Drug Delivery Device
The drug delivery device addresses the issue of inaccurate dosages by incorporating an autocalibration mechanism that aligns the plunger rod with the stopper, ensuring precise contact and eliminating the gap, thus enhancing the accuracy and reliability of the device.
Patent Information
- Application Number
- JP2024019635
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-12-19
- Filing Date
- 2024-02-13
- Publication Date
- 2025-05-12
- Estimated Expiration
- 2040-11-12
AI Technical Summary
Existing drug delivery devices face challenges in ensuring accurate drug administration due to variations in the position of the stopper within the drug container, leading to inconsistent gap lengths between the plunger rod and the stopper, which can result in inaccurate dosages.
A drug delivery device with an autocalibration function, featuring a tubular rotary body with retaining members and a biased plunger rod with counter retaining elements, which allows for precise alignment and contact between the plunger rod and the stopper, eliminating the gap and ensuring accurate dosing.
The autocalibration mechanism ensures consistent and accurate drug administration by eliminating the gap between the plunger rod and the stopper, thereby improving the reliability and precision of the drug delivery device.
Smart Images

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Abstract
Description
[Technical field]
[0001] The present invention relates to drug delivery devices, and more particularly to drug delivery devices having automated features. [Background technology]
[0002] Drug delivery devices, such as autoinjectors, inhalers, on-body devices, and the like, are commonly known for self-administration of medications by patients without formal medical training. For example, diabetes patients or those undergoing artificial insemination treatments may require repeated injections of insulin or hormones. Other patients may require regular injections of other types of medications, such as growth hormones.
[0003] The drug delivery device may use a filled drug container for delivery to an end user. The drug container is typically comprised of a glass or plastic barrel having a stopper sealing the rear end and a delivery member or a pierceable membrane located on the front end. In most cases, the drug container is first filled with a particular drug and then assembled to the drug delivery device. The drug delivery device typically comprises a plunger rod configured to push the stopper of the drug container to deliver the contained drug to the end user. However, when the drug is filled into each drug container and the stopper is placed to seal each drug container, the position of the stopper on each drug container may be different. This difference is caused by several factors, such as manufacturing temperature and / or pressure, the spread of silicone oil in the drug container, and the surface tension of the drug and / or the delivery member. Even if a batch of drug containers is fully filled with the drug and the position of each stopper is the same, when the batch is shipped by air to a market distributor or drug delivery device manufacturer, the position of each stopper may change due to pressure differences. Due to the difference in the stopper position in each drug container, the plunger rod in the drug delivery device is usually located behind the stopper of the assembled drug container and has a gap with respect to the stopper. In some cases, if the plunger rod is located too close to the stopper of the assembled drug container, the plunger rod may squeeze the stopper during assembly or air shipment, thereby causing damage to the drug container due to internal pressure buildup or contamination caused by leakage of the contained drug.
[0004] However, the gap length according to the position of the stopper may be different in each assembled drug delivery device, and thus the dose may be inaccurate. Drug delivery devices that require high delivery dose accuracy are usually arranged with an overfilled drug container and a plunger rod with a specific hard stop configuration. The delivered dose is determined by the travel distance of the plunger rod, not the total amount of drug contained in the drug container. However, due to the difference in the gap length between the front end of the plunger rod and the rear end of the stopper of the drug container, the delivered dose is actually determined by subtracting the gap length from the travel distance of the plunger rod, and thus the difference in the gap length may cause the delivered dose to be inaccurate.
[0005] Patent Document 1 discloses a drug delivery device with several automatic functions, which is very popular in the market. The drug delivery device includes a rotor and a needle shield including a needle shield link, and axial movement of the needle shield link is configured to follow a ledge on the outer surface of the rotor to rotate the rotor. Rotation of the rotor is configured to release a biased plunger with a stop member located on the inner ledge of the rotor.
[0006] In most instances, this solution works quite well. However, there remains a need for further improvements on the disclosed drug delivery device. [Prior art documents] [Patent documents]
[0007] [Patent Document 1] International Publication No. 2006 / 057604 Brochure Summary of the Invention [Means for solving the problem]
[0008] The object of the present invention is to obtain an alternative, more robust solution. In this disclosure, when the term "distal direction" is used, it refers to the direction away from the drug delivery site when the drug delivery device is in use. When the term "distal part / end" is used, it refers to the part / end of the delivery device or the part / end of each member of the delivery device that is located farthest from the drug delivery site when the drug delivery device is in use. Correspondingly, when the term "proximal direction" is used, it refers to the direction towards the drug delivery site when the drug delivery device is in use. When the term "proximal part / end" is used, it refers to the part / end of the delivery device or the part / end of each member of the delivery device that is located closest to the drug delivery site when the drug delivery device is in use.
