Method for loading a wearable drug delivery device with a pharmaceutical agent

Abstract

A system for filling an on-body syringe includes an on-body syringe having a drug reservoir, a filling cartridge having an internal chamber containing a drug, and a filling station for receiving the on-body syringe and the filled cartridge. The filling station includes a syringe socket for receiving the on-body syringe, a cartridge socket for receiving the filled cartridge, a fluid path portion providing fluid communication between the syringe socket and the cartridge socket, and a pump operably engaging the fluid path portion to transfer the drug from the internal chamber of the filled cartridge to the drug reservoir of the on-body syringe.

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Application No. 63 / 409,369, filed September 23, 2022, entitled "METHOD TO PROVIDE FOR DRUG PRODUCT FILLING INTO BODY-WORN DRUG DELIVERY DEVICE," the entire disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to a filling station for a drug delivery device and a method for filling a drug delivery device. [Background technology]

[0003] Wearable medical injection devices, which may be variously referred to as on-body injectors, wearable injectors, pass pumps, etc., are commonly used in the treatment of diseases such as diabetes, which involve the continuous infusion of medication (e.g., insulin).

[0004] For diabetes, on-body insulin pumps are typically designed to administer insulin at a basal rate and a bolus dose. During basal administration, insulin is delivered continuously for a predetermined period (e.g., 24 hours) to maintain the diabetic patient's blood glucose level within a consistent range. Basal administration can reduce fluctuations within the blood glucose range compared to a single injection and can eliminate the need for multiple needle sticks over a predetermined period. During bolus administration, insulin is delivered in discrete injection doses. Bolus administration can be indicated, for example, when a diabetic patient ingests a meal to balance the carbohydrates consumed.

[0005] Patch pumps are designed as self-contained units worn by the patient and are preferably small so as not to interfere with the user's activities. As such, patch pumps have a limited drug capacity and must be filled / refilled by a healthcare provider once all the drug has been administered.

[0006] It would be desirable if patch pumps could be filled and / or refilled by the patient or their caregiver without the traditional need for intervention by a healthcare provider. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent Application Publication No. 2020 / 0155755 Summary of the Invention

[0008] An embodiment of the present disclosure relates to a system for filling an on-body syringe. The system includes an on-body syringe having a drug reservoir, a filling cartridge having an internal chamber containing a drug, and a filling station for receiving the on-body syringe and the filled cartridge. The filling station includes a syringe socket for receiving the on-body syringe, a cartridge socket for receiving the filled cartridge, a fluid path portion for providing fluid communication between the syringe socket and the cartridge socket, and a pump operatively engaged with the fluid path portion for transferring drug from the internal chamber of the filled cartridge to the drug reservoir of the on-body syringe.

[0009] In some embodiments, the pump comprises one or more rollers configured to engage elastic tubing in the fluid path portion.

[0010] In some embodiments, the syringe socket includes a needle for piercing a septum or port of the on-body syringe.

[0011] In some embodiments, the cartridge socket comprises a needle for piercing a septum or stopper of the loaded cartridge.

[0012] In some embodiments, the syringe socket, cartridge socket, and fluid pathway portion are provided on a removable transfer tray.

[0013] In some embodiments, the filling station comprises a base for receiving a transfer tray and a lid pivotally connected to the base.

[0014] In some embodiments, the filling station comprises an expansion chamber configured to deliver a pre-filled expansion volume of air to the on-body syringe.

[0015] In some embodiments, the expansion volume of the pre-filled air is about 100 μL.

[0016] In some embodiments, the drug reservoir of the on-body syringe has a volume of about 3 mL.

[0017] In some embodiments, the filling station includes a controller for operating the pump.

[0018] In some embodiments, the controller is configured to actuate the pump to fill the drug reservoir of the on-body injector to about 10 psi.

[0019] In some embodiments, the controller is configured to operate the pump in reverse to expel air from the fluid path portion.

[0020] In some embodiments, the filling station further comprises a check valve in a reverse configuration through which air is exhausted.

[0021] In some embodiments, the filling station further comprises an auxiliary socket configured to receive an auxiliary cartridge and at least one valve movable between a first position and a second position, wherein in the first position of the at least one valve, the cartridge socket is in fluid communication with the auxiliary socket and the syringe socket is separated, and in the second position of the valve, the cartridge socket is in fluid communication with the syringe socket.

