Pharmaceutical Delivery Priming Method

Abstract

A method of priming a formulation delivery device comprises the steps of providing a formulation cartridge, inserting the formulation cartridge into a handle of the formulation delivery device, and initiating a priming sequence to simultaneously pump a first formulation and a second formulation from the formulation cartridge for a first time period, causing the first formulation and the second formulation to pass from the formulation cartridge through a pump and out of a nozzle assembly of the formulation delivery device.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Patent Application No. 63 / 291592, filed December 20, 2021, and French Patent Application No. 2201250, filed February 14, 2022, the contents of which are incorporated herein by reference in their entireties. Summary of the Invention

[0003] In one aspect, the present disclosure is directed to, among other things, systems, devices, and cartridges for delivering formulations, and methods for using the same. In one embodiment, one or more methodologies or techniques are described that are configured to deliver a cosmetic formulation having a dye component and a developer component to a user's skin, hair, etc. Advantageously, the disclosed embodiments provide a better user experience, better performance and reliability, and a more sustainable construction.

[0004] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. [Brief explanation of the drawings]

[0005] The foregoing aspects and many of the attendant advantages of this invention will become more readily appreciated as the same becomes better understood by reference to the following detailed description when taken in conjunction with the accompanying drawings.

[0006] [Figure 1] FIG. 1 is a schematic diagram of a pharmaceutical delivery system according to one exemplary embodiment of the present disclosure.

[0007] [Figure 2] FIG. 2 is a schematic diagram of a pharmaceutical formulation delivery device according to one exemplary embodiment of the present disclosure.

[0008] [Figure 3] FIG. 3 is a schematic diagram of an application of a pharmaceutical delivery system according to one exemplary embodiment of the present disclosure.

[0009] [Figure 4] FIG. 4 is an exploded perspective view of a pharmaceutical formulation delivery device according to an exemplary embodiment of the present disclosure.

[0010] [Figure 5] 5 is a side cross-sectional view of the pharmaceutical delivery device of FIG. 4. FIG.

[0011] [Figure 6] FIG. 6 is a perspective view of a formulation dispensing assembly according to an exemplary embodiment of the present disclosure.

[0012] [Figure 7] 7 is a cross-sectional side view of the formulation-dispensing assembly of FIG. 6. FIG.

[0013] [Figure 8] FIG. 8A is a first perspective view of a formulation cartridge according to an exemplary embodiment of the present disclosure.

[0014] FIG. 8B is a second perspective view of the formulation cartridge of FIG. 8A.

[0015] [Figure 9] FIG. 9 is an exploded perspective view of the formulation cartridge of FIG. 8A.

[0016] [Figure 10] FIG. 10 is a cross-sectional side view of the formulation cartridge of FIG. 8A.

[0017] [Figure 11]FIG. 11 illustrates a method for reloading a formulation cartridge according to an exemplary embodiment of the present disclosure.

[0018] [Figure 12] FIG. 12 is a perspective view of a cleaning cartridge according to an exemplary embodiment of the present disclosure.

[0019] [Figure 13] FIG. 13 is a flow chart of an exemplary method for priming a pharmaceutical delivery device according to the present disclosure.

[0020] [Figure 14] FIG. 14 is a schematic diagram of a particular priming sequence according to the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0021] One or more methodologies or techniques are described that allow a user to apply a treatment formulation to human hair and scalp tissue. The following description generally provides representative examples related to hair and scalp treatment delivery systems, devices, and formulation cartridges therefor. In one embodiment, it is beneficial to apply a treatment formulation to a target portion of the hair or scalp tissue. In one embodiment, for example, when applying a coloring dye to the roots of the hair during a color maintenance treatment, it is desirable to apply the treatment formulation to a portion of the hair that is close to the scalp. In another example, an approach requires applying a scalp treatment formulation directly to the scalp tissue while minimizing contact with the hair.

[0022] Existing systems for applying hair and scalp treatment formulations have been widely used. As an example, hair dye kits are commonly used to change the appearance of hair color or to blend gray hair, among other uses. Existing hair dye systems have several drawbacks, including difficulty of use, time consumption, uneven coverage (due to dye application), unpredictable results, excessive mess, etc. In one aspect, existing hair dye systems can be ineffective at blending and coloring the roots of hair after new hair segments grow from the scalp if the natural hair color differs from the color of the rest of the dyed hair. The present disclosure is directed to solving these and other needs.

[0023] In some embodiments, a hair dye formulation comprises at least one dye and a separate developer, which are mixed in a controlled ratio. However, in the present disclosure, "formulation" is not limited to a dye and a developer. As used herein, the term "formulation" generally refers to any of a dye, a developer, a formulation, a fluid, or any mixture thereof. In the present disclosure, "formulation" includes permanent hair dyes, semi-permanent hair dyes, developers, conditioners, hair growth treatments such as minoxidil manufactured under the trade name ROGAINE®, hair protein treatments, disulfide bond repair hair treatments, fluid hair treatments, fluid scalp treatments, and the like.

[0024] The embodiments of the present disclosure are configured to apply a formulation to a target area of ​​hair and scalp tissue. While any of the above-mentioned formulations are suitable for application using the embodiments described herein, the present disclosure generally refers to a hair dye formulation as an example of a treatment formulation applied by the systems and devices described below. However, it will be understood that any of the systems, devices, cartridges, and methods may be utilized with any of the above-mentioned formulations.

[0025] 1 illustrates one exemplary pharmaceutical formulation delivery system 100 according to the present disclosure. Pharmaceutical formulation delivery system 100 includes a number of different features, including a pharmaceutical formulation product line 102, a pharmaceutical formulation delivery device 104, and an optional application 106. Together, pharmaceutical formulation delivery system 100 enables a customized user experience.

[0026] The formulation product line 102 includes various formulations 108. Each formulation is stored in the same (common) formulation cartridge 110 type configured for use with the formulation delivery device 104. Cartridges of the common formulation cartridge type are typically configured for insertion into cartridge cavities in the reusable handle of the formulation delivery device. For example, in some embodiments, the formulation cartridge and the cleaning cartridge have a common cross-sectional shape and dimensions. Additionally, some embodiments of the common formulation cartridge type have a common number and arrangement of output nozzles.

[0027] Thus, a common formulation cartridge 110 type allows consumers to utilize many different formulations with a single formulation delivery device 104. Exemplary formulation cartridge 110 types are described below in Figures 8A-10, and an exemplary cleaning cartridge 112 is described below in Figure 12.

[0028] In one exemplary embodiment, the formulation product line 102 includes a hair color formulation and a scalp treatment formulation. In other exemplary embodiments, the formulation product line 102 includes at least two, three, four, five, six, seven, or eight of the following different formulations, each contained within the same formulation cartridge 110 type: permanent hair color and developer, semi-permanent hair color and developer, shampoo, conditioner, hair growth treatment such as minoxidil, hair protein treatment, disulfide bond repair hair treatment, or fluid scalp treatment. In further exemplary embodiments, the formulation product line 102 includes any combination of the above, in addition to an optional cleansing cartridge 112 within the same formulation cartridge 110 type.

[0029] The formulation cartridge 110 has an elongated shape and dimensions configured to be inserted into the handle of the formulation delivery device 104, specifically into a cartridge cavity in the handle. In some embodiments of the formulation delivery system 100, the elongated outer housing has different structures between the formulation-containing formulation cartridge 110 and the cleaning cartridge 112, but has a common shape and dimensions. For example, in some embodiments, the formulation-containing formulation cartridge 110 has the structure of the partially recyclable embodiment shown in Figures 8A-10, while the cleaning cartridge 112 has a similar shape and dimensions but different materials and components.

[0030] Another feature of the formulation cartridge 110 is a plurality of fluid output nozzles sized and disposed at the distal (forward) end of the formulation cartridge 110 in a configuration that fluidly communicates with a corresponding plurality of fluid inlets (e.g., first formulation inlets). In some embodiments, the fluid output nozzles are valves of a formulation packet disposed within the formulation cartridge 110.

[0031] An exemplary formulation cartridge 110 type is described below with reference to Figures 8A-10. This exemplary formulation cartridge 110 type is configured to be inserted into the formulation delivery device 104 and to store a first formulation and a second formulation.

[0032] The cleaning cartridge 112, which is of the common formulation cartridge 110 type (i.e., having common outer dimensions and multiple fluid output nozzles), allows a user to clean the formulation delivery device 104 by executing a cleaning routine that flows a cleaning liquid (e.g., water) from the cleaning cartridge 112 through the fluid conduits of the formulation delivery device 104, thereby removing any residual formulation within the formulation delivery device 104. Advantageously, the cleaning cartridge 112 and cleaning routine allow a significant portion of the formulation delivery device 104 to be reused for different formulations, thereby reducing waste and costs.

[0033] The cleaning cartridge 112 includes a refillable cleaning fluid reservoir disposed within an outer housing. The reservoir is in fluid communication with multiple output nozzles. Thus, a user can fill the cleaning fluid reservoir with a cleaning fluid, such as water, run multiple cleaning routines on the formulation delivery device 104, and refill the cleaning fluid reservoir.

[0034] The formulation delivery device 104 is a connected electromechanical appliance that interacts with a user, a formulation cartridge 110, and optionally an application 106 to provide a customized and personalized user experience. An exemplary formulation delivery device and its subsystems are described below with respect to Figures 4-7.

