Drug filling system

Abstract

A syringe assembly (2) for locking a syringe (10) to prevent backflow of a medication, the syringe assembly (2) comprising: a syringe (10) including a barrel (12) configured to carry the medication; a plunger head (16) disposed at a proximal end of a plunger (14) that communicates with the barrel (12); and a locking assembly (50) disposed around the barrel (12), the locking assembly (50) preventing the plunger (14) from moving away from the barrel (12) and drawing the medication into the barrel (12).

Description

Technical Field

[0001] Various exemplary embodiments of the present invention relate to a device that fills a delivery device with a pharmaceutical (drug).

Background Art

[0002] This application claims the benefit of 35 USC§119(e) of U.S. Provisional Patent Application Serial No. 62 / 908,377, filed September 30, 2019, which is hereby incorporated by reference in its entirety.

[0003] Systems such as delivery devices and syringe assemblies are typically used to inject a drug, such as insulin, into a patient. However, inefficiencies and inconveniences can occur. These issues include providing feedback on the dosage, minimizing the influx of air into the delivery device, preventing backflow of the drug from occurring in the delivery device during and after the filling step, and improving safety, handling, and stability.

Summary of the Invention

[0004] One aspect of the present invention is to provide a syringe assembly that locks the syringe to prevent backflow of the drug. After the delivery device is filled with the drug, the plunger of the syringe is configured to prevent backflow of the drug from the delivery device into the syringe. Such an assembly provides efficient and improved accuracy of the drug transferred to the delivery device.

[0005] Another aspect of the present invention is to provide a syringe assembly that provides tactile feedback during dose setting. Such a configuration allows the user to confirm the specified dose setting, prevents unintentional locking, and minimizes user confusion.

[0006] In another aspect of the present invention, the fluid transfer device engages with a syringe to provide different fluid paths for aspirating and injecting a drug. Such a configuration prevents backflow of the drug from the delivery device to the syringe, avoids the use of a locking mechanism, and provides efficient and improved accuracy of the drug transferred to the delivery device without changing the syringe.

[0007] The foregoing and / or other aspects of the present invention can be achieved by providing a syringe assembly that locks the syringe to prevent backflow of the drug, the syringe assembly comprising a barrel configured to carry the drug, a plunger in communication with the barrel, a plunger head disposed at the proximal end of the plunger, and a lock assembly disposed around the barrel, the lock assembly including a syringe that prevents the plunger from moving away from the barrel to draw the drug into the barrel.

[0008] The foregoing and / or other aspects of the present invention can be further achieved by providing a syringe assembly that provides tactile feedback during dose setting, the syringe assembly comprising a syringe including a barrel configured to carry the drug, and a plunger having a plunger head disposed at the proximal end of the plunger, the plunger being in communication with the barrel, the plunger including a plurality of axial ribs extending along the length of the plunger, a notch disposed in each axial rib, and a dose selector disposed around the barrel, the dose selector setting the dose by passing through one of the notches.

[0009] The foregoing and / or other aspects of the present invention can also be achieved by providing a fluid transfer device that prevents backflow of a drug, the fluid transfer device including a barrel configured to carry the drug, a plunger connected to the barrel, and a vial adapter including a first needle cannula that enables the drug to exit the fluid transfer device, a second needle cannula that enables the drug to enter the fluid transfer device and that is shorter in length than the first needle cannula, a first one-way valve connected to the first needle cannula, and a second one-way valve connected to the second needle cannula.

[0010] The foregoing and / or other aspects of the present invention can also be additionally achieved by providing a fluid transfer device that prevents backflow of a drug, the fluid transfer device including a first needle cannula that enables the drug to exit the fluid transfer device, a second needle cannula that enables the drug to enter the fluid transfer device and that is shorter in length than the first needle cannula and is disposed within the first needle cannula, and a two-way valve connected to the first needle cannula and the second needle cannula, wherein the second needle cannula is configured to draw the drug from a vial and, when the fluid transfer device is engaged with a delivery device, the first needle cannula transfers the drug to the delivery device.

