Portable handheld imaging system

Abstract

Disclosed is a portable handheld imaging system comprising at least one excitation light source, a first image sensor, a first filter, a white light source, a second image sensor, a second filter, a third image sensor, a third filter, a thermal sensor, and a processor configured to receive detected fluorescent and white light optical signals, and outputting a representation of the target surface to a display based on the detected fluorescent and white light optical signals, where the processor is further configured to receive image data from the second image sensor and the third image sensor and output a stereoscopic or three-dimensional image.

Description

[0001] This application is a divisional application of the Chinese national phase application, filed on January 17, 2020, with international application number PCT / IB2020 / 050385 and entitled "Modular System for Multimodal Imaging and Analysis". The Chinese national phase application entered the national phase on September 2, 2021, with application number 202080018404.7 and entitled "Modular System for Multimodal Imaging and Analysis".

[0002] Cross-reference to related applications

[0003] This application claims priority to provisional application No. 62 / 793,842, filed on January 17, 2019, entitled “MODULAR SYSTEM FOR MULTI-MODALIMAGING AND ANALYSIS”, the entire contents of which are incorporated herein by reference. Technical Field

[0004] A system for multimodal imaging and analysis is disclosed. Specifically, the system and method are applicable to collecting data on biochemical, biological, and / or non-biological substances. For example, the data may include one or more of white light data, fluorescence data, thermal data, and infrared data, such as for wound care applications in humans and animals. Background Art

[0005] Wound care is a significant clinical challenge. Healing and chronic non-healing wounds are associated with numerous biological and tissue changes, including inflammation, hyperplasia, connective tissue remodeling, and, most commonly, major problems, bacterial infection. A portion of wound infections are not clinically apparent and contribute to an increasing economic burden associated with wound care, particularly in older populations. Currently, the gold standard for wound assessment involves direct visual examination of the wound site under white light, combined with indiscriminate collection of bacterial swabs and tissue biopsies, resulting in delayed, costly, and often insensitive bacteriological results. This can affect the timing and effectiveness of treatment. Qualitative and subjective visual assessments provide only a general overview of the wound site but fail to provide information about underlying biological and molecular changes occurring at the tissue and cellular levels. A relatively simple and complementary approach is needed in clinical wound management to utilize “biological and molecular” information to improve the early identification of these occult changes. Early identification of at-risk wounds can guide therapeutic interventions and provide monitoring of responses over time, thereby significantly reducing morbidity and mortality, particularly for chronic wounds.

[0006] Wound care and management is a major clinical challenge, posing a significant burden and challenge to global healthcare [Bowler et al., Clin Microbiol Rev. 2001, 14: 244-269; Cutch et al., Journal of WurdCare. 1994, 3: 198-201; Dow et al., Ostomy / Wound Management. 1999, 45: 23-40]. Wounds are generally classified as: wounds without tissue loss (e.g., during surgery) and wounds with tissue loss, such as burns, trauma, abrasions, or wounds secondary to chronic diseases (e.g., venous stasis, diabetic ulcers or pressure sores, and iatrogenic wounds, such as skin graft donor sites and skin abrasions, pilosebaceous sinuses, non-healing surgical wounds, and chronic cavity wounds). Wounds are also classified by the number of layers involved: superficial wounds involve only the epidermis, partial-thickness wounds involve only the epidermis and dermis, and full-thickness wounds involve subcutaneous fat or deeper tissues as well as the epidermis and dermis. While the restoration of tissue continuity after injury is a natural phenomenon, infection, healing quality, healing speed, fluid loss, and other complications that prolong healing time are major clinical challenges. Most wounds heal without complications. However, chronic non-healing wounds involve increasing tissue loss, posing a significant challenge to wound care practitioners and researchers. Unlike surgical incisions, where tissue loss is relatively minimal and wounds typically heal without significant complications, chronic wounds disrupt the normal healing process, often rendering repair insufficient on their own. Delayed healing is often a result of impaired wound physiology [Winter (1962) Nature. 193: 293-294], commonly occurring in venous stasis and diabetic ulcers, or in elderly individuals with immunosuppression and mobility impairments due to prolonged localized pressure. These chronic conditions increase care costs and reduce patients' quality of life. As the number of these populations grows, the demand for advanced wound care products will increase.

[0007] Routine clinical assessment methods for acute and chronic wounds remain inadequate. They are typically based on a complete patient history, qualitative and subjective clinical assessment, and involve simple visual evaluation using ambient white light and “naked eye,” and sometimes color photography to capture the overall appearance of the wound under white light [Perednia (1991) J Am Acad Dermatol. 25: 89-108]. Regular reassessment of treatment progress and appropriate modification of interventions are also necessary. Wound assessment terminology is inconsistent, many questions surrounding wound assessment remain unanswered, key wound parameters that need to be measured in clinical practice are not agreed upon, and the accuracy and reliability of existing wound assessment techniques vary. Visual assessment is often combined with swabs and / or tissue biopsies for bacterial culture and diagnosis. Collecting bacterial swabs during wound examination has the significant advantage of providing identification of specific bacterial / microbial species [Bowler, 2001; Cutting, 1994; Dow, 1999; Dow G. In: Krasner et al., eds. Chronic Wound Care: A Clinical Source Book for Healthcare Professionals, 3rd ed., Wayne Pa.: HMP Communications. 2001: 343-356]. However, multiple swabs and / or biopsies are often collected randomly from the wound, and some swab techniques may actually disperse microorganisms around the wound during collection, thus affecting the patient's healing time and morbidity [Dow, 1999]. This can be a problem, especially for large, chronic (non-healing) wounds, where the efficiency of detecting bacterial presence using current swab and biopsy protocols is not ideal (diagnostic insensitivity) despite the collection of numerous swabs. Therefore, current methods for obtaining swabs or tissue biopsies from wound sites for subsequent bacterial culture are based on non-targeted or “blind” swab or perforation biopsy methods and have not been optimized to minimize wound trauma or maximize the diagnostic yield of bacteriological tests. Furthermore, obtaining bacteriological swab and biopsy samples can be laborious, invasive, painful, and expensive. More importantly, bacterial culture results typically take approximately 2–3 days to come out of the laboratory and may be inconclusive [Serena et al. (2008) Int J Low ExtremWounds. 7(1): 32–5.; Gardner et al., (2007) WOUNDS. 19(2): 31–38], thus delaying accurate diagnosis and treatment [Dow, 1999]. Therefore, bacterial swabs cannot provide real-time detection of the infection status of a wound.Although wound wiping may seem simple, improper technique can lead to inappropriate treatment, increased patient morbidity, and longer hospital stays [Bowler, 2001; Cutting, 1994; Dow, 1999; Dow, 2001]. The lack of non-invasive imaging methods to objectively and rapidly assess wound repair at a biological level (which may be more detailed than mere appearance or morphology) and to aid in the targeted collection of bacteriological swabs and tissue biopsy samples is a major obstacle to clinical wound evaluation and treatment. Alternative methods are highly desirable.

[0008] As wounds (chronic and acute) heal, numerous key biological changes occur at the tissue and cellular levels at the wound site [Cutch, 1994]. Wound healing involves complex and dynamic interactions of biological processes, divided into four overlapping phases—hemostasis, inflammation, cell proliferation, and maturation or remodeling of connective tissue—that influence the pathophysiology of wound healing [Physiological basis of wound healing, in Developments in wound care, PJBP Publications Ltd., 5-17, 1994]. A common major complication during wound healing (lasting from days to months) is infection caused by bacteria and other microorganisms [Cutch, 1994; Dow, 1999]. This can severely impede the healing process and lead to serious complications. All wounds contain varying degrees of bacteria, from contamination, colonization, severe colonization to infection, and the diagnosis of bacterial infection is based on clinical symptoms and signs (e.g., visual and olfactory cues).