[0035] Generally, the formulation delivery device 104 comprises a reusable handle configured to accept a formulation cartridge 110, a formulation dispensing assembly, and a controller. The formulation dispensing assembly and controller are both disposed within the reusable handle. The formulation dispensing assembly comprises at least one fluid conduit in fluid communication with an electric pump and a reciprocating nozzle assembly. The formulation dispensing assembly is configured to aspirate the formulation or cleaning solution from the formulation cartridge 110 and dispense it through the reciprocating nozzle assembly onto a user's hair, scalp, or body part.

[0036] The controller is configured to toggle between at least a cleaning routine and a formulation routine in response to one or more inputs indicating a cleaning cartridge or formulation cartridge inserted into the reusable handle. The controller communicates with an encryption chip reader of a cartridge authentication interface in the reusable handle to read an encryption chip disposed on the formulation cartridge 110 to authenticate which formulation 108 is stored in the formulation cartridge 110 inserted into the reusable handle at any given time. In some embodiments, the controller also authenticates the cleaning cartridge 112 when it is inserted into the reusable handle. Based on the authenticated formulation 108 or cleaning cartridge 112, the controller causes the formulation delivery device 104 to execute a formulation routine that dispenses the authenticated formulation from the formulation cartridge through the formulation dispensing assembly. Based on the authenticated cleaning cartridge 112, the controller also causes the formulation delivery device 104 to execute a cleaning routine that dispenses a cleaning fluid through the formulation dispensing assembly.

[0037] The application 106 comprises logic configured to operate on a non-transitory, machine-readable storage medium and includes modules to personalize the user experience, provide useful analytics, and enable e-commerce. The application 106 executes on a mobile device 114, such as a smartphone, tablet, or the like, and interacts with a user (e.g., an end user or salon technician) and provides actionable information through multiple modules, as described below with respect to Figure 3. In some embodiments, the application 106 communicates with the formulation delivery device 104 and a network 116 (e.g., a mobile network, a cloud-based enterprise network, a local area network, etc.).

[0038] Together, the formulation product line 102, the formulation delivery device 104, and the application 106 provide an improved and customized user experience. Each of the aforementioned elements of the formulation delivery system 100 will now be described in detail.

[0039] To facilitate understanding of this particular exemplary feature, Figure 2 shows a schematic diagram of an exemplary formulation delivery device 200. It will be understood that formulation delivery device 200 has the same features as formulation delivery device 104 of Figure 1.

[0040] The formulation delivery device 200 includes a reusable handle 202 having a hollow elongated portion configured to reversibly accept common formulation cartridge types, including the cleaning cartridge 112. The reusable handle 202 also houses a number of subassemblies, including a controller 204 including a processor 206 and a data store 208 that stores a number of modules (described below), a cartridge authentication interface 210, a power source 212, a formulation dispensing assembly 214, and an optional position sensor 216.

[0041] In some embodiments, the power source 212 is a direct current (DC) power source, such as a rechargeable battery (e.g., a lithium-ion battery) configured to be charged by plugging it into a household AC outlet. In other embodiments, the power source 212 is an alternating current (AC) power source, such as a typical household AC power source that utilizes a power cord (not shown) to power the formulation delivery device 200.

[0042] The formulation dispensing device assembly 214 delivers the formulation and / or cleaning solution from the formulation cartridge 110 to the user's scalp or hair. In one embodiment, the formulation dispensing assembly 214 includes a first fluid conduit in fluid communication with a first formulation inlet (which mates with a first fluid output nozzle of the formulation cartridge 110), a second fluid conduit in fluid communication with a second formulation inlet (which mates with a second fluid output nozzle of the formulation cartridge 110), a motor 218, a pump 220 driven by the motor 218, and a reciprocating nozzle assembly 222 also driven by the motor 218.

[0043] The cartridge authentication interface 210 is an RFID reader, a near field reader, etc. When the formulation cartridge 110 is inserted into the reusable handle 202, the cartridge authentication interface 210 is disposed within the reusable handle 202 to read an encryption chip disposed on the formulation cartridge 224 and authenticate the formulation cartridge in conjunction with a formulation routine module 226, described below.

[0044] The optional position sensor 216 includes one or more sensors that, singly or collectively, assist in determining the position and orientation of the formulation delivery device 200 relative to the user's scalp or hair. In some embodiments, the position sensor 216 includes one or more acceleration sensors, touch sensors (e.g., capacitive touch sensors), proximity sensors (e.g., optical proximity sensors), etc. Signals transmitted from the position sensor 216 are used by the controller 204, and this particular module, to improve the accuracy and efficiency of formulation application to the user's hair or scalp.

[0045] The controller 204 is operatively connected (e.g., electrically connected) to a power source 212, a cartridge authentication interface 210, a formulation dispensing assembly 214, and an optional position sensor 216. The controller 204 includes multiple modules implemented as a processor 206 (e.g., a general processing unit, a graphical processing unit, or an application-specific integrated circuit), a data store 208 (a tangible machine-readable storage medium), software logic (e.g., executable software code), firmware logic, hardware logic, or various combinations thereof. In some embodiments, the controller 204 includes a transceiver for transmitting signals from any of the modules described below to the mobile device and receiving signals transmitted from the mobile device.

[0046] In some embodiments, the controller 204 includes a communication interface having circuitry configured to enable communication with a formulation delivery system, including the formulation cartridge 224 (encryption chip), the cleaning cartridge 228, the cartridge authentication interface 210, a mobile device and applications stored thereon, and / or other network elements, over the Internet, a cellular network, an RF network, a personal area network (PAN), a local area network, a wide area network, or other networks. Accordingly, the communication interface can be configured to communicate using wireless protocols (e.g., WIFI, WIMAX, BLUETOOTH, ZIGBEE, cellular, infrared, near field, etc.) and / or wired protocols (e.g., Universal Serial Bus or other serial communications buses such as RS-216, RJ-45, or other parallel communications buses). In some embodiments, the communication interface includes circuitry configured to initiate a discovery protocol that enables the controller 204 and other network elements (e.g., formulation cartridge 110) to identify each other and exchange control information (e.g., identification of the formulation stored in the formulation cartridge 110). In one embodiment, the communication interface has circuitry configured to conduct the discovery protocol and negotiate one or more pre-shared keys.

[0047] The data store 208 is a tangible, machine-readable storage medium that includes a mechanism for storing information in a non-transitory form that is accessible by a machine (e.g., the processor 206 or the mobile device 114). For example, machine-readable storage media include recordable and non-recordable media (e.g., read-only memory (ROM), random access memory (RAM), magnetic disk storage media, optical storage media, flash memory devices, etc.).

[0048] The modules described below are representative and not limiting, and thus some embodiments of controller 204 include additional modules, while other embodiments include fewer than all of the modules.

[0049] The cartridge authentication module 230 communicates with the cartridge authentication interface 210 to authenticate any formulation cartridge 224 or cleaning cartridge 228 inserted into the reusable handle 202. For example, when a formulation cartridge 224 is inserted into the reusable handle 202, the cartridge authentication interface 210 reads encrypted information from an encryption chip located on the formulation cartridge 224. If the cartridge authentication interface 210 successfully reads the encrypted information from the encryption chip, then the cartridge authentication module 230 "unlocks" the formulation delivery device 200 (e.g., the formulation routing module 226). However, if the cartridge authentication interface 210 does not successfully authenticate the formulation cartridge inserted into the reusable handle 202, the formulation delivery device 200 is not unlocked. For example, if the formulation cartridge is a counterfeit cartridge or another cartridge containing an inferior formulation, the cartridge authentication module 230 does not unlock the functionality of the formulation delivery device 200. In this way, the cartridge authentication module 230 advantageously prevents users from suffering harm or having a poor experience.

[0050] In some embodiments, cartridge authentication module 230 is configured to read additional information from the encryption chip, including one or more of a formulation identification, a starting formulation amount, a formulation expiration date, or a formulation manufacturing date. In such embodiments, cartridge authentication module 230 transmits the additional information to other modules for subsequent use.

[0051] The formulation routine module 226 stores multiple formulation routines (e.g., hair care formulation routines) for various formulations and causes the formulation dispensing assembly 214 to execute one or more formulation routines based on the formulation cartridge 224 authenticated by the cartridge authentication module 230. The formulation routine ejects the authenticated formulation 108 from the formulation cartridge 224 through the reciprocating nozzle assembly 222. For example, the hair care formulation routine ejects one or more hair care formulations from the reciprocating nozzle assembly 222 at a specific ejection time, a specific pump liquid flow rate (e.g., an operating flow rate of about 20 mL / min to about 40 mL / min, about 20 mL / min to about 30 mL / min, about 24 mL / min to about 36 mL / min), a nozzle reciprocation frequency and / or reciprocation amplitude of the reciprocating nozzle assembly 222, and / or other device operating parameters specified by the formulation routine stored in the formulation routine module 226. In this manner, the formulation delivery device 200 adjusts one or more device operating parameters based on the particular formulation stored in the authenticated formulation cartridge 224 inserted into the formulation delivery device to provide more effective hair and scalp treatment.

[0052] In some embodiments, the formulation routine module 226 determines the amount of formulation to be dispensed from the formulation cartridge through the formulation dispensing assembly based on the dispense time of the authenticated formulation. Based on the dispense time and / or dispensed amount, the formulation routine module 226 causes a visual indicator on the reusable handle 202 to indicate the amount of formulation remaining. This helps the user predict when the formulation cartridge will need to be replaced and prompts the user to conveniently procure additional formulation cartridges using the e-commerce module of the connected application.