[0011] Additional and / or other aspects and advantages of the present invention will be described in the following description, become apparent from the description, or may be learned by practice of the present invention.

Brief Description of the Drawings

[0012] The above aspects and features of the present invention will become more apparent from the description of the exemplary embodiments of the present invention made with reference to the accompanying drawings.

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DETAILED DESCRIPTION OF THE INVENTION

[0013] Figure 1 illustrates a syringe assembly 2 according to one embodiment. The syringe assembly 2 includes a syringe 10 having a barrel 12, a plunger 14, a plunger head 16, and a needle (not shown), as conventionally understood by those skilled in the art. Specifically, the barrel 12 carries the drug, and the plunger 14 is disposed within the barrel 12 to move the drug in and out of the barrel 12. The plunger head 16 is connected to the proximal end of the plunger 14 and enables the user to move the plunger 14 to perform drug filling and dispensing operations. The needle receives the drug from the vial and distributes the drug to the insulin delivery device.

[0014] The syringe assembly 2 further includes a lock assembly 50 that locks the plunger 14 of the syringe 10 after the drug has been dispensed to advantageously prevent backflow of the drug into the barrel 12. The lock assembly 50 includes a hook 52, an arm 54, a base 56, a pivot shaft 58, a spring member 60, and a button 62.

[0015] The hook 52 is disposed at the proximal end of the arm 54 and includes a cantilevered surface configured to engage the upper surface of the plunger head 16 when the drug is dispensed from the barrel 12 of the syringe 10. The base 56 is fixed to the barrel 12 and surrounds the barrel 12. The pivot shaft 58 is disposed on the side surface of the base 56 and is rotatable. The pivot shaft 58 engages the central portion of the arm 54 to enable the hook 52 to rotate.

[0016] The distal end of the arm 54 includes a spring member 60 and a button 62. The spring member 60 contacts the barrel 12 on one side of the arm 54, and the button 62 is disposed on the opposite side of the arm 54 and provides a surface that can be pushed down by the user. The hook 52 is configured to rotate around the pivot shaft 58 disposed between the button 62 and the hook 52. The pivot shaft 58 enables the arm 54 to rotate between an engaged position and a disengaged position based on the actuation of the button 62 by the user.

[0017] Specifically, when the drug is dispensed from the syringe 10, the plunger 14 is in the distal position. The natural state of the lock assembly 50 is to place the hook 52 over the plunger head 16 to lock the movement of the plunger 14. In this state, the button 62 is free or in a released state, and the spring member 60 presses the button 62 (first compressive force) to provide maximum engagement of the hook 52 to the plunger head 16.

[0018] To unlock the syringe 10 from the lock assembly 50, the user presses the button 62 against the spring force (second compressive force) of the spring member 60. Thereby, the arm 54 rotates about the pivot shaft 58 to disengage the hook 52 from the plunger head 16. The second compressive force is greater than the first compressive force.

[0019] When the syringe fills a conventional insulin delivery device, the user must simultaneously hold the plunger head and remove the syringe from the insulin delivery device to avoid backflow of the drug into the syringe 10. The lock assembly 50 disclosed herein advantageously locks the plunger head 16 after the drug has been dispensed into the insulin delivery device. In this way, no drug flows back into the syringe 10, and the user can comfortably remove the syringe 10 from the insulin delivery device. The lock assembly 50 also advantageously enables the user to unlock the syringe 10 for use if the syringe 10 has been accidentally locked.

[0020] Figure 2 illustrates a syringe assembly 4 according to a second embodiment. This embodiment discloses a syringe 10 and a lock assembly 50 similar to those described above with the following modifications. The plunger head 16 of the syringe 10 includes a plunger head platform 20. The platform 20 is disposed below the plunger head 16 such that there is a gap between two features. The platform 20 is preferably molded as part of the plunger 14, but alternatively can be a separate part attached to the plunger 14. The hook 52 of the lock assembly 50 is advantageously configured to engage the gap to lock the plunger 14 after the drug has been dispensed from the barrel 12 of the syringe 10.

