Self-sealing prevention element integrated in flexible storage

Abstract

A drug delivery device configured to deliver a medicament to a patient, the drug delivery device comprising: a cannula for piercing the skin of the patient; a pump for driving a medicament to the cannula; and a storage bag fluidly connected to the pump. The storage bag includes a first film layer and a second film layer defining a medicament chamber. At least one of the first film layer and the second film layer includes a tunnel extending at least partially into the medicament chamber.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 409,375, entitled “Anti-Self Sealing Element Integrated in Flexible Reservoir Bag and Method of Manufacturing the Same,” the entire disclosure of which is incorporated herein by reference.

[0003] BACKGROUND OF THE DISCLOSURE

[0004] Field of the Invention

[0005] The present disclosure generally relates to devices, systems and methods for delivering pharmaceutical compositions to patients. More particularly, the present disclosure relates to an anti-self-sealing element for a storage bag for a syringe, a tool for forming such a storage bag, and associated methods.

[0006] Description of Related Technology

[0007] Wearable medical devices (e.g., auto-injectors) have the advantage of providing treatment to patients at locations remote from clinical facilities and / or while being worn separately under the patient's clothing. At the discretion of a physician, the wearable medical device can be applied to the patient's skin and configured to automatically deliver a dose of a pharmaceutical composition within a predetermined time period after the wearable medical device is applied to the patient's skin (e.g., after a 27-hour delay). After the device delivers the pharmaceutical composition to the patient, the patient can then remove and dispose of the device.

[0008] Conventional auto-injectors typically include an internal reservoir bag in which the medicament is contained. In some cases, particularly when the reservoir bag is nearly empty, opposing sides of the reservoir bag may be drawn together under the suction of the syringe's pump. This may partially or completely seal the outlet of the reservoir bag and prevent the intended delivery of the medicament.

[0009] Therefore, there is a need for an autoinjector having features that prevent inadvertent self-sealing. Summary of the invention

[0010] Embodiments of the present disclosure relate to a drug delivery device configured to deliver a medicament to a patient. The drug delivery device includes: a cannula for piercing the patient's skin; a pump for driving the medicament to the cannula; and a storage bag fluidly connected to the pump. The storage bag includes a first film layer and a second film layer defining a medicament chamber. At least one of the first film layer and the second film layer includes a tunnel that extends at least partially into the medicament chamber.

[0011] In some embodiments, the reservoir bag is an internal reservoir bag contained within an interior region of the drug delivery device.

[0012] In some embodiments, the first film layer is asymmetric relative to the second film layer.

[0013] In some embodiments, the first film layer is symmetrical with respect to the second film layer.

[0014] In some embodiments, the surface area of ​​the second film layer is greater than the surface area of ​​the first film layer.

[0015] In some embodiments, the surface area of ​​the second film layer is approximately the same as the surface area of ​​the first film layer.

[0016] In some embodiments, the tunnel has a convex profile.

[0017] In some embodiments, the tunnel defines a flow channel that is in fluid communication with a port of the storage bag.

[0018] In some embodiments, the tunnel extends the entire length of the medicament chamber.

[0019] In some embodiments, the tunnel terminates at an intermediate location within the medication chamber.

[0020] In some embodiments, the tunnel is strong enough to maintain its shape under the vacuum created by the pump.

[0021] In some embodiments, the tunnel prevents the first membrane layer and the second membrane layer from being laid completely flat against each other.

[0022] Other embodiments of the present disclosure are directed to a vacuum molding apparatus for forming a storage bag of a drug delivery device. The vacuum molding apparatus includes: a mold defining a cavity; and a vacuum channel extending from the cavity. The cavity corresponds to the profile of a tunnel to be formed in the internal storage bag. The vacuum channel is configured to pull at least one of the first film layer and the second film layer of the storage bag into the cavity.

[0023] In some embodiments, the vacuum molding apparatus further includes a sealing plate configured to bond the first film layer to the second film layer.

[0024] In some embodiments, the sealing plate includes one or more prongs configured to join the first film layer to the second film layer.

[0025] In some embodiments, the sealing plate is configured to move toward the mold.

[0026] In some embodiments, the mold includes one or more passageways through which one or more contours of the sealing plate extend.

[0027] Other embodiments of the present disclosure are directed to a pinch-forming device for forming a storage bag for a drug delivery device. The pinch-forming device includes: a pair of pinching grips configured to engage a second film layer of the storage bag on opposite sides of a tunnel to be formed in the second film layer; and an actuator configured to pull the pinching grips toward each other to form the tunnel in the second film layer. When the actuator pulls the pinching grips toward each other, the first film layer of the storage bag remains stationary.

[0028] In some embodiments, the actuator comprises a cylinder.

[0029] In some embodiments, the pinch forming device further comprises a sealing plate configured to join the first film layer to the second film layer.

[0030] In some embodiments, the sealing plate includes one or more prongs configured to join the first film layer to the second film layer.

