Method for filling drug into a body wearable drug delivery device

Abstract

A system for filling a wearable syringe includes: a wearable syringe having a medicament reservoir; the filling cylinder is provided with an inner cavity containing a medicament; and a filling station for receiving the wearable syringe and the filling cartridge. The filling station comprises: a syringe receptacle for receiving the wearable syringe; a cartridge receptacle for receiving the filling cartridge; a fluid path section providing fluid communication between the syringe receptacle and the barrel receptacle; and a pump operatively engaged with the fluid path section to deliver medicament from the lumen of the fill cartridge to the medicament reservoir of the wearable syringe.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 409,369, filed on September 23, 2022, entitled “A Method to Provide for Drug Product Filling Into Body-Worn Drug Delivery Device,” the entire disclosure of which is incorporated herein by reference.

[0003] Background of the Invention

[0004] Field of the Invention

[0005] The present disclosure relates to a filling station for a drug delivery device and a method for filling a drug delivery device.

[0006] Description of related technologies

[0007] Wearable medical injection devices (which may be variously referred to as on-body injectors, wearable syringes, route pumps, etc.) are often used in the treatment of diseases (eg, diabetes) that require continuous infusion of medication (eg, insulin).

[0008] In the case of diabetes, wearable insulin pumps are typically designed to administer insulin at a basal rate and a bolus dose. During basal administration, insulin is continuously delivered over a predetermined time period (e.g., 24 hours) to maintain the blood glucose level of the diabetic patient within a consistent range. Compared to a single injection, basal administration can produce smaller changes in the blood glucose range and eliminates the need for multiple acupunctures within a predetermined time period. During a single bolus administration, insulin is delivered in discrete injection doses. For example, a bolus dose may be indicated when a diabetic patient is eating to balance the carbohydrates consumed.

[0009] Patch pumps are designed to be self-contained units worn by the patient and are preferably small so as not to interfere with the user's activities. Consequently, the medication capacity of a patch pump is limited and once all the medication has been administered, the patch pump must be filled / refilled by a healthcare provider.

[0010] Desirably, the patch pump is filled and / or refilled by the patient or the patient's caregiver without requiring intervention from a traditional healthcare provider. Summary of the Invention

[0011] Embodiments of the present disclosure relate to a system for filling a wearable syringe. The system includes a wearable syringe having a medicament reservoir, a filling cartridge having an inner cavity containing a medicament, and a filling station for receiving the wearable syringe and the filling cartridge. The filling station includes a syringe receptacle for receiving the wearable syringe, a cartridge receptacle for receiving the filling cartridge, a fluid path segment providing fluid communication between the syringe receptacle and the cartridge receptacle, and a pump operatively engaging the fluid path segment to transfer the medicament from the inner cavity of the filling cartridge to the medicament reservoir of the wearable syringe.

[0012] In some embodiments, the pump includes one or more rollers configured to engage the elastic tubing section of the fluid path segment.

[0013] In some embodiments, the syringe receptacle includes a needle for piercing a septum or port of the wearable syringe.

[0014] In some embodiments, the cartridge receptacle includes a needle for piercing a septum or stopper of the filling cartridge.

[0015] In some embodiments, the syringe receptacle, the barrel receptacle, and the fluid path segment are disposed on a removable transport tray.

[0016] In some embodiments, the filling station includes a base for receiving the transfer tray and a cover pivotally connected to the base.

[0017] In some embodiments, the filling station includes an inflation chamber configured to deliver a pre-fill inflation volume of air to the wearable injector.

[0018] In some embodiments, the pre-fill inflation volume of air is approximately 100 μL.

[0019] In some embodiments, the medicament reservoir of the wearable injector has a volume of about 3 mL.

[0020] In some embodiments, the filling station includes a controller for actuating the pump.

[0021] In some embodiments, the controller is configured to actuate the pump to fill the medicament reservoir of the wearable injector to approximately 10 psi.

[0022] In some embodiments, the controller is configured to operate the pump in reverse to exhaust air from the fluid path segment.

[0023] In some embodiments, the filling station further comprises a reverse check valve through which air is exhausted.

[0024] In some embodiments, the filling station further comprises: an auxiliary receptacle configured to receive an auxiliary cartridge; and at least one valve movable between a first position and a second position. In the first position of the at least one valve, the cartridge receptacle is in fluid communication with the auxiliary receptacle, and the syringe receptacle is isolated. In the second position of the valve, the cartridge receptacle is in fluid communication with the syringe receptacle.