[0009] The most commonly used terms for wound infection include wound contamination, wound colonization, wound infection, and recent critical colonization. Wound contamination refers to the presence of bacteria in a wound without any host response [Ayton M. Nurs Times 1985, 81(46): suppl 16-19], wound colonization refers to the presence of bacteria in a wound that are multiplying or eliciting a host response [Ayton, 1985], and critical colonization refers to bacterial proliferation that leads to delayed wound healing, often associated with increased pain that has not been previously reported but still does not elicit a significant host response [Falanga et al., J Invest Dermatol W94, 102(1): 125-27; Kingsley A, NursStand 2001, 15(30): 50-54, 56, 58]. Wound infection refers to the deposition and proliferation of bacteria in tissues, accompanied by a host response [Ayton, 1985]. In practice, the term “critical colonization” can be used to describe wounds that are considered to have progressed from colonization to local infection. However, the challenge in a clinical setting is ensuring that this condition is recognized quickly and reassuringly, and that bacterial biocontamination is reduced as soon as possible, perhaps through the use of topical antimicrobial agents. Potential wound pathogens can be categorized into different groups based on their structure and metabolic capabilities, such as bacteria, fungi, spores, protozoa, and viruses [Cooper et al., Wound Infection and Microbiology.: Medical Communications (UK) Ltd for Johnson & Johnson Medical, 2003]. While viruses do not typically cause wound infections, bacteria can infect skin lesions formed during the course of certain viral diseases. Such infections can occur in a variety of settings, including healthcare settings (hospitals, clinics) and homes or chronic care facilities. The control of wound infections is increasingly complex, but treatment is not always guided by microbiological diagnosis. The diversity of microorganisms and the high incidence of multimicrobial communities in most chronic and acute wounds make the identification of one or more bacterial pathogens from wound cultures credible. Early identification of the pathogen causing the wound infection can help wound care professionals take appropriate action. Furthermore, incorrect collagen formation is caused by an increased bacterial load and leads to over-vascularized loose granulation tissue, which often results in wound rupture [Sapico et al. (1986) Diagn Microbiol Infect Dis. 5: 31-38].

[0010] Accurate and clinically relevant wound assessment is an important clinical tool, but this process remains a significant challenge. Current visual assessment in clinical practice only provides a gross view of the wound site (e.g., the presence of purulent material and crusting). Current best practices fail to fully utilize crucial objective information about potential key biological changes occurring at the tissue and cellular levels (e.g., contamination, colonization, infection, matrix remodeling, inflammation, bacterial / microbial infection, and necrosis) because these indicators are i) not readily available during wound examination, and ii) are not currently integrated into routine wound management procedures. Direct visual assessment of wound health using white light relies on the detection of color and topographic / texture changes within and around the wound, and may therefore be incapable and unreliable in detecting subtle changes in tissue remodeling. More importantly, direct visual assessment of the wound often fails to detect the presence of bacterial infection because bacteria are occult under white light. Clinically, infection is diagnosed through microbial testing to identify the organism and its susceptibility to antibiotics. While white light can easily reveal physical signs of bacterial infection in most wounds (e.g., purulent exudate, crusting, swelling, erythema), this is often greatly delayed, and patients are already at increased risk of morbidity (and other infection-related complications) and mortality. Therefore, standard white light direct visualization cannot detect the early presence of bacteria themselves or identify the type of bacteria within the wound.

[0011] The implantation and transplantation of stem cells has recently attracted considerable interest, for example, in wound care and treatment. However, tracking the proliferation of stem cells after implantation or transplantation remains challenging. Tracking and identifying cancer cells is also challenging. It would be desirable to monitor these cells in a minimally invasive or non-invasive manner.

[0012] It would also be useful to provide a method for detecting contamination on other target surfaces, including non-biological targets. Summary of the Invention

[0013] This disclosure addresses one or more of the aforementioned problems and / or demonstrates one or more of the desired features described above. Further features and / or advantages will become apparent from the following description.

[0014] According to one aspect of this disclosure, a portable handheld imaging system is provided. The system includes at least one excitation light source configured to emit excitation light during fluorescence imaging. A first filter is configured to detect and allow an optical signal to pass through to a first image sensor, the optical signal being responsive to illumination of a target surface with the excitation light and having a wavelength corresponding to one or more of bacterial fluorescence, bacterial autofluorescence, tissue fluorescence, and tissue autofluorescence. A white light source is configured to emit white light during white light imaging. A second filter is configured to detect and allow an optical signal to pass through to a second image sensor, the optical signal being responsive to illumination of the target surface with white light and having a wavelength in the visible light range. Furthermore, a processor is configured to receive the detected fluorescence and white light optical signals and output a representation of the target surface to a display based on the detected optical signals.

[0015] According to another aspect of this disclosure, a portable modular handheld imaging system is provided. The modular system includes a first housing portion and a second housing portion. The first housing portion includes: at least one excitation light source configured to emit excitation light during fluorescence imaging; a first filter configured to detect and allow an optical signal to pass through to a first image sensor, the optical signal being responsive to illumination of a target surface with the excitation light and having a wavelength corresponding to one or more of bacterial fluorescence, bacterial autofluorescence, tissue fluorescence, and tissue autofluorescence; a white light source configured to emit white light during white light imaging; and a second filter configured to detect and allow an optical signal to pass through to a second image sensor, the optical signal being responsive to illumination of the target surface with white light and having a wavelength in the visible light range. The second housing portion is configured to releasably receive the first housing portion and includes a display and a processor configured to receive the detected fluorescence and white light optical signals and output a representation of the target surface to the display based on the detected optical signals.

[0016] According to another aspect of this disclosure, a portable modular handheld imaging system kit is provided. The kit includes a plurality of optical housing portions and a base housing portion. Each of the plurality of optical housing portions includes: at least one excitation source configured to emit excitation light during fluorescence imaging; a first filter configured to detect and allow an optical signal to pass through to a first image sensor, the optical signal being responsive to illumination of a target surface with the excitation light and having a wavelength corresponding to one or more of bacterial fluorescence, bacterial autofluorescence, tissue fluorescence, and tissue autofluorescence; a white light source configured to emit white light during white light imaging; and a second filter configured to detect and allow an optical signal to pass through to a second image sensor, the optical signal being responsive to illumination of the target surface with white light and having a wavelength in the visible light range. The base housing portion is configured to releasably and interchangeably receive each of the plurality of optical housing portions. The base housing portion includes: a display; a power supply configured to supply power to at least one excitation source and a white light source; and a processor configured to receive the detected fluorescence and white light optical signals and output a representation of the target surface to the display based on the detected optical signals.

