WO2012156253A1 - An assembly for a drug delivery device - Google Patents
An assembly for a drug delivery device Download PDFInfo
- Publication number
- WO2012156253A1 WO2012156253A1 PCT/EP2012/058569 EP2012058569W WO2012156253A1 WO 2012156253 A1 WO2012156253 A1 WO 2012156253A1 EP 2012058569 W EP2012058569 W EP 2012058569W WO 2012156253 A1 WO2012156253 A1 WO 2012156253A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- friction wheel
- housing
- piston rod
- nut
- bearing surface
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31545—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
- A61M5/31533—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
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16H—GEARING
- F16H13/00—Gearing for conveying rotary motion with constant gear ratio by friction between rotary members
- F16H13/02—Gearing for conveying rotary motion with constant gear ratio by friction between rotary members without members having orbital motion
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16H—GEARING
- F16H19/00—Gearings comprising essentially only toothed gears or friction members and not capable of conveying indefinitely-continuing rotary motion
- F16H19/02—Gearings comprising essentially only toothed gears or friction members and not capable of conveying indefinitely-continuing rotary motion for interconverting rotary or oscillating motion and reciprocating motion
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T74/00—Machine element or mechanism
- Y10T74/18—Mechanical movements
- Y10T74/18568—Reciprocating or oscillating to or from alternating rotary
Definitions
- the present application relates to drive mechanisms suitable for use in drug delivery devices, in particular pen-type injectors, wherein a number of settable or pre-set doses of medicinal product can be administered.
- the present application relates to injection devices that use a combination of friction wheels and linear bearing surfaces to set and deliver doses of medicament from a cartridge where an injection button elevates from an end of the device a distance proportional to the set dose and wherein the set dose is injected by pressing home the injection button.
- Mechanical advantage is supplied by the use of the friction wheels engaging the linear bearing surfaces.
- one or more gear wheels are used to engage stationary and moving racks or rods (i.e., a rack & pinion system) that move a piston rod axially during injection.
- the gear racks or rods move relative to each other, as a result of which the gear wheel placed between the racks experiences a correspondingly transmitted linear forward motion.
- the gear wheel or gear rod system is a form-locking connection that is susceptible to jamming.
- a device or an assembly for a device where there is established or provided a friction wheel or friction wheel assembly.
- the friction wheel or friction wheel assembly may be used to set and deliver doses of medicament.
- the friction wheel or friction wheel assembly can transform rotational movement to linear movement between a dose setting drum and a piston rod.
- the combined use of a friction wheel with a linear bearing surface eliminates the known rack and pinion assembly where one or more toothed gear wheel engages corresponding teeth on racks or other linear surfaces.
- the drug delivery device preferably an injection device, replaces the gear wheels and associated racks or rods of prior art devices and instead uses a friction wheel system or assembly to provide the linear motion needed to set a dose and to drive the piston rod in an axial distal direction during dose delivery.
- the force exerted by a user on pushing the dose button on the injection device may transmit power to one or more friction wheels that are engaged and drive one or more linear bearing surfaces, i.e., the "friction wheel system or assembly.”
- the piston rod may be directly or indirectly connected to one of these bearing surfaces and the movement of bearing surface may drive the piston rod.
- the piston rod itself may comprise the bearing surface as an integral component.
- a friction wheel assembly (elastomer) is pulled onto a round base body (metal or plastic).
- Some of the advantages of using a friction wheel assembly include that in case of a jam of the threaded piston rod, the frictional lock may be overcome starting at a defined force (sliding coupling) and a low noise level because there is no meshing of gear teeth with rack teeth. Furthermore no jamming occurs because there are no teeth and no potential damage to the mechanism.
- the friction wheel may be "insensitive to tolerances", i.e., in a gearing based device, the division of gears is subject to the corresponding tolerances. This may have a direct effect on the uniformity of the feed motion. A narrowing of the tolerances of the gears may lead to an increase in manufacturing costs. Due to availability of various types of elastomers, the hardness and the "sliding coupling" may be adjusted, i.e. the force for sliding through may be set, for example, on a country specific basis.
- distal end of the device or a component of the device shall mean the end, which is closest to the dispensing end of the device.
- proximal end of the device or a component of the device shall mean the end, which is furthest away from the dispensing end of the device.
- a drive mechanism for use in a drug delivery device comprising a housing having a proximal and a distal end, a drive member located within the said housing such that the said drive member is movable longitudinally. Furthermore, a piston rod adapted to operate through the housing and transfer a force in the longitudinal direction to the distal end of the drug delivery device may be provided.