[0053] The cleaning routine module 232 stores a cleaning routine and causes the formulation dispensing assembly 214 to execute the cleaning routine after the cleaning cartridge 228 (having a reservoir filled with cleaning fluid) is inserted into the reusable handle 202 and authenticated by the cartridge authentication module 230. The cleaning routine dispenses cleaning fluid (e.g., for a predetermined time and at a predetermined flow rate) from the authenticated cleaning cartridge 228 through the reciprocating nozzle assembly 222 to expel any residual formulation within the formulation dispensing assembly 214. The cleaning routine is useful, for example, after one formulation has been utilized in the formulation delivery device 200, but before a second, different formulation is utilized. In some embodiments, the cleaning routine operates the pump 220 at a higher flow rate than one or more (or all) formulation routines stored by the formulation routine module 226 to clear any residual formulation. In other words, in some embodiments, the flush routine operates pump 220 at a flush flow rate, which in any embodiment may be about 1 mL / min to about 5 mL / min higher than the operating or priming flow rate of pump 220.

[0054] In some embodiments, the controller 204 is configured to toggle between at least a cleaning routine (provided by the cleaning routine module 232) and a formulation routine (provided by the formulation routine module 226) in response to one or more inputs indicative of a cleaning cartridge or a formulation cartridge inserted into the reusable handle. Exemplary inputs include authentication of the formulation cartridge or cleaning cartridge, provided by the cartridge authentication module 230.

[0055] According to the methods of the present disclosure, a method for cleaning any formulation delivery device includes inserting a cleaning cartridge at least partially filled with cleaning fluid into a reusable handle of the formulation delivery device, and performing a cleaning routine until the cleaning fluid dispensed through the formulation dispensing assembly is clean.

[0056] The power management module 234 provides power from the power source 212 to one or more of the controller 204, the cartridge authentication interface 210, the formulation dispensing assembly 214, or the position sensor 216. Additionally, the power management module 234 conserves available power resources (e.g., conserves battery life) by toggling the formulation delivery device 104 between a sleep state (passive state) and an awake state (active state).

[0057] The sleep / awake module 236 manages whether the formulation delivery device 200 is in an awake or sleep state. The formulation delivery device 200 is in a sleep state by default, which provides little or no power from the power source 212 to the formulation dispensing assembly 214, the cartridge authentication interface 210, and / or the controller 204. In the sleep state, the formulation delivery device 200 is unable to execute formulation or cleaning routines. In contrast, in the awake state, the controller 204, the cartridge authentication interface 210, the formulation dispensing assembly 214, and the position sensor 216 are sufficiently powered to enable the formulation delivery device 104 to execute one or more formulation or cleaning routines. In some embodiments, the formulation delivery device 104 is "awake," i.e., brought from the sleep state to the awake state, by pressing a button located on the reusable handle 202 or by inserting a formulation cartridge 224 or cleaning cartridge 228 into the reusable handle 202. In some embodiments, the formulation delivery device 200 returns to a sleep state after a predetermined period of inactivity (eg, 120 seconds of inactivity).

[0058] The location module 238 utilizes the location signal provided by the position sensor 216 to determine the location of the formulation delivery device 200. This location information is then provided to the formulation routine module 226 to facilitate the execution of a formulation routine, e.g., a calibration routine. In some embodiments, the location module 238 provides the location signal to an application stored on the mobile device (via the transceiver), e.g., to enable the execution of a calibration routine (described below) and / or to enable the application to display the correct application display based on the location signal.

[0059] The priming module 240 performs one or more priming sequences, which beneficially primes the formulation-dispensing assembly 214 with one or more formulations from the formulation cartridge 224. Priming is particularly beneficial when a formulation cartridge 224 containing one or more different formulations (relative to the previous cartridge) is inserted into the handle 202. In such cases, it is desirable to purge the previous formulation(s) from the fluid conduits of the formulation-dispensing assembly 214 to avoid the undesirable result of, for example, dyeing hair the wrong color. Priming also removes air pockets from the formulation-dispensing assembly 214 and ensures a uniform mixing of two or more formulations from the formulation cartridge 224.

[0060] 13-14. For example, in any embodiment, the priming sequence comprises simultaneously pumping a first formulation and a second formulation from the formulation cartridge 224 for a first time period, thereby causing the first formulation and the second formulation to flow from the formulation cartridge 224, through the pump 220, and out the reciprocating nozzle assembly 222. As another example, in any embodiment, the priming sequence comprises pumping a mixture of the first and second formulations through the reciprocating nozzle assembly 222 at a priming flow rate that is about 1 mL / min to about 5 mL / min above the operating flow rate of any formulation routine. Advantageously, this reduces the time required to complete the priming sequence, improving the user experience.

[0061] 3 illustrates an overview of an exemplary application 300, which has all the features of application 106 of FIG. 1 and is understood to be compatible with all formulation delivery systems and devices of the present disclosure. As discussed above, application 300 is configured to run on a device (e.g., a mobile device such as a smartphone or tablet). As one representative example, but not by way of limitation, application 300 is described in the context of a mobile device 302 connected to a network 304.

[0062] The mobile device 302 has a display 306 (e.g., an LED or LCD display), a processor 308, and a data store 310 that stores a number of modules. The terms "processor," "data store," and "module" have the same meaning as described above with respect to the controller 204 and as used below in connection with the exemplary pharmaceutical formulation delivery device.

[0063] Each module described below presents one or more user interfaces on display 306. Display 306 is a touch-sensitive display configured to accept user input on display 306. Thus, for each module, the user interface presented on display 306 is configured to both display information and accept user input.

[0064] Application 300 includes a number of modules that personalize the user experience, including a user profile module 312 and a user routines module 314. The modules described below are representative and not limiting. Thus, some embodiments of application 300 include additional modules, while other embodiments include fewer than all of the modules.

[0065] The user profile module 312 builds one or more profiles for users of the formulation delivery device 104. These profiles are provided as inputs to other modules, such as the user routines module 314 and the e-commerce module 316. Accordingly, the user profile module 312 provides one or more user interfaces that prompt the user to provide one or more user profile inputs. The one or more user profile inputs include hair color, hair type (e.g., curly, straight), colored / uncolored condition, ethnicity, hair condition (e.g., damaged), scalp condition (e.g., itchy), and / or age. The user profile module 312 accepts and stores the user profile inputs.

[0066] In some embodiments, the user profile module 312 communicates with the user routine module 314 by providing one or more user profile inputs, or the entire user profile, to the user routine module 314. The user routine module 314 then utilizes the one or more user profile inputs to create one or more user-specific routines for the user and / or select one or more tutorials to present on the display 306.

[0067] In some embodiments, the user profile module 312 is in communication with the formulation delivery device 104. For example, in some embodiments, the user profile module 312 adjusts at least one device operating parameter (e.g., flow rate, delivery time, shuttle amplitude, or shuttle frequency) of the formulation routine generated by the formulation routine module based on one or more of the user profile inputs.

[0068] The user routine module 314, in some embodiments, assists users in effectively utilizing the connected formulation delivery device by developing one or more user-specific routines for each user based on one or more user profile inputs. That is, the user routine module 314 constructs a new formulation routine (rather than selecting a pre-defined formulation routine) to effectively treat one or more conditions or achieve one or more goals identified by the user profile input. As a representative example, if the user input indicates that the user's hair is colored and damaged, the user routine module 314 constructs a user-specific routine that selects a hair repair formulation and shampoo formulation appropriate for the user's hair color from a formulation product line and displays (e.g., as instructions) the user-specific routine for applying the selected hair repair formulation and shampoo at determined intervals to improve the health of the user's hair.

[0069] Additionally, the user routine module 314 displays on the display 306 a) one or more passive tutorials for formulation routines, cleaning routines, and / or calibration routines, and / or one or more active instruction sets that instruct the user as they use the formulation delivery device.

[0070] In some embodiments, the user routine module 314 receives one or more of the user profile inputs, or the entire user profile, from the user profile module 312. The user routine module 314 then displays a passive tutorial (e.g., a pre-recorded instructional video) targeted to the user based on the received user profile input or the user profile. As an example, the user routine module 314 receives a user profile input from the user profile module 312 indicating that the user's hair is being colored and displays a tutorial on the display 306 that shows the user how to use the formulation delivery device to color the user's hair.

[0071] In some embodiments, the user routine module 314 receives, via the controller, one or more position signals from a position sensor of the formulation delivery device. Based on the received position signals, the user routine module 314 instructs the user on how to use the formulation delivery device when the user uses the formulation delivery device (e.g., instructing the user to move the formulation delivery device in a particular direction, at a particular speed, in a particular pattern, to a particular spatial boundary). As an example, the user routine module 314 may receive a position signal from the position sensor indicating that the formulation delivery device is positioned at the user's left temple, and based on the received position signal, the user routine module 314 may display a video instructing the user to apply a scalp treatment formulation by moving the formulation delivery device from the left temple to the right temple while expelling the scalp treatment formulation.

[0072] In some embodiments, the user routine module 314 receives a location signal from the formulation delivery device and displays the correct application display based on the location signal.

[0073] The calibration module 318 helps a user calibrate the formulation delivery device, thereby improving the effectiveness of the formulation routine executed by the formulation delivery device. In some embodiments, the calibration module 318 displays a passive tutorial (e.g., a pre-recorded instructional video) that instructs the user on how to complete the calibration routine. In some embodiments, the calibration module 318 provides one or more active instruction sets that instruct the user on how to complete the calibration routine when the user uses the formulation delivery device and when the calibration module 318 receives a position signal from the formulation delivery device.

