 are polygon-shaped protrusions located on a distal end 430 of the spindle nut 408.
  • the lock nut 409 also includes a plurality of corresponding radial protrusions 422 that extend radially from a proximal end 432 of the lock nut 409.
  • the dose setting mechanism 402 also includes a biasing member 424, such as spring 424. As shown, biasing member 424 is in communication with an inside surface 440 and a proximal end 432 of the lock nut 409.
  • the cartridge assembly 404 forces the lock nut 409 in axial direction 450 to a point where the radial protrusions 420 and 422 line up in a same axial position (as shown in Figure 4b).
  • the radial protrusions 420 and 422 are in a different axial position (as shown in Figures 4a and 4c). Specifically, when a cartridge assembly 404 that is too long is inserted, the radial protrusions 422 pass through radial protrusion 420 as the lock nut 409 is forced in distal direction 450. Further, when a cartridge assembly 404 that is too short is inserted, the lock nut 409 does not travel far enough axially in order for radial protrusions 420 and 422 to engage.
  • FIG. 5a-b Another example dose setting mechanism that beneficially ensures that a user can only dispense the correct drug from a drug delivery device is shown in Figures 5a-b.
  • the diameter of the cartridge or reservoir may be used to ensure that a cartridge assembly is correct. Specifically, if a cartridge assembly has an incorrect diameter, that cartridge assembly may not operate with a given dose setting
  • dose setting mechanism 502 is connected to a cartridge assembly 504.
  • dose setting mechanism 502 is connected to a cartridge assembly 504a; and in Figure 5b, dose setting mechanism 502 is shown with a cartridge assembly 504b and a cartridge assembly 504c.
  • Figure 5b is depicted as holding two cartridge assemblies 504b, 504c for illustrative purposes only.
  • Dose setting mechanism 502 includes a spindle 506, a spindle nut 508, and a lock nut 509, and biasing member 524.
  • Figure 5a depicts a dose setting mechanism 502 having a cartridge assembly 504a that is the correct diameter inserted. If the assembly cartridge 504a also has the correct length, the cartridge assembly 504a can be fully fastened and used with the dose setting mechanism 502.
  • the diameter of lock nut 509 may be varied in numerous ways. In the example depicted in Figure 5a, a proximal portion 512 of the lock nut 509 is splined to a body of the dose setting mechanism 502, and a distal portion 514 is not splined to the body of the dose setting mechanism 502.
  • the splines 516a-b prevent the lock nut 509 from rotating while allowing the lock nut 509 to move axially. The diameter of this distal portion 514 could be adjusted as desired.
  • Figure 5b depicts a dose setting mechanism having (i) a cartridge assembly 504b having a diameter that is too large and (ii) a cartridge assembly 504c having a diameter that is too small. Since the diameters are different, even when the assemblies are inserted in the dose setting mechanism 502, the assemblies do not supply an axial force to the lock nut 509 to displace it and engage the protrusions of the lock nut 509 and spindle nut 508. In addition, in some circumstances, a plunger 520 may not even be capable of fitting in a cartridge assembly 504 having too small a diameter, such as cartridge assembly 504c. Alternatively, a cartridge assembly 504 having too large a diameter may not fit inside the housing of the dose setting mechanism.
  • the diameter of the cartridge or cartridge assembly may be determined by the diameter of the cartridge, a connector on the proximal end of the cartridge or cartridge holder, or the holder itself.
  • a connector or a holder could be configured to have thinner walls than a standard glass cartridge, and therefore numerous coding
  • FIG. 6 An example connector 600 top is shown in Figure 6. As can be seen, the wall 602 of the connector 600 is thinner than the wall of the cartridge 604. As explained above, the cartridge may be detachable or non-detachable from the holder. Alternatively, the cartridge may be molded with integrated fastening features, in which case no separate holder is necessary.
  • Coding of cartridge assemblies to given drug delivery devices may be achieved by both different assembly lengths and diameters.
  • each drug may be coded by a circular feature, each of which is smaller in one dimension and larger in another than all other features in the system.
  • a cartridge with a small diameter will fit into a device intended for a cartridge with a large diameter.
  • a cartridge has a small diameter and a long length, it will not fit into a device intended for a cartridge with a large diameter and a short length.
  • coding combinations and robustness can be achieved with connectors having multiple shoulders and/or grooves, such as the connectors shown in Figures 7 and 8.
  • Figure 7 depicts a connector 700 having a groove 702 disposed on a cartridge assembly 704.
  • FIG. 8 depicts a connector 800 that has multiple shoulders 802 and 804 and is disposed on cartridge assembly 806. These connectors 700, 800 with a groove 702 or shoulders 802, 804 may potentially operate with different dose setting mechanisms configured to different cartridge assembly heights and/or diameters.
  • the cartridge assembly may rotate after meshing of the protrusions of the lock nut and spindle nut. This rotation may also rotate the spindle nut, and hence lead to some travel of the spindle. Therefore, the thread on the fastening means for connecting the cartridge assembly to the dose setting
  • the presently proposed system may apply to other drugs.
  • the presently proposed system may apply to various devices, including the following examples: a. An injector pen with a cartridge (e.g. 3ml cylindrical glass cartridge) and a
  • An injector pen with a cartridge e.g. 3ml cylindrical glass cartridge
  • a cartridge e.g. 3ml cylindrical glass cartridge
  • the primary pack attaches directly to the pen, e.g. an injector pen
  • the proposed system for preventing dispensing of a dose results in a number of advantages.
  • the proposed cartridge holder and dose setting mechanism assist a user to distinguish between medicaments, thereby helping to ensure that a delivery device can only be used with a medicament for which the device is intended. Therefore, with the coded dose setting mechanism that requires a correct cartridge assembly in order to allow dispensing of a dose, the cartridge assembly is prevented from being confused with any other drug by loading a cartridge assembly with an incorrect or unwanted interface.
  • the system prevents a user from dispensing a drug when an incorrect cartridge assembly is attached to the dose setting mechanism.
  • the system also results in a low cost coding mechanism since the proposed holders and dose setting mechanism do not require a large number of parts and can be manufactured in a cost effective manner. Moreover, there are quite a large number of different coding configurations between the holder and the dose setting mechanism that may be used. Consequently, with proposed schemes of preventing dispense of a dose, a large number of medicaments can be distinguished from one another. In addition, an intuitive and similar fastening system may be used for all types of drugs / cartridge assemblies.
  • drug or “medicament”, as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound, wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, a antibody, an enzyme, an antibody, a hormone or an oligonucleotide, or a mixture of the above- mentioned pharmaceutically active compound, wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis, wherein in a further embodiment the pharmaceutically
  • the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-1 ) or an analogue or derivative thereof, or exedin-3 or exedin-4 or an analogue or derivative of exedin-3 or exedin-4.
  • GLP-1 glucagon-like peptide
  • Insulin analogues are for example Gly(A21 ), Arg(B31 ), Arg(B32) human insulin;
  • Lys(B3) Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
  • Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl- LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N- palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; ⁇ 29- ⁇ -( ⁇ - carboxyheptadecanoyl)-des(B30) human insulin and B29-N-( -carboxy
  • Exendin-4 for example means Exendin-4(1 -39), a peptide of the sequence H His-Gly-
  • Exendin-4 derivatives are for example selected from the following list of compounds: H-(Lys)4-des Pro36, des Pro37 Exendin-4(1 -39)-NH2,
  • Exendin-4(1 -39) wherein the group -Lys6-NH2 may be bound to the C-terminus of the Exendin-4 derivative; or an Exendin-4 derivative of the sequence
  • Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin,
  • a polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned
  • polysaccharides and/or a pharmaceutically acceptable salt thereof.
  • An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.
  • Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
  • Acid addition salts are e.g. HCI or HBr salts.
  • Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion
  • R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10- heteroaryl group.
  • R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10- heteroaryl group.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un mécanisme d'établissement de dose (302) qui empêche la distribution d'un médicament lorsqu'un ensemble de cartouche (304) incorrect est fixé au mécanisme d'établissement de dose (302). Le mécanisme d'établissement de dose (302) comprend un logement (305), un axe (306), un écrou d'axe (308) comprenant une pluralité de parties saillantes (320), un écrou de blocage (309) comprenant une pluralité de parties saillantes correspondantes (322), et un organe de sollicitation (324) relié de manière fonctionnelle à l'écrou de blocage (309). L'écrou d'axe (308) est en prise avec l'axe (306), et l'écrou d'axe (308) est fixé en sens axial dans le logement (305) et est conçu pour tourner dans le logement (305). L'écrou de blocage (309) est fixé en rotation et est conçu pour se mouvoir en sens axial. L'organe de sollicitation (324) empêche la pluralité de parties saillantes (320) d'interagir avec la pluralité de parties saillantes correspondantes (322). Lorsqu'un ensemble de cartouche (304) d'une longueur correcte est inséré dans le mécanisme d'établissement de dose (302), l'ensemble de cartouche (304) comprime l'organe de sollicitation (324) et force la pluralité de parties saillantes (320) à interagir avec la pluralité de parties saillantes correspondantes (322).
PCT/EP2011/069583 2010-11-08 2011-11-08 Mécanisme d'établissement de dose destiné à un dispositif d'administration de médicament, système d'administration de médicaments et dispositif d'administration de médicament Ceased WO2012062718A1 (fr)

