The present application claims priority to European Patent Application No. 18207448.4 filed Nov. 21, 2018 which is herewith incorporated by reference into the present application.
The present disclosure generally relates to a self-righting supporting device for holding a medicament delivery device in a vertical position. In particular, the self-righting device comprising a support body for supporting the medicament delivery device, and an assembly comprising a self-righting device and an elongated medicament delivery device, are provided.
There is a variety of diseases which require regular treatment by an injection or an inhalation of a medicament. Often such treatments are performed by patients themselves, sometimes once or several times a day. The devices on the market for self-administering doses of medicament are widely vary depending on a kind of medicament to be delivered to the patient. Some kind of medicaments, such as for example, Bydureon, a drug used against a diabetes, shall be properly shacked during some time prior to delivery to a patient. Another drugs might be unstable and require a mixing or dissolving of an active substance just prior to the delivery. Some types of medicaments can be stored for a long time and may be filled in containers, such as cartridges, syringes, ampoules, canisters or the like, containing a ready-to-use medicament in liquid state. However, some types of medicaments are a mixture of two substances, typically a medicament agent (such as lyophilized, powdered or concentrated liquid) and a diluent (such as water, dextrose solution or saline solution). These types of medicaments cannot be pre-mixed and stored for a long time because the medicament agent is unstable and will lose its effect quickly due to degradation. Hence, a user has to perform the mixing within a limited time period prior to the delivery of a dose of medicament by manually operating a medicament delivery device. During the mixing, the container may comprise both gas and medicament, and the escaping gas might expel some amount of the medicament. In this case, the dose of medicament may be smaller than intended.
In order to facilitate the mixing, a number of containers for medicament have been developed comprising at least two chambers, known as multi-chamber containers. Multi-chamber containers typically comprise a first chamber containing the medicament agent and at least one second chamber containing the diluent. These chambers may be sealed off with a stopper such that the medicament agents cannot be mixed when stored and do not become degraded. When the medicament agent is to be mixed shortly before administering and the stopper is moved, redirecting passages are opened between the chambers. The passages allow the mixing of the medicament agent and the diluent. After sufficient mixing, the medicament is ready for delivery.
There is a risk that the medicament delivery device due to its shape falls or rolls away. This in turn risks damage to the medicament delivery device. Therefore, it is desired to avoid this risk and provide a holder or a support. The medicament delivery devices with multi-chambers containers often requires priming of the medicament delivery device before being used. This means that all gas or air bubbles in the medicament are to be evacuated. Some medicaments requires a couple of minutes shaking prior to delivery to ensure a proper mixing of ingredients. Some medicaments due to higher viscosity need to be primed for a longer period.
U.S. Pat. No. 5,797,885 A discloses an apparatus and a method for recapping of syringe needles situated on a proximal end. The apparatus comprises a cap holder with a base and a weight distribution such that a cap retained in the cap holder is always oriented in an upright position with the upper end thereof being opened.
U.S. Pat. No. 4,043,334 discloses a self-righting syringe protector for a syringe after its filling with a medicament in form of a cap to prevent leakage and contamination. The cap has a tubular coupler which automatically points upwardly. A U.S. Pat. No. 5,797,885 discloses an apparatus for recapping the used syringe needle for protection of the medical professionals from injuries.
An International application WO 2016/040126 discloses a self-righting cap developed for receiving syringes, small-bore tube connectors, catheters or enteral feeding tubes to prevent their misconnection.
An International application WO 2017/086607 discloses a syringe safety cap assembly and, particularly, a syringe safety cap assembly, which can prevent a user from being hurt when inserting a syringe needle into a cap and can also fundamentally block the reuse of a syringe or a syringe needle, which are to be discarded.
A number of different supplemental or accessory type's devices are known on the market which are to be used together with the automatic medicament delivery devices for a self-administration. Those supplemental devices are able to record information about the various times when the medicament is to be administrated, quantity to be delivered and the other parameters.
In the present disclosure, when the term “distal” is used, this refers to the direction pointing away from a 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.