[0074] According to one exemplary calibration routine, the calibration module 318 instructs the user to position the formulation delivery device at multiple calibration positions on the user's body part, for example, in a specific order (e.g., left temple, then right temple, then front hairline, then back hairline). The user then moves the formulation delivery device to each calibration position and (the calibration module 318) indicates with a button press or other action on the formulation delivery device when the formulation delivery device is in the designated calibration position and / or while the user moves the formulation delivery device from one calibration position to another.

[0075] Based on the position signal received from the position sensor of the formulation delivery device, the calibration module 318 and / or the formulation delivery device records the calibration position. The calibration module 318 and / or the formulation delivery device then adjusts one or more user-specific routines based on the recorded calibration position. In some embodiments, this adjustment step includes adjusting the spatial limits and / or temporal duration of one or more formulation routines stored in the formulation routine module.

[0076] To benefit from greater control over the formulation delivery device and a more customized user experience, the manual adjustment module 320 enables a user to manually adjust one or more device operating parameters (e.g., flow rate, ejection time, oscillation amplitude, or oscillation frequency) of the formulation delivery device. Accordingly, the manual adjustment module 320 presents a user interface having one or more user-adjustable virtual sliding scales, switches, editable value fields, etc. The user interface is configured to accept one or more operating parameter inputs from the user. The manual adjustment module 320 receives the operating parameter inputs and transmits the operating parameter inputs to the formulation delivery device (e.g., formulation routine module). The formulation delivery device adjusts corresponding device operating parameters based on (e.g., to match) the corresponding operating parameter inputs.

[0077] The analytics module 322 receives device operating parameters (e.g., from the drug delivery device) and calculates useful analytics, which the analytics module 322 then provides to a user via a user interface and / or to third parties via the network 304. Exemplary analytics include drug usage patterns, drug purchase predictions, and drug delivery device diagnostics. In some embodiments, the analytics module 322 communicates with the network 304 (e.g., an analytics platform located on one or more cloud-based servers) to obtain additional information and / or calculate the analytics.

[0078] In some embodiments, the formulation delivery device includes a location sensor that transmits a location signal to the controller and a transceiver that transmits the location signal to the mobile device. The formulation delivery device transmits the location signal to the analysis module 322. The analysis module 322 obtains user suggestions from an analysis platform on the network 116 based on the received location signal and displays the user suggestions.

[0079] The formulation creation module 324 enables a user to create a custom formulation based on the user's selection of one or more formulation inputs, which correspond to one or more desired results (e.g., a desired hair color), one or more formulation inputs (e.g., an indication that the user's hair is damaged), and / or one or more user profile inputs provided to the user profile module 312. Thus, the formulation creation module 324 is configured to receive one or more user profile inputs from the user profile module 312 and formulate a custom formulation based on these inputs.

[0080] To facilitate user creation of custom formulations, formulation creation module 324 provides a user interface with one or more user-adjustable virtual sliding scales, switches, editable value fields, etc. corresponding to each formulation input. In some embodiments, formulation creation module 324 communicates with network 304 (e.g., a database of formulations located on one or more cloud-based servers) to obtain additional information and / or formulate the custom formulation.

[0081] The e-commerce module 316 presents a purchasing interface through which a user can purchase products related to the formulation delivery device (including on a one-time or subscription basis). In some embodiments, the e-commerce module 316 obtains one or more custom formulations from the formulation creation module 324 (or a component thereof) and presents options on the purchasing interface for the user to purchase one or more formulation cartridges 110 containing the custom formulations. In some embodiments, the e-commerce module 316 obtains one or more user profile inputs and / or user-specific routine inputs from the user profile module 312 and presents options on the purchasing interface for the user to purchase one or more formulation cartridges containing formulations targeted to the user profile inputs (e.g., a formulation cartridge containing a hair repair formulation if the user input indicates damaged hair). In some embodiments, the e-commerce module 316 presents options on the purchasing interface for purchasing the cleaning cartridge 112 or the formulation delivery device 104 and / or components thereof. Such purchasing interface and purchasing options may be based on formulation usage patterns and / or formulation purchase predictions obtained from the analytics module 322.

[0082] 4-5 illustrate an exemplary formulation delivery device 400 and its components according to embodiments of the present disclosure. The formulation delivery device 400 is configured to accept a formulation cartridge type 402 (including a cleaning cartridge of the same type). One formulation cartridge embodiment of formulation cartridge type 402 is described in detail below with respect to FIGS. 8A-10. The formulation cartridge 402 shown in FIG. 4 shall be understood to have the same features as described below. Some embodiments of the formulation delivery device 400 include a formulation cartridge 402 and / or an optional pull-through adapter 404.

[0083] The formulation delivery device 400 includes a reusable handle 406 formed from ABS plastic, a similar hard polymer, or other material. In some embodiments, the reusable handle 406 is an assembly formed from multiple shells configured to be joined with fastening elements, such as snaps, screws, or the like. The reusable handle 406 has a hollow, elongated gripping portion having a cartridge cavity therein that is sized and dimensioned to receive a formulation cartridge 402. In some embodiments, the cavity includes keying features that allow for easy and accurate insertion of the formulation cartridge 402. For example, some embodiments include a cartridge interface 408 that is positioned in the opening and has a flat docking surface that interfaces with a corresponding docking surface on the formulation cartridge 402 when the formulation cartridge 402 is properly inserted into the opening.

[0084] The reusable handle 406 houses a formulation dispensing assembly 410 (described below with respect to Figures 5-7) as well as a controller 412. The formulation dispensing assembly 410 and the controller 412 have similar features to the formulation dispensing assembly 214 and the controller 204, respectively, of Figure 2. One embodiment of a formulation dispensing assembly is described in detail below with respect to Figures 6-7, although it should be understood that the formulation dispensing assembly 410 shown in Figure 4 has similar features as described therein.

[0085] The formulation dispensing assembly 410 dispenses the formulation or cleaning fluid from the formulation cartridge 402. The formulation dispensing assembly 410 includes a pump, a fluid conduit, a mixing chamber, and a reciprocating nozzle assembly 414 (described below) having a nozzle extending away from the front end of the reusable handle 406 between a plurality of optional standoff portions 416. The reciprocating nozzle assembly 414 includes a plurality of annular nozzles that reciprocate back and forth along a trajectory of the reusable handle 406 while dispensing the formulation onto the user's skin or hair. In some embodiments, the reciprocating nozzle assembly 414 reciprocates with a reciprocating amplitude of 7.0-12.0 mm (e.g., 8.0 mm-11.0 mm, or 9.0-10.0 mm) and / or a reciprocating frequency of 5.0 Hz-10.0 Hz (e.g., 6.0 Hz-9.0 Hz, 6.0 Hz-8.0 Hz). The oscillation amplitude and / or oscillation frequency can be adjusted by a formulation routine module, a cleaning routine module, a user routine module, a manual adjustment module, or other modules.

[0086] 5, the formulation cartridge 402 has one or more formulation packs 418 disposed therein. Each formulation pack 418 has an output nozzle 420 that protrudes through the distal (forward) end of the formulation cartridge 402 in a configuration that is in fluid communication with a corresponding formulation inlet 422 of the formulation dispensing assembly 410 when the formulation cartridge 402 is fully inserted into a cartridge cavity 424.

[0087] A button 426 disposed on the reusable handle 406 and electrically connected to the controller 412 activates the mechanisms of the formulation delivery device 400 described above. In some embodiments, pressing the button 426 activates the mechanisms of any of the modules described above in FIG. 2 . For example, in some embodiments, pressing the button 426 activates a sleep / awake module stored in the controller 412, thereby waking the formulation delivery device 400 from a sleep state to an awake state. In some embodiments, pressing the button 426 while a formulation cartridge is inserted into the reusable handle 406 activates a formulation routine module stored in the controller 412, which initiates a formulation routine.

[0088] In some embodiments, pressing the button 426 while the cleaning cartridge is inserted into the reusable handle 406 activates a cleaning routine module stored in the controller 412, thereby initiating a cleaning routine. A visual indicator 428 (e.g., an LED) located along the reusable handle 406 indicates one or more of the remaining amount of formulation or the remaining battery capacity, for example, based on the delivery time determined by the formulation routine module of the controller. Some embodiments include additional buttons and / or multiple types of visual indicators 428 with different functionality and are not limited to the illustrated embodiment. In some embodiments, the visual indicator 428 is a multi-segment LED, with each segment equally corresponding to the percentage of formulation remaining in the formulation cartridge.

[0089] The controller 412 includes logic (stored in this data store) that, when executed by a processor in the controller 412, causes a cartridge authentication interface 430 (e.g., an RFID reader) located in the reusable handle 406 to read an encryption chip 432 on the formulation cartridge 402 to authenticate the formulation cartridge 402. The encryption chip 432 stores at least one of the formulation cartridge 402, a formulation identification, a starting formulation quantity, a formulation expiration date, or a formulation manufacturing date.

[0090] The controller 412 also comprises logic that, when executed, causes the formulation delivery device to execute a formulation routine that dispenses a mixed formulation (of the first and second formulations) from the formulation cartridge 402 via the formulation dispensing assembly based on authentication of the formulation cartridge 402. For example, the formulation delivery device authenticates the first and second formulations after (or upon) insertion of the formulation cartridge into the reusable handle. Then, in response to depression of a button on the reusable handle, executes a formulation routine that causes the formulation dispensing assembly 410 to mix the first and second formulations sequentially or continuously and dispense the formulations from the reciprocating nozzle assembly at one or more of the predetermined device operating parameters (formulation flow rate, reciprocation frequency, or reciprocation amplitude) for as long as the button is pressed.

