User-interactive drug delivery device packaging

Abstract

A therapeutic substance delivery device (22) with a filling port (30) is for use with a syringe (28) containing a liquid (29). The liquid can be injected into the delivery device via the filling port. A device package (26) holds the delivery device in a position in which the filling port is accessible to a user without removing the delivery device from the package, and a set of packaging inserts (36) is disposed inside the device package and arranged so as to facilitate performance by the user of a filling process of the delivery device. Each packaging insert allows the user enough access to perform a single step in the filling process while inhibiting the user from performing subsequent steps in the filling process. Removal of each packaging insert facilitates performance by the user of the subsequent step in the filling process. Other applications are also described.

Description

[0001] USER-INTERACTIVE DRUG DELIVERY DEVICE PACKAGING

[0002] CROSS REFERENCE TO RELATED APPLICATIONS

[0003] The present application claims the priority of US 63 / 623,499 to Ben-David et al., filed Jan. 22, 2024, entitled, “User-interactive drug delivery device packaging,” which is assigned to the assignee of the present application and incorporated herein by reference.

[0004] The present application is related to an international patent application filed on even date herewith, entitled, "Reconstitution on-body drug delivery system," which is assigned to the assignee of the present application, is incorporated herein by reference, and claims the priority of US 63 / 623,486 to Ben-David et al., filed Jan. 22, 2024, entitled, “Reconstitution on-body drug delivery system,” which is assigned to the assignee of the present application and incorporated herein by reference.

[0005] FIELD OF THE INVENTION

[0006] The present invention relates generally to delivery of a therapeutic substance to a subject, and more specifically to wearable drug delivery devices.

[0007] BACKGROUND

[0008] Pumps are often used in the medical industry for delivering therapeutic substances, e.g., drugs, to subjects. Therapeutic substances such as saline solution, insulin, antibiotics, and chemotherapy drugs may all be delivered to a subject with medical pumps. While hospitalization is required for delivery of some therapeutic substances, other therapeutic substances, such as for example insulin, do not require that the subject be in the hospital. Wearable therapeutic substance delivery devices enable patients to go about their daily lives while receiving a therapeutic substance.

[0009] It is often the case that therapeutic substances are sold by pharmaceutical companies in lyophilized form. A lyophilized therapeutic substance needs to be reconstituted by mixing the lyophilized therapeutic substance with a liquid prior to being delivered to the subject. Additionally, some therapeutic substances are sold by pharmaceutical companies as separated liquids each containing part(s) of the therapeutic substance. The liquids containing the different parts of the therapeutic substance are intended to be mixed right before being delivered to the subject in order to avoid different parts of the therapeutic substance mixing with each other during shelf life of the therapeutic substance.

[0010] In many cases, needle syringes are used in order to fill a therapeutic substance container, e.g., to reconstitute a lyophilized drug within the container, or to mix different parts of a therapeutic substance together inside the container, or to fill an empty container, prior to delivery of the therapeutic substance to a subject.

[0011] SUMMARY OF THE INVENTION

[0012] In accordance with some applications of the present invention, a therapeutic apparatus is provided which enables a user, e.g., a patient or other non-healthcare -professional to perform a filling process of a therapeutic substance delivery device without the user having to handle a needle syringe and which facilitates the performance of the filling process in a guided manner that reduces the risk of human error, such as for example, performing steps in the filling process out of the correct order. For some applications, the purpose of the filling process may be to reconstitute a lyophilized drug disposed within a container of the therapeutic substance delivery device, to mix a therapeutic substance by adding a first liquid into a container of the therapeutic substance that contains a second liquid, or to fill an empty container of the therapeutic substance delivery device.

[0013] Thus, for some applications, the therapeutic apparatus includes a therapeutic substance delivery device that has a filling port, e.g., a Luer Lock port. Typically, upon activation of the therapeutic substance delivery device the device establishes fluid communication between the filling port and a therapeutic substance container disposed within the therapeutic substance delivery device such that liquid from a syringe, e.g., a prefilled Luer Lock syringe provided with the therapeutic apparatus, can be injected into the therapeutic substance delivery device, e.g., into the therapeutic substance container, via the filling port. Use of a syringe that is configured to engage with a filling port of the therapeutic substance delivery device, e.g., with a Luer Lock connection, enables the filling process to be performed without the user having to handle a needle syringe and thus avoids potential incidents of needle stick injuries.