[0031] Other embodiments of the present disclosure are directed to a method of forming a reservoir bag for a drug delivery device. The method includes positioning a first film layer and a second film layer on a mold, the mold defining a cavity corresponding to the contour of a tunnel to be formed in the internal reservoir bag; applying a vacuum to the cavity to draw the second film layer into the cavity; and bonding the first film layer to the second film layer to lock the tunnel in place.

[0032] In some embodiments, bonding the first film layer to the second film layer includes bonding at least one of the first film layer and the second film layer to a heated sealing plate.

[0033] In some embodiments, the mold includes one or more passages through which one or more contours of the heated sealing plate extend.

[0034] Other embodiments of the present disclosure are directed to a method of forming a storage bag for a drug delivery device. The method includes: engaging a second film layer of the storage bag with a pair of pinch handles; pulling the pinch handles toward each other to pinch the second film layer to form a tunnel in the film layer; and engaging a first film layer to the second film layer to lock the tunnel in place.

[0035] In some embodiments, bonding the first film layer to the second film layer includes bonding at least one of the first film layer and the second film layer to a heated sealing plate.

[0036] Other embodiments of the present disclosure relate to a storage bag for storing a medicine. The storage bag includes: a first film layer; and a second film layer. The first film layer and the second film layer define a medicine chamber. At least one of the first film layer and the second film layer includes a tunnel that extends at least partially into the medicine chamber. The first film layer is asymmetric relative to the second film layer.

[0037] In some embodiments, the surface area of ​​the second film layer is greater than the surface area of ​​the first film layer.

[0038] In some embodiments, the surface area of ​​the second film layer is approximately the same as the surface area of ​​the first film layer.

[0039] In some embodiments, the tunnel has a convex profile.

[0040] In some embodiments, the tunnel defines a flow channel that is in fluid communication with a port of the storage bag.

[0041] In some embodiments, the tunnel extends the entire length of the medicament chamber.

[0042] In some embodiments, the tunnel terminates at an intermediate location within the medication chamber.

[0043] In some embodiments, the tunnel is sufficiently strong to maintain its shape under the vacuum created by a pump of a drug delivery device to which the reservoir bag is connected.

[0044] In some embodiments, the tunnel prevents the first membrane layer and the second membrane layer from being laid completely flat against each other.

[0045] Other embodiments of the present disclosure relate to a filling station for filling a drug delivery device, the drug delivery device being configured to deliver a medicament to a patient. The filling station includes: a syringe receptacle for receiving the drug delivery device, the drug delivery device including a storage bag for receiving the medicament; a cartridge receptacle for receiving a refill storage bag, the refill storage bag containing the medicament; and a pump configured to deliver the medicament from the refill storage bag to the storage bag of the drug delivery device. The refill storage bag includes a first film layer and a second film layer defining a medicament chamber. At least one of the first film layer and the second film layer includes a tunnel that extends at least partially into the medicament chamber.

[0046] In some embodiments, the first film layer is asymmetric relative to the second film layer.

[0047] In some embodiments, the first film layer is symmetrical with respect to the second film layer.

[0048] In some embodiments, the surface area of ​​the second film layer is greater than the surface area of ​​the first film layer.

[0049] In some embodiments, the surface area of ​​the second film layer is approximately the same as the surface area of ​​the first film layer.

[0050] In some embodiments, the tunnel has a convex profile.

[0051] In some embodiments, the tunnel defines a flow channel that is in fluid communication with a port of the refill reservoir bag.

[0052] In some embodiments, the tunnel extends the entire length of the medicament chamber.

[0053] In some embodiments, the tunnel terminates at an intermediate location within the medication chamber.

[0054] In some embodiments, the tunnel is strong enough to maintain its shape under the vacuum created by the pump.

[0055] In some embodiments, the tunnel prevents the first membrane layer and the second membrane layer from being laid completely flat against each other.

[0056] These and other features and characteristics of the drug delivery device, storage bag, device for making a storage bag, filling station for a drug delivery device and associated methods will become more apparent upon consideration of the following description and appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals indicate corresponding parts throughout the various figures. It will be expressly understood, however, that the drawings are for illustration and description purposes only. BRIEF DESCRIPTION OF THE DRAWINGS

[0057] The above and other features, advantages and methods of achieving the features and advantages of the present disclosure will become more apparent, and the present disclosure itself will be better understood, by referring to the following description of embodiments of the present disclosure in conjunction with the accompanying drawings, in which:

[0058] Figure 1 is a perspective view of a drug delivery device according to an embodiment of the present disclosure;

[0059] Figure 2 It is a drug delivery device along Figure 1 A cross-sectional view taken along the section line AA;

[0060] Figure 3 yes Figure 1 A perspective view of a drug delivery device with a primary cover and a reservoir removed for clarity;

[0061] Figure 4 yes Figure 1 A partial bottom view of a drug delivery device;

[0062] Figure 5 It is a drug delivery device along Figure 4 A partial cross-sectional view taken along the section line BB;

[0063] Figure 6 yes Figure 1 A schematic diagram of a fluid path of a drug delivery device;

[0064] Figure 7 yes Figure 1 A schematic diagram of a storage bag of a drug delivery device;