[0091] Also, in some embodiments, the controller 412 comprises logic that, when executed, causes the formulation delivery device to execute a cleaning routine that dispenses cleaning fluid through the formulation dispensing assembly based on authentication of a cleaning cartridge inserted into the reusable handle. For example, the formulation delivery device authenticates a cleaning cartridge inserted into the reusable handle. Then, in response to pressing a button on the reusable handle, executes a cleaning routine that causes the formulation dispensing assembly 410 to continuously or continuously dispense cleaning fluid (e.g., water) from the reciprocating nozzle assembly at one or more predetermined device operating parameters (cleaning fluid flow rate, reciprocation frequency, or reciprocation amplitude) for as long as the button is pressed. In some embodiments, the cleaning fluid flow rate is higher than the formulation flow rate of any of the one or more formulation routines stored in the controller 412, for the benefit of effectively flushing residual formulation from the formulation dispensing assembly.

[0092] The pull-through adapter 404 attaches to the reusable handle 406 over the reciprocating nozzle assembly 414. In some embodiments, the pull-through adapter 404 provides an audible feedback signal when properly engaged with the reusable handle 406.

[0093] 6-7 illustrate an exemplary formulation dispensing assembly 600, which is compatible with any of the formulation delivery devices, formulation cartridges, and cleaning cartridges described herein. The primary function of formulation dispensing assembly 600 is to dispense a mixed formulation of two different formulations from the formulation cartridges onto a user's skin or hair. In some embodiments, formulation dispensing assembly 600 dispenses the mixed formulation at a flow rate of 20-40 mL / min or 120 mL per 4 minutes, e.g., 20-35 mL / min, 20-30 mL / min, 20-25 mL / min, 25-35 mL / min, 25-30 mL / min, or 35-40 mL / min.

[0094] The formulation dispensing assembly 600 includes a first formulation inlet 602 and a second formulation inlet 604, and a first fluid conduit 606 and a second fluid conduit 608. The first fluid conduit 606 and the second fluid conduit 608 are in fluid communication with the first formulation inlet 602 and the second formulation inlet 604, respectively. In some embodiments, each of the first formulation inlet 602 and the second formulation inlet 604 is formed as a protrusion extending rearward from the first fluid conduit and the second fluid conduit, respectively, toward the rear end of the reusable handle (i.e., extending toward the cartridge cavity when disposed in the reusable handle). The protrusion is configured to protrude into the formulation cartridge.

[0095] The formulation dispensing assembly 600 also includes a motor 610, a gearbox 612 operably coupled to the motor 610, and a pump 614 driven by the motor 610 via the gearbox 612. In some embodiments, the pump 614 is a peristaltic pump, which has been discovered to improve formulation delivery when utilized in combination with the mixing chamber and tapered formulation channel described herein.

[0096] The reciprocating nozzle assembly 616 includes a plurality of annular nozzles 618 arranged on a comb 620. In use, the nozzles 618 circulate back and forth along the orbit of the reusable handle 406 while dispensing formulation onto the user's skin or hair to achieve more uniform formulation coverage. Each nozzle 618 includes a formulation channel 622 extending therethrough. Each formulation channel is fluidly connected to the first fluid conduit 606 and the second fluid conduit 608 via a manifold 624. In some embodiments, each formulation channel 622 is tapered to benefit from increased formulation discharge rate and / or improved mixing of the two formulations. Tapered formulation channels have proven advantageous when utilized in combination with other features described herein, for example, when the pump 614 is a peristaltic pump and / or when the turbulent mixing chamber includes one or more helical mixers 626.

[0097] The motor 610 and gearbox 612 drive the reciprocating nozzle assembly 616 in a linear reciprocating motion. In one embodiment, the linear reciprocating motion is motivated by an eccentric roller 628 coupled to an output shaft 630 of the gearbox 612. The eccentric roller 628 rotates within an annular bracket of the comb 620. Driving the pump 614 and the reciprocating nozzle assembly 616 from a common motor 610 improves power efficiency and reduces weight and size, thereby improving the form factor of the formulation delivery device. Nevertheless, some embodiments use two or more motors to drive the pump 614 and the reciprocating nozzle assembly 616.

[0098] Nozzle 618 is fluidly connected to first fluid conduit 606 and second fluid conduit 608 via turbulent mixing chamber 632. Turbulent mixing chamber 632 mixes a first formulation, drawn from a formulation cartridge via first fluid conduit 606, with a second formulation, drawn from a formulation cartridge via second fluid conduit 608, to produce a mixed formulation. Specifically, turbulent mixing chamber 632 combines the two formulations in a common chamber under pressure and mixes the two formulations by flowing them through one or more mixing elements, creating a turbulent flow (as distinguished from laminar flow) of the mixed formulation. The ratio of the first formulation to the second formulation varies depending on the embodiment. For example, in some embodiments, the mixed formulation is a mixture of the first formulation and the second formulation in a ratio of about 0.8:1.0 to 1.2:1.0, e.g., 0.85, 0.90, 0.95, 1.00, 1.05, 1.10, or 1.15.

[0099] In some embodiments, the turbulent mixing chamber 632 is located between the pump 614 and the reciprocating nozzle assembly 616. In this configuration, the two formulations are mixed just prior to ejection. This produces a more uniform formulation consistency compared to mixing the formulations upstream of the pump 614, resulting in better formulation ejection from the nozzle 618.

[0100] In some embodiments, the turbulent mixing chamber 632 includes a helical mixer 626 disposed therein. Some embodiments include multiple helical mixers 626 fluidly connected in series along a fluid path within the turbulent mixing chamber 632 to improve mixing. In some embodiments, each helical mixer has an outer diameter between 2.00 mm and 5.00 mm, e.g., between 3.0 mm and 4.00 mm, e.g., 3.18 mm. In some embodiments, each helical mixer has an overall length between 20.0 mm and 40.0 mm, e.g., between 25.0 mm and 35.0 mm, e.g., 33.0 mm. In some embodiments, each helical mixer has a length-diameter pitch (defined as overall length / [outer diameter * # mixing elements]) between 0.75 and 1.25, e.g., between 0.80 and 0.90, e.g., 0.865. The combination of the aforementioned specifications has been found to produce the best blend of mixed formulations. In particular, the best blending of the mixed formulations occurs when the two formulations are not mixed until downstream of pump 614, just upstream of reciprocating nozzle assembly 616, and also when pump 614 is a peristaltic pump.

[0101] In use, pump 614 draws formulation from a connected formulation cartridge, through first and second fluid conduits 606, 608, through turbulent mixing chamber 632, through manifold 624, and through nozzle 618. In the illustrated embodiment, first and second fluid conduits 606, 608 remain fluidly separated downstream of pump 614 to prevent mixing of the two formulations until turbulent mixing chamber 632. As previously mentioned, mixing the two formulations just prior to ejection (i.e., between pump 614 and manifold 624) improves consistency of the mixed formulation.

[0102] 8A-10 illustrate a representative formulation cartridge 800 that is compatible with any of the formulation delivery systems, formulation delivery devices, and formulation product lines described herein. However, the formulation delivery systems, formulation delivery devices, and formulation product lines described herein are not required to use the sustainable formulation cartridge 800 illustrated in FIGS.

[0103] The formulation cartridge 800 is a specifically designed and sustainable embodiment that reduces waste and environmental impact while providing a user-friendly experience. To this end, the formulation cartridge 800 includes two main components: a handle portion 802 and a disposable refill packet 804. The disposable refill packet 804 is configured to reversibly slide into the handle portion 802. Historically, known cartridges were designed to be completely discarded after the formulation stored therein was depleted, leading to significant waste and high consumer costs.

[0104] In contrast to known cartridges, the formulation cartridge 800 is configured such that the handle portion 802 is indefinitely reusable and only the disposable refill packets 804 need to be discarded or recycled after the formulation stored in the formulation cartridge is depleted. Furthermore, each disposable refill packet 804 is configured to be disassembled into smaller components, some of which are recycled and others of which are discarded. In this manner, the formulation cartridge 800 utilizes an innovative structure to reduce waste and improve the user experience.

[0105] The handle portion 802 is sized, dimensioned, and configured for repeated insertion into the cartridge cavity of a formulation delivery device. Accordingly, the handle portion 802 is formed of ABS plastic, a similar rigid polymer, or other material. The handle portion 802 includes a hollow handle portion 802 configured to receive a disposable refill packet 804 therein and a tray portion 806 extending away from the handle portion 802. The handle portion 802 is a two-piece assembly in the exemplary embodiment shown (although it may be one piece in other embodiments) and is sized and dimensioned to form a seamless extension to the formulation delivery device handle when fully inserted into the cartridge cavity of the formulation delivery device handle. The tray portion 806 protrudes away from the handle portion 802 and has a U-shape configured to support the disposable refill packet 804 (e.g., the front body portion 810). To facilitate secure engagement and easy removal, the handle portion 802 includes coupling means for coupling the formulation cartridge 800 to the reusable handle of the formulation delivery device. Exemplary coupling means include a cartridge release 812 (eg, a latch) formed on the handle portion 802. The cartridge release 812 engages with the formulation delivery device upon proper and complete insertion.