[0025] Other embodiments of the present disclosure relate to a filling station for filling a wearable injector. The filling station includes a detachable transfer tray comprising: a syringe receptacle for receiving the wearable injector; a cartridge receptacle for receiving a filling cartridge; a fluid path segment providing fluid communication between the syringe receptacle and the cartridge receptacle; and a pump operatively engaged with the fluid path segment to transfer a medicament from an inner cavity of the filling cartridge to a medicament reservoir of the wearable injector.

[0026] In some embodiments, the pump includes one or more rollers configured to engage the elastic tubing segment of the fluid path segment.

[0027] In some embodiments, the syringe receptacle includes a needle for piercing a septum or port of the wearable syringe.

[0028] In some embodiments, the cartridge receptacle includes a needle for piercing a septum or stopper of the filling cartridge.

[0029] In some embodiments, the filling station further comprises a base for receiving the transfer tray and a cover pivotally connected to the base.

[0030] In some embodiments, the filling station further comprises an inflation chamber configured to deliver air to the wearable injector to pre-fill the inflation volume.

[0031] In some embodiments, the pre-fill inflation volume of air is approximately 100 μL.

[0032] In some embodiments, the filling station includes a controller for actuating the pump. The controller is configured to actuate the pump to fill the medicament reservoir of the wearable injector to about 10 psi.

[0033] In some embodiments, the controller is configured to operate the pump in reverse to exhaust air from the fluid path segment.

[0034] Further details and advantages of the various examples described in detail herein will become apparent upon reading the following detailed description of the various examples in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The above and other features and advantages of the present disclosure, as well as the manner in which these features and advantages are achieved, will become more apparent, and the present disclosure itself will be better understood, by referring to the following description of the embodiments of the present disclosure taken in conjunction with the accompanying drawings, in which:

[0036] Figure 1 is a perspective view of a filling station according to an embodiment of the present disclosure;

[0037] Figure 2 yes Figure 1 A schematic diagram of a conveyor tray of a filling station, the conveyor tray being loaded with a wearable syringe and a filling cartridge;

[0038] Figure 3 According to an embodiment of the present disclosure Figure 2 The fluid path diagram of the conveyor tray;

[0039] Figure 4 yes Figure 1 an exploded perspective view of a filling station in an open position, wherein a portion of the base and a portion of the lid are removed for clarity;

[0040] Figure 5 yes Figure 1 an exploded perspective view of a filling station in an open position, wherein a portion of the base and a portion of the lid are removed for clarity;

[0041] Figure 6 yes Figure 1 A perspective view of a filling station in an open position with a portion of the base and a portion of the lid removed for clarity;

[0042] Figure 7 yes Figure 1 A perspective view of a filling station in a closed position with a portion of the base and a portion of the lid removed for clarity;

[0043] Figure 8 yes Figure 1 A perspective view of a filling station in an open position with a portion of the base and a portion of the lid removed for clarity;

[0044] Figure 9 yes Figure 1 A perspective view of a filling station in an open position with a portion of the base and a portion of the lid removed for clarity;

[0045] Figure 10is an exploded perspective view of a filling station according to an embodiment of the present disclosure;

[0046] Figure 11 yes Figure 10 A perspective view of a conveyor tray;

[0047] Figure 12 yes Figure 10 A perspective view of a transfer tray in an open position;

[0048] Figure 13 yes Figure 10 A perspective view of a transfer tray in a closed position;

[0049] Figure 14 yes Figure 10 3D exploded view of the transfer tray;

[0050] Figure 15 are perspective and side views of a filling station according to an embodiment of the present disclosure;

[0051] Figure 16 yes Figure 15 A fluid path diagram of a filling station;

[0052] Figure 17 is an exploded perspective view of a filling station according to an embodiment of the present disclosure;

[0053] Figure 18 yes Figure 17 A fluid path diagram of a filling station;

[0054] Figure 19 is an exploded perspective view of a filling station according to an embodiment of the present disclosure;

[0055] Figure 20 yes Figure 17 A fluid path diagram of a filling station;

[0056] Figure 21 According to an embodiment of the present disclosure Figure 2 a fluid path diagram of a transfer tray, wherein a valve of the transfer tray is in a first position; and

[0057] Figure 22 yes Figure 21 A fluid path diagram of the embodiment in which the valve is in a second position.

[0058] Corresponding reference numerals 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

[0059] The following description is provided to enable those skilled in the art to make and use the various aspects described as contemplated for practicing the present disclosure. However, various modifications, equivalents, variations, and substitutes will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutes are intended to fall within the spirit and scope of the present disclosure.