[0009] Additionally, the terms "longitudinal," "longitudinally," "axially," or "axial" refer to a direction extending along a device or component, typically from the proximal end to the distal end, in the direction of the device and / or device component's longest extension.
[0010] Similarly, the terms "lateral" and "laterally" refer to directions generally perpendicular to the longitudinal direction.
[0011] It is an object of the present invention to provide a simple and reliable drug delivery device that performs an automatic calibration function.
[0012] According to an aspect of the present invention, the object is achieved by a reliable drug delivery device as claimed in claim 1.
[0013] Thus, there is provided a drug delivery device comprising a housing having a proximal end and a distal end, a drug container disposed within the housing and having a stopper and a delivery member, a biased delivery member cover associated with the housing and movable relative to the housing, a biased plunger rod associated with the drug container and movable relative to the housing, a tubular rotor associated with both the delivery member cover and the biased plunger rod, and a cap assembly associated with the housing, wherein a gap is defined between the proximal end of the biased plunger rod and the stopper of the drug container when the drug delivery device is in an assembled state, and wherein the proximal end of the biased plunger rod contacts the stopper of the drug container when the drug delivery device is in a calibrated state.
[0014] According to one embodiment, the tubular rotating body comprises a tubular body having at least one retaining member on an inner surface.
[0015] According to one embodiment, the tubular rotating body comprises a tubular body having a first retaining member and a second retaining member on an inner surface.
[0016] According to one embodiment, the biased plunger rod includes a counter retaining element configured to interact with at least one retaining member or to selectively interact with each of the first retaining member, the second retaining member, and the third retaining member.
[0017] According to one embodiment, the tubular rotating body comprises a tubular body having a retaining member on an inner surface, and the biased plunger rod comprises a first counter retaining element and a second counter retaining element, the first counter retaining element and the second counter retaining element configured to selectively interact with the retaining member.
[0018] According to one embodiment, the tubular rotating body comprises a tubular body having a first retaining member, a second retaining member, and a third retaining member on an inner surface, and the biased plunger rod comprises a counter retaining element, the counter retaining element configured to selectively interact with each of the first retaining member, the second retaining member, and the third retaining member.
[0019] According to one embodiment, the retaining members are radially inwardly projecting ribs.
[0020] According to one embodiment, the first retaining member and the second retaining member are ledges.
[0021] According to one embodiment, the counter retaining member is an arm that projects radially outwardly.
[0022] According to one embodiment, the first counter retaining member and the second counter retaining member are grooves.
[0023] According to one embodiment, the medication delivery device further comprises a container carrier configured to receive a medication container.
[0024] According to one embodiment, the medicament container is axially fixed to the container carrier.
[0025] According to one embodiment, the container carrier includes a dosing stop disposed on the distal end.
[0026] According to one embodiment, the biased plunger rod further comprises an interaction member configured to interact with a counter interaction member on the distal end of the container carrier.
[0027] According to one embodiment, the interaction between the interaction member and the counter-interaction member is configured to provide feedback to a user of the medication delivery device.
[0028] According to one embodiment, the biased feeding member cover includes a guide element and the tubular rotating body includes a tubular body having a guide track disposed on an outer surface thereof, the guide element being configured to interact with the guide track such that axial movement of the biased feeding member cover rotates the tubular rotating body.
[0029] According to one embodiment, the biased feeding member cover comprises a feeding member cover link, and the guide element is disposed on the feeding member cover link.
[0030] According to one embodiment, the drug delivery device is in an assembled state when the rotor is in a first rotational position defined when the plunger rod is biased to an initial position in which the counter retaining element engages the first retaining member, when the delivery member cover is biased to a first retracted position in which the guide element is positioned on a first distal end point of the guide track, and when the biased delivery member cover is held in said position by a cap assembly releasably connected to the housing.
[0031] According to one embodiment, the drug delivery device is in an assembled state when the rotor is in a first rotational position defined when the plunger rod is biased to an initial position in which the counter retaining element engages the first retaining member, when the delivery member cover is biased to a first retracted position in which the guide element is disposed on a first distal end point of the guide track, and when the biased delivery member cover is held in said position by a knob assembly axially fixedly connected to the distal end of the housing.
[0032] According to one embodiment, the drug delivery device is in a calibrated state when the rotor is in a second rotational position defined when the plunger rod is biased to a calibrated position in which the counter retaining element engages the second retaining member, and when the delivery member cover is biased to a first extended position in which the guide element is positioned on a first proximal end point of the guide track after the cap assembly is removed from the housing.