[0017] According to another aspect of this disclosure, a method for operating a modular, handheld fluorescence-based imaging device is provided. The method includes: selecting an optical housing including optical components, the optical components including at least one excitation light source for fluorescence imaging; and connecting the selected optical housing to a base housing of the imaging device to supply power from a power source in the base housing to the optical components in the optical housing. The method further includes: illuminating a target with at least one excitation light source to cause one or more of a portion of the irradiated portion of the target, its components, and biomarkers to fluoresce, reflect, or absorb light; and filtering optical signals in response to irradiation of the target with excitation light, wherein filtering of the plurality of optical signals includes preventing reflected excitation light from passing through and allowing optical signals having wavelengths corresponding to one or more of bacterial fluorescence, bacterial autofluorescence, tissue autofluorescence, and exogenous tissue fluorescence to pass through a fluorescence filter contained in the optical housing. The method further includes: detecting the filtered optical signals with an image sensor contained in the optical housing; and displaying the detected filtered signals as a composite image of the irradiated portion of the target on at least one display in the base housing, the composite image including a fluorescence representation of various tissue components present in the irradiated portion of the target. Attached Figure Description

[0018] Can be used alone or with an appendix Figure 1 The present disclosure is understood from the following detailed description. The accompanying drawings are included to provide a further understanding and are incorporated in and constitute a part of this specification. The drawings illustrate one or more exemplary embodiments of the present disclosure and, together with the description, serve to explain various principles and operations.

[0019] Figure 1 This is a front view of a first embodiment of the modular handheld imaging device according to the present disclosure.

[0020] Figure 2 yes Figure 1 Rear view of the modular handheld imaging device.

[0021] Figure 3 yes Figure 1 Front perspective view of the modular handheld imaging device.

[0022] Figure 4 yes Figure 1 Rear perspective view of the modular handheld imaging device.

[0023] Figure 5A This is a perspective view of a first optical housing separated from a base housing, according to a second embodiment of the modular handheld imaging system of the present disclosure.

[0024] Figure 5B This is a perspective view of a second optical housing separated from the base housing according to a third embodiment of the modular handheld imaging system of this disclosure.

[0025] Figure 6 Examples of white light (WL), fluorescence (FL), and thermal images obtained according to exemplary embodiments of the modular handheld imaging device of this disclosure.

[0026] Figure 7 This is an example of a measurement performed according to an exemplary embodiment of the modular handheld imaging device of this disclosure.

[0027] Figures 8A to 8D This is an example of an image acquired and created during the process of forming a three-dimensional fluorescence image of a target using an exemplary embodiment of a modular handheld imaging device, according to one aspect of this disclosure.

[0028] Figures 9A to 9E A separate charging station according to this disclosure is shown. Figures 9A to 9C ), and with imaging device ( Figure 9D and Figure 9E Use them together.

[0029] Figure 10 This is an exploded view of an example embodiment of the optical housing of an imaging apparatus according to one aspect of this disclosure.

[0030] Figure 11 This is an example embodiment of a printed circuit board for an imaging apparatus according to one aspect of the present disclosure.

[0031] Figure 12A and Figure 12BAn example hardware block diagram of an imaging apparatus used in this disclosure is shown.

[0032] Figures 13A to 13F This shows the non-connection to (According to this disclosure) 13A to 13C ) and connected to ( Figures 13D to 13E Example implementation of a cover cloth for a portable handheld imaging device.

[0033] Figures 14A to 14C This disclosure illustrates an imaging device ( Figures 14A to 14B An example implementation of a sterile cover sheet used together with an imaging device, and when the imaging device is connected to a darkening cover sheet / imaging cover sheet ( Figure 14C (The sterile cover cloth on the imaging device) DETAILED DESCRIPTION

[0034] Wound progression is currently monitored manually. The National Pressure Ulcer Advisory Group (NPUAP) developed the Pressure Ulcer Healing Scale (PUSH) tool, outlining a five-step approach to characterizing pressure ulcers. This tool uses three parameters to determine a quantitative score, which is then used to monitor changes in pressure ulcers over time. Qualitative parameters include wound size, tissue type, amount of exudate or drainage, and thermal readings after dressing removal. Wounds can be further characterized by their odor and color. This assessment of wounds currently does not include critical biological and molecular information about the wound. Therefore, all descriptions of the wound are subjective and manually recorded by the attending physician or nurse.

[0035] There is a need for a robust, cost-effective, non-invasive, and rapid imaging-based method or device for objectively assessing changes in wounds at the biological, biochemical, and cellular levels, and for rapidly, sensitively, and non-invasively detecting the early presence of bacteria / microbes within the wound. Such a method or device for detecting key biological tissue changes in the wound can complement routine clinical wound management practices to guide critical clinicopathological decisions in patient care. Such a device can be compact, portable, and capable of real-time, non-invasive, and / or non-contact questioning of the wound in a safe and convenient manner. This allows handheld imaging devices to be seamlessly integrated into routine wound management practices and is user-friendly for clinicians, nurses, and wound specialists. Handheld imaging devices can also be used in home care settings (including for patient self-use). Furthermore, such image-based devices can provide the ability to monitor wound treatment response and healing in real time by incorporating valuable “bioinformation” image guidance into the clinical wound assessment process. This could ultimately lead to potential new diagnostic, treatment planning, and treatment response monitoring strategies, thereby “adaptive” intervention strategies that may allow for enhanced wound healing responses at the individual patient level. Accurately identifying the systemic, local, and molecular factors behind individual patients' wound healing problems may allow for better customized treatment.

[0036] Molecular i:X devices represent a significant advancement in addressing many of the aforementioned challenges. Molecular i:X devices allow clinicians to rapidly, safely, and easily observe bacteria and measure wounds at the point of care. The basis and methods of use of the Molecular i:X device are described in U.S. Patent No. 9,042,967, National Phase Application PCT / CA2009 / 000680, filed internationally on May 20, 2009, which claims the benefit of U.S. Provisional Application No. 61 / 054,780, filed May 20, 2008, the entire contents of which are incorporated herein by reference.

[0037] Another imaging apparatus for cancer visualization is disclosed in U.S. Provisional Application No. 62 / 625,983 (filed February 3, 2018) entitled "Devices, Systems, and Methods for Tumor Visualization and Removal" and U.S. Provisional Application No. 62 / 625,967 (filed February 3, 2018) entitled "Devices, Systems, and Methods for Tumor Visualization and Removal," and International Patent Application No. PCT / CA2019 / 000015 (filed February 1, 2019) entitled "Devices, Systems, and Methods for Tumor Visualization and Removal," the entire contents of each of which are incorporated herein by reference. Although disclosed in the context of cancer visualization, the disclosed systems and methods relate to the visualization and imaging of tissue autofluorescence and tissue fluorescence, and details regarding the construction, function, and operation of the exemplary apparatus described therein may be similar to or identical to portions of the systems described herein.

[0038] The molecular i:X device and the device disclosed in this application utilize tissue autofluorescence imaging, which provides a unique means of obtaining biologically relevant information about normal and diseased tissues in real time, thereby allowing differentiation between normal and diseased tissue states. Autofluorescence imaging devices can be used for rapid, non-invasive, and contactless real-time imaging of wounds to detect and utilize the rich biological information of wounds, overcoming existing limitations and improving clinical care and management.

[0039] This application discloses systems, methods, and apparatus for fluorescence-based imaging. One embodiment of the apparatus is a portable optical digital imaging device. The device can utilize a combination of white light (WL) imaging, fluorescence (FL) imaging, infrared (IR) imaging, thermal imaging, and / or three-dimensional mapping, and can provide real-time wound imaging, assessment, recording / documentation, monitoring, and / or care management. The device can be handheld, compact, and / or lightweight. For example, the device may include: at least one excitation source configured to emit excitation light during fluorescence imaging; a first filter configured to detect and allow an optical signal to pass through to a first image sensor, the optical signal being responsive to illumination of a target surface with the excitation light and having a wavelength corresponding to one or more of bacterial fluorescence, bacterial autofluorescence, tissue fluorescence, and tissue autofluorescence; a white light source configured to emit white light during white light imaging; a second filter configured to detect and allow an optical signal to pass through to a second image sensor, the optical signal being responsive to illumination of the target surface with white light and having a wavelength in the visible light range; and a processor configured to receive the detected fluorescence and white light optical signals and output a representation of the target surface to a display based on the detected optical signals. This device and method are applicable to the monitoring of wounds in humans and animals.

