Drug delivery device including oscillating needle array for depositing medications in skin

Abstract

This document relates to devices and methods for delivering medication to a patient using a drug delivery device including a needle array and a reservoir. For example, this document relates to devices and methods for creating one or more punctures in a patient's tissue using the needle array and delivering the medication from the reservoir into the one or more punctures.

Description

Attorney Docket No : 07039-2356WO1 / 2023-471 DRUG DELIVERY DEVICE INCLUDING OSCILLATING NEEDLE ARRAY FOR DEPOSITING MEDICATIONS IN SKIN

[0001] This application claims the benefit of priority’ to U.S. Application No. 63 / 753.664, filed on February 4, 2025, the contents of which are hereby incorporated by reference.TECHNICAL FIELD

[0002] This document relates to devices and methods for delivering medication to a patient using a drug delivery device including a needle array and a reservoir. For example, this document relates to devices and methods for creating one or more punctures in a patient’ s skin using the needle array and delivering the medication from the reservoir into the one or more punctures.BACKGROUND

[0003] A drug delivery device can use a needle to deliver medication to targeted tissue. For example, a needle can be inserted through the outer epidermis to reach the dermis, where blood vessels and capillaries facilitate drug absorption. The device can include a reservoir holding a drug, a needle, and a syringe. Drugs can be delivered to the target through the syringe in some cases. When the drug is administered, the needle can be retracted or manually removed. Such targeted delivery using a needle can enable localized or systemic drug effects.SUMMARY

[0004] This document relates to devices and methods for delivering medication to a patient using a drug delivery' device including a needle array and a reserv oir. For example, this document relates to devices and methods for creating one or more punctures in a patient’s skin using the needle array and delivering the medication from the reservoir into the one or more punctures. The drug delivery device, in some cases, includes an oscillating needle array that transitions between an extended position and a retracted position. For instance, this oscillating needle array can create one or more punctures by piercing the patient's skin as a clinician moves the device across a targeted area. Each time that the needle array transitions to the extended position, for example, the needle array can puncture the patient’s skin and create a puncture pathway in the skin. The drug deliveryAttorney Docket No : 07039-2356WO1 / 2023-471 device can deliver medication so that the reservoir delivers medication to an area surrounding the puncture pathways created by the oscillating needle array.

[0005] In one aspect, a drug delivery system includes a needle array and a device body defining a cavity sized to receive the needle array so that a distal end of the needle array extends beyond a distal end of the device body. The needle array can be slidably attached to the device body such that the needle array is sized to move relative to the device body within the cavity. The system also includes an electrical motor for moving the needle array relative to the device body in an oscillating pattern; and a fluid dispenser defining a fluid reservoir for holding a liquid formulation, the fluid reservoir being in fluid communication with the cavity so that the needle array delivers liquid formulation to a targeted treatment site.

[0006] Particular embodiments of the subject matter described in this document can be implemented to realize one or more of the following advantages. For example, the oscillating needle array of the drug delivery device can advantageously create a plurality of openings in the patent’s skin for delivering medication, each of the openings extending to a predetermined depth. For example, the device can control a depth of at which the needle array punctures the target tissue, thus controlling areas of tissue that receive medication. For example, the device can control the needle array to puncture into the dermis without puncturing into subcutaneous tissue. This can advantageously result in the device delivering medication targeting the dermis without targeting the subcutaneous tissue. Moreover, the oscillating nature of the needle array can result in the needle array creating a plurality of punctures in the target tissue, thus creating a plurality of locations where medication is delivered. This can improve an extent to which the clinician can control the delivery of the medication by allowing the clinician to move the device along the target tissue. Furthermore, the drug delivery device can operate without manual pressure (e.g., unlike a needle and syringe system that requires manual pressure to operate), which decreases a likelihood that medication will diffuse into tissue that is not targeted for drug delivery (e.g., subcutaneous tissue).

[0007] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although methods and materials similar or equivalent to those described herein can be used to practice the invention, suitable methods and materials are described herein. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, theAttorney Docket No : 07039-2356WO1 / 2023-471 present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

[0008] The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description herein. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1 A depicts a view of a first drug delivery device including a device body and a fluid dispenser.

