Collection and analysis of data for diagnostic purposes

• US 10,438,356 B2
• Filed: 07/24/2015
• Issued: 10/08/2019
• Est. Priority Date: 07/24/2014
• Status: Active Grant

• Current Assignee: University Health Network
• Original Assignee: University Health Network
• Inventors: Dacosta, Ralph
• Primary Examiner(s): Bitar, Nancy
• Application Number:
  US15/328,214
• Publication Number:
  US 20170236281A1
• Time in Patent Office: 1,537 Days
• Field of Search: None
• 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 5/445 Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
• CPC Class Codes: G01N 21/6486 Measuring fluorescence of biological material, e.g. DNA, RNA, cells G01N21/6428 takes precedence
• CPC Class Codes: G06T 2207/10016 Video; Image sequence
• CPC Class Codes: G06T 2207/10024 Color image
• CPC Class Codes: G06T 2207/10048 Infrared image
• CPC Class Codes: G06T 2207/10064 Fluorescence image
• CPC Class Codes: G06T 2207/30088 Skin; Dermal
• CPC Class Codes: G06T 2207/30096 Tumor; Lesion
• CPC Class Codes: G06T 7/0016 involving temporal comparison
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Systems and methods for determining bacterial load in targets and tracking changes in bacterial load of targets over time are disclosed. An autofluorescence detection and collection device includes a light source configured to directly illuminate at least a portion of a target and an area around the target with excitation light causing at least one biomarker in the illuminated target to fluoresce. Bacterial autofluorescence data regarding the illuminated portion of the target and the area around the target is collected and analyzed to determine bacterial load of the illuminated portion of the target and area around the target. The autofluorescence data may be analyzed using pixel intensity. Changes in bacterial load of the target over time may be tracked. The target may be a wound in tissue.

Claims

1. A method of obtaining diagnostic data regarding a target, comprising:

directly illuminating at least a portion of a target with a uniform field of excitation light emitted by at least one light source connected to a housing of a handheld device, the at least one light source emitting at least one wavelength or wavelength band causing at least one biomarker in the illuminated portion of the target to fluoresce;

filtering optical signals responsive to illumination of the target with a filter of the handheld device and permitting passage of optical signals having a wavelength corresponding to bacterial fluorescence of the illuminated portion of the target;

collecting bacterial fluorescence data regarding the illuminated portion of the target with an image sensor of the handheld device, wherein the collected bacterial fluorescence data comprises at least one image containing data relating to bacterial autofluorescence responsive to illumination of the target and/or exogenous fluorescence of bacteria responsive to illumination of the target;

identifying pixels in the image having an intensity above a predetermined threshold; and

determining a bacterial load of the illuminated portion of the target by summing the identified pixels, wherein the bacterial load is the measurable bacteria in the target.

2. The method of claim 1, wherein directly illuminating at least a portion of a target with a uniform field of excitation light includes illuminating the target with at least one light source configured to emit excitation light having a wavelength of about 405 nm ±

10 nm.

3. The method of claim 1, wherein directly illuminating at least a portion of a target with a uniform field of excitation light includes illuminating the target with excitation light from first and second light sources.

4. The method of claim 3, wherein illuminating the target with excitation light from first and second light sources includes simultaneously illuminating the target with first and second light sources configured to emit excitation light having a wavelength of about 405 nm ±

10 nm.

5. The method of claim 1, wherein collecting bacterial fluorescence data with an image sensor of the handheld device includes detecting the filtered signals with an image sensor of a digital camera contained within the housing.

6. The method of claim 5, wherein the digital camera is embedded in a wireless communication device.

7. The method of claim 1, wherein the target is one or more of a wound, normal skin, a chronic wound, a burn wound, a non-healing wound, and an ulcer.

8. The method of claim 7, wherein illuminating at least a portion of a target comprises illuminating a periphery of a wound.

9. The method of claim 7, further comprising tracking the bacterial load of the target over time.

10. The method of claim 9, wherein the target is a wound and wherein changes in the bacterial load of the wound are indicative of wound healing or wound infection.

11. The method of claim 1, wherein illuminating at least a portion of a target comprises illuminating a wound prior to cleaning and/or debridement, and wherein determining a bacterial load of the illuminated portion of the target comprises determining the bacterial load of the wound prior to cleaning and/or debridement.

12. The method of claim 11, further comprising illuminating the portion of the wound subsequent to cleaning and/or debridement and determining the bacterial load of the wound subsequent to cleaning and/or debridement.

13. The method of claim 12, further comprising determining an efficacy of the cleaning and/or debridement of the wound based on the bacterial load of the wound subsequent to the cleaning and/or debridement.

14. The method of claim 1, further comprising determining a treatment strategy for the target based at least in part on the bacterial load.

15. The method of claim 1, further comprising displaying an image indicative of the bacterial load of the target on a display of the handheld device.

