Integrated inserter / applicator for a drug delivery system providing multiple wearing configurations

Abstract

An applicator assembly for use with a drug infusion system having multiple wearing configurations, including a tethered configuration and a patch configuration. The applicator assembly can be a multifunctional device configured to (1) selectively apply an infusion head and / or a holder to a patient's skin, and (2) insert an injection device of the infusion head into the patient's skin. The drug infusion system can be interchangeably worn by placing the drug delivery device in fluid communication with the infusion head via an intermediate tubing set to wear in the tethered configuration, or by coupling the drug delivery device to the holder and placing the drug delivery device in fluid communication with the infusion head without the intermediate tubing set to wear in the patch configuration.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 822,318, filed March 22, 2019, the disclosure of which is hereby expressly incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates to drug infusion systems, and more particularly to applicator assemblies for use with drug infusion systems having multiple wearing configurations, and to methods of using the drug infusion system. Background Technology

[0004] Drug infusion systems include a drug delivery device (e.g., a pump) configured to store a drug (e.g., insulin) and deliver it to a patient's skin via an infusion head. Some drug infusion systems can be used in a tethered configuration, where the infusion head is adhered to the patient's skin, the drug delivery device is located at a remote location away from the patient's skin, such as in a pouch, pocket, or container, and an intermediate tubing assembly is connected between them. Other drug infusion systems can be used in a patch (i.e., wearable) configuration, where both the infusion head and the drug delivery device are adhered to the patient's skin, without an intermediate tubing assembly. Manufacturers typically supply devices that can only be used in one of these configurations; therefore, patients generally do not have the option to switch from one configuration to another. Summary of the Invention

[0005] This disclosure provides an applicator assembly for use with a drug infusion system having various wearing configurations, including a tethered configuration and a patch configuration. The applicator assembly can be a multifunctional device configured to (1) selectively apply an infusion head and / or retainer to a patient's skin, and (2) insert the injection device of the infusion head into the patient's skin. The drug infusion system can be worn interchangeably by placing the drug delivery device in fluid communication with the infusion head via an intermediate tubing assembly for a tethered configuration, or by coupling the drug delivery device to a retainer and placing the drug delivery device in fluid communication with the infusion head without an intermediate tubing assembly for a patch configuration.

[0006] According to one embodiment of the present disclosure, an applicator assembly is disclosed configured for use with a medication infusion system including a medication delivery device, the medication infusion system having a tethered configuration and a patch configuration. The applicator assembly includes an infusion head having a first adhesive pad and an injection device, a holder having a second adhesive pad, the holder configured to support the medication delivery device, a housing configured to carry the infusion head and the holder, and an actuator coupled to the housing and configured to move the injection device from the housing into a patient's skin.

[0007] According to another embodiment of the present disclosure, a medication infusion system is disclosed including a medication delivery device, an infusion head having an injection device, a holder configured to support the medication delivery device, and an applicator assembly including a housing configured to carry the infusion head and the holder and an actuator coupled to the housing and configured to move the injection device from the housing into a patient's skin. The medication infusion system has a tethered configuration in which the applicator assembly positions the infusion head in adhesive communication with the patient's skin while preventing adhesive communication between the holder and the patient's skin, and a patch configuration in which the applicator assembly positions the infusion head and the holder in adhesive communication with the patient's skin.

[0008] According to yet another embodiment of the present disclosure, a method for using a medication infusion system is disclosed, the method including the steps of obtaining an applicator assembly including a housing, an infusion head having a first adhesive pad and an injection device, and a holder having a second adhesive pad, preparing the applicator assembly by selectively hiding or exposing the second adhesive pad of the holder, applying the applicator assembly to a patient's skin, the holder adhering to the patient's skin during the applying step if the second adhesive pad was exposed during the preparing step, actuating the applicator assembly to adhere the first adhesive pad of the infusion head to the patient's skin and to insert the injection device into the patient's skin, and detaching the applicator assembly from the patient's skin, the holder detaching from the patient's skin during the detaching step if the second adhesive pad was hidden during the preparing step. BRIEF DESCRIPTION OF DRAWINGS

[0009] The above mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and will be better understood by reference to the following description of embodiments of the application taken in conjunction with the accompanying drawings, wherein:

[0010] Figure 1 is an exploded perspective view of an exemplary medication infusion system of the present disclosure including a medication delivery device, an optional tubing set, an infusion head, and a holder;

[0011] Figure 2yes Figure 1 A perspective view of a drug delivery device;

[0012] Figure 3 yes Figure 1 A perspective view of the pipe assembly;

[0013] Figure 4 yes Figure 1 A perspective view of a drug infusion system arranged with a tethered structure of tubing assemblies;

[0014] Figure 5 yes Figure 1 A perspective view of a drug infusion system arranged in a patch configuration without tubing assemblies;

[0015] Figure 6 This is a bottom perspective view of a first exemplary applicator component of this disclosure, the applicator component being configured for use with... Figure 1 The first applicator assembly is shown in a ready state when used with a drug infusion system;

[0016] Figure 7 It is shown in the applied state. Figure 6 A cross-sectional view of the first applicator component;

[0017] Figure 8 It is shown in insert mode. Figure 6 A cross-sectional view of the first applicator component;

[0018] Figure 9 It is shown in a retracted state. Figure 6 A cross-sectional view of the first applicator component;

[0019] Figure 10 It is shown in a separated state. Figure 6 A cross-sectional view of the first applicator component;

