Integrated inserter / applicator for drug delivery system offering multiple mounting configurations - Patents.com

Abstract

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

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 822,318, filed March 22, 2019, the disclosure of which is expressly incorporated herein by reference in its entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to drug infusion systems, and more particularly to applicator assemblies for use with drug infusion systems having multiple mounting configurations, and methods of use thereof. [Background technology]

[0003] A drug infusion system includes a drug delivery device (e.g., a pump) configured to store and deliver a drug (e.g., insulin) to a patient's skin via an injection head. Some drug infusion systems can be used in a tethered configuration, where the injection head is adhered to the patient's skin and the drug delivery device is positioned at a remote location away from the patient's skin, such as in a pouch, pocket, or case, with an intermediate tubing set connected between them. Other drug infusion systems can be used in a patch (i.e., wearable) configuration, where both the injection head and the drug delivery device are adhered to the patient's skin without an intermediate tubing set. Manufacturers typically supply devices that can be used in only one of these configurations, and thus patients typically do not have the option to switch from one configuration to another. Summary of the Invention

[0004] The present disclosure provides an applicator assembly for use with a drug injection system having multiple attachment configurations, including a tethered configuration and a patch configuration. The applicator assembly can be a multi-function device configured to (1) selectively apply an injection head and / or a holder to a patient's skin, and (2) insert an injection device of the injection head into the patient's skin. The drug injection system can be interchangeably attached in a tethered configuration by placing a drug delivery device in fluid communication with the injection head via an intermediate tubing set, or in a patch configuration by coupling the drug delivery device to a holder and placing the drug delivery device in fluid communication with the injection head without via an intermediate tubing set.

[0005] According to an embodiment of the present disclosure, an applicator assembly is disclosed that is configured for use with a drug injection system including a drug delivery device, the drug injection system having a tethered configuration and a patch configuration. The applicator assembly includes an injection head having a first adhesive pad and an injection device, a holder having a second adhesive pad, the holder configured to support the drug delivery device, a housing configured to carry the injection head and the holder, and an actuator coupled to the housing and configured to move the injection device from the housing and into the patient's skin.

[0006] According to another embodiment of the present disclosure, a drug injection system is disclosed that includes a drug delivery device, an injection head having an injection device, a holder configured to support the drug delivery device, a housing configured to carry the injection head and the holder, and an applicator assembly including an actuator coupled to the housing and configured to move the injection device from the housing and into the patient's skin, The drug injection system has a tether configuration in which the applicator assembly positions the injection 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 injection head and the holder in adhesive communication with the patient's skin.

[0007] According to yet another embodiment of the present disclosure, a method of using a drug injection system is disclosed, comprising the steps of obtaining an applicator assembly comprising a housing, an injection 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, where if the second adhesive pad is exposed during the preparing step, the holder adheres to the patient's skin during the applying step; actuating the applicator assembly to adhere the first adhesive pad of the injection head to the patient's skin and insert the injection device into the patient's skin; and separating the applicator assembly from the patient's skin, where if the second adhesive pad is hidden during the preparing step, the holder is separated from the patient's skin during the separating step. [Brief description of the drawings]

[0008] The above and other features and advantages of the present disclosure, and the manner in which they are accomplished, will become more apparent and be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings.

