WO2011113896A1 - Dispositif d'administration de médicament - Google Patents

Dispositif d'administration de médicament Download PDF

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Publication number
WO2011113896A1
WO2011113896A1 PCT/EP2011/054041 EP2011054041W WO2011113896A1 WO 2011113896 A1 WO2011113896 A1 WO 2011113896A1 EP 2011054041 W EP2011054041 W EP 2011054041W WO 2011113896 A1 WO2011113896 A1 WO 2011113896A1
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WO
WIPO (PCT)
Prior art keywords
reservoir
chamber
dose
piston rod
medicament
Prior art date
Application number
PCT/EP2011/054041
Other languages
English (en)
Inventor
Robert Deberadine
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 WO2011113896A1 publication Critical patent/WO2011113896A1/fr

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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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/204—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically connected to external reservoirs for multiple refilling
    • 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
    • A61M2005/3123—Details having air entrapping or venting means, e.g. purging channels in pistons
    • 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
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • 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
    • A61M2005/3128—Incorporating one-way valves, e.g. pressure-relief or non-return valves
    • 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
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston
    • 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
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/3157—Means providing feedback signals when administration is completed
    • 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
    • A61M5/31578—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
    • A61M5/3158—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod performed by axially moving actuator operated by user, e.g. an injection button