[0020] Figure 11 It is shown in the second preparation state. Figure 6 A cross-sectional view of the first applicator component;

[0021] Figure 12 It is shown in the second applied state. Figure 6 A cross-sectional view of the first applicator component;

[0022] Figure 13 It is shown in the second separation state. Figure 6 A cross-sectional view of the first applicator component;

[0023] Figure 14 This is an exploded perspective view of a second exemplary applicator component of this disclosure, the applicator component being configured for use with... Figure 1 Used together with a drug infusion system;

[0024] Figure 15 is shown in a fully locked, ready-to-apply state Figure 14 is a cross-sectional view of the second applicator assembly of

[0025] Figure 16 is shown in a partially locked, applied state Figure 14 is a cross-sectional view of the second applicator assembly of

[0026] Figure 17 is shown in an unlocked, inserted state Figure 14 is a cross-sectional view of the second applicator assembly of

[0027] Figure 18 is shown in a relocked, detached state Figure 14 is a cross-sectional view of the second applicator assembly of

[0028] Corresponding reference characters indicate corresponding parts throughout the several views. The examples set forth herein illustrate exemplary embodiments of the application and such examples DETAILED DESCRIPTION

[0029] 1. Drug infusion system

[0030] Figure 1 An exemplary drug infusion system 100 of the present disclosure is shown for delivering a drug (not shown) into the skin S of a patient. The drug infusion system 100 includes a drug delivery device 110, an optional tubing set 120, an infusion head 130 configured for placement on the skin S of a patient, and an optional retainer 140 also configured for placement against the skin S of a patient. Each element of the drug infusion system 100 is described further below.

[0031] The drug delivery device 110 is configured to store and deliver the drug to the infusion head 130, either indirectly via the tubing set 120 or directly without the tubing set 120. The drug delivery device 110 is also described in more detail below. Figure 2The drug delivery device 110 can be a pump, a bolus injector, an auto-injector, an injection pen, or another suitable drug delivery device. The drug delivery device 110 can be controlled by an in-built control device (e.g., a touch screen, buttons), or by a wireless control device (e.g., a patient's smartphone). In certain embodiments, a set of multiple drug delivery devices 110 can be provided within the drug infusion system 100, where each drug delivery device 110 contains a different volume of a drug, such as 1 mL to 20 mL or more.

[0032] The drug of the drug delivery device 110 can include one or more therapeutic agents, including but not limited to insulin, insulin analogs (e.g., insulin lispro, insulin glargine), insulin derivatives, GLP-1 receptor agonists (e.g., dulaglutide, liraglutide), glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies, and any other therapeutic agent capable of being delivered by the drug delivery device 110. The drug can be formulated with one or more excipients.

[0033] The optional tubing set 120 is also shown in Figure 3 and illustratively includes a first connector 122 (e.g., a female coupling) configured to selectively couple to the drug delivery device 110, a first septum port 123 in selective fluid communication with the drug delivery device 110, a flexible tubing set tube 124, a second connector 126 (e.g., a male coupling) configured to selectively couple to the infusion set 130, and a second needle port 127 in selective fluid communication with the infusion set 130. The tubing set 120 is configured to deliver a drug from the first septum port 123, through the tubing set tube 124, and through the second needle port 127.

[0034] The infusion set 130 illustratively includes a first adhesive pad 132 configured to adhere the infusion set 130 to the skin S of a patient, a cannula 136 or injection device in the form of a needle configured for insertion into the skin S of a patient, and a connector 138 (e.g., a female coupling) configured to selectively couple to the drug delivery device 110 or the tubing set 120. The first adhesive pad 132 can define an outer perimeter of the infusion set 130. The infusion set 130 also includes at least one septum port 139 in selective fluid communication with the needle port 114 of the drug delivery device 110 or the needle port 127 of the tubing set 120. In use, a drug is directed through the septum port 139, through the cannula 136, and into the subcutaneous tissue of the skin S of a patient.

[0035] The optional holder 140 illustratively includes a second adhesive pad 142 configured to adhere the holder 140 to the patient's skin S, a removable backing 144 configured to selectively cover and expose the second adhesive pad 142, and a connector 146 (e.g., clip) configured to selectively mate with the drug delivery device 110. The connector 146 can have a rounded edge 148 to facilitate coupling with the drug delivery device 110. The second adhesive pad 142 can define an outer perimeter of the holder 140.

[0036] The drug infusion system 100 can be used interchangeably in at least two different wear configurations, including a tethered configuration with the tubing set 120 as shown in Figure 4 and a patch (i.e., wearable) configuration without the tubing set 120 as shown in Figure 5 To enable this interchangeability, the first connector 122 of the tubing set 120 can be the same or similar to the connector 138 of the infusion set 130, and the second connector 126 of the tubing set 120 can be the same or similar to the connector 112 of the drug delivery device 110, as shown in Figures 1-3 However, these connections can be adjusted based on available space and desired coupling actions (e.g., top load, side load, and angled load). Advantageously, these wear configurations can be adjusted without interfering with the insertion cannula 136 of the infusion set 130. These illustrative wear configurations are further described below, but other wear configurations are within the scope of the present disclosure.

