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Title:
DRIVE-CONTROL SYSTEM FOR AN INJECTION DEVICE
Document Type and Number:
WIPO Patent Application WO/2017/098460
Kind Code:
A1
Abstract:
A drive-control system for an injection device for delivering a set dose of a pharmaceutical substance contained in a replaceable cartridge, the system comprising a tubular housing body (2) having a longitudinal axis (A-A), a proximal end (2a) and a distal end (2b), the system further comprising a helical spring (7) contained in the housing body and a piston rod (5) provided with an external thread, the piston rod (5) being moveable towards said distal end (2b). The housing body (2) further contains (i) a driving sleeve (10) having a distal edge (10b), the driving sleeve (10) being rotatable around the axis (A-A) of the housing body (2) and slidable along said axis, the helical spring (7) being placed over the driving sleeve (10), (ii) a blocking sleeve (12) having a proximal edge (12a), the blocking sleeve (12) being stationary relative to the housing body (2) and (iii) a guiding sleeve (11) having a proximal edge (11a), the guiding sleeve (11) being located within the blocking sleeve (12) and being rotatable around the axis (A-A) of the housing body (2) and blocked in translation along said axis. Rotation of the driving sleeve (10) in a first direction by a defined angle causes its translation towards the proximal end (2a) of the housing body (2) and compression of the spring (7), with the distal edge (10b) of the driving sleeve (10) sliding on the proximal edges (11a, 12a) of the guiding sleeve (11) and the blocking sleeve (12). Rotation of the driving sleeve (10) in a second direction by the same angle, causing its translation towards the distal end (2b) of the housing body (2), is triggered by extension of the spring (7) and during the rotation of the driving sleeve (10) in the second direction the distal edge (10b) of the driving sleeve (10) is sliding only on the proximal edge (12a) of the blocking sleeve (12) causing the guiding sleeve (11) to rotate in the second direction and the piston rod (5) to move axially in the distal direction. A device comprising the drive-control system according to the invention.

Inventors:
LOZANO PLATONOFF ALBERTO (PL)
STEFANSKI ADAM (PL)
WILCZEK MATEUSZ (PL)
Application Number:
PCT/IB2016/057482
Publication Date:
June 15, 2017
Filing Date:
December 09, 2016
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
COPERNICUS SP ZOO (PL)
International Classes:
A61M5/20; A61M5/315
Domestic Patent References:
WO2011060786A12011-05-26
WO2006045529A12006-05-04
WO2013144020A12013-10-03
WO2014060369A12014-04-24
Foreign References:
US20120265151A12012-10-18
US20020052578A12002-05-02
Attorney, Agent or Firm:
KARCZ, Katarzyna (PL)
Download PDF:
Claims:
Patent claims

1. A drive-control system for an injection device for delivering a set dose of a pharmaceutical substance contained in a replaceable cartridge, the system comprising a tubular housing body (2) having a longitudinal axis (A-A), a proximal end (2a) and a distal end (2b), the system further comprising a helical spring (7) contained in the housing body and a piston rod (5) provided with an external thread, the piston rod (5) being moveable towards said distal end (2b), characterized in that the housing body (2) further contains (i) a driving sleeve (10) having a distal edge (10b), the driving sleeve (10) being rotatable around the axis (A-A) of the housing body (2) and slidable along said axis, the helical spring (7) being placed over the driving sleeve (10), (ii) a blocking sleeve (12) having a proximal edge (12a), the blocking sleeve (12) being stationary relative to the housing body (2) and (iii) a guiding sleeve (11) having a proximal edge (11a), the guiding sleeve (11) being located within the blocking sleeve (12) and being rotatable around the axis (A-A) of the housing body (2) and blocked in translation along said axis, and in that

rotation of the driving sleeve (10) in a first direction by a defined angle causes its translation towards the proximal end (2a) of the housing body (2) and compression of the spring (7), with the distal edge (10b) of the driving sleeve (10) sliding on the proximal edges (11a, 12a) of the guiding sleeve (11) and the blocking sleeve (12),

rotation of the driving sleeve (10) in a second direction by the same angle, causing its translation towards the distal end (2b) of the housing body (2), is triggered by extension of the spring (7) and during the rotation of the driving sleeve (10) in the second direction the distal edge (10b) of the driving sleeve (10) is sliding only on the proximal edge (12a) of the blocking sleeve (12) causing the guiding sleeve (11) to rotate in the second direction and the piston rod (5) to move axially in the distal direction.

2. The system according to claim 1, characterized in that

- the distal edge (10b) of the rotatable driving sleeve (10) comprises at least one track (10.2) that is slanted relative to the axis (A-A) of the housing body (2);

- the stationary blocking sleeve (12) is located at the distal end (2b) of the housing body (2), the proximal edge (12a) of the blocking sleeve (12) comprising at least one track (12.1) that is slanted relative to the axis (A-A) of the housing body (2);

- the rotatable guiding sleeve (11) is fixed in rotation with the piston rod (5) in a way enabling axial translation of the piston rod (5), the proximal edge (11a) of the guiding sleeve (11) comprising at least one track (11.1) that is slanted relative to the axis (A-A) of the housing body (2);

- the blocking sleeve (12) comprises an internal thread cooperating with the external thread of the piston rod (5).

3. The system according to claim 1, characterized in that

- the distal edge (10b) of the rotatable driving sleeve (10) comprises at least one track (10.2) that is slanted relative to the axis (A-A) of the housing body (2);

- the stationary blocking sleeve (12) is located at the distal end (2b) of the housing body (2), the proximal edge (12a) of the blocking sleeve (12) comprising at least one track (12.1) that is slanted relative to the axis (A-A) of the housing body (2);

- the rotatable guiding sleeve (11) comprises an internal thread cooperating with the external thread of the piston rod (5), the proximal edge (11a) of the guiding sleeve (11) comprising at least one track (11.1) that is slanted relative to the axis (A-A) of the housing body (2);

- the blocking sleeve (12) is fixed in rotation with the piston rod (5) in a way enabling axial translation of the piston rod (5) within the housing body (2).

