Drug Delivery Devices

Abstract

The present invention relates to a medication delivery device (10) comprising a mounting surface (16, 100) for attachment to a skin surface of a user, actuation means (28, 30), a plunger rod (36) connected to the actuation means, a medication container (54) containing a medication that is pressurized by the plunger rod and the actuation means, a valve device (66) fluidly connectable to the medication container, an injection needle (72) fluidly connected to the valve device, and control means (86, 88) operably connected to the valve device for opening and closing a fluid pathway between the medication container and the injection needle.

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates to drug delivery devices, and more particularly to devices that can be attached to the skin surface of a user to manage the delivery of drugs. [Background technology]

[0002] Many medication delivery devices, such as pen-type injectors and auto-injectors, have been developed for self-administration of medication. These devices are held and operated by the user during medication administration. Also, so-called wearable medication delivery devices have been developed that are attached to the user's body. Medication delivery devices may be developed as refillable, multi-use devices or single-use, so-called disposable devices. Wearable medication delivery devices face the challenge of being as small and unobtrusive as possible while still providing excellent functionality, especially with regard to automated functions that are not performed by the user. This challenge is even more pronounced when wearable medication delivery devices are designed as disposable devices, due to the manufacturing costs associated with accommodating critical and automated functions in a limited space. Summary of the Invention [Means for solving the problem]

[0003] The present invention aims to ameliorate the shortcomings of current drug delivery devices, particularly wearable devices.

[0004] This object is achieved by a drug delivery device comprising the features according to the independent claims.

[0005] Preferred, but not essential, aspects of the invention are defined in the dependent claims.

[0006] According to a main aspect, there is provided a medication delivery device which may comprise a mounting surface for attachment to a skin surface of a user, a drive means, a plunger rod connected to the drive means, a medication container containing a medication which is pressurized by the plunger rod and the drive means, a valve device fluidly connectable to the medication container, an injection needle fluidly connected to the valve device, and a control means operably connected to the valve device for opening and closing a fluid pathway between the medication container and the injection needle.

[0007] According to a further aspect, the control means may be designed to operate the valve arrangement to provide a pulsed injection sequence, in which case the pulsed injections may be controlled in terms of pulse frequency and pulse duration.

[0008] Furthermore, according to one aspect, the control means may include a solenoid. In this regard, the control means may further include a controller programmed to operate the solenoid.

[0009] According to another aspect, the valve device may include a needle hub, and the needle hub may include the injection needle and cartridge needle.

[0010] The valve device may further include a piston movable within a passageway by the solenoid, the piston including a fluid path such that the infusion needle and the cartridge needle are fluidly connected to the passageway such that when the piston is in a first position, the fluid connection between the needles is interrupted and when the piston is in a second position, a fluid path fluidly connects the needles. In this regard, the fluid path of the piston may include an annular groove.

[0011] The drive means and the plunger rod, when actuated, are capable of moving the drug container in contact with the cartridge needle to create a fluid connection between the drug container and the cartridge needle.

[0012] According to a further aspect, the medication delivery device may comprise a base member having a mounting surface and a unit pivotally connected to the base member, the unit comprising the drive means, the plunger rod, the medication container, the valve device, the injection needle and the control means, wherein pivoting movement of the unit relative to the base member may cause penetration of the injection needle.

[0013] Additionally, the unit may include a mounting surface for mounting to a skin surface of a user when rotated relative to the base member.

[0014] These and other aspects and advantages of the present invention will become apparent from the following detailed description of the invention and the accompanying drawings. [Brief explanation of the drawings]

[0015] In the following detailed description of the invention, reference is made to the accompanying drawings.

