Source: https://patents.google.com/patent/WO2011039207A1/en
Timestamp: 2018-05-25 14:53:00
Document Index: 328794640

Matched Legal Cases: ['art 10', 'art 10', 'art 10', 'art 10', 'art 10', 'art 10', 'art 10', 'art 10']

WO2011039207A1 - Drive mechanism for a drug delivery device - Google Patents
WO2011039207A1
WO2011039207A1 PCT/EP2010/064398 EP2010064398W WO2011039207A1 WO 2011039207 A1 WO2011039207 A1 WO 2011039207A1 EP 2010064398 W EP2010064398 W EP 2010064398W WO 2011039207 A1 WO2011039207 A1 WO 2011039207A1
PCT/EP2010/064398
A first input member (6) and a second input member (7) are arranged along a first axis (4) and coupled in such a manner that a movement of the first input member along the first axis is converted into a rotational movement of the second input member with respect to the body (1). A first output member (8) and a second output member (9) are arranged along a second axis (5) and coupled in such a manner that a rotational movement of the first output member is converted into a movement of the second output member along the second axis with respect to the body. The second input member and the first output member are releasably rotationally coupled.
Drive mechanism for a drug delivery device The present invention relates to a drive mechanism for a drug delivery device and to a drug delivery device comprising the drive mechanism.
This object is achieved by a drive mechanism according to claim 1 . Further objects are achieved by variants and embodiments according to the dependent claims.
The drive mechanism for a drug delivery device comprises a body having a distal end and a proximal end, spaced apart in the direction of a first axis and a second axis that is parallel to the first axis. A first input member and a second input member are arranged within the body along the first axis and coupled in such a manner that a movement of the first input member along the first axis is converted into a rotational movement of the second input member with respect to the body. A first output member and a second output member are arranged within the body along the second axis and coupled in such a manner that a rotational movement of the first output member is converted into a movement of the second output member along the second axis with respect to the body. The second input member and the first output member are releasably rotationally coupled. The body can be any housing or any component that forms part of a housing, for example. The body can also be some kind of an insert connected with an exterior housing. The body may be designed to enable the safe, correct, and/or easy handling of the device and/or to protect it from harmful liquids, dust or dirt. The body can be unitary or a multipart component of tubular or non-tubular shape. The body may house a cartridge, from which doses of a drug can be dispensed. The body can especially have the shape of an injection pen.
The drive mechanism can be used to expel a drug from a receptacle or cartridge inserted in the body of a drug delivery device. The drug delivery device can be a disposable or re-usable device designed to dispense a dose of a drug, especially a liquid, which may be insulin, a growth hormone, a heparin, or an analogue and/or a derivative thereof, for example. The drug may be administered by a needle, or the device may be needle-free. The device may be further designed to monitor
physiological properties like blood glucose levels, for example. Each time the second output member is shifted in the distal direction with respect to the body, a dose of the drug is expelled from the drug delivery device.
In an embodiment of the drive mechanism, a shift of the first input member in the distal direction produces a shift of the second output member in the distal direction. In a further embodiment, the second input member and the first output member are rotationally coupled when the first input member is moved in the distal direction.
An embodiment of the drive mechanism and its operation are described in the following as an example. A first output member of the drive mechanism is formed by an output sleeve, and a second output member is formed by an output shaft. The first output member is rotated by means of the input drive feature. The drive feature can comprise a first input member, formed by an input shaft, and a second input member, formed by an input sleeve. The input members are arranged along a first axis, and the output members are arranged along a second axis, parallel to the first axis. The input members and the output members are coupled by a kind of gear, which allows a unidirectional rotation of the output members. This can be achieved by an arrangement of a pinion member and a pawl member functioning in the manner of a ratchet. The pawl can be released from the pinion so that the output members are free to rotate in both directions. A clutch coupling the first input member and the second input member is provided to enable the user to set a dose without rotating the output members and to deliver a dose of the drug while the clutch is engaged and an output member rotates simultaneously with the second input member. To set a dose, the first input member is axially pulled and not rotated with respect to the body. The term "drug", 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, 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,
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; Β29-Ν-(ω- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(u)-carboxyheptadecanoyl) human insulin. 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.
des Pro36 [Met(0)14 Trp(02)25, lsoAsp28] 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
In the following, examples and embodiments of the drive mechanism are described in detail in conjunction with the appended figures. FIG. 1 shows a perspective cut-away view of an injection pen comprising an embodiment of the drive mechanism.