[0009] [Figure 1] FIG. 1 is an exploded perspective view of an exemplary drug injection system of the present disclosure, the drug injection system including a drug delivery device, an optional tubing set, an injection head, and a holder. [Diagram 2] FIG. 2 is a perspective view of the drug delivery device of FIG. 1. [Diagram 3] FIG. 2 is a perspective view of the tubing set of FIG. 1. [Figure 4] FIG. 2 is a perspective view of the drug infusion system of FIG. 1 arranged in a tethered configuration with a tubing set. [Diagram 5] FIG. 2 is a perspective view of the drug infusion system of FIG. 1 arranged in a patch configuration without a tubing set. [Figure 6]2 is a bottom perspective view of a first exemplary applicator assembly of the present disclosure configured for use with the drug injection system of FIG. 1, the first applicator assembly being shown in a ready state; FIG. [Figure 7] 7 is a cross-sectional view of the first applicator assembly of FIG. 6 shown in an applied state. [Figure 8] 7 is a cross-sectional view of the first applicator assembly of FIG. 6 shown in an inserted state. [Figure 9] 7 is a cross-sectional view of the first applicator assembly of FIG. 6 shown in a retracted state. [Figure 10] 7 is a cross-sectional view of the first applicator assembly of FIG. 6 shown in a separated state. [Figure 11] 7 is a cross-sectional view of the first applicator assembly of FIG. 6 shown in a second ready state. [Figure 12] 7 is a cross-sectional view of the first applicator assembly of FIG. 6 shown in a second application state. [Figure 13] 7 is a cross-sectional view of the first applicator assembly of FIG. 6 shown in a second separated state. [Figure 14] 2 is an exploded perspective view of a second exemplary applicator assembly of the present disclosure configured for use with the drug injection system of FIG. 1. [Figure 15] FIG. 15 is a cross-sectional view of the second applicator assembly of FIG. 14 shown in a fully locked, ready state. [Figure 16] 15 is a cross-sectional view of the second applicator assembly of FIG. 14 shown in a partially locked application state. [Figure 17] 15 is a cross-sectional view of the second applicator assembly of FIG. 14 shown in an unlocked and inserted state. [Figure 18] 15 is a cross-sectional view of the second applicator assembly of FIG. 14 shown in a re-locked separated state.

[0010] Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations set forth herein illustrate exemplary embodiments of the present invention, and such illustrations should not be construed as limiting the scope of the present invention in any way. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] 1. Drug Infusion System An exemplary drug infusion system 100 of the present disclosure for delivering a drug (not shown) to a patient's skin S is shown in Figure 1. Drug infusion system 100 includes a drug delivery device 110, an optional tubing set 120, an injection head 130 configured for placement on the patient's skin S, and an optional holder 140 also configured for placement against the patient's skin S. Each element of drug infusion system 100 is described further below.

[0012] The drug delivery device 110 is configured to store and deliver a drug to the injection head 130, either indirectly to the injection head 130 via the tubing set 120, or directly to the injection head 130 without the tubing set 120. The drug delivery device 110 is also shown in FIG. 2 and includes a connector 112 (e.g., a male buckle) having a release latch 113 and a needle port 114 that selectively fluidly communicates with the tubing set 120 or the injection head 130. The drug delivery device 110 may be a pump, a bolus injector, an autoinjector, an injection pen, or another suitable drug delivery device. The drug delivery device 110 may be controlled via a built-in control (e.g., a touch screen, buttons) or via a wireless control (e.g., a patient's smartphone). In certain embodiments, a set of multiple drug delivery devices 110 may be provided within the drug infusion system 100, with each drug delivery device 110 including a different volume of drug, such as, for example, 1 mL to 20 mL or more.

[0013] The drug of the drug delivery device 110 may 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 deliverable by the drug delivery device 110. The drug may be formulated with one or more excipients.

[0014] Optional tubing set 120 is also shown in FIG. 3 and illustratively includes a first connector 122 (e.g., a female buckle) configured to be selectively coupled to drug delivery device 110, a first septum port 123 in selective fluid communication with drug delivery device 110, flexible lineset tubing 124, a second connector 126 (e.g., a male buckle) configured to be selectively coupled to injection head 130, and a second needle port 127 in selective fluid communication with injection head 130. Tubing set 120 is configured to carry a drug from first septum port 123, through lineset tubing 124 and second needle port 127.