[0016] [Figure 1] FIG. 1 is a perspective view of a wearable device according to an embodiment of the present invention. [Figure 2] FIG. 2 is a perspective view of the device of FIG. 1 with the top cover removed. [Figure 3] FIG. 3 is a detailed view of the components of the apparatus of FIG. [Figure 4] FIG. 4 is a detailed view of the components of the apparatus of FIG. [Figure 5] FIG. 5 is a detailed view of the components of the apparatus of FIG. [Figure 6] FIG. 6 is a detailed view of the components of the apparatus of FIG. [Figure 7] FIG. 7 is a detailed view of the components of the apparatus of FIG. [Figure 8] 8 is a cross-sectional view of the device of FIG. 1 in a different operating position. [Figure 9] 9 is a cross-sectional view of the device of FIG. 1 in a different operating position. [Figure 10]10 is a cross-sectional view of the device of FIG. 1 in a different operating position. [Figure 11] FIG. 11 is a detailed view of a needle hub configured in the device of FIG. [Figure 12] FIG. 12 is a detailed view of a needle hub configured in the device of FIG. [Figure 13] FIG. 13 is a detailed view of the sensor device configured as shown in FIG. [Figure 14] 14 is a perspective view of the locking mechanism of the device of FIG. 1 with the top cover removed. [Figure 15] 15 is a perspective view of the locking mechanism of the device of FIG. 1 with the top cover removed. [Figure 16] 16 is a perspective view of the locking mechanism of the device of FIG. 1 with the top cover removed. DETAILED DESCRIPTION OF THE INVENTION

[0017] The wearable infusion device 10 shown in the drawings includes a generally rectangular base member 12 having two oppositely disposed side walls 14, an end wall 15, and a lower surface 16 intended to contact the skin surface of a wearer of the device 10. For this purpose, the lower surface 16 preferably includes an adhesive layer 18 (FIG. 4) for adhering to the skin surface. The adhesive layer 18 is protected by a peelable protective film 20 prior to use. The lower surface 16 further includes a passageway 22 (FIG. 8). Furthermore, a generally rectangular base plate 24 is attached to the base member 12 via a hinge 26 at one end of the side wall 14 of the base member 12 to provide for pivotal movement of the base plate 24 relative to the base member 12, as will be described in more detail below.

[0018] The base plate 24 further includes a power spring 28. The power spring 28 is internally guided by a tubular spring guide 30. One end of the power spring 28 contacts an end wall 32 of the base plate 24. The opposite end of the power spring 28 rests on an annular ledge 34 of the spring guide 30. The end face of the spring guide 30 moves against the end face of a plunger rod 36, as will be explained below. The plunger rod 36 is designed with plate-like segments 38 oriented generally perpendicular to the plane of the base plate 24 (FIG. 3). The segments 38 are interconnected in sequence by hinges 40, which may be grooves in the material, forming a living hinge. Each segment 38 further includes a guide plate 42 oriented generally perpendicular to the surface of the segment 38. The guide plates 42 have chamfered end faces that form V-shaped gaps 44 between adjacent guide plates 42.

[0019] The design of the plunger rod 36 allows it to be curved, and its exterior is guided by a curved support wall 46 of the base plate 24. The guide plate 42, as seen in FIG. 3, is positioned inside the curved plunger rod 36 and fits into a groove 48 on a guide bend 50, preventing lateral movement of the plunger rod 36 during operation, as will be described below. The end of the plunger rod 36 opposite the spring 28 is provided with a generally circular pusher plate 52. The pusher plate 52 is sized to fit the opening of a generally cylindrical drug container, such as a cartridge 54, which is placed in a cartridge holder 56 of the base plate 24. Prior to use, the cartridge 54 is held in an initial position between the pusher plate 52 of the plunger rod 36 and a stop ledge 58 attached to a retaining lever 60, FIG. 7, the function of which will be described below. The cartridge 54 has a movable stopper 62 and a neck at the end opposite the opening, the neck being provided with a pierceable septum 64. The cartridge 54 therefore contains a quantity of medication in the space between the stopper 62 and the septum 64.

