DEVICES AND METHODS FOR SAMPLING AND PROFILING MICROBIOTA OF SKIN

• US 20150148686A1
• Filed: 11/27/2013
• Published: 05/28/2015
• Est. Priority Date: 11/27/2013
• Status: Active Grant

• Current Assignee: Elwha LLC (Intellectual Ventures LLC)
• Original Assignee: Elwha LLC (Intellectual Ventures LLC)
• Inventors: Baym, Michael H., Hyde, Roderick A., Kare, Jordin T., Leuthardt, Eric C., McKnight, Gary L., Pan, Tony S., Sweeney, Elizabeth A., Tegreene, Clarence T., Wood, Lowell L. Jr.
• Granted Patent: US 9,549,703 B2
• Time in Patent Office: Days
• US Class Current: 600/476
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2010/0216 Sampling brushes
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/443 Evaluating skin constituents, e.g. elastin, melanin, water
• CPC Class Codes: A61B 5/445 Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 35/003 Portable hand-held applicators having means for dispensing or spreading integral media hand-held massage devices with liquid delivery A61H7/003
• CPC Class Codes: C12Q 1/04 Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor C12Q1/6897 takes precedence
• CPC Class Codes: G01N 2800/20 Dermatological disorders
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/56911 Bacteria
• CPC Class Codes: G01N 33/56938 Staphylococcus

Abstract

Devices and methods for profiling microbiota of skin are described which include a hand-held microbe profiling device including a housing defining an opening, the housing including at least one rotatable component at least partially disposed in the opening defined by the housing, an elongated flexible strip disposed on an outer surface of the at least one rotatable component, the outer surface of the elongated flexible strip positioned to contact one or more regions of a skin surface of an individual through the opening defined by the housing, a location-capture component to detect a location of one or more regions of the skin surface as the elongated flexible strip contacts said one or more regions, at least one sensor component to detect one or more signals emitted or reflected from the elongated flexible strip, and a computing component to associate the location of said one or more regions of the skin surface and the detected one or more signals.

Claims

1. A microbe profiling device comprising:

a hand-held housing defining an opening and including

at least one rotatable component at least partially disposed in the opening defined by the hand-held housing;

an elongated flexible strip disposed on an outer surface of the at least one rotatable component, an outer surface of the elongated flexible strip positioned to contact one or more regions of a skin surface of an individual through the opening defined by the hand-held housing, the outer surface of the elongated flexible strip including a microbe-capture region, the microbe-capture region configured to capture at least one type of microbe from said one or more regions of the skin surface of the individual;

a location capture component including circuitry to determine a location of said one or more regions of the skin surface of the individual as the outer surface of the elongated flexible strip including the microbe-capture region contacts said one or more regions of the skin surface of the individual;

at least one sensor component including circuitry to detect one or more signals emitted or reflected from at least one type of microbe captured on the microbe-capture region of the elongated flexible strip from said one or more regions of the skin surface of the individual and to transform the detected one or more signals into a sensor output; and

a computing component including a microprocessor, the computing component including circuitry configured to

receive information associated with the location of said one or more regions of the skin surface of the individual from the location capture component;

receive the sensor output from the at least one sensor component;

associate the location of said one or more regions of the skin surface of the individual with the detected one or more signals; and

generate an output including information regarding an association between the location of said one or more regions of the skin surface of the individual and the detected one or more signals.

4. The device of claim 1, wherein the at least one rotatable component comprises at least one rotatable reel.

6. The device of claim 1, wherein at least a portion of the elongated flexible strip is wound around an outer surface of at least one of a supply rotatable component or a take-up rotatable component.

9. The device of claim 1, further comprising:

a motor operably coupled to the at least one rotatable component, the motor including circuitry configured to drive rotation of the at least one rotatable component.

18. The device of claim 1, wherein the microbe-capture region comprises a charged surface.

19. The device of claim 1, wherein the microbe-capture region comprises at least one of an adhesive, an absorbent, or an adsorbent.

20. The device of claim 1, wherein the microbe-capture region comprises a biomolecule-binding polymer.

22. The device of claim 1, wherein the microbe-capture region comprises a plurality of specific microbe-binding elements.

23. The device of claim 22, wherein at least one of the plurality of specific microbe-binding elements comprises a specific microbe-binding antibody.

