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WO2011131777A1 - Ensemble cartouche codée, mécanisme de réglage de dose, système d'administration de médicament et réservoir de médicament codé - Google Patents

Ensemble cartouche codée, mécanisme de réglage de dose, système d'administration de médicament et réservoir de médicament codé Download PDF

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Publication number
WO2011131777A1
WO2011131777A1 PCT/EP2011/056474 EP2011056474W WO2011131777A1 WO 2011131777 A1 WO2011131777 A1 WO 2011131777A1 EP 2011056474 W EP2011056474 W EP 2011056474W WO 2011131777 A1 WO2011131777 A1 WO 2011131777A1
Authority
WO
WIPO (PCT)
Prior art keywords
cartridge assembly
cartridge
dose setting
setting mechanism
protrusions
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/EP2011/056474
Other languages
English (en)
Inventor
Richard James Vincent Avery
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 WO2011131777A1 publication Critical patent/WO2011131777A1/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
    • A61M5/24—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
    • A61M15/00—Inhalators
    • 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
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
    • 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
    • A61M2005/2485—Ampoule holder connected to rest of syringe
    • A61M2005/2488—Ampoule holder connected to rest of syringe via rotation, e.g. threads or bayonet
    • 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
    • A61M5/31536—Blocking means to immobilize a selected dose, e.g. to administer equal doses
    • A61M2005/3154—Blocking means to immobilize a selected dose, e.g. to administer equal doses limiting maximum permissible 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6018—General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
    • 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
    • A61M2205/6036—General characteristics of the apparatus with identification means characterised by physical shape, e.g. array of activating switches
    • 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
    • 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
    • A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member

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 coded cartridge assembly for use with a drug delivery device so as to prevent unwanted reservoir cross use.
  • a cartridge assembly may comprise a glass cartridge along with a cartridge holder.
  • the cartridge assembly comprises a coded molded cartridge.
  • 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 a 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.
  • Another concern that may arise with such disposable cartridges is that these cartridges are manufactured in essentially standard sizes and manufactured to comply with certain recognized local and international standards. Consequently, such cartridges are typically supplied in standard sized cartridges (e.g., 3 ml cartridges). Therefore, there may be a variety of cartridges supplied by a number of different suppliers and
  • a first cartridge containing a first medicament from a first supplier may fit a medical delivery device provided by a second supplier.
  • a user might be able to load and then dispense an incorrect medicament (such as a rapid or basal type of insulin) into a drug delivery device without being aware that the medical delivery device was perhaps neither designed nor intended to be used with such a cartridge.
  • an incorrect medicament such as a rapid or basal type of insulin
  • distal end refers to a part of the cartridge assembly or of a body or housing which is intended to be arranged at a portion of a drug delivery device from which a drug is dispensed.
  • proximal end refers to a part of the cartridge assembly or of the body or housing which is remote from the distal end.
  • distal direction refers to a movement in the same direction as a movement from the proximal end towards the distal end, not specifying a point of departure nor an end point, so that the movement may go beyond the distal end.
  • proximal direction refers to a movement in the direction opposite to the distal direction.
  • a cartridge assembly for use with a dose setting mechanism which may be part of a drug delivery device, comprises a coding feature disposed along the cartridge assembly. This coding feature is configured to pass through a corresponding coding feature provided by the dose setting mechanism or drug delivery device.
  • the cartridge assembly may comprise a cartridge along with a cartridge holder.
  • the cartridge assembly may comprise a molded cartridge.
  • the cartridge may also be provided with a groove configured to receive a pin provided by the dose setting mechanism or drug delivery device.
  • a dose setting mechanism for use with a cartridge assembly includes a coding feature provided on a distal end of the dose setting mechanism.
  • the dose setting mechanism also includes a pin provided on the distal end.
  • the dose setting mechanism is configured to attach to a cartridge assembly and the coding feature passes through a corresponding coding feature on the cartridge assembly when a user attaches the cartridge assembly to the dose setting mechanism.
  • the cartridge assembly may comprise a molded cartridge.
  • Another arrangement comprises a drug delivery system including both a cartridge assembly and a dose setting mechanism.
  • the cartridge assembly comprises (i) a groove and (ii) a first coding feature disposed on a proximal end of the cartridge assembly.
  • the dose setting mechanism comprises (i) a second coding feature provided on a distal end of the dose setting mechanism and (ii) a pin provided on the distal end.
  • This groove is configured to receive the pin as a user attaches the cartridge assembly to the dose setting mechanism, and the first coding feature passes through the second coding feature when a user attaches the cartridge assembly to the dose setting mechanism.
  • the cartridge assembly may comprise a molded cartridge.
  • Another arrangement includes a coded drug reservoir configured to be attached to a drug delivery device.
  • the coded drug reservoir comprises a groove configured to receive a pin provided by the drug delivery device and a coding feature disposed on a proximal end of the coded drug reservoir.
  • the coding feature is configured to pass through a corresponding coding feature provided by the drug delivery device.
  • An embodiment of the cartridge assembly is configured to attach to a drug delivery device and comprises a coding feature disposed along a portion of the cartridge assembly, wherein the coding feature is configured to pass through a corresponding coding feature provided by the drug delivery device.
  • a further embodiment of the cartridge assembly comprises a cartridge and a cartridge holder.
