Analysis system and probe assembly

Abstract

The present invention relates to a probe assembly for spectral analysis of a subject, particularly a skin area. The probe assembly includes a housing configured to hold a probe for Raman spectroscopy within the housing. The probe tip shield has a distal end that defines an opening for exposing the probe tip to a skin area. The probe tip shield shields the probe tip from ambient light, at least at the sensitivity wavelength of Raman spectroscopy. The shape of the probe tip shield can be adjusted to suit the body part of the subject. A retraction mechanism allows control of the pressure the tip applies to the skin. A camera can also be placed inside the housing to capture images of the skin.

Description

Technical Field

[0001] 1. Technical Field The form of the present technology relates to analysis systems, devices, and methods. The form of the present technology relates to a probe assembly for an analysis system. The systems, devices, and methods are particularly applicable to the analysis of a patient's skin, such as the analysis of skin lesions and the diagnosis of certain medical conditions.

Background Art

[0002] 2. Background Art Skin cancer is the most common cancer in the world, accounting for at least 40% of cancer cases worldwide. Moreover, its incidence is steadily increasing. Early detection and accurate diagnosis are essential for effective treatment and improving patient outcomes.

[0003] Conventionally, the diagnosis of skin cancer is performed by a dermatologist's visual inspection of suspicious skin lesions, followed by biopsy and histopathological examination. This examination is subjective, time-consuming, often invasive, and in many cases requires specialized facilities and trained personnel.

[0004] In recent years, there has been an increasing interest in the development of non-invasive diagnostic techniques to improve the diagnostic efficiency and accuracy of skin cancer. Spectroscopic and imaging techniques such as Raman spectroscopy, fluorescence spectroscopy, terahertz spectroscopy, and optical coherence tomography show great potential in this regard.

[0005] Raman spectroscopy is a non-destructive analytical technique that provides information on the molecular composition of a sample by measuring the inelastic scattering of photons. The usefulness of Raman spectroscopy in the diagnosis of skin cancer has been demonstrated by several studies. By analyzing the Raman spectra of skin tissue samples, various molecular changes associated with different types of skin cancer can be identified. These changes include changes in protein content, lipid composition, nucleic acids, and other biomolecules. The ability to detect and quantify these molecular changes is a useful tool for the diagnosis and classification of skin cancer.

[0006] Existing skin cancer diagnostic devices based on various spectroscopic techniques have limitations in their functionality and practicality. These devices often require complex calibration procedures, large equipment, and extensive data analysis, limiting their use to laboratories and specialized medical facilities. Furthermore, the various forms of spectroscopic methods employed in these devices may lack the sensitivity and specificity necessary for accurate diagnosis in diverse patient populations.

[0007] Identifying skin lesions can be useful regardless of whether they are cancerous or not. Knowing the type of skin lesion not only helps in diagnosing benign lesions but also in determining appropriate treatments for non-cancerous lesions.

[0008] 3. Purpose of the technology The objective of this technology is to provide an improved system, device, and / or method for analyzing a subject. Alternatively, the objective of this technology is to provide an improved system for spectral analysis of a subject, such as skin lesions. Alternatively, the objective of this technology is to provide an improved probe assembly for spectral analysis of a system, for example, a probe assembly that can be used as part of a spectral analysis system. Alternatively, the objective of this technology is to provide at least a useful option for the public. [Overview of the project] [Problems that the invention aims to solve]

[0009] 4. Outline of the Invention According to aspects of this technology, systems, devices, and methods are provided for analyzing a subject (e.g., a patient's skin). In certain forms, the systems, devices, and methods may use Raman spectroscopy techniques to analyze the subject. This analysis may be used to identify skin lesions and / or to diagnose certain conditions and / or diseases such as skin cancer. [Means for solving the problem]

[0010] According to one aspect of this technology, a system for analyzing a subject is provided, comprising a probe, a stimulator, a detector, and a processor. A component of the system, for example, the detector, may be considered a spectrometer. In a particular form, the probe is configured to irradiate the subject with electromagnetic radiation. The probe may further be configured to receive electromagnetic radiation from the subject. The probe may further be configured to transmit the received electromagnetic radiation to the detector. The detector may be configured to generate a signal indicating the received electromagnetic radiation and to transmit that signal to the processor. In a particular form, the processor is configured to receive the signal indicating the received electromagnetic radiation. The processor may further be configured to perform spectral analysis of the signal and generate an indicator of skin health, such as analyzing a skin area of ​​the subject and identifying skin lesions within the skin area.

[0011] According to one embodiment, a probe assembly for use in a spectrometer is provided, which may be used to analyze an area of ​​skin of a subject, such as a patient. The probe assembly may include a probe. In some embodiments, the probe assembly may be configured to be handheld.

[0012] In some forms, the probe assembly may be configured to substantially shield the subject from ambient light during probe use. For example, the probe assembly may include a probe tip shield configured to shield the tip from ambient light, for example, ambient light at least at the sensitivity wavelength of Raman spectroscopy. The probe assembly may be configured such that the shape of the distal end of the probe tip shield is adaptable to a region of the subject's body surrounding a skin area.

[0013] In some configurations, the probe assembly may include a probe housing, and the probe may be housed within the probe housing. Furthermore, the probe may be retractable into the probe housing.

[0014] In some embodiments, the probe assembly may include a retraction mechanism for moving the probe between an extended and retracted position. The retraction mechanism may include an actuator configured to act on the probe to extend or retract it. The retraction mechanism may further include a pressure control mechanism to control the pressure that the tip applies to the skin area when the probe is in the extended position.

[0015] In some forms, the probe assembly includes an observation assembly that allows the user to observe the subject being analyzed by the probe in use. The observation assembly may include a camera and a screen configured to display images from the camera.

[0016] In some forms, the probe assembly may include a camera positioned within a housing that can capture a visual image of a skin area when its distal end contacts a region of the subject's body surrounding the skin area.

[0017] According to one aspect of the present invention, a probe assembly for spectral analysis of a subject is provided. The probe assembly may include a housing configured to hold a probe within the housing. The housing may include a housing body and a probe tip shield having a proximal end provided at one end of the housing body and a distal end defining an opening for exposing the tip of the probe to the subject. The probe tip shield may be configured to substantially shield the tip from ambient light.

[0018] In certain configurations, the probe tip shield and housing body are configured to completely shield the probe tip from ambient light when the distal end is in contact with the subject.

[0019] In certain forms, the probe tip shield is configured to substantially shield the tip of the probe from ambient light that directly impinges on the tip or ambient light that is reflected from the surface of the subject. In certain forms, the probe tip shield is configured to substantially shield the tip of the probe from ambient light that scatters through the subject.

[0020] In certain forms, the probe tip shield includes a body that tapers from a proximal end to a distal end. For example, the probe tip shield can be frustoconical.

[0021] In certain forms, the probe tip shield includes a skirt that extends outwardly from the distal end of the probe tip shield and covers a surface area that substantially surrounds the subject during use.

[0022] In certain forms, the probe assembly includes a retraction mechanism for moving the probe between an extended position and a retracted position, where in the extended position, the tip is disposed substantially flush with the distal end of the probe tip shield, and in the retracted position, the tip is disposed within the housing.

[0023] In certain forms of the present technology, the probe assembly includes an observation assembly that enables a user to observe the subject when the distal end abuts the subject.

[0024] In certain forms, the observation assembly includes a camera arranged to capture an image of the subject. The camera can be disposed within the housing. The observation assembly can further include a light source configured to irradiate the subject, and this light source is disposed within the housing.

[0025] In certain forms, the observation assembly can include a screen configured to display an image from the camera to the user. The screen can be disposed outside the housing, and the wall of the housing can include the screen.

[0026] According to another aspect of the present invention, a probe assembly for spectral analysis of a skin region of a subject is provided. The probe assembly may include a housing configured to hold a probe for Raman spectroscopy within the housing. The housing may include a housing body, a proximal end provided at one end of the housing body, and a probe tip shield having a distal end defining an opening for exposing the tip of the probe to the skin region. The probe tip shield may be configured to shield the probe tip from ambient light, at least at the sensitivity wavelengths of Raman spectroscopy. The probe assembly may be configured such that the shape of the distal end of the probe tip shield conforms to a region of the subject's body surrounding the skin region.

[0027] In certain forms, the probe tip shield may be configured to be substantially flexible such that the distal end can conform to a region of the subject's body surrounding the skin region.

[0028] In certain forms, the distal end of the probe tip shield may include one or more cavities configured to facilitate conforming the distal end to a region of the subject's body surrounding the skin region.

[0029] In certain forms, the probe tip shield may include one or more creases configured to facilitate deformation of the shape of the probe tip shield such that the distal end conforms to a region of the subject's body surrounding the skin region.

[0030] In certain forms, the probe assembly may include a plurality of probe tip shields. The distal ends of each of the plurality of probe tip shields may have different shapes and / or sizes. The proximal end of each of the plurality of probe tip shields may be removably attachable to the housing body.

[0031] In certain forms, the probe tip shield may taper from a wide distal end to a narrow proximal end.

[0032] In certain configurations, the probe tip shield may be configured such that the subject's body area surrounding the skin area has a minimum width, e.g., about 5 cm, sufficient to substantially block subsurface scattered ambient light received by the probe.

[0033] In certain configurations, the probe tip shield may be configured to be substantially opaque to light of substantially all wavelengths.

[0034] In certain configurations, the probe assembly may further include a camera positioned within the housing to capture a visual image of a skin region when its distal end contacts a region of the subject's body surrounding the skin region. The probe assembly may further include a light source to illuminate the skin region while the camera captures a visual image of the skin region.

[0035] According to another aspect of the present invention, a probe assembly for spectral analysis of a subject's skin region is provided. The probe assembly may include a housing configured to hold a probe within the housing. The housing may include a housing body and a probe tip shield having a proximal end provided at one end of the housing body and a distal end defining an opening for exposing the tip of the probe to a skin region. The probe assembly may further include a retraction mechanism for moving the probe between an extended position and a retracted position. The retraction mechanism may include an actuator configured to act on the probe to extend and retract it. The retraction mechanism may further include a pressure control mechanism for controlling the pressure the tip applies to the skin region when the probe is in the extended position.

[0036] In certain configurations, the pressure control mechanism may include an actuator controller that controls the actuator to limit the movement of the probe in its extended position.

[0037] In certain configurations, the pressure control mechanism may include a pressure sensor configured to detect the pressure applied to the probe. The actuator controller may be configured to limit the movement of the probe based on the pressure on the probe detected by the pressure sensor.

[0038] In certain configurations, the pressure control mechanism may include a probe assembly configured to press the probe member against an area close to the skin area of ​​the subject's body. The probe member may be located inside the probe tip shield.

[0039] In certain configurations, the pressure control mechanism may include an imaging assembly configured to determine the point in time when the tip makes contact with the skin area. The actuator controller may be configured to restrict the movement of the probe based on the determination of the imaging assembly.

[0040] In certain configurations, the pressure control mechanism may include a mapping assembly configured to determine the shape of a skin area. The actuator controller may be configured to restrict the movement of the probe based on the determination of the mapping assembly.

[0041] In certain embodiments, the probe assembly may further include an observation assembly that allows the user to observe a skin area when the distal end is in contact with the skin area. In certain embodiments, the observation assembly may include a camera positioned within the housing to capture a visual image of the skin area.

[0042] In certain configurations, the probe tip shield may be configured to shield the tip from ambient light, at least at the sensitivity wavelength for Raman spectroscopy.

[0043] In certain configurations, the probe assembly may be configured such that the shape of the distal end of the probe tip shield is adaptable to the area of ​​the subject's body surrounding the skin area.

[0044] According to another aspect of the present invention, a probe assembly for spectral analysis of a subject's skin area is provided. The probe assembly may include a housing configured to hold a probe within the housing. The housing may include a housing body and a probe tip shield having a proximal end provided at one end of the housing body and a distal end defining an opening for exposing the tip of the probe to the skin area. The probe assembly may further include a camera positioned within the housing to capture a visual image of the skin area when the distal end contacts a region of the subject's body surrounding the skin area.

[0045] In certain configurations, the probe tip shield may be configured to shield the probe tip from ambient light, at least at the sensitivity wavelength for Raman spectroscopy. The probe assembly may further include a light source for illuminating the skin region when the camera captures a visual image of the skin region.

[0046] In certain configurations, the probe assembly may be configured such that the shape of the distal end of the probe tip shield is adaptable to the area of ​​the subject's body surrounding the skin area.

[0047] In certain configurations, the probe assembly may further include a screen configured to display images from the camera to the user.

[0048] In certain configurations, the probe assembly may be configured to transmit images from the camera to a location remotely from the probe assembly.

[0049] According to another aspect of the present invention, a probe assembly for spectral analysis of a subject's skin area is provided. The probe assembly may include a housing configured to hold a probe for Raman spectroscopy within the housing. The housing may include a housing body and a probe tip shield having a proximal end provided at one end of the housing body and a distal end defining an opening for exposing the tip of the probe to the skin area. The probe tip shield may be configured to shield the tip from ambient light at least at the sensitivity wavelength of Raman spectroscopy. The probe tip shield may include a skirt extending radially outward from the distal end of the probe tip shield to cover a surface area surrounding the skin area when in use. The skirt may be substantially opaque at least at the sensitivity wavelength of Raman spectroscopy.

[0050] In certain configurations, the radial outer edges of the skirt have a minimum width, e.g., about 5 cm, sufficient to substantially eliminate subsurface scattered ambient light received by the probe. In certain configurations, the skirt may extend radially and perpendicularly outward from the distal end of the probe tip shield. In certain configurations, the skirt may be formed to be flexible or semi-rigid so that it can bend when pressed against a subject.

[0051] According to another aspect of the present invention, a probe assembly for spectral analysis of a subject's skin area is provided. The probe assembly may include a housing configured to hold a probe within the housing. The housing may include a housing body and a probe tip shield having a proximal end provided at one end of the housing body and a distal end defining an opening for exposing the tip of the probe to a skin area. The probe assembly may further include a retraction mechanism for moving the probe between an extended position and a retracted position, in which case the tip is substantially flush with the distal end of the probe tip shield, and in which case the tip is located within the housing. The probe assembly may further include an observation assembly that allows a user to observe a skin area when the distal end is in contact with a region of the subject's body surrounding the skin area.

[0052] In certain configurations, the observation assembly may include a camera located within a housing that captures visual images of the skin area.

[0053] According to another aspect of the present invention, a system for spectral analysis of a subject's skin area is provided. The system may include a probe assembly, which includes a housing configured to hold a probe within the housing. The system may further include a probe assembly holder for holding the probe assembly when not in use. The system may further include a calibration member positioned relative to the probe assembly holder, such that the calibration member is positioned for analysis by the probe when the probe assembly is held within the probe assembly holder. The calibration member may generate a known spectrum when exposed to light from the probe.

[0054] In certain configurations, a calibration element may generate a known Raman spectrum when exposed to light from a probe.

[0055] In certain configurations, the system may further include a power meter configured to measure the power of light emitted by the probe. The power meter may include a receiver positioned relative to the probe assembly holder to receive light emitted from the probe when the probe assembly is held within the probe assembly holder.

[0056] In certain embodiments, the system may further include a calibration mechanism configured to change the relative positions of a calibration member and a receiver with respect to a probe assembly holder, such that in a first configuration, the calibration member is positioned in front of the probe when the probe is held in the probe assembly holder, and in a second configuration, the receiver is positioned in front of the probe when the probe is held in the probe assembly holder.

[0057] According to one aspect of the present invention, a probe assembly for spectral analysis of a subject is provided. The probe assembly may include a housing configured to hold a probe within the housing. The probe assembly may further include a calibration member disposed within the housing. The calibration member may generate a known spectrum when exposed to light from the probe. The probe assembly may further include a calibration mechanism configured to change the relative position of the calibration member and the probe between a calibration configuration and a subject configuration, so that in the calibration configuration the probe is positioned to analyze the calibration member, and in the subject configuration the probe is positioned to analyze the subject.

[0058] In certain configurations, the calibration mechanism may be configured to move the calibration member such that, in a calibration configuration, the calibration member is positioned in front of the probe, and in the configuration of the present invention, the calibration member is not positioned in front of the probe.

[0059] In certain embodiments, the probe assembly may include a retraction mechanism configured to move the probe between an extended position and a retracted position, where the tip is substantially flush with the end of the housing in the extended position and within the housing in the retracted position. In certain embodiments, the probe may be in a retracted position in a calibration configuration and in an extended position in the configuration of the present invention.

[0060] In certain configurations, the housing may be shaped to be suitable for the probe assembly to be held in the user's hand during use.

