Patent Application
20110259774
The present invention generally relates to a cover or a packaging for a device comprising a moveable structure, the cover or packaging being adapted to activate the moveable structure when opened by a user.
In the disclosure and discussion of the present invention reference is made to the treatment of diabetes by delivery of e.g. insulin, however, this is only an exemplary use of the present invention.
Portable drug delivery devices for delivering a drug to a patient are well known and generally comprise a reservoir adapted to contain a liquid drug and having an outlet in fluid communication with a transcutaneous access device such as a soft cannula or a hollow infusion needle, as well as expelling means for expelling a drug out of the reservoir and through the skin of the subject via the cannula or needle, the latter often in the form of an infusion set. Such devices are often termed infusion pumps.
Basically, infusion pumps can be divided into two classes. The first class comprises durable infusion pumps which are relatively expensive pumps intended for 3-4 years use, for which reason the initial cost for such a pump often is a barrier to this type of therapy. Although more complex than traditional syringes and pens, the pump offers the advantages of continuous infusion of insulin, precision in dosing and optionally e.g. programmable delivery profiles and user actuated bolus infusions in connections with meals.
Addressing the above problem, several attempts have been made to provide a second class of drug infusion devices that are low in cost and convenient to use. Some of these devices are intended to be partially or entirely disposable and may provide many of the advantages associated with an infusion pump without the attendant cost and inconveniences, e.g. the pump may be prefilled thus avoiding the need for filling or refilling a drug reservoir. Examples of this type of infusion devices are known from U.S. Pat. Nos. 4,340,048 and 4,552,561 (based on osmotic pumps), U.S. Pat. No. 5,858,001 (based on a piston pump), U.S. Pat. No. 6,280,148 (based on a membrane pump), U.S. Pat. No. 5,957,895 (based on a flow restrictor pump (also know as a bleeding hole pump), U.S. Pat. No. 5,527,288 (based on a gas generating pump), or U.S. Pat. No. 5,814,020 (based on a swellable gel) which all in the last decades have been proposed for use in inexpensive, primarily disposable drug infusion devices, the cited documents being incorporated by reference.
The disposable pumps generally comprises a skin-contacting mounting surface adapted for application to the skin of a subject by adhesive means, and with the infusion cannula or needle arranged such that in a situation of use it projects from the mounting surface to thereby penetrate the skin of the user, whereby the place where the needle penetrates the skin is covered while the appliance is in use. This kind of disposable pump are often referred to as a “patch pump” and may be either unitary as disclosed in U.S. Pat. No. 6,699,218, or in the form of an assembly comprising two or more components which when assembled constitutes a patch pump as disclosed in e.g. WO 2005/039673.
When a disposable device such as a pump is supplied to the user it normally has to be activated before being put into use. For example, the pump disclosed in U.S. Pat. No. 6,699,218 is supplied to the user with an empty reservoir which is then to be filled by the user before being mounted to a skin surface. The pump comprises electronic circuitry for communicating with a remote controller and for controlling the pump mechanism expelling fluid drug from the reservoir. In the disclosed embodiment the circuitry is activated from its dormant state when the reservoir is being filled, however, this could also be done by actuation of a user-actuatable switch.
The pump may also be supplied to the user with a pre-filled reservoir which then has to be connected to a fluid-conducting structure before being put into use. In the pre-filled pump assembly disclosed in US 2006/264835, hereby incorporated by reference, a pump-reservoir unit is provided in which a flexible, pre-filled and sealed reservoir is provided in combination with a down-stream electronically controlled suction pump. Before the unit can be taken into use the pump has to be connected with the reservoir and the electronics have to be activated. WO 2009/021950 shows a pump designed to be used in a pump-reservoir unit as disclosed in US 2006/264835, this pump being adapted to be arranged moveable relative to the reservoir, such that the pump has to be pushed towards the reservoir before the unit is activated and can be mounted on the patch unit. The actuation could be done manually by the user or it could happen when the pump-reservoir unit is mounted to the patch unit, however, it may be considered an advantage if the pump-reservoir unit was fully activated and ready-for-use when it was taken out of its primary packaging by the user.