[0021] Further, the hook 52 includes a plurality of protrusions 66 that provide a depressible surface. Thus, the user can advantageously apply force to the hook 52 where the plurality of protrusions 66 are located or apply force to the button 62 to move the hook 52 from the engaged locked position to the disengaged unlocked position. The configuration in this embodiment advantageously provides a complete surface on the plunger head 16 that can be utilized for the user to operate when engaging and disengaging the lock assembly 50.

[0022] Figures 3 - 5 illustrate a syringe assembly 6 according to a third embodiment. This embodiment discloses a syringe 10 and a lock assembly 50 similar to those described above with the following modifications. The plunger head 16 includes a dial dose 18. The dial dose 18 indicates a dosage unit amount. Specifically, the plunger head 16 is rotated to set the desired dosage identified by the dial dose 18.

[0023] In addition, the lock assembly 50 includes a position indicator 64 shaped as an arrow. The position indicator 64 preferably cooperates with the dial dosage 18 to identify the dosage position of the plunger head 16. As shown in FIG. 5, the position indicator 64 indicates a specific dosage represented by the dial dosage 18 set by the user via the rotation of the plunger head 16. The button 62 on the lock assembly 50 also includes a protrusion 66 that provides a friction surface for the user to press the button 62.

[0024] During operation, FIGS. 3 and 4 illustrate the unlocked position of the lock assembly 50, while FIG. 5 illustrates the locked position. In the unlocked position, the plunger 14 can move freely within the barrel. In the locked position, the plunger 14 cannot move because the hook 52 engages with the platform 20 to prevent movement.

[0025] FIGS. 6 and 7 illustrate a syringe assembly 8 according to a fourth embodiment. This embodiment discloses a syringe 10 similar to the above with the following modifications. This embodiment incorporates a dosage selector 70 with the syringe 10 to advantageously provide the user with tactile feedback when setting the dosage.

[0026] The plunger 14 of the syringe 10 is modified to cooperate with the dosage selector 70. Specifically, the plunger 14 includes a plurality of axial ribs 24 extending along the length of the plunger 14. The axial ribs 24 provide stability and rigidity to the plunger 14. Curved depressions 28 are disposed between each of the adjacent axial ribs 24.

[0027] FIG. 6 shows that the vertical portions of the plurality of axial ribs 24 include notches 26. A cross-section of the plunger 14 at the notch 26 is shown in FIG. 7. The notch 26 preferably provides a smooth raised surface around the plunger 14. The notch 26 also preferably provides a continuous surface between the adjacent curved depressions 28.

[0028] FIG. 6 further illustrates a dose selector 70 including an arm 72, a position indicator 74, a base 76, and a tab 78. The base 76 is fixed to and surrounds the barrel 12 of the syringe 10. The arm 72 extends upwardly from the base 76 and includes a position indicator 74, such as an arrow indicating a set dose. The base 76 and the position indicator 74 are also described above in the same manner for various embodiments of the lock assembly.

[0029] The tab 78 is an inwardly extending member disposed on the inner surface of the base 76. The tab 78 cooperates with the plunger 14 and the notch 26. Specifically, the plunger 14 can move vertically only when the tab 78 is disposed between the axial ribs 24, in the curved recess 28, and outside the notch 26 of the plunger 14. The user positions the tab 78 at a vertical position of the plunger 14 such that the notch 26 rotates the plunger 14 and the notch 26 is positioned to adjust the dosage.

[0030] Each time the tab 78 encounters a notch 26 of one of the axial ribs 24 as the user rotates the plunger 14 to set the dose, a detent or force is advantageously provided. As shown in FIG. 7, this force or detent occurs because of contact between the axial rib 24 within the notch 26 and the tab 78. This detent or force is a tactile feedback indicating that the dosage is being changed. At this position, the plunger 14 is also locked to prevent vertical movement.