[0060] Hereinafter, for descriptive purposes, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives shall relate to the present invention as oriented in the accompanying drawings. However, it should be understood that the present invention may employ various alternative variations unless expressly specified to the contrary. It should also be understood that the specific arrangements shown in the drawings and described in the following specification are merely exemplary aspects of the present invention. Accordingly, specific dimensions and other physical characteristics related to the various aspects disclosed herein should not be considered limiting.

[0061] All numbers used in the specification and claims are to be understood as being modified in all instances by the term "approximately." The terms "about," "approximately," and "substantially" refer to a range of plus or minus ten percent of the stated value. Additionally, the term "substantially equal" and similar terms refer to compared values ​​or dimensions being within plus or minus ten percent of each other.

[0062] The terms "first" and "second" and the like are not intended to refer to any particular order or sequence, but rather to different conditions, properties or elements.

[0063] As used herein in reference to an injection device (e.g., a syringe), the term "proximal" refers to the end of the device farthest from the outlet, or refers to a direction toward the end of the device farthest from the outlet. As used herein in reference to an injection device (e.g., a syringe), the term "distal" refers to the end of the device or apparatus closest to the outlet, or refers to a direction toward the end of the device closest to the outlet.

[0064] 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" refers to any one of A, B, or C, or any combination of two or more of A, B, or C. For example, "at least one of A, B, and C" includes one or more of only A; or one or more of only B; or one or more of only C; 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 all of A, B, and C.

[0065] First reference Figure 1 , Figure 1An 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 lid 120. The lid 120 may be pivotally connected to the base 110, for example, via a swivel hinge 130. In some embodiments, the lid 120 includes a handle 122 to assist a user in manipulating the lid 120. The base 110 and / or the lid 120 may removably support a transfer tray 140. The tray 140 includes various features for supporting and removably retaining a syringe, more particularly, a wearable syringe 200 (which may also be referred to as a patch pump hereinafter). The tray 140 also includes various features for supporting and removably retaining a filling cartridge 300 (e.g., containing a medicament) and for establishing fluid communication between the filling cartridge 300 and the medicament reservoir of the wearable syringe 200. In use, a user (typically a patient or a caregiver of the patient) loads an empty wearable syringe 200 and a filling cartridge 300 onto the tray 140. The user then inserts the tray 140 into the base 110 and / or the lid 120 of the filling station 100. The tray 140, the base 110, and / or the lid 120 include various structures and components for transferring the medicament from the filling cartridge 300 to the reservoir of the wearable injector 200. In some embodiments, the transfer of the medicament from the filling cartridge 300 to the medicament reservoir of the wearable injector 200 can occur automatically when the lid 120 is closed, as will be described herein with reference to the embodiments of the present invention. Figures 4 to 9 Discussed in more detail.

[0066] Now refer to Figure 2 and Figure 3 The wearable syringe 200 and the filling cartridge 300 can be detachably connected to the tray 140, thereby establishing a fluid path between the inner cavity 310 of the filling cartridge 300 and the drug reservoir 210 of the wearable syringe 200. The tray 140 includes a cartridge receptacle 142 for removably receiving the filling cartridge 300 and a syringe receptacle 144 for removably receiving the wearable syringe 200. The tray 140 also includes a fluid path section 146 that provides fluid communication between the cartridge receptacle 142 and the syringe receptacle 144. Figure 3 As shown, cartridge receptacle 142 may include a needle 143 for piercing a septum or stopper 320 of filling cartridge 300 to provide fluid communication between fluid path segment 146 and lumen 310 of filling cartridge 300. Similarly, syringe receptacle 144 may include a needle 145 for piercing a septum or port 220 of wearable injector 200 to provide fluid communication between fluid path segment 146 and medicament reservoir 210 of wearable injector 200. Fluid path segment 146 may include one or more fluid channels 152 molded and / or formed into substrate 150 of tray 140, and / or one or more tubing segments 148 connected to substrate 150.

[0067] Continue to refer Figure 2 , the tray 140, and / or other components of the filling station 100 include a pump 154 ​​or other components for transferring the medicament from the filling cartridge 300 to the wearable injector 200. The pump 154 ​​may be disposed in the fluid path section 146. The pump 154 ​​is controlled by an electronic controller 400 that is programmed or configured to actuate the pump 154 ​​until the filling or refilling operation has been completed and / or to abort the filling or refilling operation if an error occurs while loading or filling the wearable injector 200. Figure 2 In the illustrated embodiment, pump 154 ​​is a peristaltic pump having one or more rollers 156 configured to engage elastic tubing segment 148 of fluid path segment 146 to draw medication from filling cartridge 300 and inject medication into wearable injector 200 .

