Transdermal sampling and analysis device

• US 9,451,913 B2
• Filed: 09/11/2012
• Issued: 09/27/2016
• Est. Priority Date: 12/10/2010
• Status: Active Grant

• Current Assignee: Cambridge Medical Technologies, LLC, Medina Isf Equity, LLC
• Original Assignee: Touchtek Labs, LLC
• Inventors: Currie, John F., Marcanio, Joseph A., Vidalis, Joseph J.
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): MESSERSMITH, ERIC J
• Application Number:
  US13/609,838
• Publication Number:
  US 20130123595A1
• Time in Patent Office: 1,477 Days
• Field of Search: 600/345, 600/347, 600/365, 20440301-40315
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150076 by heating
• CPC Class Codes: A61B 5/150122 by heating
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/15134 Bladeless capillary blood sampling devices, i.e. devices for perforating the skin in order to obtain a blood sample but not using a blade, needle, canula, or lancet, e.g. by laser perforation, suction or pressurized fluids
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

Transdermal sampling and analysis device, method and system are provided for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples. The transdermal sampling and analysis device, method and system may cause disruption to the skin cells to create capillary-like channels from which biological samples may flow to the transdermal sampling and analysis device. The transdermal sampling and analysis device, method and system may collect the biological samples in a reservoir and transport the biological samples to a sensing chamber. The sensing chamber may contain at least two sensing electrodes coated with a biologically reactive element which reacts with the transported biological sample. The sensing chamber may be configured to mitigate the formation of air bubbles which may impede the transport and distribution of the biological sample across the entirety of the sensing chamber.

Claims

1. A transdermal sampling and analysis device comprising:

a substrate having a first side;

at least one disruptor mounted on the first side of the substrate, wherein the at least one disruptor is configured to generate a localized heat capable of altering the permeability characteristics of a stratum corneum layer of skin of an organism, wherein the localized heat causes capillary-like channels between disrupted cells in the stratum corneum;

a reservoir configured to collect and contain a biological sample that is obtained through the capillary-like channels, wherein the reservoir is substantially circular; and

a sensing chamber connected to the reservoir, wherein an outer edge of the sensing chamber intersects the reservoir at an intersection point comprising a tapered smooth surface, and wherein the sensing chamber comprises;

a plurality of channel supports; and

a plurality of channels formed between the channel supports, wherein an aspect ratio of a height to a width of each of the plurality of channels is approximately 10;

1; and

a biological sensing element comprising;

at least two sensing electrodes mounted on the first side of the substrate, wherein the biological sensing element is configured to determine the levels of an analyte in the biological sample, wherein the sensing chamber is configured to contain the biological sample around the at least two sensing electrodes.

2. The transdermal sampling and analysis device of claim 1, wherein the aspect ratio of the height to the width of each of the plurality of channels is less than 10:

1.

3. The transdermal sampling and analysis device of claim 1, wherein the height of each of the plurality of channels formed between the channel supports is about 250 μ

m.

4. The transdermal sampling and analysis device of claim 1, wherein the plurality of channels formed between the channel supports comprises six channels.

5. The transdermal sampling and analysis device of claim 1, wherein the plurality of channel supports are configured parallel to an axis between a center point of the reservoir and a center point of the sensing chamber.

6. The transdermal sampling and analysis device of claim 5, wherein each of the plurality of channel supports is tapered with a wide dimension distally located from the reservoir and a narrow dimension proximally located from the reservoir.

7. The transdermal sampling and analysis device of claim 6, wherein a distance between adjacent channel supports is approximately 30 μ

m, and wherein a distance between an outer edge of the sensing chamber and an adjacent channel support is approximately 35 μ

m.

8. The transdermal sampling and analysis device of claim 6, wherein a distance between adjacent channel supports is approximately 35 μ

m, and wherein a distance between an outer edge of the sensing chamber and an adjacent channel support is approximately 40 μ

m.

9. The transdermal sampling and analysis device of claim 1, wherein the plurality of channel supports are configured perpendicular to an axis between a center point of the reservoir and a center point of the sensing chamber.