Definitions

  • the present patent application is generally directed to an injection device for delivery of repeated small doses of medicaments from a reservoir of medicament. More particularly, the present patent application is generally directed to drug delivery devices, such as pen type drug delivery devices. Such devices provide for self administration of medicinal product from a multi-dose cartridge and permit a user to set the delivery dose.
  • drug delivery devices such as pen type drug delivery devices.
  • Such devices provide for self administration of medicinal product from a multi-dose cartridge and permit a user to set the delivery dose.
  • the present application may find application in both disposable and reusable type drug delivery devices. However, aspects of the invention may be equally applicable in other scenarios as well.
  • Pen type drug delivery devices have application where regular injection by persons without formal medical training occurs. This is increasingly common among patients having diabetes where self-treatment enables such patients to conduct effective management of their disease.
  • Diabetes has been shown to cause certain problems. For example, people with diabetes can get high blood pressure, kidney disease, nerve damage, heart disease, and even in certain circumstances blindness. The damage caused by these problems may occur in patients whose blood sugar has been out of control for years. Keeping blood sugar under control, by way of effective insulin administration, is one method that can help prevent this damage from occurring. In addition, people with diabetes can go into "diabetic coma" if their blood sugar is too high. They can also develop blood sugar that is too low (i.e, hypoglycemia) if they do not get enough food, or they exercise too much without adjusting insulin or food. Both diabetic coma and hypoglycemia can be very serious, and even fatal, if not treated quickly. Closely watching blood sugar, being aware of the early signs and symptoms of blood sugar that is too high or too low, and treating those conditions early can prevent these problems from becoming too serious.
  • Pen type drug delivery devices have been designed and developed to help patients suffering from diabetes so as to prevent such problems from occurring.
  • Diabetics have to inject themselves repeatedly with insulin solution and the volume of insulin to be injected may vary from patient to patient and even from injection to injection. For at least this reason, certain diabetics may require drug delivery devices that allow the patient to inject successive measured dosages of the same or perhaps different preset volumes of insulin solution accurately and with minimum injection force. This presents a further design challenge since, in the case of certain diabetics, users may be physically infirm with limited hand and/or finger strength.
  • a drug delivery device comprises a housing containing a dose delivery chamber and a medicament reservoir, wherein a dose dial element is operably connected to a first piston rod positioned in the chamber, and wherein a clutch is operably connected to the dose dial element and to a second piston rod positioned in the reservoir.
  • a fluid channel is connecting the chamber with the reservoir, and an outlet is located in the distal end of the chamber. Further, an equalizing vent connects the chamber with the reservoir.
  • the device comprises a check valve in fluid communication with the outlet. This can prevent unintended leakage or dripping of medicament.
  • the device comprises a needle hub in fluid communication with the outlet. This accomplishes easy use of the device as an injection device.
  • the device comprises a check valve in fluid communication with the fluid channel. Unintended backflow of medicament from the dose delivery chamber to the medicament reservoir can be prevented in that way and dose accuracy can be improved further.
  • the clutch is configured to engage the second piston rod to prevent axial movement during dose delivery.
  • the clutch is configured to disengage from the second piston rod and allow axial movement in the distal direction during dose setting.
  • a combination of both aforementioned embodiments results in an easy to use device comprising low friction for both, dose setting and dose delivery, since the amount of moving parts can be reduced with such a combined functionality of the clutch.
  • the dose dial sleeve is configured to engage the first piston rod move the rod in an axial direction during dose setting.
  • the dose dial element is configured to disengage from the first piston rod to allow the rod to move distally in an axial direction during dose delivery.
  • the reservoir is replaceable.
  • a device with a replaceable reservoir can be used multiple times and reduces manufacturing efforts and costs.
  • the reservoir is larger in volume than the chamber. Therefore, multiple doses can be delivered with the device.
  • the dose dial element is a dose dial sleeve.
  • a dose dial sleeve proved to be easy to use.
  • the fluid channel connecting the chamber with the reservoir is positioned at a distal end portion of the chamber. This increases the amount of expellable medicament from the reservoir and reduces the amount of medicament that cannot be used.
  • the device comprises an equalizing vent connecting the chamber with the reservoir at a proximal end portion of the chamber. This prevents pressure differences between dosing chamber and reservoir and helps to keep the actuation forces at the same level throughout the use of the device.
  • the medicament chamber comprises a medicament.
  • ..medicament 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,
  • ACS acute coronary syndrome
  • 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.
  • 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-myhstoyl 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-( -car
  • 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:
  • 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
  • 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 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.
  • a drug delivery device comprises a drug delivery device housing having contained therein a dose delivery chamber and a medicament reservoir, where the reservoir is larger in volume than the chamber.