[0040] In another exemplary embodiment, the device may be a modular handheld imaging device. In such an embodiment, the device includes a base portion, also referred to herein as a base portion or base housing, and an optical portion, also referred to herein as an optical housing or optical housing portion. The optical portions are releasably received by the base portion and are interchangeable with other optical portions, each configured for a specific application or to capture specific features and optical information from the target being imaged. Thus, the user will select the optical housing based on the imaging capabilities required in a given situation.

[0041] Modular handheld imaging devices can be packaged and / or sold as part of a kit, which provides a base and two or more optical units, each with different optical properties and any other optical housings. Properties that can vary from one optical housing to another include the following non-limiting examples, which can be included in any combination within each optical housing: the number of image sensors; the number of image sensors configured for white light imaging (i.e., in combination with filters for white light imaging); the number of image sensors configured for fluorescence imaging, wherein different image sensors for fluorescence imaging can be paired with different filters to allow different ranges of fluorescence emission to pass through, wherein each range is configured to capture specific features of the target (e.g., blood vessels or microvessels, collagen, elastin, blood, bone, bacteria, malignant tumors, lymphatic vessels, immune cells, adipose tissue, cartilage, tendons, nerves, gastrointestinal tissue, skin, pre-malignant or benign tissue, body fluids, urine, blood, saliva, tears, mucus, mucosal tissue, dermal tissue, and exogenous fluorescent agents, drugs, etc.).

[0042] The image sensor is configured to capture still images or videos.

[0043] The number and type of excitation sources can also vary between optical housings. The excitation sources are configured to emit excitation light with wavelengths of approximately 350 nm to approximately 400 nm, approximately 400 nm to approximately 450 nm, approximately 450 nm to approximately 500 nm, approximately 500 nm to approximately 550 nm, approximately 550 nm to approximately 600 nm, approximately 600 nm to approximately 650 nm, approximately 650 nm to approximately 700 nm, approximately 700 nm to approximately 750 nm, approximately 750 nm to approximately 800 nm, approximately 800 nm to approximately 850 nm, approximately 850 nm to approximately 900 nm, approximately 900 nm to approximately 950 nm, approximately 950 nm to approximately 1000 nm, and / or combinations thereof. Depending on the specific application, the shape of the optical housing can also vary from one housing to another. For example, special shapes can be used for specific applications, such as access to confined anatomical spaces such as recesses, the mouth, nasal cavity, anal region, abdominal region, and ear. In this case, the optical housing may take the form of an endoscope attachment. The materials forming the optical housing can vary from one housing to another. For example, the housing can have a flexible or rigid patient-facing portion, depending on the application in which the imaging device will be used. In some embodiments, the optical housing can be made waterproof or water-resistant. In some embodiments, the housing can be made of a material inherently resistant to bacterial growth, or of a material with a surface texture or topology resistant to microbial growth, such as a rough nanosurface. The size of the optical housing can vary depending on the size and number of components contained therein. Various exemplary embodiments of the optical housing may also include, in any combination, features such as an ambient light sensor, a rangefinder, a thermal imaging sensor, a structured light emitter, an infrared radiation source and detector for three-dimensional imaging, a laser for measurement, etc. Additionally or alternatively, the imaging device may also have external channels embedded in the housing to enable delivery of tools such as biopsy forceps, fiber optic spectroscopy probes, or other image-guided targets (FL) for collecting, ablating, cauterizing, or interrogating fluorescent tissue.

[0044] The base / base housing includes an interface configured to releasably receive the optical housing. The optical housing includes a portion configured to receive a portion of the base in a manner that provides electrical and power connections between components in the optical housing and a battery and processor in the base. This connection enables data transmission between the optical housing and the base, which contains a processor configured to receive data from an image sensor. Furthermore, the base can be connected to a PC to store or analyze data from the modular imaging device.

[0045] In various exemplary embodiments, the base portion includes a heat sink. In one exemplary embodiment, the heat sink forms a lip around an opening in the base portion, the lip being configured to receive an optical housing.

[0046] In various example implementations, the modular imaging apparatus includes elements in the following various configurations:

[0047] FL camera sensor – A camera sensor configured to detect fluorescence wavelengths for fluorescence imaging mode (FL). Light incident on the sensor passes through a dual-band filter to allow visualization and capture of red and green fluorescence signals that may be present, such as those generated in response to illumination of a target with excitation light. In some embodiments, the filter may be configured to recognize additional or less fluorescence signals.

[0048] WL Camera 1 - When the modular imaging device is in white light (WL) imaging mode, a first white light (WL) camera sensor is used. Light incident on this sensor passes through a short-pass filter to allow the sensor to image at visible light wavelengths. The short-pass filter blocks infrared (IR) light that may be present in the clinical environment. The short-pass filter also blocks IR light emitted by the rangefinder (if present).

[0049] WL Camera 2 - The second WL image sensor / camera sensor can be used as part of the stereo or 3D imaging (target depth) configuration of a modular imaging device.

[0050] Light incident on the sensor passes through a short-pass filter to allow the sensor to image at visible wavelengths. The short-pass filter blocks infrared (IR) light that may be present in the clinical environment. The short-pass filter also blocks IR emitted by the rangefinder (if present). When present, the second WL camera sensor must be aligned with the first WL camera sensor.

[0051] Display – High-resolution, wide color gamut displays with touchscreen functionality are available. The touchscreen functionality allows users to manipulate images and also allows the display to act as the primary user interface (UI) for clinicians / device operators, allowing the input of patient information that can be verified or registered against captured images in some way, whether on the camera or when the information is uploaded to the cloud or other storage.

[0052] Batteries – Rechargeable batteries, such as rechargeable lithium-ion batteries with integrated gas measurement capabilities, can be used to power modular imaging devices. As will be understood, other types of batteries or other power sources may be used.

[0053] Speakers – Speakers on the modular imaging device can be used to communicate with the user and can also generate camera click sounds and / or other sounds to improve the user experience.

[0054] Battery Status LED - Indicates low battery status and battery charging status during charging operation.

[0055] System status LEDs – By using on / off or different colors to indicate system status, they provide indications that the system is OK / running or that there is an internal system problem.

[0056] Wi-Fi Antenna - Enables Wi-Fi communication. Wi-Fi communication is used for cloud storage of images, on-site updates and management of system software, and pay-per-use.

[0057] The light source for a modular FL LED device may include an LED. In one example, the excitation light, such as fluorescent excitation light, may be generated by a fluorescent (FL) LED. Fluorescent excitation light can be used to extract fluorescence from bacteria, i.e., as a response to excitation light irradiation. The LED current is controlled using closed-loop control, where the setpoint of the control loop is managed by an MCU. The nominal FL LED drive current setpoint is established during device manufacturing to meet minimum target optical irradiance and uniformity requirements. The optical efficiency of the LED is temperature-dependent. A temperature sensor measures the temperature of the printed circuit board (PCB) near the LED, and this temperature is used as an input to the control loop, which adjusts the nominal drive current setpoint to compensate for temperature-dependent variations in LED irradiance. As will be understood, other types of fluorescent light sources may be used instead of FL LEDs or in addition to FL LEDs.

