Untitled record

d is cr ip c io n

Medication delivery device

Technical field

The present invention relates to a medication delivery device for administering medication and in particular to a medication delivery device in which safety and handling aspects have been improved by the interaction of a lockable injection button and a release button .

Background

Basically, a medication delivery device is a device that is simple to use without performing many stages when an individual has to administer a dose of medication by himself. This requires a solution that can keep a medication delivery device as pre-assembled and ready as possible, in order to administer the medication in a measured dosage, without many manual actions or operations. Therefore, in order to minimize the number of necessary steps, in order to perform a drug administration, it is only necessary that some known prior art devices be operated against the administration area, without the need for manual actuation, by pressing a button or similar, which causes the medication delivery device to administer. However, there is a usual demand for a medication delivery device that is very easy to use and can reliably administer an established dose of a medication in a safe manner.

US 5,925,021 discloses a pen-type injector device comprising locking means for locking the actuator button in a pressed position, a start button for releasing the actuator button and a dosing button for establishing a prescribed dose . US 5,925,021 also includes electronic elements, such as sensors and visual presentation devices, for controlling the injection, for measuring and storing expelled doses and for visually presenting information to the user. A disadvantage of this prior art is that it is necessary to establish a dose and then inject it manually by pushing the actuator button until it stops. In a stressful situation, or if handled by an inexperienced user, the injection can be interrupted halfway and the button can be accidentally released. If the button is pressed again, that is, without adjusting the dosage, a new dose of the previous setting will be initialized, which will cause the patient to receive an overdose.

WO 2005/097233 A2 discloses an administration device according to the preamble of claim 1.

Therefore, there is a need for a provision that can provide safe and simple handling both by inexperienced users and in stressful situations. Therefore, there is a need for a provision in which a predetermined dosage is fully administered, that is, a provision for administering a predetermined dose so that the administration of a previously initialized dose of medication has to be fully completed before the initialization of the dose can be initialized. administration of a subsequent predetermined dose. Therefore, as can be seen, aspects of human manipulation of the medication delivery device are crucial and there are several fundamentals to improve existing solutions.

Summary

The present invention is defined by independent claim 1.

An object of the embodiments of the present invention is to provide a medicament delivery device that is reliable, safe and intuitive to use and that does not allow a subsequent dose to be administered before a previously initialized dose has been fully administered. This is achieved by the main aspect of the invention, in which an administration device for administering predetermined amounts of medicament comprises a body that has an outer housing and an inner housing and that has a proximal end and an opposite distal end, a cartridge with medicament to be administered disposed inside said interior housing, said cartridge comprising an opening for expelling said medicament and a stopper that can move inside said reservoir, a threaded plunger rod arranged so that it can move inside said body in the longitudinal direction and in contact with said movable stopper , manually operated pushing means that can move in the longitudinal direction and which, when operated, can move said piston rod towards said movable plug, thereby expelling medicament through said opening, and spring means for deflecting said pushing means towards the distal end of the device, and a first driving element and a second driving element to transform a generally linear movement of said pushing means in a rotary movement of said piston rod, wherein said transformation means comprise a first set of protruding structures disposed in said first drive element that act in conjunction with a set of inclined projections disposed in said second drive element rotatably locked to said piston rod, in which the device it comprises a movable release element having a guide element adapted to interact with a guide frame disposed on the outer circumferential surface of the manually operated pushing means and in which said guide frame is configured to prevent the administration of a subsequent dose before a previously initialized dose has been fully administered.

According to the invention, the guide frame comprises first and second longitudinally oriented parallel rails separated by a longitudinally oriented wall element and connected to each other by means of distal and proximal transverse rails.

According to a further aspect of the invention, the guide element is arranged to protrude towards said rails.

According to the invention, said manually operated thrusting means, acting in conjunction with said release element, are disposed mobile in the longitudinal direction between a pressed position in which the guide element is generally aligned with said distal transverse rail and a released position in which the guide element is generally aligned with said proximal transverse rail.

