# US 2017/0281877 A1 · Skin Sensors and Automatic Injectors for Injectable Syringes Having Skin Sensors

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- Number: US 2017/0281877 A1
- Document ID: US20170281877A1
- Status: Published application
- Kind: A1
- Application number: 15/507,491
- Filed: 2015-08-28
- Published: 2017-10-05
- Earliest claimed: 2014-08-28
- Assignees: Unitract Syringe Pty Ltd
- Applicants: Unitract Syringe PTY LTD
- Inventors: Arthur MARLIN; William KING; Stefanie HUROWITZ
- Web page: https://patentgrep.com/patent/US20170281877A1

## CPC

- A61M 5/3234: {Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user}
- A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence)
- A61M 5/31571: {Means preventing accidental administration (for automatic syringes A61M5/20)}
- A61M 5/2053: {Media being expelled from injector by pressurised fluid or vacuum (for infusion A61M5/145, A61M5/155)}
- A61M 2005/2013: {triggering of discharging means by contact of injector with patient body}
- A61M 2005/208: {Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin}
- A61M 2005/31588: {electrically driven}
- A61M 2205/13: with means for the detection of operative contact with patient, e.g. lip sensor
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/70: with testing or calibration facilities
- 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)}

## Abstract

A skin sensing system for a drug delivery device includes a control unit and a skin sensor comprising one or more electrodes. The skin sensor may be configured to store a threshold value associated with skin sensing, receive one or more sensed signal values .from the one or more electrodes, compare the one or more sensed signal values with the threshold value, and based on the comparison, transmit a resultant signal to the control unit, The resultant signal is used by the control unit to determine whether a skin surface of a user is substantially proximate to the skin sensor upon receiving the resultant signal. A drug delivery device for sensing contact with the skin includes the skin sensing system. When the skin sensor senses that the drug delivery device is in contact with a patient's skin surface, drug delivery from the device may he permitted.

## Claims

### Claim 1

A skin sensing system for a drug delivery device comprising:
a control unit; and
a skin sensor comprising one or more electrodes, the skin sensor configured to:
(a) store a threshold value associated with skin sensing;
(b) receive one or more sensed signal values from the one or more electrodes;
(c) compare the one or more sensed signal values with the threshold value; and
(d) based on the comparison, transmit a resultant signal to the control unit; and
wherein the resultant signal is used by, the control unit to determine whether a skin surface of a user is substantially proximate to the skin sensor upon receiving the resultant

### Claim 2 (depends on 1)

The skin sensing system of claim 1, wherein the control unit determines that the skin surface of the user is substantially proximate to the skin sensor when the resultant signal indicates that the one or more sensed signals received from the respective one or more electrodes are above the threshold value.

### Claim 3 (depends on 2)

The skin sensing system of claim 2, wherein the control unit, based on the determination, causes a display unit coupled to the control unit to display a first status notification indicating that the skin surface of the user is substantially proximate to the skin sensor.

### Claim 4 (depends on 1)

The skin sensing system of claim 1, wherein the control unit determines that the skin surface of the user is not substantially proximate to the sensor when the resultant signal indicates that the one or more sensed signals received from the respective one or more electrodes are below the threshold value.

### Claim 5 (depends on 4)

The skin sensing system of claim 4, wherein the control unit, based on the determination, causes a display unit coupled to the control unit to display a second status notification indicating that the skin surface of the user is not substantially proximate to the skin sensor.

### Claim 6 (depends on 1)

The skin sensing system of claim 1, wherein the control unit is further configured to determine an operational status of a presence of a cartridge based on a cartridge status signal received from a cartridge sensor that is coupled to the control unit.

### Claim 7 (depends on 1)

The skin sensing system of claim 1, wherein the control unit is further configured to determine another operational status of a cartridge cover based on a cartridge cover status signal received from a cartridge cover sensor that is coupled to the control unit, and after the determination of the operational status of the cartridge sensor.