[0014] Furthermore, the therapeutic apparatus includes packaging that holds the therapeutic substance delivery device and facilitates the user performing the filling process in a guided manner so as to help the user avoid potential human errors in the filling process. For some applications, the packaging includes a device package that holds the therapeutic substance delivery device in a position in which the filling port is accessible to the user without removing the therapeutic substance delivery device from the device package, thus enabling the filling process to be performed before the user even removes the therapeutic substance delivery device from its packaging. For some applications, the packaging includes a set of packaging inserts disposed inside the device package, which facilitate performance by the user of the filling process. Each packaging insert is arranged to allow the user enough access to perform a single step in the filling process while inhibiting the user from performing subsequent steps in the filling process. As each packaging insert is removed the subsequent step in the filling process is facilitated. Thus, the user is guided by the packaging of the therapeutic substance delivery device through the filling process.

[0015] Furthermore, for some applications, the packaging interacts with the therapeutic substance delivery device, such that the therapeutic substance delivery device and the packaging form an integrated system which guides the user through the filling process. For example, as further described hereinbelow, for some applications an action by the user, e.g., opening the device package, activates the therapeutic substance delivery device while the therapeutic substance delivery device is disposed within the device package. For some applications, upon activation of the therapeutic substance delivery device, the therapeutic substance delivery device performs one or more startup steps, such as for example, disinfecting a septum of the therapeutic substance container and establishing fluid communication between the filling port and the therapeutic substance container. A visual or auditory or other indicator on the therapeutic substance delivery device may indicate to the user when the one or more startup steps are complete and the device is ready for filling. Thus, for some applications, another way in which the packaging may interact with the device is to inhibit access by the user to the device, e.g., with a packaging insert, e.g., to hide the device from the user, while enabling the user to see the indicator, thus enabling the therapeutic substance delivery device to perform the one or more startup steps before allowing the user to perform the filling process.

[0016] There is therefore provided, in accordance with some applications of the present invention, a therapeutic apparatus for use with a syringe containing a liquid, the apparatus including: (A) a therapeutic substance delivery device including a filling port, the filling port arranged such that the liquid from the syringe can be injected into the therapeutic substance delivery device via the filling port; and

[0017] (B) packaging holding the therapeutic substance delivery device, the packaging including:

[0018] (i) a device package configured to hold the therapeutic substance delivery device in a position in which the filling port is accessible to a user without removing the therapeutic substance delivery device from the device package, and

[0019] (ii) a set of packaging inserts disposed inside the device package and arranged so as to facilitate performance by the user of a filling process of the therapeutic substance delivery device whereby the liquid in the syringe is injected into the therapeutic substance delivery device via the filling port: each packaging insert arranged to allow the user enough access to perform a single step in the filling process while inhibiting the user from performing subsequent steps in the filling process, and removal of each packaging insert facilitating performance by the user of the subsequent step in the filling process.

[0020] For some applications, the device package is further configured to interact with the therapeutic substance delivery device such that an action by the user activates the therapeutic substance delivery device.

[0021] For some applications, the device package is configured to interact with the therapeutic substance delivery device such that opening of the device package by the user activates the therapeutic substance delivery device.

[0022] For some applications, the therapeutic substance delivery device includes: a device-activation sensor configured to detect the opening of the device package, and control circuitry configured to activate the therapeutic substance delivery device in response to the detection of the opening of the device package.

[0023] For some applications, the device-activation sensor includes a Hall effect sensor and the device package includes a magnet, the device package, the magnet, and the Hall effect sensor arranged such that the opening of the device package by the user displaces the magnet with respect to the Hall effect sensor causing the Hall effect sensor to detect the opening of the device package. For some applications, the set of packaging inserts includes a first packaging insert and a second packaging insert, and the therapeutic substance delivery device includes a visual indicator, wherein the first packaging insert:

[0024] (i) is visible to the user upon the user opening the device package, and

[0025] (ii) is configured to inhibit access to the filling port by the user while allowing the user to see the visual indicator of the therapeutic substance delivery device.

[0026] For some applications, the first packaging insert is configured to inhibit access to the filling port by hiding the filling port from the user while allowing the user to see the visual indicator of the therapeutic substance delivery device.

[0027] For some applications, the first packaging insert is configured to inhibit access to the filling port by inhibiting access to the therapeutic substance delivery device by the user.

[0028] For some applications, the first packaging insert is configured to inhibit access to the therapeutic substance delivery device by hiding the therapeutic substance delivery device from the user.

[0029] For some applications, the apparatus is configured to guide the user to wait until the visual indicator indicates that the user should remove the first packaging insert.