According to the invention, the release element, acting in conjunction with said pushing means, is arranged so that it can move along a transverse direction between a first position in which the guide element is generally aligned with said first rail and a second position in which the guide element is generally aligned with said second rail.

According to a further aspect of the invention, said release element comprises an elastic element and wherein said elastic element is arranged to deflect said release element in the transverse direction towards said first position.

According to a further aspect of the invention, said distal transverse rail comprises a longitudinally aligned ramp that can interact with said guide element to allow movement of said release element from said first position to said second position.

According to the invention, the first longitudinally oriented rail is arranged with a first stepped ramp transversely aligned at a distal end of said wall element and a second stepped ramp transversely aligned at a proximal end of said wall element, wherein said first and second stepped ramps can interact with said guide element to allow the movement of said manually operated pushing means towards the pressed position and to prevent the return movement of said manual operating pushing means towards the position released.

According to a further aspect of the invention said guide element is arranged in a flexible tongue of the release element.

By means of the medicament delivery device disclosed, erroneous administration of a dose of medication is avoided. The administration of a dose of medication may be interrupted, but a subsequent dose cannot be administered until a previously initialized dose has been completely administered. The advantages described are possible due to the fact that it is impossible to restore the manually operated pushing means, such as an injection button, for a subsequent dose without first pressing them completely to expel the rest of the current initialized dose.

These and other aspects and advantages of the present invention will be apparent from the following detailed description and from the accompanying drawings.

Brief description of the drawings

In the following description of embodiments of the invention, reference will be made to the accompanying drawings, of which: Figure 1 is a perspective view of an exemplary medicament delivery device according to the invention.

Figure 2 shows, in perspective, an inside view of the medication delivery device of Figure 1 without the outer housing.

Figure 3 illustrates, in perspective, an exploded view of the components of the drive mechanism of the medication delivery device of Figure 1.

Figure 4 illustrates, in perspective, an exploded view of the manually operated pushing means and the release element of the medication delivery device of Figure 1.

Figures 5A-5F illustrate a sequence of the manually operated pushing means and the release element in different operating states.

Figure 6A illustrates, in perspective, a second driving element of the medication delivery device of Figure 1.

Figure 6B illustrates a cross section of Figure 6A.

Figure 7 illustrates a cross-section of the manually operated pushing means of the medication delivery device of Figure 1.

Figures 8A-8F illustrate, in a sequence of transparent views, the joint action of a second driving element and a first driving element.

Detailed description

Embodiments of the present invention will now be described in detail. As should be noted in the present application, when the term "distal part / end" is used, this refers to the part / end of the delivery device, or the parts / ends of the elements thereof, which is ( n) located further away from the patient's medication administration site. Correspondingly, when the term "proximal part / end" is used, this refers to the part / end of the delivery device, or the parts / ends of the elements thereof, which is located (s) ) closer to the patient's medication administration site. According to the main aspect of the invention, a medicament delivery device for administering predetermined amounts of medicament comprises a body having an outer housing and an inner housing, and having a proximal end and an opposite distal end, a medicated cartridge that it will be administered arranged inside said interior housing, said cartridge comprising an opening for expelling said medicament and a stopper that can move inside said reservoir, a threaded plunger rod arranged so that it can move inside said body in the longitudinal direction and in contact with said movable stopper , manually operated pushing means that can move in the longitudinal direction and which, when operated, can move said piston rod towards said movable plug, thereby expelling medicament through said opening, and spring means for deflecting said pushing means towards the distal end of the device, and a first driving element and a second driving element to transform a generally linear movement of said pushing means in a rotary movement of said piston rod, wherein said transformation means comprise a first set of protruding structures disposed in said first drive element that act in conjunction with a set of inclined projections disposed in said second drive element rotatably locked to said piston rod, wherein the device comprises a mobile release element having a guide element adapted to interact with a guide frame disposed on the outer circumferential surface of the manually operated pushing means and in which said guide frame is configured to prevent the administration of a subsequent dose before a previously initialized dose has been fully administered.

