# US 12,246,154 B2 · Microarray applicator

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- Number: US 12,246,154 B2
- Document ID: US12246154B2
- Status: Granted
- Kind: B2
- Application number: 16/956,217
- Filed: 2018-12-04
- Published: 2020-12-17
- Granted: 2025-03-11
- Earliest claimed: 2017-12-19
- Assignees: Kindeva Drug Delivery L.P.
- Applicants: Kindeva Drug Delivery L.P.
- Inventors: David J. Wirtanen; Kevin L Puckett; James L. Schug; David J. White
- Web page: https://patentgrep.com/patent/US12246154B2

## CPC

- A61M 37/0015: {by using microneedles}
- A61K 9/0021: {Intradermal administration, e.g. through microneedle arrays or needleless injectors}
- A61K 9/7023: {Transdermal patches and similar drug-containing composite devices, e.g. cataplasms (galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006)}
- A61M 2025/0093: {wherein at least one needle is a microneedle}
- A61M 2037/0023: {Drug applicators using microneedles}
- A61M 2037/0061: {Methods for using microneedles}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

Microarray applicator (10000) including a microarray carrier (8000), which is retained within a housing (2000) by virtue of microarray carrier (8100) being engaged withholder (2400). Microarray patch (8200) and flexible backing (8220) are positioned such that the central portion (8210) has microneedles (8211) protrude in the direction opposite from the bottom (7200) of plunger (7000). Plunger (7000) is in a first position, having first notch (7310) engaged with ridge (2320). After activation, wherein plunger (7000) is in a second position such that second notch (7320) is engaged with ridge (2320). Here, bottom (7200) of plunger (7000) extends below first major surface (2100) of housing (2000) and has ejected microarray patch (8200).

## Claims

### Claim 1

A microarray applicator comprising:
a housing, the housing comprising:
a first major surface configured to be positioned towards skin and defining a bottom of the housing;
a second major surface opposite the first major surface and defining a top of the housing;
a cavity extending through the first and second major surfaces;
an interior surface defining the cavity, the interior surface comprising one or more ridges, each ridge of the one or more ridges comprising a ridge width and a ridge height, wherein the ridge height is defined by a distance between the ridge and the first major surface of the housing; and
a holder located between the first and second major surfaces for holding at least part of a microarray device within the housing; and
a plunger comprising:
a top, a bottom, and one or more sides;
a first set of one or more notches located proximate to the bottom of the plunger, each notch of the first set of one or more notches being located substantially a same distance from the bottom of the plunger, and extending a first depth into the one or more sides of the plunger, wherein each notch of the first set of one or more notches comprises a profile that is substantially rotationally symmetric about an axis substantially normal to the one or more sides of the plunger adjacent to the notch; and
a second set of one or more notches located proximate to the top of the plunger, each notch of the second set of one or more notches being located substantially a same distance from the top of the plunger, and extending a second depth into the one or more sides of the plunger wherein each notch of the second set of one or more notches comprises a profile that is substantially rotationally symmetric about an axis substantially normal to the one or more sides of the plunger adjacent to the notch;
wherein the second depth is equal to or less than the first depth, the second depth is equal to or greater than the ridge width, a distance between the first set of one or more notches and the second set of one or more notches is greater than the ridge height, and the plunger is slidably engageable with the cavity in the housing to be positionable at a first position wherein the first set of one or more notches is engaged with the one or more ridges in the housing and the bottom of the plunger does not extend below the first major surface of the housing, and at a second position wherein the second set of one or more notches is engaged with the one or more ridges in the housing and the bottom of the plunger extends below the first major surface of the housing, and
wherein when the plunger is at the first position, releasing the first set of one or more notches from engagement with the one or more ridges requires substantially the same first force in either direction, and when the plunger is at the second position, releasing the second set of one or more notches from engagement with the one or more ridges requires substantially the same second force in either direction.

### Claim 2 (depends on 1)

The microarray applicator of claim 1, wherein the holder is in the form of a slot in the housing.

### Claim 3 (depends on 1)

The microarray applicator of claim 1, wherein the cavity has an annular shape and the one or more ridges of the interior surface of the housing are a single ridge that forms a circle around the interior surface.

### Claim 4 (depends on 3)

The microarray applicator of claim 3, wherein the plunger is approximately cylindrical, the first set of one or more notches is one notch that forms a circle around the plunger, and
the second set of one or more notches is one notch that forms a circle around the plunger.

### Claim 5 (depends on 1)

The microarray applicator of claim 1, wherein the top of the plunger comprises a head that extends beyond the one or more sides of the plunger farther than the cavity in the housing.

### Claim 6 (depends on 5)

The microarray applicator of claim 5, wherein the top of the plunger abuts the second major surface of the housing when the plunger is in the second position.