  • a further embodiment of the cartridge assembly comprises a molded cartridge.
  • a further embodiment of the cartridge assembly further comprises a groove configured to receive a pin provided by the drug delivery device.
  • the coding feature comprises a plurality of protrusions, and the protrusions pass through the corresponding coding feature when a user attaches the cartridge assembly to the drug delivery device.
  • the drug delivery device comprises a dose setting mechanism, and the corresponding coding features are provided on the dose setting mechanism.
  • the plurality of protrusions are asymmetric around a circumference of the cartridge assembly.
  • the cartridge assembly comprises a pin-retaining portion located at an end of a groove, and the pin-retaining portion engages a pin when the pin is inserted into the pin-retaining portion.
  • the groove comprises a protrusion- retaining portion and a pin-retaining portion
  • the protrusion-retaining portion is configured to hold at least one protrusion
  • the pin-retaining portion locks the pin in when the pin is inserted into the pin-retaining portion.
  • the groove defines a path for the pin, and the path comprises an axial path portion, a helical path portion, and a rotational path portion.
  • the groove further defines an alignment portion that aids in an alignment of the cartridge assembly with the drug delivery device.
  • the protrusions pass through the corresponding coding feature during axial movement.
  • the protrusions pass through the corresponding coding feature during circumferential movement.
  • the coding feature is a coding feature for a given drug.
  • the holder further comprises a protrusion provided in a proximal portion of the groove, and the protrusion passes through an indentation in the pin of the dose setting mechanism.
  • at least one of the protrusions has a larger diameter than the other protrusions, and the at least one protrusion having the larger diameter acts as an alignment feature when a user attaches the cartridge assembly and the drug delivery device.
  • a dose setting mechanism for use with a cartridge assembly wherein the cartridge assembly is a coded cartridge assembly, comprises a coding feature provided on a distal end of the dose setting mechanism; and a pin provided on the distal end, wherein the dose setting mechanism is configured to attach to a cartridge assembly, and wherein the coding feature passes through a corresponding coding feature on the cartridge assembly when a user attaches the cartridge assembly to the dose setting mechanism.
  • the coding feature comprises a plurality of protrusions.
  • the protrusions are arranged in a circumferential direction, and the protrusions define an axial gate. In a further embodiment of the dose setting mechanism the protrusions are arranged in an axial direction, and the protrusions define a circumferential gate.
  • At least some of the protrusions are offset from another protrusion in a circumferential direction.
  • the coding feature comprises a plurality of protrusions and at least one indentation.
  • the pin is configured to engage a groove provided by the cartridge assembly.
  • the pin comprises a first pin portion and a second pin portion, an indentation is located between the first and second pin portions, and the indentation is configured to receive a protrusion of a cartridge assembly when a user attached a cartridge assembly to the dose setting mechanism.
  • a drug delivery system comprises a cartridge assembly comprising (i) a groove and (ii) a first coding feature disposed on a proximal end of the cartridge assembly; and a dose setting mechanism comprising (i) a second coding feature provided on a distal end of the dose setting mechanism and (ii) a pin provided on the distal end.
  • the groove is configured to receive the pin as a user attaches the cartridge assembly to the dose setting mechanism, and the first coding feature passes through the second coding feature when a user attaches the cartridge assembly to the dose setting mechanism.
  • a coded drug reservoir configured to be attached to a drug delivery device, comprises a groove configured to receive a pin provided by the drug delivery device; and a coding feature disposed on a proximal end of the coded drug reservoir, wherein the coding feature is configured to pass through a corresponding coding feature provided by the drug delivery device.
  • the coded drug reservoir may be at least one of a cartridge, an ampoule, a vial, and a pouch.
  • drug or “medicament”, as used herein, preferably means a pharmaceutical formulation containing at least one pharmaceutically active compound
  • 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, an enzyme, an antibody, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound,
  • 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,
  • 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,
  • diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary
  • the pharmaceutically active compound comprises at least one peptide for the treatment and/or prophylaxis of diabetes mellitus or
  • 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.
  • 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- Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe- lle-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
  • 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,
  • H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1 -39)-Lys6-NH2,
  • 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 glucosanninoglycane, 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.
  • solvates are for example hydrates.
  • Figure 1 A illustrates an exemplary pen type drug delivery device
  • Figure 1 B illustrates an exemplary drug cartridge
  • Figure 2A is a perspective view of an exemplary cartridge assembly and an exemplary dose setting mechanism
  • Figure 2B is a cross-sectional view of the dose setting mechanism of Figure 2A;
  • Figure 3 is a cross-sectional view of an exemplary cartridge assembly
  • Figures 4A and 4B are cross-sectional views of an exemplary dose setting mechanism
  • Figures 5A-5C are perspective views of an exemplary cartridge assembly and an exemplary dose setting mechanism
  • Figures 6A and 6B are perspective views of an exemplary cartridge assembly and an exemplary dose setting mechanism
  • Figure 6C is a perspective view of an alternative arrangement of the exemplary cartridge assembly and an exemplary dose setting mechanism provided with a shorter cartridge assembly;
  • Figures 7A and 7B are perspective views of an exemplary cartridge assembly and an exemplary dose setting mechanism;
  • Figure 7C is a cross-sectional view of the cartridge assembly of Figures 7A and 7B;
  • Figures 8A and 8B are perspective views of an exemplary cartridge assembly and an exemplary dose setting mechanism
  • Figure 8C is a cross-sectional view of the cartridge assembly of Figures 8A and 8B
  • Figures 9, 10A, and 10B are perspective views of an exemplary cartridge assembly and an exemplary dose setting mechanism
  • Figure 1 1 is a perspective view of an exemplary cartridge assembly and an exemplary dose setting mechanism
  • Figures 12 and 13 are perspective views of an exemplary cartridge assembly and an exemplary dose setting mechanism
  • Figure 14 is a perspective view of an exemplary cartridge assembly and an exemplary dose setting mechanism
  • Figure 15 is a perspective view of an exemplary drug reservoir that may be coded in accordance with the proposed concept.