### Claim 8 (depends on 7)

The skin sensing system of claim 7, wherein the control unit is further configured to provide the user with a user prompt to activate one or more operations of the system upon determination that: (a) the cartridge is present indicated by the cartridge status signal, (b) the cartridge cover is closed indicated by the cartridge cover status signal, and (c) after the reception of the resultant signal from the skin sensor.

### Claim 9 (depends on 1)

The skin sensing system of claim 1, wherein the control unit is further configured to cause the injection of a needle into the skin surface based on instructions received from the user in response to the user prompt.

### Claim 10 (depends on 1)

The skin sensing system of claim 1, wherein the control unit is further configured to monitor the skin sensing during a drug delivery process.

### Claim 11 (depends on 10)

The skin sensing system of claim 10, wherein during the drug delivery process the control unit is configured to determine that the skin sensor is substantially proximate to the skin surface based on the resultant signal from the skin sensor indicating that the one or more sensed signal values are within a fluctuation window of electrode signal values.

### Claim 12 (depends on 11)

The skin sensing system of claim 11, wherein the fluctuation window includes a range of electrode signal values that are stored in the skin sensor and are calculated as percentages of the threshold value.

### Claim 13 (depends on 12)

The skin sensing system of claim 12, wherein the range of values includes an upper limit defined by a percentage of the threshold value and a lower limit defined by another percentage of the threshold value.

### Claim 14 (depends on 13)

The skin sensing system of claim 13, wherein the control unit determines that the skin sensor is not substantially proximate to the skin surface during the drug delivery process when the resultant signal indicates that the one or more sensed signals is at least below the lower limit of the fluctuation window.

### Claim 15 (depends on 14)

The skin sensing system of claim 14, wherein the control unit, based on the determination that the skin sensor is not substantially proximate to the skin surface during the drug delivery, causes a drive unit coupled to the control unit to retract a needle from the skin surface of the user.

### Claim 16 (depends on 15)

The skin sensing system of claim 15, wherein the control unit causes a display unit to display a guidance message to re-position the skin sensing system prior to the retraction of the needle and before the one or more sensed signals falls below the lower limit of the fluctuation window.

### Claim 17 (depends on 1)

The skin sensing system of claim 1, wherein the threshold value selected to be stored in the skin sensor is from a group consisting of: (a) predetermined skin sensing threshold values determined by an administrator, and (b) calibrated skin sensing threshold values that are iteratively determined by the user.

### Claim 18 (depends on 1)

An automatic injector (Al) device adapted to receive a cartridge including a barrel, a needle, and a plunger assembly including a plunger seal, the cartridge defining a longitudinal axis, the AI device comprising:
a housing;
a cartridge carrier adapted to receive at least a portion of the cartridge, the cartridge carrier being disposed for movement relative to the housing in a direction parallel to the longitudinal axis of the cartridge;
a plunger carrier disposed for movement relative to the cartridge carrier;
an elongated drive device coupled to the plunger carrier, the elongated drive device being disposed to provide movement of the plunger carrier in a direction parallel to the longitudinal axis of the cartridge;
a motor;
a transmission assembly coupling the motor to the elongated device; and
the skin sensing system of claim 1; wherein the control unit controls the motor, based on the resultant signal received from the skin sensor.

### Claim 19 (depends on 18)

The AI device of claim 18, wherein the control unit controls the cartridge carrier to move the cartridge from a first position where the needle is within the housing, to a second position where the needle extends distally from the housing.

### Claim 20 (depends on 1)

A method of using the skin sensing system of claim 1 comprising:
storing a threshold value associated. with skin sensing in a skin sensor;
receiving, by the skin sensor, one or more sensed signals from one or more electrodes;
comparing the one or more sensed signals to the stored threshold value;
transmitting a resultant signal to a control unit based on the comparison; and
determining, by the control unit, whether a skin surface of a user is substantially proximate to the skin sensor upon receiving the resultant signal.