10. The transdermal sampling and analysis device of claim 1, wherein:

each of the plurality of channel supports is tapered with a wide dimension distally located from the reservoir and a narrow dimension proximally located from the reservoir;

a distance between adjacent channel supports at the wide dimension is approximately 23 μ

m;

a distance between adjacent channel supports at the narrow dimension is approximately 33 μ

m; and

a distance between an outer edge of the sensing chamber and an adjacent channel support at the intersection point is approximately 38 μ

m.

11. The transdermal sampling and analysis device of claim 1, wherein surfaces of at least one of the at least two sensing electrodes are coated with a sensing reagent.

12. The transdermal sampling and analysis device of claim 11, wherein the sensing reagent comprises a biologically reactive element, an electron mediator, and a polymer.

13. The transdermal sampling and analysis device of claim 12, wherein the biological sample is interstitial fluid and the biologically reactive element is glucose oxidase.

14. The transdermal sampling and analysis device of claim 1, wherein the aspect ratio of the height to the width of each of the plurality of channels is approximately 1:

1.

15. A transdermal sampling and analysis device comprising:

a substrate having a first side;

at least one disruptor mounted on the first side of the substrate, wherein the at least one disruptor is configured to generate a localized heat capable of altering the permeability characteristics of a stratum corneum layer of skin of an organism, wherein the localized heat causes capillary-like channels between disrupted cells in the stratum corneum;

a reservoir configured to collect and contain a biological sample that is obtained through the capillary-like channels, wherein the reservoir is substantially circular; and

a circular sensing chamber surrounding a periphery of the reservoir, the sensing chamber comprising;

a plurality of channel supports; and

a plurality of channels formed between the channel supports, wherein an aspect ratio of a height to a width of each of the plurality of channels is approximately 3;

1; and

a biological sensing element comprising at least two sensing electrodes mounted on the first side of the substrate, wherein the biological sensing element is configured to determine the levels of an analyte in the biological sample, wherein the sensing chamber is configured to contain the biological sample around the at least two sensing electrodes.

16. The transdermal sampling and analysis device of claim 15, wherein surfaces of at least one of the at least two sensing electrodes are coated with a sensing reagent.

17. The transdermal sampling and analysis device of claim 16, wherein the biologically reactive element is covered with a barrier layer, wherein the barrier layer prevents interference between the biological sample and the sensing reagent.

18. The transdermal sampling and analysis device of claim 16, wherein the sensing reagent comprises a biologically reactive element, an electron mediator, and a polymer.

19. The transdermal sampling and analysis device of claim 18, wherein the biological sample is interstitial fluid, and wherein the biologically reactive element is glucose oxidase.

20. The transdermal sampling and analysis device of claim 15, wherein the height of each of the plurality of channels formed between the channel supports is about 80 μ

m.

21. The transdermal sampling and analysis device of claim 15, wherein the plurality of channels formed between the channel supports comprises twenty four channels.

22. A transdermal sampling and analysis device comprising:

a substrate having a first side;

at least one disruptor mounted on the first side of the substrate, wherein the at least one disruptor is configured to generate a localized heat capable of altering the permeability characteristics of a stratum corneum layer of skin of an organism, wherein the localized heat causes capillary-like channels between disrupted cells in the stratum corneum;

a reservoir configured to collect and contain a biological sample that is obtained through the capillary-like channels, wherein the reservoir is substantially circular; and

a sensing chamber connected to the reservoir, wherein an outer edge of the sensing chamber intersects the reservoir at an intersection point comprising a sharp cornered surface, and wherein the sensing chamber comprises;

a plurality of channel supports; and

a plurality of channels formed between the channel supports, wherein an aspect ratio of a height to a width of each of the plurality of channels is approximately 10;

1; and

a biological sensing element comprising;

at least two sensing electrodes mounted on the first side of the substrate, wherein the biological sensing element is configured to determine the levels of an analyte in the biological sample, wherein the sensing chamber is configured to contain the biological sample around the at least two sensing electrodes.

23. The transdermal sampling and analysis device of claim 22, wherein:

each of the plurality of channel supports is tapered with a wide dimension distally located from the reservoir and a narrow dimension proximally located from the reservoir;

a distance between adjacent channel supports at the wide dimension is approximately 23 μ

m;

a distance between adjacent channel supports at the narrow dimension is approximately 33 μ

m; and

a distance between an outer edge of the sensing chamber and an adjacent channel support at the intersection point is approximately 37 μ

m.