[0033] According to one embodiment, the drug delivery device is in a calibrated state when the rotor is in a second rotational position defined when the plunger rod is biased to a calibrated position in which the counter retaining element engages the second retaining member, and when the delivery member cover is biased to a first extended position in which the guide element is positioned on a first proximal end point of the guide track after the knob assembly is pivoted from the first knob position to the second knob position.
[0034] According to one embodiment, the biased plunger rod is configured to move the biased delivery member cover from a first extended position to a second retracted position in which the guide element is disposed on a second distal end point of the guide track, thereby moving from a calibrated position to a final position in which the counter retaining element engages with the third retaining member when a drug contained in the drug container is delivered to a user of the drug delivery device.
[0035] According to one embodiment, the biased feeding member cover is axially movable from a first retracted position to a first extended position, from the first extended position to a second retracted position, and from the second retracted position to a second extended position in which the guide element is disposed on a second proximal end point of the guide track, whereby the feeding member is extended from the feeding member cover when the feeding member cover is in the first retracted position and the second retracted position, and is covered by the feeding member cover when the feeding member cover is in the first extended position and the second extended position.
[0036] According to one embodiment, the counter retaining element is configured such that the biased feeding member cover is axially movable from the first extended position to the second retracted position, thereby disengaging from the second retaining member when moving the rotating body from the second rotational position to the third rotational position.
[0037] According to one embodiment, the tubular rotating body comprises a ramp surface arranged between a first retaining member and a second retaining member, and the counter retaining element is configured to move along the ramp surface from the first retaining member to the second retaining member.
[0038] According to one embodiment, axial movement of the biased delivery member cover from the first retracted position to the first extended position causes the tubular rotor to rotate from the first rotational position to the second rotational position.
[0039] According to one embodiment, the medication delivery device comprises a resilient member configured to bias the biased delivery member cover member in a proximal direction.
[0040] According to one embodiment, the drug delivery device may be an injection device, an on-body device, an inhalation device, a nasal spray, or a medical sprayer.
[0041] According to one embodiment, the delivery member may be a syringe needle, a catheter, or a spray nozzle.
[0042] Other aspects, features, and advantages will become apparent from the above summary and the following description, including the figures and claims.
[0043] In general, all terms used in the claims should be interpreted according to their ordinary meaning in the art unless expressly specified otherwise. All references to elements, devices, components, means, etc. should be openly interpreted as referring to at least one example of the element, device, component, means, etc., unless otherwise specified.
[0044] Specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which: [Brief description of the drawings]
[0045] [Figure 1] FIG. 1 shows a drug delivery device according to a first embodiment of the present invention. [Diagram 2] FIG. 2 is a detailed enlarged view of the drug delivery device of FIG. 1. [Diagram 3] FIG. 2 is a perspective view of a tubular rotating body according to the first embodiment. [Figure 4] FIG. 2 is a perspective view of a plunger rod in the first embodiment. [Diagram 5] FIG. 2 is a diagram showing an administration stop in the first embodiment. [Figure 6A] FIG. 2 is a perspective view of the outer configuration of the tubular rotating body and the guide element on the feeding member cover in the first embodiment. [Figure 6B] FIG. 2 is a side view of the outer configuration of the tubular rotating body and the guide element on the feeding member cover in the first embodiment. [Figure 7A] FIG. 2 is a cross-sectional view of the drug delivery device of the first embodiment in an assembled state. [Figure 7B] FIG. 2 is a cross-sectional view of the drug delivery device of the first embodiment in a calibrated state. [Figure 8A] FIG. 11 is a perspective view of a cap assembly and a delivery member cover according to a second embodiment of the present invention. [Figure 8B] FIG. 11 is a perspective view of a cap assembly and a delivery member cover according to a second embodiment of the present invention. [Figure 9] FIG. 13 is a perspective view of a knob assembly according to a third embodiment of the present invention. [Figure 10] FIG. 13 is a perspective view of a knob assembly according to a third embodiment of the present invention. [Figure 11] FIG. 13 is a perspective view of the outer configuration of a tubular rotating body in the third embodiment. [Figure 12] 13 is a cross-sectional view of the interaction of the guide element and the knob assembly in the third embodiment. [Figure 13] FIG. 13 is a perspective view of an outer configuration of a tubular rotating body in a fourth embodiment of the present invention. [Figure 14] FIG. 13 is a perspective view of the interaction of the guide element, the tubular rotor, and the knob assembly in the fourth embodiment. [Figure 15A] FIG. 13 is a cross-sectional view of the drug delivery device of the third and fourth embodiments in an assembled state. [Figure 15B] FIG. 13 is a cross-sectional view of the drug delivery device of the third and fourth embodiments in a calibrated state. [Figure 16] FIG. 13 is a perspective view of a tubular rotor in an alternative embodiment of the present invention in which the drug delivery device is provided with an automatic piercing feature. [Figure 17] FIG. 13 is a perspective view of a tubular rotor in an alternative embodiment of the present invention in which the drug delivery device is provided with an automatic piercing feature. [Figure 18] FIG. 13 is a perspective view of a retaining arrangement for a tubular rotor and a plunger rod in an alternative embodiment of the present invention. [Figure 19] FIG. 13 is a perspective view of a retaining arrangement for a tubular rotor and a plunger rod in an alternative embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0046] The present application is directed to a feedback mechanism for a drug delivery device, which will now be described in more detail below with reference to the accompanying drawings, in which exemplary embodiments are shown. However, the feedback mechanism may be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein. Rather, these embodiments are provided as examples so that this disclosure will be complete and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like elements throughout the description.