[0068] Continue to refer Figure 2 The tray 140 may also include an inflation chamber 160 configured to inject a pre-fill volume of air into the wearable injector 200 before filling the wearable injector 200 with the medicament. The pre-fill volume can be used to create a controlled volume of air in the reservoir of the wearable injector 200. The pre-fill volume can additionally or alternatively be used to occupy dead space on the reservoir of the wearable injector 200 to assist in expelling more medicament from the reservoir during the injection process (particularly when the reservoir is almost empty, near the end of the injection process). In an embodiment where the wearable injector has a reservoir volume of approximately 3 milliliters (mL), the inflation chamber 160 can be configured to inject a pre-fill volume of air of approximately 100 microliters (μL) during each syringe filling operation. The inflation chamber 160 is disposed in fluid communication with the fluid path segment 146, between the cartridge receptacle 142 and the syringe receptacle 144, such that the inflation chamber 160 supplies air to the wearable injector 200 via the fluid path segment 146. In the illustrated embodiment, the inflation chamber includes a piston 162 that moves axially to expel pressurized air from the inflation chamber 160.

[0069] Continue to refer Figure 2The tray 140 may further include a forward check valve 172 disposed in the fluid path section 146 between the wearable injector 200 and the filling cartridge 300. The forward check valve 172 prevents air and / or medication from flowing back from the wearable injector 200 into the filling cartridge 300. The tray 140 may further include a reverse check valve 174 disposed in the fluid path section 146 to allow air to escape from the wearable injector 200 via the pump 154 ​​through the fluid path section 146. The reverse check valve 174 may be disposed in a branch channel 153 of the fluid path section 146. The branch channel is arranged so that fluid can flow from the wearable injector 200 to the reverse check valve 174 without flowing into the filling cartridge 300, and so that fluid can flow from the filling cartridge 300 to the reverse check valve 174 without flowing into the wearable injector 200. In other words, wearable syringe 200 and filling cartridge 300 are in a parallel fluid circuit relative to reverse check valve 174 .

[0070] Now refer to Figures 4 to 9 , these figures illustrate the loading of a filling station 100 according to an embodiment of the present disclosure. Figure 4 , the tray 140 can be removed from the base 110 and the cover 120 (or supplied separately from the base and the cover) to allow access to the cartridge receptacle 142 and the syringe receptacle 144. Figure 4 and Figure 5 As shown, the tube socket 142 can include a port, and the filling tube 300 is connected with this port snap-fit. In other embodiments, the tube socket 142 can include a bayonet connector and threaded fittings or other fixed mechanical connectors to engage and keep the filling tube 300. The tube socket 142 can present tactile feedback (e.g., snap fit) to confirm to the user that the filling tube 300 is correctly inserted into the tube socket 142. Filling the tube 300 can be connected to the tube socket 142 so that the needle 143 of the tube socket 142 can automatically pierce the septum or stopper of the filling tube 300. Similarly, the syringe socket 144 can include a port, and the wearable syringe 200 is connected with this port snap-fit. The tube socket 142 can present tactile feedback (e.g., snap fit) to confirm to the user that the filling tube 300 is correctly inserted into the syringe socket 144. Connecting the wearable injector 200 to the syringe receptacle 144 may automatically cause the needle 145 of the syringe receptacle 144 to pierce the septum of the wearable injector 200 .

[0071] Now refer to Figure 6Once the wearable injector 200 and the filling cartridge 300 are connected to the syringe receptacle 144 and the cartridge receptacle 142, respectively, the tray 140 can be inserted into the base 110 of the filling station 100. The base 110 can include locating features (e.g., detents and / or protrusions) to ensure that the tray 140 is properly aligned with the operating components of the base 110 and / or the lid 120. For example, the tray 140 must be positioned within the base 110 so that the elastic tube segments 148 of the fluid path segments 146 are operatively aligned with and engaged with the pump 154. Similarly, the tray 140 must be positioned within the base 110 so that the inflation chamber 160 is operatively aligned with the corresponding actuation rod 124 of the lid 120, and so that the wearable injector 200 is operatively aligned with the corresponding retention rod 126 of the lid 120. In some embodiments, the base 110, lid 120, and / or tray 140 can exhibit tactile feedback (e.g., a snap fit) to confirm to the user that the tray 140 is properly inserted. In some embodiments, the base 110, lid 120, and / or tray 140 can include an electromechanical device (e.g., a limit switch) configured to prevent a filling or refilling operation from being performed if the tray 140 is not properly positioned with the base 110.