[0022] Another embodiment of the present disclosure relates to a filling station for filling on-body syringes, the filling station comprising a removable transfer tray including a syringe socket for receiving an on-body syringe, a cartridge socket for receiving a filled cartridge, a fluid path portion providing fluid communication between the syringe socket and the cartridge socket, and a pump operatively engaging the fluid path portion to transfer a medication from an internal chamber of the filled cartridge to a medication reservoir of the on-body syringe; Includes.

[0023] In some embodiments, the pump comprises one or more rollers configured to engage resilient tubing in the fluid path portion.

[0024] In some embodiments, the syringe socket includes a needle for piercing a septum or port of the on-body syringe.

[0025] In some embodiments, the cartridge socket comprises a needle for piercing a septum or stopper of the loaded cartridge.

[0026] In some embodiments, the filling station further comprises a base for receiving the transfer tray and a lid pivotally connected to the base.

[0027] In some embodiments, the filling station further comprises an expansion chamber configured to deliver a pre-filled expansion volume of air to the on-body syringe.

[0028] In some embodiments, the pre-filled inflation volume of air is about 100 μL.

[0029] In some embodiments, the filling station includes a controller for operating the pump, the controller configured to operate the pump to fill the drug reservoir of the on-body injector to approximately 10 psi.

[0030] In some embodiments, the controller is configured to operate the pump in reverse to expel air from the fluid path portion.

[0031] Further details and advantages of the various examples described in detail herein will become apparent upon review of the following detailed description of the various examples in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0032] The above and other features and advantages of the present disclosure, as well as the manner in which they are achieved, will become more apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is a perspective view of a filling station according to one embodiment of the present disclosure. [Figure 2] FIG. 2 is a schematic diagram of a transfer tray at the filling station of FIG. 1 loaded with on-body syringes and filled cartridges. [Figure 3] FIG. 3 is a fluid path diagram of the transfer tray of FIG. 2 according to one embodiment of the present disclosure. [Figure 4] 4 is an exploded perspective view of the filling station of FIG. 1 in an open position with portions of the base and lid removed for clarity of illustration. [Figure 5] FIG. 5 is an exploded perspective view of the filling station of FIG. 1 in an open position with portions of the base and lid removed for clarity of illustration. [Figure 6]FIG. 6 is a perspective view of the filling station of FIG. 1 in an open position with portions of the base and lid removed for clarity of illustration. [Figure 7] FIG. 7 is a perspective view of the filling station of FIG. 1 in an open position with portions of the base and lid removed for clarity of illustration. [Figure 8] FIG. 8 is a perspective view of the filling station of FIG. 1 in an open position with portions of the base and lid removed for clarity of illustration. [Figure 9] FIG. 9 is a perspective view of the filling station of FIG. 1 in an open position with portions of the base and lid removed for clarity of illustration. [Figure 10] FIG. 10 is an exploded perspective view of a filling station according to one embodiment of the present disclosure. [Figure 11] FIG. 11 is a perspective view of the transfer tray of FIG. [Figure 12] FIG. 12 is a perspective view of the transfer tray of FIG. 10 in an open position. [Figure 13] FIG. 13 is a perspective view of the transfer tray of FIG. 10 in a closed position. [Figure 14] 14 is an exploded perspective view of the transfer tray of FIG. 10. FIG. [Figure 15] FIG. 15 is a perspective view and a side view of a filling station according to one embodiment of the present disclosure. [Figure 16] FIG. 16 is a fluid path diagram of the filling station of FIG. [Figure 17] FIG. 17 is an exploded perspective view of a filling station according to one embodiment of the present disclosure. [Figure 18] FIG. 18 is a fluid path diagram of the filling station of FIG. [Figure 19] FIG. 19 is an exploded perspective view of a filling station according to one embodiment of the present disclosure. [Figure 20] FIG. 20 is a fluid path diagram of the filling station of FIG. [Figure 21] FIG. 21 is a fluid path diagram of the transfer tray of FIG. 2 with the valve in a first position according to one embodiment of the present disclosure. [Figure 22] FIG. 22 is a fluid path diagram of FIG. 21 with the valve in a second position.

[0033] Corresponding reference characters indicate corresponding parts throughout the several views. Nothing presented herein should be construed as limiting the scope of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0034] The following description is provided to enable those skilled in the art to make and use the described embodiments intended to practice the present disclosure. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present disclosure.