  • a drug delivery device 100 in the form of a pen type syringe.
  • This drug delivery device 100 comprises a dose setting mechanism 102, a cartridge assembly 104, and a removable cap 106.
  • a proximal end 105 of the cartridge assembly 104 and a distal end 103 of the dose setting mechanism 102 are removably secured together.
  • the cartridge assembly 104 comprises a cartridge 1 19 and a cartridge holder 101 .
  • the pen type syringe may comprise a reusable or a disposable pen type syringe. Where the syringe comprises a re-usable device, the cartridge holder 101 and the dose setting mechanism 102 are removably coupled together. In a disposable device, they are permanently coupled together.
  • the dose setting mechanism 102 comprises a piston rod 109, such as a threaded piston rod 109 that rotates when a dose is injected.
  • a double ended needle assembly may be attached to a distal end 108 of the cartridge holder 101 .
  • the distal end 108 of the assembly 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 101 .
  • the removable cap 106 can be releasably retained over the cartridge assembly 104.
  • FIG. 1 B illustrates a perspective view of the cartridge 1 19 that may be used with the drug delivery device 100 illustrated in Figure 1A.
  • the cartridge 1 19 is manufactured of glass and includes a generally tubular barrel 122 extending from a distal end 130 to a proximal end 132.
  • the cartridge 1 19 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 123, and this annular bead 123 extends circumferentially thereabout at the extreme distal end of the neck 126 and defines an opening 127.
  • a pierceable seal or septum 133 may be securely held across the opening 127 by a metallic sleeve or a ferrule.
  • the medicament 125 is pre-filled into the cartridge 1 19 and may be retained within this cartridge 1 19, in part, by the pierceable seal or septum 133, a ferrule, and the stopper 128.
  • the stopper 128 is preferably 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 urge the medication 125 from the cartridge 1 19 though a double ended needle mounted onto the distal end 130 of the cartridge holder 101 and into the injection site. Such axial forces may be provided by the piston rod 109 working in unison with the dose setting mechanism 102.
  • a portion of the cartridge holder 101 defining the cartridge cavity 1 1 1 may be of substantially uniform diameter represented in Figure 1 A by diameter Di 134.
  • This diameter Di 134 is preferably slightly greater than the diameter D 2 136 ( Figure 1 B) of the cartridge 1 19.
  • the interior of the cartridge holder 101 may include an inwardly- extending annular portion or stop that is dimensioned to prevent the cartridge 1 19 from moving within the cartridge assembly 104. In this manner, when the cartridge 1 19 is loaded into the cartridge cavity 1 1 1 of the cartridge assembly 104 and the cartridge assembly 104 is then connected to the dose setting member 102, the cartridge 1 19 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 1 19.
  • the cartridge 1 19 may contain a type of medicament 125 that must be administered often, such as one or more times a day.
  • One such medicament is insulin.
  • the dose setting mechanism 102 comprises a dose setter 1 17 at the proximal end of the dose setting mechanism 102.
  • the dose setter 1 17 is rotated to set a dose.
  • the user attaches the needle assembly, which may comprise a double ended needle, on the distal end 108 of the cartridge assembly 104.
  • the needle assembly pierces the seal or septum 133 of the cartridge 1 19 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 1 19 is expended and then a new cartridge 1 19 may be loaded in the device.
  • the user is called upon to remove the cartridge assembly 104 from the dose setting mechanism 102.
  • the cartridge assembly 104 comprises a molded cartridge 1 19.
  • a molded cartridge 1 19 may comprise a plastic such as a COC, COP, PBT, LDPE, or HDPE type plastic.
  • a cartridge assembly such as cartridge assembly 104 may be coded to a drug delivery device 100, so that given cartridge assemblies 104 may only be connected with intended drug delivery devices 100 and vice versa.
  • Figure 2A illustrates a first arrangement of a coded cartridge assembly 200.
  • Such cartridge assembly 200 may comprise a molded cartridge 1 19 or alternatively may comprise a cartridge 1 19 (such as illustrated in Figure 1 B) along with a cartridge holder 101 .
  • This coded cartridge assembly 200 may be connected to a drug delivery device, such as drug delivery device 100.
  • the cartridge assembly 200 may be attached to a drug delivery device 100 that has a similarly coded portion.
  • This similarly coded portion may be, for example, a dose setting mechanism 202.
  • the coded cartridge assembly 200 is intended for use with a dose setting mechanism 202 similar to the dose setting mechanism 102 of Figure 1 A but a preferred dose setting mechanism 202 for use with the coded cartridge assembly 200 would have a slightly modified inner cavity.