According to a further aspect of the invention, the guide frame comprises first and second longitudinally oriented parallel rails separated by a longitudinally oriented wall element and connected to each other by distal and proximal transverse rails.

An exemplary embodiment of the present invention is shown in Figures 1-8. The exemplary embodiment shown in the figures is a medication injector for double medication cartridges but is not restricted thereto. Figure 1 is a perspective view of exemplary components of a complete medication delivery device 10 according to the invention. Figure 1 illustrates the preassembled medicament delivery device 10 extending in a longitudinal direction 100. Some of the components of the device may move in a transverse direction 200 that is orthogonal with respect to the longitudinal direction 100.

The exemplary delivery device comprises an outer housing 17 arranged with a first display window 11 to indicate the remaining amount of medication. A proximal end of the cartridge reservoir 14 protrudes from the proximal end of the outer housing 17. The cartridge reservoir 14 is arranged with a second display window 13 for a user to verify that the medication content (not shown) has been mixed. The cartridge reservoir 14 is also disposed at its proximal end with coupling means 12 such as, for example, threads but is not restricted thereto, so that an administration element can be connected. The administration element may be a needle, a nozzle, a nozzle, or the like. On the distal part of the outer housing 17, a release element 20 is disposed movably in the transverse direction 200 and manually operated pushing means 30, for example a push button, are arranged movably in the longitudinal direction 100.

Figure 2 is a perspective view illustrating the medication delivery device 10 without the outer housing 17 (Figure 1). An inner housing 18 is arranged to receive a distal portion of the cartridge reservoir 14 by threaded engagement between the outer distal surface of the cartridge reservoir 14 and an inner surface of the inner housing 18. A first impeller element 15 is connected to the distal part of the inner housing 18, arranged in a rotational manner but locked in a mobile direction in a longitudinal direction relative to the housings 17 and 18. By means of a structural interface (not shown) between the inner distal annular surface of the inner housing 18 and a proximal annular surface of the first driving element 15, the reverse rotation of the first driving element 15 is prevented when the manually operated pushing means 30 is moved towards a released position (will be explained below). The first impeller element 15 is arranged with external threads that are coupled to internal threads of indicator means 16. Since the indicator means 16 are rotatably locked to the outer housing 17, the rotation of the first drive element 15 is transformed into a longitudinal movement of the indicator means 16 relative to the outer housing 17 to indicate the remaining amount of medication through the first display window 11 (figure 1).

The release element 20, as shown in Figure 2, may have an annular shape and be arranged in close proximity around the manually operated pushing means 30. A guide element 21 protrudes radially inwardly from the release element 20 to engage a guide frame 31 disposed on the outer circumferential surface of the manually operated pushing means 30. The part of the release element 20 that a patient / user operates and protrudes through the outer housing 17, as shown in Figure 1, can be shaped as a push button. A user operates the release element in order to unlock the device for the administration of a dose of medication. After actuation, the release element 20 is returned by an elastic element 22 which is disposed in a transversely offset position, abutting the inside of the outer housing 17. In the exemplary embodiment, the elastic element 22 shown in Figure 2 has the shape of a flexible finger of the release element, but it can also be any other kind of flexible element, for example a helical spring. The effect can also be achieved by the native elasticity of the material and / or the conformation of the release element 20 itself. The joint action between the guide element 21 and the guide frame 31 guarantees the safe and simple administration of complete doses of medication, which will be explained in detail below.

