THERAPEUTIC METHOD AND DEVICE

• US 20180256208A1
• Filed: 09/09/2016
• Published: 09/13/2018
• Est. Priority Date: 09/11/2015
• Status: Active Grant

• Current Assignee: Pop Test LLC
• Original Assignee: Pop Test LLC
• Inventors: ALTSCHUL, Randice Lisa, THEISE, Neil David, ENE, Razvan Andrei, RAPKIN, Myron, O'BRIEN, Rebecca
• Granted Patent: US 10,441,316 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2034/2057 Details of tracking cameras
• CPC Class Codes: A61B 2090/304 using chemi-luminescent materials
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: A61B 2090/3941 Photoluminescent markers
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2560/066 catheters therefor
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/1451 : for interstitial fluid
• CPC Class Codes: A61B 5/14532 : for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 : for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/4845 : Toxicology, e.g. by detection of alcohol, drug or toxic products A61B5/4848 takes precedence
• CPC Class Codes: A61B 5/6861 : Capsules, e.g. for swallowing or implanting
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 90/20 : Surgical microscopes characterised by non-optical aspects
• CPC Class Codes: 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
• CPC Class Codes: 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

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

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 and comprising;

at least one insertion port contiguous with an insertion channel that is formed at a predetermined angle within said housing, said channel having an opening that is adapted to rest against the skin;

an ultraviolet illuminator for illumination of a fluorescent material that is previously positioned within the reticular dermis of the subject that is located underneath said housing;

a camera comprising a focus adjustment, 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 channel such that a tip of said applicator and/or sensor is positioned within the reticular dermis for delivering the applicator and/or sensor therein.

2. The device of claim 1 wherein said camera comprises a wireless transponder and said display is located remotely of said housing, said transponder providing said image to said remotely located display wherein said camera is adapted to couple to said display for displaying said image thereon.

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

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

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

6. The device of claim 1 wherein said predetermined angle is a shallow angle.

7. A method of delivering a sensor to the skin of a subject, the method comprising:

administering an imaging agent to a subject, wherein the imaging agent collects in the target area of the subject'"'"'s skin, wherein the target area is the reticular dermis of the skin of the subject, further wherein the imaging agent is a fluorescent agent;

providing a device for guiding the implanting of an applicator and/or sensor within the skin of the subject, the device comprising;

a housing comprising;

at least one insertion port contiguous with an insertion channel that is formed at a predetermined angle within said housing, said channel having an opening that is adapted to rest against the skin;

an ultraviolet illuminator for illumination a fluorescent material that is previously positioned within the reticular dermis of the subject that is located underneath said housing;

a camera comprising a focus adjustment, said camera capturing an image of the skin, including the reticular dermis, located beneath said housing; and

a display, associated with said housing, that permits a user to view said image when passing an applicator and/or sensor through said channel such that a tip of said applicator and/or sensor is positioned within the reticular dermis for delivering the sampler therein.

applying the imaging device to the skin of the subject;

illuminating the skin with the illuminator, thereby causing the imaging agent to fluoresce;

using the display to adjust the focus of the confocal microscope into the plane of the fluorescence;

inserting an applicator and/or sensor through the at least one insertion port into the sample area of the subject, wherein the user uses a display to follow the insertion of the applicator and/or sensor, wherein when the tip of the applicator and/or sensor is in the plane of the focus, the applicator and/or sensor is in the target area.

8. The method of claim 7, wherein the method further comprises:

providing a sensor device;

inserting the sensor device through the applicator and/or sensor, wherein the applicator and/or sensor is a hollow cannula, into the target area,

thereby delivering the sensor to the target area of the skin of the subject.

9. The method of claim 7, wherein the imaging is obtained in real time.

10. The method of claim 7, wherein the imaging is obtained episodically.

12. The method of claim 7, wherein the imaging agent is selected from the group consisting of radiopaque materials, MRI imaging agents, ultrasound imaging agents, and optical imaging agents, so that the agent is suitable for the imaging method.

13. The method of claim 7, wherein the sensor device is attached to the skin of the subject at an area selected from the group consisting of the upper arm, abdomen, waist, torso, and back of the subject.

14. The method of claim 7, wherein the sensor device is configured to provide data to an external device for registering and transmission of data from the sensor to monitors.

15. The method of claim 7, wherein the sensor device further comprises an internal device sufficiently small to also lay contained within the target area.

16. The method of claim 7, wherein the sensor device is configured to communicate data through direct physical connection to a processing device.

19. The method of claim 7, wherein the wireless signal is Bluetooth.

21. The method of claim 7, wherein the sensor device can measure an analyte selected from the group consisting of glucose, ions, proteins, glycoproteins, lipids, sugars, ingested nutrients, or drugs, toxins, metabolites of drugs, metabolites of toxins, and combinations thereof.

22. The method of claim 7, wherein the sensor device is coated with biologic or synthetic molecule selected from the group consisting of chitosan, hyaluronic acid, Teflon, glycosaminoglycans, Heparin, Heparin sulfate, chondroitin sulfate.

23. The method of claim 7, wherein the coating is antifibrotic and/or antiinflammatory around the sensor leading to consistent signaling over time greater than is achieved through current, imprecisely placed sensors.

11. (canceled)

17. The method of, wherein the sensor device is configured to communicate data through a wireless signal.

18. (canceled)

20. (canceled)

24-60. -60. (canceled)