[0106] The disposable refill packet 804 contains a first formulation packet 814 and a second formulation packet 816, which contain a first formulation 818 and a second formulation 820, respectively. The first formulation packet 814 and the second formulation packet 816 each have a volume between 40 mL and 70 mL, e.g., 50 mL to 60 mL, or 55 mL. In some embodiments, the first formulation packet 814 and the second formulation packet 816 have different volumes.

[0107] First formulation 818 and second formulation 820 can each be any formulation described herein. The formulations can be, for example, permanent hair dyes, semi-permanent hair dyes, color developers, conditioners, hair growth agents such as minoxidil, hair protein treatments, disulfide bond repair hair treatments, fluid hair treatments, fluid scalp treatments, etc. In some embodiments, first formulation 818 and second formulation 820 are different. For example, in some embodiments, first formulation 818 is a hair dye and second formulation 820 is a color developer. In other embodiments, first formulation 818 and second formulation 820 are the same (e.g., a conditioner or scalp treatment formulation).

[0108] As shown in FIG. 9 , each formulation packet includes a formulation-containing packet 822 and valve means for selectively fluidly coupling the disposable refill packet to a dispensing nozzle unit of a formulation delivery device when the formulation cartridge 800 is received within the handheld formulation dispensing device. Exemplary valve means includes a valve 824 through which formulation exits packet 822. Exemplary formulation packets are described in International Patent Application No. PCT / US2018 / 052345, filed September 24, 2018, and assigned to L'Oreal SA, and U.S. Patent Application No. 17 / 133110, filed December 23, 2020, and assigned to L'Oreal SA, both of which are incorporated herein by reference in their entirety for all purposes.

[0109] The disposable refill packet 804 also includes a disposable elongated body portion 826. The disposable elongated body portion 826 provides structure to the disposable refill packet 804 and includes the first formulation packet 814 and the second formulation packet 816. In some embodiments, the body portion 826 has an overall length of between 150 mm and 250 mm (e.g., 175 mm to 225 mm, 185 mm to 215 mm, 195 mm to 205 mm, or 200 mm) and a maximum cross-sectional dimension of 25 mm to 50 mm (e.g., 30 mm to 45 mm, 35 mm to 40 mm, or 36 mm). The body portion 826 includes a rear body portion 828 and an elongated front body portion 810. The rear body portion 828 has a larger cross-sectional dimension than the front body portion 810 and resides within the handle portion 802 (e.g., by a friction fit) during use. An elongated front body portion 810 is supported by the tray portion 806 of the handle portion 802 and protrudes into the cartridge cavity of the pharmaceutical delivery device during use.

[0110] In the illustrated embodiment, body portion 826 is constructed from a recyclable material, such as structured paper (e.g., cardboard). In some embodiments in which body portion 826 is formed from paper, the paper has a weight between 8 and 12 points (e.g., 8.5 points, 9.0 points, 9.5 points, 10.0 points, 10.5 points, 11.0 points, or 11.5 points) to provide sufficient rigidity without excessive disposable material. In some such embodiments, body portion 826 is formed from a single recyclable material. By way of example, in the illustrated embodiment, body portion 826 is formed from a single piece of paper. As shown in FIG. 9 , this folding configuration forms an eight-sided polygonal cross-section in rear body portion 828 and a six-sided polygonal cross-section in front body portion 810. To facilitate assembly, some embodiments of body portion 826 include one or more scores or guidelines to ensure proper folding. The polygonal cross-sections of the illustrated embodiments are representative and not limiting. Other embodiments have a triangular, rectangular, pentagonal, hexagonal, heptagonal, octagonal, or other polygonal cross-sectional shape. In other embodiments, body portion 826 has the shapes and configurations described herein but is not constructed from recyclable materials.

[0111] The optional packet sleeve 830 provides several important advantages. First, the packet sleeve 830 provides additional structure to the disposable refill packet 804 by sliding over and reinforcing the front body portion 810. Thus, in some embodiments, the packet sleeve 830 has a greater weight or thickness compared to the material forming the body portion 826, although this is not required. In some embodiments, the packet sleeve 830 is also formed from a recyclable material, which may be the same recyclable material as the body portion 826.

[0112] Second, the packet sleeve 830 couples with the valve frame 832. For example, the illustrated packet sleeve 830 includes a plurality of engagement member recesses 834 configured to reversibly couple with engagement members of the valve frame 832.

[0113] Third, the packet sleeve 830 facilitates disassembly of the disposable refill packet 804. As shown in FIGS. 8A and 9 , the packet sleeve 830 includes an optional integral tearaway 836 (e.g., perforations with a pull tab). During use, after the formulation is depleted, the user pulls the pull tab of the integral tearaway 836, thereby separating the valve frame 832 from the packet sleeve 830. Once this action is complete, the packet sleeve 830 is recycled and the valve frame 832 is discarded. In some embodiments, the integral tearaway 836 is disposed on the body portion 826, e.g., the front body portion 810.

[0114] Packet sleeve 830 provides several advantages, but is optional. In some embodiments, one or more of the above features of packet sleeve 830 are integrally formed with body portion 826.

[0115] The valve frame 832 provides a rigid structure to support the formulation packet valves 824 and the encryption chip 838 for precise and secure coupling with the formulation delivery device (particularly the formulation dispensing assembly of the formulation delivery device) and for precise positioning of the encryption chip 838 adjacent to the cartridge authentication interface of the formulation delivery device. Accordingly, the valve frame 832 is formed from ABS plastic, HDPE, or other rigid polymer or other material. A plurality of valve engagement units 840 extend through the front end of the valve frame 832. Each valve engagement unit 840 receives and secures one of the formulation packet valves 824. In some embodiments, the valve engagement units 840 are valve openings disposed through the face of the valve frame 832. The valve openings are sized to receive the valves of the formulation packet. To enable coupling with the packet sleeve 830 (or the body portion 826 in some embodiments), the valve frame 832 includes engagement members 842 (e.g., tabs) extending from the valve frame.

[0116] The encryption chip 838 is located on the disposable refill packet 804, for example, on the body portion 826 or (as in the illustrated embodiment) on the valve frame 832. The encryption chip 838 is located on the disposable refill packet 804 such that it is read by a cartridge authentication interface of a formulation delivery device when the formulation cartridge 800 is inserted into the formulation delivery device. Thus, the encryption chip 838 stores information about the formulation cartridge 800 and its contents, such as at least one of a formulation identification, a starting formulation quantity, a formulation expiration date, or a formulation manufacturing date.

[0117] Thus, the body portion 826, packet sleeve 830, formulation packet, and valve frame 832 form the disposable refill packet 804. During use, the disposable refill packet 804 is reversibly coupleable to the handle portion 802, for example, by a friction fit between the disposable refill packet 804 and the handle portion 802 and a fastening means such as a connecting tab 844 on the body portion 826 or the packet sleeve 830. The connecting tab 844 engages the handle portion 802 upon insertion of the disposable refill packet 804 into the handle portion 802 and retains it therein until it is forcefully withdrawn from the handle portion 802. To further aid in retaining the disposable refill packet 804 within the handle portion 802, the illustrated handle portion 802 includes one or more optional retention elements 846 (in this embodiment, deflectable tabs that engage the disposable refill packet 804).

[0118] Figure 11 illustrates an exemplary method 1100 of the present disclosure, which may be used with any of the formulation cartridges of the present disclosure, such as formulation cartridge 800 of Figures 8A-10.

[0119] In step 1102, an exhausted formulation cartridge is provided, i.e., a formulation cartridge in which the formulation packets therein have been exhausted of formulation. In some embodiments, the formulation cartridge is removed from the formulation delivery device, for example, by depressing a cartridge release and pulling the formulation cartridge from the formulation delivery device.

[0120] At block 1104, the disposable refill packet is separated from the reusable cartridge body, for example, by pulling the disposable refill packet away from the reusable cartridge body with sufficient force to overcome the retention force provided by the coupling tabs and retention elements.

[0121] In optional step 1106, the recyclable portion of the disposable refill packet is separated from the non-recyclable portion of the disposable refill packet. For example, the valve frame and formulation packet are separated from the body portion and / or optional packet sleeve (both of which are recyclable in some embodiments) by, for example, tearing an integral tearaway on the packet sleeve or body portion and pulling the valve frame (with the spent formulation packet secured thereto) away from the packet sleeve and body portion.

[0122] In optional step 1108, one or more recyclable portions of the disposable refill packet (i.e., the body portion and / or packet sleeve) are recycled and one or more non-recyclable portions (i.e., the spent formulation packet and valve frame) are discarded.

[0123] In step 1110, a new disposable refill packet is inserted into the reusable cartridge body.

[0124] In step 1112, a new disposable refill packet is inserted into the reusable cartridge body, and then the reloaded formulation cartridge is inserted again into the formulation delivery device.

[0125] Thus, the present disclosure not only provides a sustainable formulation cartridge, but also provides methods of use to further reduce waste and environmental impact.

[0126] 12 shows an exemplary cleaning cartridge 1200. This cleaning cartridge 1200 has similar features to the cleaning cartridges described above and is compatible with any of the formulation delivery systems, formulation delivery devices, and product lines of the present disclosure. Thus, the cleaning cartridge 1200 is of a similar cartridge type (e.g., configured to fit securely within the reusable handle of a formulation delivery device, has a similar shape and dimensions, and has multiple output nozzles) as the formulation cartridges described herein.