[0037] In the tethered configuration of Figure 4 , the infusion set 130 is adhered to the patient's skin S, while the drug delivery device 110 is located in a remote location away from the patient's skin S, such as a pocket, a pouch, or a container. The tubing set 120 is positioned in fluid communication between the tethered drug delivery device 110 and the infusion set 130, such that the tethered drug delivery device 110 delivers the drug through the tubing set 120 and subsequently to the infusion set 130 for delivery to the patient. In this arrangement, the connector 112 of the drug delivery device 110 ( Figure 2 ) mates with the first connector 122 of the tubing set 120 ( Figure 1 ), and the second connector 126 of the tubing set 120 mates with the connector 138 of the infusion set 130. Further, the needle port 114 of the drug delivery device 110 ( Figure 2 ) pierces the first septum port 123 of the tubing set 120, and the second needle port 127 of the tubing set 120 pierces the septum port 139 of the infusion set 130 ( Figure 1A small compression spring (not shown) can be provided around the needle port 114 of the drug delivery device 110 and / or the second needle port 127 of the tubing set 120 to facilitate disengagement from the corresponding septum port 123, 139. This can be consistent with drug delivery devices 110 that contain a large amount of drug when the drug delivery device 110 is relatively large and heavy (e.g., approximately 3.5 oz or more) and patients can prefer to use the drug infusion system 100 in the tethered configuration.

[0038] Although not shown in Figure 4 , the retainer 140 can optionally be adhered to the skin S of the patient in a tethered configuration. In certain embodiments, the retainer 140 can be avoided or omitted in the tethered configuration. In other embodiments, the retainer 140 can interact with (e.g., grip) the tubing set 120 to provide strain relief for the tubing set 120.

[0039] In the patch configuration of Figure 5 , both the infusion head 130 and the retainer 140 are adhered to the skin S of the patient. The drug delivery device 110 is coupled to the retainer 140 such that the drug delivery device 110 is supported on the skin S of the patient. The drug delivery device 110 is also arranged in direct fluid communication with the infusion head 130 such that the drug delivery device 110 delivers drug directly to the infusion head 130 for delivery to the patient. In this arrangement, the connector 112 of the drug delivery device 110 ( Figure 2 ) directly mates with the connector 138 of the infusion head 130. In addition, the needle port 114 of the drug delivery device 110 ( Figure 2 ) directly punctures the septum port 139 of the infusion head 130 ( Figure 1 ). As noted above, a small compression spring (not shown) can be provided around the needle port 114 of the drug delivery device 110 to facilitate disengagement from the corresponding septum port 139. This can be consistent with drug delivery devices 110 that contain a small amount of drug when the drug delivery device 110 is relatively small and light (e.g., less than approximately 3.5 oz, less than approximately 1.75 oz, etc.) and patients can prefer to use the drug infusion system 100 in the patch configuration.

[0040] As described above, the coupling action of the drug delivery device 110 with the infusion head 130 and the retainer 140 may vary in the patch configuration. In a top-loading embodiment, the drug delivery device 110 may be coupled to the infusion head 130 and the retainer 140 in a direction substantially perpendicular to the skin S. In an angled-loading embodiment, the drug delivery device 110 may be coupled to the infusion head 130 and the retainer 140 via a tilt-in method. For example, one end of the drug delivery device 110 may hook onto the retainer 140, while the other end of the drug delivery device 110 may pivot onto the infusion head 130. In a side-loading embodiment, the drug delivery device 110 may be coupled to the infusion head 130 and the retainer 140 in a direction substantially parallel to the skin S. For example, the drug delivery device 110 may slide on the retainer 140 and then lock into place on the infusion head 130. The rounded edge 148 on connector 146 facilitates this coupling action by allowing the drug delivery device 110 to pivot relative to connector 146 during alignment with infusion head 130.

[0041] In patch construction, Figure 3 The tubing assembly 120 can be stored. In some embodiments, the tubing assembly 120 can be stored in a closed-loop manner, wherein a first connector 122 of the tubing assembly 120 is coupled to a second connector 126 of the tubing assembly 120. In this arrangement, the second needle port 127 of the tubing assembly 120 pierces the diaphragm port 123 of the tubing assembly 120, thereby protecting the second needle port 127 without the need for a separate needle shield, preventing undesirable contact with the second needle port 127, and sealing any pharmaceutical product retained within the tubing assembly 120. As mentioned above, a small compression spring (not shown) may be provided around the second needle port 127 of the tubing assembly 120 to facilitate separation from the corresponding diaphragm port 123.

[0042] 2. First Applicator Component

[0043] Next reference Figures 6-13 It provides a way to interact with Figures 1-5 A first exemplary applicator assembly 200 is used in conjunction with a drug infusion system 100. The applicator assembly 200 may be supplied with the drug infusion system 100 and is considered part of the drug infusion system 100. The applicator assembly 200 may be a multifunctional device configured to (1) selectively apply an infusion head 130 and / or a retainer 140 to a patient's skin S and (2) insert a cannula 136 of the infusion head 130 into the patient's skin S.

[0044] An exemplary applicator assembly 200 includes a housing 210 configured to carry an infusion head 130 and a retainer 140 in a predetermined arrangement. For example, this predetermined arrangement may correspond to... Figure 5The patch construction. The housing 210 can be sized to surround both the first adhesive pad 132 of the infusion head 130 and the second adhesive pad 142 of the retainer 140, as... Figure 6 As shown in the diagram. In some embodiments, housing 210 may include one or more release features, such as... Figure 13 An opening 212 and / or an actuable release mechanism (not shown) facilitate separation of the infusion head 130 and / or retainer 140 from the housing 210. (See below for details.) Figure 13 The opening 212 is described in more detail. The housing 210 may also include one or more snap-fit ​​arms 213, which engage below. Figure 9 To describe in more detail.

