Patent Application
20160361505
The invention relates to an injection apparatus having a shielded needle cannula. The invention especially relates to such injection device having a mechanism which automatic expels drops of the liquid drug contained in the injection device when the needle shield is moved axially during injection.
Shielded needle assemblies are widely known. WO 2003/045480 discloses a safety needle assembly in which the axially movable shield locks after one injection such that the needle assembly cannot be reused.
WO 2008/077706 discloses a similar construction wherein the telescopic shield is prevented from axial movement when the needle assembly is removed from the injection device. However, every time the needle assembly is mounted onto the injection device the shield unlocks.
It is an object of the present invention to provide an injection device in which the tip of the needle cannula automatically is made wet prior to or during penetrating the skin of the user.
The invention is defined in the attached claim 1 followed by a number of embodiments. The individual claims are explained in details in the following.
Accordingly, in one aspect of the present invention, the injection apparatus comprises:
Further, axial movement of the telescopic shield in a proximal direction rotates the motion transforming means which operates the pressure element to move axially in a proximal direction, and wherein the pressure element abuts the flexible septum which is forced proximally upon axial movement of the pressure element such that the volume of the interior of the cartridge decreases.
In this way a gearing is established between the axial movement of the shield and the axial movement of the pressure element. The result being that a drop of liquid drug is pressed out through the lumen of the needle cannula upon axial movement of the shield such that the tip of the needle cannula is wet during injection.
When the tip of the needle cannula is wet during injection, the friction as the needle penetrates the skin of the user is minimized thus making the injection less pain full. Further due to the preservatives comprised in the liquid drug, bacteria transmission is minimized as the lumen of the needle cannula is flushed as the telescopic shield moves axially.
The motion transforming means is preferably formed as one unitary element but could be constructed from a number of parts working together to transform axial movement to rotational movement. In the same manor, the hub means can be one unitary unit or it can be assembled from a number of parts which when together form the hub means.
In a preferred embodiment, the tip of the needle cannula is maintained submerged in a cleaning solvent between injections. This cleaning solvent is preferably stored in a reservoir carried by the shield. In a preferred embodiment, the cleaning solvent is either the same preservative as present in the liquid drug or alternatively the cleaning reservoir is filled with the exact same drug as contained in the cartridge. This reservoir preferably has a proximal surface and a distal surface made from a pierceable septum material. During injection, the tip of the needle cannula penetrates through the distal septum such that the tip projects distally to perform an injection. During the penetration of the distal septum it is an advantage that the tip of the needle cannula is made increasingly more wet since this cleans the tip as it cuts through the distal septum.
In one embodiment, the hub means form part of an injection device such as a pre-filled injection device i.e. an injection device which is not to be re-filled by the user.
In another embodiment, the hub means form part of a needle assembly which is attachable to an injection device which can be either pre-filled or durable.
The telescopic shield preferably comprises an internal track for guiding the motion transforming means. This track preferably has a helical track part for introducing rotation to the motion transforming means as it move axially. The motion transforming means comprises an axial extending hollow part surrounding the needle cannula and a perpendicular bar having two opposite ends. At least one end of the perpendicular bar engages the helical part of the internal track of the telescopic shield. Further, the motion transforming means is axially secured such that the motion transforming means can only rotate around its own centre axis (X) upon axial movement of the telescopic shield.
As the shield is moved axially, without rotation, upon injection, the engagement between the shield and the motion transforming means forces the motion transforming means to rotate. In an alternative embodiment, the track can be provided in the motion transforming means and the engaging protrusion can be provided in the shield. Thus the important feature being that at least a part of the motion transforming means rotate as the shield move axially.
The proximal end of the hollow part of the motion transforming means preferably has a wave-shaped surface which engages with a similar wave-shaped distal end surface of a pressure element.
As the pressure element is axial guided preferably in the hub means, the pressure element is forced to move axially as the motion transforming means is rotated. The gearing ratio between the axial movement of the shield and the axial movement of the pressure element is thus a result of the pitch of the helical part of the track and the shape of the waves.
The axial and proximal movement of the pressure element is transferred to a proximal depressive movement of the flexible septum of the cartridge since the pressure element abuts the flexible septum.
The result being that the volume of the interior of the cartridge is decreased which again presses liquid drug out through the lumen of the connected needle cannula. The amount of liquid drug thus expelled is equal to the volume the interior of the cartridge is decreased.