[0047] Fig. 1 shows a drug delivery device in a first embodiment of the present invention, including a housing 1 having a proximal end and a distal end, and a cap assembly 2 disposed on the proximal end of the housing 1 in an assembled state of the drug delivery device. As shown in Fig. 2, the drug delivery device further includes a delivery member cover 3 axially movable but non-rotatably fixed relative to the housing 1, a resilient member 31 disposed between the distal end of the delivery member cover 3 and an inner distal ledge of the housing 1 and configured to urge the delivery member cover 3 in a proximal direction relative to the housing 1, a tubular body 4 disposed within the housing 1 and rotatable but non-axially movable relative to the housing 1, a plunger rod 5 axially movable within the housing 1, a drive element 51 disposed within the plunger rod 5 and configured to urge the plunger rod in a proximal direction, and a container carrier 6 disposed within the housing 1 and axially non-rotatably fixed relative to the housing 1, configured to receive a drug container 8. The drug container 8 is configured to contain a drug and includes a stopper 81 disposed on the distal end and a pierceable membrane disposed on the proximal end. The delivery member assembly 7 comprises a delivery member configured to deliver a dose of a drug to an end user during a drug delivery operation. The delivery member assembly further comprises a delivery member hub configured to hold the delivery member, an inner cap configured to cover the delivery member, and a retainer configured to threadably engage with the inner cap in an assembled state of the drug delivery device. The cap assembly 2 is axially fixed to the inner cap of the delivery member assembly 7, and the inner cap is fixed non-rotatably in one rotational direction. The retainer is snap-fixed to the container carrier 6, whereby the cap assembly 2 is attached to the housing 1 via the delivery member assembly 7 in the assembled state of the drug delivery device. The cap assembly 2 can be removed from the housing 1 of the drug delivery device either when the cap assembly 2 and the inner cap are screwed on or when they are removed from the retainer.Such screw movement causes the delivery member hub to move axially due to the coupling between the inner cap and the delivery member hub, thereby moving the delivery member together with the delivery member hub towards the drug container 8 and establishing fluid communication with the drug container 8.
[0048] 3 shows a tubular rotor with a first retaining member 43a and a second retaining member 43b disposed on an inner surface of the tubular rotor. The first and second retaining members are configured to selectively engage a counter retaining member 52 on the plunger rod 5 as shown in FIG. 4, thereby preventing proximal axial movement of the plunger rod. The counter retaining member 52 is configured to be located on the first retaining member 43a when the tubular rotor 4 is in a first rotational position, and is configured to disengage from the first retaining member 43a and move proximally under the biasing force of the drive element 51 to engage the second retaining member 43b when the tubular rotor 4 is in a second rotational position.
[0049] The plunger rod 5 is in its initial position when the counter retaining member 52 engages with the first retaining member 43a. When the plunger rod is in its initial position, the drug delivery device is in its assembled state, all components of the drug delivery device are assembled, and the device is ready for delivery to an end user. As shown in FIG. 7A, when the drug delivery device is in the assembled state, a gap D is defined by the proximal end of the plunger rod 5 and the distal end of the stopper 81 of the drug container 8. Thus, it is possible to prevent the stopper 81 from being accidentally squeezed forward during shipping of the drug delivery device, compromising the sealing of the drug container 8 by the plunger rod 5.
[0050] When the counter retaining member 52 of the plunger rod 5 engages with the second retaining member 43b of the tubular rotor 4, the plunger rod 5 is in a calibrated position, whereby the drug delivery device is also in its calibrated state. As shown in Fig. 7B, when the drug delivery device is in its calibrated state, the proximal end of the plunger rod 5 is positioned to contact the stopper 81 of the drug container 8, whereby there is no gap D between the proximal end of the plunger rod 5 and the distal end of the stopper 81.