[0065] Figure 8 yes Figure 7 A partial cross-sectional view of a storage bag;

[0066] Fig. 9 According to an embodiment of the present disclosure, Figure 7 A cross-sectional view of a vacuum molding device for a storage bag;

[0067] Fig.10 According to an embodiment of the present disclosure, Figure 7 A cross-sectional view of a vacuum molding device for a storage bag;

[0068] Fig.11 According to an embodiment of the present disclosure, Figure 7 A cross-sectional view of a vacuum molding device for a storage bag;

[0069] Fig.12 According to an embodiment of the present disclosure, Figure 7 A cross-sectional view of a pinch forming device for a storage bag in a first position;

[0070] Fig.13 yes Fig.12 A cross-sectional view of the pinch forming device in a second position;

[0071] Fig.14 yes Figure 7 A partial cross-sectional view of a storage bag;

[0072] Fig.15 yes Fig.14 A top view of a storage bag;

[0073] Fig.16 is a perspective view of a filling station for drug delivery according to an embodiment of the present disclosure;

[0074] Fig.17 yes Fig.16 A schematic diagram of a transfer tray of a filling station of FIG. 1 , the transfer tray being loaded with an on-body injector and a refill cartridge; and

[0075] Fig.18 yes Fig.17 A fluid path diagram of a conveyor tray;

[0076] Corresponding reference characters indicate corresponding parts throughout the several views.The exemplifications set out herein illustrate exemplary embodiments of the disclosure, and such exemplifications should not be construed as limiting the scope of the disclosure in any way. DETAILED DESCRIPTION

[0077] Spatial or directional terms (eg, "left," "right," "inner," "outer," "upper," and "lower," etc.) are not to be considered limiting as the invention can assume various alternative orientations.

[0078] All numbers used in the specification and claims are to be understood as being modified in all instances by the term "about". "About" refers to a range of plus or minus 10%. As used in the specification and claims, the singular forms "a", "an", and "the" include plural references unless the context clearly indicates otherwise.

[0079] The terms "first", "second", etc. do not refer to any particular order or sequence, but rather to different conditions, characteristics, or elements. "At least" means "greater than or equal to". "Not greater than" means "less than or equal to".

[0080] As used herein, the term “at least one of…” is synonymous with “one or more of…”. For example, the phrase “at least one of A, B, and C” refers to any one of A, B, and C, or any combination of any two or more of A, B, and C. For example, “at least one of A, B, and C” includes one or more of A only; or one or more of B only; or one or more of C only; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of A, one or more of B, and one or more of C. Similarly, as used herein, the term “at least two of…” is synonymous with “two or more of…”. For example, the phrase “at least two of D, E, and F” refers to any combination of any two or more of D, E, and F. For example, “at least two of D, E, and F” includes one or more of D and one or more of E; or one or more of D and one or more of F; or one or more of E and one or more of F; or one or more of D, one or more of E, and one or more of F.

[0081] It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary examples of the present disclosure. Therefore, specific dimensions and other physical characteristics related to the examples disclosed herein should not be considered limiting.

[0082] As used herein, the terms "fluidically connected," "fluid communication," and their derivatives may be used interchangeably to refer to a connection between a first component and a second component that allows fluid to flow from the first component to the second component, or vice versa.

[0083] First reference Figure 1 and Figure 2 , Figure 1 and Figure 2 A drug delivery device 1 according to an embodiment of the present disclosure is shown. The drug delivery device 1 generally includes components for piercing the skin of a patient and delivering a medicament to the patient. In particular, the drug delivery device 1 includes a housing 10 having a main cover 2 that is liquid-tight and / or airtightly sealed to a base 9. The base 9 houses and supports the various components described herein. The airtight seal between the main cover 2 and the base 9 prevents fluids and particles from the external environment from contaminating the internal components of the housing 10. In some embodiments, the drug delivery device 1 may also include a vent or vent membrane to provide pressure equalization within the housing 10. The base 9 may include an adhesive pad 70 for securing the drug delivery device 1 to the patient.

[0084] Figure 2is a cross-sectional view of the drug delivery device 1 showing various internal components. The main cover 2 and the base 9 define an interior 12, which can be divided into a first interior area 14 and a second interior area 16 by a barrier 20. The drug delivery device 1 includes a storage bag 4 for storing a medicament (e.g., insulin), a pump 3 for pumping the medicament out of the internal storage bag 4, and a force sensing resistor 30 for detecting the amount of pressure in the flow path of the medicament. The drug delivery device 1 also includes an electronic device 8 for programming and operating the drug delivery device 1, and an insertion mechanism 7 for inserting a cannula 47 into the patient's skin to deliver the medicament. In Figure 2 In the illustrated embodiment, the storage bag 4 is an internal storage bag contained within the interior 12 of the housing 10. In other embodiments, the storage bag 4 may be an external storage bag located outside the housing 10 and connected to the cannula 47 via tubing.