One object of the present disclosure is to provide a supporting device with a self-righting body for supporting a medicament delivery device, which self-righting supporting device improves user experience and can support the medicament delivery device in a substantially vertical position for the required time.
A further object of the present disclosure is to provide a supporting self-righting device body for supporting a medicament delivery device, which the supporting self-righting device due to keeping the medicament delivery device in up-right position improves priming of the medicament delivery device.
A still further object of the present disclosure is to provide a self-righting device for supporting a medicament delivery device, which self-righting device improves quality of mixing of two substances in the medicament delivery device achieving a homogenous ready-to-use medicament.
A still further object of the present disclosure is to provide a supporting medicament delivery device self-righting device, which self-righting device facilitates gas escape from the medicament delivery device via its up-right oriented proximal end.
A still further object of the present disclosure is to provide a medicament delivery device self-righting supporting device a, which self-righting device body enables support of different types and shapes of elongated medicament delivery devices.
A still further object of the present disclosure is to provide a medicament delivery device supporting self-righting device, which self-righting device improves accuracy of the medicament dose delivery.
A still further object of the present disclosure is to provide a medicament delivery device supporting self-righting device, which self-righting device solves two or more of the foregoing functions in combination.
A still further object of the present disclosure is to provide an assembly comprising a supporting self-righting device and a medicament delivery device while supported, which assembly solves one, several or all of the foregoing objects.
According to one aspect, there is provided a self-righting device for receiving and supporting in a substantially vertical position a medicament delivery device having a proximal end and a distal end with its proximal end in upright orientation. The supporting device comprises a support body having a least a first top surface facing upwardly in up-right position of the body. The first top surface is curved, bend or flat surface and has a receptive, a fixture or an accommodating depression for inserting of the medicament delivery device into it. The accommodating depression has an inner circumferential surface of a chosen shape and size and a bottom surface of a chosen shape. A second curved base surface intersects with the first top surface circumferentially thus defining the support body of the supporting device. The second curved surface is facing away from the first surface. A central axis A of the body is perpendicular to the first and the second surfaces and is vertical when the body is in its up-right position. The second surface is smooth with one of a spherical or elliptical shape without any irregularities allowing the central axis A of the body of the device to swing around a center of gravity in all directions if/when the body set in motion.
According to another aspect, there is provided a self-righting device comprising a support body for supporting a medicament delivery device; the support body having a mass, a center of gravity and a shape such that the self-righting device, when positioned on a substantially horizontal surface, moves from an unbalanced position to an upright position. The self-righting device further comprises a mechanical adaptor configured to be attached to the support body and for holding an elongated medicament delivery device at an angle less than 30 degrees from a vertical axis when the self-righting device is in the upright position. The mechanical adaptor or adaptors can be used when the medicament delivery devices of the different dimensions and shapes of the distal end are to be supported in one, became universal a supporting self-righting device. The adaptor/adaptors might have the varying reception parts for fitting the different medicament delivery devices and a size/shape of the outer circumference fitting in or mating with the accommodating depression or a fixture on the support body.
The self-righting supporting device according to the present disclosure facilitates preparation and handling of the medicament delivery device. Since the self-righting device is configured to automatically move from the unbalanced position to the upright position while holding the medicament delivery device in up-right position, it is avoided that the medicament delivery device lies flat on the horizontal surface. The self-righting supporting device thereby provides self-rightness of the medicament delivery device. The vertical or up-right positioning of the medicament delivery device by the self-righting device, i.e. at an angle less than 30 degrees from the vertical axis, prevents the medicament delivery device from rolling away on a flat surface or possibly fall down.
In addition, the vertical positioning (or substantially vertical positioning) of the medicament delivery device improves handling of the medicament delivery device since this orientation makes the medicament delivery device easy to grasp, particularly for patients with reduced hands or fingers ability to grasp. For example, a user may easier remove a cap from the medicament delivery device, even by one hand, when the device is situated vertically.