- the drive mechanism may further comprise a rotating friction wheel releasably engaged with the said piston rod and engaged to the said drive member and engaged to the said housing. This drive mechanism is characterized in that when the drive member moves proximally with respect to the housing the friction wheel may move proximally with respect to the piston rod.
- the friction wheel When the drive member moves distally the friction wheel may engage a linear bearing surface as it rotates and distally displaces the piston rod towards the distal end of the device.
- the drive member In a preferred embodiment of the drive mechanism the drive member is non-rotatable with respect to the housing.
- the piston rod is non-rotatable with respect to the housing.
- the engagement between the friction wheel and the piston rod acts through an axle of the friction wheel and preferably through a carrier plate supporting the friction wheel.
- the friction wheel is designed for engagement with a first linear bearing surface located on the drive member and a second linear bearing surface located on the housing. Most preferably, the first bearing surface is axially slidable relative to the housing and the second bearing surface is fixed relative to the housing.
- the friction wheel is connected to a carrier plate having pawl arms.
- the engagement between the piston rod and the friction wheel may act through an axle.
- the injection device comprises a housing wherein a piston rod, threaded with a first pitch, is non rotatable, but longitudinally displaceable, having a nut engaging the thread of the piston rod, which nut can be screwed along the threaded piston rod away from a defined position in the housing to set a dose and can be pressed back to the defined position carrying the piston rod with it when the set dose is injected.
- a dose setting drum which can be screwed outward away from the housing in the proximal direction along a thread having a second pitch to lift an injection button with it from the proximal end of the housing.
- This injection device also includes a friction wheel assembly that provides a mechanical advantage between the axial movements of the dose setting drum and/or the injection button and the nut relative to the housing, where the ratio of mechanical advantage is equal to the ratio of the second pitch to the first pitch.
- the first pitch can be less than or equal to the second pitch.
- the injection device may comprise a housing wherein a piston rod, threaded with a first pitch, is non rotatable, but longitudinally displaceable with respect to the housing.
- the injection device may comprise a displaceable nut.
- the nut may move relative to the housing and may engage the thread of the piston rod
- the nut may be configured to be screwed along the threaded piston rod away from a defined position in the housing to set a dose and may be pressed back to the defined position carrying the piston rod with it when the set dose is injected.
- the nut may be capable of moving along the piston rod in proximal direction from a first position on the piston rod to a second position on the piston rod.
- the displacement of the nut along the piston rod in a proximal direction may define a quantity of medication to be injected by the injection device.
- the injection device may comprise a dose setting drum.
- the dose setting drum may comprise a threaded surface with a second pitch.
- the dose setting drum may comprise an injection button being disposed on an end thereof.
- the dose setting drum may be configured to engage the housing and may be rotatable within the housing, such that it may be screwed outward away from the housing in the proximal direction along the thread having the second pitch to lift the injection button with it from the proximal end of the housing.
- This injection device may also include a friction wheel assembly.
- the friction wheel assembly may be configured for coupling axial movement of the injection button with axial movement of the nut.
- the friction wheel assembly may provide a mechanical advantage between the axial movements of the dose setting drum and the injection button and the nut relative to the housing. The ratio of mechanical advantage may be equal to the ratio of the second pitch to the first pitch.
- the first pitch may be less than or equal to the second pitch.
- the mechanical advantage between the movements of the injection button and the dose setting drum and the nut may be obtained by the friction wheel assembly comprising at least one friction wheel carried by a connector which projects from the external surface of the nut, where the connector is longitudinally displaceable but non-rotatable relative to the nut, a first bearing surface integral with a first element of the friction wheel assembly, which element is rotational but not longitudinally displaceable relative to the housing, and a second element of the friction wheel assembly carrying a second bearing surface projecting from said friction wheel assembly
- the at least one friction wheel engages the first and the second linear bearing surfaces, respectively, and being dimensioned to provide a mechanical advantage by which a longitudinal movement of the second bearing surface is transformed to a
- the ratio of the second pitch to the first pitch may be 2:1.
- the piston rod may be provided with a stop.
- the stop may be configured to engage and halt the movement of the nut along the thread of the piston rod when the amount of medicament remaining in the container or cartridge equals the set dose.
- This stop provides a classical dose setting limiter that involves no additional members to prevent setting of a dose exceeding the amount of liquid left in the cartridge or ampoule containing a
- An injection device comprising:
- a housing having a proximal end and a distal end;
- a threaded piston rod having a first pitch, the piston rod being linearly displaceable in the housing but being rotatably fixed with respect to the housing;
- a displaceable nut that moves relative to the housing, the nut engaging the thread of the piston rod so that the nut can screw along the thread of the piston rod, thereby being capable of moving along the piston rod in proximal direction from a first position on the piston rod to a second position on the piston rod, the displacement of the nut along the piston rod in a proximal direction defining a quantity of medication to be injected by the injection device,
- a dose setting drum having an injection button disposed on an end thereof, the drum having a threaded surface with a second pitch, the dose setting drum engaging the housing and rotatable within the housing so that it may be screwed outward from the proximal end of the housing;
- a friction wheel assembly coupling axial movement of the injection button with axial movement of the nut, the friction wheel assembly providing a mechanical advantage having a ratio corresponding to the ratio of the second pitch to the first pitch.