[0010] FIG. IB depicts another view of the first drug delivery device.

[0011] FIG. 1C depicts a cutaway view of distal tip of the device body of the first drug delivery device.

[0012] FIG. ID depicts a closeup view of the first drug delivery device including a needle array.

[0013] FIG. IE depicts an example where the first drug deliver}’ device is connected to a dispenser device 14.

[0014] FIG. 2A depicts a view of a second drug delivery device including a device body and a fluid dispenser.

[0015] FIG. 2B depicts another view of the second drug delivery device.

[0016] FIG. 2C depicts a clinician using the second drug delivery device to treat a patient.

[0017] FIG. 3 depicts three different positions of a needle array within the tissue of a patient.

[0018] FIGS. 4A-4D depict examples of needle tips.

[0019] FIG. 5 is a flow diagram illustrating how a drug delivery device can deliver a formulation to a patient.DETAILED DESCRIPTION

[0020] This document relates to devices and methods for delivering medication to a patient using a drug delivery device including a needle array and a reservoir. For example, this document relates to devices and methods for creating one or more punctures in target tissue (e.g., skin) of a patient using the needle array and delivering the medication from the reservoir into the one or more punctures. In some examples, drug delivery to target tissue can offer many advantages such as avoidance of drug metabolism in the gastro-intestinal tract, maintenance of steady plasma concentration, safety, and compliance over oral orAttorney Docket No : 07039-2356WO1 / 2023-471 parenteral pathways. For example, such drug delivery can include transdermal and / or intradermal drug delivery. However, one challenge w ith these methods of delivery is that only a limited number of potent drugs with certain physicochemical properties can passively diffuse and permeate through skin barriers to achieve therapeutic concentration in their target location. The devices and methods described herein can, in some examples, include one or more needles for creating openings in the skin that create such permeability and facilitate delivery.

[0021] In some embodiments, transdermal and intradermal drug delivery can be used to deliver therapeutic levels of medications to skin and hair to locally treat target tissue while avoiding systemic toxicity and unwanted reactions. Some transdermal and intradermal options rely on topical diffusion or single-needle delivery’ of medications into the dermis. In some cases, relying on topical diffusion and / or a single needle can lead to poor penetration into the patient’s skin, the patient perceiving pain and / or pressure, alack of needle depth control, variability in an amount of medication delivered, and irregular distribution of medication throughout the skin. These results can lead to a suboptimal clinical treatment response and lead to uncertainty as to whether negative results are related to drug efficacy substandard drug delivery.

[0022] A device, in some cases, can include an oscillating array of solid needles for penetrating the target tissue, is a process sometimes referred to as “microneedling.” In some embodiments, microneedling can physically expand the spectrum of drugs that can be effectively delivered using transdermal and intradermal delivery. Microneedling, when applied to skin in some cases, can stimulate both collagen and elastin production without resulting in de-epithelization that often occurs in response to ablative techniques. In some cases, a device can receive a cartridge of sterile needles such that the needle array is connected to a reusable needle oscillating unit. This reusable needle oscillating unit can cause the needles to oscillate in a way that continually punctures the patient’s tissue to a specified depth. The device can control a depth at w hich the needles puncture so that the needles reach an optimal depth for drug delivery. In some cases, the device can control the depth of the needles based on a thickness of skin at the targeted treatment site.

[0023] One or more devices described herein can include a reservoir configured to hold a variable viscosity formulations (e.g., medication, medical device or implant (i.e. filler) or other regenerative therapeutic (e.g., PRP, nanofat)). This reservoir can be in fluid communication with one or more needles such that the needles can deliver the medication to a targeted treatment site. In some cases, friction generated by rapid penetration of theseAttorney Docket No : 07039-2356WO1 / 2023-471 needles into the dermis of a patient can create shear stress that aids in dermal drug diffusion entrained by the needles. For example, when the needle is delivering a liquid formulation, the friction of the needle entering and exiting the patient’s skin can cause the liquid formulation to diffuse into the skin, thus diffusing into the patient. In some cases, this needling can stimulate a healing response by enhancing collagen and elastin production within the dermal layer. The device described herein can provide precision delivery to target tissue to treat a number of diseases. In some embodiments, a microneedling device, when used, can apply continuous medications / formulations to the patient’s target tissue. In some embodiments, a microneedling device, when used, can apply continuous medications and / or formulations to the patient's target tissue.