[0061] In certain embodiments, the probe assembly may further include a probe. In certain embodiments, the probe may include one or more illumination light guides configured to transmit light to illuminate a subject. The probe may further include one or more collecting light guides configured to collect light from a subject and transport the collected light along one or more collecting light guides.

[0062] According to another aspect of the present invention, a probe assembly for spectral analysis of a subject is provided. The probe assembly may include a housing configured to hold a probe within the housing. The housing may include a housing body and a probe tip shield having a proximal end provided at one end of the housing body and a distal end defining an opening for exposing the tip of the probe to a skin area. The probe assembly may further include a retraction mechanism for moving the probe between an extended position and a retracted position, in which case the tip is located within the housing. The probe assembly may further include an ultraviolet light source located within the housing and configured to irradiate the tip with ultraviolet light when the probe is in a retracted position.

[0063] According to another aspect of the present technology, a system for spectral analysis of a subject is provided. The system may include a probe assembly according to another aspect of the present technology. The system may further include a stimulus generator that generates light for illuminating the subject. The stimulus generator may supply light to one or more illumination light guides of the probe assembly. The system may further include a detector for receiving light collected from the subject, for example, light collected from one or more collecting light guides. The detector may generate a signal indicating light collected from the subject. The system may further include a processor for analyzing the signal indicating light collected from the subject. The processor may be configured to output information indicating the analysis results.

[0064] In certain configurations, the system may include a portable unit housing a stimulus generator, a detector, and a processor. In some configurations, a probe assembly, one or more illumination light guides, and one or more collection light guides may also be housed in the portable unit.

[0065] Further aspects of the present technology to be considered in all novel aspects will become apparent to those skilled in the art by reading the following description, which provides at least one example of a practical application of the present technology. [Brief explanation of the drawing]

[0066] 5. Brief description of the drawing Hereinafter, with reference to the drawings, one or more embodiments of this technology will be described for illustrative purposes only and without the intention of limitation. [Figure 1] This is a perspective view of an exemplary analysis system 100 for analyzing a subject, based on one embodiment of this technology. [Figure 2] This is a schematic diagram of an exemplary analysis system 100 for analyzing a subject, according to a specific form of this technology. [Figure 3] This is a perspective view of an exemplary probe assembly 200 for analyzing a subject, according to one embodiment of this technology. [Figure 4] This is a cross-sectional view of an exemplary probe assembly 200 for analyzing a subject, according to one embodiment of this technology. [Figure 5] This is a cross-sectional view of an exemplary probe assembly 200 for analyzing a subject, according to another embodiment of the present technology. [Figure 6] This is a perspective view of an exemplary probe tip shield 7 and skirt 6 according to one embodiment of this technology. [Figure 7] This is a perspective view of an exemplary probe tip shield 7 and skirt 6 relating to another embodiment of the present technology. [Figure 8] Figure 4 is an end view of the end wall 31 of the probe assembly 200. [Figure 9] This figure shows the inside of the end wall 31 of the probe assembly 200 shown in Figure 4. [Figure 10] This is an exploded perspective view of the tip 5 of the probe 4 according to one embodiment of this technology. [Figure 11] This is a cross-sectional side view of the tip 5 of the probe 4 according to another embodiment of this technology. [Figure 12A] This is a plan view of the skin region of the subject being spectrally analyzed, and the surrounding body region of the subject. [Figure 12B] This is a plan view of the skin region of the subject being spectrally analyzed, and the surrounding body region of the subject. [Figure 12C]This is a plan view of the skin region of the subject being spectrally analyzed, and the surrounding body region of the subject. [Figure 13A] This is a diagram of an exemplary probe assembly 200 using another form of technology in use on a patient. [Figure 13B] Figure 13A is a cross-sectional view of an exemplary probe assembly 200. [Figure 13C] Figure 13A is a cross-sectional view of an exemplary probe assembly 200. [Figure 14A] This is a diagram of an exemplary probe assembly 200 using another form of technology in use on a patient. [Figure 14B] Figure 14A is a cross-sectional view of an exemplary probe assembly 200. [Figure 14C] Figure 14A is a cross-sectional view of an exemplary probe assembly 200. [Figure 15A] This is a diagram illustrating an exemplary probe assembly 200 relating to another embodiment of the present technology. [Figure 15B] This is a diagram illustrating an exemplary probe assembly 200 relating to another embodiment of the present technology. [Figure 16] This is a diagram of an exemplary probe assembly 200 relating to another embodiment of the technology used on a patient. [Figure 17A] This is a cross-sectional view of an exemplary probe assembly 200 relating to another embodiment of the present technology. [Figure 17B] Figure 17A is a schematic plan view of a subject's skin area being spectrally analyzed using an exemplary probe assembly 200. [Figure 18A] This is a cross-sectional view of an exemplary probe assembly 200 relating to another embodiment of the present technology. [Figure 18B] Figure 18A is a schematic plan view of a subject's skin area being spectrally analyzed using an exemplary probe assembly 200. [Figure 19A] This is a cross-sectional view of an exemplary probe assembly 200, which includes a UV sterilization mechanism for sterilizing the probe tip, according to another embodiment of the present technology. [Figure 19B]This is a cross-sectional view of an exemplary probe assembly 200, which includes a UV sterilization mechanism for sterilizing the probe tip, according to another embodiment of the present technology. [Figure 20] This is an illustrative cross-sectional view of a probe assembly 200 according to another embodiment of the present technology. [Figure 21] This is a schematic diagram of an exemplary analysis system 100 for analyzing a subject, according to a specific form of this technology. [Figure 22A] This is a cross-sectional view of the calibration mechanism of an exemplary analytical system 100 in a specific form of this technology. [Figure 22B] This is a cross-sectional view of the calibration mechanism of an exemplary analytical system 100 in a specific form of this technology. [Figure 22C] This is a cross-sectional view of the calibration mechanism of an exemplary analytical system 100 in a specific form of this technology. [Figure 23A] This is a perspective view of an exemplary probe assembly 200 according to another embodiment of the present invention. [Figure 23B] This is a perspective view of an exemplary probe assembly 200 according to another embodiment of the present invention. [Figure 23C] This is a perspective view of an exemplary probe assembly 200 according to another embodiment of the present invention. [Modes for carrying out the invention]

[0067] 6. Modes for Carrying Out the Invention 6.1. Overview of the Analysis System This technology relates to systems, devices, and methods for analyzing subjects (e.g., analysis of a patient's skin lesions). Figures 1, 2, and 21 show an exemplary analysis system 100 for analyzing a subject 500 according to a particular embodiment of the technology. Figure 1 is a diagram of one embodiment of the technology showing the physical components of the exemplary analysis system. In the exemplary embodiment, the analysis system 100 includes a probe assembly 200, a conduit 33, and a portable unit 400. The probe assembly 200 may include a probe 4 and a housing 210. The conduit 33 may include a plurality of optical guides 310 (not shown in Figure 1). The portable unit 400 may consist of a housing 410, a stimulator 420, a detector 430, a processor 440, an output device 450, and a power supply 470 (not shown). These components are described in more detail below.

[0068] Figure 1 shows the physical shape of an exemplary analytical system 100, and Figure 2 shows the functional aspects of the exemplary analytical system 100. In the exemplary form, the analytical system 100 includes a probe assembly 200, a conduit 33, a stimulator 420, a detector 430, a processor 440, an output device 450, and a power supply 470. The probe assembly 200, conduit 33, stimulator 420, and detector 430 can be considered together to constitute a spectrometer. In some forms, the spectrometer can be considered to include the processor 440 and the output device 450. These components are described in more detail below. Figure 21 shows a schematic diagram of an alternative physical form of the probe assembly 200, and the functional block 110 is shown to illustrate the stimulator 420, detector 430, processor 440, output device 450, and power supply 470, all of which are components that make up the functional block 110. Figure 21 also shows a power meter 620.

[0069] In some forms, functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects.

[0070] The analysis system 100 may be used to analyze a subject 500. The form of the technique is not limited by the nature of the subject, and depending on the form, any subject may be analyzed by the system 100. The forms of the technique described herein may be particularly advantageous to the analysis of skin areas and may be particularly useful for analyzing the nature of lesions on human skin. Thus, in certain forms, subject 500 is a skin area of ​​a patient subject, and this area may include lesions on the patient's skin. The analysis may produce, or result in, a diagnosis of a lesion, such as skin cancer, or an indication that such a lesion is not present. While the forms of the technique are particularly suitable for the analysis of human skin areas, they may also be suitable for the analysis of areas of non-human animals. Depending on the form of the technique, they may also be suitable for the analysis of non-skin tissues, or for the analysis of non-skin tissues.

[0071] The various components of the analysis system 100 are described in more detail below. Where different forms of each component of the analysis system 100 are described, it should be understood that each form can be used interchangeably with any of the other described forms of the components, even if combinations of those components are not explicitly described together, as long as such combinations are not obviously impractical.

[0072] Generally speaking, in a particular form of this technology, the analysis system 100 operates by generating light of a specific wavelength(s), irradiating a subject 500 with that light, collecting the light received from the subject 500, and analyzing the spectrum of the collected light to determine one or more characteristics of the subject 500. For example, the analysis may identify the type of skin lesion on the subject 500. The operation of an exemplary analysis system 100 is described in more detail below.

[0073] In this specification, the term “light” is generally intended to refer to electromagnetic radiation, and may also refer to any part of the electromagnetic spectrum. This term is not limited to visible light or other regions of the electromagnetic spectrum unless the context clearly suggests a different meaning, or unless a narrower part of the spectrum is specified or a wavelength (or frequency) range is indicated.

[0074] 6.2. Probe Assembly In certain forms of the technology, the probe assembly 200 may be considered a physical device positioned in close proximity to the subject 500 and used to expose the subject 500 to light and collect reflected light from the subject 500. Exemplary probe assemblies 200 are shown in Figures 1, 3–5, 13–21, and 23.

[0075] 6.2.1. Housing In certain configurations, such as the illustrated example, the probe assembly 200 includes a housing 210. The housing 210 can generally form the outer surface or a large portion thereof of the probe assembly 200. The housing 210 houses many of the components of the probe assembly 200, protecting these components during use, making the probe assembly easier for the user to handle, and giving the probe assembly an aesthetically pleasing appearance.

[0076] The housing 210 may be formed from a housing body 10 and a probe tip shield 7. The housing body 10 may provide or contribute to the functions of the housing 210 described above. The probe tip shield 7 may shield the tip 5 (described later) of the probe 4, for example, substantially shielding the tip from ambient light and / or preventing the tip from unintentionally coming into contact with a nearby object. Preventing ambient light from entering the probe 4 improves the accuracy of the spectral analysis by the analysis system 100. In certain forms, the probe tip shield 7 and the housing body 10 may be configured together to completely shield the tip 5 of the probe 4 from ambient light. In particular, these components may be configured to shield the tip 5 of the probe 4 from fluorescence that, if detected by the detector 430 in the collected spectrum, could overwhelm the signal detected by the probe 4 and make spectral analysis difficult. This may be especially true when the probe assembly 200 is configured as part of an analysis system 100 that performs Raman spectroscopy on a subject 500, because in this case ambient light can particularly adversely affect the analysis.

[0077] 6.2.1.1. Housing Body The housing body 10 may be a generally elongated hollow body, having a size and shape suitable for holding in the user's hand. For example, in some forms as shown in Figures 1, 3-5, and 13-23, the housing body 10 may be approximately cylindrical or prismatic, but certain features of the housing body 10 or the presence of other components may cause the housing body 10 to deviate from such geometric shapes, and this description should be understood as a description of the approximate overall shape of the housing body. The housing body 10 is shaped to allow the user to grip it comfortably and may, for example, be ergonomically designed. In certain forms, the length of the housing body 10 may be approximately 50-300 mm and the width (or diameter) approximately 20-100 mm. The housing body 10 may be provided with one or more openings to allow components to pass through or be placed within the walls of the housing body 10. The housing body 10 may be formed opaque to prevent ambient light from entering the probe 4 during use. The housing body 10 may be formed to be substantially rigid in order to give structural rigidity to the probe assembly. For example, the housing body 10 may be formed from a hard and / or rigid material. In some embodiments, the housing body 10 may be formed from a plastic material such as polycarbonate.

[0078] In some forms of this technology, the housing body 10 may be formed in a common form factor similar to a gun, as schematically shown, for example, in Figures 21 and 23. That is, the housing body 10 may include a body portion 212 that is generally cylindrical or prismatic, and a grip portion 214 oriented at a non-zero angle to the body portion 212. The grip portion 214 may be configured to be held by the user for handling and operating the probe assembly 200 during use. The probe assembly 200 may further include one or more control interfaces 215, which may include buttons, levers, switches, dials, etc., at a location on the housing body 10 that is easily operated by the user when holding the probe assembly 200. For example, as shown in Figure 21, the control interface 215 may be located on the side of the grip portion 214 closest to the probe tip shield 7, on a portion of the grip portion 214 adjacent to the body portion 214. For example, the control interface 215 may be positioned like a trigger in a gun shape.

[0079] 6.2.1.2. Probe tip shielding The probe tip shield 7 may be a hollow body provided at the end of the housing body 10, and for example, the probe tip shield 7 may be adjacent to the end wall 31 of the housing body 10 via a friction fit, interlock, screw fit connection, or other suitable connection. For the purpose of describing the probe tip shield 7, it may be considered to have a proximal end and a distal end. In this context, “proximal” and “distal” are considered to refer to the proximity of each end of the probe tip shield 7 to the housing body 10, i.e., the proximal end of the probe tip shield 7 may be configured to connect to the housing body 10. The probe tip shield 7 may be configured to be detachably connected to the housing body 10, so that, for example, the probe tip shield 7 can be removed from the housing body 10 for cleaning or replacement and then reconnected later.

[0080] The width (or diameter) of the proximal end of the probe tip shield 7 may be substantially the same as the width (or diameter) of the end of the housing body 10 to which the probe tip shield 7 is connected. The length of the probe tip shield 7 may be shorter than the length of the housing body 10, and in some forms it may be significantly shorter. For example, in the probe assembly 200 shown in Figures 1, 2-5, 13-15, 17-20, and 23, the length of the probe tip shield 7 may be about 10-70 mm. In the probe assembly 200 shown in Figure 16, the probe tip shield 7 may be larger, for example, about 100-400 mm in length.

[0081] 6.2.1.2.1. Taper The probe tip shield 7 may be tapered such that one end is wider than the other. In different embodiments of this technology, the direction of the taper may be different, as described below.

[0082] Examples of probe tip shields 7 according to specific embodiments of this technology are shown in Figures 3 to 7. In some embodiments, the probe tip shield 7 may include a body that tapers from the proximal end to the distal end; that is, the proximal end may be wider than the distal end. In particular, the outer surface of the probe tip shield 7 may be tapered as described above. In some embodiments, the probe tip shield 7 may be frustoconical or substantially frustoconical. In other embodiments, the probe tip shield 7 may have another tapered shape, such as a frustoconical with substantially planar sides. The taper of the probe tip shield 7 makes the distal end narrower than the proximal end, which allows the user to position the probe more precisely to analyze the subject 500.

[0083] In certain embodiments, the proximal and distal ends of the probe tip shield 7 may each define an opening. In the case of the probe tip shield 7 which is tapered as described above, the opening at the proximal end may have a larger area (e.g., wider) than the opening at the distal end. In certain embodiments, the opening 220 at the distal end of the probe tip shield 7 may form a plane oriented substantially perpendicular to the longitudinal axis of the housing body 10. The opening at the proximal end of the probe tip shield 7 may also form a plane oriented substantially perpendicular to the longitudinal axis of the housing body 10, that is, the planes formed by the openings at the proximal and distal ends of the probe tip shield 7 are parallel to each other.

[0084] In some embodiments, for example, as shown in Figures 6 and 7, the opening 220 at the distal end of the probe tip shield 7 may be radially offset from the longitudinal axis of the probe tip shield 7. In such embodiments, the probe tip shield 7 can be described as having the shape of an inclined frustocone. This can be a beneficial arrangement when the probe 4 is not held centrally within the probe assembly 200, so that the tip 5 of the probe 4 aligns with the opening 220 at the distal end of the probe tip shield 7.

