Patent Application
20190240411
The present invention relates to a housing element for attaching an auxiliary unit to a medicament delivery device. More in particular, the housing element comprises an integrated mount for the auxiliary unit.
To maintain optimum conditions, a patient suffering from a chronic medical condition is required to conform to a prescribed administration schedule of a medication, adhere to a prescribed dosage, avoid extra administrations, avoid missed administrations, and adhere to various recommended health and safety best practices.
The long-term health of the patient with a chronic medical condition depends on the day-to-day management of the condition. Mismanagement of the condition can result in significant morbidity and mortality and carry an increased risk of developing complications. Focused approach to management of a chronic medical condition is essential for the patient, in order to reduce the occurrence of these complications.
For example, diabetes occurs when the body does not produce enough insulin resulting for many diabetics in a requirement of a periodic insulin injection to control glucose levels in the body. One of the dangers associated with controlling glucose levels with insulin is insulin overdose. Symptoms of an insulin overdose reflect low blood sugar levels (hypoglycemia) and can include headache, irregular heartbeat, increased heart rate or pulse, sweating, tremor, nausea, increased hunger, and anxiety.
An insulin dependent diabetic needs to keep accurate track of the type and amount of insulin he is injecting. In order to help control the administration of insulin various supervisory devices have been developed. One prior art device, WO2010128493, comprises a particular sleeve being designed to rigidly lock onto to a prefabricated injection pen of a particular design, a universal header designed to rigidly lock onto the particular sleeve irrespective of the particular model of the prefabricated injection pen, an electronics assembly housed by the universal header, a sensor to detect an injection automatically, the sensor being communicatively coupled to the electronics assembly, a display to display injection data, and a button to allow manipulation and display of the injection data, including resetting the time.
This device suffers from a number of drawbacks. The sleeve is an extra component that the user has to cope with when administrating insulin, making drug administration more complicated. It may further have a less than perfect fit with the delivery device, which may cause it to detach and fall off. It is also prone to being dislocated, which may result in reduced quality of measurements and monitoring of the administration process.
An object of the present invention is to provide an improved device to remedy the drawbacks of prior art devices.
In the present application, when the term “distal” is used, this refers to the direction pointing away from the dose delivery site. When the term “distal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located furthest away from the dose delivery site. Correspondingly, when the term “proximal” is used, this refers to the direction pointing to the dose delivery site. When the term “proximal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located closest to the dose delivery site.
Further, the term “longitudinal”, with or without “axis”, refers to a direction or an axis through the device or components thereof in the direction of the longest extension of the device or the component.
The term “lateral”, with or without “axis”, refers to a direction or an axis through the device or components thereof in the direction of the broadest extension of the device or the component. “Lateral” may also refer to a position to the side of a “longitudinally” elongated body.
In a similar manner, the terms “radial” or “transversal”, with or without “axis”, refers to a direction or an axis through the device or components thereof in a direction generally perpendicular to the longitudinal direction, e.g. “radially outward” would refer to a direction pointing away from the longitudinal axis.
Also, if nothing else is stated, in the following description wherein the mechanical structure of the device and the mechanical interconnection of its components is described, the device is in an initial non-activated or non-operated state.
As stated above, the aim of the present invention is to provide a simple and robust orientation indicator that is also reliable and easy to use.
According to a main aspect of the invention it is characterized by the features of the independent patent claims. Further advantageous features are the subject of the dependent claims.
According to a main aspect of the invention it is characterised by a housing element for a medicament delivery device, which housing element comprises a mount for releasably attaching an auxiliary unit, and wherein the mount is integral with the housing element.
According to another aspect of the invention, the housing element is integral with an outer shell of a medicament delivery device.
The housing element is to be regarded as an integral part of the medicament delivery device. It may be a separate component before assembly, but during assembly it becomes an irreplaceable part of the delivery device. As such, a user may not dislocate it or remove it. An added advantage is that an auxiliary device which is attached to the mount is more robustly and accurately positioned in relation to the delivery device.
According to another aspect of the invention, the mount is positioned on a lateral side surface of the medicament delivery device.
According to another aspect of the invention, the mount is positioned on a distal end surface of the medicament delivery device.
Depending on the intended use of the auxiliary device, the position of the mount, in relation to the medicament delivery device, is chosen to achieve the best effect. For instance, a lateral position may be the most convenient for monitoring the movement of a plunger rod of the medicament delivery device, e.g. by optically monitoring the plunger rod through a window in the casing of the delivery device. On the other hand, in some instances it may be preferable to mount the auxiliary unit on the distal end, e.g. on a dose setting member.
According to another aspect of the invention, the mount is configured to releasably attach to an auxiliary unit by positive locking.
According to another aspect of the invention, the mount is configured to releasably attach to an auxiliary unit by friction-fit.
According to another aspect of the invention, the mount is configured to releasably attach to an auxiliary unit by magnetism.
According to another aspect of the invention, the mount is configured to releasably attach to an auxiliary unit by non-permanent adhesive.
The attachment between the mount and the auxiliary unit may be selected from a range of available methods. It is important, however, that the auxiliary device is securely fastened in a predetermined position, while still being removable from the mount.