[0024] Referring now to FIGS. 1A-1D, a drug delivery device 10 includes a needle array 13, a device body 20 and a fluid dispenser 30. As depicted in FIG. 1 A, the device body 20 can include a distal tip 22 that defines a cavity 24. Cavity 24 can receive the needle array 13, as depicted in FIG. ID. In some cases, the needle array 13 can be slidably mounted to the device body 20 within the cavity 24 such that the needle array 13 is configured to move relative to the device body 20 along a longitudinal axis of device body 20. This movement, in some embodiments, can be an oscillation movement whereby needle array 13 transitions between a retracted position (depicted in FIG. ID) and an extended position where the distal end of needle array 13 extends beyond a distal end of distal tip 22, in an alternating fashion. That is. needle array 13 can repeatedly alternate between the retracted position where needle array 13 is fully within the cavity 24 defined by the distal tip 22 to an extended position where the needle array 13 extends beyond the distal end of distal tip 22. This can be oscillation can describes as be “back and forth'’ movement, “in & out” movement or subtle “arcing” movements. In some cases, needle array 13 comprises an arrangement of a set of needles, where the set of needles are placed adjacent to one another, this arrangement can be in parallel or other polygonal arrangements, based on target tissue type. The set of needles can include, in some examples, 10 needles, but this is not required. In other examples, the set of needles can include greater than 10 needles or fewer than 10 needles. In some cases, a point of each needle in the needle array 13 can be located at the same location along a longitudinal axis of needle array 13 as the points of each of the other needles. This can ensure that when needle array 13 pierces the patient’s skin, each needle extends approximately the same distance into the patient’s skin as each other needle. However, this is not a requirement as iterations of this device could set the needles within the array to variable depths or multiple depths with one application.Attorney Docket No : 07039-2356WO1 / 2023-471 Regardless, controlling a piercing depth of needle array 13 can ensure that medication is delivered to the correct layer(s) of target tissue (ex: dermis). In some examples, drug delivery device 10 is sized to be gripped by a clinician in one hand such that a clinician can manually manipulate drug delivery device 10 to perform one or more drug delivery procedures. For example, the clinician can grip the device body 20 and / or the fluid dispenser 30 to place the distal tip 22 of the device body 20 proximate to a patient’s target tissue. Because the distal tip 22 defines a cavity for receiving the needle array 13, this can result in the needle array 13 piercing the tissue of the patient one or more times to deliver a liquid formulation. The clinician can manually manipulate the drug delivery device 10 so that the needle array 13 pierces the patient’s skin in a targeted treatment area, thus achieving drug delivery in the targeted treatment area.

[0025] Because needle array 13 can repeatedly extend beyond the distal end of distal tip 22 as part of an oscillating movement of needle array 13, this means that needle array 13 can pierce the skin of the patient each time that needle array 13 extends beyond the distal tip 22 of device body 20. Each time that the needle array 13 pierces the patient’s skin, this can cause device body 20 to deliver liquid formulation to the patient. Thus, when the distal tip 22 moves along an area of skin, the formulation can be delivered at many locations along this area (e.g., in each location where needle array 13 pierces the skin). In some cases, so long as the clinician holds the distal tip 22 of device body 20 at the same vertical location relative to the patient’s skin (e.g., at the level of the patient’s skin), the needle array 13 pierces the patient’s skin to the same depth at each horizontal location where the needle array 13 pierces the skin.