- At least one friction wheel carried by a connector that projects from an external surface of the nut, the connector being longitudinally displaceable but non- rotatable with respect to the nut;
- a second friction wheel assembly carrying a second bearing surface projecting from the friction wheel assembly, the second bearing surface bearing surface being longitudinally displaceable but non-rotatable with respect to the first element and being coupled to the injection button to follow longitudinal movement of the button; and d. wherein the at least friction wheel engages the first and second bearing surfaces and is dimensioned to provide a mechanical advantage by which longitudinal movement of the second bearing surface is transformed into longitudinal movement of the connector with a ratio for the longitudinal movements of the second bearing surface and connector relative to the housing being equal in ratio to the second pitch to the first pitch.
- a drive mechanism for use in a drug delivery device comprising: a housing having a proximal and a distal end; a drive member located within the said housing such that the drive member is movable longitudinally and is non-rotatable with respect to the housing; a piston rod that is non-rotatable with respect to the housing and is adapted to operate through the housing and to transfer a force in the longitudinal direction to the distal end of the drug delivery device; a rotating friction wheel releasably engaged with the piston rod and engaged to a linear bearing surface on the drive member and engaged to linear bearing surface on the housing, characterized in that, a) when the drive member moves proximally with respect to the housing the friction wheel moves proximally with respect to the piston rod; and b) when the drive member moves distally the friction wheel moves distally displacing the piston rod towards the distal end of the device.
- the term "medicament” or medication, as used herein, preferably 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, an enzyme, an antibody or a fragment thereof, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis, wherein in a
- 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-(u)-car
- 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(0)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Lys6-des Pro36 [Met(0)14, Trp(02)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, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
- Gonadotropine Follitropin, Lutropin, Choriongonadotropin, Menotropin
- Somatropine Somatropin
- Desmopressin Terlipressin
- Gonadorelin Triptorelin
- Leuprorelin Buserelin
- Nafarelin Goserelin.
- 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.
- Antibodies are globular plasma proteins (-150 kDa) that are also known as
- immunoglobulins which share a basic structure. As they have sugar chains added to amino acid residues, they are glycoproteins.
- the basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimeric with two Ig units as with IgA, tetrameric with four Ig units like teleost fish IgM, or pentameric with five Ig units, like mammalian IgM.
- Ig immunoglobulin
- the Ig monomer is a "Y" -shaped molecule that consists of four polypeptide chains; two identical heavy chains and two identical light chains connected by disulfide bonds between cysteine residues. Each heavy chain is about 440 amino acids long; each light chain is about 220 amino acids long. Heavy and light chains each contain intrachain disulfide bonds which stabilize their folding. Each chain is composed of structural domains called Ig domains. These domains contain about 70-1 10 amino acids and are classified into different categories (for example, variable or V, and constant or C) according to their size and function. They have a characteristic immunoglobulin fold in which two ⁇ sheets create a "sandwich" shape, held together by interactions between conserved cysteines and other charged amino acids.
- Ig heavy chain There are five types of mammalian Ig heavy chain denoted by ⁇ , ⁇ , ⁇ , ⁇ , and ⁇ .
- the type of heavy chain present defines the isotype of antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.
- Distinct heavy chains differ in size and composition; a and ⁇ contain approximately 450 amino acids and ⁇ approximately 500 amino acids, while ⁇ and ⁇ have approximately 550 amino acids.
- Each heavy chain has two regions, the constant region (CH) and the variable region (V H ).
- the constant region is essentially identical in all antibodies of the same isotype, but differs in antibodies of different isotypes.
- Heavy chains ⁇ , a and ⁇ have a constant region composed of three tandem Ig domains, and a hinge region for added flexibility; heavy chains ⁇ and ⁇ have a constant region composed of four
- variable region of the heavy chain differs in antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone.
- the variable region of each heavy chain is approximately 1 10 amino acids long and is composed of a single Ig domain.
- a light chain has two successive domains: one constant domain (CL) and one variable domain (VL).
- CL constant domain
- VL variable domain
- the approximate length of a light chain is 21 1 to 217 amino acids.
- Each antibody contains two light chains that are always identical; only one type of light chain, ⁇ or ⁇ , is present per antibody in mammals.