  • Figure 2A depicts a perspective view of a distal end 204 of a dose setting mechanism 202 that could be connected to coded cartridge assembly 200.
  • the proximal end (not shown) of the dose setting mechanism 202 would include the same or similar features as the proximal end of the dose setting mechanism 102 of Figure 1 A.
  • the proximal end of coded cartridge assembly 200 includes a coding feature 206.
  • This coding feature 206 may take various forms, and examples of these forms will be described in detail below.
  • the distal end 204 of the dose setting mechanism 202 includes a corresponding coding feature 208, and this corresponding coding feature 208 is preferably located on the inner edge of dose setting mechanism 202, as shown in Figure 2A.
  • the corresponding coding feature 208 is complementary to coding feature 206.
  • the coding feature 206 interacts with (e.g., passes through) the complementary coding feature 208.
  • the two parts cannot be assembled together.
  • the coding features 206 of a cartridge assembly 200 only match the coding features 208 of a dose setting mechanism 202 when the cartridge assembly 200 is intended to be used by that particular type of dose setting mechanism 202.
  • the user is alerted at an early stage of assembly that the cartridge assembly is not intended for that particular drug delivery device.
  • the coding features 206 of the cartridge assembly 200 pass through the coding features 208 of the dose setting mechanism 202 while the cartridge assembly 200 is traveling in axial direction 210 toward the device.
  • the coding features 206 include a plurality of protrusions 212, 214, 216, 218, 220. Additional protrusions are possible, such as protrusions on the backside of the cartridge assembly 200, which is not visible in Figure 2A.
  • the cartridge assembly 200 includes a groove 222. Groove 222 may be a groove that would force an object traversing the groove to first move in an axial direction, followed by a helical direction, and then a rotational direction.
  • the coding features 208 of the dose setting mechanism 202 may include a plurality of protrusions 226, 228, 230, 232. Further, the dose setting mechanism 202 may include a pin 234.
  • Figure 2B depicts a top cross-sectional view of the dose setting mechanism 202. As seen from this cross-sectional view, the dose setting mechanism 202 may include protrusions in addition to protrusion 226, 228, 230, and 232 seen in Figure 2A.
  • dose setting mechanism 202 may include additional protrusions 236, 238, 240, 242, and 244. These protrusions 236, 238, 240, 242, and 244 may be symmetric with protrusions 226, 228, 230, and 232.
  • the coded cartridge assembly 200 will only fit into the coded dose setting mechanism 202 if the coding feature 206 (i.e., the protrusions 212, 214, 216, 218, 220) is able to pass through the coding feature 208 (i.e., the protrusions 226, 228, 230, 232, [236, 238, 240, 242, 244]).
  • the coding feature 206 i.e., the protrusions 212, 214, 216, 218, 220
  • the coding feature 208 i.e., the protrusions 226, 228, 230, 232, [236, 238, 240, 242, 244].
  • This pattern of protrusions on either the cartridge assembly 200 or the dose setting member 202 may be referred to as a "gate,” a “coded gate,” or a “coding gate.”
  • protrusions 226, 228, 230, 232 may act as a gate that either allow or prevent a cartridge assembly 200 from connecting to the dose setting member 202.
  • protrusions 212, 214, 216, 218, and 220 may act as a "gate” that allows or prevents the dose setting mechanism 202 from connecting to the cartridge assembly 200. This gate may prevent a cartridge assembly 200 from moving past the gate if the protrusions cannot pass through.
  • a given cartridge assembly 200 may be configured to accept only a given pin 234, and a second cartridge assembly 200 may be configured to accept only a second pin 234 different from the given pin 234.
  • coding features 206, 208 are depicted as protrusions, it should be understood that the coding features 206, 208 may include features other than protrusions.
  • the coding features 206, 208 may comprise indentations.
  • the dose setting mechanism 202 may comprise indentations rather than protrusions 226, 228, 230, and 232.
  • the cartridge assembly 200 is fastened to the dose setting mechanism 202 by the pin 234 following the groove 222.
  • the cartridge assembly 200 is provided with two grooves 222, 224.
  • the start of the first groove 222 is illustrated and the end of the second groove 224 is also illustrated.
  • the pin 234 follows one of these grooves first in an axial direction, then in a helical direction, and finally with rotational travel, for example.
  • An end of the groove 222, 224 that is provided on the cartridge assembly 200 may be configured to retain pin 234. Therefore, the first groove 222 and the pin 234 act together as a fastening means to fasten the cartridge assembly 200 and the dose setting member 202 together.
  • the illustrated fastening means in Figure 2A is a pin 234 in a groove 222, 224 with axial, then helical, and then rotational travel
  • the coding may be used with any fastening means and any combination of travel .
  • the travel of the pin 234 in the groove 222, 224 could be purely axial travel.
  • An example requiring purely axial travel would be a pin 234 that snaps into the end of a groove 222, 224 after the pin 234 is pushed down by a user.
  • Other examples and other types of travel are possible as well, such as axial then rotational, or helical only, or helical then rotational.
  • Figure 2A depicts one example of possible coding features 206, 208 for both the cartridge assembly 200 and drug delivery device 202.