FIG. 4 shows a cross-section according to FIG. 3 after a dispense operation. FIG. 5 shows a cross-section according to FIG. 4 after the delivery of a last dose.
FIG. 6 shows a detail of the arrangement of the pinion member and the pawl
member. FIG. 7 shows another view of the arrangement of the pinion member with the pawl member engaged.
FIG. 8 shows the view according to FIG. 7 with the pawl member disengaged. FIG. 1 shows a cross-section of an injection pen comprising a drive mechanism having input and output members. The body 1 has a distal end 2 and a proximal end 3. Input members of the drive mechanism are arranged along a first axis 4. Output members of the drive mechanism are arranged along a second axis 5, which is parallel to the first axis 4. A first input member 6 is formed by a shaft in this embodiment. The first input member 6 is coupled with a second input member 7, which is an input sleeve in this embodiment. The first input member 6 and the second input member 7 form an input drive feature of the drive mechanism. The coupling of the first input member 6 and the second input member 7 can be achieved by a screw thread 29. The first input member 6 is provided for an operation by the user and juts out of the body 1 at its proximal end 3. There, the first input member 6 is preferably provided with a grip 26, which can be used to pull the first input member 6 out of the body 1 in the proximal direction 30. The screw thread 29 coupling the first input member 6 with the second input member 7 makes the second input member 7, formed by the input sleeve, rotate with respect to the first input member 6 around the first axis 4 and thus relatively to the body 1 . An axial movement of the second input member 7 in the distal direction or in the proximal direction is inhibited by suitable components of the drive mechanism or the body 1 , like protruding elements, webs or the like. The second input member 7 therefore stays at its position and merely rotates around the first axis 4.
The second input member 7 is coupled with the first output member 8 by means of a unidirectional gear like a ratchet. The gear comprises a pinion member 1 1 and a pawl member 12. The pawl member 12 can be a hinged tongue or a kind of cantilever having a hook or edge engaging notches in a toothed circumference of the pinion member 1 1 , for example. The pinion member 1 1 is coupled with the second input member 7 by means of a clutch 13, so that the pinion member 1 1 can be released from the second input member 7 to prevent the pinion member 1 1 from rotating simultaneously with the second input member 7. A clutch spring 27 can be provided to disengage the clutch 13 as long as the first input member 6 is not pushed in the distal direction 20. Therefore, the pinion member 1 1 does not rotate together with the second input member 7 when the first input member 6 is shifted in the proximal direction 30. Only when the first input member 6 is pushed in the distal direction 20 and the clutch spring 27 is compressed, the clutch 13 engages, and the pinion member 1 1 rotates according to the rotation of the second input member 7. Then, the pinion member 1 1 drives the first output member 8, which can be coupled to the pinion member 1 1 by means of a gear wheel forming an integral part of the first output member 8 or by means of a similar device. The pawl member 12 allows the rotation of the pinion member 1 1 in one rotational direction only, and consequently the rotation of the first output member 8 is restricted to the
corresponding rotational direction according to the coupling between the pinion member 1 1 and the first output member 8.
A second output member 9 is coupled with the first output member 8. The coupling can be achieved by a further screw thread 28, for example. The first output member 8 can be an output sleeve, and the second output member 9 can be an output shaft. The coupling between the first output member 8 and the second output member 9 is such that the rotation of the first output member 8 allowed by the pawl member 12 drives the second output member 9 in the distal direction 20. The second output member 9 can be used as a piston rod or plunger driving a piston 19 in the distal direction 20. The piston 19 is provided to expel a drug from a receptacle, particularly from a cartridge 18, which is inserted in a dedicated compartment 17 at the distal end 2 of the body 1 . If the body 1 is provided with a removable and attachable part 10 at its distal end 2, the cartridge 18 can be removed and exchanged with a new one, and the device can easily be refilled. This enables the drug delivery device to be reused.