[0020] As shown in FIGS. 4 and 5 , a needle hub 66 is provided adjacent the neck end of the cartridge 54 and is attached to or integral with the base plate 24. The needle hub 66 is configured with a valve device. The needle hub 66 has a first hollow needle 68, which is a cartridge needle, extending from its side and is oriented generally horizontally relative to the plane of the base plate 24 and aligned with the septum 64 of the cartridge 54. The first needle 68 is protected by a flexible sheath 70 and kept sterile. The needle hub 66 further has a second hollow needle 72, which is an injection needle that extends downward from the bottom surface of the needle hub 66 through a passage 74 in the bottom surface of the base plate 24 and is oriented generally perpendicular to the plane of the base plate 24. The second needle 72 is protected and kept sterile by a needle sheath 76, which in turn is connected to a needle cap 78. The needle cap 78 extends from below into the passage 22 of the base member 12 and, as seen in FIG. 4, contacts or is adjacent to the bottom surface of the base plate 24 in the initial position of the device 10. The needle hub 66 further includes a passage 80, with which the openings at the inner ends of the first and second hollow needles 68, 72 are in fluid communication. A piston 82 is movably disposed within the passage 80. The piston 82 is provided with a fluid communication path, shown in this embodiment as an annular groove 84. The piston 82 is movable between a first position in which the openings at the inner ends of the two needles 68, 72 are blocked by the piston 82 and a second position in which the groove 84 is aligned with the needle openings, providing a fluid path between the two needles 68, 72 (see FIGS. 11 and 12). The piston 82 further includes suitable sealing members disposed on either side of the groove 84 .

[0021] Movement of the piston 82 is effected by a solenoid 86 attached to one end of the piston 82. The solenoid 86 is electrically connected in series to a controller 88, which comprises processor means, memory means, and appropriate sensor means. The controller 88 is powered by a battery 90. Additionally, a display 92 for displaying the status of the device 10 during use and a user-operated start button 94 are connected to the controller 88. Both the display 92 and the start button 94 are located within a top cover 96 attached to the base plate 24 for easy access (FIG. 1). The top cover 96 may further include an opening 98 through which the cartridge 54 and its contents can be viewed. Additionally, a lip 100 may be disposed on the top cover 96, which may include an adhesive layer 18 on its underside, as will be described.

[0022] The start button 94 is positioned for generally vertical movement by a vertical ledge 102 that fits into a vertical groove (not shown) in the base plate 24. However, prior to use, the start button 94 is prevented from moving by a blocking ledge 106 on a blocking lever 108 located below the start button 94 contacting a vertical ledge 110 on the start button 94. In this initial position, the start button 94 prevents movement of the spring guide 30 with the tension spring 28 by a radially extending protrusion 112 on the annular ledge 34 of the spring guide 30 abutting against the vertical ledge 110 on the start button, as seen in FIG.

[0023] The base member 12 further includes an end wall 114 (FIG. 14) disposed inside the end wall 15 of the base plate 24. A protrusion 116 is disposed on the inner surface of the end wall 114 of the base member 12. The base plate 24 further includes a blocking plate 118 adjacent to the protrusion 116. The blocking plate 118 has a guide wall 120 on the surface facing the protrusion 116, and a first generally vertically extending portion 120 I followed by a second inclined portion 120 II and a third vertical portion 120III The fourth vertical portion 120 IV is the third part 120 III When viewed vertically, the third portion 120 III and the fourth part 120 IV Beneath the space between the plates is a flexible ledge 122. The function of the exclusion plate 118 will be explained below.

[0024] The device 10 is intended to function as follows: When the device 10 is delivered to a user, the base plate 24 / top cover 96 unit is in an inclined position relative to the base member 12, as seen in FIG. 4. The unit 24 / 96 is prevented from moving relative to the base member 12 by the needle cap 78. To use the device 10, the user removes the protective layer 20 from the underside 16 of the base member 12 and the lip 100 of the top cover 96, and also removes the needle cap 78 (FIG. 8). The user then applies the device 10 by pressing the base member 12 of the device 10 against the skin surface. Pressing the device 10, and in particular the unit 24 / 96, causes a pivotal movement of the unit 24 / 96 relative to the base member 12, thereby causing the second needle 72 to penetrate the skin (FIG. 9). The unit 24 / 96 is held in this position by the adhesive layer 18 on the lip 100, which contacts the skin surface. The blocking lever 108, which blocks the start button 94, has been rotated so that its blocking ledge 106 does not contact the start button 94, and the device 10 is now in the injection position. This rotational movement of the blocking lever 108 is also detected by a sensor 130 (FIG. 13), which activates and "wakes up" the electronic circuitry on the PCB by supplying power from the battery 90. The retention lever 60, which holds the cartridge 54, has also been rotated so that the cartridge 54 is free to move within the cartridge holder 56. This activates the display 92, which can then display information that injection can begin. The rotational movement also causes the protrusion 116 on the wall of the base member 12 to contact the second inclined portion 120 of the exclusion plate 118. II15. In other embodiments, the exclusion plate 118 can be provided on the inner surface of the end wall 114 of the base member 12, with the protrusions 116 provided on the base plate 24.