[0085] Continue to refer Figure 2 , the first interior region 14 of the interior 12 of the drug delivery device 1 includes components such as the pump 3, the force sensing resistor 30, and the electronic device 8. Examples of the electronic device 8 include semiconductor chips, controllers, diodes, antennas, coils, batteries, discrete components (e.g., resistors and capacitors), and circuit boards for operating and controlling the pump 3 and other electromechanical components of the drug delivery device 1. Due to the sensitive nature of the electronic device 8, the first interior region 14 can be hermetically sealed and / or liquid-tight to prevent the ingress of fluids from the external environment.

[0086] Continue to refer Figure 2 , the second interior region 16 may include the insertion mechanism 7 and the cannula 47. In some embodiments, because the insertion mechanism 7 interfaces with the patient's skin, the second interior region 16 is neither an airtight sealed environment nor a liquid-tight environment.

[0087] Reference Figure 3 , shows a drug delivery device 1 with the main cover 2 and storage bag 4 removed so that the positions of various other components can be understood. In some embodiments, the filling port 43 is configured to be connected to the storage bag 4 ( Figure 3 ) to facilitate use of a syringe or filling station 100 ( Figures 16 to 18 ) fills the storage bag 4. The container 32 can be connected to the insertion mechanism 7 by, for example, a tube to transfer the drug to the insertion mechanism 7, and then the drug is injected into the patient's skin.

[0088] Figure 4 The adhesive pad 70 (eg Figure 11 ). During use, the bottom surface 22 is oriented toward the patient's skin so that the bottom surface 22 is neither visible nor easily accessible without disconnecting the drug delivery device 1 from the patient. Figure 4 As shown, the bottom surface 22 of the base 9 may include a first fluid channel 24 and a second fluid channel 26. The first fluid channel 24 and the second fluid channel 26 provide fluid paths between various components, such as the storage bag 4, the filling port 43, the force sensing resistor 30, the pump 3, and the insertion mechanism 7 (e.g., Figure 2 4. As shown). The first fluid channel 24 and the second fluid channel 26 can be recessed from the bottom surface 22 (or cut into the bottom surface) and can be formed by a molding process (e.g., injection molding) or a cutting process (e.g., milling). In other embodiments, the first fluid channel 24 and the second fluid channel 26 are disposed on the main cover 2, or on the base 9 within the interior 12 of the drug delivery device 1. The size of the first fluid channel 24 and the second fluid channel 26 is configured so that the flow rate of the medicament is limited by the size of the pump 3 and / or the sleeve 47, rather than by any flow restriction introduced by the first fluid channel 24 and the second fluid channel 26. In particular, the cross-sectional area of ​​the first fluid channel 24 and the second fluid channel 26 can be greater than the specification of the sleeve 47.

[0089] Continue to refer Figure 4 , and further reference Figure 5 The base 9 includes a fluid channel passage 27 at each end of the first fluid channel 24 and the second fluid channel 26. Figure 5 As shown, one of the fluid channel passages 27 fluidly connects the container 32 to the first end of the first fluid channel 24. Another of the fluid channel passages 27 can fluidly connect the second end of the first fluid channel 27 to the pump 3. Similarly, one of the fluid channel passages 27 can fluidly connect the first end of the second fluid channel 26 to the fill port 43, and another of the fluid channel passages 27 can fluidly connect the second end of the second fluid channel 26 to the pump 3.

[0090] Figure 6is a schematic diagram of an exemplary fluid path of a drug delivery device 1 according to an embodiment of the present disclosure. During operation of the drug delivery device 1, the pump 3 draws medication from the reservoir bag via the inlet port / outlet port 5 of the reservoir bag 4, the medication passes through the reservoir fluid channel 29 through the filling port 43, and enters the inlet of the pump 3 via the second fluid channel 26. Next, the pump 3 drives the medication into the first fluid channel 24, and then to the container 32 of the insertion mechanism 7. Finally, the insertion mechanism 7 receives the medication from the container 32, for example, via a tube, and delivers the medication to the patient's skin through the cannula 47.

[0091] Figure 7 The storage bag 4 is shown separated from the drug delivery device 1 and in a substantially empty state. The storage bag 4 defines a medicament chamber 44 that is in fluid communication with the inlet port / outlet port 5. The storage bag 4 can be composed of a compliant flexible film that is joined along a boundary 50 to define the medicament chamber 44. The compliant flexible film can include a first film layer 46 and a second film layer 48. The first film layer 46 and the second film layer 48 can be made of any suitable material, such as a polyolefin / styrene block copolymer. The boundary 50 can be formed by heat sealing the first film layer 46 and the second film layer 48 to each other, for example in a press or a mold.

[0092] In some embodiments, the tunnel 52 extends at least partially from the inlet port / outlet port 5 into the medication chamber 44. The tunnel 52 is defined in at least one of the first membrane layer 46 or the second membrane layer 48 and prevents the first membrane layer 46 and the second membrane layer 48 from being laid completely flat against each other. Thus, the tunnel 52 defines a flow channel 54 and maintains the flow channel 54 in fluid communication with the medication chamber 44 and the inlet port / outlet port 5. Thus, the tunnel 52 prevents the medication chamber 44 from self-sealing due to the vacuum created by the pump 3 pulling the first membrane layer 46 and the second membrane layer 48 toward each other. In some embodiments, the tunnel 52 is strong enough to maintain its shape under the vacuum created by the pump 3 during normal operation of the drug delivery device 1. In some embodiments, the tunnel 52 extends the entire length of the medication chamber 44, such as Figure 7 In other embodiments, the tunnel 52 terminates at an intermediate position within the medication chamber 44 .