[0051] When the drug delivery device is in the calibrated state, a "zero dose" state is also defined, and the drug delivery device is now ready to perform a drug delivery operation. The counter retaining member 52 of the plunger rod 5 is then configured to disengage from the second retaining member 43b of the tubular rotor 4 when the tubular rotor 4 is in the third rotational position, whereby the plunger rod moves proximally under the biasing force of the drive element 51 and acts on the stopper 81 to deliver a dose of drug. Thus, the drug delivery operation is started. The counter retaining member 52 of the plunger rod 5 is configured to move proximally to engage the dosing stop 61 when the plunger rod 5 is in the final position, whereby the drug delivery operation is ended. The dosing stop 61 can be a ledge arranged on the distal end of the container carrier 6 as shown in FIG. 5 or a ledge arranged on an additional component or a third retaining member arranged on the inner surface of the tubular rotor 4. The delivered dose is determined by the distance between the second retaining member 43b and the dose stop, i.e. the travel distance of the plunger rod 5 from the calibrated position to the final position.
[0052] The tubular rotor 4 is configured to interact with the feed member cover 3. As shown in Fig. 6A, the feed member cover 3 comprises a guide element 32 configured to move along a guide track 41 disposed on an outer surface of the tubular rotor 4. Interaction of the guide element 32 with the guide track 41 causes the tubular rotor 4 to rotate from a first rotational position to a second rotational position and from the second rotational position to a third rotational position.
[0053] As shown in FIG. 6B, during assembly, the tubular rotating body 4 is assembled into the housing 1, the feeding member cover 3 and the elastic member 31 are also assembled into the housing 1, and the guide element 32 is placed on the pre-assembly portion 41a of the guide track 41. The feeding member cover 3 protrudes from the proximal end of the housing 1 because it is biased by the elastic member 31. In the final step of assembly, the feeding member assembly 7 is placed together with the cap assembly 2 toward the proximal end of the housing 1, the proximal end of the feeding member cover 3 is pressed against the elastic member 31, and the feeding member cover 3, the needle assembly 7, and the cap assembly 2 are all moved toward the distal end of the housing, until the distal end of the needle assembly 7 is attached to the container carrier 6, thereby fixing the container carrier 6 to the needle assembly 7 in two axial directions. Such movement causes the guide element 32 to move along the assembly path 41b of the guide track 41 until the distal end of the needle assembly 7 is attached to the container carrier 6 and the needle assembly 7 together with the feeding member cover 3 can no longer move distally relative to the housing 1. The feeding member cover 3 then enters a first retracted position, compressing the resilient member 31, thereby causing the guide element 32 to be positioned on the first distal end point 41c. With the needle assembly 7 attached to the container carrier 6, the drug delivery device is now properly assembled and ready for delivery to an end user. Once the drug delivery device is assembled, the cap assembly 2 is positioned on the proximal end of the housing 1, thereby preventing the feeding member cover 3 from moving proximally, as shown in FIG. 7A. The guide element 32 is then suspended on the first distal end point 41c of the guide track 41. After the cap assembly 2 is unscrewed and completely removed from the housing 1, the delivery member cover 3 moves to a first extended position under the biasing force of the resilient member 31, whereby the proximal end of the delivery member cover protrudes from the proximal end of the housing 1 and is positioned to completely surround the delivery member, as shown in FIG. 7B.When the feeding member cover 3 moves to the first extended position, the guide element 32 moves to the proximal end point 41f of the guide track 41 and passes through the first inclined ledge 41d and the second inclined ledge 41e, thereby causing the tubular rotating body 4 to gradually rotate from the first rotation position to the second rotation position as the guide element 32 passes through the first inclined ledge 41d and the second inclined ledge 41e.
[0054] The feeding member cover 3 can be manually pushed distally to the second retracted position to trigger the drug feeding operation. When the feeding member cover 3 moves to the second retracted position, the guide element 32 moves along the third inclined ledge 41g and the operating ledge 41h toward the second proximal end point of the guide track 41. When the guide element 32 passes the third inclined ledge 41g of the guide track 41, the tubular rotor 4 rotates from the second rotational position to the third rotational position, thereby initiating the drug feeding operation.
[0055] After the drug delivery operation is completed, the delivery member cover 3 is no longer pushed in and is held in the second retracted position, and the delivery member cover 3 is arranged to move proximally under the biasing force of the elastic member 31 to the second extended position of the delivery member cover 3, again surrounding the delivery member. The proximal movement of the delivery member cover 3 causes the guide element 32 to move proximally along the operating ledge 41h of the guide track 41 to the second proximal end point 41i of the delivery member cover 3 of the guide track 41. The guide element 32 passes the locking tongue 42 of the tubular rotor 4 before moving to the second proximal end point 41i of the guide track 41. The locking tongue 42 has a proximal cliff surface, so that after the guide element 32 moves to the second proximal end point 41i of the guide track 41, further distal movement of the delivery member cover 3 is prevented due to a blockage between the guide element 32 and the proximal cliff surface of the locking tongue 42.