[0035] Hereinafter, for purposes of explanation, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and their derivatives will refer to the present invention as oriented in the drawings. However, it will be understood that the present invention may assume various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings, and described in the following specification, are merely exemplary embodiments of the present invention. As such, specific dimensions and other physical characteristics relating to aspects disclosed herein are not to be considered limiting.

[0036] All numbers used in this specification and claims should be understood as modified in all instances by the term "about." The terms "approximately," "about," and "substantially" mean within a range of plus or minus 10 percent of the stated value. Furthermore, the term "substantially equal" and similar terms mean that the compared values ​​or dimensions are within a range of plus or minus 10 percent of each other.

[0037] The terms "first," "second," and the like are not intended to refer to any particular order or chronology, but rather to different conditions, properties, or elements.

[0038] As used herein with respect to an injection device such as a syringe, the term "proximal" refers to the end of the device farthest from the outlet, or in a direction toward the end of the device farthest from the outlet. As used herein with respect to an injection device such as a syringe, the term "distal" refers to the end of the device or device nearest the outlet, or in a direction toward the end of the device nearest the outlet.

[0039] As used herein, "at least one of" is synonymous with "one or more of." For example, the phrase "at least one of A, B, and C" means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, "at least one of A, B, and C" includes one or more of only one or more As, or only one or more Bs, or only one or more Cs, or one or more As and one or more Bs, or one or more As and one or more Cs, or one or more Bs and one or more Cs, or all of A, B, and C.

[0040] Referring initially to FIG. 1 , an embodiment of a syringe filling station 100 is shown in accordance with an embodiment of the present disclosure. The filling station 100 can include a base 110 and a lid 120. The lid 120 can be pivotally connected to the base 110, for example, by a rotating hinge 130. In some embodiments, the lid 120 includes a handle 122 to aid a user in manipulating the lid 120. The base 110 and / or the lid 120 can removably support a transfer tray 140. The tray 140 includes various mechanisms for supporting and removably holding a syringe, more specifically, an on-body syringe 200 (which may also hereinafter be referred to as a patch pump). The tray 140 further includes various mechanisms for supporting and removably holding a filled cartridge 300 (e.g., containing a medicament) and establishing fluid communication between the filled cartridge 300 and a medicament reservoir of the on-body syringe 200. In use, a user (typically a patient or the patient's caregiver) loads an empty on-body syringe 200 and a filled cartridge 300 into the tray 140. The user then inserts the tray 140 into the base 110 and / or lid 120 of the filling station 100. The tray 140, base 110, and / or lid 120 include various structures and components for transferring a medication from the filled cartridge 300 to the reservoir of the on-body syringe 200. In some embodiments, as described in more detail herein with reference to FIGS. 4-9 , the transfer of a medication from the filled cartridge 300 to the medication reservoir of the on-body syringe 200 can occur automatically when the lid 120 is closed.

[0041] 2 and 3, the on-body syringe 200 and the filling cartridge 300 can be removably connected to a tray 140, thereby establishing a fluid pathway between the internal chamber 310 of the filling cartridge 300 and the drug reservoir 210 of the on-body syringe 200. The tray 140 includes a cartridge socket 142 for removably receiving the filling cartridge 300 and a syringe socket 144 for removably receiving the on-body syringe 200. The tray 140 further includes a fluid path portion 146 that provides fluid communication between the cartridge socket 142 and the syringe socket 144. As shown in FIG. 3, the cartridge socket 142 can include a needle 143 that pierces a septum or stopper 320 of the filling cartridge 300 to provide fluid communication between the fluid path portion 146 and the internal chamber 310 of the filling cartridge 300. Similarly, the syringe socket 144 may include a needle 145 for penetrating a septum or port 220 of the on-body syringe 200 to provide fluid communication between the fluid pathway section 146 and the drug reservoir 210 of the on-body syringe 200. The fluid pathway section 146 may include one or more fluid channels 152 molded and / or formed in a substrate 150 of the tray 140 and / or one or more tubing sections 148 connected to the substrate 150.

[0042] 2, other components of the tray 140 and / or filling station 100 include a pump 154 ​​and other components for transferring medication from the filled cartridge 300 to the on-body syringe 200. The pump 154 ​​may be located in the fluid path portion 146. The pump 154 ​​is controlled by an electronic controller 400 that is programmed or configured to operate the pump 154 ​​until the filling or refilling operation is complete and / or to abort the filling or refilling operation if an error occurs in loading or filling the on-body syringe 200. In the embodiment shown in FIG. 2, the pump 154 ​​is a peristaltic pump having one or more rollers 156 configured to engage the elastic tubing portion 148 of the fluid path portion 146 to draw medication from the filled cartridge 300 and inject the medication into the on-body syringe 200.