[0026] For example, device body 20 can include an electrical motor that is configured to control a movement of needle array 13 relative to device body 20. For example, a proximal end of needle array 13 can be connected to a mandrel which is connected to the electrical motor. The electrical motor can drive the mandrel to move the needle array 13 distally and proximally in an oscillating pattern so that the needle array 13 can puncture the patient’s skin each time that the needle array 13 extends beyond distal tip 22. In some cases, device body 20 includes control circuitry that controls a rate (e.g.. a frequency) at which needle array 13 oscillates and / or a distance that needle array 13 extends beyond distal tip 22. These parameters (e.g., frequency and distance) can be controlled in order to optimize a delivery of medication to the patient. For example, the distance that needle array 13 extends beyond distal tip 22 can be controlled based on a thickness of the patient’s target tissue site so that needle array 13 punctures into the proper depth without extending into anAttorney Docket No : 07039-2356WO1 / 2023-471 unwanted depth. In some cases, the frequency of needle array 13 can be controlled to determine a rate at which medication is delivered to the patient, with a higher frequency corresponding to a higher rate of delivery and a lower frequency corresponding to a lower rate of delivery. In some cases, device body 20 can include one or more actuators for controlling parameters such as the puncture depth and frequency. In some examples, the puncture depth of needle array 13 can be within a range from 0.25 millimeters (mm) to 4.0 mm.

[0027] As depicted in FIGS. 1 A-1E, the device body 20 can be fixedly attached to the fluid dispenser 30 (e.g., reservoir”) such that the device body 20 and the fluid dispenser 30 define a single tool that can be gripped by a clinician in one hand. In some cases, the device body 20 and the fluid dispenser 30 are fixedly attached so that device body 20 and fluid dispenser 30 do not move relative to each other and needle array 13 moves relative to device body 20 and fluid dispenser 30. The fluid dispenser 30 can be attached to device body 20 at a location proximal to the distal tip 22 of the device body 20 so that the distal tip 22 is the distal most part of drug delivery device 10 other than needle array 13 in the extended position. This can ensure that needle array 13 can pierce the tissue of the patient by extending from distal tip 22 without encountering physical resistance from fluid dispenser 30 which is located proximally to distal tip 22 in a location physically removed from the patient’ s skin.

[0028] Fluid dispenser 30 can. in some examples, include a fluid reservoir 32 within an outer housing of fluid dispenser 30 This fluid reservoir 32 can hold a liquid formulation (e.g., a medication, implant, device). In some cases, the fluid reservoir 32 can be in fluid communication with a valve 33 for controlling a flow of liquid formulation from the fluid reservoir 32. For example, fluid dispenser 30 of drug delivery device 10 includes an actuator 34 that controls whether valve 33 is open to allow fluid flow or closed to prevent fluid flow. In some cases, actuator 34 can control a rate that fluid flows from fluid reservoir 32. The valve 33 can be in fluid communication with a flexible tube 36 that defines a lumen terminating at opening 38. This flexible tube 36 can carry liquid formulation from fluid dispenser 30 to the distal tip 22 of device body 20.

[0029] In some cases, needle array 13 is sized to be received within the cavity 24 of distal tip 22 proximate to an opening 38 of flexible tube 36 at a distal end of flexible tube 36. In some cases, fluid dispenser 30 can deliver a liquid formulation (e.g., a medication) via flexible tube 36 and opening 38 to cavity 24 so that the liquid formulation coats a surface of needle array 13 when needle array 13 occupies the retracted position within cavity 24.Attorney Docket No : 07039-2356WO1 / 2023-471 This can cause needle array 13, coated with the liquid formulation, to deliver the liquid formulation to the skin of the patient as needle array 13 extends into the patient’s skin and retracts out of the patient’s tissue. Specifically, friction of the needle array 13 entering and exiting the patient’s skin can cause liquid formulation to diffuse into the patient’s skin in a way that delivers the formulation to the patient.

[0030] In some examples, the opening 38 can be defined in a side of the distal tip 22 such that fluid can enter the distal tip 22 that is sized to receive the needle array 13. Distal tip 22 is sized to slidably receive the needle array 13 such that the needle array 13 can move within the distal tip 22 according to an oscillating pattern. In some cases, the oscillating pattern involves the needle array 13 moving proximally towards the opening 38 when the needle array 13 withdraws and moving distally away from the opening 38 when the needle array 13 advances. Fluid can flow into the distal tip 22 through the opening 38 when the needle array 13 is retracted such that fluid collects on the needle array 13. This can allow the needle array 13 to deliver fluid to the patient when the needle array 13 advances to puncture the skin of the patient.