An “injection pen” is typically an injection apparatus having an oblong or elongated shape somewhat like a pen for writing. Although such pens usually have a tubular cross-section, they could easily have a different cross-section such as triangular, rectangular or square or any variation around these geometries.
The term “Needle Cannula” is used to describe the actual conduit performing the penetration of the skin during injection. A needle cannula is usually made from a metallic material such as e.g. stainless steel and connected to a hub to form a complete injection needle also often referred to as a “needle assembly”. A needle cannula could however also be made from a polymeric material or a glass material. The hub also carries the connecting means for connecting the needle assembly to an injection apparatus and is usually moulded from a suitable thermoplastic material. The “connection means” could as examples be a luer coupling, a bayonet coupling, a threaded connection or any combination thereof e.g. a combination as described in EP 1,536,854.
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 includes pharmaceuticals such as peptides, proteins (e.g. insulin, insulin analogues and C-peptide), and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form.
“Cartridge” is the term used to describe the container containing the drug. Cartridges are usually made from glass but could also be moulded from any suitable polymer. A cartridge or ampoule is preferably sealed at one end by a pierceable membrane referred to as the “septum” which can be pierced e.g. by the non-patient end of a needle cannula. Such septum is usually self-sealing which means that the opening created during penetration seals automatically by the inherent resiliency once the needle cannula is removed from the septum. The opposite end is typically closed by a plunger or piston made from rubber or a suitable polymer. The plunger or piston can be slidable moved inside the cartridge. The space between the pierceable membrane and the movable plunger holds the drug which is pressed out as the plunger decreased the volume of the space holding the drug. However, any kind of container—rigid or flexible—can be used to contain the drug.
Since a cartridge usually has a narrower distal neck portion into which the plunger cannot be moved not all of the liquid drug contained inside the cartridge can actually be expelled. The term “initial quantum” or “substantially used” therefore refers to the injectable content contained in the cartridge and thus not necessarily to the entire content.
By the term “Pre-filled” injection device is meant an injection device in which the cartridge containing the liquid drug is permanently embedded in the injection device such that it cannot be removed without permanent destruction of the injection device. Once the pre-filled amount of liquid drug in the cartridge is used, the user normally discards the entire injection device. This is in opposition to a “Durable” injection device in which the user can himself change the cartridge containing the liquid drug whenever it is empty. Pre-filled injection devices are usually sold in packages containing more than one injection device whereas durable injection devices are usually sold one at a time. When using pre-filled injection devices an average user might require as many as 50 to 100 injection devices per year whereas when using durable injection devices one single injection device could last for several years, however, the average user would require 50 to 100 new cartridges per year.
All references, including publications, patent applications, and patents, cited herein are incorporated by reference in their entirety and to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.
All headings and sub-headings are used herein for convenience only and should not be constructed as limiting the invention in any way.
The use of any and all examples, or exemplary language (e.g. such as) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention. The citation and incorporation of patent documents herein is done for convenience only and does not reflect any view of the validity, patentability, and/or enforceability of such patent documents.
This invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law.
The invention will be explained more fully below in connection with a preferred embodiment and with reference to the drawings in which:
The figures are schematic and simplified for clarity, and they just show details, which are essential to the understanding of the invention, while other details are left out. Throughout, the same reference numerals are used for identical or corresponding parts.
When in the following terms as “upper” and “lower”, “right” and “left”, “horizontal” and “vertical”, “clockwise” and “counter clockwise” 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 that context it may be convenient to define that the term “distal end” in the appended figures is meant to refer to the end of the needle cannula supposed to be inserted into the skin of the user whereas the term “proximal end” is meant to refer to the opposite end pointing away from the user and usually inserted into the interior of the cartridge as depicted in
The injection apparatus as depicted in
The distal flexible septum 2 is penetrated by a needle cannula 10. The needle cannula 10 has a distal part 11 with a tip 12 and a proximal part 13 and defines a lumen 14. The proximal part 13 is penetrated through the distal septum 2 of the cartridge 1 such that axial movement of the movable plunger 3 in a distal direction presses the liquid drug out through the lumen 14 of the needle cannula 10.
The needle cannula 10 is secured in a hub 20. The hub 20 can as in the depicted embodiment be permanent attached to an injection device such that the needle assembly and the injection device form one single unit which is disposed after use. Alternatively, in a different and non-shown embodiment, the hub 20 and thus the needle assembly can be releasable connected to the injection device e.g. by a thread or a bayonet connection such that the needle assembly can be discarded without discarding the entire injection device.
