WO2008083875A1

WO2008083875A1 - Information device

Info

Publication number: WO2008083875A1
Application number: PCT/EP2007/062669
Authority: WO
Inventors: Istvan Bartha; Victor Kronestedt
Original assignee: Shl Medical Ab
Priority date: 2007-01-09
Filing date: 2007-11-22
Publication date: 2008-07-17

Abstract

The application relates to a medical delivery device comprising a housing; a container (10) containing medicament arranged inside the housing; a medicament delivery means (32,35,46,50,56) in communication with the housing and capable of delivering medicament to a patient; force means (16, 26;130, 26) capable of acting inside the container for delivering medicament during a certain time period via the medicament delivery means; mechanical information means (100) acting in response to the force means; wherein said mechanical information means comprises vibrating means (101, 102, 104; 110, 112, 132, 134) having at least one unbalance member capable of causing a vibrating sensation to the housing for providing tactile information to a patient during the time period, indicating medicament delivery.

Description

INFORMATION DEVICE

Technical Field

[0001] The present invention relates medical delivery devices and in particular a device capable of informing a user regarding the status of the delivery device.

Background Art

[0002] There are a number of devices on the market that are capable of automatically or semi-automatically delivering doses of medicament, where these devices comprise a number of inter-acting components for obtaining the desired functions.

[0003] One type of such delivery devices is an injector capable of delivering doses of medicament, having functions such as penetration of the patient's skin and a subsequent injection of medicament. One such device is for example disclosed in the document EP 1349590, comprising an activation mechanism in the form of a button placed at its distal end. The button may only activate the mechanism if the front end of the device is pressed against an injection site. When done so and the button is pressed, the penetration mechanism inside the injector is released whereby the needle is pushed into the body of the patient. After this, the injection is performed.

[0004] When the injection is completed, the patient withdraws the injector with the needle from the injection site, whereby a needle shield is pushed forward until it surrounds the needle and is then locked.

[0005] With an injector of the above described type there is often a desire for the user to know the progress of the function of the device and in particular the injection process, i.e. when the injection starts and when the injection is completed and it is safe to remove the injector. A few solutions of informing the user of the status of the injection have been developed. One is described in the document US 5,688,251 where a clutch component rotates during injection due to an injection spring, and during rotation is in contact with saw teeth on the housing, causing an audible sound during injection. US 2004/0210199 describes a similar device having a clicking sound during injection wherein a collar arranged coaxially on a drive sleeve and which oscillates axially on the drive sleeve that rotates during injection.

[0006] US 6,221 ,046 describes an injection device having an 'end of injection click' including an extension on a flexible tab of a dose dial mechanism. The tab with the extension falls into a groove in the housing, causing an audible click at the end of injection. US 2004/0097883 discloses a similar end of injection click solution.

[0007] US 2004/0267208 discloses an injector having audible and tactile feedback of a dose being dialled, by a clicker and a clutch means having saw teeth that cooperate to create the audible and tactile information.

[0008] WO 2004/078226 and WO 2006/052737 disclose an injector having tactile and audible feedback on the injection progress.

[0009] However, even if some solutions have been presented regarding informing a user of a medical delivery device, there is still room for improvements, especially regarding the delivering step of a medical delivery device.

Disclosure of Invention

Summary of the Invention

[0010] The aim of the present invention is to provide information regarding the delivering process of a medical delivery device in a reliable and predictive way that is easily detectable by any user.

[0011] This aim is obtained by a device according to the features of the independent patent claim. Preferable embodiments of the invention are subject of the dependent patent claims.

[0012] According to a main aspect of the invention it is characterised by a medical delivery device comprising a housing; a container containing medicament arranged inside the housing; a medicament delivery means in communication with the housing and capable of delivering medicament to a patient; force means capable of acting inside the container for delivering medicament during a certain time period via the medicament delivery means; mechanical information means acting in response to the force means; wherein said mechanical information means comprises vibrating means having at least one unbalance member capable of causing a vibrating sensation to the housing for providing tactile information to a patient during the time period, indicating medicament delivery to the patient.