[0127] The primary function of the cleaning cartridge 1200 is to provide a cleaning fluid 1202 (e.g., water) that is in fluid communication with the formulation delivery device and that is flushed through the formulation dispensing assembly as part of a cleaning routine. Accordingly, the cleaning cartridge 1200 is a reusable assembly having a body portion 1204 formed of ABS plastic or other suitable rigid polymer. The body portion 1204 supports a cleaning fluid reservoir 1206, i.e., a tank. The cleaning fluid reservoir 1206 stores cleaning fluid 1202 therein, e.g., 50-200 mL. The cleaning fluid reservoir 1206 has multiple output nozzles 1208 sized and positioned to fluidly couple with the fluid conduits of the formulation delivery device. A refill cap 1210 facilitates refilling of the cleaning fluid reservoir 1206.

[0128] 13-14 illustrate an exemplary priming method 1300 that may be performed by a formulation delivery device of the present disclosure, or other devices. In particular, FIG. 13 describes the method, while FIG. 14 provides a specific exemplary timeline of the method. Various benefits of the priming sequence are described above with respect to FIG. 2 (particularly, priming module 240). Generally, however, the priming sequence clears residual formulation(s) and air pockets from the formulation dispensing assembly, removing any air pockets therefrom and ensuring that a uniform formulation mixture is ready for dispensing. Any of the methods described below may be implemented, in whole or in part, as logic in a data store (e.g., as logic in a priming module) of any formulation delivery device of the present disclosure.

[0129] For ease of understanding, the following methods are generally described in the context of a pharmaceutical delivery system as described above, and therefore, the terms used below have the same meanings as used above.

[0130] In optional preliminary step 1302, a cleaning sequence is initiated to remove any residual formulation in the formulation delivery device, for example, residual formulation from a previous formulation cartridge having a different formulation. The cleaning sequence may be initiated before initiating any priming sequence and before inserting any formulation cartridge into the handle of the formulation delivery device. The cleaning sequence may include any of the steps described above with respect to the cleaning routine module 232. For example, in any embodiment, the cleaning sequence comprises pumping a cleaning fluid through the formulation dispensing assembly. The cleaning fluid (e.g., water) may be provided by a cleaning cartridge, a faucet, or other source. In any embodiment, the cleaning sequence comprises inserting a cleaning cartridge into the handle of the formulation delivery device so that it is in fluid communication with the formulation dispensing assembly, and then pumping the cleaning fluid through the formulation dispensing assembly. In any embodiment, the cleaning sequence comprises pumping the cleaning fluid from the cleaning cartridge through the nozzle assembly at a cleaning flow rate. The cleaning flow rate is optionally greater than the actuation flow rate and / or the priming flow rate of the formulation delivery device. In any embodiment, the irrigation flow rate may be at least about 35 mL / min to about 50 mL / min, or about 1 mL / min to about 5 mL / min, greater than any actuation flow rate and / or any priming flow rate. In any embodiment, the irrigation sequence may include pumping irrigation fluid through the nozzle assembly until a user activates a button, switch, or similar mechanism located on the handle.

[0131] In step 1304, for example, an end user provides a formulation cartridge. The formulation cartridge can be configured to store a first formulation and a second formulation therein, such as a first formulation packet and a second formulation packet, respectively.

[0132] In step 1306, the formulation cartridge is inserted into the handle of the formulation delivery device. In any embodiment, the formulation cartridge is inserted into the handle such that the formulation cartridge fluidly couples the first formulation and the second formulation to the formulation dispensing assembly and any components thereof, such as the nozzle assembly. This step is shown in Figure 14 as occurring at t-2.

[0133] In optional step 1308, the formulation cartridge is authenticated by the formulation delivery device (e.g., by a cartridge authentication interface (e.g., an RFID reader) located within the formulation delivery device (e.g., in the handle)). As described above, authenticating the formulation cartridge can prevent user harm or a poor user experience if the formulation cartridge is counterfeit, damaged, expired, or otherwise defective. In any embodiment, the formulation cartridge is authenticated by using the cartridge authentication interface to read information encrypted on an encryption chip located on the formulation cartridge. The authenticated information includes one or more of the following: formulation identification, formulation starting amount, formulation expiration date, and formulation manufacturing date. In any embodiment, if the cartridge authentication interface successfully authenticates the formulation cartridge, i.e., successfully reads the encrypted information from the encryption chip, the formulation delivery device is “unlocked.” However, if the cartridge authentication interface cannot successfully authenticate the formulation cartridge inserted into the handle, the formulation delivery device is not unlocked. This step is also shown in FIG. 14 as occurring at t-2.

[0134] In step 1310, a priming sequence of the formulation delivery device is initiated, such as by a user performing a priming actuation sequence of a button or other actuation device on the handle. In any embodiment, the priming actuation sequence can include pressing a button or other actuation device in a predetermined pattern within a predetermined time frame (e.g., pressing a button three times within one second). As described above with respect to FIG. 2, the priming sequence prepares the formulation delivery device to deliver the matched formulation. In any embodiment, the priming sequence can optionally be initiated after successful authentication of the formulation cartridge in step 1308. The priming actuation sequence is shown as occurring at t-1 in FIG. 14.

[0135] 14, beginning at time t0, the priming sequence typically comprises simultaneously pumping the first and second formulations from the formulation cartridge for at least a first time period t1, thereby causing the first and second formulations to pass from the formulation cartridge, through at least one pump, and out of the nozzle assembly. Advantageously, this allows the first formulation to mix with the second formulation and be expelled from the nozzle assembly as a mixture having a uniform composition and consistency.

[0136] The parameters of the priming sequence can be adjusted based on the particular formulation and / or desired user experience. On the one hand, the first time period t1 should be long enough to expel a uniform mixture of the first and second formulations from the nozzle assembly and remove any previous formulations or air pockets. On the other hand, to avoid wasting formulations and compromising the user experience, the first time period t1 should not be longer than necessary to achieve the aforementioned objectives. With further reference to FIG. 14 , in any embodiment, the first time period t1 is between about 5 seconds and about 15 seconds, e.g., between about 5 seconds and about 10 seconds, or between about 10 seconds and about 15 seconds. In any embodiment, the first time period t1 does not exceed about 15 seconds, about 10 seconds, or about 5 seconds. In any embodiment, the first time period includes a second time period t2 during which the mixture exits the nozzle assembly. In any embodiment, the second time period t2 is between about 1 second and about 5 seconds. In any embodiment, the second time period t2 does not exceed about 5 seconds.

[0137] As discussed above, it may be advantageous to perform the priming sequence at a higher flow rate to shorten the priming sequence and to thoroughly remove all residual formulation and air pockets within the formulation dispensing assembly. Accordingly, in any embodiment, the priming sequence may comprise dispensing the mixture at a priming flow rate that exceeds the operating flow rate of the formulation dispensing assembly. For example, in any embodiment, the operating flow rate of the formulation dispensing assembly may be about 20 mL / min to about 40 mL / min, about 20 mL / min to about 30 mL / min, or about 24 mL / min to about 36 mL / min, and thus the priming flow rate may be about 1 mL / min to about 5 mL / min greater than the operating flow rate. Additionally or alternatively, in any embodiment, the priming flow rate may be about 1 mL / min to about 5 mL / min less than the cleaning flow rate of the cleaning sequence described above.

[0138] Thus, the foregoing method rapidly primes a formulation delivery device in a manner that allows for the delivery of a consistent mixture without producing excess waste.

[0139] The present application may also refer to quantities and numbers. Unless otherwise specified, such quantities and numbers are not intended to be limiting but rather representative of possible quantities or numbers associated with the present application. In this regard, the present application may also use the term "plurality" to refer to a quantity or number. In this regard, the term "plurality" means any number greater than 1, e.g., 2, 3, 4, 5, etc. The terms "about," "approximately," "almost," etc., mean plus or minus 5% of the stated value. For purposes of this disclosure, the phrase "at least one of A, B, and C" means, for example, (A), (B), (C), (A and B), (A and C), (B and C), or (A, B, and C), and when more than three elements are listed, is intended to further include all possible permutations.

[0140] Embodiments disclosed herein may utilize circuitry for purposes such as implementing the techniques and methodologies described herein, operatively connecting two or more components, generating information, determining operating conditions, and / or controlling an appliance, device, or method. Any type of circuitry may be used. In one embodiment, the circuitry may include one or more computing devices, such as a processor (e.g., a microprocessor), a central processing unit (CPU), a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), or any combination thereof, among others, and may include discrete digital circuit elements, analog circuit elements, or electronic circuitry, or any combination thereof.

[0141] In one embodiment, the circuitry includes one or more ASICs having multiple predefined logic components. In one embodiment, the circuitry includes one or more FPGAs having multiple programmable logic components. In one embodiment, the circuitry includes a hardware circuit implementation (e.g., an implementation in analog circuitry, an implementation in digital circuitry, etc., and combinations thereof). In one embodiment, the circuitry includes a combination of a circuit and a computer program product having software or firmware instructions stored on one or more computer-readable memories that cooperate to cause the device to perform one or more methodologies or techniques described herein. In one embodiment, the circuitry includes circuitry that requires software, firmware, etc. for operation, such as, for example, a microprocessor or portion of a microprocessor. In one embodiment, the circuitry includes an implementation comprising one or more processors or portions thereof and associated software, firmware, hardware, etc. In one embodiment, the circuitry includes a baseband integrated circuit, an application processor integrated circuit, or similar integrated circuit in a server, cellular network device, other network device, or other computing device. In one embodiment, the circuitry includes one or more remotely located components. In one embodiment, the remotely located components are operably connected via wireless communication. In one embodiment, the remotely located components are operatively connected via one or more receivers, transmitters, transceivers, and the like.