The general operation of the exemplary medicament delivery device, as shown in Figures 1 and 2, is described by the following steps. The device is operated by first unlocking and releasing the manually operated pushing means 30 by pressing the release element 20 in the transverse direction and then actuating the pushing means 30 in the longitudinal direction. A second drive element 40 (Figure 3) is arranged coaxially in the distal part of the first drive element 15. The distal end of the second driving element is arranged coaxially within the manually operated pushing means 30, acting to transform the longitudinal movement of the pushing means 30 into a rotating movement of the first driving element 15, a mechanism that will be explained continuation. A piston rod (not shown) is slidably arranged, although rotatably locked inside the first impeller element 15 and extends from the interior of the first impeller element 15 until a threaded coupling is achieved with a threaded opening in a surface distal annular of inner housing 18. The proximal end of the piston rod extends into a cartridge (not shown) that is located in the cartridge reservoir 14 and is abutting with a movable cap (not shown) acting on the medicament inside the reservoir to propel it toward the administration element when the piston rod is driven by the rotation of the first impeller element 15. Since the piston rod is rotatably locked to the first driving element 15 and since the inner housing 18 is fixed to the outer housing, the relative rotation of the first driving element 15 relative to the inner housing 18 impels the piston rod in the longitudinally proximal direction by means of the threaded coupling between the piston rod and the inner housing 18.

The exemplary embodiment, as shown in Figure 3, is an exploded view of the main components of the invention at the distal end of the medication delivery device. The first impeller element 15 can be rotated, although it is movably locked along a longitudinal axis. Spring means 19 are arranged in permanent compression between an annular projection at the distal end of the first drive element 15 and on an annular inner surface of the distal end of the second drive element 40. The second drive element can move, and to a certain extent can be rotated, along the longitudinal axis. The spring means 19 forces the second drive element 40 against the inner surface of the distal end of the manually operated pushing means 30. The manually operated pushing means 30 can move along a longitudinal axis. The releasing element 20, which can be moved transversely, is arranged coaxially with the pushing means 30 and aligned with the guide frame 31 for the interaction between the releasing element 20 and the pushing means 30. The operation of the exemplary embodiment of Figure 3 will be explained below.

Figure 4 shows a perspective view of an exemplary embodiment of the manually operated pushing means 30 and the release element 20. In order to obtain an administration device of Medicine that is safe and easy to handle according to the invention is necessary to make the device work sequentially in stages. Thus, the manually operated pushing means 30 are arranged with at least one guide frame 31, such as two guide frames located opposite each other on the circumferential surface of the pushing means. The release element 20 is arranged with at least one guide element 21, located to act in conjunction with the at least one guide frame 31.

The guide frame 31 comprises a first longitudinally oriented rail 33 that runs parallel to a second longitudinally oriented rail 34. They are separated by a longitudinally oriented wall element 32 and connected to each other by a distal transverse rail 35 and a proximal transverse rail 36. The term lane must be interpreted in its broadest sense as a path in relation to which the guide element 21 can move in a substantially confined manner, ie without leaving the lane. Different solutions for rails are conceivable. The exemplary embodiment of Figure 4 shows a guide frame having walls projecting radially from the surface of the manually operated pushing means 30 and in which the proximal transverse rail 36 is open towards the proximal side. Since the guide element 21 is arranged in the release element 20, which is movable transversely confined by the outer housing 17, the guide element 21 is still aligned with any of the longitudinal rails 33, 34 although it must be located proximally with respect to the proximal transverse rail 36, that is proximally with respect to the guide frame 31 as a whole.

The distal transverse rail 35 comprises a longitudinally aligned ramp 37. The first longitudinally oriented rail 33 comprises a first stepped ramp 38 transversely aligned at a distal end of the wall element 32 and a second stepped ramp 39 transversely aligned at a proximal end of the wall element 32. The purpose of these ramps will be explained together with figures 5A-F.