[0015] The injection head 130 illustratively includes a first adhesive pad 132 configured to adhere the injection head 130 to the patient's skin S, an injection device in the form of a cannula 136 or needle configured to be inserted into the patient's skin S, and a connector 138 (e.g., a female buckle) configured to be selectively coupled to the drug delivery device 110 or the tubing set 120. The first adhesive pad 132 may define an outer periphery of the injection head 130. The injection head 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 patient's skin S.

[0016] 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., a clip) configured to selectively mate with the drug delivery device 110. The connector 146 may have rounded edges 148 to facilitate coupling with the drug delivery device 110. The second adhesive pad 142 may define an outer periphery of the holder 140.

[0017] The drug infusion system 100 may be used interchangeably in at least two different mounting configurations, including a tethered configuration in which the tubing set 120 is used as shown in FIG. 4 and a patch (i.e., wearable) configuration in which the tubing set 120 is not used as shown in FIG. 5. To achieve this interchangeability, the first connector 122 of the tubing set 120 may be the same as or similar to the connector 138 of the injection head 130, and the second connector 126 of the tubing set 120 may be the same as or similar to the connector 112 of the drug delivery device 110 as shown in FIGS. 1-3. However, these connections may be adjusted based on the available space and the desired coupling action (e.g., top load, side load, angle load). Advantageously, these mounting configurations may be adjusted without disturbing the inserted cannula 136 of the injection head 130. These exemplary mounting configurations are further described below, although other mounting configurations are within the scope of the present disclosure.

[0018] In the tethered configuration of Figure 4, the injection head 130 is adhered to the patient's skin S and the drug delivery device 110 is positioned in a remote location away from the patient's skin S, such as a pouch, pocket, or case. The tubing set 120 is positioned to provide fluid communication between the tethered drug delivery device 110 and the injection head 130 such that the tethered drug delivery device 110 carries a drug through the tubing set 120 to the injection head 130 for delivery to the patient. In this configuration, 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 injection head 130. Also, the needle port 114 of the drug delivery device 110 (FIG. 2) penetrates the first septum port 123 of the tubing set 120, and the second needle port 127 of the tubing set 120 penetrates the septum port 139 of the injection head 130 (FIG. 1). A small compression spring (not shown) may 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 removal from the corresponding septum ports 123, 139. A patient may prefer to use the drug infusion device 100 in a tethered configuration when the drug delivery device 110 is relatively large and heavy (e.g., about 3.5 ounces or more), which may be consistent with a drug delivery device 110 containing a large amount of drug.

[0019] 4, holder 140 may optionally be adhered to the patient's skin S in a tethered configuration. In certain embodiments, holder 140 may be bypassed or ignored in the tethered configuration. In other embodiments, holder 140 may interact with (e.g., grip) tubing set 120 to provide strain relief to tubing set 120.

[0020] In the patch configuration of FIG. 5, both the injection head 130 and the holder 140 are adhered to the patient's skin S. The drug delivery device 110 is coupled to the holder 140 such that the drug delivery device 110 is supported on the patient's skin S. The drug delivery device 110 is also arranged in direct fluid communication with the injection head 130 such that the drug delivery device 110 carries the drug directly to the injection head 130 for delivery to the patient. In this arrangement, the connector 112 of the drug delivery device 110 (FIG. 2) mates directly with the connector 138 of the injection head 130. Also, the needle port 114 of the drug delivery device 110 (FIG. 2) directly penetrates the septum port 139 of the injection head 130 (FIG. 1). As mentioned above, a small compression spring (not shown) may be provided around the needle port 114 of the drug delivery device 110 to facilitate removal from the corresponding septum port 139. A patient may prefer to use the drug infusion system 100 in a patch configuration when the drug delivery device 110 is relatively small and light (e.g., less than about 3.5 ounces, less than about 1.75 ounces, etc.), which may be consistent with a drug delivery device 110 containing a small amount of drug.