[0085] In other embodiments, as shown, for example in Figures 13-15, 17-20, and 23, the probe tip shield 7 may include a body that tapers from the distal end to the proximal end, i.e., the distal end may be wider than the proximal end. The outer surface, inner surface, or both of the outer and inner surfaces of the probe tip shield 7 may be tapered as described above. In such embodiments, the opening at the distal end may have a larger area (e.g., wider) than the opening at the proximal end, but this is not necessarily the case, depending on whether the taper is present on the inner and / or outer surface of the probe tip shield 7. For example, in the embodiments of the probe tip shield 7 shown in Figures 17-20 and 23, tapers are formed on both the inner and outer surfaces, and the thickness of the probe tip shield 7 is substantially the same between the proximal and distal ends. Thus, in these embodiments, the opening at the distal end of the probe tip shield 7 is larger than the opening at the proximal end. In some embodiments, such as the probe assembly 200 shown in Figure 23A, the angle between the wall of the probe tip shield 7 and the longitudinal axis of the housing body 10 may increase from the proximal end to the distal end of the probe tip shield 7. For example, as shown, the probe tip shield 7 may have a shape that widens outward toward its tip. In some embodiments, the degree of widening may be the same around the periphery of the probe tip shield 7, but in other embodiments, the degree of widening may differ around the periphery. In the case of the probe tip shield 7 shown in Figures 14A-C, the outer surface is tapered but the inner surface is not, so the thickness of the probe tip shield 7 increases significantly toward the distal end. As a result, in this embodiment, the size of the openings at the distal and proximal ends of the probe tip shield 7 is substantially the same. In the case of the probe tip shield 7 shown in Figures 13A-C, the taper occurs in the proximal region of the outer and inner surfaces. In the distal region, the thickness of the probe tip shield 7 is considerably greater than that of the proximal end, and the inner distal region is slightly tapered to narrow the opening, but overall, in this configuration, the opening at the distal end of the probe tip shield 7 is larger than the opening at the proximal end.Similarly, in the case of the probe tip shield 7 shown in Figure 23C, there is a first region of taper at the proximal end where the width of the shield increases as it moves away from the housing body, and a second region of taper at the distal end where the width of the shield decreases as it moves away from the housing body. The amount of taper in the first region is greater than the amount of taper in the second region, and in this embodiment, the opening at the distal end of the probe tip shield 7 is larger than the opening at the proximal end. In certain embodiments, the width of the distal end of the probe tip shield 7 may be its diameter in the case of a probe tip shield having a substantially circular distal end, and may range from about 15 to 150 mm, e.g., at least 50 mm. This width and / or diameter may correspond to the width / diameter of the area of ​​the subject's body that is substantially shielded by the probe tip shield 7 during use of the probe assembly 100. In some cases, the shape of the probe tip shield 7 may be non-circular. In these embodiments, the area of ​​the subject's body that is substantially shielded by the probe tip shield 7 during use may vary along the periphery of that area. In such cases, the minimum width may range from about 15 to 150 mm, e.g., at least 30 mm, e.g., at least 50 mm.

[0086] The taper in this direction may be useful so that the distal end of the probe tip shield 7 covers a relatively wide area of ​​the subject's skin compared to the width of the housing body. In some forms of the probe 4, the subject 500 is not completely opaque, and some ambient light may enter the probe 4, for example, by subsurface scattering, passing through the subject 500 and entering the tip 5 of the probe 4. Such light is sometimes called interaction light. Since ambient light can negatively affect the accuracy of the analysis performed by the analysis system 100, including in the case of Raman spectroscopy, the probe assembly 200 may be configured to reduce the amount of interaction radiation entering the probe 4. This can be achieved by the probe tip shield 7 covering a relatively wide area of ​​the subject's skin around the area of ​​the subject's skin. For example, it has been found that a minimum width of about 50 mm (5 cm) is sufficient to adequately block ambient light for the purpose of Raman spectroscopy performed on human skin. The appropriate minimum width may vary depending on various factors, such as the degree of subsurface scattering on the subject's surface and the intensity of the illumination light. The minimum width of the probe assembly 200 suitable for a particular application can be determined experimentally regarding the width of the distal end of the shield that reduces the interacting light to a sufficient level for the type of spectral analysis being performed. In a particular form, the probe tip shield 7 is configured such that the area of ​​the subject's body surrounding the skin area 500 has a minimum width sufficient to substantially eliminate the subsurface scattered ambient light received by the probe 4.

[0087] 6.2.1.2.2. Opacity The probe tip shield 7 may be formed to be substantially opaque in order to prevent ambient light from entering the probe 4 during use. When the probe assembly 200 comes into contact with the subject 500 and the distal end of the probe tip shield 7 is in contact with the subject 500 around the entire perimeter of the opening 220, the opaque probe tip shield 7 and the housing body 10 together substantially or completely prevent ambient light from entering the tip 5 of the probe 4 during use.

[0088] In particular, the probe tip shield 7 is substantially opaque to light of wavelengths sensitive to the type of spectroscopy performed by the analysis system 100. For example, when performing Raman spectroscopy, the probe tip shield 7 may be substantially opaque to light of wavelengths of approximately 200–2000 nm to prevent ambient light that could affect the spectral analysis from entering the probe 4. In some forms, the probe tip shield 7 may be substantially opaque to light of substantially all wavelengths.

[0089] The opacity of the probe tip shield 7 can be set to a degree sufficient to reduce the amount of ambient light passing through the shield to a level low enough that noise from the ambient light in the detection spectrum does not affect the analysis results. Therefore, the appropriate degree of opacity may vary depending on the specific use case of the probe tip shield. In some forms, the optical density of the probe tip shield 7 can be about 2 or greater, and in some forms it can be about 7 or greater.

[0090] The desired opacity of the probe tip shield 7 can be achieved by selecting appropriate materials or groups of materials used to form the probe tip shield 7, and / or the physical structure of the shield. In some forms, the probe tip shield 7 may be coated with a substance that enhances the opacity of the shield, such as a light-shielding paint.

[0091] 6.2.1.2.3. Conformity In certain configurations, the probe assembly 200 is configured such that the shape of the probe tip shield 7, for example, the shape of the distal end of the probe tip shield 7, can be adapted to the area of ​​the subject's body surrounding the area of ​​the subject's skin. By adapting the probe tip shield 7 to the subject's skin in this way, light can be prevented from entering the space beneath the probe tip shield 7 through the gap between the probe tip shield 7 and the subject, thereby improving shielding from ambient light. The probe assembly 200 can be configured in various ways to achieve this adaptability, as described below.

[0092] In certain configurations, for example, as in the case of the probe tip shield 7 shown in Figures 13-16 and 23, the probe tip shield 7 may be configured to be flexible in shape so that its distal end conforms to an area of ​​the subject's skin. The flexibility of the probe tip shield 7 may be achieved by the structure of the probe tip shield 7 and / or the material from which it is made.

[0093] For example, in some embodiments as shown in Figures 13-16 and 23, the probe tip shield 7, or at least the distal end of the probe tip shield 7, may be formed with a wall thickness significantly smaller than the length and / or width of the wall. This can improve the flexibility of the shape of the probe tip shield 7.

[0094] Furthermore, or alternatively, the probe tip shield 7, or at least the distal end of the probe tip shield 7, may be formed from a material that promotes flexibility, such as a material that is relatively soft and / or has a relatively high modulus of elasticity. Examples of suitable materials include silicone rubber, thermoplastic elastomers, and elastomers such as rubber. It may be particularly desirable that the material be biocompatible to avoid harming the biological tissues of the subject that come into contact with it during use.

[0095] In some embodiments, for example in Figures 13-15 and 23, the probe tip shield 7 may include one or more flaps and / or folds to give the shield flexibility. In some embodiments, the distal end of the probe tip shield 7 may include a flap that can be folded radially inward or radially outward to form a cushion that can bend and conform to the subject's skin. In some embodiments, such as Figures 13 and 14, the flap may be folded and connected to another part of the probe tip shield 7 to form one or more cavities 71 at the distal end of the shield. The walls of the cavity 71 may be flexible to facilitate the distal end conforming to a region of the subject's body surrounding a skin area, as shown in Figures 13C and 14C. The cavity may be filled with a fluid (e.g., air or gel) or granular material (e.g., small pellets or granules) to allow the shape of the probe tip shield 7 to change when a force is applied to the wall of the cavity (e.g., a reaction force when the probe tip shield 7 contacts the subject's surface).

[0096] In some configurations, as shown, for example, in Figures 14A-C, the rigidity of the cavity 71, and consequently the rigidity of the probe tip shield 7, can be adjusted by changing the pressure of the material within the cavity 71. The probe assembly 100 may further include a tube 73, one end of which is inserted into the cavity 71 through the wall of the probe tip shield 7, and the other end of which is connected to a pump (not shown), such as a vacuum pump, configured to inject fluid into or extract fluid from the cavity 71. To prevent leakage, a seal may also be provided around the tube 73 inserted into the cavity 71. The tube 73 is oriented substantially parallel to the housing body 10 so that the probe assembly 100 can be easily handled by the user, and in some configurations, the tube 73 may be housed within the housing body 10. The pump may be configured as part of the probe assembly 100, or the pump may be configured as part of a portable unit 400, in which case the tube 73 may extend along a conduit 33. During use, the pump can be activated before and / or after the probe tip shield 7 is positioned in the desired location relative to the subject's skin to achieve the desired level of rigidity of the probe tip shield 7. In one embodiment of the example shown in Figures 14A-C, the probe tip shield 7 can function as a jamming gripper. In this embodiment, granular material can be filled into a cavity 71 formed inside the wall of the probe tip shield 7. After the probe tip shield 7 is positioned in the desired location relative to the subject's skin, a vacuum pump is used on the cavity 71, and the negative pressure generated by the pump sucks the granules in the cavity 71, causing the probe tip shield 7 to harden and grip the subject's skin.

[0097] In embodiments such as those shown in Figures 15A and 15B, 23B and 23C, the probe tip shield 7 may include one or more folds so that the shape of the probe tip shield 7 deforms to facilitate its distal end conforming to the patient's body. In the examples of Figures 15A and 15B, the probe tip shield 7 may include a flexible canopy 75 and one or more frame members 77 that provide structure to the canopy 75. The canopy 75 may be formed from a sheet of flexible material. The frame members 77 may be formed to be relatively rigid, for example, from a relatively hard or inelastic material. In some embodiments, as shown, for example, in Figure 23B, the probe tip shield 7 may include multiple folds, such as a concertina, where, for example, the canopy 75 may be folded between the frame members 77. The folds may be oriented circumferentially around the shield 7 and perpendicular to the longitudinal axis of the housing body 10. The folds may be substantially parallel to each other. Furthermore, or alternatively, the folds may be arranged substantially equally along the longitudinal direction along the shield 7 between the proximal and distal ends. In other embodiments, the folds may be oriented at different angles with respect to the longitudinal axis, and the orientation of each fold may differ. In other embodiments, the spacing between each or some of the folds may differ. The presence of the folds allows for flexibility in the shape of the probe tip shield 7, allowing it to be folded when stored as needed. As shown in Figures 15A and 15B, the probe tip shield 7 may consist of a single frame member 77 formed in a helical spiral shape, where the radius of the spiral increases with distance from the proximal end of the probe tip shield 7, forming a taper in the shield as described above.

[0098] In some embodiments, as shown in Figure 16, for example, the probe tip shield 7 may be formed from one or more sheets of material assembled to form a housing 235, such as a bag or box. The housing 235 includes a proximal end opening connected to the housing body 10 and a distal end opening. The housing 235 may include a closure mechanism, such as a drawstring, zipper, or press seal, to close the distal end opening that surrounds a part of the subject's body in order to substantially prevent light from entering the housing. The housing 235 may be large enough to accommodate a part of the subject's body, such as a foot, head, arm, leg, or head. The housing 235 may be formed from a material that blocks ambient light from entering the housing at least at the sensitivity wavelength of Raman spectroscopy, and in some embodiments at all wavelengths.

[0099] In other embodiments, the probe tip shield 7 may include a number of pins arranged parallel to each other and oriented substantially parallel to the longitudinal axis of the probe assembly 200. The pins may be attached to a base member so that each pin slides longitudinally. The ends of the pins at the distal end of the probe tip shield 7 form a surface that can conform to various shapes, and as a result can conform to various parts of the subject's body during use. In some embodiments, once the desired configuration is achieved, the position of the pins may be fixed in place.

[0100] In some embodiments, the probe tip shield 7 may be configured to fit a specific body part. For example, the probe tip shield 7 may be formed in a specific shape and size to fit around a body part that is in the vicinity of or near a site where a skin area requiring analysis is located. That is, the probe tip shield 7 may be formed so that its distal end surrounds a specific body part. Figures 12A-C show in plan view areas of a subject's body that can be spectrally analyzed using a probe assembly 200 according to a specific embodiment of the art. The skin area 510 is the area to be spectrally analyzed by the probe 4. In Figures 12A-C, the skin area 510 is located on a protruding part of the subject's body, such as the nose (Figure 12A), ear (Figure 12B), or mouth (Figure 12C). The contact area 520 shown in these figures is the area of ​​the subject's body surrounding the skin area 510 to which the distal end of the probe tip shield 7 makes contact when the probe assembly 200 is in use. The probe tip shield 7 may be configured to have a size and shape suitable for creating a contact area 520 surrounding relevant physical features (such as the nose, ears, and mouth), and in particular, to be able to contact relatively flat areas of the body around these features. This may facilitate an effective optical seal between the probe tip shield 7 and the subject's body. In some embodiments, a single probe tip shield 7 may be formed in a shape and / or size suitable for surrounding a number of different physical features, such as the types shown in Figures 12A-C. In other embodiments, different probe tip shields may be suitable for use on different physical features. In some embodiments, the probe tip shield 7 may be specifically configured for use in surrounding a particular physical feature by forming the inner wall of the probe tip shield 7 in a shape that complements the shape of the physical feature. For example, the inner wall of the probe tip shield 7 may be formed in a shape that is an inversion of, or close to, the three-dimensional shape of the body part to be the subject.

[0101] In some configurations, the probe assembly 200 may include a plurality of interchangeable probe tip shields 7. Each probe tip shield 7 may differ in one or more properties, for example, each may have a different shape, size, opacity, and / or flexibility. In some cases, the distal end of each probe tip shield 7 may thus differ. Each probe tip shield 7 may include a proximal end configured to be interchangeably attached to the housing body 10 of the probe assembly 200. Such interchangeability may be useful to enable the selection of a probe tip shield 7 suitable for a particular skin area 510 to be analyzed, the replacement of the probe tip shields 7, and / or the cleaning of the probe tip shields 7. The proximal end of each probe tip shield 7 may be detachably attached to the housing body 10 using any suitable mechanism as described above.

[0102] In other embodiments, the probe tip shield 7 may be formed temporarily for a limited number of uses of the probe assembly 200. For example, in some cases, the probe assembly 200 can be positioned in a desired location relative to the subject, and then a substance can be introduced around the subject-proximal end of the probe assembly 200 to form a light-shielding seal against the subject 500, thereby forming the probe tip shield 7. For example, a substance such as a fluid, gel, paste, putty, or granular material can be added around the end of the probe assembly. This substance can solidify or harden after a certain period of time and be held in place for use of the probe assembly 200. Since these substances are fluid or malleable in their original state, they can form a probe tip shield 7 that conforms to the complex shape of the subject's body surface.

[0103] 6.2.1.3. Skirt In some applications of the probe assembly 200, ambient light may enter the probe 4 even when the distal end of the probe tip shield 7 is positioned to contact the subject 500. In some cases, this may be due to the user not positioning the distal end of the probe tip shield 7 precisely flush with the subject 500. In such cases, improving the positioning of the probe assembly 200 relative to the subject 500 can improve the reduction of ambient light entering the housing 210. In other cases, ambient light may enter the probe 4 because the subject 500 is not completely opaque, and some ambient light can pass through the subject 500, for example by subsurface scattering, and enter the tip 5 of the probe 4. Such light may be called interaction light. Such ambient light may adversely affect the accuracy of the analysis performed by the analysis system 100.

[0104] In some embodiments, methods have already been described for reducing this ambient light by making the width of the distal end of the probe tip shield 7 relatively large. In some embodiments, the probe assembly 200 may include one or more additional components configured to reduce the amount of interaction radiation entering the probe 4. In exemplary embodiments of the technique shown in Figures 3–5, the probe assembly 200 includes a skirt 6 for this purpose. The skirt 6 may be a body of material extending radially outward from the distal end of the probe tip shield 7, and when the distal end of the probe tip shield 7 is directed at the subject 500, the skirt 6 may cover a surface area substantially surrounding the subject 500, or the area of ​​the subject 500 being analyzed, thereby reducing the amount of ambient light that can enter the surface area surrounding the subject 500. As a result, the amount of light that scatters from the subject 500 and enters the probe 4 is reduced. In certain embodiments, the skirt 6 may extend substantially radially perpendicularly outward from the probe tip shield 7, i.e., perpendicular to the longitudinal axis of the probe assembly 200, for example, like a flange. In some configurations, the skirt 6 may be inclined slightly forward with respect to the vertical (i.e., away from the housing body 10) to help cover the surface of the subject 500, especially when the surface is not flat.