[0056] The delivery member protrudes from the proximal end of the delivery member cover 3 when the delivery member cover 3 is in the first and second retracted positions and is covered by the delivery member cover 3 when the delivery member cover is in the first and second extended positions.
[0057] Axial movement of the delivery member cover 3 driven by the elastic member 31 from the first retracted position to the first extended position moves the guide element 32 from the first distal end point 41c to the proximal end point 41f of the guide track 41. As the guide element 32 passes the first inclined ledge 41d and the second inclined ledge 41e, the tubular rotor 4 gradually rotates from the first rotation position to the second rotation position.
[0058] It should be noted that since the rotor 4 engages with the plunger rod 5 by the engagement of the first retaining member 43a with the counter retaining member 52, friction occurs between the first retaining member 43a and the counter retaining member 52 when the rotor 4 rotates relative to the plunger rod 5. The degree of friction depends on the force accumulated in the driving element 51. The reason is that the force accumulated in the driving element 51 is applied to the plunger rod 5, and if this force is too high, the rotor 4 may not be rotated by the guide element 32 of the feed member cover 3, which is driven in the proximal direction by the elastic member 31. Such a defect can be eliminated by arranging a ramp surface to connect the first and second retaining members. Thus, the plunger rod 5 can move along the ramp surface from the first retaining member 43a to the second retaining member 43b. Thereby, the rotation of the tubular rotor 4 from the first rotation position to the second rotation position is mainly caused by the biasing force from the driving element 51.
[0059] The medication delivery device in the first embodiment may further provide audio / tactile feedback to a user of the medication delivery device to indicate the progress of the medication delivery operation. The feedback is provided by an interaction member 53, preferably a plurality of ratchets, disposed on the plunger rod 5 and a counter interaction member 62 disposed on the distal end of the container carrier 6. After the plunger rod 5 moves proximally and passes the distal end of the container carrier 6, a continuous feedback is thereby generated by the interaction of the interaction member 53 and the counter interaction member 62.
[0060] 8A and 8B show a second embodiment of the present invention. Most of the configuration of the second embodiment is the same as that described in the first embodiment. The feeding member is integral with the proximal end of the drug container, and the cap assembly 2' is arranged to be removed from the housing 1 by an axial pulling movement. The cap assembly 2' in the second embodiment comprises a gripping element 21' configured to grip a groove 33 arranged on the proximal part of the feeding member cover 3. After the drug feeding device is fully assembled, the gripping element 21' of the cap assembly 2 is arranged in the proximal end of the housing 1 and engages with the groove 33 of the feeding member cover, whereby the inner surface of the proximal end of the housing 1 inhibits the gripping element 21' of the cap assembly 2 from deflecting radially outward. The cap assembly 2' is thereby attached to the housing 1 of the drug feeding device by the engagement of the gripping element 21' arranged on the proximal part of the feeding member cover 3 with the groove 33. The gripping elements 21' of the cap assembly 2 are prevented from flexing radially outward by being blocked by the inner surface of the proximal end of the housing 1 when the cap assembly 2' is pulled proximally relative to the housing to remove it from the housing 1, so that the gripping elements 21' still grip the grooves 33 of the feeding member cover 3, which also pulls the feeding member cover 3 proximally together with the gripping elements 21' and the cap assembly 2'. Such pulling motion moves the feeding member cover 3 from the first retracted position to the first extended position until the gripping elements 21' of the cap assembly 2 are fully out of the housing 1 and the gripping elements 21' can flex radially outward to disengage from the grooves 33 of the feeding member cover 3. The drug delivery device is thereby moved from the assembled state to the calibrated state by the axial uncapping motion. Since the axial movement of the delivery member cover 3 from the first retracted position to the first extended position, which rotates the tubular rotating body 4 from the first rotational position to the second rotational position, is primarily a movement due to a pulling force by the user of the drug delivery device, in this case too the elastic member 31 no longer needs to accumulate a large force.
[0061] FIG. 9 shows a third embodiment of the present invention. Most of the configuration in the third embodiment is the same as the configuration described in the first embodiment. The drug delivery device in the third embodiment further includes a rotatable knob assembly 9 disposed on the distal end of the housing 1. As shown in FIG. 10, the knob assembly 9 includes a user-accessible outer knob body 91 and an inner knob body 92. The distal end of the inner knob body 92 is received in the outer knob body 91, and the proximal end of the inner knob body 92 is received in the distal part of the housing 1. The inner knob body 92 is fixed to the outer knob body 91 in an axially non-rotatable manner, whereby the inner knob body 92 can be rotated together with the outer knob body 91 relative to the housing 1 by an end user. The knob assembly 9 is rotatable between a first knob position and a second knob position relative to the housing 1. 12, the inner knob body 92 includes a retaining member 92a configured to retain the guide element 32 such that when the knob assembly 9 is in the first knob position, the delivery member cover 3 is also retained in the first retracted position by the retaining member 92a. Proximal movement of the delivery member cover 3 is prevented.