  • a dose dial sleeve is operably connected to a first piston rod positioned in the chamber and a clutch is operably connected to the dose dial sleeve and to a second piston rod positioned in the reservoir.
  • a fluid channel connecting the chamber with the reservoir at a distal end of the chamber allows fluid from the reservoir to enter and fill the chamber during dose setting.
  • An equalizing vent connecting the proximal end of chamber with the proximal end of the reservoir ensures an accurate dose is set using the dose dial sleeve.
  • the reservoir can be refilled with medicament or replaced with a full reservoir when emptied.
  • the reservoir may comprise two or more reservoirs each holding different medicaments to allow a mixed dose of medicaments to be injected simultaneously or serially.
  • Figure 1 illustrates a schematic representation of one possible embodiment of the drug delivery device of my invention at a starting or zero dose position.
  • Figure 2 illustrates the device of Figure 1 in a second position with a dose set;
  • Figure 3 illustrates the device of Figure 1 in a third position during dose delivery.
  • Corresponding reference characters indicate corresponding parts throughout the several views.
  • the drawings represent embodiments of the present invention, the drawings are not necessarily to scale, and certain features may be exaggerated or omitted in some of the drawings in order to better illustrate and explain the present invention.
  • a drug delivery device 1 in accordance with one possible embodiment of my invention and showing a plurality of operating positions: for zero dose setting, a set dose, and dose administration or injection.
  • the drug delivery device 1 comprises a housing 14 having a dose delivery chamber 2 and a medicament reservoir 3.
  • the reservoir is larger in volume than the chamber, preferably at least twice as large, more preferably the reservoir should be large enough to hold at least one week of daily doses of medicament, such as insulin or another therapeutic.
  • the shape of the housing in Figure 1 is a schematic or abstract representation, any convenient shape will work.
  • the housing is shaped in an ergonomic design, such as a pen-type design similar to existing injection devices.
  • My device can be reusable or disposable. As a disposable it is prefilled such that after the quantity of medicament originally contained in the reservoir is exhausted by multiple operations of the device, the device is discarded rather than being reset and reloaded with a replacement reservoir of medicament. Because such a prefilled disposable device has a relatively short working life, the structural components are preferably molded from one or more polymeric materials such as plastic when possible for cost effectiveness. When the device is designed for reuse then more robust and/or more durable materials of construction may be used The housing 14 has a distal end containing an attachment or hub (not shown) used to removably mount a needle 12 that is in fluid communication with a set dose of medicament during dose delivery. Any type of needle hub can be used including those that have standard bayonet or screw thread connections.
  • a one-way valve or check valve 1 1 that prevents fluid flow (such as air) in the proximal direction through needle 12 and into chamber 2 during dose setting and prevents medicament flow (leaking out) in the distal direction during dose setting.
  • fluid flow such as air
  • medicament flow leaking out
  • the pressure created by movement of piston 6 in the distal direction causes the valve 1 1 to open allowing the set dose of medicament to be forced out through needle 12.
  • the device can also have a removable cap (not shown) that can cover an attached needle and/or needle hub.
  • a removable cap (not shown) that can cover an attached needle and/or needle hub.
  • the outer dimensions of the removable or replaceable cap are similar or identical to the outer dimensions of the main housing 14 so as to provide an impression of a unitary whole when the replaceable cap is in position.
  • Chamber 2 and reservoir 3 each contain a piston, 6 and 7, that are in sealing
  • piston rods 4 and 5 Attached to pistons 6 and 7 are piston rods 4 and 5, respectively. These rods protrude through the proximal end portions of chamber 2 and reservoir 3. In one arrangement, the rods are of generally circular in cross section, however, other arrangements may also be used.
  • a pressure foot (not shown) can be used at the distal end of the rod to engage the piston proximal end. Also at the proximal end of the housing is at least one equalizing vent 15 that maintains a pressure balance between the chamber and reservoir during dose setting and thus allows piston 7 to freely move distally during dose setting.
  • Dose dial sleeve 8 is operably engaged with piston rod 4 such that rotation of the dial sleeve or rotation of the rod 4 by rotating button 9 causes the rod and piston 6 to move proximally.
  • the rod is caused to rotate during dose setting and to move piston 6 in the proximal direction while the dose dial sleeve is fixed axially relative to the housing.
  • rod 4 is in threaded engagement with dose dial sleeve 8 during dose setting and in a slidable engagement during dose delivery. This can be accomplished using flexible fingers that engage the threads on rod 4. During dose delivery the flexible finger would operate in a ratchet type fashion as the rod is pushed in the distal direction.
  • clutch 10 Operably connected to dose dial sleeve 8 is clutch 10 that releasably engages piston rod 5.
  • Clutch 10 prevents axial movement of rod 5 during dose delivery and allows free travel of rod 5 during dose setting.
  • a signal either mechanical or electrical
  • clutch 10 that causes it to firmly hold rod 5 from axial movement.
  • piston 7 remains in fluid contact with the medicament in the reservoir to maintain constant volume and to ensure that all of the set dose of medicament in chamber 2 is delivered through needle 12.
  • Device 1 is designed to set medicament doses by increments that are adequately small in resolution, such as ten or five microliters.
  • the dose dial sleeve 8 also may provide an audible click or the like upon each increment during dose setting.