Having regard to the above-identified problems, it is an object of the present invention to provide an arrangement which ensures that an assembly comprising a moveable structure can be activated when a packaging or cover fully or partly surrounding the assembly is opened by a user. In case the enclosed assembly is optimized for e.g. small size or low production costs the actuation motion may be “in conflict” with the intuitive way of handling the enclosing packaging material. Thus, the package or cover should be easy and intuitive to open but still ensure that the enclosed assembly is activated correctly and reliably. This said, the cost of the packaging and its assembly should still be cost-effective.
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, corresponding to a first aspect, an assembly is provided comprising a device and a cover arranged to cover at least a portion of the device in an initial position. The device comprises a first portion, and a second portion moveable relative to the first portion between an initial and an actuated position, wherein movement of at least a portion of the cover from the initial position in a first direction results in the second portion of the device being moved in a second direction between the initial and the actuated position, the first direction being different from the second direction. The force required to move the second portion of the device in the second direction is provided fully or in part by movement of the at least a portion of the cover, i.e. energy necessary to move the second portion is provided by the user when moving the cover or a portion thereof. As appears, this is different from traditional “actuation designs” in which movement of e.g. a stop by the user will allow a biased part to move, e.g. driven by a pre-stressed spring as disclosed in WO 2004/041334. By the arrangement of the invention it is possible to provide a cover-device assembly which is simple in design, easy and intuitive to use and open and at the same time ensures that the covered device is actuated correctly.
In illustrative examples the first and second directions may be essentially opposite to each other, however, the first and second directions may be based on movement of the same or different “kinds”, e.g. axial, rotational or composite wherein movement of different kinds always can be considered in different directions, e.g. when a rotational movement is translated into an axial or vice versa.
In a first exemplary embodiment an assembly is provided comprising a removable cover in the form of a container and a device arranged in the container. The device comprises a first portion, and a second portion moveable relative to the first portion between an initial and an actuated position, and the container comprises a cavity portion and a closure member which together form an enclosure in which the device is arranged initially, wherein movement of the closure member from an initial position in a first direction results in the second portion of the device being moved in a second direction between the initial and the actuated position, the first direction being different from the second direction.
To accomplish the translation of movement the container may be provided with an actuation structure which moves the second portion of the device in the second direction, however, it could also be pulled or rotated. The actuation structure may comprise a pivot member with a proximal and a distal portion, wherein the pivot member initially is connected to either the cavity portion or the first portion of the device by a pivoting joint located between the proximal and the distal portion. The closure member is connected to the pivoting member in such a way that movement of the closure member from the initial position results in a pivoting movement of the distal portion of the pivot member, whereby the pivoting movement pushes, pulls or rotates the second portion of the device in the second direction.
In an exemplary embodiment the pivoting joint is adapted to disengage when the pivot member has moved the second portion of the device to its actuated position, this arrangement allowing the closure member to be removed from the cavity portion. The closure member may comprise an outer shell connected to the proximal portion of the pivot member by a flexible connection (e.g. hinged structure or string), this allowing a pulling force to be transmitted to the pivot member when the closure member is moved in the first direction.
The actuation structure may comprise two pivoting members arranged to pivot in opposite directions when the closure member is moved from the initial position, whereby the distal portions of the pivot members will be moved in opposite directions. In an exemplary embodiment the actuation structure is adapted to exert an essentially axial force on the second portion relative to a predetermined direction of movement between the first and second portion, this preventing kinking of the second portion relative to the first portion in respect of the predetermined direction of movement. A pair of pivot members being moved against or towards each other could be used to ensure such an axial force.