[0025] Now, when the start button 94 is pressed into the top cover 96, its projection 112 can pass through the notch 132 in the vertical ledge 110 of the start button 94, thereby unblocking the spring guide 30 (FIG. 6). The power spring 28 is released, allowing the spring guide 30 to move under its force. The spring guide 30 acts on the split plunger rod 36, which moves against the stopper 62. Due to the incompressibility of the medicament, the force from the power spring 28 on the plunger rod 36 moves the cartridge 54, causing the first needle 68 to pierce the now-compressed needle sheath 70 and the septum 64 of the cartridge 54 (FIG. 10). The movement of the cartridge 54 stops when its front contacts the needle hub 66. The medicament is pressurized by the plunger rod 36 acting against the stopper 62. Furthermore, pressing the start button 94 is detected by the sensor 134 (FIG. 13) and provides a start signal to initiate the injection sequence. The injection sequence is preprogrammed and stored in the memory means of the controller 88. The electronics activate the solenoid 86 to move the piston 82 from the first, closed position (FIG. 11) to the second position (FIG. 12), where the annular groove 84 creates a flow path between the first needle 68 and the second needle 72, initiating the injection. In response to the stored injection sequence, the solenoid 86 repeatedly moves the piston 82 between the first and second positions, thereby creating, for example, a pulsed delivery of the medication. The injection sequence can be designed differently for various embodiments. The pulses can be short or long in duration and can be fast or slow in frequency. The pressure of the medication within the cartridge 54 is maintained by a constantly acting spring force. However, the spring force decreases as the spring expands, and this situation can be handled by varying the pulse start time to maintain a constant drug flow rate over a time span that includes at least one complete pulse cycle. Typically, the solenoid 86 produces an audible click upon activation, which can be used as an indication to the user that an injection is in progress. Additionally, the start button 94 may be returned to its initial position by a spring means 136 (FIG. 6) when the user stops pressing it.Further depression is detected by sensor 134 and stops the injection sequence. This can start and stop the injection several times. In this way, the user can control the injection independently of the pre-programmed injection sequence.

[0026] Once the injection is complete, the display 92 indicates that it is safe to remove the device 10 from the skin surface. In this regard, there may be a third sensor capable of detecting the movement position of the plunger rod 36 at the end of the transfer / injection. Additionally, the opening 98 may indicate the status of the injection to the user, in that the stopper 62 may be visible therein. The user then grasps the unit 24 / 96, thereby loosening the adhesive film on the lip 100 from the skin. This action causes the unit 24 / 96 to rotate back to its initial position relative to the base member 12, positioning the second needle 72, the injection needle, within the device. The pivoting movement of the unit 24 / 96 further engages the protrusion 116 on the base member 12 with the fourth portion 120 of the lockout plate 118. IV 16, thereby locking the unit 24 / 96 in its initial position and preventing any attempt to return the unit 24 / 96 to the injection position, thereby avoiding the risk of an unintentional needle stick. Further pulling on the device 10 will completely detach it from the skin surface. The device 10 can now be safely disposed of.

[0027] It will be understood that the embodiments described above and shown in the drawings are to be considered only as non-limiting examples of the invention, many variations of which are possible within the scope of the claims.

Claims

1. A drug delivery device (10), comprising: a mounting surface (16, 100) for attachment to a user's skin surface; Drive means (28, 30); a plunger rod (36) connected to the drive means (28, 30); a drug container (54) containing a drug that is pressurized by the plunger rod (36) and the driving means (28, 30); a valve device fluidly connectable to the drug container (54); an injection needle (72) fluidly connected to said valve device; control means (86, 88) operably connected to the valve device for opening and closing a fluid path between the drug container (54) and the injection needle (72); 12. A drug delivery device comprising:

2. 2. A medication delivery device according to claim 1, wherein said control means (86, 88) is designed to operate said valve arrangement to provide a pulsed injection sequence.