[0093] Figure 8 A cross-sectional view of the tunnel 52 is shown when the medicament chamber 44 is substantially empty, showing how the tunnel 52 prevents the first membrane layer 46 and the second membrane layer 48 from being laid flat against each other in a manner that could impede flow to the inlet port / outlet port 5. This is particularly evident when the medicament chamber 44 is substantially empty, when the first membrane layer 46 and the second membrane layer 48 are most likely to meet each other in a manner that could impede flow. The tunnel 52 may have a convex profile, such as an arched profile, such as Figure 8As shown, however other curved profiles and polygonal profiles are understood to be within the scope of the present disclosure.

[0094] like Figure 8 As shown, tunnels 52 may be formed in second film layer 48, and thus, the surface area of ​​second film layer 48 is greater than the surface area of ​​first film layer 46. Thus, first film layer 46 is asymmetric with respect to second film layer 48. In other embodiments, the surface area of ​​second film layer 48 is approximately equal to the surface area of ​​first film layer 46. In some embodiments, first film layer 46 may be symmetric with respect to second film layer 48.

[0095] In some embodiments, tunnel 52 is not actively formed in reservoir bag 4 during manufacturing; rather, it is the result of the difference in surface area and asymmetry of first film layer 46 and second film layer 48. That is, as the drug reservoir is emptied by pump 3, the larger surface area of ​​second film layer 48 is forced to form one or more folds to account for the additional surface area of ​​second film layer 48 relative to first film layer 46. These one or more folds form tunnel 52.

[0096] Figures 9 to 13 Various embodiments of tools for forming tunnels 52 in storage bag 4 are shown. Fig. 9 and Fig.10 , Fig. 9 and Fig.10 A vacuum molding apparatus 60 is shown for forming the tunnel 52. The vacuum molding apparatus 60 includes a mold 62 defining a cavity 64 corresponding to the contour of the tunnel 52. A vacuum channel 66 extends from the cavity 64 to an external vacuum source 79. The first film layer 46 and the second film layer 48 are positioned on the mold 62 covering the cavity 64. The vacuum applied to the vacuum channel 66 pulls the second film layer 48 into the cavity 64 to form the tunnel 52 in the second film layer 48. As the second film layer 48 is pulled into the cavity 64, the first film layer 46 remains stationary, resulting in asymmetry between the first film layer 46 and the second film layer 48.

[0097] Reference Figure 10 to Figure 11 , the molding device 60 may include a sealing plate 68 to join the first film layer 46 to the second film layer 48 after the tunnel 52 has been formed. After being so joined, the first film layer 46 and the second film layer 48 cannot slide relative to each other, which means that the tunnel 52 is locked in place and cannot collapse. The sealing plate 68 includes one or more profiles 72, such as one or more forks, that are heated by an external power source. The heated profiles 72 contact the first film layer 46 and / or the second film layer 48 to create spot welds 86 that join the first film layer 46 and the second film layer 48 to each other. Fig.10An embodiment of the molding apparatus 60 is shown in which the sealing plate 68 is positioned on an opposite side of the first film layer 46 and the second film layer 48 relative to the mold 62. The sealing plate 68 is moved toward the mold 62 in the direction of arrow D so that the one or more profiles 72 engage the first film layer 46 and / or the second film layer 48.

[0098] Fig.11 An alternative embodiment is shown in which the sealing plate 68 is positioned below the mold 62 (i.e., on the opposite side of the mold 62 relative to the first and second film layers 46, 48). One or more profiles 72 (e.g., prongs) extend through corresponding channels 74 in the mold 62 to allow the profiles 72 to engage the first and / or second film layers 46, 48 as the sealing plate 68 is advanced toward the mold 62 in the direction of arrow E. A backing plate for holding the first and second film layers 46, 48 against the mold 62 is not shown.

[0099] Fig.12 and Fig.13 An alternative embodiment of a tool for forming a tunnel 52 is shown. A pinch forming device 80 for forming a tunnel 52 includes a pair of pinch handles 82 that engage the second film layer 48 on opposite sides of the tunnel to be formed. The pair of pinch handles 82 are connected to an actuator 84, such as a cylinder, that pulls the pinch handles 82 toward each other. Thus, the distance G between the pinch handles 82 is increased from a first initial position (such as Fig.12 to the second pinching position (as shown) Fig.13 The pinch handles 82 are pulled together to pinch the second film layer 48 to form the tunnel 52. The first film layer 46 remains stationary as the pinch handles 82 move between the first position and the second position to form the tunnel 52 in the second film layer 48. Fig.10 As with the embodiment of FIG. 5 , the tool may also include a sealing plate 68 having one or more profiles 72 to engage the first membrane layer 46 and the second membrane layer 48 to lock the tunnel 52 in place.