[0142] One embodiment includes one or more data stores that store, for example, instructions or data. Non-limiting examples of the one or more data stores include volatile memory (e.g., random access memory (RAM), dynamic random access memory (DRAM), etc.), non-volatile memory (e.g., read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), compact disc read-only memory (CD-ROM), etc.), persistent memory, etc. Further non-limiting examples of the one or more data stores include erasable programmable read-only memory (EPROM), flash memory, etc. The one or more data stores may be connected to one or more computing devices, for example, by one or more instruction, data, or power buses.

[0143] In one embodiment, the circuitry includes one or more computer-readable medium drives, interface sockets, Universal Serial Bus (USB) ports, memory card slots, etc., and one or more input / output components (e.g., graphical user interfaces, displays, keyboards, keypads, trackballs, joysticks, touchscreens, mice, switches, dials, etc.), as well as any other peripheral devices. In one embodiment, the circuitry includes one or more user input / output components operably connected to at least one computing device to control (electrically, electromechanically, software-implemented, firmware-implemented, or otherwise, or a combination thereof) one or more aspects of the embodiment.

[0144] In one embodiment, the circuitry includes a computer-readable medium drive or memory slot configured to accept a signal-bearing medium (e.g., a computer-readable memory medium, a computer-readable recording medium, etc.). In one embodiment, a program for causing a system to perform any of the disclosed methods may be stored on, for example, a computer-readable recording medium (CRMM), a signal-bearing medium, etc. Non-limiting examples of signal-bearing media include recordable media such as any form of flash memory, magnetic tape, floppy disks, hard disk drives, compact discs (CDs), digital video discs (DVDs), Blu-ray discs, digital tape, computer memory, and transmission-type media such as digital and / or analog communications media (e.g., fiber optic cables, wave guides, wired communications links, wireless communications links (e.g., transmitters, receivers, transceivers, sending logic, receiving logic, etc.)). Further non-limiting examples of signal bearing media include, but are not limited to, DVD-ROM, DVD-RAM, DVD+RW, DVD-RW, DVD-R, DVD+R, CD-ROM, Super Audio CD, CD-R, CD+R, CD+RW, CD-RW, video compact disc, Super Video Disc, flash memory, magnetic tape, magneto-optical disk, minidisc, non-volatile memory card, EEPROM, optical disk, optical storage, RAM, ROM, system memory, web server, and the like.

[0145] The detailed description set forth above in connection with the accompanying drawings, in which like numerals refer to like elements, is intended as a description of various embodiments of the present disclosure and is not intended to represent the only embodiment. Each embodiment described in this disclosure is provided merely as an example or illustration and should not be construed as preferred or advantageous over other embodiments. The illustrative examples provided herein are not intended to be exhaustive or to limit the disclosure to the precise form disclosed. Similarly, any step described herein may be interchangeable with other steps or combinations of steps to achieve the same or substantially similar results. In general, the embodiments disclosed herein are non-limiting, and the inventors contemplate that other embodiments within the scope of the present disclosure may include structure and functionality from two or more of the specific embodiments illustrated in the figures and described herein.

[0146] In the foregoing description, specific details are set forth to provide a thorough understanding of exemplary embodiments of the present disclosure. However, it will be apparent to those skilled in the art that the embodiments disclosed herein may be practiced without embodying all of the specific details. In some instances, well-known process steps have not been described in detail in order to avoid unnecessarily obscuring various aspects of the present disclosure. Furthermore, it will be understood that embodiments of the present disclosure may employ any combination of the features described herein.

[0147] This application may include references to directions such as "vertical," "horizontal," "front," "back," "left," "right," "top," and "bottom." These references, and other similar references herein, are intended to aid in the description and understanding of particular embodiments (such as when an embodiment is positioned for use), and are not intended to limit the disclosure to these orientations or locations.

[0148] The principles, representative embodiments, and modes of operation of the present disclosure have been set forth in the foregoing description. However, the aspects of the disclosure intended to be protected should not be construed as limited to the particular embodiments disclosed. Moreover, the embodiments described herein are to be considered illustrative and not restrictive. It is to be understood that variations and modifications may be made, and equivalents employed, by others without departing from the spirit of the present disclosure. Accordingly, all such variations, modifications, and equivalents are expressly intended to be within the spirit and scope of the present disclosure as claimed.

[0149] While exemplary embodiments have been shown and described, it will be appreciated that various changes can be made thereto without departing from the spirit and scope of the invention.

Claims

1. 1. A method of priming a pharmaceutical product delivery device, the method comprising: Steps to prepare, inserting, and a step of starting the The providing step includes providing a formulation cartridge configured to store a first formulation and a second formulation; the inserting step includes inserting the formulation cartridge into a handle of the formulation delivery device such that the formulation cartridge fluidly couples the first formulation and the second formulation to a formulation dispensing assembly of the formulation delivery device; the formulation dispensing assembly comprising a nozzle assembly and at least one pump in fluid communication with the nozzle assembly; a controller operatively connected to the formulation dispensing assembly; The initiating step includes initiating a priming sequence of the pharmaceutical product delivery device; the priming sequence comprising simultaneously pumping the first formulation and the second formulation with the at least one pump for a first time period, causing the first formulation and the second formulation to pass from the formulation cartridge, through the at least one pump, and out the nozzle assembly; The method, wherein the first time period is a time period that allows the first formulation to mix with the second formulation and be expelled from the nozzle assembly as a mixture having a uniform composition and consistency.

2. 10. The method of claim 1, The method, wherein the first time period includes a second time period during which the first formulation and the second formulation exit the nozzle assembly.

3. 3. The method of claim 2, the first formulation and the second formulation exit the nozzle assembly as a mixture; During the second time period, the first formulation and the second formulation exit the nozzle assembly as the mixture.

4. 3. The method of claim 2, The second period of time is from about 1 second to about 5 seconds.

5. 2. The method of claim 1, The method, wherein the first period of time is from about 5 seconds to about 15 seconds.

6. 10. The method of claim 1, The method further comprises authenticating the formulation cartridge by reading an encryption chip located on the formulation cartridge using a cartridge authentication interface located on the handle prior to initiating the priming sequence.

7. 7. The method of claim 6, The method further comprises unlocking the formulation delivery device after authenticating the formulation cartridge.

8. 4. The method of claim 3, the controller comprising logic configured to operate the at least one pump so that the mixture exits the nozzle assembly at an actuation flow rate and a priming flow rate; the priming flow rate is greater than the actuation flow rate; The method, wherein the priming sequence comprises pumping the first formulation and the second formulation such that the mixture exits the nozzle assembly at the priming flow rate.

9. 9. The method of claim 8, The method, wherein the operating flow rate is between about 20 mL / min and about 40 mL / min, and the priming flow rate is at least 5 mL / min higher than the operating flow rate.

10. 10. The method of claim 1, Initiating the priming sequence comprises executing a priming actuation sequence of a button disposed on the handle; The method, wherein the priming activation sequence comprises pressing the button in a predetermined pattern within a third time period.

11. 9. The method of claim 8, and initiating a cleaning sequence of the product delivery device before inserting the product cartridge into the handle. the cleaning sequence comprises inserting and actuating steps; The inserting step includes inserting a cleaning cartridge into the handle such that the cleaning cartridge is fluidly coupled to the formulation dispensing assembly; The method, wherein the actuating step includes actuating the at least one pump to pump cleaning fluid from the cleaning cartridge through the formulation dispensing assembly.

12. A pharmaceutical delivery system comprising a pharmaceutical cartridge and a handle; the formulation cartridge is configured to store a first formulation and a second formulation in a first formulation packet and a second formulation packet, respectively; the handle is configured to reversibly receive the formulation cartridge; the handle houses a formulation dispensing assembly comprising a nozzle assembly and at least one pump fluidly coupled to the nozzle assembly; a controller operatively connected to the formulation dispensing assembly; the controller comprises a processor and a data store storing logic; the logic, when executed by the processor, performs a priming sequence comprising pumping the first formulation and the second formulation simultaneously with the at least one pump for a first time period, whereby the first formulation and the second formulation pass from the formulation cartridge through the at least one pump and out the nozzle assembly; The system, wherein the first time period is a time period for allowing the first formulation to mix with the second formulation and be expelled from the nozzle assembly as a mixture having a uniform composition and consistency.

13. 13. The pharmaceutical delivery system of claim 12, the controller comprises logic configured to actuate the at least one pump such that the first formulation and the second formulation exit the nozzle assembly at an actuation flow rate and a priming flow rate; the priming flow rate is greater than the actuation flow rate; The system, wherein the priming sequence comprises pumping the first formulation and the second formulation at the priming flow rate.

14. 13. The pharmaceutical delivery system of claim 12, the handle houses a cartridge authentication interface; the controller comprising logic that, when executed by the processor, authenticates the formulation cartridge inserted into the handle by reading an encryption chip located on the formulation cartridge with the cartridge authentication interface; The system wherein the priming sequence can only be initiated after successful authentication of the formulation cartridge.

15. 13. The pharmaceutical delivery system of claim 12, the controller is operably connected to buttons located on the handle; The controller includes logic for executing the priming sequence in response to the button being pressed in a predetermined pattern within a second time period.

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