4. The system according to claim 2 or 3, characterized in that the at least one track (11.1) is shorter than the at least one track (12.1), and during the rotation of the driving sleeve (10) in the first direction, its tracks (10.2) are sliding on the tracks (11.1, 12.1), so that in the first part of their travel the tracks (10.2) of the driving sleeve (10) are sliding on the mutually adjoining tracks (11.1, 12.1) and in the second part of their travel, the tracks (10.2) are sliding only on the tracks (11.1), the angle of rotation of the driving sleeve (10) enabling its tracks (10.1) to travel along the whole tracks (11.1) and to return to the tracks (12.1), while during the rotation of the driving sleeve (10) in the second direction its tracks (10.2) are sliding only on the tracks (12.1).

5. The system according to claim 2 or 3, characterized in that the driving sleeve (10), the guiding sleeve (11) and the blocking sleeve (12) each comprises three tracks respectively (10.2), (11.1) and (12.1), evenly spaced along the edge of each sleeve, so that each edge is formed as a generally toothed line comprising three teeth, each teeth having an edge forming the respective track (10.2), (11.1) and (12.1), with the teeth of the edge of the driving sleeve (10) fitting into the spaces between the teeth of the edge of the guiding sleeve (11) and the teeth of the edge of the blocking sleeve (12) when the spring (7) is in its extended position.

6. The system according to claim 2 or 3, characterized in that the width of the tracks (10.2) is larger than the width of the tracks (11.1) and larger than the width of the tracks (12.1).

7. The system according to claim 2 or 3, characterized in that when the spring (7) is in its extended position, the tracks (11.1) of the guiding sleeve (11) are not fully aligned with the tracks (12.1) of the blocking sleeve (12), but the peaks of each track (11.1) are located in points (X) above the tracks (12.1) and spaced from the peaks of the respective tracks (12.1), each track of the driving sleeve (10.2) being shaped so as not to collide with the peak of the respective track (11.1) of the guiding sleeve (11).

8. The system according to claim 2 or 3, characterized in that the tracks (11.1) are shorter than the tracks (12.1), preferably the length of each track (11.1) constitutes about 85 % of the length of each track (12.1).

9. The system according to claim 1 or 2, characterized in that the rotatable guiding sleeve (11) is associated with the piston rod (5) by means of a shape coupling (Z) comprising at least one longitudinal guiding protrusion (11.2) formed inside the guiding sleeve (11) and at least one cooperating longitudinal guiding groove (5.1) formed along the external surface of the piston rod (5).

10. The system according to claim 1 or 3, characterized in that the blocking sleeve (12) is associated with the piston rod (5) by means of a shape coupling (Ζ') comprising at least one longitudinal guiding protrusion (12.2) formed inside the blocking sleeve (12) and at least one cooperating longitudinal guiding groove (5.1) formed along the external surface of the piston rod (5).

11. The system according to any of the preceding claims, characterized in that the blocking sleeve (12) constitutes an integral part of the housing body (2).

12. The system according to claim 1, characterized in that the piston rod (5) and the driving sleeve

(10) are provided with mutually cooperating blocking means (5.2, 10.3) for preventing translation of the driving sleeve (10) in the proximal direction when the piston rod (5) projects out of the housing body (2) by a defined distance.

13. The system according to claim 12, characterized in that, the blocking means (5.2) of the piston rod (5) is selected from a group comprising a widened proximal ending of the piston rod (5), a projection located on the proximal ending of the piston rod (5) and an abutment ring located on the proximal ending of the piston rod (5).

14. The system according to claim 12 or 13, characterized in that the blocking means (10.3) of the driving sleeve (10) is constituted by a ledge projecting from its internal surface, more preferably a ring reducing the internal diameter of the driving sleeve (10).

15. An injection device for delivering a set dose of a pharmaceutical substance contained in a replaceable cartridge, the device having a disposable injecting means fitted on the distal end, characterized in that it is equipped with the drive-control system (6) according any of the claims 1-14 , and in that:

- the housing body (2) of the drive-control system (6) is provided with a triggering activating means (8) and a knob (4), both cooperating with system (6);

- the guiding sleeve (11) and the triggering activating means (8) contain mutually complementary engaging means (11.3, 8.3) for limiting the rotation of the guiding sleeve (11) and for retaining the spring (7) in at least partially compressed position when mutually engaged and for enabling the rotation of the guiding sleeve (11) when mutually disengaged.

16. The device according to claim 15, characterized in that the complementary engaging means (11.3, 8.3) are constituted by an engaging projection (8.3) located on the triggering activating means (8) and at least one recess (11.3) located on an external surface of the guiding sleeve

(11) , one recess (11.3) corresponding to each track (11.1) of the guiding sleeve (11).

17. The device according to claim 15 or 16, characterized in that the engagement of the complementary engaging means (11.3, 8.3) provides a play (L) enabling a limited rotation of the guiding sleeve (11), a partial extension of the spring (7) and a respective limited translation of the piston rod (5) in the distal direction.

18. The device according to claim 17, characterized in that the limited rotation of the guiding sleeve (11), the partial extension of the spring (7) and the respective limited translation of the piston rod (5) in the distal direction caused by said play (L) occurs when the distal edge (10b) of the driving sleeve (10) is sliding only on the proximal edge (12a) of the blocking sleeve (12).