[0031] In some embodiments. The distal tip 22 includes a crosspiece 42 that separates an upper section 44 from a lower section 46. Crosspiece 42 can, in some embodiments, direct fluid from the opening 38 to the needle array 13 as the needle array 13 moves through the gap 48 between the upper section 44 and the lower section 46. For example, crosspiece 42 can be sloped downward so that when fluid flows from the opening 38, the fluid flows downward towards gap 48 to contact the needle array 13. The needle array 13 can deliver the fluid to the patient. Crosspiece 42 can separate the upper section 44 from the lower section 46 such that the gap 48 is the only opening that connects the upper section 44 to the lower section 46. In some cases, the gap 48 is sized to receive the needle array 13 such that the needle array 13 occupies all or nearly all of the gap 48. Fluid can therefore adhere to the needle array 13 to be delivered to the patient.

[0032] Fluid dispenser 30, in some embodiments, can dispense liquid formulation to cavity 24 at a rate that sufficiently replenishes liquid formulation at a rate that needle array 13 delivers the liquid formulation to the skin of the patient. For example, each time that the needle array 13 punctures the patient’s skin, the needle array 13 can deliver liquid formulation to the patient that is coated on the needle array 13. This means that the needle array 13 can be re-coated with liquid formulation delivered via flexible tube 36 when needle array 13 retracts into cavity 24 so that needle array 13 can continue to deliver liquid formulation through another puncture. Fluid dispenser 30 (e.g., valve 33) can control theAttorney Docket No : 07039-2356WO1 / 2023-471 rate at which liquid formulation is delivered to cavity 24 so that needle array 13 is replenished with liquid formulation at approximately the same rate that needle array 13 dispenses liquid formulation.

[0033] In some examples, fluid dispenser 30 can be connected to a greater fluid reservoir that supplies liquid formulation to the fluid reservoir 32. In some cases, this greater fluid reservoir can resupply fluid reservoir 32 with liquid formulation as fluid reservoir 32 supplies liquid formulation to the distal tip 22 for delivery to the patient by needle array 13. In some cases, a flexible tube can connect the fluid reservoir 32 with the greater fluid reservoir. In some cases, this greater fluid reservoir is part of a dispenser device 14 (FIG. IE) that controls a rate at which liquid formulation is delivered to fluid dispenser 30. The dispenser device 14. in some cases, can include a manufactured engineered fluid dispensing (EFD) unit that can dispense fluid at a predetermined rate that is set by a user.

[0034] In some cases, drug delivery device 10 can serve to quantify medication delivery to deliver precise doses to the patient. In some cases, each puncture by needle array 13 can deliver a predetermined amount of medication to the patient. This means that an amount of medication delivered to the patient can be estimated based on a number of punctures performed by needle array 13. Drug delivery device 10 is not limited to needle array 13 including solid needles. In some cases, one or more needles of needle array 13 can include a hollow needle or alternate needle shapes with or without a lumen, for delivering medication to the patient. These hollow lumen needles can, in some examples, be controlled to deliver a precise amount of medication to the patient. For example, a pump can control an exact amount of medication delivered through the lumen of a needle.

[0035] Referring now to FIGS. 2A-2C, another example drug delivery' device 50 can include a needle cartridge 52, a device body 60, and a fluid dispenser 70. In some examples, the device body 60 and the fluid dispenser 70 are configured to slide relative to each other along a longitudinal axis (‘'in-line”) of the drug delivery' device 50 such that drug delivery' device 50 can transition between an open position (FIG. 2A) and a closed position (FIG. 2B). For example, as depicted in FIG. 2A, device body 60 can slide proximally relative to fluid dispenser 70 to define a gap 51 sized to receive the needle cartridge 52. Needle cartridge 52 represents a disposable cartridge that can be inserted into drug delivery device 50 for a single use and disposed thereafter. Needle cartridge 52 can be inserted and removed via gap 51 when drug delivery' device 50 occupies the open position. This can promote sterility, as the needle cartridge 52 can be prepared andAttorney Docket No : 07039-2356WO1 / 2023-471 packaged to medical standards, thus ensuring that each use of device body 60 includes sterile needles.