Sliding on the outside of the hub 20 is the telescopic shield 30. The shield 30 is urged in a distal direction by a spring 31 encompassed between the hub 20 and the shield 30. The shield 30 further carries a reservoir 32 for keeping the tip 12 of the needle cannula 10 clean between subsequent injections.
Such cleaning reservoir 32 for cleaning the tip 12 of the needle cannula 10 between injections is further described in International patent application No.: PCT/EP2014/071746. Distally this reservoir 32 has a distal septum 33 carried by the shield 30 and proximally the reservoir 32 is bordered by a proximal septum 23 which is carried by an auxiliary element 25 sliding in the hub 20. Since the reservoir 32 is filled with a cleaning liquid, which in a preferred embodiment is identical to the liquid drug contained in the interior 4 of the cartridge 1, the volume of the reservoir 32 remains constant. The auxiliary element 25 thus moves axially together with the reservoir 32 and the telescopic shield 30. The auxiliary element 25 is preferably provided with stop protrusions 26 such that the auxiliary element 25 cannot slide distally out of its engagement with the hub 20.
As depicted in
The telescopic shield 30 is internally provided with a track 35 which has a helical part 36 and an axial part 37 as depicted in
Guided in the hub 20 and surrounding the needle cannula 10 is the motion transforming element 40. This motion transforming element 40, which is depicted in perspective in
The hub 20 is preferably provided with a cut-out 21 in which the perpendicular bar 43 of the motion transforming element 40 is axially locked but able to rotate a predetermined angle.
At least one end 44a of the perpendicular bar 43 engages the internal track 35 in the telescopic shield 30 as disclosed in
The track (or tracks) 35 have a helical part 36 and an axial part 37 as will be explained.
As an injection is performed, the user presses the shield 30 against the skin which pushes the shield 30 in a proximal direction as indicated by the arrow “P” in
Once the one end 44a of the perpendicular bar 43 is out of the helical part 36 of the track 35 it enters the axial part 37 of the track 35 thus allowing the tip 12 of the needle cannula 10 to reach its fully extended position as depicted in
After the liquid drug has flown into the body of the user, the telescopic shield 30 is removed from the skin of user where after the spring 31 moves the shield 30 back into its initial position of
The axial hollow part 41 of the axial movement 40 has a wave-shaped proximal surface 45. In the disclosed embodiment, the shape consists of 4 tops and 4 valleys, however any number can be provided.
Between the flexible septum 2 of the cartridge 1 and the motion transforming element 40, a pressure element 50 is provided. This pressure element 50 has a number of guiding elements 51 which are axially guided in similar guiding tracks 22 provided in the hub 20. Further, the pressure element 50 has a proximal end 52 and a wave-shaped distal end 53. This wave-shaped distal end 53 abuts the proximal wave-shaped end 45 of the motion transforming element 40. The wave-shaped surfaces 45, 53 are identical in shape such that when one surface is rotated and the opposite is prevented from rotation one of the surfaces 45, 53 will be forced to move axially.
In the disclosed embodiment, the motion transforming element 40 rotates when the telescopic shield 30 is moved axially as explained above. Since the two wave-shaped surfaces 45, 53 are forced to rotate relatively to each other the proximal end 52 of the pressure element 50 is forced axially further into its abutment with the distal septum 2 of the cartridge 1. This relative rotation forces the pressure element 50 to move axially as the guiding interface 22, 51 between the hub 20 and the pressure element 50 prevents rotation of the pressure element 50.
In the depicted embodiment each of the two wave-shaped surfaces consists of 4 tops and 4 valleys thus requiring a 45 degrees relative rotation to reach its maximum axially departed extension.
When forcing the distal septum 2 of the cartridge 1 further into the interior 4 of the cartridge 1 the volume of the interior 4 decreases. This will consequently press a small amount of liquid drug equal to the decreased volume out through the lumen 14 of the needle cannula 10. Since the volume of the lumen 14 of the needle cannula 10 is very little only a minor decrease in the volume of the interior 4 of the cartridge 1 is needed to actually make a drop of the liquid drug appear on the tip 12 of the needle cannula 10. The expelling of liquid drug is illustrated by the drop “D” in
Some preferred embodiments have been shown in the foregoing, but it should be stressed that the invention is not limited to these, but may be embodied in other ways within the subject matter defined in the following claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 14156344.5 | Feb 2014 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2015/051964 | 1/30/2015 | WO | 00 |