  • Different coding for different cartridge assemblies 200 and/or dose setting mechanisms 202 may be achieved by varying the coding features 206, 208 in different ways.
  • many different holders and/or devices may be coded in different ways, which results in the ability to distinguish a large number of holders and/or drug delivery devices.
  • the coding may be varied by varying the number of coding features.
  • the coding may be varied by changing the number of "gates" on the cartridge assembly 200 or the dose setting mechanism 202. For instance, there may be two gates at different axial positions or different orientations.
  • the coding may be varied by changing the size of the coding features.
  • the axial extent, circumferential extent, radial extent, cross-section shape (in any plane, e.g., longitudinal or traverse) of the protrusions may be varied.
  • the size of each protrusion may be different from the others.
  • a coding system may consist of a number of coding features, each of which is smaller in one area and larger in another than all of the other coding features of the system.
  • the positions of the coding features 206, 208 on either the cartridge assembly 200 or the dose setting mechanism 202 may also be varied.
  • the axial, circumferential, and/or radial positions of the coding features may be varied. Varying the position especially relative to a standard feature may be particularly useful.
  • the axial length from the proximal end or fastening means may be varied.
  • the number of coding combinations may be increased if the cartridge assembly 200 fits into the dose setting mechanism 202 in only one orientation.
  • the cartridge assembly only fitting in one orientation may be achieved in various ways. For example, this might be achieved if one or more of the coding features (or an additional feature) has an asymmetric position or size around the axis. Another example of how this may be achieved is if one (or more) of the features is unique, such as an indentation that is smaller than the others.
  • FIG. 3 illustrates a cross section of coded cartridge assembly 300 where the coding would allow a user to insert a cartridge assembly 300 in more than one position.
  • Cartridge assembly 300 includes a first set of protrusions 302, 304 and a first pin 306.
  • the coding may depend on the size or position in more than one dimension.
  • a coding system may consist of a number of coding protrusions, each of which is smaller in one dimension and larger in another dimension than all of the other protrusions in the system.
  • the cartridge assembly for one drug might have a protrusion with a small circumferential extent and a large radial extent, while another drug might have a protrusion with a large circumferential extent and a small radial extent.
  • Neither cartridge assembly will fit to the device intended for the wrong drug.
  • Figures 4A and 4B depict a protrusion with a small circumferential extent and a large radial extent that does not fit into an indentation intended for a protrusion with a large circumferential extent and a small radial extent.
  • the number of coding combinations may be increased by offsetting each feature in an axial direction relative to the other features.
  • the coding may be designed to block all cartridge assemblies other than those for a single drug.
  • the coding may be designed to block cartridge assemblies of a given type, but not all types of cartridge assemblies.
  • the coding may block only cartridge assemblies intended for housing the most dangerous drugs. For instance, a short-acting drug could be fitted into a device intended for long-acting drugs, but not vice versa. As another example, a low concentration drug could be fitted into a device intended for high concentration drugs, but not vice versa.
  • the protrusions of the gate of the dose setting mechanism may follow the groove of the cartridge assembly.
  • the protrusions need not act as part of the fastening mechanism of the cartridge assembly and dose setting mechanism.
  • Such an arrangement may beneficially reduce the radial space needed for coding the cartridge assembly.
  • FIGs 5A-5C An example arrangement is illustrated in Figures 5A-5C.
  • Figure 5A depicts a coded cartridge assembly 500 having coding feature 504 and a coded dose setting mechanism 502 having a corresponding coding feature 506. Accordingly, the cartridge assembly 500 may be connected to dose setting mechanism 502. However, a cartridge assembly without such coding features may not be able to be connected to dose setting mechanism, because the coding features will block it.
  • the cartridge assembly 500 may have protrusions 508, 510 and a first groove 512 and a second groove 513.
  • the start of the first groove 512 and the end of the second groove 513 are illustrated.
  • the dose setting mechanism 502 may have protrusions 514, 516 and pin 518.
  • the coding features operate in a fashion similar to the coding features described with reference to Figure 2A.
  • the second groove 513 has a slightly modified configuration. Near an end 520 of the second groove 513, the second groove 513 has a pin-retaining portion 522 as well as a protrusion-retaining portion 524.
  • the pin-retaining portion 522 allows the second groove 513 to retain a pin, such as pin 518, while the protrusion-retaining portion 524 allows protrusions to follow the second groove 513 and allows the second groove 513 to retain protrusions, such as protrusions 514, 516.
  • Figure 5B depicts the cartridge holder and dose setter just as the pin 518 is fully inserted into the first groove 512.
  • the protrusions 508, 510 pass through the gate formed by protrusions 514, 516. This allows the pin 518 to be fully inserted into the first groove 512.
  • Figure 5C depicts the cartridge holder and the dose setter as the pin 518 reaches the pin-retaining part 522 and the protrusions 514, 516 reach the protrusion-retaining portion 524.
  • the cartridge assembly 500 has a diameter D 5 530.
  • This diameter D 5 530 includes the coding features (i.e., the protrusions).
  • This diameter D 5 530 may be compared to the diameter D 2 260 of the cartridge assembly 200.