[0013] [0003] According to another aspect of the invention, the unbalance member is arranged as a rotating unbalance member or as a pivoting unbalance member.

[0014] [0004] According to a further aspect of the invention, the medical delivery device further comprises a turnable dose setting mechanism, which dose setting mechanism rotates back to its original position during medicament delivery, and whereby said rotating unbalance is rotatably connected to the dose setting mechanism.

[0015] [0005] According to yet another aspect of the invention, the vibrating means comprises a ratchet arranged on a longitudinally movable plunger rod which is a part of the force means and a ledge which is part of the pivoting unbalance member, and wherein the ledge is arranged to be contact with the ratchet, such that during medicament delivery they move in relation to each other allowing the pivoting unbalance member to be moved.

[0016] [0006] The advantage with the present invention is as follows. Because the device is arranged with tactile mechanical information means that are acting during the delivering process, a user, even with reduced hearing, is able to gain information of the start, progress and stop of the delivering, and is well aware when it is safe to withdraw the device from e.g. an injection site.

[0017] [0007] Preferably a vibration is created in the device that can be sensed via the housing and transferred to the hand of the user. The vibrating means comprise an unbalance, which is a good vibration creator, and in particular when the medical delivery device is arranged with rotating components for delivering a dose, or a ratchet means, which is suitable when longitudinally moving components are used for delivering a dose.

[0018] These and other aspects of and advantages with the present invention will become apparent from the following detailed description and from the accompanying drawings. Brief Description of Drawings Description of Drawings

[0019] In the following detailed description of the invention, reference will be made to the accompanying drawings, of which:

[0020] Fig. 1 shows one embodiment in cross-section of a medical delivery device comprising the present invention,

[0021] Fig. 2 shows a cross-sectional view of Fig. 1 ,

[0022] Fig. 3 shows a detailed view of a further embodiment of the present invention, in perspective,

[0023] Fig. 4 shows the embodiment of Fig. 3 in three side views,

[0024] Fig. 5 shows yet an embodiment of the present invention in perspective, and

[0025] Fig. 6 shows the embodiment of Fig. 5 in a side view.

[0026] Fig. 7 shows the embodiment of Fig. 5 in cross-section of a medical delivery device comprising the present invention.

Best Mode for Carrying Out the Invention

Detailed Description of the Invention

[0027] Figure 1 shows a cross-sectional view of a medical delivery device, as an example of a delivery device, comprising the present invention. The delivery device comprises a dose setting member, to the right in Fig. 1 , which hereafter will be named the distal end. The opposite end of the device, to the left in the figure, is the end which is closest to the patient during medicament delivery, and will be named the proximal end. At its proximal end, the device is arranged with a container housing.

[0028] The delivery device 2 comprises in its distal end a dose setting mechanism and in its proximal end a container 10, e.g. a cartridge, a syringe, an ampoule, or the like having at least one chamber, coupled to an outer cover 40. The container 10 is intended to be filled with a medicament to be administered to the patient and the delivery device is thus provided with means in order to be connected to a suitable medicament administrating member, e.g. a mouth, a nasal piece, a member that introduces the medicament to the eye of a patient, a suitable nozzle that sprays the medicament to the eye, a spray nozzle to spray the medicament onto the skin of a patient or a needle for the injection of a medicament into the body of a patient; wherein the medicament is a liquid that can have a low or a high viscosity.

[0029] The dose setting mechanism comprises dose setting a member 4 having a dose wheel turning member 5 and a housing member 6 housing the energy accumulating member (see below), which members are adapted in order to be firmly, and removably, connected with each other. For this purpose, the interior of the proximal part of the dose wheel turning member 5 is provided with a number of equally distributed splines (not shown), which are adapted to engage corresponding inward protruding means (not shown) of the housing member. Thus, when the splines and the protruding means are engaged, the housing member 6 is rotated along with the turning member 5, when the later is rotated for instance clock-wise, which will be described in further detail below. When the turning member 5 is pulled towards the distal end of the delivery device, the splines and protruding means are brought out of engagement and the dose wheel turning member is thus adapted to also release the housing member. The housing member 6 is further provided with a shoulder adapted to be in contact with a corresponding means (not shown) in the outer cover of the device (not shown).