- variable (V) regions are responsible for binding to the antigen, i.e. for its antigen specificity.
- VL variable light
- VH variable heavy chain
- CDRs Complementarity Determining Regions
- an "antibody fragment” contains at least one antigen binding fragment as defined above, and exhibits essentially the same function and specificity as the complete antibody of which the fragment is derived from.
- Limited proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical amino terminal fragments, each containing one entire L chain and about half an H chain, are the antigen binding fragments (Fab).
- the Fc contains carbohydrates, complement-binding, and FcR-binding sites.
- F(ab')2 is divalent for antigen binding.
- the disulfide bond of F(ab')2 may be cleaved in order to obtain Fab'.
- the variable regions of the heavy and light chains can be fused together to form a single chain variable fragment (scFv).
- 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 N+(R1 )(R2)(R3)(R4), wherein 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.
- FIG. 1 schematically shows a sectional view of an injection device according to the present application
- FIG. 2 shows schematically a sectional view of the friction wheel assembly along the line I- I in FIG. 1 ;
- FIG. 3 shows a longitudinal sectional view in the dose setting part of another embodiment of an injection device according to the invention
- FIG. 4 shows a longitudinal sectional view perpendicular to the view in FIG. 3;
- FIG. 5 shows an exploded picture of the of the device shown in FIGS. 3 and 4;
- FIG. 6 shows a sectional view of another embodiment of the drug delivery device in accordance with the present invention in a first, cartridge full, position;
- FIG. 7 shows a further sectional view of the embodiment of the drug delivery
- an elongated cylindrical housing 1 has a partitioning wall 2 that divides the housing into a compartment containing a dose setting mechanism and a compartment 3 configured to accommodate a not shown ampoule.
- An example of such a cartridge or ampoule is illustrated as item 204 in another embodiment of the injection device shown in Fig. 6.
- a threaded piston rod 4 has a not round cross section by which it fits through a central opening in the wall 2 so that the piston rod 4 can be displaced longitudinally through the central opening in the wall 2 but not rotated relative to this wall.
- the wall 2 Concentrically with the housing 1 the wall 2 carries on its side turning away from the compartment 3 a tubular element 5 a part of which is adjacent to the wall 2 provided with an outer thread 6 and which has at its free end a circumferential recess 7.
- a ring shaped coupling element 8 on a friction wheel assembly 9 engages the recess 7.
- the friction wheel assembly 9 there can be two integral friction wheels journaled on a shaft 1 1 , which runs perpendicular to the longitudinal axis of the device between two axial connection bars 12.
- the connection bars 12 project from the friction wheel assembly towards the partition wall 2 and are connected to a nut 13, which adjacent to the wall 2 engages the thread of the piston rod 4.
- the friction wheel assembly 9 comprises a friction wheel 14 that frictionally engages a linear bearing surface 15, which is guided in the friction wheel assembly 9 to be displaced in the longitudinal direction of the device, and a friction wheel 16 with a smaller diameter engaging a bearing surface 10 in FIG. 2 extending in the longitudinal direction of the device on the inner wall of the friction wheel assembly 9.
- the friction wheel 16 with the smaller diameter may be divided into two friction wheels placed on each side of the of friction wheel 14.
- a tubular dose setting drum 17 fitting into the housing 2 is at an end provided with an internal thread mating and engaging the outer thread 6 of the tubular element 5 and has at its other end a part with enlarged diameter forming a dose setting button 18. Due to the engagement with the thread 6 the dose setting drum 17 may be screwed in and out of the housing 1 to show a number on a not shown helical scale on its outer surface in a not shown window in the housing 1.
- a bottom 19 in a deep cup shaped element which has a tubular part 20 fitting into the dose setting drum 17 and encompassing the friction wheel assembly 9, forms an injection button. Coupling means between the dose setting drum 17 and the cup shaped element ensures that rotation of the dose setting drum 17 is transmitted to the cup shaped element. Further, the inner wall of the tubular part 20 has longitudinal recesses 22 engaged by protrusions 23 on the friction wheel assembly 9 so that rotation of the dose setting drum 17 via the cup shaped element is transmitted to the friction wheel assembly 9.
- a rosette of V-shaped teeth are provided, which teeth engage a corresponding rosette of V-shaped teeth 24 on a ring 25 which is pressed against the edge of the cup shaped element by a spring 26, which is compressed between a non-toothed side of the ring 25 and a round track on shoulder 27 on the inner wall of the dose setting drum 17 at an inner end of the inner thread of this drum.