  • the cartridge assembly 200 including the protrusions 212, 214, 216, 218, 220 has a diameter D 3 250. This is greater than the diameter D 2 260 of the cartridge assembly 200 without the protrusions 212, 214, 216, 218, 220. Therefore, allowing the protrusions of the dose setting mechanism to follow the groove may beneficially allow for reducing the diameter of the cartridge assembly.
  • a fastening means often incorporates a locking feature (e.g., a detent) to prevent accidental disassembly.
  • a locking feature e.g., a detent
  • one or more of the coding protrusions may form part of this detent, which further reduces the total space needed for the coding and fastening means.
  • the cartridge assembly and/or the dose setting member may include an alignment feature or alignment features that help a user align the coding features in order to insert the cartridge assembly into a portion of the drug delivery device, such as the dose setting mechanism.
  • chamfers or ramped/helical surfaces may help the user to align the coding features on the cartridge assembly with the coding features on the device.
  • the cartridge assembly and the device may be aligned by the fastening pin.
  • the fastening pin may enter the groove before the coding features pass through each other.
  • cartridge assembly 600 and dose setting mechanism 602 are aligned by the fastening pin 604 of the dose setting mechanism 602.
  • the pin 604 travels an alignment portion 608 defined by axial distance "X" before the protrusions 610, 612, 614 of the cartridge assembly 600 pass through the gate of the dose setting mechanism 602 formed by protrusions 616, 618, 620.
  • the overlap between the pin 604 and the groove 606 at the beginning of the groove 606 has been increased.
  • the protrusions 610, 612, 614 of the cartridge assembly 600 may pass through the gate formed by protrusions 616, 618, 620 of the dose setting member 602, as depicted in Figure 6B.
  • the gate formed by protrusions 616, 618, 620 may prevent further axial travel until the fastening pin 604 is fully aligned, as shown in Figure 6C.
  • the gate prevents further axial travel until the coding is fully aligned (e.g., a protrusion that is wider than any of the indentations that it might contact).
  • the cartridge assembly may be aligned if one of the gate features in unique.
  • one of the gate features may have a larger outer diameter than that of the main inside diameter on the opposite part of the dose setting mechanism. This part may force the user to align that part before the user passes the members through the respective gates.
  • Such an alignment feature is described with reference to Figures 7A-7C.
  • Figure 7A depicts a coded cartridge assembly 700 and a corresponding coded dose setting mechanism 702.
  • This cartridge assembly 700 and dose setting mechanism 702 have a unique protrusion and gate feature respectively that aid alignment.
  • cartridge assembly 700 includes protrusions 704, 706, 708 and dose setting mechanism 702 includes indentations 710, 712, 714.
  • Protrusion 704 and indentation 710 are unique in that protrusion 704 has a greater diameter than the other protrusions 706, 708 and indentation 710 is deeper than the other indentations 712, 714.
  • Figure 7C depicts a cross-sectional view of the cartridge assembly 700, and this Figure 7C clearly shows that protrusion 704 has a greater diameter.
  • Figure 7B when the cartridge assembly 700 is moved down in axial direction 716, the protrusion 704 passes through the gate created by indentation 710. After this action, the pin 718 enters groove 720 and pin 718 may thereafter be retained in the pin-retaining portion of the groove.
  • the protrusions of a coding feature of the dose setting mechanism may follow the groove of the cartridge assembly, but in this case the protrusions are not part of the fastening mechanism.
  • Such an arrangement may also include an alignment feature that is similar to the alignment feature shown described with reference to Figures 7A-7C.
  • An arrangement is depicted in Figures 8A-8C. Specifically, Figures 8A-8B depict perspective views of a cartridge assembly and dose setter and Figure 8C depicts a cross section of a cartridge assembly. In this arrangement, cartridge assembly 800 may have a protrusion 804 that has a larger radial extent than another protrusion 806.
  • Dose setting mechanism 802 may have an indentation 808 that is configured to accept the larger protrusion 804. This indentation 808 helps a user to align the cartridge assembly 800 and the dose setting mechanism 802. Once the protrusion 804 is inserted into indentation 808, the pin 810 and protrusions 812, 814 may enter the groove 816, as shown in Figure 8B.
  • the embodiments described above have what may be referred to herein as an "axial gate.”
  • the coding features of the cartridge assembly pass through the coding features of the dose setting mechanism during axial travel. This may occur when, for example, the user first inserts the cartridge assembly into the dose setting mechanism for attachment.
  • the coding features may form what may be referred to as a "circumferential gate,” rather than an axial gate. That is, the coding features may pass through one another during circumferential travel, rather than axial travel. This may occur, for example, as a user is twisting the cartridge assembly into the dose setting mechanism. Examples of circumferential gates are depicted in Figures 9-1 1 .
  • Cartridge assembly 900 includes protrusions 904, 906, 908, and these protrusions 904, 906, 908, unlike in the prior embodiments discussed above, are arranged in an axial direction.
  • Cartridge assembly 900 also includes groove 910, which is the same as or similar to the grooves described above.
  • Dose setting mechanism 902 in this arrangement includes protrusions 912, 914, 916, 918 which form a circumferential gate.
  • the dose setting mechanism 902 also includes fastening pin 920, which is the same as or similar to pins described above.
  • the pin 920 enters groove 910.
  • the coding features of the cartridge assembly 900 do not pass through the coding features of the dose setting mechanism 902 until the end of the pin's 920 travel through the groove 910, which is finally reached when a user twists the cartridge assembly 900 and forces the pin 920 to move along the helical groove 910.