[0030] An elongated screw threaded plunger rod 16 is provided in the interior of the delivery device 2, running along the longitudinal axis of said device 2, which device thus is provided with means in order to house such a screw threaded member 16. The plunger rod 16 is in its proximal end adapted to be in contact with a stopper 22 through a non-rotating means, which stopper 22 is sealingly and slidably provided inside the container 10.

[0031] The housing member 6 is adapted to house an energy accumulating member in the form of a flat spiral spring 26, which spring 26 is provided winded in layers around the exterior of the proximal part of the housing member 6. The flat spiral spring 26 is in its inner end provided with inner holding means in order to be attached to the housing member 6, such as for instance a protruding member adapted to be fitted with a corresponding slit in the housing member 6, or alternatively a hole of a suitable size in the flat spiral spring 26, and a smaller screw or other similar means for the anchoring of the flat spiral spring 26 in the housing member 6.

[0032] At the outer end of the flat spiral spring 26, said flat spiral spring 26 is provided with outer holding means in order to be connected to the flat spiral spring cover of the delivery device 2. Said outer holding means comprises preferably a bend of the outer end of the flat spiral spring 26, which hitches corresponding means in the flat spiral spring cover. The cover is provided with means (not shown) in order to be rotationally fixed in the outer cover.

[0033] The dose setting member 4 is further in its proximal end adapted to house a coupling member 46. Said coupling member 46 is in its proximal end provided with a crown, which proximal end in turn is provided with at least one, preferably two equally distributed, bevelled protrusions. The crown of the coupling member is adapted to engage a plunger rod driving member 35, e.g. in the form of a nut. The nut is in this case adapted to engage with the plunger rod 16, i.e. the interior of the nut is provided with latches in order to be engaged in corresponding slots on the plunger rod 16. The nut is designed as to in its proximal end be provided with outwardly protruding flanges and in its distal end be provided with a skirt, the distal end of which is provided with a number of equally distributed bevelled recesses, which correspond to the protrusions of the crown. The coupling member is further provided with a helical coupling spring 32, which proximal end is in contact with the distal end of the crown. The proximal end of the coupling spring 32 is firmly fixed to the coupling member 35.

[0034] When the delivery device 2 of the first embodiment is in a locked state, i.e. a non-medicament delivery state, as will be described in further detail below, the nut is held in a locked non- rotatable state by means of an actuation sleeve 50. The interior of said sleeve is for this purpose provided with inward protruding stopper means (not shown), adapted to be provided in between the protruding flanges of the nut. The actuation sleeve is further adapted to engage a dose actuation member (not shown), and is at its distal end provided with means in order to be connected to a helical actuation spring 56, said spring 56 is provided surrounding the distal end of the actuation sleeve and the distal end of the actuation spring 56 is in contact with the outer cover 40.

[0035] The predetermined dose is in a first dose delivery step set by the use of the dose wheel 5, with the use of which the dose is increased by predetermined equally large dose increment steps.

[0036] One predetermined dose increment step, corresponds to a clock-wise rotation of the dose wheel 5 with one step, which step corresponds to a predetermined number of degrees. Thus, with each dose increment step, the dose wheel is turned clock-wise an additional step corresponding to said predetermined number of degrees.

[0037] So, in order to set a predetermined dose that corresponds to for instance two dose increment steps, the dose wheel turning member 5 is turned clock- wise two steps.