[0043] 2, the tray 140 can further include an expansion chamber 160 configured to inject a pre-expansion volume of air into the on-body syringe 200 prior to filling the on-body syringe 200 with medication. The pre-expansion volume can be used to generate a controlled amount of air within the reservoir of the on-body syringe 200. Additionally or alternatively, the pre-expansion volume can be used to occupy dead space in the reservoir of the on-body syringe 200 to help expel more medication from the reservoir during an injection procedure, particularly toward the end of the injection procedure when the reservoir is nearly empty. In embodiments in which the on-body syringe 200 has a reservoir volume of approximately 3 milliliters (mL), the expansion chamber 160 can be configured to inject a pre-filled expansion volume of approximately 100 microliters (μL) of air per syringe fill operation. The expansion chamber 160 is disposed in fluid communication with the fluid path 146 between the cartridge socket 142 and the syringe socket 144 such that the expansion chamber 160 supplies air to the on-body syringe 200 via the fluid path 146. In the illustrated embodiment, the expansion chamber includes a piston 162 that moves axially to expel pressurized air from the expansion chamber 160.

[0044] 2 , the tray 140 may further include a forward check valve 172 disposed in the fluid path portion 146 between the on-body syringe 200 and the loaded cartridge 300. The forward check valve 172 prevents the flow of air and / or medication from the on-body syringe 200 back to the loaded cartridge 300. The tray 140 may further include a reverse-positioned check valve 174 disposed in the fluid path portion 146 to allow air to escape from the on-body syringe 200 via the fluid path portion 146 via the pump 154. The check valve 174 may be disposed in a branch channel 153 of the fluid path portion 146, positioned to allow fluid to flow from the on-body syringe 200 to the check valve 174 without flowing into the loaded cartridge 300, and to allow fluid to flow from the loaded cartridge 300 to the check valve 174 without flowing into the on-body syringe 200. In other words, the on-body syringe 200 and the loaded cartridge 300 are in a parallel fluid circuit with respect to the check valve 174 .

[0045] 4-9, installation of the filling station 100 is shown in accordance with one embodiment of the present disclosure. Referring initially to FIG. 4, the tray 140 can be detached (or supplied separately) from the base 110 and lid 120 to allow access to the cartridge socket 142 and syringe socket 144. As shown in FIGS. 4 and 5, the cartridge socket 142 can include a port for a snap-fit ​​connection with the filled cartridge 300. In other embodiments, the cartridge socket 142 can include a bayonet connection, a threaded joint, or other fixed mechanical connection for engaging and retaining the filled cartridge 300. The cartridge socket 142 can provide tactile feedback, such as a snap-fit, to confirm to the user that the filled cartridge 300 is properly inserted into the cartridge socket 142. When the filled cartridge 300 is connected to the cartridge socket 142, the needle 143 of the cartridge socket 142 can automatically pierce the septum or stopper of the filled cartridge 300. Similarly, the syringe socket 144 can include a port for a snap-fit ​​connection with the on-body syringe 200. Syringe socket 144 may provide tactile feedback, such as a snap fit, to allow the user to confirm that on-body syringe 200 is properly inserted into syringe socket 144. Connection of on-body syringe 200 to syringe socket 144 may automatically cause needle 145 of syringe socket 144 to pierce a septum of on-body syringe 200.

[0046] 6 , once the on-body syringe 200 and filling cartridge 300 are connected to the syringe socket 144 and cartridge socket 142, respectively, the tray 140 can be inserted into the base 110 of the filling station 100. The base 110 may include positioning features, such as detents and / or protrusions, to ensure that the tray 140 is properly aligned with the operating components of the base 110 and / or lid 120. For example, the tray 140 must be positioned within the base 110 such that the resilient tube portion 148 of the fluid path portion 146 operatively aligns with and engages the pump 154. Similarly, the tray 140 must be positioned within the base 110 such that the expansion chamber 160 is operatively aligned with the corresponding actuation lever 124 of the lid 120, and such that the on-body syringe 200 is operatively aligned with the corresponding retention lever 126 of the lid 120. In some embodiments, the base 110, the lid 120, and / or the tray 140 may exhibit tactile feedback, such as a snap fit, to ensure the user that the tray 140 is properly inserted. In some embodiments, the base 110, the lid 120, and / or the tray 140 may include an electromechanical device, e.g., a limit switch, configured to prevent a fill or refill operation from being performed if the tray 140 is not properly positioned relative to the base 110.

