# US 11,439,750 B1 · Mechanically driven medication delivery patch

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- Number: US 11,439,750 B1
- Document ID: US11439750B1
- Status: Granted
- Kind: B1
- Application number: 17/546,030
- Filed: 2021-12-08
- Granted: 2022-09-13
- Earliest claimed: 2021-12-08
- Assignees: Gina G. Stetsko
- Applicants: Gina G. Stetsko
- Inventors: Gina G. Stetsko; Gregg A. Henderson; Jason A. Belton; James R. Norling; Rick W. Walker
- Web page: https://patentgrep.com/patent/US11439750B1

## CPC

- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61J 1/1468: {Containers characterised by specific material properties}
- A61M 5/14248: {of the skin patch type}
- A61M 5/148: flexible (A61M5/155 takes precedence)
- A61M 2005/14252: {with needle insertion means}
- A61M 2005/1426: {with means for preventing access to the needle after use}
- A61M 2005/14272: {for emergency, field or home use, e.g. self-contained kits to be carried by the doctor}
- A61M 2005/14506: {mechanically driven, e.g. spring or clockwork}
- A61M 2005/1585: {Needle inserters}
- A61M 2005/1586: {Holding accessories for holding infusion needles on the body}
- A61M 2205/3386: Low level detectors
- 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)}
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE

## Abstract

A medication delivery patch that is applied to the skin and activated to deliver a medication or other fluid into or through the skin. The patch may be completely mechanically driven, with no electronic components, for low cost, safety, and reliability. Pressing an activation button may set in motion a sequence of mechanical events that result in a needle exiting the patch into the skin of the user, and flow of fluid from an internal pouch in the patch into the user. When delivery is complete, another sequence of mechanical events may occur to retract the needle from the skin and stop the flow of fluid, and to show a visible indicator that delivery is complete. The patch may contain a fluid channel, such as a microfluidic channel, that controls the rate and time of delivery; this channel can be configured or selected for different medications or use cases.

## Claims

### Claim 1

A mechanically driven medication delivery patch, comprising:
a bottom surface of a patch, said bottom surface configured to be coupled to skin of a user;
a top cover of said patch;
a pouch configured to contain a fluid to be delivered to said user, said pouch situated between said bottom surface and said top cover;
an activation button;
a wedge configured to move from an initial position to an end-of-delivery position, and from said end-of-delivery position to an end-of-travel position, and configured to apply pressure to said fluid between said initial position and said end-of-delivery position;
a wedge force element configured to apply force to said wedge to cause said wedge to move;
a wedge latch that holds said wedge in said initial position prior to activation;
a needle sled comprising
a pouch needle configured to penetrate a pouch septum in contact with said fluid;
a skin needle configured to penetrate said skin of said user; and
a fluid channel coupling an interior of said pouch needle and an interior of said skin needle;
wherein said needle sled is configured to move between a retracted position and a deployed position;
a needle sled force element configured to apply force to said needle sled to cause movement of said needle sled to said deployed position and to cause
said pouch needle to penetrate said pouch septum;
said skin needle to penetrate said skin of said user; and
said fluid to flow from said pouch through said pouch needle, through said fluid channel, and through said skin needle into said user;
a needle sled latch that holds said needle sled in said retracted position;
wherein
when said activation button is pressed,
said wedge latch is released, allowing said wedge to move from said initial position, and
said needle sled latch is released, allowing said needle sled to move to said deployed position; and
when said wedge reaches said end-of-delivery position,
said wedge applies force to said needle sled to move said needle sled towards said retracted position, and to
retract said pouch needle from said pouch septum; and
retract said skin needle from said skin of said user and into an interior of said patch.

### Claim 2 (depends on 1)

The mechanically driven medication delivery patch of claim 1, wherein said patch contains no electronic components.

### Claim 3 (depends on 1)

The mechanically driven medication delivery patch of claim 1, wherein said pouch comprises a flexible material.

### Claim 4 (depends on 1)

The mechanically driven medication delivery patch of claim 1, further comprising
a plate between said wedge and said pouch;
wherein said wedge applies force to said plate and said plate transfers said force to said pouch to apply said pressure to said fluid between said initial position and said end-of-delivery position.