[0045] The exemplary applicator assembly 200 also includes an inserter subassembly 220 configured to insert the cannula 136 of the infusion head 130 into the patient's skin S. The inserter subassembly 220 includes an actuator 222 (e.g., a button), a rotation link 223, and an inserter hub 224 that carries the inserter needle 226. Although the exemplary inserter subassembly 220 controls both insertion and retraction of the inserter hub 224 via the same actuator 222, separate actuators for automatic and / or manual insertion and / or retraction of the inserter hub 224 are also within the scope of this disclosure.

[0046] The exemplary applicator assembly 200 also includes an optional alignment guide 230, which is supported on top of the infusion head 130 within the housing 210. The alignment guide 230 is shaped to fit the infusion head 130 to prevent lateral or rotational movement between them.

[0047] We will continue to refer to this. Figures 6-13 An exemplary method of using the applicator component 200 is described below. This method can be performed by a patient and / or the patient's caregiver, referred to as the "user". The applicator component 200 may have an ergonomic shape and be sized to be received in the user's hand throughout the method.

[0048] exist Figure 6 In the diagram, the applicator assembly 200 is shown in a ready state during a preparation step. During this preparation step, the user prepares the drug infusion system 100 for use in the desired wearing configuration. This is to accommodate the tethered structure ( Figure 4 The user can choose to apply the infusion head 130 only to the patient's skin S, by ensuring that the first adhesive pad 132 of the infusion head 130 is exposed while the backing 144 remains on the second adhesive pad 142 of the retainer 140, as shown. Figure 6 As shown. On the other hand, in order to accommodate patch construction ( Figure 5), the user can choose to apply both the infusion head 130 and the holder 140 to the patient's skin S by ensuring that both the first and second adhesive pads 132, 142 are exposed, which can involve removing the backing 144 from the second adhesive pad 142. In this ready state, the infusion head 130 and the holder 140, along with their first and second adhesive pads 132, 142, can be carried by the housing 210, as shown in Figure 6 .

[0049] In Figure 7 , the applicator assembly 200 is shown in an applied state during an application step. During this application step, the user positions the applicator assembly 200 in contact with the patient's skin S. If the user chooses not to attach the holder 140 to the skin S, the backing 144 will be retained to conceal the second adhesive pad 142 and prevent contact with the skin S, as shown in Figure 7 . On the other hand, if the user chooses to attach the holder 140 to the patient's skin S, the second adhesive pad 142 will be exposed to contact and adhere to the skin S. In this applied state, the cannula 136 of the infusion head 130 can be retracted above the holder 140 in the housing 210 to avoid premature contact with the patient's skin S, as shown in Figure 7 .

[0050] In Figure 8 , the applicator assembly 200 is shown in an inserted state during an insertion step. During this insertion step, the user presses inward on the actuator 222, which rotates the rotating link 223 and drives the introducer hub 224, the alignment guide 230, and the infusion head 130 down past the snap arms 213 of the housing 210 toward the patient's skin S. This downward movement causes the introducer needle 226 to pierce the patient's skin S and allow the cannula 136 to enter the puncture site. The infusion head 130 moves from its retracted position in Figure 7 to alignment with the holder 140 for mutual contact with the patient's skin S, and the exposed first adhesive pad 132 of the infusion head 130 contacts and adheres to the patient's skin S. Although the injection device of the illustrative infusion head 130 is a cannula 136, the injection device can take another form, such as a needle. In this case, the introducer hub 224 and the introducer needle 226 can not be needed.

[0051] In Figure 9In FIG. 2A, the applicator assembly 200 is shown in a retracted state during a retraction step. During this retraction step, the rotary link 223 is retracted and pulls the introducer hub 224 and introducer needle 226 upward and out of the patient's skin S. As the introducer hub 224 moves upward, the catch arms 213 of the housing 210 hold the infusion head 130 and the guide 230 down. The adhesive connection between the first adhesive pad 132 of the infusion head 130 and the patient's skin S also holds the infusion head 130 down, allowing the cannula 136 of the infusion head 130 to remain implanted in the patient's skin S in the retracted state. The inserter subassembly 220, including the actuator 222, can be held in this retracted state to prevent unwanted reinsertion of the introducer needle 226.

[0052] In FIG. 2B, the applicator assembly 200 is shown in a detached state during a detachment step. During this detachment step, the user lifts the applicator assembly 200 away from the patient's skin S, leaving the adhered infusion head 130 and / or the adhered holder 140 behind. The adhesive strength of the first and second adhesive pads 132, 142 can be sufficient to release the adhered infusion head 130 and / or the adhered holder 140 from the housing 210 of the applicator assembly 200. In other embodiments, the user can use a release feature of the housing 210, such as the opening 212 of the housing 210, to facilitate such a release. The opening 212 is described in more detail below in connection with FIG. 2C. In the detached state of FIG. 2B, the user has decided not to attach the holder 140 to the patient's skin S by continuing to conceal the second adhesive pad 142 with the backing 144. The absence of exposed adhesive between the holder 140 and the patient's skin S allows the housing 210 to remain within the housing 210 and detached from the patient's skin S. Figure 10 Figure 13 In FIG. 2C, the applicator assembly 200 is shown in a second ready state during a second preparation step. During this second preparation step, the user can prepare to adjust the medication infusion system 100 from a tethered configuration (FIG. 1A) to a patch configuration (FIG. 1B). The user can choose to apply the holder 140 to the patient's skin S by removing the backing 144 from the second adhesive pad 142 (FIG. 1C) unless it was previously applied during the prior application step of FIG. 2A. Figure 13 Figure 10 In FIG. 2D, the applicator assembly 200 is shown in a second applied state during a second application step. During this second application step, the user can apply the holder 140 to the patient's skin S by removing the backing 144 from the second adhesive pad 142 (FIG. 1C). The user can then apply the infusion head 130 to the patient's skin S by removing the backing 134 from the first adhesive pad 132 (FIG. 1B). The user can then adjust the medication infusion system 100 from the tethered configuration (FIG. 1A) to the patch configuration (FIG. 1B).