After a cartridge 18 has been emptied, the removable and attachable part 10 is removed from the body 1 and the empty cartridge 18 taken out of the compartment 17. The second output member 9 has to be shifted back to its initial position near the proximal end 3 of the body 1 , before a full cartridge 18 comprising a piston 19 at a proximal position can be inserted. The first output member 8 is not shifted axially with respect to the body 1 , and the second output member 9 is therefore shifted relatively to the first output member 8. Because of the coupling between the first output member 8 and the second output member 9, by means of the screw thread 28 for instance, the shift of the second output member 9 in the proximal direction 30 is accompanied with the rotation of the first output member 8 in the rotational direction that is not allowed by the pinion member 1 1 and the engaged pawl member 12. To make the shift of the second output member 9 possible, the pawl member 12 is disengaged from the pinion member 1 1 , so that the pinion member 1 1 is free to rotate in both rotational directions. A resilient element 14 can be provided to drive the pawl member 12 out of its engagement with the pinion member 1 1 , when the removable and attachable part 10 is removed and the unidirectional gear is thus released. When the removable and attachable part 10 is attached, the resilient element 14 is restrained from its action on the pawl member 12. The pawl member 12 is preferably also resilient or at least resiliently mounted, so that the pawl member 12 is automatically re-engaged with the pinion member 1 1 , when the removable and attachable part 10 is attached. This enables a reset operation to be performed after the removal of an emptied cartridge. The operation of the drive mechanism will now be described with reference to FIGs. 2 to 8.
FIG. 2 shows a schematic cross-section of the drive mechanism in an initial state. The gear coupling the input drive feature and the output members is schematically represented by the pinion member 1 1 shown in cross-section. The removable and attachable part is attached, and the pawl member engages with the pinion member 1 1 , restricting the rotation to one rotational direction. In this start position, a set operation can be performed by pulling the first input member 6 in the proximal direction, i. e. to the right in FIG. 2. FIG. 3 shows a cross-section according to FIG. 2 after the set operation. The first input member 6 has been shifted in the proximal direction and sticks out of the body 1 . The movement of the first input member 6 caused the second input member 7, the input sleeve, to rotate. The clutch 13 provided to couple the second input member 7 with the pinion member 1 1 is disengaged during the set operation. The pinion member 1 1 does therefore not rotate with the second input member 7. Consequently, the output members are not moved. In the state of the drive mechanism shown in FIG. 3, the set dose can be dispensed by just pushing the first input member 6 in the distal direction. This movement makes the clutch 13 engage, because the second input member 7 is pressed towards the pinion member 1 1 against the force of the clutch spring 27, compressing the clutch spring 27. The clutch 13 may be formed by an angular arrangement of teeth or the like. Instead of a toothed structure, the friction occurring between the surfaces of the second input member 7 and the pinion member 1 1 , which are pressed together, may suffice to engage the pinion member 1 1 with the rotating second input member 7. As a result, the rotating pinion member 1 1 rotates the first output member 8. The coupling of the first output member 8 with the second output member 9 causes the second output member 9 to be shifted in the distal direction, thus driving the piston to expel the preset dose.
FIG. 4 shows the cross-section according to FIG. 3 after the delivery of the set dose. The state of the drive mechanism is now comparable to the initial state shown in FIG. 2, except for the second output member 9 having been shifted a small distance in the distal direction, i. e. to the left in FIG. 4. A further dose can now be set and delivered, again by moving the second output member 9 by the defined distance in the distal direction. This process can be repeated until the cartridge is empty. An axial groove or track 25 of the body 1 can be provided to lock the second output member 9 rotationally to the body 1 and allow a shift of the second output member 9 along the second axis 5 without rotation with respect to the body 1 . FIG. 5 shows the position of the second output member 9 within the drive mechanism after the last dose of the drug has been dispensed. When the resilient element 14 is caused to disengage the pawl member 12 from the pinion member 1 1 by removing the removable and attachable part 10 from the main part of the body 1 , the second output member 9 can be shifted in the proximal direction to its start position with the first output member 8 and the pinion member 1 1 freely rotating. The clutch 13 is disengaged, so that the second input member 7 does not rotate and, consequently, the first input member 6 is held stationary with respect to the body 1 . In this way, the start position according to FIG. 2 is obtained.
In this operational concept, the last-dose nut 21 is moved in one direction, axially with respect to the body 1 , during a set operation, while the last-dose nut 21 stays stationary in the axial direction during a dispense operation. The distance by which the last-dose nut 21 is shifted in each set operation is designed such that the last-dose nut 21 comes to a stop after the last dose has been expelled. To this purpose, the drive mechanism or the body can be provided with a stop feature, like the stop element 24, to inhibit the further movement of the last-dose nut 21 in the axial direction. As the set operation can only be performed by a movement of the input shaft 6 which makes the input sleeve 7 rotate and thus the last-dose nut 21 be shifted in the axial direction, stopping the movement of the last-dose nut 21 inhibits a shift of the input shaft 6 and thus prevents the user from setting a further dose.