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US41101110P 2010-11-08 2010-11-08
US61/411,011 2010-11-08
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EP10194731 2010-12-13

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WO2016001292A1 (fr) * 2014-07-01 2016-01-07 Sanofi Dispositif d'administration de médicament pourvu d'un corps fileté et d'un piston, et son procédé de fabrication
JP2016521187A (ja) * 2013-05-16 2016-07-21 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 薬物送達デバイスの組立体および薬物送達デバイス

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US20020111587A1 (en) * 2001-02-15 2002-08-15 Edgar Hommann Injection device for injecting fluid
WO2003017915A1 (fr) * 2001-08-27 2003-03-06 Novo Nordisk A/S Cartouche et systeme medical de distribution accueillant une telle cartouche
WO2005018721A1 (fr) * 2003-08-12 2005-03-03 Eli Lilly And Company Appareil de distribution de medicaments a triple filetage presentant un avantage mecanique
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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016521187A (ja) * 2013-05-16 2016-07-21 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 薬物送達デバイスの組立体および薬物送達デバイス
US10149946B2 (en) 2013-05-16 2018-12-11 Sanofi-Aventis Deutschland Gmbh Assembly for a drug delivery device and drug delivery device
WO2016001292A1 (fr) * 2014-07-01 2016-01-07 Sanofi Dispositif d'administration de médicament pourvu d'un corps fileté et d'un piston, et son procédé de fabrication
CN106659853A (zh) * 2014-07-01 2017-05-10 赛诺菲 具有带螺纹的壳体和活塞杆的药物输送装置及其制造方法
US10426893B2 (en) 2014-07-01 2019-10-01 Sanofi Drug delivery device with threaded housing and piston, and method for manufacturing the same

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