- the ring 25 is provided with an inner recess, which is engaged by a longitudinal rib 28 on the tubular element 5 so that the ring 25 can be displaced in the axial direction of the device, but cannot be rotated relative to the housing 1. Thereby, a click coupling is established which makes a click noise when the V-shaped teeth at the edge of the cup shaped element by rotation of this element rides over the V-shaped teeth of the ring 25.
- a head 29 on the projecting end of the bearing surface 15 is fixed at the bottom of the cup shaped element between the bottom 19 forming the injection button 37 and an inner wall 30 near this bottom.
- the bearing surface is fixed in a position with its head pressed against the wall 30 by a spring 31 between the bottom 19 and the head 29.
- the dose setting button 18 is rotated to screw the dose setting drum 17 up along the thread 6. Due to the coupling 21 the cup shaped element will follow the rotation of the dose setting drum 17 and it will be lifted with this drum up from the end of the housing 1. By the rotation of the cup shaped element the V-shaped teeth 24 at the edge of its open end will ride over the V-shaped teeth of the non-rotatable ring 25 to make a click sound for each unit the dose is changed. If too high a dose is set, it can be reduced by rotating the dose setting button 18 in the opposite direction of the direction for increasing the dose.
- the ring 25 When the dose setting drum is screwed up along the thread 6 on the tubular element 5 the ring 25 will follow the dose setting drum in its axial movement as the spring 26 is supported on the shoulder 27. The spring will keep the V-shaped teeth of the ring 25 and the cup shaped element in engagement and maintain in engagement the coupling 21 , which may comprise an inverted V-shaped protrusions 32 on the cup shaped element engaging V-shaped recesses in an inner ring 33 in the dose setting button 18.
- a dose setting limiter which ensures that the size of the set dose does not exceed the amount of medicament left in the ampoule, can be established by providing the piston rod 4 with a stop 35 which limits the movement of the nut 13 up along the piston rod 4.
- the bearing surface 15 is drawn with the injection button 37 outward. Also the axial movement of the nut 13 relative to the housing 1 will be transmitted to the friction wheel assembly 9 through the connection bars 12 and this movement will through the friction wheel assembly 9 induce an outward movement of the bearing surface 15. This induced outward movement has to be the same as the outward movement induced by outward movement of the injection button 37. This is obtained by dimensioning the diameter of the friction wheels contained in the friction wheel assembly 9 so that the ratio of the movements of the connection bars 12 and the bearing surface 15 relative to the housing corresponds to the ratio of the pitches for the thread on the piston rod and for the thread 6 for the longitudinal movement of the dose setting drum 17.
- the friction force between the friction wheel and bearing surface 15 is adjusted by varying the roughness of the bearing surface 15, the friction wheel surface, the materials of construction of the bearing surface 15 or friction wheels, or both. Texturing the surfaces or using different materials of construction can perform this manipulation of the roughness.
- the injection button 37 is pressed by pressing on the bottom 19.
- the spring 31 is compressed where after the pressing force is directly transmitted to the head 29 of the bearing surface 15 and this way to the bearing surface 15 itself.
- the force is transformed and is transmitted through the connection bars 12 to the nut 13, which will press the piston rod 4 into the compartment 3 until the dose-setting drum 17 abuts the wall 2.
- the inverted V-shaped protrusions 32 on the cup shaped element will be drawn out of their engagement with the V-shaped recesses in the ring 33.
- the dose setting drum 17 can now rotate relative to the injection button and will do so when the inverted V-shaped protrusions 32 press against a shoulder 34 at the bottom of the dose setting button 18. Only a force sufficient to make the dose setting drum rotate to screw itself downward along the thread 6 is necessary as the force necessary to make the injection is transmitted to the piston rod 4 through the friction wheel assembly 9.
- a helical reset spring 36 concentric with the dose setting drum can be mounted at the lower end of this drum and can have one end anchored in the dose setting drum 17 and the other end anchored in the wall 2.
- this spring may be tighter coiled so that on the dose setting drum 17 it exerts a torque approximately corresponding to the torque necessary to overcome the friction in the movement of the dose setting drum 17 along the thread 6 so that the force which the user have to exert on the injection button 37 is only the force necessary to drive the piston rod into an ampoule to inject the set dose.
- connection bars 12 are fixed relative to the nut 13.
- the connection bars may be, e.g.
- FIGS. 3 and 4 show another preferred embodiment wherein only one size friction wheel is used and wherein elements corresponding to elements in FIGS. 1 and 2 are given the same references as these elements with a prefixed "1 ".
- the partitioning wall 102 and the tubular element 105 are made as two parts which are by the assembling of the device connected to each other to make the assembled parts act as one integral part.
- a circumferential recess 107 is provided as an outer recess at the free end of the tubular part 105 and a ring shaped coupling element is provided as an inner bead 108 on the friction wheel assembly element 109.