[0036] Drug delivery device 50 includes a distal tip 62 that defines a cavity sized for receiving at least a portion of needle cartridge 52. For example, when needle cartridge 52 is received within gap 51 and device body 60 transitions to the closed position as depicted in FIG. 2B, a portion of needle cartridge 52 can extend distally from the distal end of cavity 64. For example, as depicted in FIG. 2B, when needle cartridge 52 is inserted into drug delivery device 50 and the drug delivery device 50 occupies the closed position, a distal portion of needle cartridge 52 can extend form a distal opening of the cavity 64 for receiving the needle cartridge 52.

[0037] In some embodiments, needle cartridge 52 includes a needle array 53 and an engagement element 55. The needle array 53 can include a set of needles in a polygonal arrangement so that a tip of each of the needles is located at a same position as the tips of other needles along a longitudinal axis of drug delivery device 50. Some versions could also include alternating needle depths within the same array. The engagement element 55 can engage with device body 60 when drug delivery device 50 occupies the closed position such that an electrical motor within device body 60 can control an oscillation of the needle cartridge 52 relative to drug delivery device 50. After a use of drug delivery device 50 on a patient is complete, the needle cartridge 52 can be removed from drug delivery' device 50 such that engagement element 55 disengages from device body 60. Another needle cartridge can be inserted and removed in a similar manner for another use.

[0038] In some examples, to transition the drug deliver} device 50 from the open position depicted in FIG. 2A to the closed position depicted in FIG. 2B, the device body 60 can slide distally relative to the fluid dispenser 70 in a way that closes the gap 51 and pushes the needle cartridge 52 so that the distal portion of needle cartridge 52 extends out of the cavity 64. This can hold needle cartridge 52 in a position such that the electrical motor of device body 60 can transition the needle cartridge 52 between an extended position and a retracted position. In some embodiments, transitioning the needle cartridge 52 between the extended position and a retracted position involves moving the entire needle cartridge 52 between the extended position and the retracted position. In some embodiments, transitioning the needle cartridge 52 between the extended position and a retracted position involves moving the needle array 53 between the extended position and the retracted position without moving the entire needle cartridge 52. In any case, the electrical motor ofAttorney Docket No : 07039-2356WO1 / 2023-471 device body 60 can cause the needle array 53 to repeatedly extend and retract, thus causing needle array 53 to puncture the skin of the patient numerous times.

[0039] The device body 60 includes one or more actuators 68 for controlling one or more parameters relating to the oscillation of needle array 53. For example, the one or more actuators 68 can include an actuator for controlling a frequency at which the needle array 53 oscillates. Additionally, or alternatively, the one or more actuators 68 can include an actuator for controlling a distance that needle array 53 extends into the skin of the patient. That is, the actuator can control a distance that needle array 53 extends beyond any other part of the drug delivery’ device 50. The frequency and / or the puncture depth can be adjusted based on a desired depth and rate of delivery'.

[0040] In some cases, the fluid dispenser 70 includes a fluid reservoir 72. a refill port 73. and an actuator 74. The fluid reservoir 72 can store liquid formulation for delivery via the needle cartridge 52. For example, the needle cartridge 52 can include an aperture 57 through which liquid formulation can flow from the fluid reservoir 72 to the needle array 53. For example, when drug delivery device 50 is in the closed position as depicted in FIG.2B, the fluid reservoir 72 can be in fluid communication with the aperture 57 of the needle cartridge 52. In some cases, liquid formulation can flow from the fluid reservoir 72 and into the aperture 57 so that the liquid formulation can flow through a lumen of the needle cartridge 52 to reach the needle array 53. Similar to how the needle array 13 of FIGS. 1 A-1E can be coated with liquid formulation to deliver liquid formulation through punctures, needle array 53 can be coated with liquid formulation delivered through the aperture 57. The fluid dispenser is disposable. The fluid dispenser can be prepared with clean or sterile technique for medical grade applications.