[0021] As noted above, the coupling of the drug delivery device 110 to the injection head 130 and holder 140 in the patch configuration may vary. In a top-loading embodiment, the drug delivery device 110 may be coupled to the injection head 130 and holder 140 in a direction generally perpendicular to the skin S. In an angle-loading embodiment, the drug delivery device 110 may be coupled to the injection head 130 and holder 140 via a tilt-in approach. For example, one end of the drug delivery device 110 may be hooked to the holder 140 and the other end of the drug delivery device 110 may be pivoted relative to the injection head 130. In a side-loading embodiment, the drug delivery device 110 may be coupled to the injection head 130 and holder 140 in a direction generally parallel to the skin S. For example, the drug delivery device 110 may slide over the holder 140 and be locked into place on the injection head 130. Rounded edges 148 on the connector 146 may facilitate this mating action by allowing the drug delivery device 110 to pivot relative to the connector 146 during alignment with the injection head 130 .

[0022] In the patch configuration, the tubing set 120 of FIG. 3 may be stored. In certain embodiments, the tubing set 120 may be stored in a closed loop manner with the first connector 122 of the tubing set 120 coupled to the second connector 126 of the tubing set 120. In this arrangement, the second needle port 127 of the tubing set 120 penetrates the septum port 123 of the tubing set 120, protecting the second needle port 127 without the need for a separate needle shield, preventing unwanted contact with the second needle port 127, and sealing any formulation remaining within the tubing set 120. As noted above, a small compression spring (not shown) may be provided around the second needle port 127 of the tubing set 120 to facilitate removal from the corresponding septum port 123.

[0023] 2. First Applicator Assembly 6-13, a first exemplary applicator assembly 200 is provided for use with the drug injection system 100 of Figures 1-5. The applicator assembly 200 may be supplied with, and may be considered a part of, the drug injection system 100. The applicator assembly 200 may be a multi-function device configured to (1) selectively apply the injection head 130 and / or holder 140 to the patient's skin S, and (2) insert the cannula 136 of the injection head 130 into the patient's skin S.

[0024] The exemplary applicator assembly 200 includes a housing 210 configured to carry the injection head 130 and the holder 140 in a predetermined arrangement. The predetermined arrangement may correspond to the patch arrangement of FIG. 5, for example. The housing 210 may be sized to enclose both the first adhesive pad 132 of the injection head 130 and the second adhesive pad 142 of the holder 140, as shown in FIG. 6. In certain embodiments, the housing 210 may include one or more release features, such as the opening 212 of FIG. 13 and / or an actuatable release mechanism (not shown), to easily separate the injection head 130 and / or the holder 140 from the housing 210. The opening 212 is described in more detail below in connection with FIG. 13. The housing 210 may also include one or more snap arms 213, which are described in more detail below in connection with FIG. 9.

[0025] The illustrative applicator assembly 200 also includes an inserter subassembly 220 configured to insert the cannula 136 of the injection head 130 into the patient's skin S. The inserter subassembly 220 includes an actuator 222 (e.g., a button), a rotational linkage 223, and an introducer hub 224 that holds an introducer needle 226. The illustrative inserter subassembly 220 controls both the insertion and retraction of the introducer hub 224 via the same actuator 222, although it is within the scope of this disclosure to provide separate actuators for automatic and / or manual insertion and / or retraction of the introducer hub 224.

[0026] The exemplary applicator assembly 200 further includes an optional alignment guide 230 that is supported atop injection head 130 within housing 210. Alignment guide 230 conforms to injection head 130 to prevent lateral or rotational movement therebetween.

[0027] An exemplary method of using applicator assembly 200 will now be described with continued reference to Figures 6-13. The method may be performed by a patient and / or a caregiver for the patient, hereafter referred to as a "user." Applicator assembly 200 may have an ergonomic shape sized to fit in the hand of a user throughout the method.