- the bead 108 engages the recess 107 to provide a rotatable but not axially displaceable connection between the tubular part 105 and the friction wheel assembly.
- a tubular element 120 having ridges 122 which engages recesses 123 on the friction wheel assembly is at its upper end closed by a button 1 19. Pressing this button 1 19 creates a force that is transmitted to the tubular element 120.
- the friction wheel assembly is formed by two shells, which together form a cylinder fitting into the tubular element where the shells are guided by the engagement between the ridges 122 and the recesses 123.
- Bearing surfaces 1 10 and 1 15 are provided along edges of the shells facing each other.
- One shell forming the friction wheel assembly element 109 is provided with the inner bead 108, which engages the circumferential recess 107 at the end of the central tubular part 105 and carries the bearing surface 1 10.
- the other shell is axially displaceable in the tubular element 120 and forms the bearing surface 1 15.
- the shell carrying the bearing surface 1 15 is provided with a flange 140 that is positioned in a cut out 141 in the end of the tubular element 120 carrying the button 1 19 so that this button and the tubular element 120 can be moved so far inward in the device that the engagement of the teeth 132 and 133 can be released before the button 1 19 abuts the flange 140.
- a tubular connection element 1 12 connects the threaded piston rod 104 with the friction wheel assembly.
- a nut 1 13 that engages the piston rod 104.
- Nut 1 13 has an internal thread mating the external thread of the piston rod.
- connection element 1 12 At the opposite end of the connection element 1 12 are two pins 1 1 1 projecting perpendicular to the longitudinal axis of the connection element 1 12 at each side of this element. This end of the connection element engages the friction wheel assembly.
- Each pin 1 1 1 carries a friction wheel 1 14 that is placed between and engages the two bearing surfaces 1 10 and 1 15. This way the connection element 1 12 will be rotated with the friction wheel assembly but can be displaced axially relative to said friction wheel assembly when the bearing surfaces 1 10 and 1 15 are moved relative to each other.
- a ring 125 which is at its periphery provided with a rosette of teeth 124 and has a central bore fitting over the central tube in the housing 101 so that this ring 125 can be axially displaced along said central tube 105, but internal ridges 128 in the central bore of the ring 125 engages longitudinal recesses 137 in the central tube to make the ring non-rotatable in the housing so that a rosette of teeth at the edge of the tubular element 120 can click over the teeth 124 of the ring when said tubular element is rotated together with the dose setting drum 1 17.
- a spring 126 working between the ring 125 and an internal shoulder 127 provided in the dose setting drum 1 17 makes the ring follow the tubular element 120 when this element with the dose setting drum is moved longitudinally in the housing.
- a roller bearing is included having an outer ring 142 supported by the shoulder 127 and an inner ring 143 supporting a pressure bushing 144 which supports the spring 126.
- the bearing is shown as a radial bearing but can be replaced by an axial bearing.
- FIGS. 6 & 7 there is shown a drug delivery device in accordance with the present invention.
- the drug delivery device 201 comprises a cartridge retaining part 202, and a main (exterior) housing part 203.
- the proximal end of the cartridge retaining part 202 and the distal end of the main housing 203 are secured together by any suitable means known to the person skilled in the art.
- the cartridge retaining part 202 is secured within the distal end of the main housing part 203.
- a cartridge 204 from which a number of doses of a medicinal product may be dispensed is provided in the cartridge retaining part 202.
- a piston 205 is retained in the proximal end of the cartridge 204.
- a removable cap 222 is releasably retained over the distal end of the cartridge retaining part 202.
- the removable cap 222 may be optionally provided with one or more window apertures through which the position of the piston 205 within the cartridge 204 can be viewed.
- the distal end of the cartridge retaining part 202 in the illustrated embodiment is provided with a distal threaded region 206 designed for the attachment of a suitable needle assembly to enable medicament to be dispensed from the cartridge 204.
- the main housing part 203 is provided with an internal housing 207.
- the internal housing 207 is secured against rotational and/or axial movement with respect to the main housing part 203.
- the internal housing is provided with a first linear bearing surface 208 extending along the main axis of the internal housing 207.
- the internal housing 207 may be formed integrally with the main housing part 203. Additionally, the internal housing 207 is provided with a plurality of guide lugs (not shown) and pawl means (not shown). The pawl means may be an integral part of the internal housing 207 or may be a separate component as illustrated.
- a piston rod 210 extending through the main housing 203 has a first set of indentations (not shown) extending longitudinally along external surfaces of the piston rod 210.
- a second set of indentations 21 1 extend longitudinally along internal surfaces of the piston rod 210.