Furthermore, the vertical positioning (or substantially vertical positioning) of the medicament delivery device enables gas that appears during mixing of the multicomponent medicament to escape. Thus, the self-righting supporting device ensures that the medicament delivery device is primed and oriented in the proper position before use.
The self-righting supporting device, e.g. having the mechanical adaptor thereof, which is to be inserted into the accommodating depression or in an accommodating member and configured to hold the distal end of the medicament delivery device which is opposite to the proximal end from which the medicament delivery occurs. The dimension and shape of the outer circumference surface of the adaptor shall mate with the inner circumference surface dimension and shape of the accommodating member or fit into it, wherein the inner circumference surface dimension and shape of the adaptor shall mate the outer surface of the distal end of the supported medicament delivery device to be inserted in it. The distal ends of the different medicament delivery devices may also have the different shapes and dimensions, and therefore, the adaptor allows to use the single supporting device or the support body for supporting the different medicament delivery devices in the up-right position just by changing to the correspondent adaptor. Throughout the present disclosure, the self-righting supporting device may be referred to as a self-balancing cap or module.
The medicament delivery device may comprise an elongated tubular housing of varied cross-sectional shapes. The medicament delivery device according to the present disclosure may comprise at least two chambers for containing two medicament agents to be manually mixed before being delivered. The medicament delivery device may for example be an injection or an auto-injection device for injecting a medicament, such as a drug mixture, by a user. Alternatively, it might be an inhaler.
The support body may be generic, such that various different types of mechanical adaptors can be attached to the support body. The mechanical adaptor may be configured to hold a particular type (or a particular end) of medicament delivery device. Thus, the mechanical adaptor may be adapted for a particular type of medicament delivery device. The self-balancing cap or the support body and the adaptor (s) may be delivered together with the corresponding medicament delivery device or separately. At the change of the medicament/medicament delivery device, it is not required to obtain a new supporting device, but just to change the adaptor, which is economic and environmental advantageous.
The mechanical adaptor may be constituted by a coupler between the support body and the medicament delivery device. The mechanical adaptor may be tubular or may comprise a tubular portion. When the self-righting supporting device does not hold any medicament delivery device and when the mechanical adaptor is attached to the support body, the mechanical adaptor may be accessible in an upward direction when the self-righting device adopts the upright position. The mechanical adaptor may be provided with friction increasing material in order to more securely hold an end of the medicament delivery device.
The self-righting supporting device may be configured such that the center of gravity of the self-righting support body is positioned along a central axis at a location causing the support body to automatically orient the medicament delivery device when been supported in a substantially vertical or up-right orientation when the self-righting device is placed on a flat substantially horizontal surface. The support body and/or the mechanical adaptor may be manufactured by an injection molding, for example from thermoplastic materials.
Throughout the present disclosure, the self-righting supporting device may be a medical-use self-righting device. The self-righting device according to the present disclosure is not a toy but a useful accessory for improving a self-administration of the medicament.
The self-righting supporting device according to the present disclosure may be an accessory to the medicament delivery device purchased when/if needed. The self-righting device may for example be delivered together with the medicament delivery device as a kit.
The support body or the self-balancing cap may comprise at least a proximally-facing first surface which faces generally upwards in an upright position of the self-righting device, a distally-facing convex second surface which faces generally downwards in an upright position of the self-righting device. The second surface may comprise a continuous convex shape. That is, for each point on the second surface having a continuous convex shape, a normal to the point points in a unique direction. The second surface may not comprise any flat portion. The convex shape may be substantially hemispherical, or hemispherical. The support body may thus form a hemisphere.
The positioning of the center of gravity causes the self-righting supporting device to rock from any unbalanced position, where the second surface is in contact with the substantially horizontal surface, to the upright position. When the medicament delivery device is held such that its longitudinal axis is parallel with a vertical axis, the first surface may be horizontal, or substantially horizontal.
The center of gravity may be located between the first surface and the second surface. For example, the center of gravity may be distanced less than 40%, such as less than 15%, of a height of the self-righting device from a lowermost point of the second surface (when the self-righting device adopts the upright position).