  • the protrusions 904, 906, 908 interact with protrusions 912, 914, 916, 918. Since the cartridge assembly 900 is intended for dose setting mechanism 902, the respective protrusions will pass through one another. However, the circumferential gate prevents a cartridge assembly that was not intended for the dose setting mechanism from being attached.
  • the coding features may be arranged in a circumferential gate but each feature may be offset from others in a circumferential direction. Offsetting the coding features in a circumferential direction relative to others may beneficially increase the number of coding options, as well as facilitate molding.
  • Figure 1 1 depicts cartridge assembly 1 100 and dose setting mechanism 1 102, which is a modified version of dose setting mechanism 902.
  • This dose setting mechanism 1 102 includes protrusions 1 104, 1 106, 1 108, 1 1 10 that form a circumferential gate. These protrusions 1 104, 1 106, 1 108, 1 10 are arranged in an axial direction and are offset circumferentially from one another.
  • the coding features may comprise a discontinuous thread.
  • a discontinuous thread may beneficially serve as an additional way to code a device, resulting in even more coding options to distinguish one holder from another. Examples of such arrangements are shown in Figures 12-14.
  • Figures 12-13 depict a coded cartridge assembly 1200 and a corresponding coded dose setting mechanism 1202.
  • the cartridge assembly 1200 and dose setting mechanism 1202 are similar in many respects to the cartridge assemblies and dose setting mechanisms described above, and thus will not be described comparatively detailed. It should be explicitly noted, however, that many possibilities and permutations described above with respect to the other cartridge assemblies and dose setting mechanisms may equally apply to coded cartridge assembly 1200 and a corresponding coded dose setting mechanism 1202.
  • dose setting mechanism 1202 includes an additional protrusion 1204 located at the beginning of groove 1214. Further, dose setting mechanism 1202 includes a pin 1206 that is discontinuous. This
  • pin 1206 contains a first part 1208 and a second part 1210, separated by an indentation 1212. This may provide an additional way to code, as the pin 1206 must pass over protrusion 1204 in order to enter groove 1214. In this arrangement, the gate may be crossed before the pin 1206 enters the groove 1214.
  • FIG. 12-13 shows its application to a helical screw thread.
  • Figure 14 depicts a cartridge assembly 1400 and a dose setting mechanism 1402. Before the helical thread 1404 may interact with helical thread 1406, the coding feature 1408 must pass over the coding feature 1410.
  • the coding features discussed above may be detected by electro-mechanical means, such as microswitches and/or optical or magnetic switches.
  • a programmable device such as a programmable pen, could then respond to the drug type in a variety of ways. For example, for a particular drug type, the device could limit the maximum dose or set a minimum dose. Other types of responses to particular drug types are possible as well.
  • Standard parts may be used on devices for dispensing all drugs, and the coding applied by inserting coding discs or strips in the device, holder, cartridge, and/or adaptor.
  • One advantage of such an arrangement is that it reduces the number of variations of the larger parts, and also the number of parts that are more sensitive to tolerances can be standard, which therefore reduces cost. These may be inserted at various stages.
  • Cartridge assemblies may be standard parts, and the coding may be provided by an adaptor attached to a portion of a cartridge, such as the sidewall of the cartridge.
  • this codes the cartridge directly to the device, avoiding the need to code the cartridge to the holder, and then the holder to the device.
  • the proposed coding schemes may apply to insulin or other drugs and to various devices, including the following examples: a. an injector pen with a cartridge (e.g. 3ml cylindrical glass cartridge) and a separate cartridge assembly;
  • a cartridge e.g. 3ml cylindrical glass cartridge
  • a separate cartridge assembly e.g. 3ml cylindrical glass cartridge
  • an injector pen with a cartridge (e.g. 3ml cylindrical glass cartridge) non-removably retained in a cartridge assembly, so that the assembly will be disposed of with the primary pack;
  • a cartridge e.g. 3ml cylindrical glass cartridge
  • an injector pen where the primary pack attaches directly to the pen e.g. an injector pen where the primary pack attaches directly to the pen, e.g. an injector pen where the primary pack attaches directly to the pen, e.g. an injector pen where the primary pack attaches directly to the pen, e.g. an injector pen where the primary pack attaches directly to the pen, e.g. an injector pen where the primary pack attaches directly to the pen, e.g. an injector pen where the primary pack attaches directly to the pen, e.g. an injector pen where the primary pack attaches directly to the pen, e.g. an injector pen where the primary pack attaches directly to the pen, e.g. an injector pen where the primary pack attaches directly to the pen, e.g. an injector pen where the primary pack attaches directly to the pen, e.g. an injector pen where the primary pack attaches directly to the pen, e.g. an injector
  • Figure 15 illustrates a drug reservoir 1500 comprising a vessel 1504 that contains a medicament 1506.
  • a stopper 1508 may be provided along a distal end of the vessel 1504 and attached to the vessel 1504 so as to prevent the medicament 1506 from exiting the vessel 1504.
  • the coding described above may be provided on the output port 1510 of the vessel.
  • the proposed coding system may apply to any location on any components of a drug delivery system.