### Claim 7 (depends on 1)

The microarray applicator of claim 1, wherein the plunger is adapted to move from the second position to the first position when sufficient force is applied to the bottom of the plunger in the second position.

### Claim 8 (depends on 1)

The microarray applicator of claim 1, wherein the microarray device does not include an energy storage device.

### Claim 9 (depends on 1)

The microarray applicator of claim 1, the microarray device comprising one or more microneedles.

### Claim 10 (depends on 9)

The microarray applicator of claim 9, wherein the microarray device comprises a microarray patch having the one or more microneedles protruding therefrom, and a microarray carrier that releasably retains the microarray patch.

### Claim 11 (depends on 10)

The microarray applicator of claim 10, wherein the one or more microneedles protrude from a central portion of a flexible backing of the microarray patch.

### Claim 12 (depends on 10)

The microarray applicator of claim 10, wherein the microarray carrier further comprises a plurality of tabs that releasably retain the microarray patch.

### Claim 13 (depends on 1)

The microarray applicator of claim 1, wherein the holder is adapted to releasably engage the microarray device such that after application of the microarray device using the microarray applicator, any portion of the microarray device remaining engaged by the holder is removable and replaceable with another microarray device, thereby facilitating reuse of the microarray applicator.

### Claim 14 (depends on 1)

A method of ejecting one or more microneedles from a microarray applicator, the method comprising:
inserting the microarray device into the holder of the housing of the microarray applicator of claim 1; and
moving the plunger of the microarray applicator from the first position to the second position.

### Claim 15 (depends on 14)

The method of claim 14, wherein the microarray device comprises:
a microarray patch having one or more microneedles protruding therefrom; and
a microarray carrier that releasably retains the microarray patch;
wherein moving the plunger from the first position to the second position releases the microarray patch from the microarray carrier and ejects the microarray patch below the second major surface of the housing.

### Claim 16 (depends on 15)

The method of claim 15, further comprising removing the microarray carrier from the holder after release of the microarray patch, followed by inserting another microarray device in the holder.

### Claim 17 (depends on 14)

The method of claim 14, wherein the top of the plunger abuts the second major surface of the housing when the plunger is in the second position.

### Claim 18 (depends on 14)

The method of claim 14, wherein the microarray device does not include an energy storage device.

### Claim 19

A microarray applicator comprising:
a housing, the housing comprising:
a first major surface configured to be positioned towards skin and defining a bottom of the housing;
a second major surface opposite the first major surface and defining a top of the housing;
a cavity extending through the first and second major surfaces;
an interior surface defining the cavity, the interior surface comprising one or more ridges, each ridge of the one or more ridges comprising a ridge width and a ridge height, wherein the ridge height is defined by a distance between the ridge and the first major surface of the housing; and
a microarray device releasably engaged with a holder, the holder located between the first and second major surfaces within the housing; and
a plunger comprising: a top, a bottom, and one or more sides;
a first set of one or more notches located proximate to the bottom of the plunger, each notch of the first set of one or more notches being located substantially a same distance from the bottom of the plunger, and extending a first depth into the one or more sides of the plunger such that when a first notch of the first set of one or more notches is fully engaged with a ridge of the one or more ridges of the interior surface of the housing, wherein the first notch of the first set of one or more notches comprises a profile that is substantially rotationally symmetric about an axis substantially normal to the one or more sides of the plunger adjacent to the first notch; releasing the first notch in a direction towards the bottom of the housing requires substantially the same force as releasing the first notch in a direction towards the top of the housing; and
a second set of one or more notches located proximate to the top of the plunger, each notch of the second set of one or more notches being located substantially a same distance from the top of the plunger, and extending a second depth into the one or more sides of the plunger such that when a second notch of the second set of one or more notches is fully engaged with a ridge of the one or more ridges of the interior surface of the housing, wherein the second notch of the second set of one or more notches comprises a profile that is substantially rotationally symmetric about an axis substantially normal to one or more sides of the plunger adjacent to the second notch; releasing the second notch in the direction towards the bottom of the housing requires substantially the same force as releasing the second notch in the direction towards the top of the housing;
wherein the second depth is equal to or less than the first depth; wherein the plunger is slidably engageable with the cavity in the housing to be moveable between a first position wherein the first set of one or more notches is engaged with the one or more ridges in the housing and the bottom of the plunger does not extend below the first major surface of the housing, and a second position wherein the second set of one or more notches is engaged with the one or more ridges in the housing and the bottom of the plunger extends below the first major surface of the housing, and wherein the holder is adapted for insertion and removal of the microarray device when the plunger is in the first position, thereby facilitating reuse of the microarray applicator.

### Claim 20 (depends on 19)

The microarray applicator of claim 19, wherein movement of the plunger from the first position to the second position is unaided by an energy storage device.