The support body may comprise the accommodating member, and the mechanical adaptor may be shaped and dimensioned so as to securely hold a predetermined medicament delivery device to the self-righting supporting device by attachment to the accommodating member. In this case, the mechanical adaptor may be permanently attached to the accommodating member. The permanent attachment to the accommodating member may be achieved by at least one of glue, press-fit or snap-fit connection between the mechanical adaptor and the accommodating member.
Alternatively, the mechanical adaptor may hold the medicament delivery device to the self-righting supporting device by releasable attachment to the accommodating member. The releasable attachment to the accommodating member may be achieved by at least one of a threaded coupling, a bayonet coupling or a friction-fit coupling between the mechanical adaptor and the medicament delivery device, and between the mechanical adaptor and the accommodating member. Any other known releasable connection types are also can be used.
The accommodating member may be a socket in the first surface of the support body, and the center of gravity may be located between the socket bottom and the second surface. Alternatively, the accommodating member may be a fixture on the first top surface of the support body (not shown).
The support body may comprise at least one of a weight element such as e.g. a battery or a motor and the other components such as LED indicators, loudspeakers, a temperature sensor or a communication module. The motor may be used to shake the medicament delivery device for mixing the medicament for a prescribed time. Alternatively, the motor may be used to provide a status indication, for example by vibrating, swinging and/or “dancing”. Also the LED indicators and the speakers may be used to provide a status indication to the user of the either mixing completion or the medicament delivery device priming completion processes or the both.
The weight element may for example be formed either by a sold piece of the support body material itself or comprise additionally a tungsten. The self-righting supporting device may comprise one or several weight elements. As its name implies, a weight element adds weight to the self-righting device. Of course, a weight element may provide further functions than only adding weight.
The support body may comprise at least a battery and a motor which motor may be activated to mix a diluent and a medicament contained in the different separate chambers of the medicament container of the medicament delivery device supported by the support body. Alternatively, or in addition, the support body may comprise at least a battery, a communication module and a motor, which communication module may, wirelessly or by direct contact, obtain a status from the medicament delivery device supported by the support body to activate the motor to perform a motion of the support body, which motion indicates the status of the medicament delivery device supported by the support body.
The support body may further comprise a communication module and at least one of a LED indicator and a speaker, which communication module may, wirelessly or by direct contact, obtain a status from the medicament delivery device supported by the support body to visibly and/or audibly indicate the status of the medicament delivery device supported by the support body to the user. In such a case, the motor or alternatively battery might function as a weight element.
According to a further aspect, there is provided a self-righting supporting device comprising a support body for supporting a medicament delivery device in the upright position; the support body having a mass, a center of gravity and a shape such that the self-righting device, when positioned on a substantially horizontal surface, moves from an unbalanced position to an upright position. The self-righting device is configured to hold the elongated medicament delivery device at an angle less than 30 degrees from a vertical axis when the self-righting device is in the upright position. Thus, the self-righting supporting device according to the present disclosure does not necessarily comprise a mechanical adaptor. The self-righting device without the mechanical adaptor is easier to manufacture, cheaper and can provide a good support for a particular type of the medicament delivery device. If the user only uses one type of medicament or the medicament delivery device, a self-righting device without a mechanical adaptor is sufficient. According to a further aspect, there is provided an assembly of the self-righting device according to the present disclosure, and an elongated medicament delivery device to be supported. The medicament delivery device may comprise a temperature sensor e.g. as a chip or another kind of sensors at its distal end attached to the support body and the self-righting device may comprise a communication module for reading temperature data from the chip of the temperature sensor or the other data. The medicament delivery device supporting body may have a memory or be able to communicate with the other devices e.g. a computer and suitable gadgets in a known manner for transferring or recording of data.