3. 3. The drug delivery device of claim 2, wherein the pulsed injection is controlled with respect to pulse frequency and pulse duration.

4. A medication delivery device according to any one of claims 1 to 3, wherein the control means comprises a solenoid (86).

5. 5. The medication delivery device of claim 4, wherein the control means further comprises a controller (88) programmed to activate the solenoid (86).

6. The medication delivery device of any one of claims 1 to 5, wherein the valve arrangement comprises a needle hub (66), the needle hub comprising the injection needle (72) and the cartridge needle (68).

7. The valve device includes a piston (82) movable within a passage (80) by the solenoid (86); the injection needle (72) and the cartridge needle (68) are fluidly connected to the passageway (80); 7. The drug delivery device of claim 6, wherein the piston (82) comprises a fluid path (84), and when the piston (82) is in a first position, the fluid connection between the needles is interrupted, and when the piston (82) is in a second position, the fluid path (84) fluidly connects the needles.

8. 8. The medication delivery device of claim 7, wherein the fluid path (84) of the piston (82) comprises an annular groove (84).

9. 9. The medication delivery device of claim 6, wherein the drive means (28, 30) and the plunger rod (36), when actuated, move the medication container (54) into contact with the cartridge needle (68) to create a fluid connection between the medication container (54) and the cartridge needle (68).

10. 10. The drug delivery device of claim 1, further comprising: a base member (12) having the mounting surface; and a unit (24, 96) pivotally connected to the base member (12), the unit (24, 96) comprising the drive means (28, 30), the plunger rod (36), the drug container (54), the valve device (66), the injection needle (72), and the control means (86, 88), wherein pivoting movement of the unit (24, 96) relative to the base member (12) causes penetration of the injection needle (72).

11. 11. The medication delivery device of claim 10, wherein the unit (24, 96) comprises a mounting surface (100) for mounting to a skin surface of a user when rotated relative to the base member.

12. a holding lever (60) pivotally connected to the unit (24, 96) and engaging with the base member (12); a stop ledge (58) attached to said retaining lever (60); A drug delivery device as described in claim 10 or 11, wherein before use, the stop ledge (58) holds the drug container (54) in an initial position, and the pivoting movement of the unit (24, 96) relative to the base member (12) causes the holding lever (60) to pivot, thereby allowing the stop ledge (58) to free the drug container (54) to move.

13. a start button (94) for selectively engaging said drive means (28, 30); a blocking lever (108) pivotally connected to the unit (24, 96) and engaging with the base member (12); and at least one blocking ledge (106) provided on said blocking lever (108), Prior to use, the start button (94) engages the drive means (28, 30) to prevent the drive means (28, 30) from applying pressure to the plunger rod (36), and the start button (94) is prevented from moving by contact with the at least one blocking ledge (106); 13. A medication delivery device as claimed in any one of claims 10 to 12, wherein the pivoting movement of the unit (24, 96) relative to the base member (12) causes the blocking lever (108) to pivot, thereby causing the at least one blocking ledge (106) to move out of contact with the start button (94), freeing the start button (94) to move out of engagement with the drive means (28, 30).

14. one of the base member (12) and the unit (24, 96) includes a protrusion (116), and the other of the base member (12) and the unit (24, 96) includes a lockout plate (118); 14. The medication delivery device of claim 10, wherein the protrusion (116) causes the exclusion plate (118) to move during the pivoting movement of the unit (24, 96) relative to the base member (12) to cause penetration of the injection needle (72), whereby the exclusion plate (118) prevents the pivoting movement of the unit (24, 96) relative to the base member (12) from being repeated after a single use of the device.

15. 15. The medication delivery device of claim 14, wherein the exclusion plate (118) prevents the protrusion (116) from moving over a flexible ledge (122) on the exclusion plate (118) to prevent repeated pivoting of the unit (24, 96) relative to the base member (12).

Images