[0062] As shown in FIG. 11, the guide track 41' of the tubular rotor 4 in the third embodiment includes an initial guide ledge 41a' and a first inclined ledge 41b'. When a user of the drug delivery device rotates the knob assembly 9 from the first knob position to the second knob position, the retaining member 92a displaces from the guide element 32, thereby causing the delivery member cover 3 to move proximally under the biasing force of the elastic member 31. Thus, the guide element 32 moves along the initial guide ledge 41a' and the first inclined ledge 41b' to the first proximal end point 41f' of the guide track 41'. After the guide element 32 passes the first inclined ledge 41b', the tubular rotor 4 rotates from the first rotation position to the second rotation position.
[0063] FIG. 13 shows a fourth embodiment of the present invention. Most of the configuration of the fourth embodiment is the same as that described in the third embodiment. The guide track 41″ of the tubular rotor 4 in the fourth embodiment comprises an initial ledge 41a″ configured to hold the guide element 32 of the feeding member cover 3 in a first retracted position when the drug delivery device is properly assembled and ready for feeding to an end user. The tubular rotor 4 in the fourth embodiment further comprises a pivot portion 44″, which is configured to engage a pivot pin 93′ disposed on the knob assembly 9 as shown in FIG. 14. When a user of the drug delivery device rotates the knob assembly 9, the pivot pin 93′ rotates the tubular rotor 4 by engaging with the pivot portion 44″. The rotation of the tubular rotor 4 releases the guide element 32 from the assembled ledge 41a″, and thus the feeding member cover 3 moves proximally to a first extended position under the biasing force of the elastic member 31. The guide element 32 moves to a first distal end point 41c'' of the guide track 41'' and moves along a curved ledge 41b'' of the guide track 41'' due to proximal movement of the feeding member cover 3 towards a first proximal end point 41f'' of the guide track 41''. After the guide element 32 passes the curved ledge 41b'', the tubular rotor 4 rotates from the first rotation position to a second rotation position.
[0064] 15A and 15B show the drug delivery device in assembled and calibrated states in the third and fourth embodiments of the present invention. Pivotal movement of the knob assembly 9 from a first knob position shown in FIG. 15A to a second knob position shown in FIG. 15B pivots the drug delivery device from the assembled state to the calibrated state. In the third and fourth embodiments, the cap assembly 2 is no longer involved in the automatic calibration mechanism, and therefore the cap assembly 2 may have greater design versatility.
[0065] The automatic calibration mechanism described in the first to fourth embodiments can also be used with a drug delivery device including a movable drug container, such as a drug delivery device with an automatic piercing function. As shown in FIG. 16, the tubular rotator 4 for the drug delivery device with an automatic piercing function may be modified to include a holding arm 45 configured to engage with a holding shelf 11' disposed on the inner surface of the housing 1 when the drug delivery device is in the assembled state and the calibrated state as shown in FIG. 17. The tubular rotator may further include a connection portion 46 configured to fit into the distal end of the counter connection portion of the container carrier 6. After the feeding operation is triggered, the feeding member cover 3 pivots the rotator from the second rotation position to the third rotation position as described above, and then the holding arm 45 is disengaged from the holding shelf 11'. Thereby, the tubular rotator 4, the plunger rod 5, the container carrier 6, and the drug container 8 move in the proximal direction under the biasing force of the drive element 51.
[0066] The arrangement of the retaining member of the tubular rotor 4 and the counter retaining member of the plunger rod 5 may be configured inversely to the automatic calibration mechanism described in the first to fourth embodiments. As shown in FIG. 18, the counter retaining member of the plunger rod may be changed to a first counter retaining member 52a' and a second counter retaining member 52b', and the retaining member of the tubular rotor 4 may be changed to a retaining member 43' shown in FIG. 19. The first counter retaining member 52a' is configured to engage with the retaining member 43' on the inner distal surface of the tubular rotor 4 when the tubular rotor 4 is in the first rotational position. When the tubular rotor 4 moves to the second rotational position, the first counter retaining member 52a' disengages from the retaining member 43' and the second counter retaining member 52b' engages with the retaining member 43', thereby moving in the proximal direction until the drug delivery device is rotated from the assembled state to the calibrated state.