[0053] In FIG. 2E, the applicator assembly 200 is shown in a second retracted state during a second retraction step. During this second retraction step, the user can retract the medication infusion system 100 from the patch configuration (FIG. 1B) to the tethered configuration (FIG. 1A). The user can then remove the infusion head 130 from the patient's skin S by removing the backing 134 from the first adhesive pad 132 (FIG. 1B). The user can then remove the holder 140 from the patient's skin S by removing the backing 144 from the second adhesive pad 142 (FIG. 1C). Figure 11 Figure 4 In FIG. 2F, the applicator assembly 200 is shown in a second detached state during a second detachment step. During this second detachment step, the user can detach the medication infusion system 100 from the patch configuration (FIG. 1B) to the tethered configuration (FIG. 1A). The user can then remove the infusion head 130 from the patient's skin S by removing the backing 134 from the first adhesive pad 132 (FIG. 1B). The user can then remove the holder 140 from the patient's skin S by removing the backing 144 from the second adhesive pad 142 (FIG. 1C). Figure 5 Figure 6 In FIG. 2G, the applicator assembly 200 is shown in a second applied state during a second application step. During this second application step, the user can apply the holder 140 to the patient's skin S by removing the backing 144 from the second adhesive pad 142 (FIG. 1C). The user can then apply the infusion head 130 to the patient's skin S by removing the backing 134 from the first adhesive pad 132 (FIG. 1B). The user can then adjust the medication infusion system 100 from the tethered configuration (FIG. 1A) to the patch configuration (FIG. 1B). Figure 7

[0054] In FIG. 2H, the applicator assembly 200 is shown in a second retracted state during a second retraction step. During this second retraction step, the user can retract the medication infusion system 100 from the patch configuration (FIG. 1B) to the tethered configuration (FIG. 1A). The user can then remove the infusion head 130 from the patient's skin S by removing the backing 134 from the first adhesive pad 132 (FIG. 1B). The user can then remove the holder 140 from the patient's skin S by removing the backing 144 from the second adhesive pad 142 (FIG. 1C). Figure 12 ​​​​​In FIG. 2A, the applicator assembly 200 is shown in a first application state during a first application step. During this first application step, the user positions the applicator assembly 200 in contact with the patient's skin S while aligning the applicator assembly 200 with the infusion head 130. The alignment of the applicator assembly 200 with the infusion head 130 controls the position of the retainer 140 relative to the infusion head 130. The first adhesive pad 142 is now exposed, and the retainer 140 will adhere to the skin S at a predetermined position controlled by the applicator assembly 200. This predetermined position of the retainer 140 can be the same whether the retainer 140 is applied with the infusion head 130 during the first application step or after the infusion head 130 during the second application step. Instead of using an integrated alignment guide 230, using a separate tool (e.g., a separate spacer, a separate alignment plate) to control the position of the retainer 140 relative to the infusion head 130 is also within the scope of the present disclosure. Figure 7 In FIG. 2B, the applicator assembly 200 is shown in a second application state during a second application step. During this second application step, the user positions the applicator assembly 200 in contact with the patient's skin S while matching the alignment guide 230 with the inserted infusion head 130. The shape-matching conformity between the alignment guide 230 and the inserted infusion head 130 controls the position of the retainer 140 relative to the inserted infusion head 130. With the second adhesive pad 142 now exposed, the retainer 140 will adhere to the skin S at a predetermined position controlled by the alignment guide 230. This predetermined position of the retainer 140 can be the same whether the retainer 140 is applied with the infusion head 130 during the first application step or after the infusion head 130 during the second application step. Instead of using an integrated alignment guide 230, using a separate tool (e.g., a separate spacer, a separate alignment plate) to control the position of the retainer 140 relative to the inserted infusion head 130 is also within the scope of the present disclosure. Figure 12 In FIG. 2C, the applicator assembly 200 is shown in a third application state during a third application step. During this third application step, the user positions the applicator assembly 200 in contact with the patient's skin S while matching the alignment guide 230 with the inserted infusion head 130. The shape-matching conformity between the alignment guide 230 and the inserted infusion head 130 controls the position of the retainer 140 relative to the inserted infusion head 130. With the third adhesive pad 142 now exposed, the retainer 140 will adhere to the skin S at a predetermined position controlled by the alignment guide 230. This predetermined position of the retainer 140 can be the same whether the retainer 140 is applied with the infusion head 130 during the first application step or after the infusion head 130 during the second application step. Instead of using an integrated alignment guide 230, using a separate tool (e.g., a separate spacer, a separate alignment plate) to control the position of the retainer 140 relative to the inserted infusion head 130 is also within the scope of the present disclosure.