[0072] Now refer to Figure 7 Once the tray 140 is properly positioned within the base 110, the user can close the lid 120 to begin the filling or refilling operation. Closing the lid 120 causes the retaining rod 126, which can be integrally formed with the lid 120, to engage the wearable syringe 200 to prevent movement of the wearable syringe 200 during the filling or refilling operation. Closing the lid 120 also causes the actuating rod 124, which can be integrally formed with the lid 120, to engage the inflation chamber 160, thereby injecting a pre-filled inflation volume of air into the medicament reservoir 210 of the wearable syringe 200. The retaining rod 126 and the actuating rod 124 can be timed so that during closing of the lid 120, the retaining rod 126 first engages the wearable syringe 200, followed by the actuating rod 124 engaging the inflation chamber 160, so that the wearable syringe 200 is fully supported by the retaining rod 126 before the pre-filled inflation volume of air is delivered.

[0073] Once the lid 120 is closed, Figure 7 As shown, the filling or refilling operation can be started. The filling station 100 can include one or more sensors (not shown) configured to detect the closing of the lid 120 and cause the controller 400 to start performing the filling or refilling operation. During the filling or refilling operation, as combined with Figure 7As described above, air is delivered to the pre-filled inflation volume of the wearable injector 200. The controller 400 can initially actuate the pump 154 ​​in the reverse direction for a predetermined time to expel air from the wearable injector 200 and the fluid path section 146 of the tray 140. After the predetermined time, the controller can actuate the pump 154 ​​in the forward direction to extract the medicament from the lumen 310 of the filling cartridge 300 and inject the medicament into the medicament reservoir 210 of the wearable injector 200. The controller 400 can actuate the pump 154 ​​until the medicament reservoir 210 is filled to a predetermined pressure, such as approximately 10 psi. Filling of the wearable injector 200 is then complete, and the controller stops actuating the pump 154. The pump 154 ​​can be controlled by the controller throughout the entire filling or refilling operation. In some embodiments, the controller can be configured to emit sensory feedback (e.g., illuminate a light or emit a sound) to indicate to the user that the wearable injector 200 has been filled.

[0074] Now refer to Figure 8 Once the filling of the wearable syringe 200 is completed, the cap 120 can be opened automatically by the controller or manually by the user. Opening the cap 120 releases the retaining rod 126 from the wearable syringe 200 and releases the actuating rod 124 from the inflation chamber 160. If the user opens the cap 120 before the filling or refilling operation is completed, the controller can also pause the operation of the pump 154 ​​as a safety measure to stop further filling of the wearable syringe 200. With the retaining rod 126 and the actuating rod 124 detached from the wearable syringe 200 and the inflation chamber 160, respectively, the tray 140 can be removed from the base 110, as shown. Figure 9 As shown. The wearable injector 200 and filling cartridge 300 can then be removed from the tray 140, and the wearable injector 20 can be attached to the patient and used as if the wearable injector 200 had been filled by a healthcare provider. In some embodiments, the filling cartridge 300 can contain enough medicament to fill multiple wearable injectors 200, in which case the filling cartridge 300 can be removed from the tray 140 and stored for future filling or refilling operations. In some embodiments, the filling cartridge 300 only contains enough medicament to perform a single filling or refilling operation, so the filling cartridge 300 can be disposed of after the filling or refilling operation. In some embodiments, the tray 140 can also be disposable and can be replaced after each filling or refilling operation or after a predetermined number of filling or refilling operations.