[0030] For some applications: the device package is further configured to hold the syringe in a position in which a user can access the syringe, and the first packaging insert is further configured to inhibit access to the syringe by the user and is arranged such that removing the first packaging insert allows the user to remove the syringe from the device package.

[0031] For some applications, the first packaging insert is configured to inhibit access to the syringe by hiding the syringe from the user.

[0032] For some applications, the second packaging insert:

[0033] (i) is visible to the user upon the user removing the first packaging insert, and

[0034] (ii) is configured to inhibit removal of the therapeutic substance delivery device from the device package while allowing the user access to the filling port of the therapeutic substance delivery device. For some applications, the second packaging insert is configured to inhibit removal of the therapeutic substance delivery device by hiding the therapeutic substance delivery device from the user while allowing the user access to the filling port of the therapeutic substance delivery device.

[0035] For some applications, the apparatus is configured to guide the user to inject the liquid disposed in the syringe into the therapeutic substance delivery device via the filling port.

[0036] For some applications, the apparatus is further configured to guide the user to, following the injection of the liquid into the therapeutic substance delivery device, move the device package in a manner that mixes the liquid.

[0037] For some applications: the device package is further configured to hold the syringe in a position in which a user can access the syringe, and the first packaging insert is further configured to inhibit access to the syringe by the user such and is arranged such that removing the first packaging insert allows the user to remove the syringe from the device package.

[0038] For some applications, the first packaging insert is configured to inhibit access to the syringe by hiding the syringe from the user.

[0039] For some applications, the second packaging insert is arranged such that removing the second packaging insert allows the user to remove the therapeutic substance delivery device from the device package.

[0040] For some applications, the apparatus is configured to guide the user to remove the therapeutic substance delivery device from the device package and move the therapeutic substance delivery device in a manner that mixes the liquid.

[0041] For some applications, the apparatus is further configured to guide the user to move the device package in a manner that mixes the liquid prior to the user removing the therapeutic substance delivery device from the device package.

[0042] The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Fig. 1 is a schematic illustration showing a therapeutic apparatus, including a therapeutic substance delivery device, and packaging including a device package, in accordance with some applications of the present invention;

[0044] Fig. 2 is a schematic illustration showing a transition from a closed state of the device package to an open state of the device package, in accordance with some applications of the present invention;

[0045] Figs. 3-4 are schematic illustrations of various components of the therapeutic substance delivery device, in accordance with some applications of the present invention;

[0046] Fig. 5 is a schematic illustration of the therapeutic substance apparatus before and after removal of a first packaging insert of a set of packaging inserts, in accordance with some applications of the present invention;

[0047] Fig. 6 is a schematic illustration of a liquid-injecting step of the filling process enabled by the removal of the first packaging insert of the set of packaging inserts, in accordance with some applications of the present invention; and

[0048] Fig. 7 is a schematic illustration of a transition from the liquid-injecting step of the filling process through to removing the second packaging insert, enabling the user to remove the therapeutic substance delivery device from the device package, in accordance with some applications of the present invention.

[0049] DETAILED DESCRIPTION

[0050] Reference is now made to Fig. 1 , which is a schematic illustration showing a therapeutic apparatus 20, including a therapeutic substance delivery device 22 and packaging 24, including a device package 26, in accordance with some applications of the present invention. Therapeutic apparatus 20 is typically for use with a syringe, e.g., syringe 28 shown in Figs. 5-7 hereinbelow, containing a liquid 29. Therapeutic substance delivery device 22 includes a filling port 30, which is arranged such that liquid from the syringe can be injected into therapeutic substance delivery device 22, e.g., into a therapeutic substance container 32 disposed at least partially within therapeutic substance delivery device 22, via filling port 30. Filling port 30 is typically a Luer Lock connector, e.g., a female Luer Lock port, and syringe 28 is typically a Luer Lock syringe. Thus, the filling processes can be carried out by the user, e.g., patient, without the user having to handle a needle syringe.

[0051] As described hereinabove, for some applications therapeutic substance delivery device 22 contains a lyophilized therapeutic substance disposed within container 32. The lyophilized therapeutic substance needs to be reconstituted prior to delivery of the therapeutic substance to the patient. Thus, for some applications, syringe 28 contains a liquid 29, e.g., saline, that when mixed with the powder of the lyophilized therapeutic substance reconstitutes the therapeutic substance. Some examples of therapeutic substances that may be sold in lyophilized form include (a) antibiotics, such as some types of semi-synthetic penicillins and cephalosporins, (b) some of the salts of erythromycin, doxycycline, and chloramphenicol, and (c) some biological drugs. Some additional examples of therapeutic substances that may be sold in lyophilized form include Ethyol® (Medimmune), Zithromax® (Pfizer), Azactam® (Bristol Myers Squibb), Cytovene® (Roche).