[0055] In FIG. 2D, the applicator assembly 200 is shown in a fourth application state during a fourth application step. During this fourth application step, the user positions the applicator assembly 200 in contact with the patient's skin S while matching the alignment guide 230 with the inserted infusion head 130. The shape-matching conformity between the alignment guide 230 and the inserted infusion head 130 controls the position of the retainer 140 relative to the inserted infusion head 130. With the fourth adhesive pad 142 now exposed, the retainer 140 will adhere to the skin S at a predetermined position controlled by the alignment guide 230. This predetermined position of the retainer 140 can be the same whether the retainer 140 is applied with the infusion head 130 during the first application step or after the infusion head 130 during the second application step. Instead of using an integrated alignment guide 230, using a separate tool (e.g., a separate spacer, a separate alignment plate) to control the position of the retainer 140 relative to the inserted infusion head 130 is also within the scope of the present disclosure. Figure 13 In FIG. 2E, the applicator assembly 200 is shown in a second detachment state during a second detachment step. During this second detachment step, the user lifts the applicator assembly 200 away from the patient's skin S, leaving the newly adhered retainer 140 behind. The adhesive strength of the second adhesive pad 142 can be sufficient to release the adhered retainer 140 from the housing 210 of the applicator assembly 200. In other embodiments, the user can use a release feature of the housing 210, such as the opening 212 of Figure 13 , to facilitate such a release. For example, the user can insert his or her finger into the opening 212 and press down on top of the retainer 140 with a releasing force.

[0056] Once the infusion head 130 and the retainer 140 have been applied to the patient's skin S, the user can adjust the medication infusion system 100 from the patch configuration Figure 5 ) to the tethered configuration Figure 4 ) by simply pulling and removing the retainer 140 from the patient's skin S without disturbing the inserted infusion head 130.

[0057] It is to be understood that the above-described method of using the applicator assembly 200 can vary according to the needs of a particular patient, such as by reordering and / or eliminating certain steps. For example, if the user applies the retainer 140 during the first application step of Figure 7 , or if the user uses the medication infusion system 100 only in the tethered configuration without the retainer 140 Figure 4 , the second preparation step of Figure 11 , the second application step of Figure 12 , and the third application step ofFigure 13 The second separation step. Advantageously, the same applicator component 200 can be used throughout this customizable method, thereby minimizing manufacturing, storage, and purchasing costs and maximizing user flexibility.

[0058] 3. Second Applicator Assembly

[0059] Next reference Figure 14 It provides a way to interact with Figures 1-5 A second exemplary applicator assembly 1200 used in conjunction with the drug infusion system 100. The second applicator assembly 1200 may be similar to... Figure 6 and Figure 7 The first applicator assembly 200, wherein the same reference numerals denote the same elements, except as described below.

[0060] The second applicator assembly 1200 includes a configuration that supports an infusion head 130 and a retainer 140. Figure 15 The second applicator assembly 1200 includes an upper housing 1210a and a lower housing 1210b. The second applicator assembly 1200 also includes an inserter subassembly 1220 having an actuator 1222, a rotating link 1223, and an inserter hub 1224 that carries the inserter needle 1226. The second applicator assembly 1200 also includes an alignment guide 1230 with a snap-fit ​​arm 1232. The lower housing 1210b includes a window 1214 that captures the snap-fit ​​arm 1232 of the alignment guide 1230 during insertion of the infusion head 130, the snap-fit ​​arm 1232 being similar to... Figure 9 The latching arm 213. The lower housing 1210b also includes a retainer 140 ( Figure 15 ) The flexible braking beam 1216 is a collaborative mechanism.

[0061] The exemplary applicator assembly 1200 also includes a preventive retainer 140 ( Figure 15 The premature release of the carriage 1240. The carriage 1240 is coupled to the actuator 1222. The carriage 1240 includes a spring 1242 that biases the actuator 1222 outward, a rail 1244, a clamping arm 1246 that cooperates with the brake beam 1216 of the lower housing 1210b, and a catch 1248.

[0062] The exemplary applicator assembly 1200 also includes a preventive infusion head 130 ( Figure 15 The safety lock 1250 is designed to prevent premature insertion. The safety lock 1250 includes a spring 1252 that is biased downward, a contact protrusion 1254 that cooperates with the patient's skin, a locking protrusion 1256 that cooperates with the rail 1244 of the carriage 1240, and a latching arm 1258 that cooperates with the latch 1248 of the carriage 1240.

[0063] Now refer to Figures 15-18An exemplary method of using the second applicator assembly 1200 will now be described.

[0064] In Figure 15 , the second applicator assembly 1200 is shown in a ready state during a ready step. During this ready step, the safety lock 1250 is biased downward with the contact tab 1254 extending vertically below the housing 1210a, 1210b and the locking tab 1256 positioned in horizontal alignment with the rail 1244 on the carriage 1240. This interaction between the locking tab 1256 of the safety lock 1250 and the rail 1244 of the carriage 1240 prevents horizontal movement of the carriage 1240 toward the safety lock 1250. As a result, this interaction prevents premature triggering of the actuator 1222. In addition, the carriage 1240 is biased rearward with the clamping arms 1246 above the detent beam 1216 on the lower housing 1210b. This interaction between the clamping arms 1246 of the carriage 1240 and the detent beam 1216 of the lower housing 1210b causes the detent beam 1216 to engage the retainer 140 and prevents the detent beam 1216 from bending outward away from the retainer 140. As a result, this interaction prevents premature release of the retainer 140. This ready state can also be referred to as a "fully locked" state because both the actuator 1222 and the retainer 140 are locked. This ready state can have other features in common with the ready state of Figure 6 .