[0100] Fig.14 and Fig.15 Shown is a Figures 9 to 13 A cross section of the storage bag 4 of the tunnel 52 formed by the tool. As discussed above, the storage bag 4 includes spot welds 86 in which one or more prongs 72 join the first film layer 46 to the second film layer 48.

[0101] Reference Figures 16 to 18 In some embodiments, the storage bag 4 described in the present disclosure can be configured as a refill storage bag 300 to be connected to a syringe filling station 100 for filling (and / or refilling) one or more drug delivery devices 1. The refill storage bag 300 may include a syringe refill bag 300 in combination with the present invention. Figures 1 to 15 The storage bag 4 described above has the same or similar features. Fig.16 , Fig.16 An embodiment of a syringe filling station 100 according to an embodiment of the present disclosure is shown. The filling station 100 may include a base 110 and a cover 120. The cover 120 may be pivotally connected to the base 110, for example, by a rotating hinge 130. In some embodiments, the cover 120 includes a handle 122 to assist a user in manipulating the cover 120. The base 110 and / or the cover 120 may removably support a transfer tray 140. The tray 140 includes various features for supporting and removably holding a drug delivery device 1 to be filled, such as a snap-fit ​​connector, a bayonet connector, etc. The tray 140 also includes various features for supporting and removably holding a refill storage bag 300 containing a medicament, such as a snap-fit ​​connector, a bayonet connector, etc. The tray 140 includes various features for establishing fluid communication between the refill storage bag 300 and the storage bag 4 of the drug delivery device 1. In use, a user (usually a patient or a caregiver of the patient) loads an empty drug delivery device 1 and a refill storage bag 300 onto the tray 140. The user then inserts the tray 140 into the base 110 and / or the cover 120 of the filling station 100. The tray 140, base 110 and / or cover 120 include various structures and components for transferring the medicament from the refill storage bag 300 to the reservoir of the drug delivery device 1, such as the combination of Fig.17 and Fig.18 In some embodiments, transfer of medicament from the refill reservoir bag 300 into the reservoir bag 4 of the drug delivery device 1 may occur automatically when the lid 120 is closed.

[0102] Reference Fig.17 and Fig.18 The drug delivery device 1 and the refill storage bag 300 can be detachably connected to the tray 140 so that the drug chamber 310 (corresponding to the refill storage bag 300) Figure 7 ) and the medicament chamber 44 (as shown in FIG. Figure 7 The tray 140 includes a cartridge receptacle 142 for detachably receiving the refill storage bag 300 and a syringe receptacle 144 for detachably receiving the drug delivery device 1. The tray 140 also includes a fluid path section 146 that provides fluid communication between the cartridge receptacle 142 and the syringe receptacle 144. Fig.18As shown, the cartridge receptacle 142 may include a needle 143 for piercing a septum or stopper 320 of the refill reservoir bag 300 to provide fluid communication between the fluid path segment 146 and the medicament chamber 310 of the refill reservoir bag 300. Similarly, the syringe receptacle 144 may include a needle 145 for piercing a septum or port 220 of the drug delivery device 1 to provide fluid communication between the fluid path segment 146 and the medicament reservoir 210 of the drug delivery device 1. The fluid path segment 146 may include one or more fluid channels 152 molded and / or formed in the substrate 150 of the tray 140, and / or one or more tube segments 148 connected to the substrate 150.

[0103] Continue to refer Fig.17 , other components of the tray 140 and / or filling station 100 include a pump 154 ​​or other components for transferring the medicament from the refill storage bag 300 to the storage bag 4 of the drug delivery device 1. The pump 154 ​​may be disposed in the fluid path section 146. The pump 154 ​​is controlled by an electronic controller 400, which is programmed or configured to actuate the pump 154 ​​until the refilling operation has been completed and / or to abort the refilling operation in the event of an error in loading or refilling the drug delivery device 1. Fig.17 In the illustrated embodiment, the pump 154 ​​is a peristaltic pump having one or more rollers 156 configured to engage the elastic tube segment 148 of the fluid path segment 146 to draw the medicament from the refill reservoir bag 300 and inject the medicament into the reservoir bag 4 of the drug delivery device 1.

[0104] Continue to refer Fig.17 and Fig.18 , the tray 140 may also include an inflation chamber 160, which is configured to inject a pre-filled volume of air into the drug delivery device 1 before refilling the drug delivery device 1 with a medicament. In an embodiment where the drug delivery device 1 has a reservoir volume of approximately 3 milliliters (mL), the inflation chamber 160 can be configured to inject approximately 100 microliters (μL) of pre-filled inflation volume of air in each syringe refilling operation. The inflation chamber 160 is arranged to be in fluid communication with the fluid path section 146, between the barrel socket 142 and the syringe socket 144, so that the inflation chamber 160 supplies air to the drug delivery device 1 via the fluid path section 146. In the illustrated embodiment, the inflation chamber includes a piston 162, which moves axially to discharge pressurized air from the inflation chamber 160.

