The present invention generally relates to motorized drug delivery devices adapted to receive a drug filled cartridge and subsequently expel a dose therefrom.
In the disclosure of the present invention reference is mostly made to the treatment of diabetes by subcutaneous drug delivery, however, this is only an exemplary use of the present invention.
The most common type of durable drug delivery devices adapted to receive a drug filled cartridge and expel a set dose therefrom are driven by manual means or by a spring energized during dose setting, the cartridge being of the type comprising an axially displaceable piston having an initial proximal position and which is moved distally by a piston rod. Subcutaneous drug delivery takes place via an injection needle arranged in fluid communication with the cartridge. The device may be pen-formed or in the form of a more box-shaped so-called doser. In order to improve convenience, user-friendliness and provide additional features, e.g. detection and storing of expelling data, drug delivery devices have been provided with electrically driven means, typically in the form of an electronically controlled motor driving a piston rod through a gear arrangement, e.g. as shown in U.S. Pat. No. 6,514,230 and US 2011/306927. A further type of motorized drug delivery device is known from WO 2007/118907 disclosing a portable infusion pump.
Although motorized drug delivery devices facilitate a number of benefits to the customer as many trivial routines can be automated, these devices are often rather large in comparison to conventional mechanical devices and thus they are impractical to carry and store. Addressing this issue WO 03/099357 discloses a pen-formed drug delivery device comprising a drive arrangement including a piston rod in the form of a tubular body that can be moved into a drug cartridge when being advanced in a distal direction, the tubular body defining an internal hollow wherein at least a portion of a motorized drive assembly is arranged when the tubular body is positioned in a retracted proximal position. This configuration for a drive assembly may be termed “motor-in-piston”. Such a drive assembly could also be considered a telescopic drive assembly in which the inner motor drive assembly is the stationary part and the outer tubular body is the moved telescopic part.
As the different moving components of the drive mechanism is arranged in the internal hollow of the tubular body it may be a challenge to design a robust and cost-effective mechanism that will fit in the small space inside the tube.
Having regard to the above, it is an object of the present invention to provide a motorized drug delivery device, e.g. of the motor-in-piston type, as well as components therefor which provide a high degree of reliability in a cost-effective way.
In the disclosure of the present invention, embodiments and aspects will be described which will address one or more of the above objects or which will address objects apparent from the below disclosure as well as from the description of exemplary embodiments.
Thus, in accordance with a first aspect of the invention a drug delivery device is provided comprising a compartment adapted to receive and hold a drug-filled cartridge, the cartridge comprising an outlet, a generally cylindrical proximal portion and an axially displaceable piston. The device further comprises a housing and drug expelling means comprising a piston driver comprising a distal end adapted to engage and axially move, directly or indirectly, the piston of a loaded cartridge to thereby expel an amount of drug from the cartridge through the outlet, and a motor assembly for moving the piston driver. A base member is provided and adapted to engage a cartridge and position the cartridge relative to the piston driver, the base member comprising a main portion with a central passage, a portion of the piston driver being arranged axially displaceable through the passage, the piston driver distal end being arranged distally of the central passage. The base member further comprises first flexible centring means extending distally from and being radially moveable relative to the main portion, the first flexible centring means being adapted to receive the proximal end of a cartridge and centre it relative to the central passage and thereby to the piston driver.
As the first flexible centring means does not form part of the base member portion defining the central passage, the base member will be centring the cartridge relative to the piston driver, the tolerance chain from the cartridge to the piston driver will be as short as possible as they are aligned in the same component, this making a larger diameter piston driver possible.
The base member may further comprise second flexible centring means adapted to engage the housing and centre the base member relative to the housing. When the base member is centred in relation to the housing, the tolerance chain from the piston diameter to the chassis will also be as short as possible. The term “housing” covers an outer housing as well as internal housing components such as a frame or a chassis.
The piston driver may be in the form of a tubular piston member comprising an inner thread, the motor assembly having a distal portion and a proximal portion, the distal portion comprising a rotatable drive shaft and being adapted to be received inside the tubular piston member. For such an arrangement it is an advantage that the diameter of the motor assembly can be as large as possible thereby reducing manufacturing costs and improving reliability.