[0065] In Figure 16 , the second applicator assembly 1200 is shown in an applied state during an application step. During this application step, the user positions the applicator assembly 1200 in contact with the skin of a patient, which causes the contact tab 1254 of the safety lock 1250 to move upward against the bias of the spring 1252. This upward movement of the safety lock 1250 releases the locking tab 1256 of the safety lock 1250 from the rail 1244 of the carriage 1240, which allows triggering of the actuator 1222 and forward movement of the carriage 1240. However, the clamping arms 1246 of the carriage 1240 remain engaged with the detent beam 1216 of the lower housing 1210b to retain the retainer 140. The upward movement of the safety lock 1250 also moves the catch arm 1258 of the safety lock 1250 into horizontal alignment with the catch 1248 of the carriage 1240 Figure 14 . This applied state can also be referred to as a "partially locked" state because the actuator 1222 is unlocked and the retainer 140 is locked. This applied state can have other features in common with the applied state of Figure 7 .

[0066] In Figure 17In the diagram, the second applicator assembly 1200 is shown in an inserted state during the insertion step. During this insertion step, the user presses the actuator 1222 forward, which causes the carriage 1240 to move forward against the bias of the spring 1242. As previously discussed... Figure 8 The insertion steps are as described above, and refer again to... Figure 16 This forward movement of the carriage releases the rotating linkage 1223, allowing it to rotate and drive the infusion head 130 downward toward the patient's skin S over the latching arm 1213 of the housing 1210b. This downward movement causes the infusion needle 1226 to pierce the patient's skin S and allows the cannula 136 to enter the puncture site. The infusion head 130 then... Figure 15 The retracted position moves to align with the retainer 140 so as to contact the patient's skin S, and the infusion head 130 contacts and adheres to the patient's skin S. Forward movement of the carriage 1240 also releases the clamping arm 1246 of the carriage 1240 from the brake beam 1216 of the lower housing 1210b, thereby releasing the brake beam 1216. Return to Figure 17 Although the brake beam 1216 is now free, the retainer 140 is still held by the beam because there is no force to release it. The forward movement of the carriage 1240 also causes the latch 1248 of the carriage 1240 to move past the latch arm 1258 of the safety lock 1250. Figure 14 The latch arm 1258 of the safety lock 1250 extends behind the latch 1248 of the carriage 1240, thereby preventing the carriage 1240 and the actuator 1222 from returning or moving backward. Figure 15 The initial position. This insertion state can also be referred to as the "unlocked" state, because both actuator 1222 and retainer 140 are unlocked. This insertion state can be compared with... Figure 8 The insertion states share other common characteristics.

[0067] exist Figure 18 In the diagram, the second applicator assembly 1200 is shown in a separated state during the separation step. During this separation step, the user lifts the applicator assembly 200 away from the patient's skin S. If the removable backing 144 ( Figure 1 The adhesive 142 exposed on the retainer 140 has been removed from the retainer 140. Figure 1) adhering to the patient's skin S, and the act of pulling the second applicator assembly 1200 away from the skin S provides the force needed to release the retainer 140 from the detent beam 1216. As the user continues to remove the second applicator assembly 1200 from the skin S, the spring 1252 returns the safety lock 1250 downward. The catch arm 1258 of the safety lock 1250 can fall under the catch 1248 of the carriage 1240, allowing the carriage 1240 and the actuator 1222 to return or move back. As the carriage 1240 moves back, the rail 1244 of the carriage 1240 can slide under the locking protrusion 1256 of the safety lock 1250. When the carriage 1240 passes the locking protrusion 1256 and resumes its initial position Figure 15 ), the safety lock 1250 can continue to move downward until the locking protrusion 1256 reengages the rail 1244 and resumes preventing premature triggering of the actuator 1222. In addition, the clamping arm 1246 of the carriage 1240 can reengage the detent beam 1216 on the lower housing 1210b and continue to prevent premature release of the retainer 140 unless it was previously released. This disengaged state can also be referred to as a "relocked" state, as both the actuator 1222 and the retainer 140 are locked, if they still exist. This disengaged state can have common other features with Figure 10 the disengaged state of FIG. 1.

[0068] The operation of the carriage 1240 and the safety lock 1250 can vary. For example, instead of unlocking the safety lock 1250 when the contact protrusion 1254 contacts the patient's skin, the safety lock 1250 can unlock with a separate button or slide mechanism, a dual-function actuator with a first unlocking movement (e.g., sliding) and a second insertion movement (e.g., pressing), or various other mechanisms. In another example, the user can maintain pressure on the actuator 1222 to hold the carriage 1240 in the forward position, instead of relying on the catch arm 1258 to lock the carriage 1240 and the actuator 1222 in the forward position.

[0069] While this application has been described as having exemplary designs, the present application can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the application using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this application pertains and fall within the limits of the appended claims.

Claims

1. An applicator assembly configured for use with a drug infusion system including a drug delivery device, the drug infusion system being configured to be used interchangeably in at least two different wearing configurations, the wearing configurations including a tether configuration and a patch configuration, the applicator assembly comprising: An infusion head having a first adhesive pad and an injection device; A retainer having a second adhesive pad, the retainer being configured to be attached to and support the drug delivery device in the patch configuration; A housing configured to carry the infusion head and the retainer, each of which can be selectively released from the housing for adhesion to the patient's skin; as well as An actuator, coupled to the housing, is configured to move the injection device from the housing into the patient's skin.