Further details, advantages and aspects of the present disclosure will become apparent from the following embodiments taken in conjunction with the drawings, wherein:
In the following, a self-righting device comprising a support body for supporting a medicament delivery device, which might be a manual injector, an automatic or semi-automatic injector or an inhaler, and an assembly comprising a self-righting device and an elongated medicament delivery device, will be described. The same reference numerals will be used to denote the same or similar structural features.
The medicament delivery device 2 of this example comprises an elongated tubular housing 26 and a cap 27 attached to the housing 26 at the proximal end 21 thereof. The medicament delivery device 2 further comprises an opening 25 on its side surface for viewing a syringe. In the example in
The support body 11 has a mass and a center of gravity G. The support body 11 comprises a proximally-facing first top surface 12 and a distally-facing opposite second base surface 13. The center of gravity G of the support body 11 is positioned between the first surface 12 and the second surface 13. In the example in
The mass, the center of gravity G and the shape of the support body 11 thereby causes the support body 11, when holding the medicament delivery device 2, to move from any of unbalanced positions 46a, 46b, 46c on a substantially horizontal surface to an upright position 47. The self-righting device 1 thus prevents the medicament delivery device 2 from laying horizontally in the unbalanced position 46a. In the upright position 47, the proximal end 21 of the medicament delivery device 2 is directed upwards.
The gravity force of the self-righting device 1 generates a moment on the self-righting device 1 and on the medicament delivery device 2 such that the self-righting device 1, and the medicament delivery device 2 held by the self-righting device 1, are rotated from any of the unbalanced position 46a, 46b, 46c, towards the upright position 47. The self-righting device 1 and medicament delivery device 2 will eventually become stable and at rest in the upright position 47. However, the hemispherical shape of the support body 11 causes the self-righting device 1 to swing back and forth before becoming stable and at rest in the upright position 47.
Prior to delivering a dose of medicament, a user may for example remove the cap 27 and initiate mixing of two medicament components. The mixing process may be initiated in various ways, for example by pushing a button, rotating two parts relative to each other or releasing a lock. When the mixing has been initiated, a first chamber of a medicament container containing a medicament agent and a second chamber of the medicament container containing a diluent are brought into communication. When the medicament agent and the diluent are mixed, air bubbles often develop. In order to release these bubbles, the medicament delivery device 2 should be held in an upright position, preferably in substantially vertical orientation for some time that might be different for different medicaments, for example a few minutes. As known, this process is called priming. The self-righting supporting device 1 assists in priming for a user that do not need to hold the medicament delivery device in a hand by supporting the medicament delivery device 2 in a generally vertical orientation and by swinging about its axis.
When the mixing has been initiated, the medicament delivery device 2 may be inserted by the user into the self-righting device 1. The user might be a patient itself or medically trained personnel. Alternatively, mixing of the medicament delivery device 2 may be initiated while already being supported by the self-righting supporting device 1. When the mixing has been initiated, the user may place the assembly 44 on a substantially horizontal surface, such as on a table surface. Unless the medicament delivery device 2 is placed in a perfectly vertical orientation, the self-righting device 1 and the medicament delivery device 2 will swing slightly about a vertical axis. This swinging enhances the mixing, e.g. by making the mixing more homogenous and/or by more efficiently venting gases.
The self-righting device 1 of the example in
The self-righting supporting device 1 in
The self-righting supporting device 1 of the example in
The distal end 22 of the medicament delivery device 2 in
The self-righting supporting device 1 of the example in
The distal end 22 of the medicament delivery device 2 in
The self-righting supporting device 1 in
Instead of the external thread 34 in
The mechanical adaptor 3 in
As shown in
Although the mechanical adaptor 3 in
As shown in
The self-righting supporting device 1 in
While the present disclosure has been described with reference to exemplary embodiments, it will be appreciated that the present invention is not limited to what has been described above. For example, it will be appreciated that the dimensions of the parts such as the accommodating member 14 of the support body 11 and the distal end 22 of the medicament delivery device 2 may be adapted to each other to mate as needed and the adapter 3 might be omitted as illustrated in
Number | Date | Country | Kind |
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18207448.4 | Nov 2018 | EP | regional |