FIG. 6 shows the coupling between the drive feature and the output members by means of the pinion member 1 1 and the pawl member 12. The pawl member 12 is formed to be a hook or cantilever having a tip or edge 16 engaging notches 15 in the toothed pinion member 1 1 . The resilient element 14 is kept away from the pawl member 12 by a protruding element or the like provided on the removable and attachable part 10. The pawl member 12 is therefore engaged with the pinion member 1 1 , and a rotation of the pinion member 1 1 is only permitted in one rotational direction. This is the rotational direction that enables the second output member 9, the output shaft functioning as the piston rod, to be moved in the distal direction, but not be moved back in the proximal direction. FIG. 7 shows the arrangement according to FIG. 6 in another perspective. The resilient element 14 is shown to be held at a distance from a protruding element of the pawl member 12. The pawl member 12 is therefore engaged with the pinion member 1 1 . This can be achieved by the pawl member 12 being resiliently mounted. The pawl member 12 can be a plastic element, for instance, which is mounted to the drive mechanism or to the body in such a manner that the pawl member 12 occupies a position where a tip or edge 16 at the end of the pawl member 12 engages notches 15 between the teeth of the pinion member 1 1 , when no external force is exerted on the pawl member 12.
FIG. 8 shows the view according to FIG. 7 when the removable and attachable part 10 has been removed from the body 1 , so that the resilient element 14 is free to relieve its tension and to come in contact with the protruding element of the pawl member 12. The resilient element 14 then pushes the pawl member 12 out of its engagement with the pinion member 1 1 . This enables the second output member 9 to be shifted in the proximal direction, making the output sleeve 8 and the pinion member 1 1 rotate in the opposite rotational direction, which is now allowed by the release of the pawl member 12 from the pinion member 1 1 .
The drive mechanism can be used in a wide range of reusable devices, particularly injection pens, and enables easy handling and an easy refill. Reference numerals
I I pinion member
Drive mechanism for a drug delivery device, comprising:
a body (1 ) having a distal end (2) and a proximal end (3), spaced apart in the direction of a first axis (4) and a second axis (5) that is parallel to the first axis, a first input member (6) and a second input member (7), arranged within the body along the first axis and coupled in such a manner that a movement of the first input member along the first axis is converted into a rotational movement of the second input member with respect to the body, and
a first output member (8) and a second output member (9), arranged within the body along the second axis and coupled in such a manner that a rotational movement of the first output member is converted into a movement of the second output member along the second axis with respect to the body,
the second input member and the first output member being releasably rotationally coupled.
The drive mechanism according to claim 1 , wherein
a shift of the first input member (6) in the distal direction (20) produces a shift of the second output member (9) in the distal direction.
The drive mechanism according to claim 1 or 2, wherein
the second input member (7) and the first output member (8) are rotationally coupled when the first input member (6) is moved in the distal direction (20).
a pinion member (1 1 ) releasably rotationally coupling the second input member (7) and the first output member (8),
a pawl member (12) engaging with the pinion member allowing rotation of the pinion member in only one direction, and
a clutch (13) coupling the second input member with the pinion member in a releasable fashion.
5. The drive mechanism according to claim 4, wherein
the clutch (13) couples the second input member (7) with the pinion member (1 1 ) when a force is exerted on the first input member (6) in the distal direction (20), and
the second input member and the pinion member are not coupled when the first input member is being shifted in the proximal direction (30).
6. The drive mechanism according to claim 4 or 5, further comprising:
the pinion member (1 1 ) having notches (15),
the pawl (12) being a hinged tongue or a resilient or resiliently mounted cantilever, and
the pawl having a tip or edge (16) that engages the notches, thus preventing rotation of the pinion member in one direction.
a set operation is performed by shifting the first input member (6) in the proximal direction (30).
8. The drive mechanism according to one of claims 1 to 7, wherein
a dispense operation is performed by shifting the first input member (6) in the distal direction (20).
9. The drive mechanism according to one of claims 1 to 8, wherein
the first input member (6) is an input shaft, the input shaft being axially movable relatively to the body (1 ),
the second input member (7) is an input sleeve, the input sleeve being rotatable around the first axis (4) relatively to the body,
the first output member (8) is an output sleeve, the output sleeve being rotatable around the second axis (5) relatively to the body, and
the second output member (9) is an output shaft, the output shaft being axially movable relatively to the body.