[0105] Continue to refer Fig.17 and Fig.18, the tray 140 may further include a forward check valve 172 disposed in the fluid path section 146 between the drug delivery device 1 and the refill storage bag 300. The forward check valve 172 prevents air and / or medicament from flowing back from the drug delivery device 1 into the refill storage bag 300. The tray 140 may further include a reverse check valve 174 disposed in the fluid path section 146 to allow air from the fluid path section 146 to escape. The reverse check valve 174 may be disposed in a branch channel 153 of the fluid path section 146, the branch channel being arranged so that fluid can flow from the drug delivery device 1 to the reverse check valve 174 without flowing into the refill storage bag 300, and so that fluid can flow from the refill storage bag 300 to the reverse check valve 174 without flowing into the drug delivery device 1. In other words, the drug delivery device 1 and the refill storage bag 300 are in a parallel fluid circuit relative to the reverse check valve 174.

[0106] In some embodiments, the cartridge receptacle 142 may include a port to which the refill storage bag 300 is snap-fitted. In other embodiments, the cartridge receptacle 142 may include a bayonet connector, a threaded fitting, or other fixed mechanical connector to engage and retain the refill storage bag 300. The cartridge receptacle 142 may present tactile feedback (e.g., a snap fit) to confirm to the user that the refill storage bag 300 is correctly inserted into the cartridge receptacle 142. The connection of the refill storage bag 300 to the cartridge receptacle 142 may automatically cause the needle 143 of the cartridge receptacle 142 to pierce a septum or stopper (which may, for example, be included in a cartridge such as a cartridge receptacle 142) of the refill storage bag 300. Figure 7 144). Likewise, the syringe receptacle 144 may include a port that snaps into contact with the filling port 43 of the drug delivery device 1. The refill receptacle 142 may present tactile feedback (e.g., a snap fit) to confirm to the user that the drug delivery device 1 is properly inserted into the syringe receptacle 144. The connection of the drug delivery device 1 to the syringe receptacle 144 may automatically cause the needle 145 of the syringe receptacle 144 to pierce the septum of the drug delivery device 1.

[0107] By various mechanical and / or electromechanical components, the pump 154 ​​may be automatically actuated when the handle 122 of the filling station 100 is manipulated to close the lid 120. As described above, the pump 154 ​​then transfers the medicament from the refill reservoir bag 300 to the reservoir bag 4 of the drug delivery device 1. The handle 122 may then be lifted to open the lid 120, and the refilled drug delivery device 1 may be removed and put into use.

[0108] Although the present disclosure has been described in detail based on what are currently considered to be the most practical and preferred embodiments for the purpose of illustration, it should be understood that such details are only for this purpose and that the present disclosure is not limited to the disclosed embodiments, but rather, the present disclosure is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A drug delivery device, the drug delivery device being configured to deliver a medicament to a patient, the drug delivery device comprising: a cannula for piercing the patient's skin; a pump for driving a drug into the cannula; as well as a reservoir bag fluidly connected to the pump, the reservoir bag comprising a first film layer and a second film layer defining a medicament chamber, At least one of the first membrane layer and the second membrane layer comprises a tunnel, and the tunnel at least partially extends into the drug chamber.

2. The drug delivery device according to claim 1, wherein: The reservoir bag is an inner reservoir bag contained within an interior region of the drug delivery device.

3. The drug delivery device according to claim 1, wherein: The first film layer is asymmetric with respect to the second film layer.

4. The drug delivery device according to claim 1, wherein: The first film layer is symmetrical with respect to the second film layer.

5. The drug delivery device according to claim 1, wherein: The surface area of ​​the second film layer is greater than the surface area of ​​the first film layer.

6. The drug delivery device according to claim 1, wherein: The surface area of ​​the second film layer is approximately the same as the surface area of ​​the first film layer.

7. The drug delivery device according to claim 1, wherein: The tunnel has a convex profile.

8. The drug delivery device according to claim 1, wherein: The tunnel defines a flow channel that is in fluid communication with a port of the reservoir bag.

9. The drug delivery device according to claim 1, wherein: The tunnel extends the entire length of the medicament chamber.

10. The drug delivery device according to claim 1, wherein: The tunnel terminates at an intermediate position within the medication chamber.

11. The drug delivery device according to claim 1, wherein: The tunnel is strong enough to maintain its shape under the vacuum created by the pump.

12. The drug delivery device according to claim 1, wherein: The tunnel prevents the first and second membrane layers from being laid completely flat on each other.

13. A vacuum molding device for forming a storage bag for a drug delivery device, the vacuum molding device comprising: a mold defining a cavity; as well as a vacuum passage extending from the cavity, wherein the cavity corresponds to the contour of a tunnel to be formed in the storage bag inside, and The vacuum channel is configured to pull at least one of the first film layer and the second film layer of the storage bag into the cavity.

14. The vacuum molding device according to claim 13, further comprising: A sealing plate is configured to bond the first film layer to the second film layer.

15. The vacuum molding device according to claim 14, wherein: The sealing plate includes one or more prongs configured to join the first film layer to the second film layer.