[0038] When the dose wheel turning member 5 is rotated, the housing member 6 and the coupling member 34 will rotate correspondingly and hence also the inner holding means of the flat spiral spring 26. Also the shoulder of the housing member 6 will be brought out of engagement with the corresponding means of the outer cover when the housing member 6 is rotated clock-wise.

[0039] When the coupling member rotates clock-wise, the protrusions will move along the bevelled edge of the recesses of the plunger rod driving member, with which recesses the protrusions are initially in engage with, and the coupling member will thus move towards the distal end of the delivery device 2, compress the coupling spring, and unlock the dose wheel from the plunger rod driving member. The flat spiral spring 26 is hereby free to wind up and accumulate energy corresponding to the rotation of the dose wheel turning member 5 the number of degrees corresponding to one clock-wise step turn. Due to the power accumulated in the compressed coupling spring 32, the coupling member will now move back towards the proximal end of the delivery device 2 when the protrusions climbs over the edge of the bevelled recesses and lock the coupling member as well as the dose wheel 5 to the plunger rod driving member, when the protrusions engage the recesses following the recesses it was previously in engagement with. The dose wheel turning member 5 is turned the additional and final step, whereby the above described procedure is repeated. The flat spiral spring 26 has thus after the completion of the first dose delivery step, accumulated the energy that corresponds to the rotation of the dose wheel turning member 5 the number of degrees corresponding to a two step clock- wise turn.

[0040] The delivery device 2 is now ready to deliver the predetermined dose corresponding to two dose increment steps, i.e. the delivery device 2 is now ready to be set in a medicament delivery state. This is accomplished by in a second dose delivery step, activate, i.e. pushing, the dose actuation member. When the dose actuation member is activated, said actuation member will actuate the actuation sleeve 50 towards the distal end of the device 2, whereby the protruding stopper means of the actuation sleeve 50 and the external means of the plunger rod driving member are brought out of engagement and the plunger rod driving member is released for rotation.

[0041] Due to the energy accumulated in the flat spiral spring 26 in the first dose delivery step, the coupling member and the plunger rod driving member will due to the output torque of the spring 26 when said spring now is free to unwind, rotate counter clock-wise the number of degrees corresponding to the two step turn. The rotation of the plunger rod driving member will rotate the plunger rod, and due to the non- rotating means adapted to engage a longitudinal extending means on the plunger rod so that the plunger rod moves towards the proximal end of the container the predetermined distance without rotation. The movement of the plunger rod causes the stopper to move forward in the container, thereby causing medicament contained in the container to be expelled through e.g. a needle and thus perform an injection.

[0042] Also the housing member 6 will rotate during this step. According to the present invention, the delivery device comprises mechanical information means 100 acting in response to the force means 16, 26. Further, the inner surface of the housing member 6 is arranged with vibrating means, e.g. a circumferentially ratchet 101 and a small cog-wheel 102 arranged rotatably on a shaft 104 and both arranged on a stationary part of the device. The cog-wheel is in engagement with the teeth of the ratchet 101. Said vibrating means comprise further an unbalance member 105 attached to the cog-wheel. Thus when the housing member is rotating during delivering, the engagement between the ratchet and the cog-wheel will cause the latter to rotate with a high revolution. Because of the rotating unbalance member, it will cause a vibration of the device and thus tactile information during the whole delivering step. The user is thus informed when the delivering starts, the progress of the delivering and its finish, and can thus safely remove the device after termination of vibrations.

[0043] When the predetermined dose has been delivered and the user of the delivery device 2 releases the dose actuation member, the actuation sleeve 50 will, due to the power accumulated in the actuation spring 56 when the actuation sleeve is pushed towards the distal end of the device 2, move back to its original position and once again lock the plunger rod driving member for rotation. The plunger rod 16 will stay at its current position, with its proximal end in contact with the stopper 22, and the delivery device 2 is ready to be used again.