According to another aspect of the invention, the mount is shaped to only allow attachment to a correspondingly shaped auxiliary unit.
Such a keyed attachment prevents a user from accidentally attaching an incorrect auxiliary unit to a medicament delivery device that he intends to use.
According to a main aspect of the invention it is further characterized by an auxiliary unit for releasable attachment to the mount of said housing element, wherein the auxiliary unit is an electronics unit.
According to another aspect of the invention, the auxiliary unit is adapted to determine and to provide information about an operational state and/or usage of a medicament delivery device in which the housing element is comprised.
According to another aspect of the invention, the auxiliary unit is adapted to communicate measurements and information to another unit.
The electronics unit may comprise a processor capable of processing data program code for performing different tasks. The electronics unit may also comprise memory elements, in which retrieved data may be stored. The electronics unit may further comprise a power supply such as button cells, photovoltaic panels, etc.
Communication elements of the electronics unit may communicate with another unit, such as a user or a smartphone, etc. The communication elements may comprise display elements that visual communication, e.g. by text on a display. In addition to, or instead, the user communication elements may comprise audio elements that can communicate audibly, via loudspeakers of the electronics unit. The communication elements may further comprise circuits for near range communication technology such as RFID, NFC or the like, as well as Bluetooth, Ant, ZigBee, just to mention a few.
According to another aspect of the invention, the auxiliary unit is correspondingly shaped with regard to the mount.
The corresponding shapes only allow a correct combination of a medicament delivery device with a predetermined auxiliary unit.
According to a further main aspect of the invention it is characterized by a medicament delivery device comprising said housing element.
According to another aspect of the invention, the medicament delivery device is a disposable medicament delivery device.
According to another aspect of the invention, the medicament delivery device is a pen injector.
According to another aspect of the invention, the medicament delivery device is an inhalation device.
A further advantage of the present invention is that it may be adapted for disposable medicament delivery devices, where the user removes the auxiliary device from the mount and disposes of the medicament delivery device, for instance by putting it in a sharps container, when the delivery device is expended. The auxiliary unit may then be reused and attached to a new disposable device. Pen injectors represent a type of delivery device that is often disposable. They are often used for administration of insulin.
These and other features and advantages of the present invention will become apparent from the following detailed example of an embodiment and the accompanying drawings.
In the following detailed description, reference will be made to the accompanying drawing of which
The housing element 20 of
The mount 30 of
For instance, it may be advantageous to position the mount 30 and the auxiliary unit 40 on the lateral side surface of the medicament delivery device 10 in order detect relative axial movements of housing parts of the delivery device 10, e.g. movement of a dose setting member 60 in relation to the housing 50. In some cases, however, a position on a distal end surface of the medicament delivery device 10 may be more useful. The position of the mount 30 and the auxiliary unit 40 must also be positioned such that they support user interaction with the auxiliary unit 40 without hindering normal use of the delivery device 10.
There are many different ways in which the auxiliary unit 40 may be releasably attached to the mount 30. Examples include positive locking, friction-fit, magnetism, or non-permanent adhesive.
The mount 30, as exemplified by
Likewise, friction-fit is easily achieved in the same manner. Friction-fit is advantageous in that the mount and the auxiliary unit may be detached without unlocking any locking members.
Attachment by magnets or non-permanent adhesive is preferably combined with a shaped form-fit such that the relative positions of the mount 30 and the auxiliary unit 40 is uniquely determined by their complimentary shapes as they dock with each other.
Regardless of the type of attachment, the mount 30 and the auxiliary unit 40 may be keyed to each other by corresponding shapes or positions of the respective attachment devices such that a particular auxiliary unit 40 may only be attached to a certain mount 30 of a housing element 20, comprised in a predetermined medicament delivery device 10. Such a keyed attachment only allows the correct auxiliary unit 40 to be attached to the intended medicament delivery device 10.
The various types of attachment devices, e.g. snaps, latches, hooks, gripping members, slots, grooves, holes, recesses, etc., are not shown in the drawings since they are obvious variations that are readily available to a skilled person.
The auxiliary unit 40 shown in
In use, a medicament delivery device 10 is unpacked by the user. The auxiliary unit 40 is thereafter removably attached to the mount 30, which is integrated with the housing element 20 of the medicament delivery device 10. In the example of
The user may then remove the medicament delivery device 10 from the administration site, detach the auxiliary unit 40, and discard the medicament delivery device 10, for instance in a sharps container, if the delivery device is a needle-based injection device.
The auxiliary unit 40 is kept by the user for later use with another medicament delivery device 10. In this way, the auxiliary unit is used for a number of delivery devices, possibly for the whole treatment of an affliction. In the case where the auxiliary unit 40 is an electronics unit, the data collected may be analysed and used to improve the therapy of a patient/user.
It should be understood that the housing element described above and shown in the drawings is to be regarded only as a non-limiting example and that it may be modified in many way within the scope of the patent claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| EP16193873.3 | Oct 2016 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2017/074075 | 9/22/2017 | WO | 00 |