The first device portion may be in the form a housing with an opening in which the second device portion is slidably arranged, the closure member in its initial position sealing the opening. The container comprises locking means for directly or indirectly locking the second portion relative to the first portion when the cover is in its initial position, the locking means being adapted to unlock when the cover is moved away from its initial position. For example, the first portion may be locked to the closure member and the second portion to the cavity portion, the closure member and the cavity portion being locked to each other. The cover may be arranged to move a predetermined distance to unlock the locking means before the second portion of the device is being moved.
In accordance with the above-described first exemplary embodiment an assembly is provided in which a device is enclosed in a container from which it can be removed, however, the invention may also be realized in a configuration corresponding to a second exemplary embodiment in which an assembly is provided comprising a device and a cover attached to a portion thereof, where the device comprises a first portion, and a second portion moveable relative to the first portion between an initial and an actuated position. Movement and/or removal of the cover from an initial position in a first direction results in the second portion of the device being moved in a second direction between the initial and the actuated position, the first direction being different from the second direction. This configuration may then be modified corresponding to the above disclosure of the first exemplary embodiment.
More generally, and corresponding to a further aspect of the invention, an assembly is provided comprising a sub-assembly and a cover attached to a portion thereof, the sub-assembly comprising a first portion, and a second portion moveable relative to the first portion between an initial and an actuated position, wherein movement of the cover from an initial position in a first direction results in the second portion of the sub-assembly being moved in a second direction between the initial and the actuated position, the first direction being different from the second direction.
The sub-assembly may be in the form of a device comprising the first and second portion, with the cover being attached to the first portion. Alternatively, the sub-assembly may be in the form of a device arranged at least partly in the interior of a cavity portion, the cavity portion and the cover together forming an enclosure in which the device is arranged initially.
For all of the above embodiments of the invention, the first portion may comprise a fluid-filled reservoir (e.g. containing a fluid drug), and the second portion may comprise a fluid conducting structure, the fluid conducting structure being adapted to be arranged in fluid communication with the reservoir in the actuated position. The fluid conduction structure may be in the form of an electronically controlled suction pump, e.g. a membrane pump. As used herein, the term “drug” is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a hollow needle in a controlled manner, such as a liquid, solution, gel or fine suspension. Representative drugs include pharmaceuticals such as peptides, 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. Correspondingly, the term “subcutaneous” infusion is meant to encompass any method of transcutaneous delivery to a subject.
In a further aspect of the invention a method for arranging a device in a container is provided, comprising the steps of (a) providing a container comprising a cavity portion and a closure portion which together form an enclosure, (b) providing a device adapted to be arranged at least partly in the cavity portion, (c) providing an actuation unit comprising a pivot member, the actuation unit being adapted to lock to the closure portion, (d) arranging the device at least partly in the cavity portion, (e) arranging the actuation unit with the pivot member in pivoting engagement with either the cavity portion or the device, (f) arranging the closure portion in engagement with the cavity portion to thereby form an enclosure in which the device is arranged, and (g) locking the actuation unit to the cover portion. As appears, the described method allows the different components to be assembled efficiently in a “stacked” fashion.
The device may comprise a first portion and a second portion moveable relative to the first portion between an initial and an actuated position, and the actuation unit may be adapted to provide a pivoting movement of the pivot member when the cover portion is moved away from the cavity portion, the pivoting movement moving the second portion of the device towards the actuated position. In order to allow the cover portion to be removed from the cavity portion the pivot member may be adapted to be released from the pivoting engagement with the cavity portion or the device when the. The actuation unit may comprise a hinged structure adapted to be reversibly locked in an initial folded configuration, the actuation unit being arranged in engagement with either the cavity portion or the device in its folded configuration.
In the following 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”, “above” and “below”, “horizontal” and “vertical” or similar relative expressions are used, these only refer to the appended figures and not to an actual situation of use. The shown figures are schematic representations for which reason the configuration of the different structures as well as there relative dimensions are intended to serve illustrative purposes only.