  • the progress of dose setting may be visually apparent by using a dose display (not shown) that shows the user a one or two-digit number with the incrementing resolution.
  • a dose display (not shown) that shows the user a one or two-digit number with the incrementing resolution.
  • a scale arrangement can be used where the maximum settable dose by the drug delivery device is "80" Units and the minimum settable dose is "0" Units. Between the maximum and minimum reference numerals, other doses are noted in increments of 2: (e.g., 2, 4, 6, 8 etc.).
  • Chamber 2 and reservoir 3 can be made of a medically and mechanically suitable material, such as glass or more preferably a polymer or blend of polymer materials, such as a plastic, to facilitate its manufacture and accuracy in sizing in production.
  • a fluid channel 13 located at the distal end of the housing provides for fluid
  • This fluid channel may be equipped with a check valve 16 to ensure no set amount of
  • medicament from chamber 2 returns to reservoir 3 upon dose delivery.
  • Positioning the channel 13 such that it opens as low as possible into each the chamber minimizes wastage of the contained medication at the end of the life of the reservoir.
  • chamber 2 and reservoir 3 are tubular in shape and are parallel to each other as well as arranged laterally of each other. Along their internal piston engaging lengths, each has a constant inner diameter, with the reservoir a greater diameter than the chamber. These constant inner diameters allow the associated pistons 6 and 7 to maintain a sealing engagement with the internal walls.
  • Other cross-sectional shapes and arrangements of the tubular portions may be used in alternate embodiments. Because the pistons 6 and 7 may translate without rotation during use, such as in the shown embodiment, the cross-sectional piston shapes and shapes of the chamber/reservoir may be different from the standard circular shape. These other shapes may be used to create fluid containers that, for example, maximize the use of available space to create optimally sized and shaped devices.
  • Piston 6 closes the proximal end of injection chamber 2 and is axially slidably and sealably engaged with the interior wall of the chamber.
  • the distal, outlet end of injection chamber can be sealed by a septum (not shown).
  • the distal end of chamber 2 can have a stepped-down neck portion shaped more similar to the distal end of a standard cartridge to better accommodate standard pen needles.
  • piston 6 and rod 4 are drivingly shifted by the dose dial sleeve a distance which is approximately 1 .7 times as large and in the opposite direction as the reservoir piston 7 and rod 5. Varying the volume of the chamber and/or reservoir will impact this ratio of relative movement of the two piston rods and associated pistons. Larger or smaller volumes may be used within the scope of the invention. Likewise, other ratios may be used, for example, ratios of six, four, or two can be used depending on the expected injection force a group of targeted users will be able to employ.
  • piston rod 4 is illustrated and described as providing a direct injection action, it is within the scope of my invention to include an actuation mechanism that provides mechanical advantage.
  • Such an actuator can serve as a trigger that initiates a spring assisted, or possibly fully automatic, or electronic motorized advancement of the injection piston rod 4 to expel the set dose from the injection chamber 2.
  • the structure of injection device 1 will further be understood in view of the following brief explanation of its general operation. With device arranged as shown in FIG. 1 , when a user needs to select and inject a dose of the medicine, the user rotates dial sleeve 8 in a first direction to cause piston rod 4 and piston 6 to move axially in the proximal direction until a desired dose it set as shown in FIG. 2.
  • piston rod 4 As piston 6 is shifted upward (proximally) within chamber 2, piston rod 5 and associated piston 7 are free to move axially in a distal direction because clutch 10 is not engaged with rod 5. Piston 7 will move downwards (distally) as the medicament in reservoir 3 flows through channel 13 into chamber 2 as piston 6 moves proximally. At the zero dose setting shown in FIG. 2, the reservoir contains a medicament volume equal to F.
  • Valve 1 1 prevents air, or other fluid, from being sucked into chamber 2 through needle 12, when piston 6 begins to move proximally. This valve also prevents the medicament from prematurely exiting as it fills into the chamber.
  • a check valve 16 is employed in fluid channel 13, then it must be in the open position to allow medicament flow into chamber 2. If the proximal end of the housing is well sealed then a one-way valve at the top of the device (not shown) can be used to allow ambient air to enter the system to prevent a vacuum from building as the medicament is dosed. Once the desired dose is set (FIG.
  • FIG. 3 shows the relative positions of the pistons and rods as the dose is being delivered, where rod 4 has been moved a distance ⁇ i.
  • Reservoir 3 remains constant in volume of F-Fi and the remaining dose to be delivered is Fi-Fo, where Fo is the amount of the set dose already injected or expelled from the device.
  • An end of injection click may be provided, such as via the use of a detent or the like, to provide an audible indication to a user of when the injection is complete
  • My device can also be configured to allow the user to dial back a set dose down to a lower dosage or down to the zero position if it is not desired to use the medication at that time. Should a user inadvertently dial beyond a desired dosage, the device can allow the dosage to be dialed down without dispense of medicinal product from the cartridge using the dose dial sleeve 8 and rotating it in the opposite direction used to set the dose. This causes the system to act in reverse. The device can continue to be used to deliver medicine using a new needle for each injection until not enough medicine remains in the reservoir to deliver a desired dose, which can be indicated to a user in a variety of ways known to the art. When insufficient medicine remains, the device is to be disposed of or refilling the reservoir with medicament.