[0052] Alternatively, for some applications, liquid 29 within syringe 28 may be a first liquid containing a first part of therapeutic substance, and container 32 may contain a second liquid containing a second part of the therapeutic substance. The first liquid and the second liquid need to be mixed in order to form the therapeutic substance prior to delivery of the therapeutic substance to the patient. For example, some therapeutic substances are maintained in separated liquid parts during shelf life in order to avoid certain ingredients within the therapeutic substance mixing together during the shelf life of the therapeutic substance. For some applications, maintaining the liquid parts of the therapeutic substance separate can increase the shelf-life of the therapeutic substance. For example, some chemotherapy drugs may be maintained in separate liquids that need to be mixed prior to delivery.

[0053] Alternatively, for some applications, container 32 of therapeutic substance delivery device 22 may be empty when therapeutic apparatus 20 is sold for commercial sale, and liquid 29 disposed within syringe 28 is the therapeutic substance, such that the filling processes fills empty container 32 with the therapeutic substance from syringe 28.

[0054] Typically, packaging 24 includes a device package 26, e.g., an outer box, that holds therapeutic substance delivery device 22 in a position in which filling port 30 is accessible to a user without removing therapeutic substance delivery device 22 from device package 26 (as described with reference to Fig. 5). Enlarged view box 27 in Fig. 1 illustrates that therapeutic substance delivery device 22 is held inside device package 26, typically in the upright orientation of therapeutic substance delivery device 22 shown in Fig. 1. As further described hereinbelow with reference to Figs. 2 and 5-7, packaging 24 typically includes a set of packaging inserts 36 (for example as shown in Figs. 2 and 5-7) disposed inside device package 26 and arranged so as to facilitate performance by the user of a filling process of therapeutic substance delivery device 22 whereby liquid 29 in syringe 28 is injected into therapeutic substance delivery device 22 via filling port 30. In order to guide the user through the filling process in a manner which inhibits human errors such as performing the steps of the filling process out of order, each packaging insert 36 is arranged to allow the user enough access to perform a single step in the filling process while inhibiting the user from performing subsequent steps in the filling process. Removal of each packaging insert 36 facilitates performance by the user of the subsequent step in the filling process.

[0055] Reference is now made to Fig. 2, which is a schematic illustration showing a transition from a closed state of device package 26 to an open state of device package 26, in accordance with some applications of the present invention. As described hereinabove, for some applications packaging 24 interacts with therapeutic substance delivery device 22, such that therapeutic substance delivery device 22 and packaging 24 form an integrated system that guides the user through the filling process. Thus, for some applications, device package 26 interacts with therapeutic substance delivery device 22 such that an action by the user, e.g., opening of the device package by the user, activates therapeutic substance delivery device 22. Fig. 2 shows device package 26 in a closed state on the left side of the figure. Typically, therapeutic apparatus 20 guides the user, e.g., by including written and / or pictorial instructions, to open a top lid 38 of device package 26. For example, as illustrated in Fig. 2 by dashed box 39 (shown also in Fig. 1), top lid 38 may include written instructions that read "Open the top lid using the green tab." The right side of Fig. 2 shows device package 26 after the user has opened top lid 38.

[0056] Reference is now made to Figs. 3-4, which are schematic illustrations of various components of therapeutic substance delivery device 22, in accordance with some applications of the present invention. Therapeutic substance delivery device 22 includes a top shell 40 and a bottom shell 42, which together form an outer housing of therapeutic substance delivery device 22. A chassis 44 including mechanical interior components of therapeutic substance delivery device 22, a battery 46, and a printed circuit board (PCB) 48 are all disposed within therapeutic substance delivery device 22 and illustrated in exploded view in Fig. 3. Container 32 is shown with arrow 50 indicating that container 32 is inserted into therapeutic substance delivery device 22, typically prior to therapeutic substance delivery device 22 being packaged for commercial sale. Filling port 30 is shown on the exterior of bottom shell 42.