19. The device according to claim 15, characterized in that the driving sleeve (10) has a proximal portion (10a) and a distal portion (10b) and it is connected with the knob (4) by means of a clutch (9) having a form of a sleeve with a proximal portion (9a) connected with the knob (4) an a distal portion (9b) slidably arranged within the proximal portion (10a) of the driving sleeve (10), the external surface of the distal portion (9b) of the clutch (9) and the internal surface of the proximal portion (10a) of the driving sleeve (10) being provided with mutually cooperating means for blocking the rotation of the clutch (9) relative to the driving sleeve (10).

20. The device according to claim 19, characterized in that the clutch (9) comprises an abutment ring (9.3) and the driving sleeve (10) comprises an annular abutment step (10.1) between its proximal and distal portions (10a, 10b), the spring (7) being located between the abutment ring (9.3) and the abutment step (10.1).

21. The device according to claim 19 or 20, characterized in that an abutment projection (9.2) for blocking the rotation of the clutch (9) beyond a defined angle is located on the external surface of the proximal portion (9a) of the clutch (9).

Description:
DRIVE-CONTROL SYSTEM FOR AN INJECTION DEVICE

The invention relates to devices for delivering pharmaceutical substances by injection into patients. In particular, the invention relates to a drive-control system for an injection device for delivering a set dose of a pharmaceutical substance and an injection device equipped with such a system. The pharmaceutical substance may be e.g. insulin or growth hormone.

The devices of the above described type are known and commonly used. They may have a form of e.g. injectors for delivering a settable or a determined dose of the substance.

In US 2002/0052578 a syringe is described enabling delivery of a settable dose of a substance.

Upon setting a dose by rotating a controlling member a user axially presses a button located at the end of the syringe, causing a piston to be pushed out and consequently the dose to be delivered. The syringes of this type have a disadvantage consisting in that the delivery of the dose requires the button to be operated manually (not automatically) so that the force exerted thereon as well as the speed of its application depend on the user. This is inconvenient because the ability of the user may influence the speed and the force of pushing the piston out. Consequently, such syringes are usually provided with transmission mechanisms providing suitable gearing of the applied externally force.

Injectors also exist in which the delivering of a dose is assisted by a spring. Such an injector is described e.g. in WO 2014/060369. The disclosed injector comprises a torsion spring for driving a piston moving along the housing of the injector. The torsion spring applies a rotational torque onto a drive member engaging the piston rod which is then driven forward. A disadvantage of this solution is the use of the torsion spring which is tensioned and hence it needs to be firmly connected with a tensioning member and the drive member. The torsion spring is also relatively long and heavy because, due to the way of its operation, it needs to comprise many tight coils.

It is an objective of the invention to provide a drive-control system for an injection device for repeated delivery of a set dose of a pharmaceutical substance and an injection device equipped with such a system, enabling automatic and precise delivery of a determined dose of the pharmaceutical substance, in which the ability and force of the user have no impact on the speed and the force of the delivery.

It is another objective of the invention to provide a drive-control system and a respective injection device for automatic delivery of a pharmaceutical substance that are driven by a helical pressure spring.

Still another objective of the invention is to provide a drive-control system and a respective injection device for automatic delivery of a set dose of a pharmaceutical substance that are provided with an autopriming feature.

Still another objective of the invention is to provide an injection device for repeated delivery that has a feature of disabling the possibility to be set up upon delivery of the last dose.

According to the invention a drive-control system is provided for an injection device for delivering a set dose of a pharmaceutical substance contained in a replaceable cartridge, the system comprising a tubular housing body having a longitudinal axis, a proximal end and a distal end, the system further comprising a helical spring contained in the housing body and a piston rod provided with an external thread, the piston rod being moveable towards said distal end.

The system according to the invention is characterized in that the housing body further contains (i) a driving sleeve having a distal edge, the driving sleeve being rotatable around the axis of the housing body and slidable along said axis, the helical spring being placed over the driving sleeve, (ii) a blocking sleeve having a proximal edge, the blocking sleeve being stationary relative to the housing body and (iii) a guiding sleeve having a proximal edge, the guiding sleeve being located within the blocking sleeve, and being rotatable around the axis of the housing body and blocked in translation along said axis,

and in that

the rotation of the driving sleeve in a first direction by a defined angle causes its translation towards the proximal end of the housing body and compression of the spring, the distal edge of the driving sleeve sliding on the proximal edges of the guiding sleeve and the blocking sleeve,

the rotation of the driving sleeve in a second direction by the same angle, causing its translation towards the distal end of the housing body, is triggered by extension of the spring and during the rotation of the driving sleeve in the second direction the distal edge of the driving sleeve is sliding only on the proximal edge of the blocking sleeve causing the guiding sleeve to rotate in the second direction and the piston rod to move axially in the housing body in the distal direction.

In a preferred embodiment of the system according to the invention:

- the distal edge of the rotatable driving sleeve comprises at least one track that is slanted relative to the axis of the housing body;

- the stationary blocking sleeve is located at the distal end of the housing body, the proximal edge of the blocking sleeve comprising at least one track that is slanted relative to the axis of the housing body;

- the rotatable guiding sleeve is fixed in rotation with the piston rod in a way enabling the axial translation of the piston rod, the proximal edge of the guiding sleeve comprising at least one track that is slanted relative to the axis of the housing body;

- the blocking sleeve comprises an internal thread cooperating with the external thread of the piston rod.

In another preferred embodiment of the system according to the invention:

- the distal edge of the rotatable driving sleeve comprises at least one track that is slanted relative to the axis of the housing body;

- the stationary blocking sleeve is located at the distal end of the housing body, the proximal edge of the blocking sleeve comprising at least one track that is slanted relative to the axis of the housing body;

- the rotatable guiding sleeve comprises an internal thread cooperating with the external thread of the piston rod, the proximal edge of the guiding sleeve comprising at least one track that is slanted relative to the axis of the housing body;

- the blocking sleeve is fixed in rotation with the piston rod in a way enabling the axial translation of the piston rod within the housing body.

