WO2012127366A1

WO2012127366A1 - Injection system and actuating device for attachment to a pen-injector to form such injection system

Info

Publication number: WO2012127366A1
Application number: PCT/IB2012/051210
Authority: WO
Inventors: Helen Marie MOORE
Original assignee: Pfizer Limited
Priority date: 2011-03-23
Filing date: 2012-03-14
Publication date: 2012-09-27
Also published as: AR085465A1; TW201304831A; JP2012200601A

Abstract

Injection system (1) comprising a pen-injector (2) including: - a shell (3) having an elongated outer surface and proximal and distal sections, and - an actuator (10) slidably mounted on the proximal section of the shell (3), wherein said injection system further comprises an actuating device (15) comprising: - a lever (30) pivotally connected to the proximal section of the shell (3) and adapted to cover and press at least a part of the actuator (10) when actuated by a patient, - a holding member (50) radially protruding from the outer surface of the shell (3) and adapted to bear on a patient's finger (61) while enabling the patient to actuate the lever (30) with another finger (62).

Description

Injection system and actuating device for attachment to a pen-injector to form such injection system

The invention relates to an injection system and to an actuating device for attachment to a pen-injector to form such an injection system.

In particular, the invention relates to an injection system comprising a pen-injector used to ease the injection of a product, especially a therapeutic or pharmaceutical product, to a patient by the patient.

More specifically, the invention relates to an injection system comprising a pen-injector including:

- a shell for accommodating a container of a product to be injected and an injection mechanism for expelling a dose of the product from said container upon actuation, said shell having an elongated outer surface extending along a central axis, and having proximal and distal sections, and

- an actuator for actuating said injection mechanism, said actuator being slidably mounted along the central axis on the proximal section of the shell.

Commonly known pen-injectors can hardly be handled and actuated by patients having a limited dexterity, in particular by patients suffering from arthritis, especially rheumatoid arthritis, or by children. It is then very difficult, if not impossible, for such patients to inject themselves the product using conventional pen-injectors.

The invention aims to solve the above mentioned problem.

To this end, according to a first aspect, the invention provides for an injection system of the aforementioned type further comprising an actuating device comprising:

- a lever pivotally connected to the proximal section of the shell by a pivot connection having a pivot axis substantially perpendicular to the central axis of the shell, said lever being adapted to cover and press at least a part of the actuator when actuated by a patient,

- a holding member radially protruding from the outer surface of the shell at an axial distance from the pivot connection, said holding member being adapted to bear on a patient's finger while enabling the patient to actuate the lever with another finger.

Hence, the pen-injector can be held in the opened hand of the patient, especially in the palm of the patient, with the holding member bearing on one finger and the lever moved by another finger, especially the thumb, with a limited amount of force. The actuating device eases the holding and the actuation of the pen-injector, even by a patient having a limited dexterity, thereby enabling the patient to inject himself the product to be injected.

The holding member may comprise a curved tab having a concavity turned towards a distal direction. The lever may be movable in a radial plane containing the central axis and a direction in which the holding member extends, the pivot connection and the holding member lying on a same side of the central axis in said radial plane.

In one embodiment, the lever may be directly pivotally mounted on the proximal section of the shell and the holding member may be made integral with the shell.

In another embodiment, the actuating device may further comprise a body extending along a longitudinal axis and being coaxially attached to the outer surface of the shell, the lever being pivotally mounted on a proximal portion of the body.

The body of the actuating device may be releasably attached to the shell.

In particular, the body may be provided with releasable attaching means engaging the proximal section of the shell.

For example, releasable attaching means comprises a collar coaxially snap-fitted onto the outer surface of shell of the pen-injector.

Besides, the holding member may be made integral with the body of the actuating device.

In addition, the injection system as previously defined may further comprise a container of a product to be injected and an injection mechanism accommodated in said shell, said container containing a medicament for the treatment of arthritis.