In the following an embodiment of the present invention will be described in which an actuatable pump unit is arranged in a packaging container from which it is to be removed. The pump unit 100 comprises a housing 110 in which a pump assembly 120 is slidingly mounted. The container 101 (see
The flexible metal locking member 500 shown in
Before turning to a description of the working principle of the disclosed embodiment of the invention, it will be described how the different components can be assembled in a cost-efficient way.
In a first step the locking member 500 is mounted in the case 200 where after the pump unit with the pump assembly in its initial position is placed in the case. In a next step the actuation member 400 in its folded configuration is mounted in the case whereby the axle heads are positioned in their corresponding axle seats. When the actuation member is in its folded configuration the axle heads cannot be inserted into the axle seats via the peripheral openings 238, however, the inherent flexibility of the case allows the axle seats of the case to “open and close” around the axle heads when the axle heads for forced into engagement with the ramps 239, this allowing the actuation member to be inserted in a general axial direction (as defined by the case). Indeed, alternatively the actuation member could be “folded into place” via the openings in the axle seats. During this insertion the release projection 411 first passes below the slanted edge 520 of the flexible locking member 500 where after the locking projections 412 engage the proximal surface of the slanted edge, thereby forcing the latch 525 into engagement with the indentation 125 in the pump assembly, this locking the pump assembly 120 relative to the case. At the same time a portion of the actuation member engages the free edge portion 112 of the pump unit housing, thereby effectively locking the pump assembly relative to the pump housing, this preventing undesired movement of the two components during handling of the assembly. It should be noted that in this position the distal free ends 436 of the pivot members 430 do not engage the pump assembly. To properly position the base member 410 relative to the case the two pairs of projections 412, 413 are adapted to fit into the gap between the interior ridges 211, just as the stop members 414 prevents the base members from being inserted too deep into the case by engaging the free distal edge of the case.
In a final step the cover is slid over the case with the guide flanges 301 being inserted in the corresponding grooves 210 of the case. As the cover is mounted on the case the latches 415 of the actuation member engages the corresponding hooks on the interior end surface of the cover, thereby permanently locking the two components to each other. As the cover prevents the axle seats from moving outwards, this ensures that the actuation member is properly locked to the case via the pivoting joints. In the fully mounted position locking protrusions 315 on the interior of the cover releasably engages corresponding locking grooves 215 on the exterior surface of the case just as the circumferential seal structure 219 on the case effectively seals the gap between the cover and case, thereby protecting the interior of the container from e.g. dust and water.
With reference to
As the cover is pulled further apart from the case the pivot members continue to rotate, the pivoting free ends 436 thereby forcing the pump assembly from its initial position towards its actuated position fully inserted into the pump housing. As appears, the two symmetrically arranged pivot members will ensure that the pump assembly is moved linearly into the pump housing.
When the pivot members have been rotated to fully insert the pump assembly into the pump housing as shown in
The above-described pump unit may be adapted to be used in combination with a patch unit of the type shown in e.g. EP 1 527 792 or WO 2006/077263, which is hereby incorporated by reference. In WO 2006/077263 a pump unit is shown in which a pump assembly (comprising pump and actuator) is arranged stationary in a pump housing, the pump comprising a moveable needle connector which is pushed into contact with the reservoir when the pump unit is connected to a patch unit for the first time. Compared with this earlier version the above-described embodiment of a pump unit comprises a pump of the type shown in WO 2009/021950 (hereby incorporated by reference) where a needle connector projects from the pump, a fluid communication between the pump and reservoir being established by moving the pump (and thus the pump assembly) relative to the reservoir.
With reference to
As also described above, a given device does not have to be fully enclosed in the interior of a container to implement the present invention, it may suffice if only a portion of a device is covered or enclosed with a member (e.g. protecting cover) which is to be removed prior to use. For example,
In the above description of the preferred 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 |
|---|---|---|---|
| PA 200801261 | Sep 2008 | DK | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/EP2009/061738 | 9/10/2009 | WO | 00 | 7/13/2011 |