Preferably, at least one track of the guiding sleeve is shorter than the at least one track of the blocking sleeve, and during the rotation of the driving sleeve in the first direction the tracks of the driving sleeve are sliding on the tracks of the guiding sleeve and on the tracks of the blocking sleeve, so that in the first part of their travel the tracks of the driving sleeve are sliding on the mutually adjoining tracks of the guiding sleeve and the blocking sleeve and in the second part of their travel the tracks of the driving sleeve are sliding only on the tracks of the guiding sleeve, the angle of rotation of the driving sleeve enabling its tracks to travel along the whole tracks of the guiding sleeve and to return to the tracks of the blocking sleeve, while during the rotation of the driving sleeve in the second direction the tracks of the driving sleeve are sliding only on the tracks of the blocking sleeve. Preferably, the driving sleeve, the guiding sleeve and the blocking sleeve each comprises three tracks evenly spaced along the edge of each sleeve, so that each edge is formed as a generally toothed line comprising three teeth, each teeth having an edge forming the respective track, with the teeth of the edge of the driving sleeve fitting into the spaces between the teeth of the edge of the guiding sleeve and the teeth of the edge of the blocking sleeve when the spring is in its extended position.

The width of the track of the driving sleeve is preferably larger than the width of the track of the guiding sleeve and larger than the width of the track of the blocking sleeve.

Preferably, when the spring is in its extended position, the tracks of the guiding sleeve are not fully aligned with the tracks of the blocking sleeve, but the peaks of each track of the guiding sleeve are located in points above the tracks of the blocking sleeve and spaced from the peaks of the respective tracks of the blocking sleeve, each track of the driving sleeve being shaped so as not to collide with the peak of the respective track of the guiding sleeve.

The tracks of the guiding sleeve are preferably shorter than the tracks of the blocking sleeve, e.g. the length of each track of the guiding sleeve may constitute about 85 % of the length of each track of the blocking sleeve.

The rotatable guiding sleeve is preferably associated with the piston rod by means of a shape coupling comprising at least one longitudinal guiding protrusion formed inside the guiding sleeve and at least one cooperating longitudinal guiding recess formed along the external surface of the piston rod.

Optionally, the blocking sleeve may be associated with the piston rod by means of a shape coupling comprising at least one longitudinal guiding protrusion formed inside the blocking sleeve and at least one cooperating longitudinal guiding recess formed along the external surface of the piston rod.

The blocking sleeve preferably constitutes an integral part of the housing body.

The piston rod and the driving sleeve may be provided with mutually cooperating blocking means for preventing translation of the driving sleeve in the proximal direction when the piston rod projects out of the housing body by a defined distance.

Preferably, the blocking means of the piston rod is selected from a group comprising a widened proximal ending of the piston rod, a projection located on the proximal ending of the piston rod and an abutment ring located on the proximal ending of the piston rod.

Preferably, the blocking means of the driving sleeve is constituted by a ledge projecting from its internal surface, more preferably a ring reducing the internal diameter of the driving sleeve.

According to the invention an injection device for delivering a set dose of a pharmaceutical substance contained in a replaceable cartridge is provided, the device having a disposable injecting means fitted on the distal end. The device according to the invention is characterized in that it is equipped with the drive-control system according to the invention, and in that:

- the housing body of the system is provided with a triggering activating means and a knob, both cooperating with the drive-control system;

- the guiding sleeve and the triggering activating means contain mutually complementary engaging means for limiting the rotation of the guiding sleeve and for retaining the spring in at least partially compressed position when mutually engaged and for enabling the rotation of the guiding sleeve when mutually disengaged.

Preferably, the complementary engaging means are constituted by an engaging projection located on the triggering activating means and at least one recess located on an external surface of the guiding sleeve, one recess corresponding to each track of the guiding sleeve. In a preferred embodiment, the engagement of the complementary engaging means ensures a play enabling a limited rotation of the guiding sleeve, a partial extension of the spring and a respective limited translation of the piston rod in the distal direction.

Preferably, the limited rotation of the guiding sleeve, the partial extension of the spring and the respective limited translation of the piston rod in the distal direction caused by said play occurs when the distal edge of the driving sleeve is sliding only on the proximal edge of the blocking sleeve.

The driving sleeve may have a proximal portion and a distal portion and it is preferably connected with the knob by means of a clutch having a form of a sleeve with a proximal portion connected with the knob an a distal portion slidably arranged within the proximal portion of the driving sleeve, the external surface of the distal portion of the clutch and the internal surface of the proximal portion of the driving sleeve being provided with mutually cooperating means for blocking the rotation of the clutch relative to the driving sleeve.

The clutch preferably comprises an abutment ring and the driving sleeve preferably comprises an annular abutment step between its proximal and distal portions, the spring being located between the abutment ring and the abutment step.

An abutment projection for blocking the rotation of the clutch beyond a defined angle may be located on the external surface of the proximal portion of the clutch.

The drive-control system and the injection device according to the invention enable repeated automatic deliveries of successive fixed defined doses of a pharmaceutical substance.

The device according to the invention may be provided with an autopriming feature. This feature consists in that a small defined dose of the pharmaceutical substance is expelled from the cartridge before each successive delivery, in particular before each injection. As a consequence, the dose delivered to the patient is more precise because all possible dose volume perturbations resulting from the storage, needle fitting etc. are eliminated.

Further, the device according to the invention may be provided with a set-up disabling function consisting in that upon delivery of a certain number of full doses the device is automatically blocked while being set up for delivery of a next dose. As the cartridge contains only a determined number of full doses and the next dose would exceed its limits of operation, this next dose of the substance will not be delivered.