[0028] In FIG. 6, the applicator assembly 200 is shown in a prepared state during a preparation step during which the user prepares the drug infusion system 100 for use in a desired wearing configuration. To accommodate the tethered configuration (FIG. 4), the user may choose to apply only the injection head 130 to the patient's skin S by ensuring that the first adhesive pad 132 of the injection head 130 is exposed, while leaving the backing 144 on the second adhesive pad 142 of the holder 140, as shown in FIG. 6. On the other hand, to accommodate the patch configuration (FIG. 5), the user may choose to apply both the injection 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 may involve removing the backing 144 from the second adhesive pad 142. Injection head 130 and holder 140 and their first and second adhesive pads 132, 142 may be carried in this ready state by housing 210, as shown in FIG.

[0029] In FIG. 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 is retained to hide the second adhesive pad 142 and prevent contact with the skin S, as shown in FIG. 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 is exposed to contact and adhere to the skin S. The cannula 136 of the injection head 130 may be retracted into the housing 210 above the holder 140 in this applied state to avoid premature contact with the patient's skin S, as shown in FIG.

[0030] In FIG. 8, the applicator assembly 200 is shown in an inserted state during an insertion step. During this insertion step, the user pushes the actuator 222 inward, which rotates the rotating linkage 223 and drives the introducer hub 224, the alignment guide 230, and the injection head 130 downward through the snap arm 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 allows the cannula 136 to enter the puncture site. The injection head 130 moves from the retracted position of FIG. 7 to align with the holder 140 for mutual contact with the patient's skin S, and the exposed first adhesive pad 132 of the injection head 130 contacts and adheres to the patient's skin S. Although the injection device of the exemplary injection 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 may not be necessary.

[0031] In FIG. 9 , the applicator assembly 200 is shown in a retracted state during a retraction step. During this retraction step, the rotating linkage 223 recoils, pulling 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 snap arm 213 of the housing 210 holds the alignment guide 230 and the injection head 130 downward. The adhesive connection between the first adhesive pad 132 of the injection head 130 and the patient's skin S may also maintain the injection head 130 downward, thereby allowing the cannula 136 of the injection head 130 to remain embedded in the patient's skin S in the retracted state. The inserter subassembly 220, including the actuator 222, may be held in this retracted state to prevent unwanted reinsertion of the introducer needle 226.

[0032] In FIG. 10, 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 from the patient's skin S, leaving behind the attached injection head 130 and / or the attached holder 140. The adhesive strength of the first and second adhesive pads 132, 142 may be sufficient to release the attached injection head 130 and / or the attached holder 140 from the housing 210 of the applicator assembly 200. In other embodiments, the user may use a release feature(s) of the housing 210, such as the opening 212 of FIG. 13, to facilitate such release. The opening 212 is described in more detail below in connection with FIG. 13. In the detached state of FIG. 10, the user has decided not to attach the holder 140 to the patient's skin S by keeping the second adhesive pad 142 hidden by the backing 144. The absence of exposed adhesive between the holder 140 and the patient's skin S allows the housing 210 to remain internal to the housing 210 and separated from the patient's skin S.

[0033] In Fig. 11, the applicator assembly 200 is shown in a second preparation state during a second preparation step. During this second preparation step, a user may prepare to adjust the drug infusion system 100 from the tethered configuration (Fig. 4) to the patch configuration (Fig. 5). The user may choose to apply the holder 140 to the patient's skin S by removing the backing 144 (Fig. 6) from the second adhesive pad 142 (unless already applied during the previous application step of Fig. 7).

[0034] In FIG. 12, 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 mating the alignment guide 230 with the inserted injection head 130. A form-fitting fit between the alignment guide 230 and the inserted injection head 130 controls the location of the holder 140 relative to the inserted injection head 130. With the second adhesive pad 142 exposed, the holder 140 adheres to the skin S at a predetermined location controlled by the alignment guide 230. This predetermined location of the holder 140 can be the same regardless of whether the holder 140 is applied together with the injection head 130 during the first application step of FIG. 7 or after the injection head 130 during the second application step of FIG. 12. It is also within the scope of this disclosure to use a separate tool (e.g., a separate spacer, a separate alignment plate) to control the location of the holder 140 relative to the inserted injection head 130 rather than using an integrated alignment guide 230.