[0044] Figures 3 and 4 show a variant of the present invention. Also here said vibrating means comprises e.g. a circumferential ratchet 110 attached to a part rotating during delivering of the delivery device. A small cog-wheel 112 is also arranged to be in engagement with the ratchet, and is thus rotating with a rather high rotational speed when the ratchet is rotating during delivering. On the cog-wheel 112 a further vibrating means is attached, e.g. an unbalance member 114. Said unbalance member 114 is arranged with four 'arms' 116 onto which magnets 118 are placed in a circular pattern with equal pitch. A fixedly arranged magnetic metal member 120 is further arranged adjacent the circular path of the magnets. Thus, when the cog-wheel and thus the magnets are moving in the circular pattern, the magnets will pass the magnetic metal member. Each passing of a magnet will cause a temporary retardation of the cog-wheel, and thus a vibration, that is transmitted to the delivery device, thereby providing the same type of tactile information as described above.

[0045] Figures 5, 6 and 7 show yet a variant of the present invention. In this embodiment, the vibrating means comprises a ratchet 132 arranged on a longitudinally movable plunger rod 130 which is a part of the force means and a ledge 134 which is part of a pivoting unbalance member 131 pivoted arranged on a fixed adjacent component of the device e.g. a housing 137, and wherein the ledge 134 is arranged to be contact with the ratchet 132. The pivoting unbalance member 131 comprises the ledge 134 at one end and a massive ledge/head 135 at the opposite end resting against the housing 137. During the delivering step, the plunger rod moves in its longitudinal direction, pushing the stopper into the container. During this longitudinal movement the ledge 134 will slide over the ratchet 132 up along one saw-toothed shaped tooth and then down onto the next tooth. This movement will cause the pivoting unbalance member to be moved, e.g. about a pivot 136, allowing the massive ledge/head 135 to vibrate against the housing 137 and will thus provide the same type of tactile information as the previous embodiments.

[0046] It is to be understood that the embodiments described above and shown in the drawings are to be regarded only as non-limiting examples of the present invention and that it can be modified within the scope of the patent claims.

Claims

1. Medical delivery device comprising: a housing; a container (10) containing medicament arranged inside the housing; a medicament delivery means (32, 35, 46, 50, 56) in communication with the housing and capable of delivering medicament to a patient; force means (16, 26; 130, 26) capable of acting inside the container for delivering medicament during a certain time period via the medicament delivery means; mechanical information means (100) acting in response to the force means; characterised in that said mechanical information means comprises vibrating means (101 , 102, 104; 110,112; 132, 134) having at least one unbalance member capable of causing a vibrating sensation to the housing for providing tactile information to a patient during the time period, indicating medicament delivery to the patient.

2. Device according to claim 1 , characterised in that the unbalance member is arranged as a rotating unbalance member (105; 114).

3. Device according to claim 2, characterised in thatthe device further comprising a turnable dose setting mechanism (5, 6), which dose setting mechanism rotates back to its original position during medicament delivery, and whereby said rotating unbalance member is rotatably connected to said dose setting mechanism.

4. Device according to claim 1 , characterised in that the unbalance member is arranged as a pivoting unbalance member (131) pivoted arranged on a fixed adjacent component of the device.

5. Device according to claim 4, characterised in that the vibrating means comprises a ratchet (132) arranged on a longitudinally movable plunger rod (130) which is a part of the force means and a ledge (134) which is part of the pivoting unbalance member (131), and wherein the ledge (134) is arranged to be contact with the ratchet (132), such that during medicament delivery they move in relation to each other allowing the pivoting unbalance member to be moved.

6. Device according to any of claims 1-5 characterised in that the device is adapted to be connected to a medicament administrating member in the form of a mouth or nasal piece.

7. Device according to any of claims 1-5 characterised in that the device is adapted to be connected to a medicament administrating member in the form of a nozzle, whereby the predetermined dose of medicament is sprayed to the eye or onto the skin of the patient.

8. Device according to any of claims 1-5 characterised in that the device is adapted to be connected to a medicament administrating member in the form of a needle for the injection of the predetermined dose of medicament into the body of the patient