[0057] For some applications, therapeutic substance delivery device 22 further includes a deviceactivation sensor 52. As shown in Fig. 3, device-activation sensor 52 is disposed on a dedicated PCB 54 including control circuitry 55 that activates therapeutic substance delivery device 22. Fig. 4 illustrates how PCB 54 is coupled to a PCB housing 56, which is coupled to chassis 44 such that when PCB 54 is installed within therapeutic substance delivery device 22 device-activation sensor 52 is positioned in close proximity to the exterior 58 of bottom shell 42 of therapeutic substance delivery device 22. This positions device-activation sensor 52 in close proximity to device package 26 when therapeutic substance delivery device is packaged for commercial sale. Thus, for some applications, the interaction between device package 26 and therapeutic substance delivery device 22 that enables the action by the user (e.g., opening of the device package by the user) to activate therapeutic substance delivery device 22 is an interaction between device package 26 and device-activation sensor 52 of therapeutic substance delivery device 22. Thus, for some applications, device-activation sensor 52 detects the opening of device package 26, and control circuitry 55 activates therapeutic substance delivery device 22 in response to the detection of the opening of device package 26.

[0058] For some applications, device-activation sensor 52 is a Hall effect sensor and top lid 38 of device package 26 includes a magnet 60 (shown in Fig. 2). When device package 26 is in its closed state, e.g., as shown on the left side of Fig. 2, magnet 60 is positioned in close proximity to the Hall effect sensor. The opening of device package 26 displaces top lid 38, in turn displacing magnet 60 with respect to the Hall effect sensor, e.g., as shown on the right side of Fig. 2. Thus, the Hall effect sensor detects the opening of device package 26. In response to the detection of the opening of device package 26 by the Hall effect sensor, control circuitry 55 activates therapeutic substance delivery device 22.

[0059] As described hereinabove, upon activation of therapeutic substance delivery device 22, therapeutic substance delivery device 22 typically performs one or more startup steps. These startup steps may include, for example, disinfecting a disinfection chamber including a septum of container 32, and establishing fluid communication between filling port 30 and therapeutic substance container 32. Typically, the startup steps are steps that should be performed by therapeutic substance delivery device 22 prior to the user filling therapeutic substance container 32 with the therapeutic substance. For example, if the user were to fill therapeutic substance container 32 prior to the septum of therapeutic substance container 32 being disinfected, then bacteria could enter the therapeutic substance and have a negative impact on the patient. Similarly, if the user were to fill therapeutic substance container 32 prior to the fluid connection between filling port 30 and therapeutic substance container 32 being established then the therapeutic substance may enter parts of therapeutic substance delivery device 22 other than therapeutic substance container 32, causing damage to therapeutic substance delivery device 22 and rendering the therapeutic substance unusable.

[0060] Thus, for some applications, therapeutic substance delivery device 22 includes a visual indicator 62 (shown in Figs. 3-4), e.g., a light emitting diode (LED) that switches between two colors, e.g., between red and green. For some applications, visual indicator 62 is positioned on PCB 54. A hole 64 in bottom shell 42 of therapeutic substance delivery device 22 enables visual indicator 62 to be seen by the user. Upon activation of therapeutic substance delivery device 22, visual indicator 62 is used to indicate to the user that therapeutic substance delivery device 22 is not yet ready for the user to inject liquid 19 via filling port 30. Once therapeutic substance delivery device 22 has completed the startup steps, visual indicator 62 will change its state, e.g., change color, in order to indicate to the user that they may proceed with the filling process.

[0061] Reference is now made to Fig. 5, which is a schematic illustration of therapeutic apparatus 20 before and after removal of a first packaging insert 66 of the set of packaging inserts 36, in accordance with some applications of the present invention. For some applications, the set of packaging inserts 36 include first packaging insert 66 and a second packaging insert 68. Upon the user opening device package 26, first packaging insert 66 is visible to the user, as shown on the left side of Fig. 5. First packaging insert 66 inhibits access to filling port 30 of therapeutic substance delivery device 22 by the user, e.g., hides filling port 30 from the user, while allowing the user to see visual indicator 62, e.g., via a hole 70 in first packaging insert 66 that lines up with hole 64 (shown in Figs. 3-4). For some applications, first packaging insert 66 inhibits access to therapeutic substance delivery device 22 by the user, e.g., first packaging insert 66 hides therapeutic substance delivery device 22 from the user. For some applications, syringe 28 is included within device package 26 and device package 26 holds syringe 28 in a position in which a user can access syringe 28. In cases where syringe 28 is disposed within device package 26, first packaging insert 66 typically inhibits access to syringe 28 by the user in addition to inhibiting access to therapeutic substance delivery device 22 by the user, e.g., first packaging insert 66 hides syringe 28 from the user.