[0058] An ambient light sensor is provided to monitor ambient light in the imaging environment near the imaging target. Fluorescence (FL) imaging requires a sufficiently dark environment to obtain usable images. The ambient light sensor is used to provide clinicians with feedback on the ambient light level. The ambient light level before the system enters FL imaging mode can be stored in the image metadata. The light level may be useful in later analysis. The measured ambient light level may also be useful during white light imaging mode to enable a WL flashlight or control its intensity. The ambient light sensor can be configured to indicate to the user that the imaging environment is dark enough to capture a fluorescence image. This can take the form of providing indications of whether the imaging environment is satisfactory and / or unsatisfactory depending on the imaging mode.

[0059] A rangefinder is used to measure the distance between a camera sensor and the target being imaged. Minimal blue light irradiance and uniformity are effective within the camera-to-target distance range. The rangefinder provides feedback to clinicians / users to guide them to image at the correct distance by indicating that an appropriate distance has been reached. The target distance can be stored in image metadata. The target distance can be useful for sticker detection algorithms, which can be used during the measurement process to determine the minimum and maximum expected sticker size in sensor pixels, a function of the distance between the sticker and the camera sensor. In some implementations, changes in the measured target distance can be used to initiate a camera sensor refocusing action.

[0060] Flashlight LED – During white light imaging mode, one or more white light sources can be provided to illuminate the target. The white light source may include one or more white LEDs. Other white light sources can be used besides LEDs or in place of LEDs.

[0061] USB-C Port - Provides a USB-C port for battery charging, factory software loading, factory testing and calibration of the device, and image downloading.

[0062] Additional or alternative ports may be provided for information transmission and / or billing.

[0063] Figures 1 to 5B An exemplary embodiment of the modular handheld imaging device 100 is shown in the figure. For example... Figures 1 to 5B As shown, in some example embodiments, the base portion 110 of the device 100 may have a generally square or rectangular shape. The front or user-facing side 115 of the base portion 110 includes a display screen 120 for displaying images and videos captured by the device. Although depicted as square or rectangular, the device may take any shape that would reasonably support a display screen such as a touchscreen display. In addition to displaying images captured by the imaging device 100, the display screen also serves as a user interface, allowing the user to control the functions of the device via touchscreen input.

[0064] Positioned on the opposite side of the device, i.e., the patient-facing side 125, may be a handheld area 130, configured to facilitate the user's grip on the device during imaging. Figure 4 As shown, the handheld area may include a protrusion or an area extending away from the base 110 sufficient to allow a user's fingers to grasp or wrap around the protrusion. Various other types of handheld devices and alternative handheld positioning can be used. One factor to consider in such handheld positioning is the user's ability to balance the imaging device when using it and inputting commands via the touchscreen display. The weight distribution of the imaging device will also be a consideration in providing a user-friendly and ergonomic device. The patient-facing side 125 of the device may also include contacts 135 for wireless charging of the device.

[0065] like Figures 9A to 9EAs shown, a charging station 136 may be provided for wireless charging of device 100. As illustrated in the example embodiment, charging station 136 may include contacts, such as contact pins 137 for wireless charging of device 100. Contact pins 137 may be spring-loaded and may be separated from each other in a manner that prevents short circuits due to unintentional placement of other objects (i.e., small metal objects) on contact pins 137. In one example, a protrusion, such as a protrusion, on the surface of charging station 136 may separate contact pins 137. Charging station 136 may also include an indicator light 138 that engages / illuminates when device 100 is correctly placed on charging station 136. Additionally or alternatively, indicator light 138 may indicate when device 100 is fully charged.

[0066] According to one aspect of this disclosure, the patient-facing side 125 of the device 100 also includes an optical housing 140. (As...) Figures 5A to 5B As shown, the optical housing 140 can be separated from the base portion 110. The optical housing portion 140 is shown as a rectangular housing, configured to be received in a rectangular opening 145 on the base portion 110. However, both the optical housing portion 140 and the opening 145 can take other shapes, such as square, rectangular, elliptical, or circular. Furthermore, the optical housing portion 140 may not have the same shape as the opening 145, but can be bridged using a connector element having the same shape as the opening 145 of the base portion 110 or otherwise configured to be received in the opening 145 of the base portion 110. The opening 145 is configured to releasably receive the optical housing portion 140. When the optical housing portion 140 is located in the opening 145, it can be locked in place, such that the optical housing portion 140 is locked to the base portion 110. In this configuration, electrical contact is made between the base portion 110 and the optical components contained in the optical housing portion 140, and the components in the optical housing portion are powered by a power source (e.g., a battery) contained in the base portion 110.

[0067] In various exemplary embodiments, the base portion 110 includes a heat sink 150. In one exemplary embodiment, the heat sink 150 forms a lip around an opening 145 in the base portion 110, the lip being configured to receive the optical housing portion 140.

[0068] like Figure 5A and Figure 5B As shown, the optical housing 140 can take different shapes or configurations. For example, as Figure 5A As shown, the optical housing portion 140 has a generally flat rectangular shape. The optical components are arranged in a generally linear manner along the width of the optical housing. Figure 5BA second optical housing 185 is shown, which includes an endoscope portion 190. Unlike the optical housing portion 140, the optical components contained in the second optical housing 185 are contained in the distal tip 195 of the endoscope portion 190 of the second optical housing 185 and are not arranged in a linear manner. The arrangement of the optical components in each optical housing will vary depending on the size and shape of the optical housing and the number and type of optical components contained in a given housing.

[0069] The optical housing 140 may include various optical components configured to facilitate the collection of optical signals from the target being imaged. Properties that can vary from one optical housing to another include the following non-limiting examples, which may be included in any combination within each optical housing: the total number of image sensors; the number of image sensors configured for white light imaging (i.e., in combination with filters for white light imaging); the number of image sensors configured for fluorescence imaging, wherein different image sensors for fluorescence imaging may be paired with different filters to allow different ranges of fluorescence emission to pass through, wherein each range is configured to capture specific features of the target (e.g., blood vessels or microvessels, collagen, elastin, blood, bone, bacteria, malignant tumors, healthy or diseased cartilage, ligaments, tendons, connective tissue, lymphatic vessels, nerves, muscles, etc.).

[0070] The optical housing 140 may include one or more excitation sources. The excitation source may provide excitation light of a single wavelength, selected to excite tissue autofluorescence emission and induced porphyrin fluorescence emission in tumors / cancer cells. Additionally or alternatively, the excitation source may provide excitation light wavelengths selected to excite bacterial autofluorescence emission and / or exogenous fluorescence emission in one or more tissues and bacteria in a wound. In one example, the excitation light may have a wavelength in the range of about 350 nm to about 600 nm, or 350 nm to about 450 nm and 550 nm to about 600 nm, or, for example, 405 nm, or, for example, 572 nm.