The drug delivery device may further comprise a drive member having an outer thread, wherein the tubular piston member is arranged axially displaceable but non-rotational relative to the motor assembly, the motor assembly proximal portion is connected to the housing, the drive shaft is connected to the drive member, and the drive member outer thread is in threaded engagement with the tubular piston member inner thread, whereby rotation of the drive shaft results in axial, non-rotational displacement of the tubular piston member relative to the housing. The drive shaft may be connected to the driver via a first universal joint, and the motor assembly proximal portion may be connected to the housing via a second universal joint.
The piston driver may also be in the form of a traditional solid piston rod, the drive mechanism for the piston driver being arranged outside a mounted cartridge. For such a design the present invention also improves reliability, e.g. when the piston rod is made from metal and the cartridge has a small inner diameter.
In an exemplary embodiment the piston driver distal end comprises flexible centring means adapted to engage a cartridge inner surface proximally of the piston, thereby centring the cartridge and the piston driver distal end relative to the each other.
As used herein, the term “drug” is meant to encompass any flowable medicine formulation capable of being passed through a delivery means such as a cannula or hollow needle in a controlled manner, such as a liquid, solution, gel or fine suspension, and containing one or more drug agents. Representative drugs include pharmaceuticals such as peptides (e.g. insulins, insulin containing drugs, GLP-1 containing drugs as well as derivatives thereof), proteins, and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form. In the description of the exemplary embodiments reference will be made to the use of insulin containing drugs, this including analogues thereof as well as combinations with one or more other drugs.
In the following exemplary embodiments of the invention will be further described with reference to the drawings, wherein
In the figures like structures are mainly identified by like reference numerals.
When in the following terms such as “upper” and “lower”, “right” and “left”, “horizontal” and “vertical” or similar relative expressions are used, these only refer to the appended figures and not necessarily to an actual situation of use. The shown figures are schematic representations for which reason the configuration of the different structures as well as their relative dimensions are intended to serve illustrative purposes only. When the term member or element is used for a given component it generally indicates that in the described embodiment the component is a unitary component, however, the same member or element may alternatively comprise a number of sub-components just as two or more of the described components could be provided as unitary components, e.g. manufactured as a single injection moulded part. The term “assembly” does not imply that the described components necessarily can be assembled to provide a unitary or functional assembly during a given assembly procedure but is merely used to describe components grouped together as being functionally more closely related.
Before turning to a detailed description of an exemplary embodiment of the invention a schematic representation of drug delivery device with a telescopic motor-in-piston drive assembly will be described to better provide an understanding of the general working principle of such an arrangement.
More specifically,
Although shown as two components, the compartment portion and the main portion are rigidly connected to each other or formed as a single component providing a chassis or platform for other components of the device.
The drive assembly comprises an outer piston drive tube 220 with an inner thread, a motorgear assembly 240 having a distal portion and a proximal portion, the distal portion comprising a rotatable drive shaft defining a z-axis and to which is mounted a drive member 241 comprising an outer thread in engagement with the piston drive tube inner thread. The motorgear assembly is arranged axially non-displaceable and non-rotational relative to the chassis, the drive member is mounted axially non-displaceable and non-rotational on the drive shaft, and the piston drive tube is arranged axially displaceable but non-rotational relative to the chassis and thus also to the motor assembly, whereby rotation of the drive shaft results in axial, non-rotational displacement of the piston drive tube relative to the chassis, the piston drive tube being adapted to engage and axially move distally, directly or indirectly, the piston of a loaded cartridge to thereby expel drug from the cartridge. In the shown embodiment the piston drive tube is provided with a distal drive head 222 adapted to engage the piston 205 of a loaded cartridge 202.
The shown embodiment of
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The cartridge 10 comprises a cylindrical body portion, a distal outlet portion 12 with a distal needle-penetrable septum, and an axially displaceable piston having a proximal surface allowing a piston driver forming part of the expelling mechanism (see below) to engage the piston. The cartridge may for example contain an insulin, a GLP-1 or a growth hormone formulation. The cartridge is provided with distal coupling means in the form of a needle hub mount 15 having, in the shown example, combined thread and bayonet coupling means, each being adapted to engage an inner thread or bayonet coupling means of a corresponding hub of a needle assembly. The shown exemplary hub mount further comprises a circumferential flange with a number of distally facing pointed projections serving as a coupling means for the cartridge holder assembly as will be described in more detail below. A hub mount of the shown type is described in U.S. Pat. No. 5,693,027. Alternatively the needle hub mount may be formed as part of the cartridge holder, e.g. in the form of a “split” hub mount having two parts arranged on each side of the gripping shoulders.