- the first set of indentations (element 223 in Fig. 7) of the piston rod 210 extend through and are engaged with the pawl means (element 221 in Fig. 7) of the internal housing 207 to prevent movement of the piston rod 210 in the proximal direction during setting of the device.
- a bearing surface 212 located at the distal end of the piston rod 210 is disposed to abut the proximal face of the piston 205.
- the longitudinal spacing of the first set of indentations and the second set of indentations 21 1 is essentially equal.
- Pawl arms 229 located on the carrier 228 are releasably engaged with the second set of indentations 21 1 of the piston rod 210.
- the pawl arms 229 of the carrier 228 are designed to transmit force to the piston rod 210 in the distal direction during dispense and to allow relative movement between the friction wheel assembly 213 and the piston rod 210 in the proximal direction during setting.
- the circumferential surface of the friction wheel 227 is permanently engaged with a first the linear bearing surface 208 of the internal housing 207.
- a drive member 214 extends about the piston rod 210.
- the drive member 214 comprises a longitudinal part 215 and an activation part 216.
- the longitudinal part 215 and the activation part 216 are secured to each other to prevent rotational and/or axial movement there between.
- the drive member 214 may be a unitary component consisting of a longitudinal part 215 and activation part 216.
- the longitudinal part 215 is provided with a second linear bearing surface 217 extending along the main axis of the longitudinal part 215.
- the second linear bearing surface 217 is permanently engaged with the
- the drive member 214 has a plurality of guide slots (not shown) in which the guide lugs (not shown) of the internal housing 207 are located. These guide slots define the extent of permissible axial movement of the drive member 214 with respect to the housing part 203. In the illustrated embodiment the guide slots also prevent rotational movement of the drive member 214 relative to the main housing part 203.
- the activation part 216 of the drive member 214 has a plurality of grip surfaces 218 and a dispensing face 219. To increase intuitiveness of the operation of the device, the main housing part 203 may optionally be provided with a window aperture through which graphical status indicators provided on the drive member 214, can be viewed.
- a user grips the grip surfaces 218 of the drive member 214.
- the user then pulls the drive member 214 in a proximal direction away from the main housing part 203 thereby moving the longitudinal part 215 in a proximal direction.
- the proximal movement of the longitudinal part 215 causes the friction wheel 227 to rotate and move proximally by virtue of the engagement with the circumferential surface of the friction wheel
- the piston rod 210 is prevented from moving proximally by interaction of pawl means 221 of the internal housing 207 with a first set of indentations 223 on the piston rod 210.
- the drive member 214 travels in the proximal direction relative to the piston rod 210, the pawl arms 229 of the carrier 228 are displaced inwardly by interaction with the second set of indentations 21 1 of the piston rod 210.
- the proximal travel of the drive member 214 is limited by the guide slots of the longitudinal part 215. At the end of the travel of the drive member 214, the pawl arms 229 of the carrier
- the drive member 214 and the longitudinal part 215 are moved axially in the distal direction relative to the main housing part 203.
- the friction wheel 227 is caused to rotate and move in the distal direction thus moving the friction wheel assembly 213 longitudinally in the distal direction.
- the pawl arms 229 of the carrier 228 of the friction wheel assembly 213 is engaged with the second set of indentations 21 1 of the piston rod 210, the piston rod 210 is caused to move longitudinally in the distal direction with respect to the internal housing 207.
- the distal axial movement of the piston rod 210 causes the bearing surface 212 of the piston rod 210 to bear against the piston 205 of the cartridge 204 causing a dose of medicament to be dispensed through the attached needle (not shown).
- the distal travel of the drive member 214 is limited by the guide slots (not shown) of the longitudinal part 215.
- Audible and tactile feedback to indicate that the dose has been dispensed is provided by the interaction of the pawl means (not shown) of the internal housing 207 with the first set of indentations (not shown) of the piston rod 210.
- visual feedback regarding dose dispensing may optionally be indicated by a graphical status indicator, provided on the drive member 214, which can be viewed through an optional window aperture in the main housing part 203.
- Further doses may be delivered as required up to a pre-determined maximum number of doses.
- the proximal face 232 of the carrier 228 abuts an internal distal face 233 of the piston rod 210 to prevent further axial movement of the gear 213 and thus the drive member 214 in proximal direction.