[0031] As shown in FIG. 7, when the tab 78 is disposed between two of the axial ribs 24, no contact occurs and thus no detent or force is provided. That is, the tab 78 does not contact the curved recess 28. Accordingly, the user advantageously experiences an alternative pressure (tactile feedback) when rotating between dose setting positions.

[0032] Figure 8 illustrates a syringe assembly 9 according to the fifth embodiment. This embodiment discloses a syringe 10 and a lock assembly 50 similar to those described above with the following modifications. Specifically, the plunger head platform 20 includes a rounded circumferential surface with which the hook 52 engages. More specifically, the hook 52 includes a hook recess 53 that is contoured to engage and receive the rounded circumferential surface of the plunger head platform 20. Such a configuration advantageously provides a more secure and smooth engagement of the hook 52 to the platform 20 when the lock assembly 50 is in the locked position.

[0033] Figures 9 - 11 show cross-sectional views of a fluid transfer device 120 attached to a syringe 121 according to the fifth embodiment. Figure 10 illustrates the fluid transfer device 120 engaged to a vial 100 for receiving a medicament. Figure 11 illustrates the fluid transfer device 120 engaged to an insulin delivery device (IDD) 110 for delivering a medicament. Further details of the fluid transfer device 120 are provided below.

[0034] The syringe 121 is generally understood by those skilled in the art and includes, for example, a barrel 122 for carrying a medicament and a plunger 124 disposed within the barrel 122 for aspirating and dispensing the medicament. The syringe 121 is configured to engage with a vial adapter 130 of the fluid transfer device 120 to establish fluid communication. In an alternative embodiment, the fluid transfer device 120 includes a barrel 122 and a plunger 124 that are in fluid communication with the vial adapter 130.

[0035] The vial adapter 130 includes a first needle cannula 132, a second needle cannula 134, a first one-way valve 136, and a second one-way valve 138. The first needle cannula 132 is used to transfer a medicament from the barrel 122 to the insulin delivery device 110 as shown in Figure 11. The second needle cannula 134 is used to receive a medicament from the vial 100 as shown in Figure 10.

[0036] The first needle cannula 132 is advantageously longer than the second needle cannula 134 such that only the first needle cannula 132 engages with the insulin delivery device 110. As shown in FIG. 11, the second needle cannula 132 is too short to engage with the insulin delivery device 110.

[0037] On the other hand, the second needle cannula 134 is advantageously shorter than the first needle cannula 132 to receive more drug from the vial 100. FIG. 10 shows that both the first needle cannula 132 and the second needle cannula 134 are disposed within the vial 100. However, the distal end of the second needle cannula 134 is close to the bottom of the vial 100. When the drug exits the vial 100, the associated fluid level drops within the vial 100. Having the short needle cannula 134 advantageously optimizes the amount of drug that can be removed from the vial 100.

[0038] The first one-way valve 136 controls the flow of drug through the first needle cannula 132 such that the drug within the barrel 122 can only exit through the first needle cannula 132. That is, the first one-way valve 136 does not permit the first needle cannula 132 to receive drug from the barrel 122.

[0039] On the other hand, the second one-way valve 138 controls the flow of drug through the second needle cannula 134 such that drug can only enter and fill the barrel 122 through the second needle cannula 134. Conversely, the second one-way valve 138 does not permit the second needle cannula 134 to dispense drug from the barrel 122.

[0040] The fluid transfer device 120 of the present embodiment provides an alternative means for preventing backflow of drug from the insulin delivery device 110 to the syringe 121. To achieve this advantage, the fluid transfer device 120 does not use a plunger lock mechanism and does not require manual holding of the syringe plunger after fluid delivery, and advantageously provides a separate fluid path.