[0047] 7, once the tray 140 is properly positioned within the base 110, the lid 120 can be closed by the user to begin the fill or refill operation. Closing the lid 120 engages a retention lever 126, which may be integrally formed with the lid 120, with the on-body syringe 200 to prevent movement of the on-body syringe 200 during the fill or refill operation. Closing the lid 120 also engages an actuation lever 124, which may be integrally formed with the lid 120, with an expansion chamber 160, thereby injecting an expansion volume of pre-filled air into the drug reservoir 210 of the on-body syringe 200. The retaining lever 126 and the actuating lever 124 can be timed so that the retaining lever 126 engages the on-body syringe 200 before the actuating lever 124 engages the inflation chamber 160 while the lid 120 is closed, thereby allowing the on-body syringe 200 to be fully supported by the retaining lever 126 before the inflation volume of pre-filled air is delivered.

[0048] As shown in FIG. 7 , once the lid 120 is closed, a fill or refill operation can begin. The filling station 100 may include one or more sensors (not shown) configured to detect that the lid 120 is closed and to activate the controller 400 to perform a fill or refill operation. During a fill or refill operation, an expanded volume of pre-filled air is delivered to the on-body syringe 200, as described in connection with FIG. 7 . The controller 400 may first operate the pump 154 ​​in the reverse direction for a predetermined time to expel air from the on-body syringe 200 and the fluid path portion 146 of the tray 140. After the predetermined time, the controller may operate the pump 154 ​​in the forward direction to draw the drug from the internal chamber 310 of the filled cartridge 300 and inject the drug into the drug reservoir 210 of the on-body syringe 200. The controller 400 may operate the pump 154 ​​until the drug reservoir 210 is filled to a predetermined pressure, for example, approximately 10 psi. The on-body syringe 200 then completes filling and the controller stops operation of the pump 154. The pump 154 ​​can be controlled by the controller through a filling or refilling operation. In some embodiments, the controller can be configured to provide sensory feedback, such as illuminating a light or emitting a sound, to indicate to the user that the on-body syringe 200 has filled.

[0049] Referring now to FIG. 8 , once filling of the on-body syringe 200 is complete, the lid 120 can be opened automatically by the controller or manually by the user. Opening the lid 120 disengages the retention lever 126 from the on-body syringe 200 and the activation lever 124 from the expansion chamber 160. If the user opens the lid 120 before the filling or refilling operation is complete, the controller can also disable operation of the pump 154 ​​as a safety measure to stop further filling of the on-body syringe 200. Once the retention lever 126 and activation lever 124 are disengaged from the on-body syringe 200 and the expansion chamber 160, respectively, the tray 140 can be removed from the base 110, as shown in FIG. 9 . The on-body syringe 200 and loaded cartridge 300 can then be removed from the tray 140, and the on-body syringe 200 can be attached to a patient so that the on-body syringe 200 can be used as pre-filled by a healthcare provider. In some embodiments, the fill cartridge 300 may contain enough medicament to fill multiple on-body injectors 200, in which case the fill cartridge 300 may be removed from the tray 140 and stored for future fill or refill operations. In some embodiments, the fill cartridge 300 contains only enough medicament to perform a single fill or refill operation, thereby allowing the fill cartridge 300 to be disposed of after the fill or refill operation. In some embodiments, the tray 140 may also be disposable and replaced after each fill or refill operation, or after a predetermined number of fill or refill operations.