30. The device of claim 1, wherein the location-capture component comprises a fiducial reader.

35. The device of claim 1, wherein the at least one sensor component comprises at least one of an optical sensor component, a fluorescence sensor component, an electromagnetic sensor component, an electrical current sensor component, a piezoelectric sensor component, a magnetic sensor component, an acoustic sensor component, a radiofrequency sensor component, or a radioactivity sensor component.

36. The device of claim 1, wherein the at least one sensor component includes a directed energy source, the directed energy source configured to emit directed energy to elicit one or more signals from the microbe-capture region.

38. The device of claim 1, wherein the computing component includes circuitry configured to

receive the sensor output from the at least one sensor component, the sensor output including information associated with at least one property of the detected one or more signals emitted or reflected from the at least one type of microbe captured on the micro-capture region from said one or more regions of the skin surface of the individual;

compare the at least one property of the detected one or more signals from the at least one type of microbe with a database of reference microbe signal properties;

generate a digital alignment of the location of said one or more regions of the skin surface of the individual with the detected one or more signals emitted or reflected from the at least one type of microbe captured on the microbe-capture region from said one or more regions of the skin surface of the individual;

identify the at least one type of microbe captured on the microbe-capture region from said one or more regions of the skin surface of the individual based on the comparison of the at least one property of the detected one or more signals emitted or reflected from the at least one type of microbe with the database of reference microbe signal properties; and

report to a user a microbe profile, the microbe profile including at least one of a spatial distribution or an identity of the at least one type of microbe on the skin surface of the individual.

41. The device of claim 38, wherein the computing component includes circuitry configured to

compare the microbe profile with a reference microbe profile;

generate a recommended treatment regimen for the individual based on the comparison; and

report the recommended treatment regimen to a user.

44. The device of claim 1, further comprising:

at least one reservoir, the at least one reservoir configured to hold and controllably release at least one agent.

48. The device of claim 1, further comprising:

one or more skin engaging guides.

49. The device of claim 1, further comprising:

a vacuum source, the vacuum source positioned to pull fluid and the at least one type of microbe through the opening defined by the hand-held housing and onto the elongated flexible strip.

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50. A microbe profiling device comprising:

a hand-held housing defining an opening and including

at least one rotatable component at least partially disposed in the opening defined by said hand-held housing;

an elongated flexible strip disposed on an outer surface of the at least one rotatable component, an outer surface of the elongated flexible strip positioned to contact one or more regions of a skin surface of an individual through the opening defined by the hand-held housing, the outer surface of the elongated flexible strip including a plurality of signal-generating complexes, at least one of the plurality of signal-generating complexes to emit one or more signals in response to contact with at least one type of microbe from said one or more regions of the skin surface of the individual;

a location capture component including circuitry to determine a location of said one or more regions of the skin surface of the individual as the outer surface of the elongated flexible strip including the plurality of signal-generating complexes contacts said one or more regions of the skin surface of the individual;

at least one sensor component including circuitry to detect one or more signals emitted from the at least one of the plurality of signal-generating complexes in response to contact with the at least one type of microbe from said one or more regions of the skin surface of the individual and to transform the detected one or more signals into a sensor output; and

a computing component including a microprocessor, the computing component including circuitry configured to

receive information associated with the location of said one or more regions of the skin surface of the individual from the location capture component;

receive the sensor output from the at least one sensor component;

associate the location of said one or more regions of the skin surface of the individual with the detected one or more signals; and

generate an output including information regarding an association between the location of said one or more regions of the skin surface of the individual and the detected one or more signal.

51. The device of claim 50, wherein each of the plurality of signal-generating complexes comprises at least one signal-generating element operably coupled to at least one specific microbe-binding element, the at least one signal-generating element to emit one or more signals in response to contact of the operably coupled specific microbe-binding element with at least one type of microbe.

55. The device of claim 50, wherein at least one of the plurality of signal-generating complexes is an optical signal-generating complex, a fluorescing signal-generating complex, an electromagnetic signal-generating complex, a radio signal-generating complex, an electrical current signal-generating complex, an acoustic signal-generating complex, or a magnetic signal-generating complex.

57. The device of claim 50, wherein the location capture component comprises a fiducial reader.

61. The device of claim 50, wherein the at least one sensor component comprises at least one of an optical sensor component, a fluorescence sensor component, electromagnetic sensor component, an electrical current sensor component, a piezoelectric sensor component, a magnetic sensor component, an acoustic sensor component, or a radiofrequency sensor component.