As shown, the cartridge holder assembly 310 has the same general appearance as a traditional cartridge holder which is detachably coupled to the housing by e.g. a threaded coupling or a bayonet coupling and into which a new cartridge can be received as well as removed through a proximal opening, i.e. it comprises no additional user operated release or locking means. Instead, what appears merely to be the cartridge holder per se is in fact user operated coupling means in the form of an outer rotatable tubular actuation sleeve 316 operated by the user to control movement of cartridge holding means in the form of an inner cartridge holder member 317 to thereby open and close gripping shoulders 318 configured to grip and hold a cartridge. More specifically, each gripping shoulder is provided with a plurality of gripping teeth spaced circumferentially to provide a plurality of gaps, each tooth having a triangular configuration with a proximally oriented pointed end, thereby creating a plurality of gaps having a distally oriented pointed configuration, this allowing the above-described distally facing pointed projections on the cartridge to be received between the teeth to thereby serve as a gripping means when the cartridge holding means has been moved into engagement with the cartridge. In this way an easy-to-use front loaded drug delivery device is provided which appears as a traditional rear loaded device and which is also actuated by rotational movement to mount and remove a cartridge, the resemblance providing for ease of acceptance and adaptation among users accustomed to traditional types of rear loaded drug delivery devices.
When it is time to mount a new cartridge the outer tube member 316 is rotated e.g. 90 degrees by which action the gripping shoulders 318 are moved distally and slightly outwards, this allowing the mounted cartridge to be removed. For ease of operation the cartridge may be moved distally a certain distance as the shoulders are moved, e.g. by engagement with arms forming the gripping shoulders and/or by additional spring means providing a biasing distally directed force (see below). Depending on the design of the locking and actuation mechanism the gripping shoulders may be able to be left in the open position or they may be retracted automatically as the outer tube member is rotated backwards by return spring means. Whether or not a spring is provided the cartridge holder may be provided with locking means allowing the outer tube member to be securely parked in either the open or closed position, e.g. by a rotational snap lock. When a new cartridge is inserted the drive expelling means has to be in a state allowing a new cartridge with a proximally positioned piston to be inserted. An exemplary embodiment providing this functionality will be described below.
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The motor-gear drive assembly comprises a tubular main portion composed of a proximal motor assembly 351 and a distal gearbox assembly 352 having a rotatable drive shaft 353 defining a z-axis of rotation. The assembly further comprises a distal cylindrical drive member 355 having an outer thread adapted to be arranged in engagement with the piston drive tube inner thread. At the proximal end a disc-formed chassis connector 356 is arranged. In the shown embodiment the drive assembly is provided with flexible joints in the form of a distal universal joint 357 arranged between the drive shaft and the drive member and a proximal universal joint 358 arranged between the motor assembly proximal portion and the chassis tube proximal portion. A corresponding drive assembly is described in greater detail in patent application EP 14166859.0, which is hereby incorporated by reference.
A number of further details can be seen in
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As all components are manufactured with a given tolerance the actual dimension selected for the outer piston tube diameter has to take into account the tolerances for all relevant components. Thus, the smaller the aggregate tolerances between the piston tube outer circumference and the cartridge inner circumference the larger the outer diameter for the piston tube can be selected.
Addressing this issue a base member is provided, the base member having (i) a central opening guiding and centring the piston, and (ii) flexible portions engaging the cartridge outer circumference and centring it relative to the piston, this reducing the tolerance chain between piston and cartridge making a larger diameter piston possible. The base member may be provided with additional flexible portions centring the base member relative to the chassis.
When the base member is centring the cartridge, the tolerance chain from the cartridge to the piston tube will be as short as possible because they are aligned in the same component. When the base member is centred in relation to the chassis, the tolerance chain from the piston diameter to the chassis will also be as short as possible. Each of the centring features can be implemented independently if only one is required.
As described with reference to
Addressing this issue
In the above description of exemplary embodiments, the different structures and means providing the described functionality for the different components have been described to a degree to which the concept of the present invention will be apparent to the skilled reader. The detailed construction and specification for the different components are considered the object of a normal design procedure performed by the skilled person along the lines set out in the present specification.
Number | Date | Country | Kind |
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14185310.1 | Sep 2014 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2015/071322 | 9/17/2015 | WO | 00 |