[0050] 10-14, a method or process for filling or refilling an on-body syringe 200 is shown from the perspective of a user (e.g., a patient or a patient's caregiver) operating the filling station 100. As shown in FIG. 10, the user first obtains a tray 140, an on-body syringe 200, and a filling cartridge 300. One or more of the tray 140, the on-body syringe 200, and the filling cartridge 300 can be disposable components supplied in individual packaging. For example, the tray 140 may be supplied in tray packaging 149, and the on-body syringe 200 may be supplied in syringe packaging 290. The user removes the tray 140, the on-body syringe 200, and the filling cartridge 300 from any associated packaging, and then, as shown in FIG. 11, the user can load the on-body syringe 200 and the filling cartridge 300 into the tray 140 in the manner described herein with respect to FIGS. 4 and 5. As shown in FIG. 12 , a user can open the lid 120 of the filling station 100 and insert the tray 140 loaded with the on-body syringe 200 and loaded cartridge 300 into the base 110. As shown in FIG. 13 , a user can close the lid 120 and begin performing a filling or refilling operation, as described herein with respect to FIGS. 6-8 . As shown in FIG. 14 , after the filling or refilling operation has been performed, the user can open the lid 120 (or, in some embodiments, the lid 120 can be opened automatically by a controller) and remove the tray 140 loaded with the on-body syringe 200 and loaded cartridge 300. The user can then remove the on-body syringe 200 from the tray 140 and subsequently attach the on-body syringe 200 to a patient and administer a medication from the on-body syringe 200. The user can also discard the tray 140 and / or loaded cartridge 300 when they have reached the end of their useful life.As described herein, the tray 140 and / or the filling cartridge 300 may be disposable components configured for use in a predetermined number of filling operations (e.g., one), after which the tray 140 and / or the filling cartridge 300 need to be discarded due to hygiene concerns.

[0051] 15-20, an alternative embodiment of the filling station 100 is shown. The embodiment of the filling station 100 shown in FIGS. 15-20 can operate on the same principles and for the same purpose as the embodiment described with respect to FIGS. 1-14. That is, the embodiment of FIGS. 15-20 is intended to fill an on-body syringe 200. Components of the embodiment of FIGS. 15-20 may correspond to components having the same reference numbers in FIGS. 1-14. Referring first to the embodiment shown in FIGS. 15 and 16, the embodiment of the filling station 100 includes a base 170 having a receiving surface 172 for receiving and supporting the on-body syringe 200. The base 170 has an integral or removable fluid path portion 174 that is functionally similar to the fluid path portion 146 of the embodiment described herein with respect to FIGS. 2 and 3. 15 and 16 , the fluid path portion 174 provides fluid communication between a needle 175 that penetrates a septum or port 220 of the on-body syringe 200 and a cartridge socket 176. The cartridge socket 176 is configured to support a fill cartridge 300 and provide fluid communication between the fluid path portion 174 and an internal chamber 310 of the fill cartridge 300. As shown in FIG. 16 , the cartridge socket 176 may include a needle 177 for penetrating a septum or stopper 320 of the fill cartridge 300 to access the internal chamber 310. The pump 154 ​​in the embodiment of FIGS. 15 and 16 may include a ram for driving a plunger 330 through the internal chamber 310 of the fill cartridge 300 to inject a medication contained in the internal chamber 310 of the fill cartridge 300 via the fluid path portion 174 and into the medication reservoir 210 of the on-body syringe 200.

[0052] 15 and 16, the base 170 may include a button or switch 180 that is actuated by a user to initiate a fill or refill operation once the on-body syringe 200 is connected to the base 170. Actuation of the button or switch 180 may cause the controller 400 to activate the pump 154 ​​to inject medication from the loaded cartridge 300 into the on-body syringe 200. Once the fill or refill operation is complete, the user may remove the on-body syringe from the base 170 and attach the on-body syringe 200 to a patient to administer the medication.

[0053] 17 and 18 , an embodiment of filling station 100 includes a base 180 and a lid 182 that is rotatable relative to the base. Lid 182 may be configured to receive a transfer tray 190 that has on-body syringes 200 and loaded cartridges 300 attached to it. In particular, lid 182 is configured to receive tray 190 from a front side 183 of lid 182, opposite hinge 184. A user can depress lid 182 relative to base 180 once tray 190 is attached to begin a filling or refilling operation. Tray 190 is functionally similar to tray 140 of the embodiment of FIG. 14 and includes a syringe socket 144 for receiving and supporting on-body syringes 200, a cartridge socket 142 for receiving and supporting loaded cartridges 300, and a fluid path portion 192 that provides fluid communication between cartridge socket 142 and syringe socket 144. 18 , the cartridge socket 142 may include a needle 143 for penetrating a septum or stopper 320 of the loaded cartridge 300 to provide fluid communication between the fluid path portion 192 and the internal chamber 310 of the loaded cartridge 300. Similarly, the syringe socket 144 may include a needle 145 for penetrating a septum or port 220 of the on-body syringe 200 to provide fluid communication between the fluid path portion 192 and the medication reservoir 210 of the on-body syringe 200. The pump 154 ​​in this embodiment includes a piston 158 for injecting medication from the loaded cartridge 300 into the on-body syringe 200 via the fluid path portion 192.