An important advantage of the invention is the use of a helical cylindrical pressure spring which is an improvement as compared to the prior art solutions where torsion springs are used. A helical cylindrical pressure spring is easier to produce than a torsion spring because it does not need the special endings enabling its tension by rotation. Further, the pressure spring may contain fewer coils which makes it about 70% smaller, lighter and cheaper.

Preferred embodiments of the inventions are shown in the appended drawings in which:

Fig. 1 shows a longitudinal section of a first embodiment of the device according to the invention, connected with a pharmaceutical substance container;

Fig. 2 shows an exploded perspective view of the device of fig. 1 and the associated pharmaceutical substance container;

Figs. 3a-3h show various views of a first embodiment of the drive-control system according to the invention without the housing body, in different stages of dose setting and dose delivery;

Fig. 4 shows a perspective view as seen from the distal end of the drive-control system shown in figs. 3a-3h; Fig. 5 shows an exploded perspective view of the device according to the invention and the associated pharmaceutical substance container, the device comprising the drive-control system according to a second embodiment of the invention;

Figs. 6a and 6b show two different views of selected elements of the drive-control system of fig. 5;

Figs. 7a and 7b show a fragment of the drive-control system according to a third embodiment of the invention;

Figs. 8a and 8b show longitudinal sections of the drive-control system according to the invention, provided with the set-up disabling feature, in two different positions;

Fig. 9a shows a longitudinal section of a fragment of the injection device according to the invention, where a fragment of the drive-control system and the trigger of the activating device may be seen;

Fig. 9b shows a partially sectional view of the fragment of the device shown in fig. 9a, with the trigger disengaged from the driving sleeve;

Figs. 10a and 10b show perspective views as seen from the distal end of a fragment of the device in two different positions of the driving sleeve (respectively before and after the autopriming).

Fig. 1 shows a longitudinal section of the first embodiment of the device 1 according to the invention, connected with a container 3 comprising a pharmaceutical substance cartridge (not shown). The device 1 comprises a typical tubular housing body 2 to be connected with the container 3 designed for installation of the cartridge. A protective cap (not shown) is fitted onto the container. The housing body 2 has a proximal end 2a provided with a knob 4 and a distal end 2b to be connected with the container 3. The container has a distal end 3b onto which a disposable injecting means, in particular a hollow needle (not shown) is fitted. Further, the container 3 has a proximal end 3a to be connected with the housing body 2 of the device 1.

The terms„distal" and„proximal" are used here in relation to various elements and they should be understood as meaning respectively„the side of the end applied to a patient" and„the side of the end held by a user".

A piston rod 5 is typically arranged within the housing body 2. The piston rod is adapted to move axially along the device and gradually into the cartridge located in the container 3 so that successive doses of the pharmaceutical substance are pushed out if it. The axial movement of the piston rod 5 during the dose delivery is caused by the action of a drive-control system 6 (see fig. 2), propelled by a helical pressure spring 7 arranged within the housing body 2 and by activating a triggering activating means 8 by a user. The drive-control system 6 is connected to the knob 4 by means of a clutch 9.

Each use of the device 1 includes setting it up in a position of delivery readiness by means of the knob 4 cooperating with the drive-control system 6, and then - upon applying the needle into a patient - activating the device 1 by means of the triggering activating means 8, also cooperating with the drive- control system 6, and resulting in the automatic delivery of a dose into the patient.

Hence, the device may adopt two positions - a passive position and the dose delivery readiness position. In the passive position the spring 7 is extended while in the delivery readiness position the spring 7 is compressed. The transition from the passive position to the delivery readiness position is realized by rotation of the knob 4, and the dose delivery is realized by activation of the triggering activating means 8 by the user.

In fig. 2 individual components of the device 1, its drive-control system 6 as well as the container 3 for the pharmaceutical substance cartridge may be seen. The components of the system 6 are arranged along a common longitudinal axis A-A constituting the longitudinal axis of the device 1. The device 1 is connected to the container 3. The individual components of the device 1 will now be described in detail.

Figs. 3a-3h illustrate the structure and the principle of operation of the drive-control system 6 according to the invention. Fig. 3a shows the system 6 in its passive position, figs. 3b and 3c - during preparation for setting of the dose, fig. 3d - in the delivery readiness position, figs. 3e-3g during the delivery of the dose, 3h - after the delivery.

The drive-control system 6 comprises the housing body 2 (not shown in figs. 3a-3h), the helical pressure spring 7, the piston rod 5, a driving sleeve 10, a guiding sleeve 11 and a blocking sleeve 12. The spring 7 located between the driving sleeve 10 and the housing body 2 is alternately compressed and extended.

The driving sleeve 10 comprises two portions - a proximal portion 10a and a distal portion 10b. The spring 7 is placed over the proximal portion 10a of the driving sleeve 10. The proximal portion 10a has a smaller external diameter than the distal portion 10b. The boundary line between the proximal portion 10a and the distal portion 10b is defined by an annular abutment step 10.1.