The guide element 21 may be arranged as an protruding element, for example in the form of a stepped ramp, oriented radially inwardly so that it protrudes towards the rails of the guide frame 31 for interaction with them. Said protruding element is arranged in at least one flexible tongue, or a recess, in the circumference of the release element 20. The manually operated pushing means 30 can move in the longitudinal direction while the release element 20 can move in the transverse direction. The manually operated pushing means 30 are arranged to move in the longitudinal direction between a pressed position in which the guide element 21 is generally aligned with said distal transverse rail 35 and a released position in which the guide element 21 is generally aligned with said proximal transverse rail 36. The release element 20 is arranged so that it can move in the transverse direction between a first position in which the guide element 21 is generally aligned with said first rail 33 and a second position in which the guide element is generally aligned with said second lane 34.

The manually operated pushing means 30 are permanently deflected longitudinally in the distal direction, released, by the spring means 19 (Figure 3) and the release element 20 is permanently deflected transversely to the first position by the element 22 elastic. The user of the device requires force to move the release element 20 and the thrust means 30 against their respective deflection directions.

Referring now to Figures 5A-F, a sequence of steps showing the operation of the medication delivery device 10 and the interaction between the manually operated pushing means 30 and the release element 20 is illustrated. In Fig. 5A the medication delivery device 10 is in a locked position in which the pushing means 30 is in the pressed position and its movement towards the released position is blocked by a coupling between the guide element 21 and the first ramp 38 staggered aligned transversely. The release element is stable in the first position due to the permanent spring deflection of the elastic element 22. To unlock the medication delivery device 10, the user has to move the release element 20 into the second position by exerting a transverse force on the release element 20 that exceeds the spring deflection of the elastic element 22. A certain additional frictional force is required to overcome the resistance of the longitudinally aligned ramp 37 in order to reduce the risk of accidental unlocking of the device.

Turning to Fig. 5B, a state in which the medication delivery device 10 has been unlocked is illustrated, in which the user still holds the release element 20 in the second position after displacement from the first position (Fig. 5A ). The manually operated pushing means are diverted to the distally released position by means of the spring means 19. Accordingly, the thrust means 30 travel distally towards the released position. Figure 5C shows the thrust means 30 moving distally towards the released position.

As illustrated in Figure 5D, the pushing means 30 have reached the released position while the user is still holding the release element 20 in the second position. As the user releases the release element 20, it is returned to the first position by deflecting the element 22 elastic, as seen in figure 5E. Referring again to Figure 5C, if the user releases the release element 20 while the pushing means 30 is still moving, the wall element 32 will still hold the guide element 21 and the release element 20 in the second position. , thereby preventing the return movement of the release element 20 to the first position. When the pushing means 30 reach the released position, the guide element 21 is aligned with the proximal transverse rail 36, allowing the return movement of the release element 20.

Figure 5F illustrates the pushing means 30 and the release element 20 after the initial pressure of the pushing means 30. When the thrust means 30 are pressed proximally as shown in Figure 5F, the second cross-sectioned stepped ramp 39 moves past the guide element 21, an audible click sound is produced when the guide element 21 and the second stepped ramp 39 is engaged to give a locking coupling to each other. The only possible movement of the guide element 21 and the thrust means 30 after this is the continued pressure of the thrust means 30. The purpose of the second stepped ramp 39, apart from providing an audible indication to the user, is to prevent the pushing means 30 from returning to the released position and thereby being restored for a subsequent dose before the dose has been fully administered. Current initialized previously. The mechanism for resetting the device is explained together with Figures 6-8. When fully pressed, the thrust means return to the pressed position, shown in Figure 5A. When the first transversely aligned stepped ramp 38 exceeds the guide element 21, an audible sound is produced when the guide element 21 and the first stepped ramp 38 are engaged to give a locking coupling to each other, blocking the device and also indicating the user that the dose has been fully administered.

Although the main aspects of the invention are related to the interaction between the release element 20 and the manually operated pushing means 30, as shown by way of example by means of Figures 4 and 5A-F, a crucial part of the operation of the medication delivery device 10 is the interaction between the first driving element 15 and the second driving element 40. An example of this type is shown in Figures 6-8.