According to a second aspect, the invention proposes an actuating device for attachment to a pen-injector having a shell with an elongated outer surface extending along a central axis, and an actuator slidably mounted along the central axis on a proximal section of the shell, said actuating device comprising:

- a body having a longitudinal axis and adapted to be coaxially attached to the outer surface of the shell,

- a lever pivotally mounted on a proximal portion of the body by a pivot connection having a pivot axis substantially perpendicular to the longitudinal axis, said lever being adapted to cover and press at least a part of the actuator of the pen-injector when actuated by a patient,

- a holding member radially protruding from the body at an axial distance from the pivot connection, said holding member being adapted to bear on a patient's finger while enabling the patient to actuate the lever with another finger.

The holding member may comprise a curved tab having a concavity turned towards a distal direction.

The body may be provided with releasable attaching means adapted to engage the proximal section the shell of the pen-injector.

For example, the releasable attaching means comprises a collar adapted to coaxially snap-fit onto the outer surface of the shell of the pen-injector.

Besides, the holding member may be made integral with the body. Other objects and advantages of the invention will emerge from the following disclosure of particular embodiments of the invention given as non limitative examples, the disclosure being made in reference to the enclosed drawings in which:

- Figure 1 is a perspective view of an injection system according to a first embodiment of the invention, the injection system comprising a pen-injector and an actuating device, the actuating device comprising a lever and a holding member attached to a body fitted onto the pen-injector,

- Figure 2 is a view in longitudinal cross section of the injection system of Figure 1 ,

- Figure 3 is a lateral view of the actuating device of the injection system of Figure 1 , - Figure 4 is an exploded view of the injection system of Figure 1 ,

- Figure 5 is a view in longitudinal cross section of an injection system according to a second embodiment of the invention, the lever of the actuating device being directly attached to the pen-injector and the holding member of the actuating device being integral with the pen- injector,

- Figures 6a and 6b are perspective views of a use of the injection system of Figure 1 , illustrating the injection system held by the hand of a patient, the holding member bearing on the patient's middle finger while enabling the patient to actuate the lever with the thumb.

On the Figures, the same reference numbers refer to the same or similar elements. Figures 1 to 4 represent a first embodiment of an injection system 1 used, in particular by a patient himself, to inject a dose of a therapeutic or pharmaceutical product, such as a medicine or a drug.

On Figures 1 and 2, the injection system 1 comprises a pen-injector 2 of a general cylindrical shape around a central axis A.

The pen-injector 2 comprises a cylindrical hollow shell 3 of circular cross-section. The shell 3 extends along the central axis A between opposite proximal 4 and distal 5 sections and presents an elongated inner surface 6 defining a housing 7 and an elongated outer surface 8 opposite to the inner surface 6. The housing 7 is adapted to accommodate a container (not shown) of the product to be injected and an injection mechanism (also not shown) for expelling the dose of product from the container. For example, the container and the injection mechanism together form a syringe received and held within the housing 7 so that at least a part of a needle of the syringe extends out of the distal section 5 of the shell 3. As an alternative, the injection mechanism may comprise a piston slidably mounted along the central axis on the shell 3 and a needle secured to the shell 3 so that at least a part of it extends out of the distal section 5 of the shell 3. In this alternative, the container can be placed within the housing 7 to cooperate with the injection mechanism mounted on the shell 3.

To actuate the injection mechanism, a cylindrical actuator 10 of circular cross-section is mounted on the proximal section 4 of the shell 3. The actuator 10 extends along the central axis A between a lower surface 1 1 arranged within the housing 7 and an upper surface 12 which protrudes from the proximal section 4 of the shell 3. The actuator 10 is mounted so as to slide along a stroke extending along the central axis A. To actuate the pen-injector 2, the actuator 10 is lowered through a pressure exerted on its upper surface 12. The actuator 10 may then be resiliency biased or otherwise moved to an upstanding position for a subsequent actuation.

The invention disclosed in relation to a pen-injector 2 having a general cylindrical shape of circular cross-section is not limited thereto and could have any other cross-section, such as elliptic or polygonal, and more generally any other shape.