[0041] Figures 12 to 15 show cross-sectional views of a fluid transfer device 220 according to a sixth embodiment. The fluid transfer device 220 includes a vial adapter 230, a first needle cannula 232, a second needle cannula 234, a bidirectional valve 236, a vent membrane 239, and a syringe adapter 242. FIG. 14 shows the vial adapter 230 being engaged with the vial 200, preferably via snap-lock engagement, although other means are contemplated herein. The syringe adapter 242 is preferably configured to engage with a syringe (not shown) via a luer lock, although other means are contemplated herein.

[0042] As similarly described above, the first needle cannula 232 is used to transfer a drug from a syringe to the insulin delivery device 210, as shown in FIG. 15. The second needle cannula 234 is used to receive a drug from the vial 200, as shown in FIG. 14.

[0043] The first needle cannula 232 is advantageously longer than the second needle cannula 234 such that only the first needle cannula 232 engages with the insulin delivery device 210. The bottom surface of the vial adapter 230 advantageously controls the insertion depth of the first needle cannula 232 within the insulin delivery device 210. As shown in FIG. 15, the second needle cannula 232 is too short to engage with the insulin delivery device 210. Specifically, the second needle cannula 232 does not extend beyond the bottom surface of the vial adapter 230, advantageously ensuring that fluid communication with the insulin delivery device 210 does not occur.

[0044] On the one hand, the second needle cannula 234 is advantageously shorter than the first needle cannula 232 to receive more drug from the vial 200. FIG. 14 shows that the distal end of the second needle cannula 234 is close to the bottom of the vial 200. When the drug exits the vial 200, the associated fluid level drops within the vial 200. Having the short second needle cannula 234 optimizes the amount of drug removed from the vial 200. The depth of the cavity within the vial adapter 230 that engages the vial 200 advantageously controls the insertion depth of the second needle cannula 234.

[0045] Furthermore, the first needle cannula 232 is advantageously disposed within the second needle cannula 234. Such a configuration optimizes space, provides a simple design, and continues to provide different fluid paths, as will be described in more detail below.

[0046] The bidirectional valve 236 is preferably a combination of a duckbill and an umbrella valve. However, other combinations of valves can be used to achieve the functional advantages described herein. The bidirectional valve 236 controls the flow of drug through the first needle cannula 232 such that the drug within the syringe can only exit through the first needle cannula 232. That is, the bidirectional valve 236 does not permit the first needle cannula 232 to receive drug into the syringe.

[0047] The bidirectional valve 236 also controls the flow of drug through the second needle cannula 234 such that the drug can only enter through the second needle cannula 234 to fill the syringe. Similarly, the bidirectional valve 236 does not permit the second needle cannula 234 to dispense drug from the syringe.

[0048] In view of the above, the bidirectional valve 236 advantageously controls the transfer of drug. However, the bidirectional valve 236 does not control the exchange of air. Further description of the air flow path 254 within the fluid transfer device 220 is provided below.

[0049] Figures 12 to 15 also show a vent membrane 239 connected to the airflow path 254, as well as a drug inlet path 250 and a drug outlet path 252. FIG. 12 shows a syringe filled with a drug. Specifically, the drug inlet path 250 is described as a path in which the drug enters the distal end of the second needle cannula 234, is routed in an offset path from the center line of the vial adapter 230 to the bidirectional valve 236, and finally enters the syringe adapter 242 to fill the syringe.

[0050] FIG. 14 shows the drug inlet path 250 when the vial adapter 230 engages the vial 200. The vent membrane 239 cooperates in the transfer of the drug from the vial 200 to the syringe and is located upstream of the bidirectional valve 236.

[0051] Specifically, when the drug exits the vial 200, air advantageously enters the vial 200 via the airflow path 254 and the vent membrane 239. The airflow path 254 is upstream from the bidirectional valve 236 and includes a path through the first needle cannula 232. In this way, no vacuum is created within the vial 200 and the pressure within the vial 200 equals the ambient pressure.

[0052] FIGS. 13 and 15 show the drug outlet path 252 that enables the drug to exit the syringe and enter the insulin delivery device 210. The drug outlet path 252 moves through the bidirectional valve 236, through the center line of the fluid transfer device 220, and finally through the first needle cannula 232 before entering the insulin delivery device 210.