As may be seen e.g. in fig. 3a, the distal portion 10b of the driving sleeve 10 has a distal edge comprising at least one track 10.2 that is slanted relative to the axis A-A. The term„slanted relative to the axis A-A" used herein means that said track lies neither in a plane perpendicular to the axis A-A nor in a plane parallel thereto. In consequence, the distal edge 10.2 of the driving sleeve 10 is formed as a generally toothed line. In the described embodiment, the distal edge 10.2 of the driving sleeve 10 comprises three tracks, i.e. three teeth, each having one side extending along the axis A-A and one side slanted relative thereto. The slanted sides of the teeth constitute the tracks 10.2. The three tracks (teeth) are evenly spaced along the periphery of the driving sleeve 10, each one covering the section of the periphery defined by an angle of 120°. A different number of the tracks (teeth) may also be foreseen, e.g. 2 or 4. If the driving sleeve 10 has two tracks each of them covers a section of the periphery defined by an angle of 180°. The distal edge 10b of the driving sleeve 10 may slide along the proximal edges of two sleeves - the guiding sleeve 11 and the blocking sleeve 12. In the described embodiment the blocking sleeve 12 is arranged within the housing body 2 at its distal end 2b and it is fixedly connected thereto. The guiding sleeve 11 may not be moved along the axis A-A; it is rotatably arranged within the blocking sleeve 12 so as to contact its inner surface.

The piston rod 5 extends along the axis A-A, through the driving sleeve 10, the guiding sleeve 11 and the blocking sleeve 12. The piston rod 5 may be rotated and moved axially in the distal direction. The outer surface of the piston rod 5 is threaded and its distal end is provided with a piston 13 (see fig. 2).

The guiding sleeve 11 and the blocking sleeve 12 have generally cylindrical side walls with its respective proximal edges 11.1 and 12.1 formed as a generally toothed line, similarly to the distal edge of the driving sleeve 10. The number of the teeth of the proximal edges 11.1 and 12.1 is the same as the number of the sleeves of the driving sleeve edge 10.2. The teeth of the sleeves 11 and 12 comprise slanted tracks 11.1 and 12.1 („slanted" as explained above). The mutually cooperating edges of the sleeves 11 and 10 are shaped in such a way that in the passive position of the system (when the spring 7 is in its extended position - see fig. 3a) the teeth of the driving sleeve 10 fit into the spaces between the teeth of the edge of the guiding sleeve 11 and the teeth of the edge of the blocking sleeve 12. When the spring 7 is compressed, the teeth of the driving sleeve 10 leave said spaces. Further, the teeth of the guiding sleeve 11 and the blocking sleeve 12 are shaped in such a way that in the passive position of the system, the tracks of the guiding sleeve 11 are not fully aligned with the tracks of the blocking sleeve 12, but the peaks X of each track 11.1 of the guiding sleeve 11 are located above the tracks 12.1 of the blocking sleeve 12 and spaced from the peaks of the respective tracks 12.1 of the blocking sleeve 12. The width of the track 10.2 of the driving sleeve 10 is larger than the width of the track 11.1 of the guiding sleeve 11 and larger than the width of the track 12.1 so that when sliding along the tracks 11.1 and 12.1, the track 10.2 covers at least a part of each of the tracks 11.1 and 12.1. The tracks 10.2 of the driving sleeve 10 are shaped so as not to collide with the peaks X of the respective tracks 11.1 of the guiding sleeve 11 (the tracks 10.2 are provided with suitable recesses).

In fig. 4 a perspective view as seen from the distal end of the drive-control system shown in figs. 3a-3h may be seen (with the blocking sleeve 12 removed). As shown, the guiding sleeve 11 is engaged with the piston rod 5 by means of a shape coupling Z comprising an inner longitudinal protrusion 11.2 of the guiding sleeve 11 cooperating with an outer longitudinal groove 5.1 on the outer surface of the piston rod 5. Due to the connection Z, the piston rod 5 rotates along with the guiding sleeve 11 and it may move axially relative thereto. Further, the piston rod 5 is in thread engagement G with the blocking sleeve 12 (and hence with the housing body 2) - see fig. 1. As a consequence, when the guiding sleeve 11 rotates, its rotation is transferred to the piston rod 5. The piston rod 5 then moves along the axis A-A because its rotation causes it to move axially toward out of the housing body 2.

Fig. 5 shows an exploded perspective view of the device according to the invention and the associated pharmaceutical substance container, the device comprising the drive-control system 6' according to a second embodiment of the invention.

Figs. 6a and 6b show two different views of selected elements of the drive-control system 6' of the device 1' according to the second embodiment of the invention.

The second embodiment differs from the first embodiment in that here the blocking sleeve constitutes an integral element of the housing body 2. As shown in figs. 6a and 6b, an integral blocking thickening 12' is formed within the housing body 2 near its distal end. The blocking thickening 12' is of a generally sleeve-like shape and it comprises tracks 12.1', which are similar to the above described tracks 12.1. In this second embodiment, the housing body 2 is composed of two halves so as to enable the inner elements of the device to be mounted within.

Figs. 7a and 7b show a fragment of the drive-control system according to a third embodiment of the invention. Fig. 7a is a view of the inside of the system (without the piston rod and the spring), with one of the halves of the housing body 2 removed, and fig. 7b is a view from the outside as seen from the distal end.

In this embodiment, the piston rod 5 is in thread engagement G' with the guiding sleeve 11 and it is engaged with the blocking thickening 12' by means of a shape coupling Z', similar to that of the above described second embodiment. The connection Z' comprises an inner longitudinal protrusion 11.2 of the blocking thickening 12' cooperating with an outer longitudinal groove 5.1 on the outer surface of the piston rod 5. In figs. 7a and 7b the blocking thickening 12' is an integral portion of the housing body 2 but the third embodiment of the system may also be realized with a separate blocking sleeve 12 mounted within the housing body 2.