To ease the holding and the actuation of the pen-injector 2, the injection system comprises an actuating device 15.

In the first embodiment of Figures 1 to 4, the actuating device 15 is formed as a separate component and comprises a body 16 mounted on the shell 3 of the pen-injector 2.

On Figure 3, the body 16 comprises a collar 17 around a longitudinal axis B. In the represented embodiment, the collar 17 is cylindrical, and especially annular, around the longitudinal axis B. The collar 17 has an outer surface 19 and an inner surface 18 defining an opening adapted to receive the pen-injector 2 for fitting the collar 17 onto the outer surface 8 of the shell 3. To improve the retention of the collar 17 onto the shell 3, the inner surface 18 of the collar 17 and the outer surface 8 of the shell 3 may have complementary retention members, in the form, in the represented embodiment, of an annular bead 20 on the inner surface 18 of the collar 17 and an annular groove 21 on the outer surface 8 of the shell 3.

Of course, the shape and the dimensions of the collar 17, and especially of the inner surface 18, could be different to adapt to the shape and the dimensions of the outer surface 8 of the shell 3 of the pen-injector 2. Besides, although the represented cylindrical collar 17 is continue to form an attachment element fitted along the central axis A of the pen-injector 2, the cylindrical collar 17 could be discontinue, i.e. opened in a direction perpendicular to the longitudinal axis B, to form an attachment element either fitted along the central axis A or clamped in a direction perpendicular to the central axis A.

The body 16 also comprises a wall 25 arranged at a distance, measured transversally with respect to the longitudinal axis B, from the longitudinal axis B. in particular, the wall 25 is integral with the collar 17 and extends substantially along the longitudinal axis B from the collar 17 to a proximal portion 26. The wall 25 is inclined with respect to the longitudinal axis B, moving away from the longitudinal axis B. It should be noted that, in other embodiments, the wall 25 could be straight along the longitudinal axis B or the wall 25 could be a part of the collar 17 on which the proximal portion 26 is formed.

The proximal portion 26 of the wall 25 supports a lever 30.

The lever 30 has a connecting end 31 and a free end 32 and presents a length between these connecting 31 and free 32 ends. For reasons that will become apparent from the following of the description, the length of the lever 30 is greater than a transverse dimension of the collar 17, measured perpendicularly to the longitudinal axis B, corresponding, in the illustrated embodiment, to a diameter of the outer surface 19 of the collar 17. In an actionable position shown on Figure 3, the lever 30, thereby, extends transversally with respect to the longitudinal axis B, toward the longitudinal axis B, and crosses the longitudinal axis B. The length of the lever 30 is, therefore, greater than a transverse dimension of the pen-injector 2, measured perpendicularly to the central axis A of the pen-injector 2, corresponding, in the illustrated embodiment, to a diameter of the outer surface 8 of the shell 3.

On Figure 3, the lever 30 is curved between the connecting end 31 and the free end 32 and presents a concavity directed towards the collar 17 in the actionable position of Figure 3. The lever 30 presents a lower surface 33, facing the opening of the collar 17 in the actionable position, and an upper surface 34 opposite to the lower surface 33. The lower surface 33 is provided with a protrusion 35, in the form of a central knob 36. The upper surface 34 is provided with a grip portion 37, in the form of transverse ribs 38, arranged close to the free end 32 of the lever 30.

The lever 30 is pivotally mounted on the proximal portion 26 of the wall 25 by a pivot connection. In the represented embodiment, the pivot connection is a hinge 40 which includes a socket 41 extending along a pivot axis P substantially perpendicular to the longitudinal axis B, and a pin 42 extending within the socket 41 . In the represented embodiment, the socket 41 is attached to the proximal portion 26 of the wall 25 and the pin 42 is attached to the connecting end 31 of the lever 30. As an alternative, the attachments of the socket 41 and the pin 42 could be inverted.