[0105] In the illustrated configuration, the skirt 6 is composed of an annular body, the inner edge of which is provided on the outer surface of the distal end of the probe tip shield 7. Therefore, the shape of the holes in the skirt 6 may be configured to match the shape (and size) of the outer surface of the distal end of the probe tip shield 7. In some configurations, the skirt 6 may be attached to the probe tip shield 7 via friction fitting, interlocking, screw fitting connections, or other suitable connections. In other configurations, the skirt 6 and the probe tip shield 7 may be integrally connected and formed, for example, as a single unit. The skirt 6 may be a substantially planar object with a depth significantly smaller than its width. In the drawing, the skirt 6 is shown as a circular annular body, but in other configurations, the skirt 6 may have different planar shapes, such as elliptical, square, or rectangular, each with holes formed in them, or other suitable configurations.

[0106] In some configurations, the distance the skirt 6 extends outward from the distal end of the probe tip shield 7 is in the range of approximately 5–50 mm, or in some configurations, it may be greater. If the width of the skirt 6 is considered as the dimension from one side to the other, for example, its diameter in the case of an annular skirt 6, then its width is in the range of approximately 15–150 mm, i.e., the radial outer edge of the skirt 6 has this width / diameter. A larger size skirt 6 may be used if the transparency of the subject 500 or the area surrounding the subject 500 is high. As mentioned above, it has been found that a minimum width of approximately 50 mm is sufficient to provide a sufficiently effective shield for Raman spectroscopy performed on human skin. In some configurations, the radial outer edge of the skirt 6 has a minimum width sufficient to substantially eliminate the subsurface scattered ambient light received by the probe 4.

[0107] The skirt 6 may be formed to be substantially opaque in order to prevent ambient light from entering the area surrounding the subject 500. The opacity may be at least at wavelengths of sensitivity to the type of spectroscopy performed, e.g., Raman. In some embodiments, the skirt 6 may be formed to be flexible or semi-rigid so that it can be bent when pressed against the subject 500; for example, the skirt 6 may be formed from a relatively soft and / or elastic material, or the skirt 6 may be formed thin enough to bend in it. In other embodiments, the skirt 6 may be formed to be rigid; for example, the skirt 6 may be formed from a hard and / or rigid material, or the skirt 6 may be thick enough to provide rigidity. In some embodiments, the skirt 6 may be formed from a plastic or elastomer material, e.g., polycarbonate or silicon.

[0108] In some configurations, the skirt 6 is detachably connected to the probe tip shield 7, and the skirt 6 can be removed from the probe tip shield 7. In such configurations, skirts of different sizes can be selectively attached to the probe tip shield 7. A skirt of the appropriate size can be selected depending on the intended application. Interchangeable skirts formed from different materials or shapes, for example, skirts with different transparency or different rigidity, may also be provided.

[0109] In some configurations, the probe tip shield 7, skirt 6, and / or assembly including the probe tip shield 7 and skirt 6 (the probe tip shield 7 and skirt 6 may be formed as a single component) may be interchangeably attached to the end of the housing body 10. Since this component is replaceable for each patient, a clean component can be used to contact the patient each time. Suitable interchangeable mounting methods may be used, such as friction mating, interlocking, screw connection, or other appropriate connections.

[0110] 6.2.1.4. Spacers In certain embodiments of this technology, the probe assembly 200 may include a spacer 211. The spacer 211 may be configured to facilitate positioning the probe assembly at a desired distance from the subject 500, particularly from the skin area 500, during use. The probe assembly 200 may include a function to extend and retract the probe 4 to carefully position the tip of the probe 4 relative to the subject (an exemplary extension and retraction mechanism is described later), but it may also be advantageous to adjust the position of the probe assembly 200, particularly from the housing body 10, relative to the subject 500. In some embodiments, the spacer 211 may function as a rough positioning guide for the user to roughly position the probe assembly 200 relative to the subject, and a retraction mechanism may allow for more precise positioning and alignment of the probe relative to the skin area.

[0111] In some embodiments, the spacer 211 may protrude from the patient-proximal end of the housing body 10, as shown, for example, in Figures 23A and 23B. For example, the spacer 211 may protrude from the end wall 31 of the housing body. The spacer 211 may protrude outward from the housing body 10 from a point offset from the opening 28 through which the probe 4 extends through the wall of the housing body 10. The proximal end of the spacer 211 may be close to the opening 28, for example, directly adjacent to the opening 28. In some embodiments, the spacer 211 may be connected to the housing body 10 via a suitable connection mechanism, while in other embodiments, the spacer 211 may be formed integrally with the housing body 10. As shown in Figures 23A and 23B, the spacer 211 may protrude from the end wall 31 of the housing body 10 in a direction substantially parallel to the longitudinal axis of the housing body 10. In other embodiments, the spacer 211 may protrude at a non-zero angle with respect to this axis. The spacer 211 may take the shape of an elongated member, such as a rod. The spacer 211 may be configured to be rigid or semi-rigid so that when the probe assembly 200 is brought close to the subject during use, the spacer 211 comes into contact with the subject's skin, allowing the user holding the probe assembly 200 to feel it and indicate that the probe assembly 200 should not be brought any closer to the subject. The rigidity of the spacer 211 may be achieved by selecting the shape of the spacer 211 (e.g., rod-shaped) or by selecting the material from which the spacer 211 is formed (e.g., it may be formed from one or more hard or rigid materials, or both).

[0112] As shown in Figures 23A and 23B, in some embodiments, the spacer 211 may be located inside the probe tip shield 7. In other embodiments, the spacer may be located outside the probe tip shield 7 or may be configured as part of the probe tip shield 7. For example, in some embodiments, the spacer 211 may be formed as part of the probe tip shield 7, for example, embedded within it.

[0113] Although only a single spacer 211 has been described above and shown in Figures 23A and 23B, in other embodiments the probe assembly 200 may include one or more spacers 211 of any of the embodiments described above. Multiple spacers 211 may be arranged around the probe 4, for example, on both sides of the probe.

[0114] 6.2.2. Probe In certain embodiments of this technology, the probe assembly 200 includes a probe 4. The probe 4 may be configured to irradiate a subject 500 with electromagnetic radiation (i.e., light) and collect light from the subject 500 during use. The light can irradiate the subject 500 from the tip 5 of one end of the probe 4 and collect light from the subject 500 at the tip 5 of the other end of the probe 4. The tip 5 is positioned proximal to the subject 500 during use and may therefore be called the subject-proximal end of the probe 4. The other end of the probe 4 is positioned further away from the subject 500 during use and may therefore be called the subject-distal end of the probe 4.

[0115] 6.2.2.1. Optical Guide The probe 4 may be a structure configured to transmit light from one location to another. In certain forms, the probe 4 may include multiple optical guides 310 that perform the function of transmitting light. The optical guides may be, for example, fiber optic cables. The multiple optical guides 310 may include multiple types of optical guides. The first type is called an illumination optical guide 312 and is configured to transmit light from the distal end of the probe to the subject (right side in Figures 4 and 5) to the proximal end of the probe to the subject (left side in Figures 4 and 5), and the light is emitted from the probe 6 and can illuminate the subject 500. The second type is called a collection optical guide 314 and is configured to collect light from the subject 500 and transmit the collected light from the proximal end of the probe to the distal end of the probe to the subject, where the light exits the probe 6 and enters, for example, a conduit 33. The probe 4 may include one or more of each type of optical guide, for example, 1 to 50 optical guides.

[0116] Figure 10 shows the tip 5 of an exemplary probe 4 according to one embodiment of the present technology. In this embodiment, a single illumination light guide 312 is positioned axially centered within the probe 4. The illumination light guide 312 may be encased in an opaque inner sheath 320. Multiple collection light guides 314 are arranged around the illumination light guide 312. In the example in Figure 10, there are eight collection light guides 314, but this number may differ in other embodiments (and the number of illumination light guides 316 may also differ in other embodiments). The collection light guides 314 may be encased in an opaque outer sheath 322, which may form part of the outer casing of the probe 4.

[0117] 6.2.2.2. Filters The subject-proximal end of the probe 4, which comes into contact with the subject 500 during use, may further include one or more filters 315 configured to remove unwanted wavelengths of light. One or more filters 315 may include one or more illumination filters 316 and / or one or more collection filters 318. For example, in some applications of the technology, a light source from an excitation fiber 312 having a wavelength of about 830 nm may be used, and it may be advantageous to use a filter 316, including a specific bandpass filter, to ensure that only light of about 830 nm wavelength is excited to the subject. In some examples, it may be advantageous to use a filter 318 to ensure that only collected light generated from the subject scattered by the light source is detected by the detector 430. For example, in some applications, a light source from an excitation fiber 312 having a wavelength of about 830 nm may be used, and it may be advantageous to exclude light close to this wavelength using a bandpass filter that attenuates light below a predetermined wavelength, such as about 840 nm, so that only collected light longer than this wavelength generated from the subject scattered by the light source is detected by the detector 430. Furthermore, or alternatively, the filter may attenuate light beyond another predetermined wavelength.

[0118] The filter 315 is positioned adjacent to the optical guide 310, and when in use, the filter may be positioned between the probe 4 and the subject 500. In some embodiments, the filter 315 is positioned directly adjacent to the tip of the optical guide 310, i.e., the filter is in contact with the end of the optical guide. In the exemplary embodiment shown in Figure 10, the filter includes an illumination filter 316 and a collection filter 318. The illumination filter 316 may be positioned between the illumination optical guide 312 and the subject 500 when in use, for example, directly adjacent to the tip of the illumination optical guide 312. The illumination filter 316 may be a cylindrical member. The collection filter 318 may be positioned between the collection optical guide 314 and the subject 500 when in use, for example, directly adjacent to the tip of the collection optical guide 314. The collection filter 318 may be an annular member.

[0119] 6.2.2.3. Transparency window In some examples, the proximal end of the subject may further, or alternatively, include one or more transmission windows. The transmission windows may be located at the proximal end of the probe 4 and provide an interface between the stimulus (light) generated by the stimulus generator 420 and the subject 500 in use. In addition, the interface may allow the incident light to be detected by the detector 430. The transmission windows may be composed of any suitable light-transmitting medium. The transmission windows may be formed of a material with a low nonlinear refractive index and may be desirable to have a transmission range wide enough to cover the range of frequencies that are to be transmitted and received by the analysis system 100.

[0120] Figure 11 shows another form of the technique in which the probe 4 includes a transmission window 340. The transmission window 340 may be positioned between the filter 315 (if present) and the subject 500.

[0121] The transmission window 340 allows for the dispersion of light emitted from the probe 4, creating a larger spot on the subject 500 than would otherwise be possible. Therefore, the length of the transmission window can be adjusted in various ways to control the spot size and / or allow the use of lenses with different focal lengths.

[0122] The transparent window 340 may be composed of magnesium fluoride (MgF2), barium fluoride (BaF2), calcium fluoride (CaF2), or quartz.

[0123] For example, the inventors determined that a transmission window 340 with a length of approximately 2 mm is preferable when the spot size is approximately 1 mm, and a transmission window 340 with a length of approximately 3 mm is preferable when the spot size is approximately 1.2 mm in diameter. When the lens 330 has a relatively thin structure, the divergence of the emitted light is mainly due to the refraction of the transmission window material (magnesium fluoride crystal in one example). The width of the lens 330 is approximately 50 μm to approximately 250 μm, for example, approximately 100 μm, while the width of the transmission window 340 is approximately 1 mm to approximately 5 mm, for example, approximately 2 mm to approximately 3 mm. In this way, by using a longer transmission window 340, the emitted light can be magnified / diverged more than is possible with conventional probes 4. For example, in conventional laser spot measurement devices, the projected spot size is approximately 0.6 mm.

[0124] In some technical examples, it may be advantageous to provide a relatively large spot size to allow for increased power of the stimulator 420. For example, a 30 mW stimulator (such as a laser) may be used to obtain a good signal-to-noise ratio while maintaining the power density on the surface of the subject 500 within the maximum permissible skin exposure (MPE) limit.

[0125] In configurations where the transmissive window 340 is long, as is well known to those skilled in the art, it may be desirable to select the radius of curvature of the lens 330 in order to also increase the effective focal length (EFL).

[0126] 6.2.2.4. Lenses In some examples of this technology, it may be advantageous for the transmission window to include a lens that helps to focus or defocus the light emitted from the probe 4 and the incident light collected by the probe 4. In other examples, the transmission window is substantially planar or substantially perpendicular to the longitudinal axis of the probe 4, minimizing the deflection of the emitted or incident light. In yet another example, it may be advantageous to use a transmission window that includes a substantially planar region and a lens region.

[0127] In the configuration shown in Figure 11, the probe 4 includes a lens 330. The lens 330 may be positioned between the filter 315 (if present) and the transmission window 340. In the illustrated configuration, the tips of the optical guide 310, filter 315, lens 330, and transmission window 340 are positioned adjacent to each other.

[0128] In some embodiments of this technology, it may be advantageous for the probe 4 to include a lens 330 that helps to focus or blur the light emitted from the probe 4 and the collected light received by the probe 4. The lens 330 may be a convex lens, such as a plano-convex lens. The use of a plano-convex lens may be advantageous in converting the light collected from a spot on the subject 500 into parallel rays that can be received by the detector, for example, via a collected light guide 314. In some embodiments, it may be advantageous for the illumination light guide 312 to be positioned substantially perpendicular to the lens 330 along the principal axis of the lens, thereby minimizing the deflection of the illumination light by the lens 330.

[0129] Lens 330 may be made of any suitable material known to those skilled in the art, such as sapphire or diamond. Sapphire and diamond are hard materials and are substantially transparent to light of wavelengths usable in the exemplary analytical system 100 according to this art. Some exemplary dimensions of lens 330 are described above.

[0130] Detailed information regarding components suitable for use in probe 4 by a particular form of technology is found in Australian Patent Application No. 2022903699, which is incorporated herein by reference in whole.

[0131] 6.2.2.5. Retention structure The probe 4 is held within the housing 210. As shown in Figures 3-5, 13B-C, 14B-C, and 17-20, the probe 4 may be fully or substantially fully housed within the housing 210. The probe 4 may be held within the housing 210 such that the tip 5 of the probe 4 is positioned inside the probe tip shield 7 and the other, more subject-distal portion of the probe 4 is housed within the housing body 10. The probe 4 may be oriented so that its longitudinal axis is substantially parallel to the longitudinal axis of the housing 210.

[0132] To hold the probe 4 within the housing 210, the housing 210 may include one or more retaining structures. For example, the housing body 10 includes openings at one end or both ends (both ends in the example of Figure 4), through which each end of the probe 4 extends, and the openings are sized to interference fit with each end of the probe 4, thereby holding the probe 4 in place. The opening in the end wall 31 of the housing body 10 that connects to the probe tip shield 7 is shown as opening 28 in Figures 4 and 8. The end wall 31 of the housing body 10 is shown in Figure 8. In this exemplary embodiment, opening 28 is positioned radially offset from the longitudinal central axis of the housing 210. As a result, the opening 220 at the distal end of the probe tip shield 7 may be similarly offset.

[0133] In the example shown in Figure 4, an additional retaining structure in the form of a clamp 19 may be provided inside the housing body 10. The clamp 19 extends outward from the inner surface of the wall 21 of the housing body 10 and holds the middle portion of the probe 4 in place.

[0134] 6.2.3. Retraction Mechanism In certain embodiments, the probe assembly 200 includes a retraction mechanism configured to move the probe 4 between an extended position and a retracted position. Figures 4, 5, and 18A show the probe 4 in an exemplary extended position, with the tip 5 of the probe 4 positioned substantially flush with the end of the housing 210, i.e., the distal end of the probe tip shield 7. In other embodiments, the tip 5 of the probe 4 may not extend as far in the extended position; for example, in Figures 17A, 19A, and 20, the tip 5 may be set inward from the distal end of the probe tip shield 7 in the extended position. In the retracted position, the tip 5 may be positioned within the housing 210, for example, within the housing body 10 or within the probe tip shield 7. More generally, the tip 5 may be positioned further away from the distal end of the probe tip shield 7 in the retracted position compared to the extended position.

[0135] In a particular embodiment of this technology, the probe 4 can move longitudinally, i.e., along its length, between an extended position and a retracted position.