16. The method of claim 15, wherein displaying the image indicative of the bacterial load of the target includes co-registering bacterial load data relative to at least one of target topography, target anatomy, target area, target depth, target volume, target margins, and necrotic tissue in the image.

17. The method of claim 1, further comprising converting the summed pixels into an area measurement to provide an area of the target containing bacteria.

18. The method of claim 1, further comprising:

illuminating the target with white light;

detecting signals responsive to white-light illumination of the target with the image sensor of the handheld device;

determining a number of pixels representative of the target; and

determining an area of the target based on the number of pixels.

19. The method of claim 1, wherein the at least one image includes at least one RGB image and further comprising:

separating the at least one RGB image into individual channels; and

converting individual green and red image channels from the at least one RGB image to gray scale, wherein identifying pixels having an intensity above a predetermined threshold comprises identifying pixels whose gray scale intensity is above the predetermined threshold.

20. A system for acquiring data regarding a wound in tissue, comprising:

at least one excitation light source configured to directly illuminate a target with a uniform field of excitation light and cause bacteria present on and/or in the target to fluoresce;

an optical sensor configured to detect signals responsive to illumination of bacteria on and/or in the target with excitation light, each signal indicative of at least one of endogenous fluorescence, exogenous fluorescence, absorbance, and reflectance in the illuminated target;

a processor configured to receive the detected signals, to identify pixels corresponding to bacterial fluorescence emitted from the target and having an intensity above a predetermined threshold, to calculate bacterial load of the target based on the identified pixels, and to output data regarding the bacterial load of the target; and

a display for displaying the output data regarding the illuminated target output by the processor.

21. The system of claim 20, further comprising a filter configured to permit passage of optical signals responsive to illumination of the bacteria on and/or in the target with the excitation light and having a wavelength corresponding to bacterial autofluorescence and exogenous fluorescence of bacteria.

22. The system of claim 21, wherein the filter is configured to permit optical signals having a wavelength greater than about 600 nm to pass through the filter to the optical sensor.

23. The system of claim 20, wherein the at least one excitation light source is configured to emit excitation light having a wavelength of about 405 nm ±

10 nm.

24. The system of claim 20, further comprising a white-light source being positioned to illuminate the target with white light during white-light imaging.

25. The system of claim 24, wherein the processor is further configured to determine a size of the target based on a number of pixels associated with the target identified in a white-light image of the target.

26. The system of claim 20, wherein the processor is further configured to identify at least one of a target cleaning protocol, a target debridement protocol, a target sampling protocol, a target treatment protocol, and other target intervention strategy based at least in part on the bacterial load.

27. The system of claim 20, wherein the processor is further configured to identify an indication of at least one of wound infection, wound healing, and a wound healing failure based at least in part on the bacterial load.

28. The system of claim 20, wherein the processor is further configured to track changes in the bacterial load of the target over time.

29. The system of claim 28, wherein the processor is further configured to recommend adjustments to an intervention strategy based, at least in part, on changes in the bacterial load of the illuminated portion of the target over time.

30. The system of claim 20, wherein the processor is further configured to receive signals corresponding to tissue fluorescence and identify tissue components of the target.

31. The system of claim 30, wherein the processor is further configured to track changes in the tissue components of the target over time.

32. The system of claim 31, wherein the processor is further configured to recommend adjustments to an intervention strategy based, at least in part, on changes in the tissue components of the illuminated portion of the target over time.

33. A method of obtaining diagnostic data regarding a target, comprising:

directly illuminating at least a portion of a target with a uniform field of excitation light emitted by at least one excitation light source connected to a housing of a handheld device, the housing including an enclosure for receiving a wireless communication device having a digital camera, the at least one light source emitting at least one wavelength or wavelength band causing bacteria in and/or on the illuminated portion of the target to fluoresce;

capturing fluorescence of the bacteria responsive to illumination of the illuminated portion of the target with an image sensor of the digital camera of the wireless communication device, the wireless communication device being secured in the housing;

identifying pixels in the captured fluorescence having an intensity above a predetermined threshold;

determining a bacterial load of the illuminated portion of the target based on the number of pixels identified; and

tracking changes in bacterial load of the target over time.

34. The method of claim 33, further comprising determining an intervention strategy based at least in part on the bacterial load of the illuminated portion of the target.

35. The method of claim 34, further comprising adjusting the intervention strategy based on changes in the bacterial load of the illuminated portion of the target over time.

36. The method of claim 33, further comprising:

illuminating the target with white light;

detecting signals responsive to white-light illumination of the target with the image sensor of the digital camera of the wireless communication device;

determining a number of pixels representative of the target; and

determining an area of the target based on the number of pixels.

37. The method of claim 36, further comprising tracking changes in the area of the target over time.

38. The method of claim 37, further comprising determining an intervention strategy based at least in part on the area of the target.

39. The method of claim 38, further comprising adjusting the intervention strategy based on changes in the area of the target overtime.