[0041] Actuator 74, in some cases, can control a flow of liquid formulation from the fluid reservoir 72 to the needle array 53 of needle cartridge 52. For example, a user can press actuator 74 to cause liquid formulation to flow to needle array 53 at a predetermined rate. This predetermined rate can be controlled by actuator 74, another actuator on drug delivery' device 50, or by other techniques. In any case, the rate at which liquid formulation flows to needle array 53 can. in some embodiments, be similar to a rate at which needle array 53 delivers medication to the patient. In some cases, needle array 53 can deliver medication to a patient in a manner that is similar to the way in which needle array 13 of FIGS. 1A-1E delivers medication to the patient.

[0042] In use, in some embodiments, a clinician can insert needle cartridge 52 into the gap 51 formed by the drug delivery device 50 when the drug delivery device 50 is in theAttorney Docket No : 07039-2356WO1 / 2023-471 open position depicted in FIG. 1 A. The clinician can insert needle cartridge 52 such that a distal tip of needle cartridge 52 faces a distal end of the drug delivery device 50. In some cases, needle cartridge 52 is packaged in sterile packaging so that needle cartridge 52 is sure to be sterile before use. The clinician can remove needle cartridge 52 from the sterile packaging before inserting needle cartridge 52 into gap 51. After inserting the needle cartridge 52, the clinician can transition the drug delivery device 50 from the open position depicted in FIG. 2A to the closed position in FIG. 2B. This transition can involve sliding the device body 60 distally relative to fluid dispenser 70 until drug delivery device 50 occupies the closed position.

[0043] When drug delivery' device 50 occupies the closed position, the engagement element 55 of needle cartridge 52 can be removably connected to the device body 60 such that device body 60 can move the needle array 53 relative to the distal tip 62 of the drug delivery device 50. For example, an electrical motor of device body 60 can move the needle array 53 according to an oscillating pattern. The clinician can, in some examples, use one or more actuators on the device body 60 to start the oscillation of needle array 53 according to a predetermined depth and frequency. As discussed above, the clinician can control the predetermined depth and frequency of the needle array 53. To perform a drug delivery' procedure, the clinician can move the drug delivery device 50 along an area of the patient’s skin as the needle array 53 oscillates, thus causing the needle array 53 to puncture the patient's skin at a plurality’ of locations in the area. Each time that needle array 53 punctures the patient’s tissue, the needle array 53 can deliver medication to the patient.

[0044] After the drug delivery procedure is complete, the clinician can remove the used needle cartridge 52 from drug delivery’ device 50 by transitioning the drug delivery' device 50 from the closed position depicted in FIG. 2B to the open position depicted in FIG. 2A. This transition can involve the clinician moving the device body 60 distally relative to the fluid dispenser 70 so that the gap 51 is exposed. This allows the clinician to detach the needle cartridge 52 from the device body 60 for disposal. Another needle cartridge can be inserted into gap 51 for another use of drug delivery device 50. Using disposable needle cartridges in this way can provide sterility by ensuring that needles are only used one time. FIG. 2C depicts clinician 82 using the drug delivery device 50 to perform a drug delivery procedure on patient 80.

[0045] Referring now to FIG. 3, a puncture depth of a needle array can be controlled to achieve delivery goals. For example, needles can puncture through the epidermis and into the dermis, without puncturing into the subcutaneous tissue. This can allow the needleAttorney Docket No : 07039-2356WO1 / 2023-471 array to deliver medication to the dermis layer without reaching the subcutaneous tissue. In other cases, the needle can puncture through the epidermis and the dermis to reach the subcutaneous tissue. Any of the drug delivery devices described herein can control a depth that the needle array pierces, thus controlling a depth at which medication is delivered. In some cases, a device can dynamically adjust a piercing depth to account for varying skin depths or procedures that require varying delivery- depths.

[0046] Referring now to FIGS. 4A-4D, needle arrays described herein include various types of needle tips. For example, the needle tip depicted in FIG. 4A can include a rounded tip edge and a single flat face, the needle tip depicted in FIG. 4B can include a point and several flat faces, the needle tip depicted in FIG. 4C can include a flat edge and several flat faces, and the needle tip depicted in FIG. 4D can include a cone with a single point. The needle arrays described herein are not limited to using the needle tips depicted in FIGS. 4A-4D. In some cases, a needle array can include one or more points not depicted in FIGS.4A-4D.