[0075] Now refer to Figures 10 to 14, the method or process of filling or refilling the wearable injector 200 is shown from the perspective of a user (e.g., a patient or a patient's caregiver) operating the filling station 100. Figure 10 As shown, the user first obtains the tray 140, the wearable syringe 200, and the filling cartridge 300. One or more of the tray 140, the wearable syringe 200, and the filling cartridge 300 may be disposable components supplied in separate packaging. For example, the tray 140 may be supplied in the tray packaging 149, and the wearable syringe 200 may be supplied in the syringe packaging 290. The user may remove the tray 140, the wearable syringe 200, and the filling cartridge 300 from any associated packaging and then, as shown, Figure 11 As shown, users can combine Figure 4 and Figure 5 The wearable syringe 200 and the filling cartridge 300 are loaded onto the tray 140 in the manner described. Figure 12 As shown, the user can open the cover 120 of the filling station 100 and insert the tray 140 loaded with the wearable syringe 200 and the filling cartridge 300 into the base 120. Figure 13 As shown, the user can close the lid 120 and begin performing a filling or refilling operation, as described herein in conjunction with Figures 6 to 8 As described. Figure 14 As shown, after a filling or refilling operation has been performed, the user can open the lid 120 (or, in some embodiments, the lid 120 can be automatically opened by the controller) and the user can remove the tray 140 loaded with the wearable injector 200 and the filling cartridge 300. The user can then remove the wearable injector 200 from the tray 140 and continue attaching the wearable injector 200 to a patient to administer a medicament from the wearable injector 200. The user can also dispose of the tray 140 and / or the filling cartridge 300 if the components of the tray 140 and / or the filling cartridge 300 have reached the end of their useful life. As described herein, the tray 140 and / or the filling cartridge 300 can be disposable components configured for use for a predetermined number of filling operations (e.g., one), and for hygienic reasons, the tray 140 and / or the filling cartridge 300 should be discarded after the predetermined number of filling operations (e.g., one).

[0076] Now refer to Figures 15 to 20 , these figures show an alternative embodiment of a filling station 100 . Figures 15 to 20 The embodiment of the filling station 100 shown in FIG. 1 may be implemented in combination with Figures 1 to 14 The embodiments described above operate on the same principles and purposes. Figures 15 to 20 The embodiment is intended for use in filling a wearable injector 200 . Figures 15 to 20 The components of the embodiment may correspond to Figures 1 to 14Parts with the same reference numerals in FIG. Figure 15 and Figure 16 In the embodiment shown, the embodiment of the filling station 100 includes a base 170 having a receiving surface 172 for receiving and supporting the wearable injector 200. The base 170 has an integrated or removable fluid path section 174 that functions similarly to the fluid path section described herein. Figure 2 and Figure 3 The functionality of the fluid path segment 146 of the described embodiment.

[0077] Continue to refer Figure 15 and Figure 16 , the fluid path segment 174 provides fluid communication between the needle 175 that pierces the septum or port 220 of the wearable syringe 200 and the cartridge receptacle 176. The cartridge receptacle 176 is configured to support the filling cartridge 300 and provide fluid communication between the fluid path segment 174 and the inner cavity 310 of the filling cartridge 300. Figure 16 As shown, cartridge receptacle 176 may include a needle 177 for piercing a septum or stopper 320 of filling cartridge 300 to access lumen 310 . Figure 15 and Figure 16 The pump 154 ​​in the embodiment may include a ram for driving the plunger 330 through the inner cavity 310 of the filling barrel 300 to inject the medicament contained in the inner cavity 310 of the filling barrel 300 into the medicament reservoir 210 of the wearable injector 200 via the fluid path segment 174.

[0078] Continue to refer Figure 15 and Figure 16 The base 170 may include a button or switch 180 that a user may actuate to initiate a filling or refilling operation once the wearable injector 200 has been connected to the base 170. Actuation of the button or switch 180 may cause the controller 400 to actuate the pump 154 ​​to inject the medication from the filling or refilling cartridge 300 into the wearable injector 200. Once the filling or refilling operation is complete, the user may remove the wearable injector from the base 170 and attach the wearable injector 200 to a patient to administer the medication.

[0079] Now refer to Figure 17 and Figure 18, an embodiment of the filling station 100 includes a base 180 and a cover 182 rotatable relative to the base. The cover 182 can be configured to receive a transfer tray 190 loaded with wearable syringes 200 and filling cartridges 300. In particular, the cover 182 is configured to receive the tray 190 from a front side 183 of the cover 182 opposite the hinge 184. Once the tray 190 has been loaded, the user can press the cover 182 into the base 180 to initiate a filling or refilling operation. The tray 190 is functionally similar to Figure 14 The tray 140 of the embodiment includes a syringe receptacle 144 for receiving and supporting the wearable syringe 200, a cartridge receptacle 142 for receiving and supporting the filling cartridge 300, and a fluid path section 192 for providing fluid communication between the cartridge receptacle 142 and the syringe receptacle 144. Figure 18 As shown, cartridge receptacle 142 may include a needle 143 for piercing a septum or stopper 320 of filling cartridge 300 to provide fluid communication between fluid path segment 192 and lumen 310 of filling cartridge 300. Similarly, syringe receptacle 144 may include a needle 145 for piercing a septum or port 220 of wearable syringe 200 to provide fluid communication between fluid path segment 192 and medicament reservoir 210 of wearable syringe 200. Pump 154 ​​in this embodiment includes a piston 158 for injecting medicament from filling cartridge 300 into wearable syringe 200 via fluid path segment 192.