62. The device of claim 50, wherein the computing component includes circuitry configured to

receive the sensor output from the at least one sensor component, the sensor output including information associated with at least one property of the detected one or more signals emitted from the at least one of the plurality of signal-generating complexes in response to contact with at least one type of microbe from said one or more regions of the skin surface of the individual;

compare the at least one property of the detected one or more signals emitted from the at least one of the plurality of signal-generating complexes with a database of properties of reference signal-generating complexes;

generate a digital alignment of the location of said one or more regions of the skin surface of the individual with the detected one or more signals emitted from the at least one of the plurality of signal-generating complexes in response to contact with at least one type of microbe from said one or more regions of the skin surface of the individual;

identify the at least one type of microbe from said one or more regions of the skin surface of the individual based on the comparison of the at least one property of the detected one or more signals emitted from the at least one of the plurality of signal-generating complexes in response to contact with the at least one type of microbe with a database of properties of reference signal-generating complexes; and

report to a user a microbe profile, the microbe profile including at least one of a spatial distribution or an identity of the at least one type of microbe on the skin surface of the individual.

65. The device of claim 62, wherein the computing component includes circuitry configured to

compare the microbe profile with a reference microbe profile;

generate a recommended treatment regimen for the individual based on the comparison; and

report the recommended treatment regimen to a user.

68. The device of claim 50, further comprising:

at least on reservoir, the at least one reservoir configured to hold and controllably release at least one agent.

71. The device of claim 50, further comprising:

a vacuum source, the vacuum source positioned to pull fluid and the at least one type of microbe through the opening defined by the housing and onto the elongated flexible strip.

73. The device of claim 50, further comprising:

a motor operably coupled to the at least one rotatable component, the motor including circuitry configured to drive rotation of the at least one rotatable component.

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76. A method of profiling microbiota of skin, comprising:

contacting one or more regions of a skin surface of an individual with a hand-held microbe profiling device, the hand-held profiling device including

a housing defining an opening, the housing including;

at least one rotatable component at least partially disposed in the opening defined by the housing,

an elongated flexible strip disposed on an outer surface of the at least one rotatable component, an outer surface of the elongated flexible strip positioned to contact said one or more regions of the skin surface of the individual through the opening defined by the housing, the outer surface of the elongated flexible strip including a microbe-capture region,

a location capture component including circuitry to determine a location of said one or more regions of the skin surface of the individual;

at least one sensor component; and

a computing component including a microprocessor, the computing component including circuitry;

determining a location of said one or more regions of the skin surface of the individual with the location-capture component as the elongated flexible strip including the microbe-capture region contacts said one or more regions of the skin surface of the individual and generating a location output, the location output including information associated with the location of said one or more regions of the skin surface of the individual;

advancing the elongated flexible strip past the opening defined by the housing to the at least one sensor component;

analyzing the microbe-capture region on the elongated flexible strip with the at least one sensor component to detect one or more signals emitted or reflected from at least one type of microbe captured on the microbe-capture region from said one or more regions of the skin surface of the individual and transforming the detected one or more signals into a sensor output, the sensor output including at least one property of the detected one or more signals emitted or reflected from the at least one microbe captured on the microbe-capture region;

receiving the sensor output with the computing component and comparing the at least one property of the detected one or more signals emitted or reflected from the at least one type of microbe captured on the microbe-capture region from said one or more regions of the skin surface of the individual with a database of reference microbe signal properties;

receiving the location output with the computing component and generating a digital alignment of the location of said one or more regions of the skin surface of the individual with the detected one or more signals emitted or reflected from the at least one type of microbe captured on the microbe-capture region from said one or more regions of the skin surface of the individual;

generating a microbe profile from the digital alignment with the computing component, the microbe profile including a spatial distribution of the at least one type of microbe on the skin surface of the individual; and

reporting the microbe profile to a user.

78. The method of claim 76, wherein determining the location of said one or more regions of the skin surface of the individual with the location-capture component comprises

capturing one or more images of said one or more regions of the skin surface of the individual as the microbe-capture region contacts said one or more regions of the skin surface;

and

aligning the one or more images of said one or more regions of the skin surface of the individual with a reference image of the skin surface of the individual.