[0062] Typically, therapeutic apparatus 20 guides the user, e.g., by including written and / or pictorial instructions, e.g., by including written and / or pictorial instructions visible on first packaging insert 66, to wait until visual indicator 62 indicates that the user should remove first packaging insert 66. For example, as illustrated in Fig. 2 by box 67 (shown also in Fig. 5), first packaging insert 66 may include written instructions that read "Wait for the flashing light to turn GREEN. When Green, remove the lid" (i.e., remove first packaging insert 66). Thus, the user is guided to wait until therapeutic substance delivery device 22 has finished performing the startup steps, as described hereinabove, while therapeutic substance delivery device 22, and for some applications syringe 28, remain inaccessible to the user, e.g., hidden from the user, by first packaging insert 66. This inhibits the user from prematurely injecting liquid 29 within syringe 28 into therapeutic substance delivery device 22 via filling port 30.

[0063] For some applications, syringe 28 is not disposed within device package 26, but rather is provided as a separate accessory along with therapeutic apparatus 20. It is noted that even in such cases where the user would have access to syringe 28 outside of device package 26, first packaging insert 66 still acts to inhibit premature filling of therapeutic substance delivery device 22 with liquid 29 by keeping filling port 30 (and possibly the entire therapeutic substance delivery device 22) inaccessible to the user, e.g., hidden from the user, until visual indicator 62 indicates to the user that they should remove first packaging insert 66.

[0064] The right side of Fig. 5 depicts therapeutic apparatus 20 after the user has removed first packaging insert 66. As illustrated, second packaging insert 68 is visible to the user upon the user removing first packaging insert 66. Arrow 72 indicates the removal of first packaging insert 66 by lifting first packaging insert 66 out of device package 26. Typically, second packaging insert 68 inhibits removal of therapeutic substance delivery device 22 from device package 26, e.g., keeps therapeutic substance delivery device 22 still hidden from the user, while allowing the user access to filling port 30 of therapeutic substance delivery device 22. Typically, second packaging insert 68 has a corresponding hole 74 that aligns with hole 70 of first packaging insert 66 and hole 64 of bottom shell 42 of therapeutic substance delivery device 22 so as to allow the user to see visual indicator 62 prior to the removal of first packaging insert 66. As illustrated in Fig. 5, first packaging insert 66 is shaped to form a recess, and hole 70 is positioned adjacent to or on the recessed area of first packaging insert 66. This places the area of first packaging insert 66 that surrounds hole 70 adjacent to or in contact with the area of second packaging insert 68 that surrounds hole 74, which is in turn adjacent to or in contact with the area of bottom shell 42 that surrounds hole 64. Thus, the user is able to easily see visual indicator 62 through the succession of holes 64, 74, and 70.

[0065] Reference is now made to Fig. 6, which is a schematic illustration of a liquid-injecting step of the filling process enabled by the removal of first packaging insert 66 of the set of packaging inserts 36, in accordance with some applications of the present invention. Once first packaging insert 66 is removed, the user has access to enough of the apparatus in order to connect syringe 28 to filling port 30, e.g., with a Luer Lock connection, and inject liquid 29 disposed in syringe 28 into therapeutic substance delivery device 22, e.g., into therapeutic substance container 32, while still inhibiting the user from removing therapeutic substance delivery device 22 from device package 26. Typically, therapeutic apparatus 20 guides the user, e.g., by including written and / or pictorial instructions, e.g., by including written and / or pictorial instructions visible on second packaging insert 68, to inject liquid 29 disposed in syringe 28 into therapeutic substance delivery device 22 via filling port 30. As illustrated in Fig. 6, second packaging insert 68 may include a combination of pictorial and written instructions to guide the user through the liquid-injecting step of the filling process. It is noted that typically, therapeutic substance delivery device 22 includes a cap 31, e.g., a Luer cap, disposed on filling port 30. Before injecting liquid 29 into therapeutic substance delivery device 22, cap 31 should be removed from filing port 30 by the user. For illustrative purposes, Luer cap 31 is shown in Fig. 1 and is not shown in the rest of the figures in order for the Luer Lock port to be visible in the figures. For example, under pictorial instruction (a) may be written "twist off Luer cap," under pictorial instruction (b) may be written "remove syringe from packaging and twist syringe into Luer," and under pictorial instruction (c) may be written "inject the saline." For applications in which syringe 28 is disposed within device package 26, removing first packaging insert 66 also allows the user to remove syringe 28 from device package 26, such as is shown by way of example in the transition from the left side to the right side of Fig. 6. For applications in which syringe 28 is provided separately from device package 26, removing first packaging insert 66 allows the user to access filling port 30 with syringe 28.