[0054] 19 and 20 , an embodiment of filling station 100 includes a base 185 having a drawer 186 for receiving a transfer tray 194, a first receptacle 187 for receiving an on-body syringe 200, and a second receptacle 188 for receiving a filled cartridge 300. The first receptacle 187 may be protected by a lid 189 to maintain sterility of the on-body syringe 200 during a filling or refilling operation. As shown in FIG. 20 , the transfer tray 194 is similar to the transfer tray 140 of the embodiment of FIGS. 1-14 . However, unlike the embodiment of FIGS. 1-14 , the transfer tray 194 of the embodiment of FIGS. 19-20 is loaded into the drawer 186 before connecting the on-body syringe 200 and filled cartridge 300 to the transfer tray 194. When tray 194 is installed in drawer 186, tray 194 aligns with first receptacle 187 and second receptacle 188 such that on-body syringe 200 and filled cartridge 300 can connect to tray 194 via base 185. In particular, on-body syringe 200 can be inserted via first receptacle 187 to connect to syringe socket 144 of tray 194, and filled cartridge 300 can be inserted via second receptacle 188 to connect to cartridge socket 142.

[0055] 20, the pump 154 ​​may include a peristaltic pump similar to the embodiment of FIGS. 1-14. Performance of the filling or refilling operation is also similar to that of the embodiment of FIGS. 1-14. The controller 400 activates the pump to inject medication from the loaded cartridge 300 into the on-body syringe 200. The tray 194 and loaded cartridge 300 may be disposed of after a predetermined number of uses (e.g., one use).

[0056] 21 and 22 , some embodiments of the present disclosure include an auxiliary socket 444 configured to receive an auxiliary cartridge 450. The auxiliary cartridge 450 can, in some examples, contain a reconstitutable medication, such as a lyophilized powder. FIGS. 21 and 22 schematically illustrate a transfer tray embodiment identical to that of FIG. 3 , except that it includes an auxiliary cartridge 444 and related components. The auxiliary socket 444 can include an auxiliary cartridge needle 445 configured to pierce a stopper or septum of the auxiliary cartridge 450 to establish fluid communication between the auxiliary cartridge 450 and the fluid path portion 146. The fluid path portion 146 includes at least one valve 440 for selectively providing fluid communication between the auxiliary socket 444 and the fluid path portion 146. The valve 440 is located on the opposite side of the resilient tubing 148 (which couples with the pump 154, as shown in FIG. 2 ) from the cartridge socket 142. The valve 440 moves to a first position, as shown in FIG. 21 , isolating the syringe socket 144 and providing fluid communication between the cartridge socket 142 and the auxiliary socket 144. In this position, the pump 154 ​​(see, e.g., FIG. 2 ) can be activated to inject fluid from the loading cartridge 300 attached to the cartridge socket 142 into the auxiliary cartridge 450 attached to the auxiliary socket 444. The fluid injected from the loading cartridge 300 into the auxiliary cartridge 450 can reconstitute the medication contained in the auxiliary cartridge 450 into a liquid. The resulting reconstituted medication can be pumped back and forth (by the pump 154) between the auxiliary cartridge 450 and the loading cartridge 300 to ensure complete reconstitution of the medication. The reconstituted medication can then finally be pumped into the loading cartridge 300 to fill the on-body syringe 200.

[0057] Once the entire reconstituted medication has been pumped into the loading cartridge 300, the valve 440 can be moved to a second position, as shown in FIG. 22, in which the cartridge socket 142 is in fluid communication with the syringe socket 144. Also in the second position, the auxiliary socket 444 is isolated so that the reconstituted medication cannot re-enter the auxiliary cartridge 450. In this position of the valve 440, the reconstituted medication can be pumped (by the pump 154) from the loading cartridge 300 to the on-body syringe 200 in the same manner as described with respect to FIGS. 1-9. At least one valve 440 can be automatically moved between the first position of FIG. 21 and the second position of FIG. 22 in a predetermined sequence by the controller 400 (see FIG. 2).