[0136] In various embodiments of this technology, any suitable retraction mechanism can be used. In the example shown in Figure 4, the probe assembly 200 includes an actuator 18 configured to act on the probe 4 to extend and retract it, for example, moving it back and forth in the longitudinal direction. The retraction mechanism may include a gripping member that grips a portion of the probe 4 in order to impart movement from the actuator 18 to the probe 4. The actuator 18 may include a motor. The actuator 18 may be mounted on the inner surface of the wall 21 of the housing body 10, for example, on the side wall, but in other embodiments, the actuator 18 may be located elsewhere within the housing body 10.

[0137] The components of the probe assembly 200, which serve the function of holding the probe 4 within the housing 210, can also function as guides that help maintain the probe 4 in place through extension and retraction movements.

[0138] By retracting probe 4, it may be possible to observe the subject 500 more clearly than when probe 4 is not retracted. This may allow the user to position probe 4 more precisely for the analysis of subject 500. It also becomes possible to capture images of subject 500 for saving and recording the analysis, or for later analysis (using the image capture mechanism described later). By changing the position of probe 4 in the extended position, it is possible to accommodate subjects 500 where probe 4 is not perfectly flush with the surrounding area, or to reduce discomfort caused by the probe pressing against skin lesions.

[0139] 6.2.3.1. Pressure control mechanism In certain configurations, the retraction mechanism may include a pressure control mechanism to control the pressure applied by the tip 5 of the probe 4 to the skin area 510 when the probe 4 is in the extended position. The pressure control mechanism can help avoid the probe 4 applying an uncomfortable or harmful level of force to the skin area 510 during the analysis process. It can also help maintain consistency in the level of force applied by the probe 4 to the skin area 510 during the analysis process, potentially improving the consistency of the spectral analysis results. Controlling the amount of pressure applied to a subject can be useful because different parts of the body and different types of skin lesions can protrude by varying amounts from the area surrounding the subject's skin. Depending on the configuration of the technology, the form of the pressure control mechanism used will also differ. Some examples are given below.

[0140] In some embodiments, as shown in Figure 4, for example, the pressure control mechanism may include an actuator controller 25 that controls the actuator 18 to control the extension and retraction of the probe 4, for example, the extension and retraction speed, and / or the limits of movement of the probe 4 in the extended and retracted positions, for example, controlling the extended and retracted positions as described above. Limiting movement in the extended position may be particularly useful for controlling the amount of pressure that the tip 5 applies to the skin area 510. The actuator controller 25 may be configured to control the limiting of movement in the extended position based on one or more of various factors, such as feedback from one or more other parts of the probe assembly 200 (as described below) or manual control by the user. The actuator controller 25 may be configured so that the position of the tip 5 in the extended position is different each time the probe assembly 200 is used. The actuator controller 25 is mounted on the inner surface of the wall 21 of the housing body 10, for example, on the side wall, but in other embodiments, the actuator controller 25 may be located elsewhere within the housing body 10.

[0141] In some configurations, the actuator controller 25 may be operated by direct control by the user. For example, a user interface may be provided on the side of the probe assembly 200 to allow the user to directly control the movement of the probe 4. The user interface may include any suitable input mechanism such as buttons, dials, or scroll wheels.

[0142] In some embodiments, the pressure control mechanism may include a pressure sensor configured to detect pressure applied to the probe 4, particularly pressure applied to the probe 4 longitudinally, such as pressure applied to the probe 4 by the skin area 510 during use, which acts to resist further extension of the probe 4. In some embodiments, the probe assembly 200 may include an output display configured to show the user the pressure detected by the pressure sensor, or an indication of the pressure level. The user can manually control the extension of the probe 4 to achieve a desired pressure. Alternatively, the actuator controller 25 may be configured to receive a signal from the pressure sensor indicating the detected pressure and to control the movement of the probe 4 based on the detected pressure. For example, the actuator controller 25 may be configured to prevent the probe from moving further forward (extending) if the detected pressure exceeds a predetermined threshold. Alternatively, the actuator controller 25 may be configured to allow further extension by a predetermined amount if the pressure detected on the probe 4 exceeds a predetermined threshold. As an example of how this actually works, if a portion of the subject 500 extends to the opening at the distal end of the probe tip shield 7, the probe 4 may come into contact with the subject 500 before reaching its fully extended position. In this scenario, the actuator controller 25 can act to stop the extension of the probe 4 when it detects that the pressure level detected by the pressure sensor indicates contact between the probe 4 and the subject 500. This makes the probe assembly 200 more comfortable for the patient to use, as excessive pressure can cause pain or harm depending on the skin lesion. Any suitable form of pressure sensor, or combination of pressure sensors, can be used. In some forms, the pressure sensor includes one or more pressure transducers, switches, and / or touch sensors (e.g., conductive or inductive sensors).

[0143] In the embodiment of the technology shown in Figure 5, the pressure control mechanism includes a spring 230 positioned to act between the probe 4 and the housing 210, for example, the housing body 10. For example, the spring 230 may take the form of a helical coil mounted around a portion of the probe 4. The spring may act against the surface of the housing body 10 by being mounted, for example, in a spring housing 232. The outer surface of the probe 4 may have projections or recesses that form another surface on which the spring 230 acts. Alternatively, the spring 230 may be wound tightly enough around the probe 4 to grip it by friction. The spring 230 may be configured such that the probe 4 retracts when a force pushes the tip 5 of the probe 4 inward, and returns to a resting position when the force is removed. The resting position of the probe 4 may be a position where the tip 5 of the probe 4 is substantially flush with the end of the housing 210, i.e., the distal end of the probe tip shield 7. During operation, the spring may allow the probe 4 to adapt to a subject 500 that is not perfectly flush with the surrounding area.

[0144] In some embodiments of this technology, the pressure control mechanism comprises one or more components of the probe assembly 200, configured to act on the subject's body during use, physically pressing or otherwise manipulating a part of the subject's body to modify the pressure applied to the body by the probe 4. These one or more components act to thrust at the subject's body and are therefore referred to as the “thrusting assembly” in the following description. For example, the probe assembly 200 shown in Figure 20 includes a thrusting assembly 240, which is configured to press one or more thrusting rod members 242, which may be included as part of a thrusting rod assembly 240, against an area of ​​the subject's body adjacent to the skin area 510. In some embodiments, the thrusting assembly 240 may be housed within the housing body 10. In particular, the thrusting rod members 242 may be positioned inside the probe tip shield 7 so that they can act on the subject's body while the skin area 510 is shielded from ambient light. The probe assembly 240 may further include a probe actuator (not shown) configured to move the probe member 242, which is configured, for example, to extend or retract the longitudinal probe member 242 relative to the probe assembly 200. The probe actuator may be manually controlled by the user via a suitable control interface, or the probe actuator may optionally work in conjunction with an actuator controller 25 to receive feedback from a pressure sensor to achieve a desired level of pressure applied by the probe 4 to the skin area 510. In the embodiment of Figure 20, the probe member 242 includes two rods projecting outward from the housing body inside the probe tip shield 7. The two rods may be positioned opposite each other. The distal ends of the rods may be spaced apart so that the skin area 510 can be positioned between the distal ends during use. The rods may be angled away from each other toward the distal ends. In other forms, the poking rod member(s) 242 may take other forms, such as a plate, a pad, or a poking rod having a curved (e.g., ring-shaped) distal end.

[0145] In some forms, the poking rod assembly 240 may be useful in moving specific physical features to a position that does not interfere with the operation of the probe assembly 200. For example, the poking rod member 242 may be used to bend the ear, thereby allowing the probe 5 to analyze a skin area 510 located behind the ear. The poking rod member 242 may be formed in a shape that facilitates such a function.

[0146] In some configurations, the pressure control mechanism includes an imaging assembly 250. The imaging assembly 250 may be configured to determine whether the tip 5 is in contact with a skin area 510. For example, in the configurations shown in Figures 17A-B and 18A-B, the imaging assembly 250 may include a camera 8 positioned to image the skin area 510 when the probe assembly 200 is in use, i.e., the camera 8 may be positioned so that its field of view includes the tip 5 of the probe 4 in its extended position and the area surrounding the tip 5. The appropriate positioning of the camera 8 will be described further later. The imaging assembly 250 may further include one or more light sources 9 for illuminating the subject 500 when the subject 500 is located within or immediately in front of the distal end of the probe tip shield 7. The images captured by the camera 8 are transmitted for analysis to a processor, e.g., a processor 440 (described later), which determines the timing of contact between the tip 5 and the skin area 510, and optionally the amount of pressure applied by the tip 5 to the skin area 510. Using one of several techniques for analyzing images captured by camera 8, it can be determined whether tip 5 is in contact with skin area 510 and, optionally, whether skin area 510 is being pushed down by tip 5. For example, this can be determined by analyzing the position of the shadow of tip 5 relative to tip 5 itself, and / or by analyzing the shadow 252 created by the pushing down of skin area 510 and / or the area surrounding the skin, as shown in Figures 18A and 18B. In such a form, the actuator controller 25 may be configured to limit the movement of probe 4 based on the decisions of the imaging assembly. For example, the processor 440 may be configured to send a control signal to the actuator controller 25 when it determines that the pressure applied to skin area 510 by tip 5 has reached a desired level, causing the actuator controller 25 to stop the movement of probe 4. In other forms, the user can view images captured by camera 8 and manually control the extension of probe 4 to a desired position.

[0147] In certain configurations, the pressure control mechanism includes a mapping assembly 260. The mapping assembly 260 may be configured to determine the shape of a skin region 510 and, optionally, the region of the subject 500 surrounding the skin region 510. For example, in the configuration shown in Figures 18A-B, the mapping assembly 260 may include a camera 8 positioned to image the skin region 510 when the probe assembly 200 is in use. That is, the camera 8 may be positioned such that its field of view includes the tip 5 of the probe 4 when it is in its extended position and the region surrounding the tip 5. The mapping assembly 260 may further include a plurality of light sources 9 that illuminate the subject 500 when the subject is positioned within or directly in front of the distal end of the probe tip shield 7. In the configuration shown in Figure 18A-B, the light source 9 generates light of different colors (e.g., red, green, blue), which can be transmitted to a processor (e.g., processor 440) for analysis of the images captured by the camera 8 to determine the shape of the skin region 510 and, optionally, the area of ​​the subject 500 surrounding the skin region 510. A conventional stereoscopic mapping process may be used to perform this analysis. Once the shape of the skin region 510 is determined, the actuator controller 25 may be configured to restrict the movement of the probe 4 based on the determination of the mapping assembly 260. For example, the processor may send a signal to the actuator controller 25 to achieve an amount of extension of the probe 4 that is deemed appropriate to achieve a desired level of pressure applied by the tip 5 to the skin region 510.

[0148] In some configurations, the pressure of the tip 5 on the skin region 510 can be determined by manipulating the probe 5 and using the processor 440 to analyze the spectral signal received by the detector 430 to determine whether there is contact between the tip 5 and the skin region 510. During this process, the stimulation generated by the stimulation generator 420 may be at a relatively low level, so that the subject will not be harmed even if the probe 4 is not properly positioned. The properties of the spectrum indicating the presence or absence of contact with the subject's skin may be determined experimentally, after which the processor 440 is programmed to identify the properties of the received spectrum, for example, through an AI training process.

[0149] 6.2.4. Observation Assembly In certain forms of the technology, the probe assembly may include an observation assembly that allows the user to observe the subject 500 being analyzed or scheduled to be analyzed by the probe 4 during use. In the forms of the technology shown in Figures 3-5, 13-15, 17, 18, and 22C, the observation assembly includes a camera 8 and a screen 16. The camera 8 is positioned so that the position of the subject 500 when the probe assembly 4 is in use is within its field of view, and the camera 8 captures an image of the subject. When in use, the probe assembly 4 is positioned so that the subject 500 is located within or directly in front of the distal end of the probe tip shield 7, so the camera 8 may be positioned so that the opening or part of the distal end of the probe tip shield 7 is within its field of view. The positioning of the camera 8 may also mean that the tip 5 of the probe 4 is within its field of view when the probe 4 is in its extended position, allowing the camera 8 to observe the skin area 510 when the distal end of the probe tip shield 7 is in contact with the area of ​​the subject's body surrounding the skin area 510.

[0150] In the illustrated configuration, the camera 8 is located within the housing 210. The housing can be made opaque, and the probe assembly 200 is positioned to contact the subject 500 during use, preventing light from entering through the opening at the distal end of the probe tip shield 7. This means that ambient light does not enter the camera's field of view when capturing images using the camera, and the illumination of the field of view can be controlled. In the examples of Figures 4, 5, and 8, the camera 8 is mounted on the end wall 31 of the housing body 10. For example, the camera 8 may be positioned adjacent to the opening 28 of the end wall 31. In other configurations, the camera may be mounted on the end wall 31 of the housing body 10 or on the side wall of the probe tip shield 7.

[0151] The probe assembly 200 may be configured so that ambient light does not enter the camera's field of view during use; therefore, the observation assembly may further include one or more light sources 9 that illuminate the subject 500 when the subject is positioned within or directly in front of the distal end of the probe tip shield 7. In the configurations shown in Figures 4, 8, 17, and 18, one or more light sources 9 are mounted on the end wall 31 of the housing body 10. For example, four light sources 9 may each be positioned near the outer periphery of the end wall 31 of the housing body 10. In other configurations, one or more light sources 9 may be further, or alternatively, mounted on the side wall of the probe tip shield 7. In some configurations, one or more light sources 9 may be further, or alternatively, mounted on the camera 8. The light sources may be LEDs or any suitable light sources. User interface controls, such as buttons 12 and 13 which may be located on the outer surface of the housing 210, may be provided to switch the light sources on and off. In other configurations, the light sources may be configured to automatically turn on when the camera is activated and then automatically turn off. Buttons 12 and 13 may be operablely connected to the light source 9 via, for example, a wire 24. The light source may be configured to produce light of wavelengths that do not interfere with the properties of the light used to illuminate the subject 500 and the properties of the light collected from the subject. For example, in some forms, the light source may be configured to optically produce white light and / or optically produce blue light.

[0152] The screen 16 may be configured to display images from the camera 8 to the user. Any suitable type of screen 16 can be used. As shown in Figures 3-5, 13-15, 17, 18, and 22C, the screen 16 may be positioned outside the housing 210 for user viewing. Alternatively, the screen 16 may form part of the wall of the housing 210; that is, the wall of the housing may include the screen 16. In the illustrated configuration, the screen 16 is mounted on a panel 17. The panel 17 is attached to the housing body 10, for example, in a movable (e.g., pivotal) manner, allowing the user to change the position or orientation of the screen 16 for optimal viewing.

[0153] Camera 8 may be configured to capture still images and / or video images, and screen 16 may be configured to display still images and / or video images.

[0154] The observation assembly may be configured so that the image from the camera 8 is displayed to the user on the screen 16, with one or more alignment marks added to the image indicating the position of the tip 5 of the probe 4, or the future position of the tip when the probe 4 is in the extended position, thereby assisting the user in correctly positioning the probe assembly 200 to analyze the intended skin area.

[0155] Figures 4, 5, and 9 show one or more wires 22 connected to the camera 8. The wires may supply power and control signals to the camera 8 and transmit signals indicating images captured from the camera 8. One or more wires 22 may be connected to the screen 16 and a power supply, which may be a power supply 23 included as part of the probe assembly 200, or a power supply 470 located separately from the probe assembly 200, for example, in a portable unit 400. As shown in Figure 9, in some embodiments, the wires 22 may pass through an opening in the end wall 31 to connect to the camera 8.

[0156] The observation assembly may further include user interface controls, such as a button 14, that allow the user to activate the camera 8. The button 14 may be operably connected to the camera 8, for example, via a wire 24. The button 14 may be located on the outer surface of the housing 210.

[0157] In some forms, data communication with and / or control of camera 8 may be performed wirelessly via one or more suitable wireless communication protocols, such as Bluetooth, WiFi, NFC, RF, etc.

[0158] In some forms of this technology, images from camera 8 may be stored in memory included as part of the probe assembly 200. This storage of camera images may be done in addition to, or alternative to, transmitting images to screen 16 for display to a user. In some forms of this technology, images from camera 8 may be transmitted to a location away from the probe assembly 200. This remote communication of camera images may be performed in addition to, or alternative to, transmitting images to screen 16 for display to a user and / or storing camera images in memory on the probe assembly. The camera images are displayed to a user at a remote location or stored in memory for later use, for example, for display or analysis. In some forms, the remote location refers to a processor 440 configured as part of a portable unit 400. In such forms, the camera images may be displayed on an output device 450 included as part of the portable unit 400. In other forms, the remote location may be any other data receiving device, such as a computer, smartphone, or other portable communication device. Communication of camera images to a location away from the probe assembly 200 may be done via wired or wireless communication. For example, wired communication can be performed via a wire 32 housed within a conduit 33. Such a wire may be connected to, for example, a processor 440 in a portable unit 400. Alternatively (or, in some forms, further), camera images may be communicated via one or more suitable wireless communication protocols such as Bluetooth, WiFi, NFC, RF, etc.

