# US 10,441,316 B2 · Intradermal applicator/analyte sensor placement using fluorescence

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- Number: US 10,441,316 B2
- Document ID: US10441316B2
- Status: Granted
- Kind: B2
- Application number: 15/758,531
- Filed: 2016-09-09
- Published: 2018-09-13
- Granted: 2019-10-15
- Earliest claimed: 2015-09-11
- Assignees: Pop Test LLC
- Applicants: Pop Test LLC
- Inventors: Randice Lisa Altschul; Neil David Theise; Razvan Andrei Ene; Myron Rapkin; Rebecca O'Brien
- Web page: https://patentgrep.com/patent/US10441316B2

## CPC

- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 5/0071: {by measuring fluorescence emission}
- A61B 5/0077: {Devices for viewing the surface of the body, e.g. camera, magnifying lens}
- A61B 5/076: {Permanent implantation}
- A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)}
- A61B 5/1451: {for interstitial fluid}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/4845: {Toxicology, e.g. by detection of alcohol, drug or toxic products (A61B5/4848 takes precedence)}
- A61B 5/6861: {Capsules, e.g. for swallowing or implanting}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 10/0045: {Devices for taking samples of body liquids}
- A61B 10/0233: {Pointed or sharp biopsy instruments}
- A61B 17/34: Trocars; Puncturing needles
- A61B 17/3403: {Needle locating or guiding means}
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 90/20: Surgical microscopes characterised by non-optical aspects
- A61M 37/00: Other apparatus for introducing media into the body (for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30); Percutany, i.e. introducing medicines into the body by diffusion through the skin (salt baths A61H33/04)
- A61M 37/0069: {Devices for implanting pellets, e.g. markers or solid medicaments (for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027)}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 2010/008: {Interstitial fluid}
- A61B 2017/3407: {including a base for support on the body}
- A61B 2034/2057: {Details of tracking cameras}
- A61B 2090/304: {using chemi-luminescent materials}
- A61B 2090/3925: {ultrasonic}
- A61B 2090/3933: {Liquid markers}
- A61B 2090/3941: {Photoluminescent markers}
- A61B 2090/395: {with marking agent for marking skin or other tissue}
- A61B 2090/3954: {magnetic, e.g. NMR or MRI}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61B 2560/066: catheters therefor
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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

The present invention provides for a method and apparatus for inserting and using dermal interstitial sensors in, for example, an analyte monitoring system. The present invention permits the proper positioning of a cannula tip and/or sensor(s) within the reticular dermis.

## Claims

### Claim 1

A device for guiding the implanting of a sensor within the skin of a subject, the device comprising:
a housing that is adapted for placement on the outer skin of the subject, said housing defining an area of the skin over which an ultraviolet illuminator and a camera are positioned in said housing at a predetermined distance above the area of the skin, and comprising:
at least one insertion port contiguous with an insertion channel that is formed at a predetermined angle within said housing, said insertion channel having an opening that is adapted to rest against the skin;
said ultraviolet illuminator illuminating a fluorescent material that is previously positioned within the reticular dermis of the subject that is located underneath said housing;
said camera capturing an image of the skin, including the reticular dermis, located beneath said housing;
and
a display that permits a user to view said image when passing an applicator and/or sensor through said insertion port and down through said insertion channel and out of said opening such that a tip of said applicator and/or sensor is visible in said image and is positioned within the reticular dermis for delivering the applicator and/or sensor therein.

### Claim 2 (depends on 1)

The device of claim 1 wherein said camera comprises a wireless transponder for communicating wirelessly with said display, said transponder providing said image to said display.

### Claim 3 (depends on 1)

The device of claim 1 wherein the camera is a confocal microscope.

### Claim 4 (depends on 1)

The device of claim 1 wherein the focal plane of the camera is adjusted via the display.

### Claim 5 (depends on 1)

The device of claim 1 wherein the display is a smartphone.