[0067] Although the inventive concept has been primarily described above with reference to a few examples, those skilled in the art will readily appreciate that other embodiments besides those disclosed above are equally possible within the scope of the inventive concept as defined by the appended claims. [Explanation of symbols]
[0068] 1. Housing 2, 2' Cap Assembly 3 Feeding member cover 4. Tubular Rotating Body 5 Plunger Rod 6 Container Carrier 7 Feeding member assembly 8. Drug containers 9 Knob Assembly 11' Holding Shelf 21' gripping element 31 Elastic member 32 Guidance elements 33 Groove 41, 41', 41” Guide Track 41a Before assembly 41a', 41a” Initial guide ledge 41b Assembly path 41b First Sloping Ledge 41b” Curved Ledge 41c, 41c" first distal end point 41d First Sloping Ledge 41e Second Sloping Ledge 41f Proximal end point 41f', 41f" first proximal end point 41g 3rd Sloping Ledge 41h Operation Ledge 41i Second proximal end point 42 Locking Tongue 43a first holding member 43b Second holding member 43' Retaining member 44” Swivel section 45 Holding Arm 46 Connection 51 Driving elements 52 Counter retaining member 52a' first counter holding member 52b' second counter retaining member 53 Interacting Components 61 Administration stopped 62 Counter interacting member 81 Stopper 91 Outer knob body 92 Inner knob body 92a Retaining member 93' Pivot Pin
Claims
1. 1. A drug delivery device comprising: A housing (1) having a proximal end and a distal end; a biased plunger rod (5) associated with a medicament container (8) and movable relative to the housing (1), the medicament container (8) being located proximal to the biased plunger rod (5); a tubular rotating body (4) associated with both the feeding member cover (3) and the biased plunger rod (5), the tubular rotating body (4) being a tubular body having a first holding member (43a) and a second holding member (43b) on an inner surface thereof; the medication delivery device having a calibrated state such that the medication delivery device is ready to perform a medication delivery operation; the biased plunger rod (5) comprises a counter retaining element (52) configured to interact with the first retaining member (43a) and the second retaining member (43b); the drug delivery device is in an assembled state when the tubular rotor (4) is in a first rotational position and the biased plunger rod (5) is in an initial position in which the counter retaining element (52) engages with the first retaining member (43a); the medication delivery device is in the calibrated state when the tubular rotor (4) is in a second rotational position and the biased plunger rod (5) is in a calibrated position in which the counter retaining element (52) engages with the second retaining member (43b); A drug delivery device, wherein when the tubular rotating body (4) rotates from the first rotational position to the second rotational position, the biased plunger rod (5) moves in a proximal direction, the counter retaining element (52) engages the second retaining member (43b), and the drug delivery device changes from the assembled state to the calibrated state.
2. 2. The drug delivery device of claim 1, wherein the tubular rotating body (4) has a ramp surface arranged between the first retaining member (43a) and the second retaining member (43b), and the counter retaining element (52) is configured to move along the ramp surface from the first retaining member (43a) to the second retaining member (43b).
3. 3. The drug delivery device according to claim 1 or 2, comprising a biased delivery member cover (3) associated with the housing (1) and movable relative to the housing (1), the drug delivery device comprising a resilient member (31) configured to bias the biased delivery member cover (3) in a proximal direction, the biased delivery member cover (3) comprising a guide element (32), the tubular rotating body (4) comprising a tubular body having a guide track (41; 41'; 41") arranged on an outer surface thereof, the guide element (32) being configured to interact with the guide track (41; 41'; 41") such that an axial movement of the biased delivery member cover (3) rotates the tubular rotating body (4).
4. The drug delivery device of claim 3, wherein when the biased delivery member cover (3) is in a first retracted position, the guide element (32) is positioned on a first distal end point (41c) of the guide track (41), and the biased delivery member cover (3) is held in the first retracted position by a cap assembly (2; 2') releasably connected to the housing (1).
5. The drug delivery device of claim 4, wherein when the biased delivery member cover (3) is in a first extended position, the guide element (32) is positioned on a first proximal end point (41f) of the guide track (41) after the cap assembly (2; 2') is removed from the housing (1).
6. 6. The drug delivery device of claim 5, wherein the biased delivery member cover (3) is axially movable from the first retracted position to the first extended position, from the first extended position to a second retracted position in which the guide element (32) is disposed on a second distal end point (41i) of the guide track (41), and from the second retracted position to a second extended position in which the guide element (32) is disposed on a second proximal end point (41i) of the guide track (41), whereby the delivery member is extended from the delivery member cover (3) when the delivery member cover is in the first retracted position and the second retracted position, and is covered by the delivery member cover (3) when the delivery member cover is in the first extended position and the second extended position.
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