[0159] Images captured by camera 8 can be used for one or more of the following purposes, but are not limited to: displaying them in real time to guide the user in positioning the probe assembly 200 (for example, to verify the alignment of the tip 5 of probe 4 with the subject's skin area 510); analyzing the appearance of the skin area 510 through subsequent image analysis by processor 440; storing images of the skin area 510 along with spectral data of the skin area in memory (such as a database); and detecting ambient light within the probe tip shield 7 to determine whether the probe assembly 200 is properly positioned for use.

[0160] In another embodiment of this technology, the observation assembly may include a window in the wall of the housing 210, allowing the user to observe the subject 500 through the window when the probe assembly 200 is properly positioned for use. The window may be formed in the wall of the probe tip shield 7 or the housing body 10. The window may be formed as an opening in the wall or may include a substantially transparent member positioned in the opening in the wall. Examples of substantially transparent members include transparent panels and lenses. In such embodiments, the observation assembly may include an opaque closing member, such as a swivel flap or a sliding flap, that can cover the window when the probe 4 is in operation, in order to substantially prevent ambient light from hitting the subject 500 while the probe 4 is in use. In some embodiments, the window may be configured with alignment marks, such as crosshairs, indicating the position of the tip 5 of the probe 4 or the future position of the tip when the probe 4 is in the extended position, to help the user properly position the probe assembly 200 to analyze the intended skin area.

[0161] 6.2.5. Calibration Members and Mechanisms In certain embodiments of this technology, the probe assembly 200 may include a calibration mechanism. The calibration mechanism may be configured to enable calibration of the analysis system 100, i.e., to ensure that the measurement parameters of the detected spectrum, e.g., wavelength and / or frequency, are substantially equal to the true values ​​of these parameters (this is sometimes called wavenumber calibration). In some embodiments, the calibration mechanism operates by detecting the spectrum of a substance having a known spectrum, comparing the detected spectrum with the known spectrum, and, if necessary, modifying the method of analyzing the spectrum to correct for differences. In relevant embodiments of this technology, the calibration mechanism within the probe assembly 200 includes a mechanism that, when exposed to a specific type of light from the probe 4, allows the probe 4 to irradiate and collect light from a material having a known spectrum.

[0162] In exemplary embodiments of this technology, such as those shown in Figures 4 and 5, the probe assembly 200 includes a calibration member 1 formed from a material that produces a known spectrum when exposed to light of a specific wavelength or wavelength range. For example, in some embodiments, the calibration member 1 may be formed from silicon or calcite. Other suitable materials may be used instead.

[0163] The calibration mechanism may be configured to change the relative position of the calibration member 1 and the probe 4. This can be achieved by moving only the calibration member 1, by moving only the probe 4, or by moving both the calibration member 1 and the probe 4. The relative position of these two components can also be changed to move between the two configurations, and in this description, these configurations will be referred to as the “calibration configuration” and the “subject configuration” to distinguish between the two configurations. In the calibration configuration, the probe 4 is configured to analyze the calibration member 1, thereby performing the calibration of the analysis system 100. In the subject configuration, the probe 4 is configured to analyze the subject 500. In the calibration configuration, the calibration member 1 may be positioned in front of the probe 4, for example, directly in front of the tip 5 of the probe 4. In this configuration, the calibration member 1 may not be positioned in front of the probe 4. Instead, the subject 500 may be positioned in front of the probe 4, for example, directly in front of the tip 5 of the probe 4.

[0164] The calibration mechanism may include an actuator 3 for moving the calibration member 1 between the calibration configuration and the subject configuration. Another actuator may also move the probe 4 between the positions of the calibration configuration and the subject configuration, and this other actuator may be a retraction actuator 18 in some forms, as described below. That is, the calibration mechanism may include a retraction mechanism such that the probe 4 is in a retracted position in the calibration configuration and in an extended position in the subject configuration.

[0165] Next, an exemplary calibration mechanism in the form shown in Figures 4 and 9 will be described. In this embodiment, the calibration member 1 is movably mounted within the housing 210. For example, the calibration member 1 may be rotatably mounted inside the housing body 10, for example, on one inner surface of the walls of the housing body 10. In the illustrated embodiment, the calibration member 1 is rotatably mounted on a pivot rod extending outward from the inner surface of the end wall 31 in a direction substantially parallel to the longitudinal axis of the housing 210. In some embodiments, the calibration member 1 is mounted on a carrier, and the carrier itself is pivotally mounted on the rod. The actuator 3 is configured to move the calibration member 1 between the calibration configuration and the subject configuration by, for example, rotating the calibration member 1 around the pivot rod. The actuator 3 may be positioned in any suitable location, but in the example of Figure 4, it is shown as being mounted on the end wall 31.

[0166] The probe assembly 200 may be configured such that the probe 4 is positioned adjacent to the pivot rod, as shown in Figure 4. Figure 4 shows a configuration in which the calibration member 1 is positioned offset from the axis of the probe 4, and the probe 4 extends through an opening 28 in the end wall 31 to the probe tip shield 7. In some embodiments, the probe assembly may further include an additional guide member 2 through which the probe 4 can pass, as shown in Figure 4, for example, but this may not be present in other embodiments. In Figure 4, the guide member 2 is a ring through which the probe 4 passes. This ring is also rotatably mounted on the pivot rod, but is located on the opposite side from the mounting position of the calibration member 1. In this configuration, the ring is axially aligned with the opening 28 in the end wall 31. The guide member 2 may help prevent the actuator 3 from acting and causing the calibration member 1 to collide with the side of the probe 4 and cause damage when the probe 4 is extended.

[0167] In a calibration configuration, the calibration member 1 is positioned aligned with the longitudinal axis and axial direction of the probe 4. The actuator 3 can rotate the calibration member 1 around the pivot rod to reach this position. In the configuration shown in Figure 4, this cannot be achieved because the probe 4 is in the extended position; therefore, the first probe 4 must be retracted by the actuator 18 so that the tip 5 of the probe 4 is retracted backward beyond the longitudinal position of the calibration member 1. In some configurations, the operation of actuators 3 and 18 can be controlled together, and the actuator 3 can begin to move the calibration member 1 only after the probe 4 has been retracted to a suitable distance; therefore, actuators 3 and 18 can be connected, for example, by a wire 29. If a guide member 2 is present, the probe 4 is retracted from the guide member 2 and no longer passes through the guide member. This allows the calibration member 1 to rotate in a straight line with the probe 4, while the guide member 2 may rotate out of line. In a calibration configuration, the probe 4 can be positioned such that the calibration member 1 is positioned in front of the tip 5 of the probe 4, for example, just in front of the tip 5. This allows the analysis system 100 to be activated and the calibration member 1 to undergo spectral analysis, and as a result, the analysis system 100 can be calibrated by, for example, the processor 440.

[0168] Other mechanisms for calibrating the analysis system 100 are described in the following section on portable units.

[0169] 6.2.6. Cleaning Mechanism In certain forms of this technology, the probe assembly 200 may include a mechanism for cleaning the tip 5 of the probe 4. For example, when used on different subjects, it may be useful to clean the tip 5 between uses to avoid contamination of one subject with substances from another subject.

[0170] In some embodiments, the cleaning member may be positioned within the housing 210 such that the tip 5 contacts the cleaning member when the probe 4 is retracted. The cleaning member may be treated with a cleaning agent, such as a disinfectant. In some embodiments, the cleaning member may include an absorbent material, such as a sponge impregnated with a liquid cleaning agent.

[0171] Another embodiment of the cleaning mechanism 270 is shown in Figures 19A and 19B. In this embodiment, the cleaning mechanism 270 includes one or more ultraviolet light sources 272 located within the housing 210 and configured to irradiate the tip 5 of the probe 4 with ultraviolet light when the probe 4 is in the retracted position. For example, multiple ultraviolet light sources 272 may be located on the inner surface of the walls of the housing body 10 and configured to project ultraviolet light radially inward toward the probe 4. The UV light sources 272 may be positioned longitudinally along the housing 210 so as to be substantially horizontal to the longitudinal position of the tip 5 when the probe 4 is retracted. The UV light sources 272 can be operated by an appropriate control mechanism to irradiate the tip 5 with UV light of sufficient intensity for a sufficient amount of time to substantially sterilize the tip 5. For example, the UV light sources 272 can be manually turned on after the user operates the control panel, or they can be automatically turned on when the probe 4 returns to the retracted position.

[0172] 6.2.7.Safety mechanism The operation of the probe assembly 200, if used in an unintended manner, could cause harm to the subject. For example, harm can occur if light of certain properties (e.g., light of a specific wavelength or high intensity) is shone on a specific part of the body. The human eye is of particular concern. Therefore, the probe assembly 200 may incorporate one or more features to mitigate the risk of unintentional exposure to the eyes. Some examples of such features are described below.

[0173] In some forms, the probe assembly 200 may include one or more pressure sensors, as described above in relation to the pressure control mechanism. Feedback from the pressure sensors can be used as a safety mechanism, and the stimulus generator 420 may be activated only if its feedback meets certain criteria set to determine that the probe assembly 200 is in a position where it can be used safely. The pressure sensors included as part of the safety mechanism described herein may be the same as, or additional to, the pressure sensors included as part of the pressure control mechanism.

[0174] In some embodiments, the probe assembly 200 may include a plurality of pressure sensors positioned at the distal end of the probe tip shield 7 and configured to measure the pressure applied to the probe tip shield 7. The analysis system 100 may be configured so that the stimulator 420 does not activate unless all pressure sensors detect contact with something. In some embodiments, for the stimulator 420 to activate, each pressure sensor must detect a pressure value exceeding a predetermined threshold. In some embodiments, the pressure sensors may include pressure transducers, conductive sensors, and / or inductive sensors. In some embodiments, one or more pressure sensors may each include a switch, such as a mechanical switch or a pressure switch, and the analysis system 100 may be configured so that the stimulator 420 does not activate unless each switch is closed. In some embodiments, the probe assembly 200 may be configured to detect contact between the tip 5 of the probe 4 and an object, for example, using the pressure sensors of the aforementioned pressure control mechanism. The analysis system 100 may be configured such that the stimulus generator 420 does not activate unless all pressure sensors around the probe tip shield 7 and the pressure sensor detection contacts of the tip 5 meet or exceed certain criteria, such as a specific threshold.

[0175] In other configurations, the actuator controller 25 may be configured such that the probe 4 does not extend unless certain criteria from the safety mechanism are met, and the stimulation generator 420 does not operate unless the probe 4 is extended.

[0176] In some forms, the safety mechanism may include a suction mechanism configured to apply negative pressure to the volume within the probe tip shield 7. The safety mechanism may further include one or more pneumatic sensors, e.g., a pneumatic sensor positioned to measure the air pressure inside the housing 210 (e.g., inside the probe tip shield 7) and a pneumatic sensor positioned to measure the ambient air pressure (e.g., the sensor may be positioned on the outer surface of the housing 210). If the pressure difference indicates that tissue is being drawn up to the probe tip shield 7, this may indicate that the tissue is suitable for analysis, in which case the stimulation generator 420 may be activated.

[0177] In some forms, the safety mechanism may involve analysis of images captured by camera 8. If this analysis determines that an object in front of probe 4 is unsuitable for analysis, the stimulus generator 420 may not be activated. Conversely, the analysis system 100 may be configured not to activate the stimulus generator 420 until an object deemed safe to analyze within the images captured by camera 8 is identified. In certain forms, an object recognition algorithm may be applied to the image. For example, a machine learning model trained to recognize eyes may be applied to the image, and after determining that an eye is within the field of view of camera 8, the stimulus generator 420 may not be activated.

[0178] In certain configurations, safety mechanisms may involve the manner in which the stimulus generator 420 is activated. For example, the stimulus generator 420 may be configured to produce a stimulus signal at an intensity and wavelength level that does not damage the human eye in the initial stages, and at a level sufficient to trigger an avoidance response that helps mitigate the condition of the eye being in front of the probe 4 when the full analytical stimulus is generated.

[0179] 6.2.8. Other features of the probe assembly The probe assembly 200 may include one or more user interfaces. These user interfaces allow the user to control specific functions of the probe assembly 200, such as enabling and / or disabling specific mechanisms or functions of the probe assembly 200. Specific examples of user interfaces, such as buttons 12, 13, and 14 for enabling / disabling the camera 8 and light source 9, have already been described. In addition, a user interface control in the form of a button 11 may be optionally provided for activating the probe 4 to analyze the subject 500. Furthermore, an additional user interface control in the form of a button 30 or switch may be optionally provided to switch the probe assembly 200 on and off, for example, to selectively power the probe assembly 200.

[0180] The probe assembly 200 may include any suitable type of user interface. For example, while Figure 4 shows multiple buttons, other types of control interfaces such as switches, dials, touchpads, and touchscreen displays may also be provided. These types of interfaces can be provided in any combination. In other forms, control of the probe assembly 200 may be achieved remotely, for example, via a remote control device connected to the probe assembly 200 via a wired or wireless connection. In some forms, the remote control device may be a dedicated handheld controller or any suitable device such as a computer, laptop, tablet, or smartphone.

[0181] As shown in Figure 4, the probe assembly 200 may include a power supply 23, but in other forms, as previously described, the power supply 470 may be located away from the probe assembly 200, for example in a portable unit 400, and connected to the probe assembly 200 via power transmission wires. In some forms, the power supply 23 includes a rechargeable battery, and the probe assembly 200 is connected to the battery and includes a port 26 located in the wall 21 of the housing body 10, through which the battery can be recharged. The port 26 may be, for example, a USB port or another suitable type of port.

[0182] In some forms, the probe assembly 200 may include a controller, such as a Raspberry Pi or other microcontroller. The controller may be operationally connected to one or more functions of the probe assembly 200, for example via wire 15, and may control their operation.

[0183] In some embodiments, the probe assembly may include an alignment light source that projects light to facilitate alignment of the probe 4 with the subject's skin area 510. For example, the alignment light source may be configured to project a ray in a certain direction, which projects a light spot onto an object placed just in front of the distal end of the probe tip shield 7, indicating where the tip 5 of the probe 4 should be positioned when the probe 4 is in its extended position. This light spot is easily visible to the user, and the light source can be turned off when the probe assembly 200 is correctly positioned. In some embodiments, the alignment light source is a stimulator 420 (described later) that generates relatively low levels of light in the visible wavelength (compared to when the stimulator 420 generates light for spectral analysis purposes), and this light can be projected onto the subject 500 by one or more light guides 310. In other embodiments, a separate light source for the light guides may be provided.

[0184] 6.3. Conduit In some forms of this technology, the analysis system 100 may include a conduit 33. The conduit 33 may be configured to transmit one or more of the following between the probe assembly 200 and other components of the analysis system 100: light illuminating the subject 500, light collected from the subject 500, power, and control signals.

[0185] For example, the conduit may include multiple optical guides 20. The optical guides 20 may be physical extensions of the optical guides (both the illumination and collection light guides of the probe 4), or they may be optically connected to the optical guides of the probe 4 (i.e., configured to transmit light). The optical guides 20 may be, for example, fiber optic cables. At the distal end of the conduit from the probe assembly 200, the illumination light guide 20 may be optically connected to the stimulus generator 420, and the collection light guide 20 may be optically connected to the detector 430.

[0186] In addition, the conduit 33 may include a wire 32. The wire 32 may be connected to a processor 440 in, for example, a portable unit 400, and may transmit control signals to and from the probe assembly 200. In some forms, the wire 32 may be connected to a power supply 470, which may supply power to the probe assembly 200.

[0187] The conduit 33 may include a sheath for housing and protecting the optical guide and wires within the conduit 33. The sheath may be, for example, a plastic sleeve. In some forms, the length of the conduit 33 may be 500 to 5000 mm.

[0188] 6.4. Stimulator In certain embodiments of this technology, the analysis system 100 includes a stimulation generator 420 configured to generate light for irradiating a subject 500. In certain embodiments, the stimulation generator 420 may include one or more lasers, such as laser diodes. In one example, the light is generated in the near-infrared spectrum, for example, at wavelengths of about 700–1400 nm, for example, about 800–850 nm, for example, about 830 nm. In other examples, light of different wavelengths may be used.