[0071] Alternatively, the excitation source can be configured to provide excitation light of two or more wavelengths. As those skilled in the art will understand, the wavelength of the excitation light can be selected for different purposes. For example, by changing the wavelength of the excitation light, the depth to which the excitation light penetrates a target surface such as an operating table or wound can be changed. As the penetration depth increases with the corresponding increase in wavelength, different wavelengths of light can be used to excite tissue below the surface of the target surface. In one example, excitation light having a wavelength in the range of 350 nm to 450 nm (e.g., 405 nm) and excitation light having a wavelength in the range of 550 nm to 600 nm (e.g., 572 nm) can penetrate the target tissue to different depths, such as about 500 nm to about 1 mm and about 2.5 mm, respectively. This will allow the user of the device, such as a physician, surgeon, or pathologist, to visualize tissue cells at the surface and subsurface of the target. Additionally or alternatively, excitation light with wavelengths in the near-infrared / infrared range can be used, for example, excitation light with wavelengths between about 750 nm and about 800 nm, such as 760 nm or 780 nm. Furthermore, to penetrate tissue to deeper levels, this type of light source can be used in conjunction with a second type of imaging / contrast agent, such as an infrared dye (e.g., IRDYE800, ICG). This, for example, enables visualization of vascularization, perfusion, and blood pooling in the target tissue. Additionally, visualization of perfusion can improve anastomosis during reconstruction or allow observation of wound healing.

[0072] Imaging apparatus 100 may include an additional light source, such as a white light source for white light (WL) imaging of the target surface. The use of white light provides an anatomical background for other images, such as fluorescence images. The white light source may include one or more white LEDs. Other white light sources may be used as appropriate. As will be understood by those skilled in the art, the white light source should be stable and reliable and should not overheat during prolonged use.

[0073] The substrate 110 of the imaging device 100 may include controls that allow switching / conversion between white light imaging and fluorescence imaging. These controls may also enable the use of various excitation light sources together or individually, in various combinations and / or sequentially. The controls can cycle through various different combinations of light sources, can control the light sources sequentially, can control strobe light sources, or otherwise control the time and duration of light source use. As will be understood by those skilled in the art, the controls may be automatic, manual, or a combination thereof. As described above, the touchscreen display 120 of the substrate 110 may serve as a user interface to allow control of the imaging device 100. Alternatively, it is conceivable that separate controls, such as manual controls (e.g., buttons), may be used in place of touchscreen controls or in addition to touchscreen controls. For example, such manual controls may be located on a handle 130 to allow the user to easily actuate the controls while holding and using the imaging device.

[0074] The optical housing 140 of the imaging device 100 may further include one or more optical imaging filters configured to prevent reflected excitation light from passing through the camera sensor. In one example, the optical imaging filter may also be configured to allow emission with wavelengths corresponding to the autofluorescence emission of tissue cells and the fluorescence emission of induced porphyrins in tissue cells. In another example, the device 100 may include one or more optical imaging filters configured to allow emission corresponding to the autofluorescence emission of bacteria contained in the target and the exogenous fluorescence emission of bacteria generated due to the use of a contrast agent on the target surface. The imaging device 100 may also include a filter configured to capture the fluorescence and autofluorescence of both bacteria and tissue.

[0075] These optical filters can be selected to detect specific optical signals from the target / tissue / wound surface based on the desired light wavelength. For example, liquid crystal tunable filters (LCTFs) or acousto-optic tunable filters (AOTFs), which are solid-state electronically tunable spectral bandpass filters, can also be used to achieve spectral filtering of the detected optical signal (e.g., absorption, fluorescence, reflectance). Spectral filtering can also involve the use of continuously variable filters and / or manually operated bandpass optical filters. These filters / filtering mechanisms can be placed in front of the imaging sensor to produce multispectral, hyperspectral, and / or wavelength-selective imaging of the tissue.

[0076] Imaging device 100 can be modified by attaching optical or variable orientation polarization filters (e.g., linear or circular, in combination with waveplates) to the excitation / irradiation source and imaging sensor in a reasonable manner. In this way, imaging device 100 can be used to image a target surface by polarized light irradiation and non-polarized light detection, or vice versa, or by polarized light irradiation and polarized light detection, utilizing white light reflection and / or fluorescence imaging. This allows for imaging of wounds with minimal specular reflection (e.g., glare from white light imaging) and the ability to image fluorescence polarization and / or anisotropy-related changes in connective tissue (e.g., collagen and elastin) within and around the wound in normal tissue. This may yield useful information about the spatial orientation and organization of connective tissue fibers associated with wound remodeling during the healing process [Yasui et al., (2004) Appl. Opt. 43: 2861-2867].

[0077] exist Figure 10 In one example embodiment shown, the imaging device 200 includes three camera sensors 260, 265, and 270, and each sensor includes fixed filters 261, 266, and 271. For example, first and second white light sensors may be provided, each configured to receive visible optical signals via a dedicated filter fixed to the respective sensor. Additionally, sensors for fluorescence imaging may be configured to allow various desired emission wavelengths to pass through to the fluorescence camera sensor. As previously described, different optical housings may contain different configurations of sensors, filters, and light sources, which together are configured to create images of specific features of a target.

[0078] Figure 10 An exploded view of the optical housing 240 of the imaging device 200 is shown. (As shown...) Figure 10 As shown, the base portion 210 may include a heat sink 212 located behind the heat sink 250 of the optical housing 240. The optical housing 240 may further include three camera sensors 260, 265, 270, a printed circuit board (PCB) 273, an external heat sink pad 252, a camera hood 244, three filters 261, 266, 271, a light diffuser 253 for a white light source, an internal pad / filter holder 274, windows 275a, 275b, 275c, tape 276 (or other means for securing the windows), and a lens assembly tip 280, which may include features that allow attachment of accessories.

[0079] As those skilled in the art will understand, the arrangement of components within the optical housing of an imaging apparatus can take many configurations. Such configurations may be influenced by the size of the apparatus, its footprint, and the number of components used. However, functional factors should also be considered when arranging the components. For example, problems such as light leakage from the apparatus's light source and / or ambient light entering the optical housing can interfere with the proper or optimal operation of the apparatus and may, for example, lead to undesirable outputs, such as image artifacts. Figure 10 The arrangement shown is one in which the camera sensor is isolated to prevent light leakage from the light source and ambient light.

[0080] Figure 11 Example PCB 273 is shown. As shown, the PCB may include an excitation light source 302, such as two fluorescent LEDs, for example, violet / blue LEDs with wavelengths between approximately 400 nm and approximately 450 nm, and in one example, a wavelength of approximately 405 nm. Additional LEDs with the same wavelengths may be provided, or only one LED may be used. Alternatively, it is envisioned that additional excitation light sources with different wavelengths may be provided. PCB 273 may also include two temperature sensors 304, a white light or flashlight LED 306 providing white light for white light imaging, an ambient light sensor 308, and a rangefinder 312, for example, the rangefinder 312 may be a laser-based rangefinder.

[0081] When the device 100 or 200 is held above the surface of the target tissue (e.g., a wound) to be imaged, the illumination source can illuminate the tissue / wound surface with narrow-band or broadband violet / blue wavelengths or other wavelengths or bands, thereby generating a flat and uniform light field within the region of interest. The light also illuminates or excites the tissue to a certain shallow depth. This excitation / illumination light interacts with both normal and diseased tissue and can result in the generation of optical signals (e.g., absorption, fluorescence, and / or reflection) within the target tissue, which are then captured by one of the camera sensors.

[0082] By correspondingly altering the excitation and emission wavelengths, imaging devices 100 and 200 can interrogate target tissue components (e.g., connective tissue and bacteria within the wound) at the inner surface and specific depths of the target tissue (e.g., a wound). For example, by changing violet / blue (approximately 400-500 nm) wavelength light to green (approximately 500-540 nm) wavelength light, excitation of deeper tissue / bacterial fluorescent sources can be achieved, for instance, within the wound. Similarly, by detecting longer wavelengths, fluorescence emission from bacterial sources originating from tissue and / or deep within the tissue can be detected at the tissue surface. The ability to interrogate surface and / or subsurface fluorescence can be useful for wound assessment, for example, for detecting and potentially identifying bacterial contamination, colonization, critical colonization, and / or infection that may occur at the surface and depth within the wound (e.g., in chronic non-healing wounds).