As a variant, the lever 30 could be connected to the proximal portion 26 of the body 16 by a pivot connection formed of a resiliency deformable portion integral with both the lever 30 and the wall 25.

The body 16 further comprises an arm 43 extending parallel to the longitudinal axis B from the collar 17 opposite to the wall 25. The arm 43 is intended to be in contact with the shell 3 of the pen-injector 2 and is, therefore, conformed to match the outer surface 8 of the shell 3. In particular, the arm 43 has an inner surface 44 curved around the longitudinal axis B and an outer surface 45 opposite to the inner surface 44.

A holding member 50 integral with the arm 43 of the body 16 is provided to enable the patient to hold the pen-injector 2 when the actuating device 15 is mounted on the pen-injector 2.

The holding member 50 is arranged at an axial distance, along the longitudinal axis B, from the pivot connection 40 and protrudes from the outer surface 45 of the arm 43. In particular, the holding member 50 extends in a radial direction with respect to the longitudinal axis B, opposite to the longitudinal axis B. In the represented embodiment, the holding member 50 has an end attached to the arm 43 and arranged substantially in alignment with the connecting end 31 of the lever 30 and the pivot connection 40 along the longitudinal axis B. With this arrangement, the lever 30 and the holding member 50 extend in a same radial plane containing the longitudinal axis B and the radial direction in which the holding member 50 extends, the pivot connection 40 and the holding member 50 being arranged on the same side of the longitudinal axis B in the radial plane. Besides, the lever 30 in its actionable position shown of Figure 3 and the holding member 50 extend in opposite directions with respect to the longitudinal axis B. It should be noted, however, that any other suitable relative orientations of the lever 30 and the holding member 50 could be provided, the body 16, and especially the arm 43, being adapted accordingly.

The holding member 50 is shaped and arranged to bear on a patient's finger while enabling the patient to actuate the lever 30 with another finger. By "finger", it is meant one of the five digits of a hand, including the thumb. In this respect, the holding member 50 comprises a curved tab 51 having opposite upper 52 and lower 53 contact surfaces extending substantially transversally with respect to the longitudinal axis B. The tab 51 has a curvature matching substantially that of the fingers of the patient. The curvature of the tab 51 is advantageously a concavity 53A directed opposite to the lever 30 to act as a purchase as the lever 30 is depressed.

The invention is not limited to the holding member 50 in the form of the curved tab 51 . Any other suitable shape could be provided for the holding member, for example, the holding member may comprise one or several loops of which the arcuate tab 51 forms a part.

As can be seen on Figure 4, the body 16 of the actuating device 15 is coaxially attached to the outer surface 8 of the shell 3 of the pen-injector 2. In particular, the collar 17 is snap-fitted onto the shell 3 of the pen-injector 2, the inner surface 19 of the collar 17 being in contact with the outer surface 8 of the shell 3 and the bead 20 of the collar 17 being engaged in the groove 21 of the shell 3. The longitudinal axis B of the body 16 is coaxial to the central axis A of the pen-injector 2 and the proximal portion 26 of the body 16 is arranged at the vicinity of the proximal section 4 of the shell 3.

In the represented embodiment, the collar 17 is snap-fitted to the shell 3 on its proximal section 4 whereas it could alternatively be fitted on any other part of the shell 3, the dimension of the wall 25 being adapted accordingly to have the proximal portion 26 arranged at the vicinity of the proximal section 4 of the shell 3.

As can be seen from Figures 1 and 2, once the actuating device 15 has been mounted, the lever 30 is pivotally mounted on the proximal section 4 of the shell 3, through the collar 17, the wall 25 and the pivot connection 40. The pivot connection 40 and the holding member 50 lie on the same side of the radial plane in which the holding member 50 and the lever 30 extend. The radial plane contains the central axis A and the pivot axis P is perpendicular to the central axis A of the pen-injector 2. In the actionable position, the lever 30 extends transversally with respect to the central axis A, toward the central axis A. The connecting end 31 of the lever 30 is attached on a first side of the actuator 10 and the free end 32 of the lever 30 protrudes transversally with respect to a second side of the actuator 10, opposite to the first side in relation to the central axis A. The lever 30 covers the actuator 10 of the pen-injector 2, with the knob 36 in contact with the upper surface 12 of the actuator 10 and the free end 32 arranged at a distance, measured transversally with respect to the central axis A, from the actuator 10. The lever 30 is moveable in the radial plane to actuate the actuator 10.