[0189] In some examples of this technology, the stimulus generator 420 may be configured to generate multiple stimulus signals, such as light of multiple different frequencies / wavelengths. In these examples, the stimulus generator 420 may be configured to generate stimulus sources simultaneously, while in other examples, the stimulus generator 420 may be configured to generate each stimulus source sequentially, resulting in only one stimulus being present at a time. In some forms, the stimulus generator 420 may include multiple light sources, each configured to generate light of a different wavelength, while in other forms, the stimulus generator 420 may include a single light source configured to generate light of multiple wavelengths.

[0190] In certain configurations, the stimulus generator 420 may include a modulator configured to modulate a light source (such as a laser) so that the light source is sequentially turned on and off. For example, the modulator can control the light source to oscillate in pulses at a predetermined frequency (i.e., pulse modulation). The effect of this modulation is to reduce the total exposure time of the subject 500 to radiation. This may reduce the power density of radiation received by the subject 500 (compared to a stimulus generator that does not generate pulses) while simultaneously allowing for a good signal-to-noise ratio using sufficient laser power. If the subject 500 is the patient's skin, the modulation can help keep the radiation exposure within a range that is safe for the patient, for example, as set by the health authorities. In addition, it may enable the measurement of larger skin lesions and improve the signal-to-noise ratio.

[0191] The stimulus generator 420 may be configured to operate for a predetermined time, which in some exemplary forms can be between 10 and 30 seconds. The analysis system 100 may allow the user to select the activation time through a user interface, or the processor 440 may determine the activation time based on one or more parameters selected by the user.

[0192] The stimulation generator 420 is optically connected to the conduit 33, and the light generated by the stimulation generator 420 is transmitted by an illumination light guide inside the conduit and irradiated onto the subject 500 by the probe 4.

[0193] 6.5. Detector In a particular form of the technology, the analysis system 100 may include one or more detectors 430 configured to receive light collected from a subject 500. The detectors 430 are optically connected to a conduit 33, and the collected light received by the detectors 430 is received from the conduit 33, for example, by a collecting light guide 314 which provides light to the detectors 430. The detectors 430 may generate a signal indicating the collected light by converting the received stimulus (light) into an electronic reading that can be processed to determine information about the received light.

[0194] Appropriate types of detectors and their operating techniques are well known to those skilled in the art and will not be described in detail here for brevity, but it should be understood that these include, for example, gratings (such as diffraction gratings), charge-coupled device (CCD) detectors, and linear arrays. In some forms, the detector 430 is configured to detect the received light as a Raman spectrum.

[0195] 6.6. Processor In certain embodiments of this technology, for example, the embodiments shown in Figures 1 and 2, the analysis system 100 may include at least one processor 440. The processor 440 is configured to analyze a signal representing light collected from the subject 500, i.e., the signal generated by the detector 430. In certain embodiments, the processor 440 performs spectral analysis on the signal. For example, the processor 440 may be configured to perform one or more of the following: Raman spectroscopy, infrared spectroscopy, near-infrared spectroscopy, ultraviolet-visible spectroscopy. The type of spectral analysis may vary depending on the region of the electromagnetic spectrum used to irradiate the subject 500 and the properties of the subject 500.

[0196] In some examples of this technology, the processor 440 may be an application-specific integrated circuit (ASIC), a microprocessor, a computer processor, or other suitable processor known to those skilled in the art. The processor 440 may be dedicated to spectral analysis performed by the analysis system 100. In other forms, the processor 440 may be a processor in a general-purpose computing device such as a server, PC, laptop, tablet, or smartphone. In some forms, the processor 440 may comprise a plurality of separate processor devices that collectively analyze signals. The plurality of processors may be formed from a plurality of physical processing devices, which may be physically connected or physically separated, or may be configured to communicate with each other remotely via, for example, the Internet or other suitable network infrastructure.

[0197] In some forms, the analysis system 100 may further include memory, and the processor 440 may be configured to record or store information determined as a result of or as part of spectral analysis in the memory. The memory may take the form of a hard drive, solid-state drive, or removable storage device. In some forms, the memory consists of multiple separate data stores, which may be physically connected or physically separated and remotely connected (e.g., a distributed memory system). In some forms, the memory and the processor 440 may be configured as part of the same computing device, such as a PC, laptop, tablet, or smartphone.

[0198] 6.6.1. Spectral Analysis In certain embodiments, the processor 440 may be configured to filter the received signal representing the light collected from the subject 500. For example, the processor 440 may apply a bandpass filter to the received signal. In other embodiments, the bandpass filter may be a separate component that filters the signal before analysis by the processor 440. The filter may be configured to filter wavelengths that are not necessary for a particular type of analysis performed by the analysis system 100. In some embodiments, the processor 440 may be configured to process the received signal to remove etaloning effects, fluorescence background signals, and / or background scattering effects. In some embodiments, the method of filtering the signal may differ for each different part of the received spectrum.

[0199] In some forms, the processor 440 may apply a machine learning process to an artificial intelligence (AI) model to analyze the received signal. A suitable model that can be applied by the processor 440 in the analysis process may be generated using training data such as spectra (e.g., Raman spectra) of known types of skin lesions that have been pre-classified by a dermatologist. A method for training a machine learning model to classify spectra in this way will be apparent to those skilled in the art.

[0200] In certain forms, the types of skin lesions that are represented in the training data and can be identified by the resulting trained machine learning model may include one or more of the following:

[0201] Inflammatory lesions, such as various types of eczema (prurigo nodularis, discoid eczema, atopic eczema), dermatitis, DLE (discatheter lupus erythematosus), psoriasis, scabies, urticaria, hematoma, hemangioma, rash, morphoea, granuloma annulare, epidermal cyst, cutaneous leishmaniasis, cutaneous lupus, chronic lichen simplex, etc. Cancerous lesions, such as malignant melanoma (primitive, superficial spreading, cystic, lentigo), basal cell carcinoma (BCC) (nodular, superficial spreading), squamous cell carcinoma (SCC); and Neoplastic lesions, such as various subtypes of nevi (Becker nevus, blue nevus, compound nevus, congenital nevus, atypical nevus, halo nevus, intradermal melanocytic nevus, lentigo conjugate nevus, lentigo, linear epidermal nevus, pedunculated nevus, malformed lentigo), sebaceous hyperplasia, vascular malformations, warts, scars, sebaceous adenomas, seborrheic keratosis, solar lentigines, cysts, actinic keratosis, circumflex keratosis, hyperkeratosis, Kaposi's sarcoma, fibrous papules, café-au-lait spots, angiokeratomas, acrochordons, burns, etc.

[0202] The output of the analysis method performed by processor 440 is the analysis result, and in the form of the technique used to analyze a patient's skin lesions, it may include the determination of the type of skin lesion determined in subject 500. The output may identify the type of skin lesion identified or the category of the skin lesion (melanoma / non-melanoma, benign / malignant, etc.). In some forms, the output may include an indicator of the reliability of the determination (such as a percentage of the risk that the skin lesion is melanoma, or a 10-point score of the likelihood that the lesion is benign). In other words, in some forms, the output may be the identification of discrete characteristics such as the type of skin lesion, or the identification of continuous characteristics such as a confidence score for a certain characteristic. This output may correspond to a diagnosis of one or more specific medical conditions, or it may be used to determine such a diagnosis. Alternatively, the output may indicate that such a medical condition does not exist.

[0203] In some forms, training data can be preprocessed before being input into the AI ​​model, for example, by smoothing the training spectrum, scaling the spectrum to the same peak height relative to a reference wavelength, or mean-centering the data. The preprocessed spectrum can then be used to build a classification model for classifying skin lesions spectrally. In some cases, this can be achieved using partial least squares with discriminant analysis (PLS-DA algorithm). This classification method can be more robust than algorithms such as artificial neural networks (ANNs) because it decomposes and reduces the data, extracts relevant spectral information, ignores baseline noise, and simultaneously regresses relevant features on their class information (type of skin lesion, e.g., BCC, SCC, melanoma, nevus, etc.). Cross-validation, for example using Venetian blinds, can also be used to validate the model.

[0204] 6.7. Output Devices In some forms, the analysis system 100 may include an output device 450 for outputting the results of the analysis performed by the processor 440. The output device 450 may be any device suitable for outputting information to the user and / or another computing device, for example, another part of the analysis system 100 and / or another system.

[0205] In some forms, the output device 450 may be physically connected to the processor 440, for example, both the output device 450 and the processor 440 may form part of the same computing device, such as a PC, laptop, tablet, or smartphone. In other forms, the output device 450 may be physically separated from the processor 440 but be able to communicate with the processor 440 and receive information from the processor 440, for example, via a wired or wireless communication protocol.

[0206] In some forms, the output device 450 may include a display screen. In other forms, the output device 450 may include a signal transmitter configured to output data to a remote location, for example, via a wired or wireless communication link.

[0207] In some configurations, the analysis system 100 also includes an input device that allows the user to input information provided to the analysis system 100, such as data provided to the processor 440. The input device may be one or more of the following: a keyboard, keypad, touchpad, mouse, touchscreen display, remote communication receiver, etc. In some configurations, the input device and the output device 450 are located on the same physical device.

[0208] 6.8.Power supply In certain embodiments of this technology, the analysis system 100 may include a power supply 470 configured to power one or more other components within the analysis system 100. Any suitable power supply, such as a battery or multiple batteries, may be used. In some embodiments, the analysis system 100 may be configured to receive power from an external power supply, such as a mains power supply.

[0209] 6.9. Portable Unit For example, as shown in the exemplary embodiments of Figures 1 and 21, the analysis system 100 may include a portable unit 400. The portable unit 400 may include one or more other components of the analysis system 100 and may be configured to be portable so that the analysis system 100 or its components can be conveniently carried by the user.

[0210] In the configuration shown in Figure 1, the portable unit 400 includes a housing 410, which is a case configured for easy transport, for example, the case may take the form of a box with a handle similar in shape to a briefcase. The case may be rigid to protect the components housed inside. In the configuration of Figure 1, the stimulus generator 420, detector 430, processor 440, and output device 450 are housed in the portable unit 400. In some configurations, a power supply 470 in the form of a portable battery may also be housed in the portable unit 400. In some configurations, the conduit 33 and / or probe assembly 200 are stored in the portable unit 400 and then withdrawn from the portable unit 400 to be used in the analysis system 100 and the subject 500 is analyzed.

[0211] In some embodiments, as shown in Figure 21, for example, the analysis system 100 may include a probe assembly holder 402 configured to hold the probe assembly 200 when it is not in use. The probe assembly holder 402 may take the form of a component or an assembly of components and form a negative space suitable for housing the probe assembly 200 or a portion of the probe assembly 200 inside. In some embodiments, the probe assembly holder 402 may be configured as part of a portable unit 400. In the embodiment shown in Figure 21, the probe assembly holder 402 includes a tube 404 configured (e.g., shape and size) to house part or all of the housing 210 of the probe assembly 200. If the housing body 10 is formed with a general shape factor similar to a gun as described above, the probe assembly holder 402 may be formed to house the probe assembly 200 like a holster. In some embodiments, as shown, for example, the tube 404 may have an open end 405 and a closed end 406. The probe assembly 200 may be positioned to be held within the probe assembly holder 402 by inserting the subject-proximal end of the housing 210 into the open end 405. In some embodiments, the probe assembly holder 402 may be configured to hold the probe assembly 200 even if the probe tip shield 7 is not attached to the housing body 10. In other embodiments, the probe assembly holder 402 may be configured to hold the probe assembly 200 with the probe tip shield 7 attached to the housing body 10. In yet another embodiment, the probe assembly holder 402 may be configured to hold the probe assembly 200 regardless of whether the probe tip shield 7 is attached to the housing body 10 or not.

[0212] In some configurations, the contents of the portable unit 400 are thought to include a spectrometer.

[0213] 6.9.1. Calibration mechanism Several types of calibration mechanisms for the analytical system 100 have already been described. This section describes other types of calibration mechanisms that may be used in specific forms of technology. Examples of specific forms of calibration mechanisms are shown in Figures 21 and 22A-C.

[0214] The analysis system 100 may include a calibration member 610, which is a component used to facilitate the calibration of the system, particularly the calibration of the spectral analysis performed by the analysis system 100 (e.g., wavenumber calibration). The calibration member 610 may be positioned relative to the probe assembly holder 402 such that the calibration member 610 is positioned for analysis by the probe 4 when the probe assembly 200 is held in the probe assembly holder 402. For example, the calibration member 610 may be positioned adjacent to the closed end 406 of the tube 404 such that the probe 4 is directed towards the calibration member 610 when the probe assembly 200 is held in the probe assembly holder 402. In some embodiments, the calibration member 610 may be configured as part of the probe assembly holder 402, for example, the calibration member 610 may be positioned inside the closed end 406 of the tube 404. Alternatively, the calibration member 610 may be positioned outside the tube 404 and may also serve to close the end of the tube 404. Alternatively, the calibration member 610 may be positioned in another part of the portable unit 400 that can be easily targeted by the user holding the probe assembly 200.

[0215] The calibration member 610 can generate a known spectrum when exposed to light from the probe 4. For example, the calibration member 610 may be formed from a material that generates a known spectrum when exposed to light of a specific wavelength or wavelength range. In particular, in a configuration in which the analysis system 100 uses Raman spectroscopy, the calibration member 610 generates a known Raman spectrum when exposed to light from the probe 4. In some configurations, the calibration member 1 may be formed from silicon or calcite, but in other configurations, other suitable materials may be used instead. The calibration member 610 may be formed as a monolithic mass of material and may have sufficiently large dimensions so that when the calibration member 610 is analyzed using the probe 4, the detected spectrum is substantially from the calibration member 610 alone. In some configurations, the calibration member 610 may be in the form of a silicon wafer. Silicon has a Raman spectrum of 521.0 cm⁻¹. -1 It has a characteristic sharp peak (1086 cm⁻¹) and is easily detectable in the detected spectrum, making it a suitable material for forming the calibration member 610. Calcite also has a characteristic sharp peak (1086 cm⁻¹). -1 ) is present, but the intensity of this peak can vary depending on the orientation and origin of the calcite crystals.

[0216] During use, the processor 440 may compare the position of the peak in the spectrum detected from the calibration member 610 with a known reference value for that peak. If these differ, the processor 440 may calibrate the analysis process accordingly, for example, by introducing an offset into the signal generated by the detector 430 before analyzing the signal.

[0217] In addition to spectral calibration, the calibration mechanism can further, or alternatively, calibrate the power of the stimulus generator. In some embodiments, for example, as shown in Figures 21 and 22A-C, the analysis system 100 may further include a power meter 620 configured to measure the power of light emitted by the probe 4 when the stimulus generator 420 generates a stimulus. The power meter 620 includes a receiver 625 positioned relative to the probe assembly holder 402, so that the receiver 625 receives light emitted by the probe 4 when the probe assembly 200 is held in the probe assembly holder 402. For example, the receiver 625 may be positioned adjacent to the closed end 406 of the tube 404 so that the probe 4 is directed towards the receiver 625 when the probe assembly 200 is held in the probe assembly holder 402. In some embodiments, the receiver 625 is configured as part of the probe assembly holder 402, and for example, the receiver 625 may be positioned inside the closed end 406 of the tube 404. Alternatively, the receiver 625 may be located outside the tube 404, but it serves to close the end of the tube 404. Alternatively, the receiver 625 may be located in another part of the portable unit 400 so that it can be easily targeted by the user holding the probe assembly 200. The receiver 625 may be configured to communicate with the analysis unit 627, for example, via a wired or wireless connection. Depending on the reading of the power meter 620 when the stimulus generator 420 is operating, the power of the generated stimulus can be adjusted to a desired level. This reduces the possibility of system malfunctions that could cause the generation of stimuli at power levels that could be harmful to the subject 500.

[0218] In some embodiments, the analysis system 100 includes both a calibration member 610 for facilitating spectral calibration of the analysis system 100 and a power meter 620 for facilitating power calibration of the analysis system 100. In such embodiments, the analysis system 100 may include a mechanism to facilitate both types of calibration. For example, there may be a calibration mechanism configured to change the relative positions of the calibration member 610 and the receiver 625 with respect to the probe assembly holder 402, such that in a first configuration, the calibration member 610 is positioned in front of the probe 4 when the probe 4 is held in the probe assembly holder 402, and in a second configuration, the receiver 625 is positioned in front of the probe 4 when the probe 4 is held in the probe assembly holder 402. As described, it should be understood that to change the relative positions of the calibration member 610 and the receiver 625 with respect to the probe assembly holder 402, the actual positions of one or more of the calibration member 610, the receiver 625, and the probe assembly holder 402, or parts thereof, can be moved by various forms of technology.