[0083] The handheld imaging devices 100 and 200 also include imaging lenses and image sensors in the optical housings 140 and 240 of the device. The imaging lens or lens assembly can be configured to focus filtered autofluorescence emission and fluorescence emission onto the image sensor. Wide-angle imaging lenses or fisheye imaging lenses are examples of suitable lenses. Wide-angle lenses can provide a 180-degree field of view. The lens can also provide optical magnification. The imaging device requires very high resolution to distinguish between very small cell populations. The image sensor is configured to detect filtered autofluorescence emission from tissue cells and fluorescence emission from induced porphyrins in tissue cells. The image sensor can have 4K video capability as well as autofocus and optical or digital zoom capabilities. CCD or CMOS imaging sensors can be used. In one example, a CMOS sensor combined with a filter, i.e., a hyperspectral image sensor, such as those sold by Ximea, can be used.

[0084] Example filters include a visible light filter (https: / / www.ximea.com / en / products / hyperspectral-cameras-based-on-usb3-xispec / mq022hq-im-sm4x4-vis) and an infrared filter (https: / / www.ximea.com / en / products / hyperspectral-cameras-based-on-usb3-xispec / mq022hg-im-sm5x5-nir). Handheld devices 100 and 200 may also include a processor configured to receive detected emissions and output data regarding detected filtered autofluorescence and / or exogenous fluorescence emissions. The processor may have the ability to seamlessly run synchronized programs (including, but not limited to, wireless signal monitoring, battery monitoring and control, temperature monitoring, image reception / compression, and button press monitoring). The processor interfaces with internal memory and physical controls (e.g., buttons, optics, and wireless modules). The processor also has the ability to read analog signals.

[0085] Imaging devices 100 and 200 may also include a wireless module and be configured for fully wireless operation. They can utilize high-throughput wireless signals and have the ability to transmit high-definition video with minimal latency. The device can simultaneously enable Wi-Fi and Bluetooth—Wi-Fi for data transmission and Bluetooth for fast connection. The device can operate using the 5GHz wireless transmission band for isolation from other devices. Furthermore, the device can operate as a soft access point, eliminating the need for an internet connection and maintaining isolation between the device and modules and other devices related to patient data security. The device can be configured for wireless charging and includes an inductive charging coil. Additionally or alternatively, the device may include a port configured to receive a charging connection.

[0086] Figure 12A and Figure 12B Alternative implementations of hardware block diagrams of devices 100 and 200 are shown. Figure 12A and Figure 12B Example block diagrams are shown illustrating various components of a handheld imaging device 100, 200 according to an exemplary embodiment of the present disclosure.

[0087] The components of the handheld imaging devices 100 and 200 can be grouped within the optical PCB and electronic system. Figure 12B In this embodiment, the optical PCB includes four fluorescent wavelength LEDs, two infrared LEDs, and two white LEDs. The optical PCB further includes an ambient light sensor, a laser rangefinder, and a temperature sensor.

[0088] The optical PCB is operatively coupled to the electronic system 302. This electronic system may include, for example, but not limited to, electronic control components such as an application processor module, a real-time microcontroller unit (MCU), and a power management subsystem. The electronic system may further include components and systems that interface with other electronic components of the handheld imaging device. For example, the electronic system may include a CMOS camera interface for the optical filter system and motor drive electronics. The electronic system may also include connectors for fluorescence and white light cameras, respectively, to facilitate switching between fluorescence and white light imaging modes discussed herein. Although in Figure 12B Only two cameras are shown, a white light camera and a fluorescent camera, but this disclosure contemplates the use of an additional camera, specifically a white light camera. For example, Figure 12A The example block diagram discloses the presence of three cameras: two white light cameras and one fluorescent camera. The addition of additional cameras is within the scope of this disclosure.

[0089] Other supporting electronic systems and components of electronic systems may include memory (e.g., flash memory devices), rechargeable batteries (e.g., lithium-ion batteries), and inductive battery charging systems. Some components of the electronic systems may include communication components (e.g., Wi-Fi and / or Bluetooth wireless electronic systems), and spatial orientation components, such as one or more of magnetometers, accelerometers, and gyroscopes.

[0090] The electronic system may include various user controls, such as power switches, system status LEDs, charging status LEDs, image capture switches, video capture switches, and imaging mode switches. These user controls can interface with other components of the electronic system through a user interface module, which provides signals to and receives signals from the user controls.

[0091] Other components of the electronic system may include drivers for fluorescent, infrared, and white LEDs, a USB hub for uplink or downlink data signals, and / or power from an external computer system, which can be connected to the electronic system via the USB hub, such as a workstation or other computer. The electronic system may also include one or more devices for providing feedback to the user, such as, but not limited to, a speaker. Other feedback devices may include various auditory and visual indicators, haptic feedback devices, displays, and other devices.

[0092] The modular handheld imaging devices 100 and 200 of this application can be used with various accessories. For example, devices 100 and 200 can be used with a cover cloth configured to darken the area around the target being imaged by blocking or reducing ambient light around the target. The cover cloth may include an adapter configured to be mounted on the patient-facing side of the optical housing and configured to isolate and / or separate the optics of the optical housing from ambient light by forming a barrier between the optics of the optical housing. Examples of cover types used with this device can be found, such as U.S. Provisional Patent Application No. 62 / 669,009, filed May 9, 2018, entitled "Darkening Drape, Packaging for Drape, Method of Use and Method for Deploying Same"; International Patent Application PCT / CA2019 / 000061, filed May 9, 2019, entitled "IMAGING DRAPES, PACKAGING FOR DRAPES, METHODS OF USE OF IMAGING DRAPES, AND METHODS FOR DEPLOYING DRAPE"; U.S. Design Patent Application No. 29 / 647,110, filed May 9, 2018, entitled "Darkening Drape"; and Design Application No. 29 / 676,893, filed January 15, 2019, entitled "Adaptor for Supporting a "DarkeningDrape", the entire contents of each of which are incorporated into this article by reference.

[0093] According to one example implementation, a darkening cover 500 is disclosed. 13A to 13C An example embodiment of the imaging cover 500 is shown. The imaging cover 500 is shown as being connected to an imaging device, such as previously described. Figures 13D to 13FThe imaging devices 100 and 200 discussed herein. Cover 500 can be used with any imaging device disclosed herein. Cover 500 includes a connecting element 501. In an exemplary embodiment, connecting element 501 includes a ridge 510 for forming a press-fit or snap-fit ​​connection with imaging devices 100 and 200. Protrusions on imaging devices 100 and 200 (described below) can engage with the ridge 510 to provide a press-fit or snap-fit ​​connection. Additionally, one or more protrusions 520 can be configured to engage with protrusions on imaging devices 100 and 200 to grip and better secure them to the cover 500. In some embodiments, protrusions 520 are toothed members that engage with protrusions on imaging devices. When the imaging device is properly aligned and pressed down into the connecting element, the protrusions 520 clamp into the protrusions on the imaging device to provide a snap-fit ​​connection.