[0035] In FIG. 13, the applicator assembly 200 is shown in a second separated state during a second separation step. During this second separation step, the user lifts the applicator assembly 200 from the patient's skin S, leaving behind the newly adhered holder 140. The adhesive strength of the second adhesive pad 142 may be sufficient to release the adhered holder 140 from the housing 210 of the applicator assembly 200. In other embodiments, the user may use a release feature(s) of the housing 210, such as the opening 212 of FIG. 13, to facilitate such release. For example, the user may insert their finger into the opening 212 and press the top of the holder 140 with a downward release force.

[0036] Once the injection head 130 and holder 140 are applied to the patient's skin S, the user may adjust the drug injection system 100 from the patch configuration (FIG. 5) to the tether configuration (FIG. 4) by simply pulling and removing the holder 140 from the patient's skin S without disturbing the inserted injection head 130.

[0037] It will be appreciated that the above-described method of using the applicator assembly 200 can be varied according to the needs of a particular patient, such as by rearranging and / or eliminating certain steps. For example, the second preparation step of FIG. 11, the second application step of FIG. 12, and the second separation step of FIG. 13 can be eliminated if the user applies the holder 140 during the first application step of FIG. 7, or if the user uses the drug infusion system 100 only in the tethered configuration without the holder 140 (FIG. 4). Advantageously, the same applicator assembly 200 can be used throughout this customizable method, thereby minimizing manufacturing, storage, and purchasing costs and maximizing flexibility to the user.

[0038] 3. Second Applicator Assembly 14, a second exemplary applicator assembly 1200 is provided for use with the drug infusion system 100 of Figures 1-5. The second applicator assembly 1200 may be similar to the first applicator assembly 200 of Figures 6 and 7, with like reference numbers indicating like elements, except as described below.

[0039] The second applicator assembly 1200 includes an upper housing 1210a and a lower housing 1210b configured to support the injection head 130 and the holder 140 (FIG. 15). The second applicator assembly 1200 also includes an inserter subassembly 1220 having an actuator 1222, a rotating linkage 1223, and an introducer hub 1224 that holds an introducer needle 1226. The second applicator assembly 1200 further includes an alignment guide 1230 having a snap arm 1232. The lower housing 1210b includes a window 1214 that captures the snap arm 1232 of the alignment guide 1230 during insertion of the injection head 130, similar to the snap arm 213 of FIG. 9. The lower housing 1210b also includes a flexible detent beam 1216 that cooperates with the holder 140 (FIG. 15).

[0040] The exemplary applicator assembly 1200 also includes a carriage 1240 that prevents premature release of the holder 140 (FIG. 15). 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 a detent beam 1216 of the lower housing 1210b, and a catch 1248.

[0041] The illustrative applicator assembly 1200 further includes a safety lock 1250 that prevents premature insertion of the injection head 130 (FIG. 15). The safety lock 1250 includes a spring 1252 that biases the safety lock 1250 downward, a contact tab 1254 that cooperates with the patient's skin, a locking tab 1256 that cooperates with a rail 1244 of the carriage 1240, and a snap arm 1258 that cooperates with a catch 1248 of the carriage 1240.

[0042] An exemplary method of using second applicator assembly 1200 will now be described with reference to FIGS.

[0043] In Fig. 15, the second applicator assembly 1200 is shown in a ready state during a priming step. During this priming step, the safety lock 1250 is biased downward with the contact tab 1254 extending vertically below the housings 1210a, 1210b and the locking tab 1256 positioned to be horizontally aligned 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 the carriage 1240 from moving horizontally toward the safety lock 1250. As a result, this interaction prevents premature triggering of the actuator 1222. The carriage 1240 is also biased rearward with the clamping arm 1246 positioned over the detent beam 1216 on the lower housing 1210b. This interaction between the clamping arm 1246 of the carriage 1240 and the detent beam 1216 of the lower housing 1210b forcefully engages the detent beam 1216 with the holder 140 and prevents the detent beam 1216 from bending outwardly from the holder 140. As a result, this interaction prevents premature release of the holder 140. This ready state may also be referred to as a "fully locked" state because both the actuator 1222 and the holder 140 are locked. This ready state may have other features in common with the ready state of FIG. 6.