[0219] An example of such a calibration mechanism is shown in Figures 22A-C. In this embodiment, the calibration member 610 and receiver 625 remain in fixed positions, and the mechanism is configured to move a portion of the probe assembly holder 402 to move the components between a first configuration and a second configuration. In the illustrated embodiment, the probe assembly holder 402 includes a tube 404 having an open end 405 and a closed end 406. The closed end 406 at the base of the tube 404 is provided with a movable base member 407 configured to engage with the subject proximal end of the probe assembly 200. In the illustrated embodiment, the base member 407 includes an opening 408 into which the subject proximal end of the probe assembly 200 fits. The base member 407 can be moved so that the probe assembly 200 also moves when the subject proximal end of the probe assembly 200 is fitted into the opening 408 of the base member 407. As a result, the probe assembly 200 can be moved between a first position when the probe 4 is pointed toward the calibration member 610 and a second position when the probe 4 is pointed toward the receiver 625. Both the calibration member 610 and the receiver 625 can be positioned at the closed end 406 of the probe assembly holder 402, for example, at the base. The opening 408 of the base member 407 is a through hole, so that the calibration member 610 and the receiver 625 are exposed to the probe 4 when aligned with the opening 408 at different positions on the base member 407. In the illustrated embodiment, the base member 407 is attached to the inner surface of the closed end 406 via a pivot connection, and the base member 407 can be pivoted between the two positions to selectively expose either the calibration member 610 or the receiver 625 to the probe 4. In other embodiments, the base member 407 can be moved in different ways, such as by sliding the base member 407 along a slide path. In some embodiments, the base member 407 may be manually movable and may include a handle 409 that can be operated by a user to move the base member 407, for example, as shown in Figures 22A-C. In other embodiments, a base member actuator may be provided for moving the base member 407. The base member actuator may be operated manually, for example, via a button or other operating part, to operate or stop the base member actuator.Alternatively, the base member actuator can be controlled automatically. For example, the calibration process can be automatically started when the analysis system 100 is first turned on. Subsequently, the base member actuator moves the base member 407 to align the probe 4 with the calibration member 610 and the other of the receiver 625, and the stimulus generator 420 is again properly operated for the second calibration step.

[0220] Figure 9 has been described above as showing part of the calibration mechanism within the probe assembly 200, but in another embodiment, Figure 9 may also show the calibration mechanism included as part of the probe assembly holder 402, as shown in Figure 21 or 22. In this other embodiment, Figure 9 shows an end view of the base of the probe assembly holder 402, where the item labeled 1 is the calibration member and the item labeled 2 is the receiver. These components can be mounted so as to be movable relative to the probe. For example, by rotating as shown in Figure 9, the calibration member and receiver can be selectively moved for alignment with the probe.

[0221] 6.10. Operation of the Analysis System Next, an example of how to operate the analytical system 100 for analyzing a patient's skin lesions according to a particular embodiment of the technology of the present invention will be described. It will be understood that what is described in this section is only one example of the many ways in which the analytical system 100 can be used, but it is provided as a concrete example to demonstrate the convenience and ease of use of a particular embodiment of the technology.

[0222] In an exemplary manner, the portable unit 400 is opened and the probe assembly 200 and conduit 33 are removed from the storage cavity. The spectrometer is turned on by pressing the “on” switch, and power is supplied to the stimulus generator 420, detector 430, processor 440, and output device 450, which in this exemplary embodiment is powered by a power supply 470, which is a rechargeable battery.

[0223] Power is also supplied to the probe assembly 200, and the probe assembly 200 is turned on. This puts the probe assembly 200 into setup mode, initiating the calibration process described above, and calibrating the probe 4. The processor 440 compares the spectrum detected from the calibration member 1 with a reference spectrum stored in the memory associated with the processor 440, and as a result determines the necessary changes to the spectral signal.

[0224] In some configurations, the output device 450 (such as a display screen) prompts the user to input information about the patient being evaluated. The user can then input patient information (personal information, health information, etc.) using an input device.

[0225] An indicator on the probe assembly 200, for example on the screen 16 of the probe assembly 200, may include an indicator indicating that the probe assembly 200 is ready for use. The user then attaches a new sterile assembly, consisting of the probe tip shield 7 and skirt 6, to the end of the housing body 10. The user then places the opening at the distal end of the probe tip shield 7 over the lesion on the patient's skin and uses the observation assembly (e.g., an image captured by the camera 8 and displayed on the screen 16) to determine the position of the probe assembly 200. The user can then press a button to capture an image of the skin lesion using the camera 8. The image can be stored in the memory on the probe assembly 200 and / or in memory associated with the processor 440, for example, in the portable unit 400.

[0226] Next, the user presses another button, causing the retraction mechanism to extend probe 4 toward the lesion (probe 4 is previously in a retracted position). Camera 8 may continue to capture images displayed on screen 16 for the user to confirm that probe 4 has extended until it makes contact with the lesion.

[0227] Next, the user presses another button to start the spectral analysis. This activates the stimulation generator 420, the light collected by the probe 4 is detected by the detector 430, and analyzed by the processor 440. The camera 8 also continuously captures images displayed on the screen 16 so that the user can confirm that the probe 4 remains in contact with the target skin lesion. This is especially important when the exposure time is long (10-30 seconds in the case of Raman spectroscopy).

[0228] The processor 440 performs an initial analysis to determine whether the measurement was successful, and the user may be provided with feedback accordingly, for example by displaying "Success" or "Failure" on the screen 16. The data showing the captured spectrum, such as raw data and / or a text / graphic display of the data, can be stored in the memory associated with the processor 440 and / or output to the output device 450. In some forms, the memory stores the spectral data in association with images of skin lesions captured by the camera 8. This links the spectral data and images of skin lesions in the memory, allowing the user to later view the spectral data and images of skin lesions to help identify the lesions to which the spectral data is associated.

[0229] The processor 440 can then perform a more detailed analysis of the detected spectrum and determine analysis results that may include determining the type of skin lesion and indicating whether the skin lesion is benign or malignant (which may be binary or non-binary results, such as a percentage indication of the likelihood of it being malignant). Determining the type of skin lesion includes determining the type of skin cancer detected (e.g., melanoma, non-melanoma, etc.), which may be individual or sequential. The determined results may be output to the screen 16 and / or output device 450.

[0230] 6.11. Other points to note Unless otherwise clearly indicated in the context, throughout this specification and the claims, terms such as “comprise,” “comprising,” and similar terms shall be interpreted in a comprehensive sense, i.e., “including, but not limited to,” and not in an exclusive or exhaustive sense.

[0231] All disclosures of all applications, patents, and publications cited above and below are incorporated herein by reference, where applicable.

[0232] References to prior art in this specification do not constitute, nor should they be interpreted as, an acknowledgment or suggestion in any way that such prior art forms part of the common general knowledge of the art in any country of the world.

[0233] Broadly speaking, this technology can also be said to consist of the components, elements, and features mentioned or indicated in the specification of the application, individually or collectively, or any combination of two or more or all of the said components, elements, or features.

[0234] Where, in the preceding description, integers or their equivalents are referred to as components for which integers are known, those integers are incorporated herein as if they were listed separately.

[0235] Various changes and modifications to the currently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the Art and without impairing any incidental advantages. Accordingly, such changes and modifications are intended to be included within the Art.

Claims

1. A probe assembly for spectral analysis of a subject's skin area, wherein the probe assembly comprises: A housing configured to hold a probe for Raman spectroscopy within the housing, The housing body and The housing includes a probe tip shield having a proximal end provided at one end of the housing body and a distal end defining an opening for exposing the tip of the probe to a skin area, The probe tip shield is configured to shield the tip from ambient light at least at the sensitivity wavelength of Raman spectroscopy. The probe assembly is configured such that the shape of the distal end of the probe tip shield is adaptable to a region of the subject's body surrounding a skin area.

2. The probe assembly according to claim 1, wherein the probe tip shield is substantially flexible and the distal end is adaptable to a region of the subject's body surrounding the skin region.

3. The probe assembly according to claim 2, wherein the distal end of the probe tip shield includes one or more cavities configured to facilitate the distal end conforming to a region of the subject's body surrounding a skin region.

4. The probe assembly according to claim 2 or 3, wherein the probe tip shield includes one or more folds that deform the shape of the probe tip shield to facilitate the distal end conforming to a region of the subject's body surrounding the skin region.

5. The probe assembly according to any one of claims 1 to 4, wherein the probe assembly includes a plurality of probe tip shields, the distal end of each of the plurality of probe tip shields being of a different shape and / or size, and the proximal end of each of the plurality of probe tip shields being interchangeably attached to the housing body.

6. The probe assembly according to any one of claims 1 to 5, wherein the probe tip shield tapers from a wider distal end to a narrower proximal end.

7. The probe assembly according to any one of claims 1 to 6, wherein the probe tip shield is configured to have a minimum width, for example about 5 cm, sufficient to substantially block subsurface scattered ambient light received by the probe from the area of ​​the subject's body surrounding the skin area.

8. The probe assembly according to any one of claims 1 to 7, wherein the probe tip shield is configured to be substantially opaque to light of substantially all wavelengths.

9. The probe assembly is A camera disposed within the housing, which captures a visual image of the skin region when its distal end contacts the area of ​​the subject's body surrounding the skin region, The probe assembly according to any one of claims 1 to 8, further comprising a light source for illuminating a skin region when the camera captures a visual image of the skin region.

10. A probe assembly for spectral analysis of a subject's skin area, A housing configured to hold the probe within the housing, The housing body and The housing includes a probe tip shield having a proximal end provided at one end of the housing body and a distal end defining an opening for exposing the tip of the probe to a skin area, The probe assembly further includes a retraction mechanism for moving the probe between an extended position and a retracted position, the retraction mechanism is An actuator configured to act on the probe to extend and retract the probe, A probe assembly comprising a pressure control mechanism that controls the pressure applied by the tip of the probe to a skin area when the probe is in an extended position.

11. The probe assembly according to claim 10, wherein the pressure control mechanism includes an actuator controller that controls the actuator to restrict the movement of the probe in the extended position.

12. The probe assembly according to claim 11, wherein the pressure control mechanism includes a pressure sensor configured to detect the pressure applied to the probe, and the actuator controller is configured to restrict the movement of the probe based on the pressure applied to the probe detected by the pressure sensor.

13. The probe assembly according to any one of claims 10 to 12, wherein the pressure control mechanism includes a probe assembly configured to press a probe member against a region of the subject's body close to the skin region, the probe member being located inside the probe tip shield.

14. The probe assembly according to any one of claims 10 to 13, wherein the pressure control mechanism includes an imaging assembly configured to determine whether the tip is in contact with a skin area, and the actuator controller is configured to restrict the movement of the probe based on the determination of the imaging assembly.

15. The probe assembly according to any one of claims 10 to 14, wherein the pressure control mechanism includes a mapping assembly configured to determine the shape of a skin region, and the actuator controller is configured to restrict the movement of the probe based on the determination of the mapping assembly.

16. The probe assembly according to any one of claims 10 to 15, further comprising a viewing assembly that allows the user to view the skin area when the distal end is in contact with the skin area.

17. The probe assembly according to claim 16, wherein the viewing assembly includes a camera positioned within the housing to capture a visual image of the skin region.

18. The probe assembly according to any one of claims 10 to 17, wherein the probe tip shield is configured to shield the tip from ambient light at least at the sensitivity wavelength of Raman spectroscopy.

19. The probe assembly according to any one of claims 10 to 18, wherein the shape of the distal end of the probe tip shield is configured to conform to a region of the subject's body surrounding a skin area.

20. A probe assembly for spectral analysis of a subject's skin area, wherein the probe assembly comprises: A housing configured to hold the probe within the housing, The housing body and The housing includes a probe tip shield having a proximal end provided at one end of the housing body and a distal end defining an opening for exposing the tip of the probe to a skin area, The probe assembly is A probe assembly further comprising a camera disposed inside the housing, the camera capturing a visual image of a skin region when its distal end contacts a region of the subject's body surrounding a skin region.

21. The probe assembly according to claim 20, wherein the probe tip shield is configured to shield the tip from ambient light at least at the sensitivity wavelength of Raman spectroscopy, and the probe assembly further includes a light source that illuminates the skin region when the camera captures a visual image of the skin region.

22. The probe assembly according to claim 20 or 21, wherein the shape of the distal end of the probe tip shield is configured to conform to a region of the subject's body surrounding a skin region.

23. The probe assembly according to any one of claims 20 to 22, further comprising a screen configured to display images from the camera to a user.

24. The probe assembly according to any one of claims 20 to 23, wherein the probe assembly is configured to communicate images from the camera to a location away from the probe assembly.

25. A probe assembly for spectral analysis of a subject's skin area, wherein the probe assembly comprises: A housing configured to hold a probe for Raman spectroscopy within the housing, The housing body and The housing includes a probe tip shield having a proximal end provided at one end of the housing body and a distal end defining an opening for exposing the tip of the probe to a skin area, The probe tip shield is configured to shield the tip from ambient light at least at the sensitivity wavelength of Raman spectroscopy. The probe tip shield includes a skirt that extends radially outward from the distal end of the probe tip shield to cover the surface area surrounding the skin area during use. The skirt of the probe assembly is substantially opaque, at least at the sensitivity wavelength of Raman spectroscopy.

26. The probe assembly according to claim 25, wherein the radially outer edge of the skirt has a minimum width, for example about 5 cm, sufficient to substantially exclude subsurface scattered ambient light received by the probe.

27. The probe assembly according to claim 25 or 26, wherein the skirt portion extends radially and vertically outward from the distal end of the probe tip shield.

28. The probe assembly according to any one of claims 25 to 27, wherein the skirt portion is formed to be flexible or semi-rigid so as to be able to flex when pressed against a subject.

29. A probe assembly for spectral analysis of a subject's skin area, wherein the probe assembly comprises: A housing configured to hold the probe within the housing, The housing body and The housing includes a probe tip shield having a proximal end provided at one end of the housing body and a distal end defining an opening for exposing the tip of the probe to a skin area, The probe assembly is A retraction mechanism for moving the probe between an extended position and a retracted position, wherein in the extended position, the tip is positioned substantially flush with the distal end of the probe tip shield, and in the retracted position, the tip is positioned within the housing; A probe assembly comprising: an observation assembly that allows a user to observe a skin area when the distal end is in contact with a region of the subject's body surrounding the skin area.

30. The probe assembly according to claim 29, wherein the observation assembly includes a camera disposed within the housing for capturing visual images of the skin region.

31. A system for spectral analysis of a subject's skin area, wherein the system is A probe assembly including a housing configured to hold the probe within the housing, A probe assembly holder for holding the probe assembly when not in use, The probe assembly includes a calibration member positioned relative to the probe assembly holder such that the calibration member is positioned for analysis by the probe when the probe assembly is held in the probe assembly holder, The calibration member is a system that generates a known spectrum when exposed to light from the probe.

32. The system according to claim 31, wherein the calibration member generates a known Raman spectrum when exposed to light from the probe.

33. The system according to claim 31 or 32, further comprising a power meter configured to measure the power of light emitted by the probe, wherein the power meter includes a receiver positioned relative to the probe assembly holder such that the receiver is positioned to receive light emitted by the probe when the probe assembly is held in the probe assembly holder.

34. The system according to any one of claims 30 to 33, further comprising a calibration mechanism configured to change the relative positions of the calibration member and the receiver with respect to the probe assembly holder, wherein in a first configuration, the calibration member is positioned in front of the probe when the probe is held in the probe assembly holder, and in a second configuration, the receiver is positioned in front of the probe when the probe is held in the probe assembly holder.

35. A probe assembly for spectral analysis of a subject, wherein the probe assembly is A housing configured to hold the probe within the housing, A calibration member disposed within the housing, wherein the calibration member generates a known spectrum when exposed to light from the probe, A probe assembly comprising: a calibration mechanism configured to change the relative position of the calibration member and the probe between the calibration configuration and the subject configuration, wherein in the calibration configuration the probe is positioned to analyze the calibration member, and in the subject configuration the probe is positioned to analyze the subject.

36. A probe assembly for spectral analysis of a subject, wherein the probe assembly is A housing configured to hold the probe within the housing, The housing body and The housing includes a probe tip shield having a proximal end provided at one end of the housing body and a distal end defining an opening for exposing the tip of the probe to a skin area, The probe assembly is A retraction mechanism for moving the probe between an extended position and a retracted position, wherein the tip of the probe is positioned inside the housing in the retracted position, A probe assembly further comprising: an ultraviolet light source disposed within the housing and configured to irradiate the tip of the probe with ultraviolet light when the probe is in a retracted position.

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