[0053] On the other hand, as described above, the same airflow path 254 through the first needle cannula 232 and the vent membrane 239 is used to remove air from the insulin delivery device 220. Advantageously, no vacuum is created in the insulin delivery device 220 and the pressure within the insulin delivery device 220 equals the ambient pressure.

[0054] The fluid transfer device 220 of this embodiment provides an alternative means for preventing the backflow of the drug from the insulin delivery device 210 into the syringe. To achieve this advantage, the fluid transfer device 220 does not use a plunger lock mechanism, does not require manual holding of the syringe plunger after fluid delivery, and advantageously provides separate fluid and air paths.

[0055] The above detailed description of specific exemplary embodiments is provided to explain the principles of the present invention and its actual uses, thereby enabling those skilled in the art to understand the present invention with respect to various embodiments and the present invention with various modifications suitable for specific uses considered. The description herein is not necessarily intended to be exhaustive or to limit the present invention to the detailed embodiments described. Additionally, any of the embodiments, features, and / or elements disclosed herein may be combined with each other to form various additional combinations that are not specifically disclosed, provided that the combined embodiments, features, and / or elements do not conflict with each other. Therefore, additional embodiments are possible and are intended to be encompassed within the scope of this specification and the present invention. This specification describes specific examples for achieving more general goals that can be achieved in other ways.

[0056] As used in this application, the terms "front", "rear", "upper", "lower", "upward", "downward", and other directional descriptors are intended to facilitate the description of exemplary embodiments of the present invention and are not intended to limit the structure of the exemplary embodiments of the present invention to a particular position or direction. Terms of degree such as "substantially" or "approximately" refer to a reasonable range around a given value, for example, a general tolerance range associated with the manufacture, assembly, and use of the described embodiments, as will be understood by those skilled in the art.

Claims

1. A syringe assembly for locking a syringe to prevent backflow of a drug, comprising: a syringe, a barrel configured to carry the drug, a plunger associated with the barrel, a plunger head disposed at a proximal end of the plunger, the syringe including the above, the syringe assembly further comprising: a lock assembly disposed around the barrel, the lock assembly including: a hook configured to engage the plunger head, a pushable button for controlling engagement and disengagement between the hook and the plunger head, the lock assembly preventing the plunger from moving away from the barrel for drawing the drug into the barrel. A syringe assembly.

2. The plunger head includes a dose dial that rotates to indicate a unit dose, the lock assembly including: a base that engages the barrel, the hook disposed proximally to the base, the pushable button disposed distally to the base. The syringe assembly according to claim 1.

3. The lock assembly includes: a spring member connected to the hook, the spring member providing a compressive force to control engagement and disengagement between the hook and the plunger head. The syringe assembly according to claim 2.

4. The lock assembly further includes: an arm connecting the pushable button and the spring member to the hook, a shaft connecting the arm to the base. The syringe assembly according to claim 3.

5. The shaft allows the arm to rotate along the axis of the shaft to control engagement and disengagement between the hook and the plunger head. The syringe assembly according to claim 4.

6. The spring member contacts the barrel and is disposed on one side of the arm while the button is disposed on the opposite side of the arm. When the button is in a free state, the spring member is compressed by a first compressive force and the hook is engaged with the plunger head. When the button is pushed, the spring member is compressed by a second compressive force and the hook disengages from the plunger head. The second compressive force is greater than the first compressive force. The syringe assembly according to claim 4.

7. ​ ​ ​ ​ ​ ​ ​ The plunger head further includes a platform disposed distally from the upper surface of the plunger head, The hook is configured to engage with the plunger between the upper surface of the plunger head and the platform to lock the plunger. The syringe assembly according to claim 3.

8. The hook includes a recess mechanism that engages and disengages the platform to ensure engagement. The syringe assembly according to claim 7.

9. The hook includes one of a protrusion and a position indicator to assist in handling and dose setting. The syringe assembly according to claim 3.

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