[0044] In Fig. 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 patient's skin, 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 causes the locking tab 1256 of the safety lock 1250 to free itself from the rail 1244 of the carriage 1240, thereby allowing triggering of the actuator 1222 and forward movement of the carriage 1240. However, the clamping arm 1246 of the carriage 1240 remains engaged with the detent beam 1216 of the lower housing 1210b to retain the holder 140. The upward movement of the safety lock 1250 also moves the snap arm 1258 of the safety lock 1250 into horizontal alignment with the catch 1248 of the carriage 1240 (FIG. 14). This applied state may also be referred to as a "partially locked" state because the actuator 1222 is unlocked and the holder 140 is locked. This applied state may have other features in common with the applied state of FIG.

[0045] In Figure 17, the second applicator assembly 1200 is shown in an inserted state during an insertion step. During this insertion step, the user pushes the actuator 1222 forward, which causes the carriage 1240 to move forward against the bias of the spring 1242. As previously described with respect to the insertion step of Figure 8, and again with reference to Figure 16, this forward movement of the carriage releases and rotates the rotating linkage 1223, allowing the introducer hub 1224, alignment guide 1230, and injection head 130 to be driven downwardly through the snap arm 1213 of the housing 1210b and towards the patient's skin S. This downward movement allows the introducer needle 1226 to pierce the patient's skin S and the cannula 136 to enter the puncture site. The injection head 130 moves from the retracted position of FIG. 15 into alignment with the holder 140 for mutual contact with the patient's skin S, and the injection head 130 contacts and adheres to the patient's skin S. The forward movement of the carriage 1240 also frees the clamping arm 1246 of the carriage 1240 from the detent beam 1216 of the lower housing 1210b, thereby freeing the detent beam 1216. Returning to FIG. 17, the detent beam 1216 is now free, but the holder 140 remains gripped by the beam as there is no force causing it to release. The forward movement of the carriage 1240 also moves the catch 1248 of the carriage 1240 past the snap arm 1258 of the safety lock 1250 (FIG. 14). The snap arm 1258 of the safety lock 1250 extends behind the catch 1248 of the carriage 1240, thereby preventing the carriage 1240 and the actuator 1222 from moving back or rearward to the initial position of FIG. 15. This inserted state may also be referred to as an "unlocked" state because both the actuator 1222 and the holder 140 are unlocked. This inserted state may have other features in common with the inserted state of FIG. 8.

[0046] In FIG. 18, the second applicator assembly 1200 is shown in a detached state during a detachment step. During this detachment step, the user lifts the applicator assembly 200 from the patient's skin S. When the removable backing 144 (FIG. 1) is removed from the holder 140, the exposed adhesive 142 (FIG. 1) on the holder 140 adheres to the patient's skin S, and the act of pulling the second applicator assembly 1200 away from the skin S provides the force necessary to release the holder 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 snap arm 1258 of the safety lock 1250 can drop under the catch 1248 of the carriage 1240, thereby allowing the carriage 1240 and the actuator 1222 to move back or backward. As the carriage 1240 moves rearward, the rail 1244 of the carriage 1240 can slide under the locking tab 1256 of the safety lock 1250. When the carriage 1240 clears the locking tab 1256 and returns to its initial position (FIG. 15), the safety lock 1250 can be left facing downward until the locking tab 1256 re-engages the rail 1244 and resumes preventing premature triggering of the actuator 1222. Also, the clamping arm 1246 of the carriage 1240 can re-engage the detent beam 1216 on the lower housing 1210b and resume preventing premature release of the holder 140, unless it was previously released. This separated state can be referred to as a "relocked" state, since both the actuator 1222 and the holder 140 are locked if they remain. This separated state can have other features in common with the separated state of FIG. 10.