Figs. 8a and 8b show longitudinal sections of the drive-control system according to the invention, provided with a final dose set-up disabling feature (described in detail below). Fig. 8a shows the system in a situation where the piston rod 5 has been advanced a certain distance out of the housing body 2 after n doses have been delivered. Fig. 8b shows the system in a situation after a failed attempt to set the system in the position of delivery readiness. The final dose set-up disabling feature is advantageous because it eliminates the possibility of setting the device up for delivery of a dose beyond the content of pharmaceutical in the cartridge and the user is notified about it before attempting to deliver a next dose. As may be seen in figs. 8a and 8b, the piston rod 5 and the driving sleeve 10 are provided with mutually cooperating blocking means 5.2 and 10.3 which prevent the driving sleeve 10 from moving in the proximal direction when the piston rod 5 extends out of the housing body 2 by a determined distance. The blocking means 5.2 and 10.3 may be realized in any suitable manner. The blocking means 5.2 may have a form of e.g. a widening of the proximal ending of the piston rod 5, a protrusion or a ring located on its proximal end. In the described embodiment, the blocking means 5.2 is a widened head of the piston rod 5. On the other hand, the blocking means 10.3 is an abutment projecting from the inner surface of the driving sleeve 10 (it may also be realized in another way), preferably it is a ring reducing the inner diameter of the driving sleeve 10, located on the boundary line between its narrower proximal portion 10a and its larger distal portion 10b. Obviously, the lengths of the piston rod 5 and of the housing body 2 need to be adapted to the number n of the doses contained in the cartridge.

The principle of operation of the drive-control system 6 according to the invention is described below (in the case of the system 6' the principle of operation is the same).

As indicated above, in the passive position of the system 6 shown in fig. 3a as well as in fig. 3h, when the spring 7 is extended, the teeth of the distal edge of the driving sleeve 10 fit into the spaces between the teeth of the proximal edges of the sleeves 11 and 12. Due to the rotation of the driving sleeve 10 in a first direction by a certain angle (shown by an arrow in fig. 3b), the rotation being caused by an external force applied by a user, the tracks 10.2 of the distal edge of the driving sleeve 10 which are wider than the tracks 11.1 and 12.1, slide initially both on the respective tracks 11.1 of the guiding sleeve 11 and on the tracks 12.1 of the adjoining blocking sleeve 12. Hence, the driving sleeve 10 moves axially in the proximal direction of the system 6. The abutment step 10.1 moves along causing compression of the spring 7 that is blocked within the housing body 2. The rotation of the driving sleeve 10 combined with its axial movement continues undisturbed until the tracks 10.2 reach the peaks X of the guiding sleeve tracks 11.1 protruding above the tracks. 12.1. As may be seen, in the first part of their travel, the tracks 10.2 slide on both the tracks 11.1 and 12.1; then in the second part of their travel, the tracks 10.2 rise above the tracks 12.1 and slide only on the tracks 11.1 up to the peaks X. Fig. 3c shows the situation where peaks X are just being overrun by the tracks 10.2. Upon passing the projecting peaks X of the guiding sleeve tracks 11.1, the tracks 10.2 fall back on the tracks 12.1. This situation is shown in fig. 3d. The geometry of the individual components of the system is so designed that the driving sleeve 10 is able to rotate by such an angle that the endings of the tracks 10.2 pass the endings of the tracks 11.1 but do not fall down from the tracks 12.1. At this moment, if the external force stops being applied to the driving sleeve 10, the spring 7 starts to extend and to push the abutment step 10.1 causing the tracks 10.1 to slide back. However, now the tracks 10.1 slide only on the blocking sleeve tracks 12.1 while the driving sleeve 10 rotates in the second, opposite direction, back to its starting position as shown in fig. 3e. As the width of the tracks 10.2 is larger than the width of the tracks 12.1, the tracks 10.2 push on the axial sides of the teeth of the guiding sleeve edge 11.1 prompting the guiding sleeve 11 to rotate. In figs. 3f and 3g the driving sleeve tracks 10.2 slide on the blocking sleeve tracks 12.1, pushing the guiding sleeve 11 on until it reaches back its passive position shown in fig. 3h.

The piston rod 5 of the system 6 according to the first embodiment is engaged with the guiding sleeve 11 by means of the shape coupling Z. Hence, the rotation of the guiding sleeve 11 is transferred to the piston rod 5 and the latter moves axially in the distal direction because its thread engagement G with the stationary blocking sleeve 12 causes it to be screwed out and advanced axially out of the housing body 2 by a distance determined by the angle of rotation of the driving sleeve 10. On the other hand, in the system 6 according to the third embodiment (see figs. 7a and 7b), the piston rod 5 is engaged with the blocking thickening 12' by means of the shape coupling Z' and it is in thread engagement G' with the guiding sleeve 11. Therefore, the piston rod 5 does not rotate but it is moved axially in the distal direction by cooperation with the rotating guiding sleeve 11 which in turn is unable to move axially. Hence, in this embodiment the piston rod 5 is translated out of the housing body 2 (without being rotated) by a distance defined by the angle of rotation of the driving sleeve 10. The kinematics of the piston rod 5 is more advantageous because no additional friction forces are generated between the piston rod and the piston.

The piston rod 5 can only move in the distal direction; subsequent rotation of the driving sleeve 10 in the first direction with the associated compression of the spring 7 as well as the later extension thereof will cause the piston rod 5 to advance step by step out of the housing body 2.

As it results from the above description, the drive-control system 6, 6' according to the invention enables repeated delivery of a dose by advancement of the piston rod 5 step by step in the distal direction through consecutive rotations of the driving sleeve 10 by a defined angle, the rotations causing compression of the spring 7. The spring 7 is then allowed to extend and to make the driving sleeve return to its initial position.

The device according to the invention is shown in figs. 1 and 2. The device 1 comprises the described above drive-control system 6 as well as a clutch 9, a knob 4 and the triggering activating means 8.

Figs. 9a, 9b, 10a and 10b show in detail the structure and the operation of the triggering activating means 8.