[0066] Allowing the user access to filling port 30 in order to inject liquid 29 into therapeutic substance delivery device 22 while inhibiting the user from removing therapeutic substance delivery device 22 from device package 26 helps inhibit the user from making an error such as forgetting to fill therapeutic substance delivery device 22 before placing therapeutic substance delivery device 22 on their body for the treatment. Typically, device package 26 has a window 76 that aligns with an opening 78 of therapeutic substance delivery device 22 (shown in Fig. 1) through which therapeutic substance container 32 is visible. Thus, the user can see the contents of therapeutic substance container 32 from the outside of device package 26. This enables the user to visually ensure that liquid 29 is entering therapeutic substance container 32 as the user is injecting liquid 29 into therapeutic substance delivery device 22 via filing port 30.

[0067] Reference is now made to Fig. 7, which is a schematic illustration of a transition from the liquid- injecting step of the filling process through to removing second packaging insert 68 enabling the user to remove therapeutic substance delivery device 22 from device package 26, in accordance with some applications of the present invention. For some applications, when a lyophilized therapeutic substance is reconstituted or two separate liquid parts of a therapeutic substance are brought together, the resulting therapeutic substance needs to be mixed, e.g., stirred or swirled. Thus, for some applications, mixing the therapeutic substance is the last step in the filling process that should be done prior to placement of therapeutic substance delivery device 22 on the user's body for treatment. As illustrated in the transition from the left side to the right side of Fig. 7, removing second packaging insert 68 (illustrated by arrow 73) allows the user to remove therapeutic substance delivery device 22 from device package 26. At this point, assuming the user correctly followed the guidance of therapeutic apparatus 20, liquid 19 is disposed within therapeutic substance delivery device 22, e.g., within therapeutic substance container 32.

[0068] Thus, for some applications, therapeutic apparatus 20 guides the user, e.g., by including written and / or pictorial instructions, to move device package 26 in a manner that mixes liquid 19 inside therapeutic substance delivery device 22, e.g., according to instructions provided by the pharmaceutical company of the therapeutic substance, and subsequently to remove therapeutic substance delivery device 22 from device package 26. Therapeutic substance delivery device 22 is now ready to be attached, e.g., adhered, to the body of the patient, e.g., the user, for the treatment process. Alternatively or additionally, for some applications, therapeutic apparatus 20 guides the user, e.g., by including written and / or pictorial instructions, to first remove therapeutic substance delivery device 22 from device package 26 and then move therapeutic substance delivery device 22 in a manner that mixes liquid 19 inside therapeutic substance delivery device 22 prior to attaching therapeutic substance delivery device 22 to the body of the patient, e.g., the user. For example, as illustrated in Fig. 7 by dashed box 69, once second packaging insert 68 is removed, the user may see written instructions on device package 26 that read: "Grab the device from its sides and remove the device from the packaging. Begin swirling the device according to pharmaceutical drug requirements. "

[0069] Alternatively, for some applications, therapeutic apparatus 20 guides the user, e.g., by including written instructions, e.g., by including written and / or pictorial instructions visible on second packaging insert 68, to move device package 26 in a manner that mixes liquid 19 inside therapeutic substance delivery device 22 prior to removing second packaging insert 68 from device package 26. Instructing the user to first move device package 26 in order to mix the liquid and only then remove second packaging insert 68 may help inhibit an error such as attaching therapeutic substance delivery device to the body of the patient prior to mixing the liquid.

[0070] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

Claims

CLAIMS1. A therapeutic apparatus for use with a syringe containing a liquid, the apparatus comprising:(A) a therapeutic substance delivery device comprising a filling port, the filling port arranged such that the liquid from the syringe can be injected into the therapeutic substance delivery device via the filling port; and(B) packaging holding the therapeutic substance delivery device, the packaging comprising:(i) a device package configured to hold the therapeutic substance delivery device in a position in which the filling port is accessible to a user without removing the therapeutic substance delivery device from the device package, and(ii) a set of packaging inserts disposed inside the device package and arranged so as to facilitate performance by the user of a filling process of the therapeutic substance delivery device whereby the liquid in the syringe is injected into the therapeutic substance delivery device via the filling port: each packaging insert arranged to allow the user enough access to perform a single step in the filling process while inhibiting the user from performing subsequent steps in the filling process, and removal of each packaging insert facilitating performance by the user of the subsequent step in the filling process.