[0047] FIG. 5 is a flow diagram illustrating how a drug delivery device 10 can deliver a formulation to a patient. For example, a needle array 13 can move relative to a device body 20 in an oscillating pattern by transit oning the needle array 13 between an extended position and a retracted position (102). The needle array 13 can pierce the skin of the patient to create a puncture passageway in the skin of the patient as the needle array 13 transitions to the extended position (104). The needle array 13 can withdraw from the puncture passageway in the skin of the patient as the needle array 13 transitions to the retracted position (106). The needle array 13 can deliver a liquid formulation at an opening of the puncture passageway in the skin of the patient when the needle array withdraws form the puncture passageway so that the liquid formulation travels into the puncture passageway through the opening (108).[004S] While this specification contains many specific implementation details, these should not be constmed as limitations on the scope of any invention or of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments of particular inventions. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub combination. Moreover, although features may be described herein as acting in certain combinations and even initially claimed as such, oneAttorney Docket No : 07039-2356WO1 / 2023-471 or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

[0049] Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system modules and components in the embodiments described herein should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single product or packaged into multiple products.

[0050] Particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve desirable results. As one example, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results. In certain implementations, multitasking and parallel processing may be advantageous.

Claims

Attorney Docket No : 07039-2356WO1 / 2023-471CLAIMSWhat is claimed is:

1. A drug delivery system comprising:a needle array;a device body defining a cavity sized to receive the needle array so that a distal end of the needle array extends beyond a distal end of the device body, wherein the needle array is slidably attached to the device body such that the needle array is sized to move relative to the device body within the cavity;an electrical motor for moving the needle array relative to the device body in an oscillating pattern; anda fluid dispenser defining a fluid reservoir for holding a liquid formulation, the fluid reservoir being in fluid communication with the cavity’ so that the needle array delivers liquid formulation to a targeted treatment site.

2. The system of claim 1, wherein a disposable needle array cartridge comprises the needle array, the cavity being sized to receive the needle array cartridge so that the needle array slides relative to the device body in the oscillating pattern.

3. The system of claim 2, wherein the disposable needle array cartridge is removably attached to the device body such that the needle array cartridge is detachable after the needle array’ delivers the liquid formulation.

4. The system of claim 1, wherein the device body comprises a fluid actuator for controlling a flow of the liquid formulation from the fluid reservoir to the needle array, the fluid actuator permitting the liquid formulation to flow from the fluid reservoir to the needle array in an activated position, and the fluid actuator preventing the liquid formulation from flowing to the needle array in a deactivated position.

5. The system of claim 1, wherein the device body is sized to be gripped by a clinician in one hand to cause the needle array to deliver the liquid formulation to the targeted treatment site.Attorney Docket No : 07039-2356WO1 / 2023-471 6. The system of claim 1, wherein to move the needle array relative to the device body in the oscillating pattern, the electrical motor is configured to transition the needle array between an extended position and a retracted position according to a plurality of oscillation cycles so that when the device body is maintained in a stationary position, the needle array moves distally from the distal end of the device body when transitioning to the extended position and the needle array moves proximally towards the distal end of the device body when transitioning to the retracted position.

7. The system of claim 6, wherein the targeted treatment site comprises skin of a patient, and wherein the needle array is configured to:pierce the skin of the patient to create a puncture passageway in the skin of the patient as the needle array transitions to the extended position;withdraw the needle array from the puncture passageway in the skin of the patient as the needle array transitions to the retracted position; anddeliver the liquid formulation at an opening of the puncture passageway in the skin of the patient when the needle array withdraws from the puncture passageway so that the liquid formulation travels into the puncture passageway through the opening.

8. The system of claim 7, wherein the needle array is configured to repeat the pierce, withdraw, and deliver steps as a clinician moves the device body along the targeted treatment site of the patient.

9. The system of claim 7, wherein to pierce the skin of the patient to create the puncture passageway in the skin of the patient, the needle array is configured to extend through an epidermis layer and into a dermis layer of the skin of the patient without extending into subcutaneous tissue.

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