[0058] Embodiments of the filling station 100 described herein may be particularly suitable for filling and / or refilling on-body syringes 200. Examples of on-body syringes 200 are described in detail in U.S. Patent Application Publication No. 2006 / 0129994, the disclosure of which is incorporated herein by reference in its entirety. However, embodiments of the filling station 100 may also be adapted for use with various syringe types, including those not limited to being worn on a patient's body. Thus, embodiments of the filling station 100 described herein are not specifically limited to use with filling on-body syringes or to any particular type, brand, or model of syringe.

[0059] While the present invention has been described in detail for purposes of illustration, based on what are presently considered to be the most practical and preferred embodiments, it should be understood that such detail is for this purpose only, and that the present invention is not limited to the disclosed embodiments or aspects, but on the contrary, 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 invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. 1. A system for filling an on-body syringe, comprising: an on-body syringe having a medication reservoir; a filled cartridge having an internal chamber containing a medicament; a filling station for receiving the on-body syringe and the filling cartridge, a syringe socket for receiving the on-body syringe; a cartridge socket for receiving the filled cartridge; a fluid path portion that provides fluid communication between the syringe socket and the cartridge socket; a pump operatively engaged with the fluid pathway portion to transfer a medication from the internal chamber of the loaded cartridge to the medication reservoir of the on-body syringe; a charging station comprising: Including, the system.

2. The system of claim 1 , wherein the pump comprises one or more rollers configured to engage resilient tubing in the fluid path portion.

3. The system of claim 1 , wherein the syringe socket includes a needle for piercing a septum or port of the on-body syringe.

4. The system of claim 1 , wherein the cartridge socket comprises a needle for piercing a septum or stopper of the filled cartridge.

5. The system of claim 1 , wherein the syringe socket, the cartridge socket, and the fluid path portion are mounted on a removable transfer tray.

6. The filling station comprises: a base for receiving the transfer tray; a lid pivotally connected to the base; The system of claim 5 , comprising:

7. 10. The system of claim 1, wherein the filling station comprises an expansion chamber configured to deliver a pre-filled expansion volume of air to the on-body syringe.

8. 8. The system of claim 7, wherein the expansion volume of the pre-filled air is approximately 100 μL.

9. 10. The system of claim 1, wherein the drug reservoir of the on-body syringe has a volume of approximately 3 mL.

10. The system of claim 1 , wherein the filling station includes a controller for operating the pump.

11. 11. The system of claim 10, wherein the controller is configured to operate the pump to fill the drug reservoir of the on-body syringe to approximately 10 psi.

12. The system of claim 10 , wherein the controller is configured to operate the pump in reverse to expel air from the fluid path portion.

13. 13. The system of claim 12, wherein the filling station further comprises a check valve in a reverse configuration through which the air is discharged.

14. The filling station comprises: an auxiliary socket configured to receive an auxiliary cartridge; at least one valve movable between a first position and a second position; Furthermore, In the first position of the at least one valve, the cartridge socket is in fluid communication with the auxiliary socket and the syringe socket is isolated; The system of claim 1 , wherein in the second position of the valve, the cartridge socket is in fluid communication with the syringe socket.

15. 1. A filling station for filling on-body syringes, comprising: A removable transfer tray, a syringe socket for receiving the on-body syringe; a cartridge socket for receiving a filled cartridge; a fluid path portion providing fluid communication between the syringe socket and the cartridge socket; a pump operatively engaged with the fluid pathway portion to transfer a medication from the internal chamber of the loaded cartridge to a medication reservoir of the on-body syringe; a transfer tray comprising: Including, a filling station.

16. 16. The filling station of claim 15, wherein the pump comprises one or more rollers configured to engage a resilient tubing portion in the fluid path portion.

17. 16. The filling station of claim 15, wherein the syringe socket includes a needle for piercing a septum or port of the on-body syringe.

18. 16. The filling station of claim 15, wherein the cartridge socket includes a needle for piercing a septum or stopper of the filled cartridge.

19. The filling station comprises: a base for receiving the transfer tray; a lid pivotally connected to the base; 16. The filling station of claim 15, further comprising:

20. 16. The filling station of claim 15, further comprising an expansion chamber configured to deliver a pre-filled expansion volume of air to the on-body syringe.

21. 21. The filling station of claim 20, wherein the pre-filled expansion volume of air is about 100 μL.

22. 16. The filling station of claim 15, wherein the filling station includes a controller for operating the pump, the controller configured to operate the pump to fill the drug reservoir of the on-body syringe to approximately 10 psi.

23. 23. The filling station of claim 22, wherein the controller is configured to operate the pump in reverse to expel air from the fluid path portion.

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