Figure 6A shows a perspective view of the second impeller element 40, comprising a protruding longitudinal rib 41 disposed on the outer circumferential surface. Inclined ramps 42 are disposed on the distal end surface of the second drive element 40. Figure 6B illustrates a cross section of the second drive element 40 in which its inner circumferential surface comprises inwardly inclined projections 43 generally oriented proximally and return projections 44 generally oriented distally.

The inclination of the projections and the number of projections depend on the amount of medication to be administered per dose and are set according to predetermined values ​​during the manufacture of the second drive element 40. In the embodiment illustrated in Figure 6B, for example, there are two inclined projections 43 arranged opposite that correspond to two protruding structures 50 in the outer circumference of the first drive element 15, shown by way of example in Figure 3.

Figure 7 is a cross section of the manually operated pushing means 30. Outstanding longitudinal slats 301 (Figure 7) are arranged on the inner circumferential surface. A seat 302 is disposed on the inner surface oriented proximally of the manually operated pushing means 30.

The operation of the first and second driving elements is best described by the sequence of drawings illustrated in FIGS. 8A-F, which is a sequence of transparent views of the second driving element 40 and the first driving element 15 corresponding to the sequence of the Figures 5A-F. Figure 8A depicts the locked position of the medication delivery device 10, showing the protruding structure 50 of the first driving element at the distal end of the inclined projection 43. Due to the pressed position of the manually operated pushing means 30 (not shown) the inclined ramps 42 disposed at the distal end of the second drive element are pressed to the seat 302 (Figure 7) by the force of the spring means 19 (not shown), rotationally blocking the second drive element 40.

Figures 8B-C show that the actuation of the release element 20 towards the second position does not directly affect the driving elements (Figure 8B), but as the pushing means 30 move towards the released position by means 19 of spring, the force of the ramps 42 inclined against the seat 302 is relaxed, allowing the return projection 44 to slide against the proximal inclined surface 54 of the first drive element 15. This rotates the second drive element 40 relative to the first drive element 15 and the thrust means 30. The rotation is limited by the longitudinal rib 41 of the second drive element 40 which is loosely confined between the longitudinally projecting slats 301 (Figure 7) on the inner circumferential surface of the pushing means 30. The inverse rotation of the first drive element 15 during this phase is prevented by the interaction of a structural interface, for example a type of ratchet interface, between the inner distal annular surface of the inner housing 18 and a proximal annular surface of the first impeller element 15 (not shown).

With reference to Fig. 8D, when the proximal end of the return boss 44 slides past the protruding structure 50 and the second drive element 40 reaches the released position, the inclined ramps 42 are driven again against the seat 302 , causing the second impeller element 40 to rotate again relative to the first impeller element 15 and the thrust means 30, aligning the distal inclined surface 52 with the proximal end of the inclined projection 43.

Figure 8E represents the state in which the release element 20 is returned to the first position (not shown).

In Fig. 8F the user is pressing the pushing means 30 (not shown) to start expelling a dose of medication. This causes the inclined projection 43 of the second impeller element 40 to engage the distal inclined surface 52 of the first impeller element 15, resulting in rotation of the latter. The second drive element is rotatably blocked due to the coupling between the inclined ramps 42 and the seat 302. When the first impeller element 15 rotates, the piston rod also rotates (not shown). The movement of the piston rod impels a cap (not shown) to expel medication through the administration element. If the user releases the thrust means 30 at some time during the administration of medication, the coupling between the inclined projection 43 and the inclined surface 52 is relaxed, but the first impeller element 15 remains stationary since no force is acting on the same. Therefore, it is possible to resume and complete the administration of the dose at any time. The pushing means 30, and consequently the second drive element 40, must be fully depressed, as illustrated in Figure 8A, before a subsequent dose can be initialized.

The present invention is not limited to the preferred embodiment described above. Various alternatives, modifications and equivalents can be used. Therefore, it should not be understood that the above embodiment limits the scope of the invention, which is defined by the appended claims.