2. The applicator assembly according to claim 1, wherein, The applicator assembly has a ready state, in which: For the tethered configuration, the first adhesive pad of the infusion head is exposed to the patient's skin, and the second adhesive pad of the retainer is concealed from the patient's skin; as well as With the patch configuration, the first adhesive pad of the infusion head is exposed to the patient's skin, and the second adhesive pad of the retainer is exposed to the patient's skin.

3. The applicator assembly according to claim 1 or 2, wherein, The retainer also includes a removable backing that conceals the second adhesive pad within the tethering configuration.

4. The applicator assembly according to any one of the preceding claims 1-3, wherein, The applicator assembly has: In the application state, the retainer contacts the patient's skin, and the injection device of the infusion head retracts above the retainer within the housing; and In the insertion state, the infusion head is aligned with the retainer so as to make contact with the patient's skin.

5. The applicator assembly according to any of the preceding claims 4, wherein, The injection device is a cannula, and the applicator assembly further includes an introducer hub with an introducer needle that, in the inserted state, pierces the patient's skin to receive the cannula, wherein the applicator assembly has a retracted state in which the introducer needle retracts into the housing and the cannula remains in the patient's skin.

6. The applicator assembly according to any one of the preceding claims 1-5, further comprising an alignment guide located within the housing, wherein, The applicator assembly has: In the second ready state, the infusion head is adhered to the patient's skin, and the retainer remains within the housing; and In the second application state, the alignment guide mates with the infusion head to adhere the retainer to the patient's skin at a predetermined position relative to the infusion head.

7. The applicator assembly according to any one of the preceding claims 1-6, wherein, The housing surrounds the first adhesive pad of the infusion head and the second adhesive pad of the retainer.

8. The applicator assembly according to any one of the preceding claims 1-7 further includes a safety lock, the safety lock having: A locked state, which prevents the actuator from moving; and The unlocked state allows the actuator to move in order to move the injection device.

9. The applicator assembly of claim 8, wherein, The safety lock includes a contact protrusion that extends below the housing in the locked state and retracts into the housing when in contact with the patient's skin in the unlocked state.

10. The applicator assembly according to any of the preceding claims 1-7, further comprising a carriage coupled to the actuator and having: The first state, in which... The carriage cooperates with the retainer to prevent the retainer from being released from the housing; and In the second state, the carriage disengages from the retainer to allow the retainer to be released from the housing.

11. The applicator assembly of claim 10, further comprising a safety lock, the safety lock having: The locked state, which locks the carriage in the first state; and The unlocked state allows the carriage to move to the second state.

12. The applicator assembly of claim 1, wherein, The tubing assembly is positioned in a tethered configuration to provide fluid communication between the drug delivery device and the infusion head, wherein the first connector of the tubing assembly is the same as or similar to the connector of the infusion head, and the second connector of the tubing assembly is the same as or similar to the connector of the drug delivery device.

13. A drug infusion system, comprising: Drug delivery device; Infusion head with injection device; A retainer configured to support the drug delivery device; as well as Applicator components, comprising: A housing configured to carry the infusion head and the retainer; and An actuator coupled to the housing and configured to move the injection device from the housing into the patient's skin; The drug infusion system is configured to be used interchangeably in at least two different wearing configurations, the wearing configurations including: A tethering configuration wherein the applicator assembly positions the infusion head in adhesive communication with the patient's skin while preventing adhesive communication between the retainer and the patient's skin; and A patch construction in which the applicator assembly positions the infusion head and the retainer in adhesive communication with the patient's skin.

14. The drug infusion system of claim 13, further comprising a tubing assembly positioned in the embolization configuration in fluid communication between the drug delivery device and the infusion head.

15. The drug infusion system according to claim 14, wherein: The drug delivery device includes a needle port; The infusion head includes a diaphragm port; and The tube assembly includes a diaphragm port at one end and a needle port at the other end; in: In the embolization configuration, the needle port of the drug delivery device communicates with the diaphragm port of the tubing assembly, and the needle port of the tubing assembly communicates with the diaphragm port of the infusion head; and In the patch configuration, without the tubing assembly, the needle port of the drug delivery device is in communication with the diaphragm port of the infusion head.

16. The drug infusion system according to claim 14 or 15, wherein: The drug delivery device includes a male connector; The infusion head includes a female connector; and The pipe assembly includes a female connector at one end and a male connector at the other end; in: In the embolization configuration, the male connector of the drug delivery device is coupled to the female connector of the tubing assembly, and the male connector of the tubing assembly is coupled to the female connector of the infusion head; and In the patch configuration, without the tubing assembly, the male connector of the drug delivery device is coupled to the female connector of the infusion head.

17. The drug infusion system according to any of the preceding claims 14-16, wherein, The tube bundle is stored in a closed loop in the patch structure, wherein one end of the tube bundle is coupled to the other end of the tube bundle.

18. The drug infusion system according to any of the preceding claims 13-17, wherein, The applicator assembly further includes an alignment guide configured to adjust the drug infusion system from the tether configuration to the patch configuration. The applicator assembly mates the alignment guide with the infusion head while positioning the retainer in adhesive communication with the patient's skin.

19. The drug infusion system according to claim 13, wherein, The tubing assembly is positioned in a tethered configuration to provide fluid communication between the drug delivery device and the infusion head, wherein the first connector of the tubing assembly is the same as or similar to the connector of the infusion head, and the second connector of the tubing assembly is the same as or similar to the connector of the drug delivery device.

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