### Claim 5 (depends on 1)

The mechanically driven medication delivery patch of claim 1, further comprising
a fill port coupled by a fill channel to said pouch; and,
a fill septum closing said fill port and configured to be penetrated by a fill needle to fill said pouch with said fluid.

### Claim 6 (depends on 1)

The mechanically driven medication delivery patch of claim 1, further comprising
a delivery complete indicator configured to provide a visual indication that said wedge reaches said end-of-travel position.

### Claim 7 (depends on 6)

The mechanically driven medication delivery patch of claim 6, wherein
said top cover comprises a window;
said delivery complete indicator is coupled to or integrated into said wedge;
said delivery complete indicator is visible through said window when said wedge reaches said end-of-travel position.

### Claim 8 (depends on 1)

The mechanically driven medication delivery patch of claim 1, wherein
one or more of a shape, length, diameter, materials, valves, and flow restrictors of said fluid channel are configured to provide a desired rate of delivery of said fluid to said user over a desired time period between a start time when said activation button is pressed and a finish time when said wedge reaches said end-of-travel position.

### Claim 9 (depends on 8)

The mechanically driven medication delivery patch of claim 8, wherein said fluid channel comprises a microfluidic channel.

### Claim 10 (depends on 8)

The mechanically driven medication delivery patch of claim 8, wherein said one or more of a shape, length, diameter, materials, valves, and flow restrictors of said fluid channel are configured to select said desired time period in a range between 10 seconds and 7 days.

### Claim 11 (depends on 1)

The mechanically driven medication delivery patch of claim 1, wherein
said wedge force element comprises one or more wedge springs; and,
said needle sled force element comprises one or more needle sled springs.

### Claim 12 (depends on 1)

The mechanically driven medication delivery patch of claim 1, wherein
said activation button comprises one or more activation button extensions extending into an interior of said patch and configured to contact said wedge latch when said activation button is pressed and to apply force to said wedge latch to release said wedge latch.

### Claim 13 (depends on 1)

The mechanically driven medication delivery patch of claim 1, wherein
said wedge is configured to
contact a needle sled release element coupled to said needle sled latch, and
transmit a portion of said force applied by said wedge force element to said needle sled release element to release said needle sled latch.

### Claim 14 (depends on 13)

The mechanically driven medication delivery patch of claim 13, wherein
when said wedge contacts said needle sled release element, said needle sled release element pivots to release said needle sled latch.

### Claim 15 (depends on 1)

The mechanically driven medication delivery patch of claim 1, further comprising
a needle sled push carriage coupled to said needle sled force element and releasably coupled to said needle sled, and configured to transmit force from said needle sled force element to said needle sled.

### Claim 16 (depends on 15)

The mechanically driven medication delivery patch of claim 15, wherein said needle sled push carriage is configured to detach from said needle sled when said needle sled reaches said deployed position.

### Claim 17 (depends on 16)

The mechanically driven medication delivery patch of claim 16, further comprising
one or more carriage release elements configured to contact one or more portions of said needle sled push carriage when said needle sled reaches said deployed position and to decouple said needle sled push carriage from said needle sled.

### Claim 18 (depends on 1)

The mechanically driven medication delivery patch of claim 1, wherein
a gauge of said pouch needle is in a range between 18 gauge and 27 gauge; and,
a gauge of said skin needle is in a range between 25 gauge and 34 gauge.

### Claim 19 (depends on 1)

The mechanically driven medication delivery patch of claim 1, further comprising
a curved channel through which said skin needle travels when said needle sled moves from said retracted position to said deployed position, causing said skin needle to change orientation from substantially parallel to said skin of said user in said retracted position to non-parallel with said skin of said user in said deployed position.

### Claim 20 (depends on 19)

The mechanically driven medication delivery patch of claim 19, wherein
when said needle sled is in said deployed position, an angle between said skin needle and said skin of said user is greater than or equal to 30 degrees and less than 90 degrees.