16. The vacuum molding device according to claim 14, wherein: The sealing plate is configured to move toward the mold.

17. The vacuum molding apparatus according to claim 14, wherein: The mold includes one or more passages through which one or more contours of the sealing plate extend.

18. A pinch forming device for forming a storage bag of a drug delivery device, the pinch forming device comprising: a pair of pinch handles configured to engage the second film layer of the storage bag on opposite sides of a tunnel to be formed in the second film layer; as well as An actuator is configured to draw the pinch handles toward each other to form the tunnel in the second film layer, wherein the first film layer of the storage bag remains stationary when the actuator draws the pinch handles toward each other.

19. The pinch forming device according to claim 18, wherein: The actuator includes a cylinder.

20. The pinch forming device according to claim 18, further comprising: A sealing plate is configured to bond the first film layer to the second film layer.

21. The pinch forming device according to claim 20, wherein: The sealing plate includes one or more prongs configured to join the first film layer to the second film layer.

22. A method of forming a storage bag for a drug delivery device, the method comprising: positioning a first film layer and a second film layer on a mold, the mold defining a cavity corresponding to the contour of a tunnel to be formed in the storage bag inside; applying a vacuum to the cavity to draw the second film layer into the cavity; as well as The first membrane layer is bonded to the second membrane layer to lock the tunnel in place.

23. The method according to claim 22, wherein: Bonding the first film layer to the second film layer includes bonding at least one of the first film layer and the second film layer to a heated sealing plate.

24. The method according to claim 23, wherein: The mold includes one or more passages through which one or more contours of the heated sealing plate extend.

25. A method of forming a storage bag for a drug delivery device, the method comprising: engaging the second film layer of the storage bag with a pair of pinch handles; pulling the pinching handles toward each other to pinch the second film layer to form a tunnel in the film layer; as well as The first film layer is bonded to the second film layer to lock the tunnel in place.

26. The method according to claim 25, wherein: Bonding the first film layer to the second film layer includes bonding at least one of the first film layer and the second film layer to a heated sealing plate.

27. A storage bag for storing medicines, the storage bag comprising: The first film layer; as well as The second film layer, wherein the first film layer and the second film layer define a drug chamber; wherein at least one of the first film layer and the second film layer comprises a tunnel, the tunnel at least partially extending into the drug chamber; and The first film layer is asymmetric relative to the second film layer.

28. The storage bag according to claim 27, wherein: The surface area of ​​the second film layer is greater than the surface area of ​​the first film layer.

29. The storage bag according to claim 27, wherein: The surface area of ​​the second film layer is approximately the same as the surface area of ​​the first film layer.

30. The storage bag according to claim 27, wherein: The tunnel has a convex profile.

31. The storage bag according to claim 27, wherein: The tunnel defines a flow channel that is in fluid communication with a port of the reservoir bag.

32. The storage bag according to claim 27, wherein: The tunnel extends the entire length of the medicament chamber.

33. The storage bag according to claim 27, wherein: The tunnel terminates at an intermediate position within the medication chamber.

34. The storage bag according to claim 27, wherein: The tunnel is sufficiently strong to maintain its shape under the vacuum created by a pump of a drug delivery device to which the reservoir bag is connected.

35. The storage bag according to claim 27, wherein: The tunnel prevents the first and second membrane layers from being laid completely flat on each other.

36. A filling station for filling a drug delivery device, the drug delivery device being configured to deliver a medicament to a patient, the filling station comprising: a syringe receptacle for receiving the drug delivery device, the drug delivery device including a storage bag for receiving a medicament; a cartridge receptacle for receiving a refill reservoir bag containing the medicament; as well as a pump configured to transfer the medicament from the refill reservoir bag to the reservoir bag of the drug delivery device, wherein the refill storage bag comprises a first film layer and a second film layer defining a medicament chamber, At least one of the first membrane layer and the second membrane layer comprises a tunnel, and the tunnel at least partially extends into the drug chamber.

37. A filling station according to claim 36, wherein The first film layer is asymmetric with respect to the second film layer.

38. A filling station according to claim 36, wherein The first film layer is symmetrical with respect to the second film layer.

39. The filling station of claim 36, wherein: The surface area of ​​the second film layer is greater than the surface area of ​​the first film layer.

40. The filling station of claim 36, wherein: The surface area of ​​the second film layer is approximately the same as the surface area of ​​the first film layer.

41. The filling station of claim 36, wherein: The tunnel has a convex profile.

42. The filling station of claim 36, wherein: The tunnel defines a flow passage that is in fluid communication with a port of the refill reservoir bag.

43. The filling station of claim 36, wherein: The tunnel extends the entire length of the medicament chamber.

44. The filling station of claim 36, wherein: The tunnel terminates at an intermediate position within the medication chamber.

45. The filling station of claim 36, wherein: The tunnel is strong enough to maintain its shape under the vacuum created by the pump.

46. ​​The filling station of claim 36, wherein: The tunnel prevents the first and second membrane layers from being laid completely flat on each other.

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