[0047] The operation of the carriage 1240 and safety lock 1250 may vary. For example, rather than unlocking the safety lock 1250 when the contact tab 1254 contacts the patient's skin, the safety lock 1250 may be unlocked with a separate button or slide mechanism, a dual function actuator having a first unlocking action (e.g., sliding) and a second insertion action (e.g., pushing), or a variety of other mechanisms. In another example, a user may maintain pressure on the actuator 1222 to keep the carriage 1240 in a forward position rather than relying on a snap arm 1258 to lock the carriage 1240 and actuator 1222 in a forward position.

[0048] While the present invention has been described as having an exemplary design, the present invention can be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the present invention using its general principles. Further, this application is intended to cover such departures from the disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

Claims

1. 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 interchangeably used in at least two different mounting configurations including a tethered configuration and a patch configuration, the applicator assembly comprising: an injection head having a first adhesive pad and an injection device; a holder having a second adhesive pad, the holder being separate from the injection head and configured to be coupled to the drug delivery device to support the drug delivery device; a housing configured to releasably couple the injection head and the holder, the injection head and the holder each being releasable from the housing for attachment to a patient's skin; and an actuator coupled to the housing and configured to move the injection device from the housing to the patient's skin.

2. The holder further includes a removable backing covering the second adhesive pad; The applicator assembly includes: in the tethered configuration, the first adhesive pad of the injection head is exposed to the patient's skin and the second adhesive pad of the holder is concealed by the removable backing to prevent contact with the patient's skin; 2. The applicator assembly of claim 1, having a ready state in which, in the patch configuration, the first adhesive pad of the injection head is exposed to the patient's skin and the second adhesive pad of the holder is exposed to the patient's skin by removing the removable backing.

3. The applicator assembly includes: an application state in which the holder is in contact with the patient's skin and the injection device of the injection head is retracted into the housing above the holder; 3. The applicator assembly of claim 1 or 2, further comprising an insertion state in which the injection head is moved into contact with the patient's skin.

4. 4. The applicator assembly of claim 3, wherein the injection device is a cannula, and the applicator assembly further comprises an introducer hub including an introducer needle that pierces the patient's skin to receive the cannula in the inserted state, the applicator assembly having a retracted state in which the introducer needle is retracted into the housing and the cannula remains on the patient's skin.

5. an alignment guide positioned within the housing, the applicator assembly further comprising: a second ready state in which the injection head is adhered to the patient's skin and the holder remains positioned within the housing; and 5. The applicator assembly of claim 1, wherein the alignment guide has a second application state in which it mates with the injection head to adhere the holder to the patient's skin at a predetermined location relative to the injection head.

6. The applicator assembly of any one of claims 1 to 5, wherein the housing surrounds the first adhesive pad of the injection head and the second adhesive pad of the holder.

7. a locked state in which movement of the actuator is prevented; 7. The applicator assembly of claim 1, further comprising a safety lock, the safety lock having an unlocked state that allows movement of the actuator to move the injection device.

8. 8. The applicator assembly of claim 7, wherein the safety lock includes a contact tab that extends below the housing in the locked state and that retracts into the housing upon contact with the patient's skin in the unlocked state.

9. a carriage coupled to the actuator; and a first state in which the carriage cooperates with the holder to prevent the holder from being released from the housing; The applicator assembly of any one of claims 1 to 6, further comprising a carriage having a first condition and a second condition in which the carriage disengages the holder to allow the holder to be released from the housing.

10. a locked state in which the carriage is locked in the first state; 10. The applicator assembly of claim 9, further comprising a safety lock having an unlocked state that allows movement of the carriage to the second state.

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