[0080] Now refer to Figure 19 and Figure 20 , an embodiment of the filling station 100 includes a base 185 having a drawer 186 for receiving a transfer tray 194, a first container 187 for receiving a wearable syringe 200, and a second container 188 for receiving a filling cartridge 300. The first container 187 can be covered by a cover 189 to maintain the sterility of the wearable syringe 200 during the filling or refilling operation. Figure 20 As shown, the transfer tray 194 is similar to Figures 1 to 14 However, unlike the conveyor tray 140 of the embodiment Figures 1 to 14 Unlike the embodiment of the present invention, before connecting the wearable syringe 200 and the filling cylinder 300 to the transfer tray 194, Figures 19 to 20The transfer tray 194 of the embodiment of the present invention is loaded into the drawer 186. When the transfer tray 194 is loaded into the drawer 186, the transfer tray 194 is aligned with the first container 187 and the second container 188 so that the wearable syringe 200 and the filling cartridge 300 can be connected to the transfer tray 194 through the base 185. In particular, the wearable syringe 200 can be inserted through the first container 187 to connect to the syringe receptacle 144 of the tray 194, and the filling cartridge 300 can be inserted through the second container 188 to connect to the cartridge receptacle 142.

[0081] Continue to refer Figure 20 , similar to Figures 1 to 14 In an embodiment, the pump 154 ​​may include a peristaltic pump. The filling or refilling operation is also performed similarly to Figures 1 to 14 The filling or refilling operation of the embodiment of FIG. 4 is performed in which the controller 400 actuates the pump to inject the medicament from the filling cartridge 300 into the wearable injector 200. The tray 194 and the filling cartridge 300 can be discarded after a predetermined number of uses (e.g., one use).

[0082] Now refer to Figure 21 and Figure 22 Some embodiments of the present disclosure include an auxiliary receptacle 444 configured to receive an auxiliary cartridge 450. In some examples, the auxiliary cartridge 450 may contain a reconstitutable drug, such as a lyophilized powder. Figure 21 and 22 Schematically shows the same as the auxiliary cylinder 444 and related parts. Figure 3 The auxiliary socket 444 may include an auxiliary cylinder needle 445 configured to pierce a stopper or septum of the auxiliary cylinder 450 to establish fluid communication between the auxiliary cylinder 450 and the fluid path segment 146. The fluid path segment 146 includes at least one valve 440 for selectively providing fluid communication between the auxiliary socket 444 and the fluid path segment 146. The valve 440 is located in the elastic tube segment 148 (such as Figure 2 As shown, the elastic tube section is connected to the pump 154 ​​on the side opposite to the cartridge receptacle 142. Figure 21 As shown, the valve 440 can be moved to a first position to provide fluid communication between the cartridge receptacle 142 and the auxiliary receptacle 144 while isolating the syringe receptacle 144. In this position, the pump 154 ​​(e.g., see Figure 2) can be actuated to pump fluid from the filling cartridge 300 attached to the cartridge receptacle 142 into the auxiliary cartridge 450 attached to the auxiliary receptacle 444. The fluid pumped from the filling cartridge 300 into the auxiliary cartridge 450 can reconstitute the drug contained in the auxiliary cartridge 450. The resulting reconstituted drug can be pumped back and forth between the auxiliary cartridge 450 and the filling cartridge 300 (via the pump 154) to ensure complete reconstitution of the drug. The fully reconstituted drug is then pumped into the filling cartridge 300 a final time to be filled into the wearable injector 200.

[0083] Once the fully reconstituted drug has been pumped into the filling cartridge 300, the valve 440 may be moved to the second position, such as Figure 22 As shown, in this position, the cartridge receptacle 142 is in fluid communication with the syringe receptacle 144. Still in the second position, the auxiliary receptacle 444 is isolated so that the reconstituted drug cannot re-enter the auxiliary cartridge 450. In this position of the valve 440, the valve 440 can be operated in accordance with the method described in conjunction with the Figures 1 to 9 The reconstituted drug is pumped from the filling cartridge 300 to the wearable injector 200 (via pump 154) in the same manner as described above. At least one valve 440 may be controlled by the controller 400 (see Figure 2 ) automatically in a predetermined order Figure 21 The first position of Figure 22 to move between the second positions.