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Engineering & Computer Science (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Anesthesiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Vascular Medicine (AREA)
- Mechanical Engineering (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/116,897 US20140236097A1 (en) | 2011-05-13 | 2012-05-09 | Assembly for a Drug Delivery Device |
DK12719400.9T DK2707062T3 (en) | 2011-05-13 | 2012-05-09 | DEVICE FOR PHARMACEUTICAL DISPENSER DEVICE |
EP12719400.9A EP2707062B1 (en) | 2011-05-13 | 2012-05-09 | Assembly for a drug delivery device |
CA2833744A CA2833744A1 (en) | 2011-05-13 | 2012-05-09 | An assembly for a drug delivery device |
JP2014509725A JP6021896B2 (en) | 2011-05-13 | 2012-05-09 | Drug delivery device assembly |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161485870P | 2011-05-13 | 2011-05-13 | |
US61/485,870 | 2011-05-13 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2012156253A1 true WO2012156253A1 (en) | 2012-11-22 |
Family
ID=46044717
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2012/058569 WO2012156253A1 (en) | 2011-05-13 | 2012-05-09 | An assembly for a drug delivery device |
Country Status (6)
Country | Link |
---|---|
US (1) | US20140236097A1 (en) |
EP (1) | EP2707062B1 (en) |
JP (1) | JP6021896B2 (en) |
CA (1) | CA2833744A1 (en) |
DK (1) | DK2707062T3 (en) |
WO (1) | WO2012156253A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2016055624A3 (en) * | 2014-10-09 | 2016-06-02 | Sanofi | Drive mechanism and drug delivery device herewith |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
MX2016006672A (en) * | 2013-11-22 | 2016-09-06 | Sanofi Aventis Deutschland | Drug delivery device. |
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DE3144825A1 (en) * | 1981-11-11 | 1983-05-19 | Dr. Eduard Fresenius, Chemisch-pharmazeutische Industrie KG, 6380 Bad Homburg | Injection pump |
FR2586192A1 (en) * | 1985-08-14 | 1987-02-20 | Cassou Robert | Device for drawing, keeping or injecting liquid substances of the organic type |
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WO2001095959A1 (en) * | 2000-06-16 | 2001-12-20 | Novo Nordisk A/S | An injection device with a gearbox |
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EP1656170B1 (en) * | 2003-08-12 | 2019-03-13 | Eli Lilly And Company | Medication dispensing apparatus with triple screw threads for mechanical advantage |
EP1642607A1 (en) * | 2004-10-04 | 2006-04-05 | Sanofi-Aventis Deutschland GmbH | Dose display mechanism for a drug delivery device |
US20080221530A1 (en) * | 2005-04-24 | 2008-09-11 | Novo Nordisk A/S | Injection Device With A GearBox |
US20070265487A1 (en) * | 2006-05-09 | 2007-11-15 | Worldwide Medical Technologies Llc | Applicators for use in positioning implants for use in brachytherapy and other radiation therapy |
WO2009055610A1 (en) * | 2007-10-26 | 2009-04-30 | Cytori Therapeutics, Inc. | Syringe system for controlled delivery or removal of material |
CN101932350B (en) * | 2008-01-28 | 2013-04-17 | Shl集团有限责任公司 | Injector with thumb operable scroll wheel |
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-
2012
- 2012-05-09 JP JP2014509725A patent/JP6021896B2/en active Active
- 2012-05-09 WO PCT/EP2012/058569 patent/WO2012156253A1/en active Application Filing
- 2012-05-09 US US14/116,897 patent/US20140236097A1/en not_active Abandoned
- 2012-05-09 DK DK12719400.9T patent/DK2707062T3/en active
- 2012-05-09 CA CA2833744A patent/CA2833744A1/en not_active Abandoned
- 2012-05-09 EP EP12719400.9A patent/EP2707062B1/en active Active
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DE3144825A1 (en) * | 1981-11-11 | 1983-05-19 | Dr. Eduard Fresenius, Chemisch-pharmazeutische Industrie KG, 6380 Bad Homburg | Injection pump |
FR2586192A1 (en) * | 1985-08-14 | 1987-02-20 | Cassou Robert | Device for drawing, keeping or injecting liquid substances of the organic type |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2016055624A3 (en) * | 2014-10-09 | 2016-06-02 | Sanofi | Drive mechanism and drug delivery device herewith |
CN106794317A (en) * | 2014-10-09 | 2017-05-31 | 赛诺菲 | Drive mechanism and the delivery device with it |
US10426895B2 (en) | 2014-10-09 | 2019-10-01 | Sanofi | Drive mechanism and drug delivery device herewith |
Also Published As
Publication number | Publication date |
---|---|
EP2707062A1 (en) | 2014-03-19 |
DK2707062T3 (en) | 2018-01-08 |
CA2833744A1 (en) | 2012-11-22 |
JP6021896B2 (en) | 2016-11-09 |
EP2707062B1 (en) | 2017-10-04 |
US20140236097A1 (en) | 2014-08-21 |
JP2014519371A (en) | 2014-08-14 |
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