The inner surface 44 of the arm 43 of the actuating device 15 is in contact with the outer surface 8 of the shell 3. The upper 52 and lower 53 contact surfaces of the curved tab 51 extend substantially transversally with respect to the central axis A of the pen-injector 2, with the concavity turned towards a distal direction, i.e. towards the distal section 5 of the shell 3.

As represented on Figures 6a and 6b, to inject the product contained in the container arranged within the housing 7 of the pen-injector 2, the injection system 1 can be held by the patient with his opened hand 60. The curved tab 51 of the actuating device 15 bears on the middle finger 61 , and the lever 30 is pressed toward the proximal section 4 of the shell 3 by another finger of the patient, for example the thumb 62, placed on the grip portion 37 of the lever 30. Thanks to these provisions, the patient does not need to firmly grasp the pen-injector 2 by closing the hand 60. Moreover, the free end 31 of the lever 30 arranged at a distance from the actuator 10 reduces the force to be exerted to move the actuator 10.

Although the invention has been disclosed in relation to an actuating device 15 snap- fitted onto the pen-injector 2, in other embodiments, the actuating device 15 could be attached , permanently or removably, to the pen-injector 2 in any other appropriate manner, for example by clamping, gluing or welding the body 16 to the outer surface 8 of the shell 3. Besides, the holding member 50 could be separate from the body 16 and mounted on the shell 3 apart of the body 16 on which the lever 30 is articulated.

Figure 5 represents a second embodiment of an injection system 1 '.

In the second embodiment, the pen-injector 2' is similar to that of the first embodiment and will not be disclosed in details. On Figure 5, the elements of the second embodiment similar to that of the first embodiment are referenced with the same reference numbers with the mark ""' added. Their description will not be repeated and reference is made to the description already made for more details.

The injection system 1 ' according to the second embodiment differs mainly with respect to that of the first embodiment in the realisation of the actuating device 15' formed as an integrated component. Actually, in the second embodiment, the lever 30' is directly mounted on the proximal section 4' of the shell 3' of the pen-injector 2' and the holding member 50', also represented in the form of an arcuate tab 51 ', is integral with the shell 3' of the pen-injector 2'. The connecting end 31 ' of the lever 30' is pivotally mounted on a wall 25' arranged on the proximal section 4' of the shell 3' and extending to a proximal portion 26' of the shell 3'. The actuating device 15' comprises a hinge 40', as pivot connection, which includes a socket 41 ' extending along the pivot axis P' and a pin 42' extending within the socket 41 '. The socket 41 ' is mounted on the proximal portion 26' of the shell 3' and the pin 42' is mounted on the connecting end 31 ' of the lever 30'. The attachments of the socket 41 ' and the pin 42' could be inverted.

The tab 51 ' protrudes from the outer surface 8' of the shell 3' with the upper 52' and lower 53' contact surfaces extending transversally with respect to the central axis A'.

The injection system 1 ' of the second embodiment functions in a similar manner as that of the injection system 1 of the first embodiment.