[0084] The embodiments of the filling station 100 described herein may be particularly suitable for filling and / or refilling a wearable syringe 200. An example of a wearable syringe 200 is described in detail in U.S. Patent Application Publication No. 2020 / 0155755, the entire disclosure of which is incorporated herein by reference. However, embodiments of the filling station 100 may also be suitable for use with various types of syringes, including but not limited to syringes worn on a patient's body. Therefore, the embodiments of the filling station 100 described herein are not specifically limited to use when filling a wearable syringe, nor are they limited to any particular type, brand, or model of syringe.

[0085] Although 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 intended for that purpose only and that the invention is not limited to the disclosed embodiments, but rather 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 may be combined with one or more features of any other embodiment.

Claims

1. A system for filling a wearable syringe, the system comprising: The wearable injector has a drug reservoir; a filling cartridge having an inner cavity containing a medicament; A filling station, the filling station is used to receive the wearable syringe and the filling cylinder, the filling station comprising: a syringe socket, the syringe socket being used to receive the wearable syringe; a cartridge receptacle for receiving the filling cartridge; a fluid path segment providing fluid communication between the syringe receptacle and the barrel receptacle; and A pump operatively engages the fluid path segment to transfer the medicament from the lumen of the filling cartridge to the medicament reservoir of the wearable injector.

2. The system according to claim 1, wherein: The pump includes one or more rollers configured to engage the elastic tube section of the fluid path segment.

3. The system according to claim 1, wherein: The syringe receptacle includes a needle for piercing a septum or port of the wearable syringe.

4. The system according to claim 1, wherein: The cartridge receptacle includes a needle for piercing a septum or stopper of the filling cartridge.

5. The system according to claim 1, wherein: The syringe receptacle, the cartridge receptacle, and the fluid path segments are disposed on a removable transport tray.

6. The system according to claim 5, wherein: The filling station comprises: a base for receiving the transport tray; and A cover is pivotally connected to the base.

7. The system according to claim 1, wherein: The filling station includes an inflation chamber configured to deliver a pre-fill inflation volume of air to the wearable injector.

8. The system according to claim 7, wherein: The pre-fill inflation volume of air was approximately 100 μL.

9. The system according to claim 1, wherein: The drug reservoir of the wearable injector has a volume of about 3 mL.

10. The system according to claim 1, wherein: The filling station includes a controller for actuating the pump.

11. The system according to claim 10, wherein: The controller is configured to actuate the pump to fill the medicament reservoir of the wearable injector to approximately 10 psi.

12. The system according to claim 10, wherein: The controller is configured to operate the pump in reverse to exhaust air from the fluid path segment.

13. The system according to claim 12, wherein: The filling station also includes a reverse check valve through which air is exhausted.

14. The system of claim 1, wherein: The filling station also includes: an auxiliary receptacle 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 receptacle is in fluid communication with the auxiliary receptacle and the syringe receptacle is isolated, and wherein in the second position of the valve, the cartridge receptacle is in fluid communication with the syringe receptacle.

15. A filling station for filling a wearable syringe, the filling station comprising: A detachable conveying tray, the detachable conveying tray comprising: a syringe socket, the syringe socket being used to receive the wearable syringe; a cartridge receptacle for receiving a filling cartridge; a fluid path segment providing fluid communication between the syringe receptacle and the barrel receptacle; and A pump operatively engages the fluid path segment to transfer medicament from the lumen of the filling cartridge to a medicament reservoir of the wearable injector.

16. A filling station according to claim 15, wherein The pump includes one or more rollers configured to engage the elastic tube section of the fluid path segment.

17. The filling station of claim 15, wherein: The syringe receptacle includes a needle for piercing a septum or port of the wearable syringe.

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

19. The filling station of claim 15, further comprising: a base for receiving the transport tray; as well as A cover is pivotally connected to the base.

20. The filling station of claim 15, further comprising an inflation chamber configured to transfer air to a pre-fill inflation volume to the wearable injector.

21. A filling station according to claim 20, wherein The pre-fill inflation volume of air was approximately 100 μL.

22. The filling station of claim 15, wherein: The filling station includes a controller for actuating the pump, wherein the controller is configured to actuate the pump to fill the medicament reservoir of the wearable injector to approximately 10 psi.

23. A filling station according to claim 22, wherein The controller is configured to operate the pump in reverse to exhaust air from the fluid path segment.

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