As may be seen in figs. 1, 2 and 5, the proximal end 2a of the housing body 2 is equipped with the knob 4 that is rotatable about the axis A-A of the housing body 2 on the external surface of which the triggering activating means 8 is located comprising a trigger 8.1 and trigger cap 8.2. The triggering activating means 8 may be of any suitable conventional type similar to that described below with reference to the operation of the device.

The knob 4 is fixedly attached to a typical rotatable clutch 9 located in the housing body 2. The clutch 9 has a generally cylindrical shape comprising a proximal portion 9a and a distal portion 9b. The outer surface of the proximal portion 9a comprises a longitudinal abutment projection 9.1. The function of the projection 9.1 is to rest against a suitable cooperating element within the housing body in order to block the rotation of the clutch 9 beyond a defined angle. Consequently, the track 10.2 may not be slid beyond the track 12.1. The distal portion 9b of the clutch has a shape of a sleeve.

The proximal portion 10a of the driving sleeve 10 is placed over the distal portion 9b of the clutch 9. Inside the proximal portion 10a of the driving sleeve 10 at least one longitudinal groove is located, cooperating with at least one longitudinal projection 9.2 formed on the outside of the distal portion 9b of the clutch 9. Due the cooperation of these formations the driving sleeve 10 may not be rotated around the clutch 9 but it may be translated along the axis A-A. The described solution allows to define precise angles of operation of the system.

An abutment ring 9.3 is formed on the clutch 9. The spring 7 is placed over the proximal portion 10a of the driving sleeve 10. The spring 7 is a helical pressure spring the proximal end of which rests against the abutment ring 9.3 of the clutch 9 and the distal end of which rests against the annular abutment step 10.1 formed on the driving sleeve 10. The proximal end of the spring may also rest against a suitable inner element provided within the housing body 2.

In figs. 9a and 9b a fragment of the device according to the invention is shown with a fragment of the drive-control system 6 and the trigger 8.1 of the activating means 8 visible. As shown in figs. 9a and 9b, the guiding sleeve 11 and the trigger 8.1 of the activating means 8 are equipped with complementary engaging means. In the described embodiment of the device, the complementary engaging means have a form of at least one recess 11.3 on the outside of the guiding sleeve 11 at its distal end and an engagement projection 8.3 of the trigger 8.1. The engaging means 11.3 and 8.3 limit the rotation of the guiding sleeve 11 so as to retain the spring 7 at least partially compressed when mutually engaged. The trigger 8.1 may be axially advanced by means of the cap 8.2 (see fig. 2) so that its engagement projection 8.3 leaves the recess 11.3 causing disengagement of the complementary engaging means. When the engaging means 11.3 and 8.3 are disengaged the guiding sleeve 11 may rotate freely within the blocking sleeve 12. The number of the projections corresponds to the number of the teeth on the proximal edge of the guiding sleeve 11; in the described embodiment there are three projections.

The way of operation of the device according to the invention is the following.

The device may adopt two stable positions - a passive position and a position of delivery readiness. These two positions correspond to the same respective positions (passive and delivery readiness) of the drive-control system 6 described above. The dose delivery occurs during transition of the device 1 from its delivery readiness position to its passive position. In the passive position (shown in fig. 3a) the spring 7 is extended within its operation limits (note that the spring is pre-compressed), and the engagement projection 8.3 of the triggering activating means 8 is engaged with the recess 11.3. The transition from the passive position to the delivery readiness position is effected by applying an external force to rotate the knob 4 by a defined angle in the first direction (see fig. 3b). Along with the knob 4, the driving sleeve 10 is rotated and also translated by a defined distance in the proximal direction, the distance corresponding to the rotation of said angle. The translation of the driving sleeve 10 causes compression of the spring 7. In the delivery readiness position (fig. 3d) the spring 7 is compressed, the tracks 10.2 have fallen back on the tracks 12.1 and push against the guiding sleeve 11. However, the engagement projection 8.3 of the triggering activating means 8 remains engaged with the recess 11.3 so that the guiding sleeve 11 is immobilized. Activation of the triggering means 8 by disengagement of the projection 8.3 and the recess 11.3 releases the guiding sleeve 11 and its rotation (caused by the action of the spring 7 which is now extending) in the opposite direction back to its initial position (fig. 3e). Due to the operation of the drive-control system 6, the extension of the spring 7 causes the piston rod 5 to be moved (translated or translated with rotation) out of the device 1 and its digging into the cartridge of the container 3 by a defined distance (pitch), causing the delivery of a defined dose of a pharmaceutical. Figs. 10a and 10b show perspective views as seen from the distal end of a fragment of the device in two different positions of the trigger 8.1; in this embodiment the device of the invention is provided with the autopriming function.

In the device shown in figs. 10a and 10b, the complementary engaging means in the form of at least one recess 11.3 and at least one engagement projection 8.3 of the trigger are mutually engaged with a defined play L. The play L is present due to the fact that the recess 11.3 is larger along the periphery of the guiding sleeve 11 than the corresponding dimension (width) of the engagement projection 8.3. Thanks to the play L, when the tracks 10.2 fall back on the tracks 12.1 and the recess 11.3 is remains engaged with the engagement projection 8.3, the guiding sleeve 11, acting under the pressure of the tracks 10.2, rotates back by a small angle defined by the size of the play L causing a preliminary tiny advancement of the piston rod 5 out of the housing body 2. Hence, the piston 12 digs into the cartridge forcing a tiny amount of the pharmaceutical out and that is show the autopriming function is realized. After the autopriming, the device is in its delivery readiness position. At this stage the user (a patient) applies the needle to his body and activates the triggering means 8 releasing the guiding sleeve 11 and causing its rotation through the spring 7 acting on the driving sleeve 10. The rotation of the guiding sleeve 10 causes in turn a further advancement of the piston rod 5 out of the housing body 2 and into the cartridge and hence the delivery of a dose.