80. The method of claim 76, further comprising:

reading one or more fiducials on the skin surface of the individual with the location-capture component to determine the location of the one or more regions of the skin surface.

82. The method of claim 76, wherein advancing the elongated flexible strip past the opening defined by the housing of the hand-held microbe profiling device comprises advancing the elongated flexible strip by manually advancing the elongated flexible strip along the skin surface of the individual.

83. The method of claim 76, wherein advancing the elongated flexible strip past the opening defined by the housing of the hand-held microbe profiling device comprises advancing the elongated flexible strip using a motor operably coupled to the at least one rotatable component of the hand-held microbe profiling device.

88. The method of claim 76, further comprising:

identifying the at least one type of microbe captured on the microbe-capture region from said one or more regions of the skin surface of the individual based on the comparison of the at least one property of the detected one or more signals emitted or reflected by the at least one type of microbe captured on the microbe-capture region from said one or more regions of the skin surface of the individual with the database of reference microbe signal properties;

adding the identification of the at least one type of microbe to the microbe profile; and

reporting the microbe profile to a user, the microbe profile including at least one of the identification or the spatial distribution of the at least one type of microbe on the skin surface of the individual.

89. The method of claim 76, further comprising:

comparing the microbe profile with a reference microbe profile;

generating a recommended treatment regimen for the individual based on the comparison; and

reporting the recommended treatment regimen to a user.

90. The method of claim 76, further comprising:

releasing an agent from a reservoir included in the hand-held microbe profiling device to the skin surface of the individual.

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91. A method of assessing a microbiota of a skin surface, comprising:

contacting one or more regions of a skin surface of an individual with a hand-held microbe profiling device, the hand-held microbe profiling device including

a housing defining an opening, the housing including;

at least one rotatable component at least partially disposed in the opening defined by the housing,

an elongated flexible strip disposed on an outer surface of the at least one rotatable component, an outer surface of the elongated flexible strip positioned to contact said one or more regions of the skin surface of the individual through the opening defined by the housing, the outer surface of the elongated flexible strip including a plurality of signal-generating complexes,

a location capture component including circuitry to determine a location of said one or more regions of the skin surface of the individual;

at least one sensor component; and

a computing component including a microprocessor, the computing component including circuitry;

determining a location of said one or more regions of the skin surface of the individual with the location capture component as the elongated flexible strip including the plurality of signal-generating complexes contacts said one or more regions of the skin surface of the individual and generating a location output, the location output including information associated with the location of said one or more regions of the skin surface of the individual;

advancing the elongated flexible strip past the opening defined by the housing to the at least one sensor component;

analyzing the elongated flexible strip with the at least one sensor component to detect one or more signals emitted from at least one of the plurality of signal-generating complexes in response to contact with at least one type of microbe from said one or more regions of the skin surface of the individual and transforming the detected one or more signals into a sensor output, the sensor output including at least one property of the detected one or more signals emitted from the at least one of the plurality of signal-generating complexes;

receiving the sensor output with the computing component and comparing the at least one property of the detected one or more signals emitted from the at least one of the plurality of signal-generating complexes in response to contact with the at least one type of microbe from said one or more regions of the skin surface of the individual with a database of properties of reference signal-generating complexes;

receiving the location output with the computing component and generating a digital alignment of the location of said one or more regions of the skin surface of the individual with the detected one or more signals emitted from the at least one of the plurality of signal-generating complexes in response to contact with the at least one type of microbe from said one or more regions;

generating a microbe profile from the digital alignment with the computing component, the microbe profile including a spatial distribution of the at least one type of microbe on the skin surface of the individual; and

reporting the microbe profile to a user.

104. The method of claim 91, further comprising:

identifying the at least one type of microbe from a comparison of the at least one property of the detected one or more signals emitted from the at least one of the plurality of signal-generating complexes in response to contact with the at least one type of microbe with the database of properties of reference signal-generating complexes;

adding the identification of the at least one type of microbe to the microbe profile; and

reporting the microbe profile to a user, the microbe profile including the identification and the spatial distribution of the at least one type of microbe on the skin surface of the individual.

105. The method of claim 91, further comprising:

comparing the microbe profile with a reference microbe profile;

generating a recommended treatment regimen for the individual based on the comparison; and

reporting the recommended treatment regimen to a user.

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