# US 12,214,346 B2 · Dermal patch with a diagnostic test strip

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 12,214,346 B2
- Document ID: US12214346B2
- Status: Granted
- Kind: B2
- Application number: 18/090,063
- Filed: 2022-12-28
- Published: 2023-05-11
- Granted: 2025-02-04
- Earliest claimed: 2021-10-13
- Assignees: Satio, Inc.
- Applicants: Satio, Inc.
- Inventors: Namal Nawana; Ziad Tarik Al-Shamsie
- Web page: https://patentgrep.com/patent/US12214346B2

## CPC

- A61B 5/15113: {Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button}
- B01L 3/5023: {with a sample being transported to, and subsequently stored in an absorbent for analysis}
- A61B 5/150022: {for capillary blood or interstitial fluid}
- A61B 5/150099: {by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes}
- A61B 5/150358: {Strips for collecting blood, e.g. absorbent}
- A61B 5/150412: {Pointed piercing elements, e.g. needles, lancets for piercing the skin (blade-like piercing elements A61B5/150442)}
- A61B 5/150748: {Having means for aiding positioning of the piercing device at a location where the body is to be pierced (means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489)}
- A61B 5/150862: {intermediate range, e.g. within room or building}
- A61B 5/15087: {short range, e.g. between console and disposable (using implanted devices A61B5/150877)}
- A61B 5/150969: {Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing}
- A61B 5/15109: {Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin}
- A61B 5/15117: {comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap}
- A61B 5/15144: {comprising driving means, e.g. a spring, for retracting the piercing unit into the housing}
- A61B 5/15194: {fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin}
- A61B 5/155: {Devices} specially adapted for continuous or multiple sampling, e.g. at predetermined intervals {(devices loaded with multiple lancets simultaneously A61B5/15146)}
- A61B 5/157: {Devices} characterised by integrated means for measuring characteristics of blood
- B01L 2200/04: Exchange or ejection of cartridges, containers or reservoirs
- B01L 2200/10: Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
- B01L 2200/16: Reagents, handling or storing thereof
- B01L 2300/023: Sending and receiving of information, e.g. using Bluetooth®
- B01L 2300/044: pierceable, e.g. films, membranes
- B01L 2300/0672: Integrated piercing tool
- B01L 2300/069: Absorbents; Gels to retain a fluid
- B01L 2300/0825: Test strips
- B01L 2400/049: vacuum
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE

## Abstract

A system for analyzing a physiological sample includes a cartridge configured to attach to the skin of a subject. The cartridge includes: a processing fluid pack that is configured to release a processing fluid stored therein, a diagnostic test strip, and a vacuum pin. The system also includes a lancet with a needle. The lancet is configured to deploy the needle upon engagement with the cartridge to draw a physiological sample from the subject. The vacuum pin is configured to create a vacuum within the cartridge to draw the released processing fluid and the drawn physiological sample to the diagnostic test strip.

## Claims

### Claim 1

A system for analyzing a physiological sample, comprising:
a cartridge configured to attach to the skin of a subject, wherein the cartridge includes:
a processing fluid pack that is configured to release a processing fluid stored therein,
a diagnostic test strip, and
a vacuum pin, and
a lancet with a needle, wherein the lancet is configured to automatically deploy the needle upon engagement of the lancet with the cartridge to draw a physiological sample from the subject,
wherein the vacuum pin is configured to create a vacuum within the cartridge to draw the released processing fluid and the drawn physiological sample to the diagnostic test strip.

### Claim 2 (depends on 1)

The system of claim 1, wherein the drawn physiological sample and the released processing fluid interact to form a processed physiological sample and the diagnostic test strip is configured to detect a biomarker, when present, within the processed physiological sample.

### Claim 3 (depends on 1)

The system of claim 1, wherein the vacuum pin is moveable between an undeployed position and a deployed position and wherein the vacuum pin creates the vacuum within the dermal patch as the vacuum pin moves to the deployed position.

### Claim 4 (depends on 3)

The system of claim 3, wherein a strength of the vacuum is based on a distance the vacuum pin moves.

### Claim 5 (depends on 3)

The system of claim 3, wherein the cartridge further includes:
a vacuum chamber, wherein the vacuum pin is moveable between the undeployed position and the deployed position within the vacuum chamber.

### Claim 6 (depends on 5)

The system of claim 5, wherein the cartridge further includes:
a physiological sample channel in open communication with the vacuum chamber,
wherein the physiological sample channel is configured to carry the drawn physiological sample, and
wherein the vacuum draws the physiological sample to the diagnostic test strip via the physiological sample channel.

### Claim 7 (depends on 1)

The system of claim 1, wherein the cartridge further includes:
a moveable button that is configured to compress the processing fluid pack.

### Claim 8 (depends on 7)

The system of claim 7, wherein the button is configured to move from a locked position to a deployed position, and wherein the cartridge is configured to prevent the button from compressing the processing fluid pack when the button is in the locked position and is configured to allow the button to compress the processing fluid pack when the button is in the deployed position.

### Claim 9 (depends on 8)

The system of claim 8, wherein the cartridge further includes:
a piercing element, and
wherein the button is configured to compress the processing fluid pack into the piercing element to rupture the processing fluid pack.

### Claim 10 (depends on 1)

The system of claim 1, wherein the lancet is configured to automatically retract the needle into a housing of the lancet after deployment of the needle.

### Claim 11 (depends on 1)

The system of claim 1, wherein the vacuum pin includes an elastomeric O-ring that seals the vacuum pin within the cartridge.

### Claim 12 (depends on 1)

The system of claim 1, further comprising:
a computer system configured to image the diagnostic test strip and determine a result of a test associated with the diagnostic test strip based on the image.

### Claim 13 (depends on 12)

The system of claim 12, further comprising:
an electronic medical record database that stores a plurality of electronic medical records,
wherein the cartridge further includes a quick response code, and
wherein the computer system is configured to associate the quick response code with an electronic medical record within the electronic medical record database.

### Claim 14 (depends on 13)

The system of claim 13, wherein the computer system is configured to:
update the associated electronic medical record with the determined result.

### Claim 15 (depends on 1)

The system of claim 1, wherein the processing fluid is a lysing agent.

### Claim 16 (depends on 1)

The system of claim 1, wherein the diagnostic test strip is a lateral flow test strip.

### Claim 17

A cartridge configured to attach to skin of a subject comprising:
a processing fluid pack that is configured to release a processing fluid stored therein,
a diagnostic test strip, and
a vacuum pin, and
a lancet with a needle, wherein the lancet is configured to automatically deploy the needle upon engagement of the lancet with the cartridge to draw a physiological sample from the subject,
wherein the vacuum pin is configured to create a vacuum within the cartridge to draw the released processing fluid and the drawn physiological sample to the diagnostic test strip.