2. The therapeutic apparatus according to claim 1, wherein the device package is further configured to interact with the therapeutic substance delivery device such that an action by the user activates the therapeutic substance delivery device.

3. The therapeutic apparatus according to claim 2, wherein the device package is configured to interact with the therapeutic substance delivery device such that opening of the device package by the user activates the therapeutic substance delivery device.

4. The therapeutic apparatus according to claim 3, wherein the therapeutic substance delivery device comprises: a device-activation sensor configured to detect the opening of the device package, andcontrol circuitry configured to activate the therapeutic substance delivery device in response to the detection of the opening of the device package.

5. The therapeutic apparatus according to claim 4, wherein the device-activation sensor comprises a Hall effect sensor and the device package comprises a magnet, the device package, the magnet, and the Hall effect sensor arranged such that the opening of the device package by the user displaces the magnet with respect to the Hall effect sensor causing the Hall effect sensor to detect the opening of the device package.

6. The therapeutic apparatus according to any one of claims 1-5, wherein the set of packaging inserts comprises a first packaging insert and a second packaging insert, and the therapeutic substance delivery device comprises a visual indicator, wherein the first packaging insert:(i) is visible to the user upon the user opening the device package, and(ii) is configured to inhibit access to the filling port by the user while allowing the user to see the visual indicator of the therapeutic substance delivery device.

7. The therapeutic apparatus according to claim 6, wherein the first packaging insert is configured to inhibit access to the filling port by hiding the filling port from the user while allowing the user to see the visual indicator of the therapeutic substance delivery device.

8. The therapeutic apparatus according to claim 6, wherein the first packaging insert is configured to inhibit access to the filling port by inhibiting access to the therapeutic substance delivery device by the user.

9. The therapeutic apparatus according to claim 8, wherein the first packaging insert is configured to inhibit access to the therapeutic substance delivery device by hiding the therapeutic substance delivery device from the user.

10. The therapeutic apparatus according to claim 6, wherein the apparatus is configured to guide the user to wait until the visual indicator indicates that the user should remove the first packaging insert.

11. The therapeutic apparatus according to claim 6, wherein: the device package is further configured to hold the syringe in a position in which a user can access the syringe, andthe first packaging insert is further configured to inhibit access to the syringe by the user and is arranged such that removing the first packaging insert allows the user to remove the syringe from the device package.

12. The therapeutic apparatus according to claim 11, wherein the first packaging insert is configured to inhibit access to the syringe by hiding the syringe from the user.

13. The therapeutic apparatus according to claim 6, wherein the second packaging insert:(i) is visible to the user upon the user removing the first packaging insert, and(ii) is configured to inhibit removal of the therapeutic substance delivery device from the device package while allowing the user access to the filling port of the therapeutic substance delivery device.

14. The therapeutic apparatus according to claim 13, wherein the second packaging insert is configured to inhibit removal of the therapeutic substance delivery device by hiding the therapeutic substance delivery device from the user while allowing the user access to the filling port of the therapeutic substance delivery device.

15. The therapeutic apparatus according to claim 13, wherein the apparatus is configured to guide the user to inject the liquid disposed in the syringe into the therapeutic substance delivery device via the filling port.

16. The therapeutic apparatus according to claim 15, wherein the apparatus is further configured to guide the user to, following the injection of the liquid into the therapeutic substance delivery device, move the device package in a manner that mixes the liquid.

17. The therapeutic apparatus according to claim 13, wherein: the device package is further configured to hold the syringe in a position in which a user can access the syringe, and the first packaging insert is further configured to inhibit access to the syringe by the user such and is arranged such that removing the first packaging insert allows the user to remove the syringe from the device package.

18. The therapeutic apparatus according to claim 17, wherein the first packaging insert is configured to inhibit access to the syringe by hiding the syringe from the user.

19. The therapeutic apparatus according to claim 13, wherein the second packaging insert is arranged such that removing the second packaging insert allows the user to remove the therapeutic substance delivery device from the device package.

20. The therapeutic apparatus according to claim 19, wherein the apparatus is configured to guide the user to remove the therapeutic substance delivery device from the device package and move the therapeutic substance delivery device in a manner that mixes the liquid.

21. The therapeutic apparatus according to claim 19, wherein the apparatus is further configured to guide the user to move the device package in a manner that mixes the liquid prior to the user removing the therapeutic substance delivery device from the device package.

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