10. The drive mechanism according to one of claims 1 to 9, further comprising:
a last-dose nut (21 ) arranged within the body (1 ), the last-dose nut being movable relatively to the body along the first axis (4) and being rotationally coupled with the first output member (8), the last-dose nut and the second input member (7) being coupled by a screw thread (22),
the screw thread generating a movement of the last-dose nut in either the distal or the proximal direction when a rotation of the second input member is generated by a shift of the first input member (6) in the proximal direction (30), and
the body, the first output member or the second input member being provided with a stop element (24) limiting the movement of the last-dose nut in the distal or the proximal direction.
1 1 . The drive mechanism according to one of claims 1 to 10, wherein
the drive mechanism is provided for a fixed-dose drug delivery device.
12. The drive mechanism according to claim 1 1 , further comprising:
the body (1 ) or the second input member (7) being provided with a stop element, the stop element limiting the movement of the first input member (6) in the proximal direction (30).
13. The drive mechanism according to one of claims 1 to 12, further comprising:
a groove or track (25) of the body (1 ) locking the second output member (9) rotationally to the body and allowing a shift of the second output member along the second axis (5).
14. A drug delivery device comprising a drive mechanism according to one of claims 1 to 13, further comprising:
a compartment (17) provided for a cartridge (18) containing a drug and a piston (19) that is provided to expel the drug from the cartridge, the piston being driven in the distal direction (20) by the second output member (9).
PCT/EP2010/064398 2009-09-30 2010-09-29 Drive mechanism for a drug delivery device WO2011039207A1 (en)
EP09171740.5 2009-09-30
CN 201080043840 CN102548601B (en) 2009-09-30 2010-09-29 A drive mechanism for a drug delivery device
EP20100759891 EP2482892B1 (en) 2009-09-30 2010-09-29 Drive mechanism for a drug delivery device
DK10759891T DK2482892T3 (en) 2009-09-30 2010-09-29 A drive mechanism for drug delivery device
ES10759891T ES2435296T3 (en) 2009-09-30 2010-09-29 actuator mechanism drug delivery device
CA 2773460 CA2773460A1 (en) 2009-09-30 2010-09-29 Drive mechanism for a drug delivery device
RU2012117616A RU2545438C2 (en) 2009-09-30 2010-09-29 Actuation mechanism for drug delivery device
JP2012531375A JP5744035B2 (en) 2009-09-30 2010-09-29 The drive mechanism for the drug delivery device
US13395615 US9352098B2 (en) 2009-09-30 2010-09-29 Drive mechanism for a drug delivery device
WO2011039207A1 true true WO2011039207A1 (en) 2011-04-07
PCT/EP2010/064398 WO2011039207A1 (en) 2009-09-30 2010-09-29 Drive mechanism for a drug delivery device
WO2013170392A1 (en) * 2012-05-16 2013-11-21 Tecpharma Licensing Ag Improved device for adjusting a dosage with a limiting mechanism for a device for administering a product
NL2012054C (en) * 2014-01-07 2015-07-08 Sharpsight B V A device for dispensing a substance, in particular a medicament.
ALFONSO R. GENNARO: 'Remington's Pharmaceutical Sciences 17. ed.', 1985, MARK PUBLISHING COMPANY
JP2015516242A (en) * 2012-05-16 2015-06-11 テクファーマ・ライセンシング・アクチェンゲゼルシャフト Comprising a limiting mechanism for a device to administer the product, improved device for adjusting the dosage
JP2016209619A (en) * 2012-05-16 2016-12-15 テクファーマ・ライセンシング・アクチェンゲゼルシャフト Improved device for adjusting dose comprising limitation mechanism for device for dosage of product
WO2015105418A1 (en) * 2014-01-07 2015-07-16 Sharpsight B.V. Device for dispensing a substance, in particular a medicine
RU2012117616A (en) 2013-11-10 application
ES2435296T3 (en) 2013-12-18 grant
EP2482892A1 (en) 2012-08-08 application
RU2545438C2 (en) 2015-03-27 grant
JP2013506446A (en) 2013-02-28 application
US20130035647A1 (en) 2013-02-07 application
CA2773460A1 (en) 2011-04-07 application
JP5744035B2 (en) 2015-07-01 grant
EP2482892B1 (en) 2013-08-28 grant
CN102548601A (en) 2012-07-04 application
CN102548601B (en) 2014-10-22 grant
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