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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

La présente invention concerne un dispositif d'administration de médicament qui comprend une chambre d'administration de dose (2) en communication fluidique avec un réservoir de médicament plus grand (3) lors du réglage de dose, qui permet une précision de dose élevée et une faible force d'injection. Ledit dispositif comprend également des ensembles tige de piston (4, 5) dans la chambre et le réservoir, un orifice de ventilation d'égalisation de pression (15), un ou plusieurs clapets de non-retour (13) et un embrayage (10).
PCT/EP2011/054041 2010-03-19 2011-03-17 Dispositif d'administration de médicament WO2011113896A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US31549910P 2010-03-19 2010-03-19
US61/315,499 2010-03-19
EP10158581.8 2010-03-31
EP10158581 2010-03-31

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WO2011113896A1 true WO2011113896A1 (fr) 2011-09-22

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104507517A (zh) * 2012-05-31 2015-04-08 卡贝欧洲有限公司 药物输送装置
CN107362402A (zh) * 2017-08-07 2017-11-21 广东省人民医院(广东省医学科学院) 单筒自动造影注射器
EP3868420A1 (fr) * 2020-02-19 2021-08-25 Ivoclar Vivadent AG Récipient de dosage permettant de doser des composants de matière visqueuse

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WO2001089613A1 (fr) * 2000-05-22 2001-11-29 Pharmacia Ab Dispositif medical
WO2002049697A1 (fr) * 2000-12-21 2002-06-27 Arnold Neracher Dispositif d'injection a moyen de generation de pression reutilisable
WO2004108193A1 (fr) * 2003-05-30 2004-12-16 Eli Lilly And Company Appareil de distribution de medicament a chambres multiples

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001089613A1 (fr) * 2000-05-22 2001-11-29 Pharmacia Ab Dispositif medical
WO2002049697A1 (fr) * 2000-12-21 2002-06-27 Arnold Neracher Dispositif d'injection a moyen de generation de pression reutilisable
WO2004108193A1 (fr) * 2003-05-30 2004-12-16 Eli Lilly And Company Appareil de distribution de medicament a chambres multiples
US20070060894A1 (en) 2003-05-30 2007-03-15 He Dai Multiple chamber medication dispensing apparatus

Non-Patent Citations (1)

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Title
"Remington's Pharmaceutical Sciences", 1985, MARK PUBLISHING COMPANY

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104507517A (zh) * 2012-05-31 2015-04-08 卡贝欧洲有限公司 药物输送装置
CN107362402A (zh) * 2017-08-07 2017-11-21 广东省人民医院(广东省医学科学院) 单筒自动造影注射器
EP3868420A1 (fr) * 2020-02-19 2021-08-25 Ivoclar Vivadent AG Récipient de dosage permettant de doser des composants de matière visqueuse

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