  • the coding system may apply in the following examples: a. the interface between a cartridge (or a feature attached to the cartridge) and its holder;
  • the proposed coding system results in a number of advantages.
  • the proposed coded cartridge assembly 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 coding system applied to a cartridge assembly (or the cartridge), the cartridge assembly (or cartridge) is prevented from being confused with any other drug by loading a cartridge assembly (or cartridge) with an incorrect or unwanted interface.
  • the coded system prevents a user from fully attaching the cartridge assembly onto an incorrect dose setting mechanism.
  • the coded 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 alignment interface schemes, a large number of medicaments can be distinguished from one another. In addition, with the coding schemes, if a user attempts to load an incorrect cartridge assembly into a dose setting mechanism designed for a different cartridge assembly, the user will be alerted at an early stage of the assembly process.

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Abstract

L'invention concerne un ensemble cartouche s'utilisant avec un dispositif d'administration de médicament. L'ensemble cartouche (200), conçu pour être fixé à un dispositif d'administration de médicament, comprend un élément de codage (212, 214, 216, 218, 220) placée sur une partie de l'ensemble cartouche. L'élément de codage est conçu pour passer à travers un élément de codage correspondant (226, 228, 230, 232), fourni par le dispositif d'administration de médicament. L'ensemble cartouche peut comprendre une cartouche et un élément de retenue de cartouche. Dans une autre forme de réalisation, l'ensemble cartouche peut comprendre une cartouche moulée.
PCT/EP2011/056474 2010-04-23 2011-04-21 Ensemble cartouche codée, mécanisme de réglage de dose, système d'administration de médicament et réservoir de médicament codé Ceased WO2011131777A1 (fr)

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US32727810P 2010-04-23 2010-04-23
US61/327,278 2010-04-23
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EP3597240A1 (fr) * 2018-07-18 2020-01-22 Sanofi Unité de cartouche pour dispositif d'administration de médicaments
KR20210032459A (ko) * 2018-07-18 2021-03-24 사노피 약물 전달 장치용 시스템
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US11904141B2 (en) 2010-08-13 2024-02-20 Sanofi-Aventis Deutschland Gmbh Coding system for a drug delivery device and drug delivery device
US20130218078A1 (en) * 2010-08-13 2013-08-22 Sanofi-Aventis Deutschland Gmbh Coding System for a Drug Delivery Device and Drug Delivery Device
US9974907B2 (en) * 2010-08-13 2018-05-22 Sanofi-Aventis Deutschland Gmbh Coding system for a drug delivery device and drug delivery device
JP2015513982A (ja) * 2012-04-13 2015-05-18 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング コード付け手段付きネブライザ
US10220163B2 (en) 2012-04-13 2019-03-05 Boehringer Ingelheim International Gmbh Nebuliser with coding means
US10258736B2 (en) 2012-05-17 2019-04-16 Tandem Diabetes Care, Inc. Systems including vial adapter for fluid transfer
WO2013173157A1 (fr) * 2012-05-17 2013-11-21 Tandem Diabetes Care, Inc. Procédés et dispositifs pour le transfert de plusieurs fluides
US9180242B2 (en) 2012-05-17 2015-11-10 Tandem Diabetes Care, Inc. Methods and devices for multiple fluid transfer
US9750871B2 (en) 2012-05-17 2017-09-05 Tandem Diabetes Care, Inc. Pump device with multiple medicament reservoirs
US9962486B2 (en) 2013-03-14 2018-05-08 Tandem Diabetes Care, Inc. System and method for detecting occlusions in an infusion pump
CN105813673B (zh) * 2013-12-09 2019-12-10 赛诺菲-安万特德国有限公司 用于药物输送装置的操作构件和机构以及药物输送装置
CN105813673A (zh) * 2013-12-09 2016-07-27 赛诺菲-安万特德国有限公司 用于药物输送装置的操作构件和机构以及药物输送装置
JP2017501774A (ja) * 2013-12-09 2017-01-19 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操作部材および機構、ならびに薬物送達デバイス
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KR20210032459A (ko) * 2018-07-18 2021-03-24 사노피 약물 전달 장치용 시스템
JP2021531101A (ja) * 2018-07-18 2021-11-18 サノフイSanofi 薬物送達デバイス用のシステム
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JP7410118B2 (ja) 2018-07-18 2024-01-09 サノフイ 薬物送達デバイス用のシステム
WO2020016163A1 (fr) * 2018-07-18 2020-01-23 Sanofi Unité de cartouche pour dispositif d'administration de médicament
KR102753158B1 (ko) 2018-07-18 2025-01-14 사노피 약물 전달 장치용 시스템
EP3597240A1 (fr) * 2018-07-18 2020-01-22 Sanofi Unité de cartouche pour dispositif d'administration de médicaments
US12383677B2 (en) 2018-07-18 2025-08-12 Sanofi System for a drug delivery device
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WO2021255215A1 (fr) 2020-06-19 2021-12-23 Sanofi Système pour dispositif d'administration de médicaments et dispositif d'administration de médicaments
JP2023530007A (ja) * 2020-06-19 2023-07-12 サノフイ 薬物送達デバイスのためのシステムおよび薬物送達デバイス
RU2839348C1 (ru) * 2020-06-19 2025-04-30 Санофи Система для устройства доставки лекарственного средства и устройство доставки лекарственного средства

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