Claims

1 . Injection system comprising a pen-injector (2; 2') including:

- a shell (3; 3') for accommodating a container of a product to be injected and an injection mechanism for expelling a dose of the product from said container upon actuation, said shell (3; 3') having an elongated outer surface (8; 8') extending along a central axis (A; A'), and having proximal (4; 4') and distal (5; 5') sections, and

- an actuator (10; 10') for actuating said injection mechanism, said actuator being slidably mounted along the central axis (A; A) on the proximal section (4; 4') of the shell (3; 3'), said injection system (1 ; 1 ') being characterised in that it further comprises an actuating device (15; 15') comprising:

- a lever (30; 30') pivotally connected to the proximal section (4; 4') of the shell (3; 3') by a pivot connection (40; 40') having a pivot axis (P; P') substantially perpendicular to the central axis (A; A) of the shell (2; 2'), said lever (30; 30') being adapted to cover and press at least a part of the actuator (10; 10') when actuated by a patient,

- a holding member (50; 50') radially protruding from the outer surface (8; 8') of the shell at an axial distance from the pivot connection (40; 40'), said holding member (50; 50') being adapted to bear on a patient's finger (61 ) while enabling the patient to actuate the lever (30; 30') with another finger (62).

2. Injection system according to claim 1 , wherein the holding member (50) comprises a curved tab (51 ; 51 ') having a concavity (53A; 53A) turned towards a distal direction.

3. Injection system according to claim 1 or 2, wherein the lever (30; 30') is movable in a radial plane containing the central axis (A; A) and a direction in which the holding member (50; 50') extends, the pivot connection (40; 40') and the holding member (50; 50') lying on a same side of the central axis (A; A) in said radial plane.

4. Injection system according to anyone of claims 1 to 3, wherein the lever (30') is directly pivotally mounted on the proximal section (4') of the shell (3') and the holding member (50') is made integral with the shell (3').

5. Injection system according to anyone of claims 1 to 3, wherein the actuating device (15) further comprises a body (16) having a longitudinal axis (B) and being coaxially attached to the outer surface (8) of the shell (3), the lever (30) being pivotally mounted on a proximal portion (26) of the body (16).

6. Injection system according to claim 5, wherein the body (16) of the actuating device (15) is releasably attached to the shell (3).

7. Injection system according to claim 5 or 6, wherein the body (16) is provided with releasable attaching means (17) engaging the proximal section (4) of the shell (3).

8. Injection system according to claim 7, wherein the releasable attaching means comprises a collar (17) coaxially snap-fitted onto the outer surface (8) of the shell (3).

9. Injection system according to anyone of claims 5 to 8, wherein the holding member (50) is made integral with the body (16) of the actuating device (15).

10. Injection system according to anyone of claims 1 to 9, further comprising a container of a product to be injected and an injection mechanism accommodated in said shell (3; 3'), said container containing a medicament for the treatment of arthritis.

1 1 . Actuating device for attachment to a pen-injector (2) having a shell (3) with an elongated outer surface (8) extending along a central axis (A), and an actuator slidably mounted along the central axis (A) on a proximal section (4) of the shell (3), said actuating device comprising:

- a body (16) having a longitudinal axis (B) and adapted to be coaxially attached to the outer surface (8) of the shell (3),

- a lever (30) pivotally mounted on a proximal portion (26) of the body (16) by a pivot connection (40) having a pivot axis (P) substantially perpendicular to the longitudinal axis (B), said lever (30) being adapted to cover and press at least a part of the actuator (10) of the pen- injector (2) when actuated by a patient,

- a holding member (50) radially protruding from the body (16) at an axial distance from the pivot connection (40), said holding member (50) being adapted to bear on a patient's finger (61 ) while enabling the patient to actuate the lever (30) with another finger (62).

12. Actuating device according to claim 1 1 , wherein the holding member (50) comprises a curved tab (51 ) having a concavity (53A) turned towards a distal direction.

13. Actuating device according to claim 1 1 or 12, wherein the body (16) is provided with releasable attaching means (17) adapted to engage the proximal section (4) the shell (3) of the pen-injector (2).

14. Actuating device according to claim 13, wherein the releasable attaching means comprises a collar (17) adapted to coaxially snap-fit onto the outer surface (8) of the shell (3) of the pen-injector (2).

15. Actuating device according to anyone of claims 1 1 to 14, wherein the holding member (50) is made integral with the body (16).