[0094] The connecting element 501 may also include an end cup member 550 to facilitate a snap-fit ​​connection between the connecting element 501 and the imaging device. Figure 13A As shown, the end cup member 550 can be a smooth member disposed at either end of the opening 533, which is formed within the connecting element 501. The end cup member 550 can provide guidance to center / position the imaging head / optical head of the imaging device that is engaged in the connecting element 501.

[0095] Figure 13A An opening 533 with a rectangular shape is shown, wherein a protrusion 520 is provided on the long side of the rectangle, and an end cup member 550 is provided on the short side of the rectangle. However, it is also conceivable that the protrusion 520 may be provided on the short side of the rectangle, and the end cup member 550 may be provided on the long side of the rectangle. Although Figure 13A Two end cup members 550 are shown, but only one end cup member 550 may be used on one side of the opening 533. Furthermore, in some embodiments, the connecting element 501 may not include end cup members 550. In this embodiment, the protrusion 520 may be provided around most or the entire perimeter of the opening 533 on the connecting element 501. As described above, the connecting element 501 may be formed of injection-molded plastic.

[0096] Figure 13A A top perspective view of the connecting element 501 that is fixed to the cover is shown. Figure 13B A top view of the connecting element 501 and an external view of the cover are shown. Figure 13C A bottom view of the connecting element 500 and a view of the portable imaging environment formed by the interior of the cover are shown.

[0097] The connecting element 501 may also include a top flat surface 503, a one-way valve such as a flap valve 555, and a protrusion 554. As shown, the protrusion 554 is arranged on the top surface of the connecting element 501. Therefore, the protrusion 554... Figure 13B The top view is visible, but in Figure 13C It is not visible from the inside of the cover cloth in the view. Protrusion 554 helps keep the cover cloth material out of the imaging field of view.

[0098] exist Figures 13A to 13F In some embodiments, the connecting element 501 may be formed from injection-molded plastic such as polyethylene. Therefore, the connecting element 501 can be a relatively rigid component. In some embodiments, the connecting element 501 has a thickness of approximately 1.8 mm. The protrusion 554 may be formed from the same material as the rest of the connecting element 501, but may be less rigid. Therefore, the protrusion 554 may be thinner than the rest of the connecting element 501. The cover body may be formed from the same material as the connecting element 501, but may not be injection-molded, such that the cover body material is not as rigid as the connecting element 501 (including the protrusion 554). In some embodiments, the cover body material is also thinner than the connecting element 501 (including the protrusion 554). The cover body may be formed from a soft material welded to the relatively rigid material of the connecting element 501. This reduces manufacturing costs by allowing the valve 555 to be integrated into the cover by being formed from the material of the cover body.

[0099] The connecting element 501 also includes an opening 533 to provide FL and / or white light imaging within the cover's internal environment from the imaging devices 100, 200. 13A to 13C In this embodiment, the opening 133 is approximately rectangular in shape. However, other shapes may be used for further consideration.

[0100] Figures 13D to 13F It shows the fixation to 13A to 13C An example of an imaging device 600 is shown with the connecting element 501 of the cover sheet. The imaging device 600 can be configured as described with respect to devices 100, 200 discussed above. The imaging device 600 is securely fastened to the connecting element 501 by a snap-fit ​​connection that prevents / reduces any ambient light from entering the interior of the cover sheet through the top of the cover sheet. As described above, protrusions on the imaging device 600 can engage with protrusions 520 and ridges 510 on the connecting element 501 to provide a snap-fit ​​connection.

[0101] This disclosure provides an exemplary embodiment of a modular handheld imaging device 600. The imaging device 600 includes a base portion having a generally square or rectangular shape. The front side or user-facing side of the base portion includes a display screen for displaying images and videos captured by the device. A protrusion projects outward from the optical head / optical housing, although alternatively, it may be positioned on the base portion. Although in the exemplary embodiment the protrusion is located on the top of the base portion, it is also conceivable that, depending on the position of the protrusion 520 on the connecting element 501, the protrusion may be arranged on the other side of the base portion.

[0102] Although depicted as a square or rectangle, the imaging device 600 can take any shape that would reasonably support a display screen such as a touchscreen. In addition to displaying the images captured by the imaging device 600, the display screen also serves as a user interface, allowing the user to control the device's functions via touchscreen input.

[0103] Located on the opposite side of the device, i.e., the patient-facing side, this can be a handheld area configured to allow the user to hold the device during imaging. The patient-facing side of the device may also include contacts for wireless charging.

[0104] According to one aspect of this disclosure, the patient-facing side of the device 600 also includes an optical housing. The optical housing is separable from the base portion. The optical housing portion is shown as a rectangular housing, configured to be received in an opening of a connecting element on the cover.

[0105] The optical housing can be configured in various ways. For example, the optical housing may have a generally flat rectangular shape. The optical components for FL and / or white light imaging are arranged in a generally linear manner across the width of the optical housing. The optical components are described in more detail below.

[0106] According to another aspect of this disclosure, the imaging devices 100, 200, and 600 of this disclosure can be used with sterile covers. The sterile covers are configured to form a sterile barrier between the imaging devices 100, 200, and 600 and the environment in which the imaging devices are used. Figures 14A to 14C An example embodiment of a sterile drape for use with the imaging apparatus of this disclosure is shown. Figure 14A As shown, the sterile cover 700 can be configured as the main body for receiving the imaging device 800. When the sterile cover 700 is positioned on the imaging device 800, the imaging device can engage with the darkened cover 500, as described above. Figures 13A to 13F The topics discussed and such Figure 14B and Figure 14C As shown.

[0107] The optical housings can be configured such that a single adapter will fit all optical housings to attach the darkening cover. Alternatively, separate adapters can be provided to attach to each optical housing.

[0108] According to one aspect of this disclosure, a modular handheld device can be used to acquire three-dimensional fluorescence images of a target. Systems and methods for acquiring such three-dimensional images are disclosed in U.S. Provisional Application No. 62 / 793,837, filed January 17, 2019, entitled “Systems Methods, and Devices for Three-Dimensional Imaging, Measurement, and Display of Wounds and Tissue Specimens,” the entire contents of which are incorporated herein by reference.

[0109] Other uses of this device may include:

[0110] • Clinical and research-based imaging of small and large animals (e.g., veterinary).

[0111] • Detect and monitor contamination (e.g., bacterial contamination) during the preparation of meat, poultry, dairy products, fish, and agricultural food / animal products.

[0112] • Detect “surface contamination” (e.g., bacterial or biological contamination) in public (e.g., healthcare) and private environments.

[0113] • Multispectral imaging and detection of cancers in human and / or veterinary patients.

[0114] • As a research tool for multispectral imaging and monitoring of cancer in experimental animal models of human diseases (e.g., wounds and cancer).

[0115] • Forensic examination, for example, for potential fingerprints and biological fluids on non-biological surfaces.

[0116] • To image and monitor dental plaque, carriers, and cancer in the oral cavity.

[0117] • Imaging and monitoring devices for clinical microbiology laboratories.

[0118] • Test antimicrobial agents (e.g., antibiotics) and disinfectants.

[0119] The device typically includes: i) one or more excitation / illumination sources and ii) one or more image sensors, which may be combined with one or more optical emission filters or spectral filtering mechanisms. The device may have a viewing / control screen (e.g., a touchscreen), image capture, and zoom controls. The device may also have: iii) wired and / or wireless data transmission ports / modules, and iv) power and power / control switches.

[0120] The device may include software that allows users to control the device, including control of imaging parameters, visualization of images, storage of image data and user information, transmission of image and / or related data, and / or related image analysis (e.g., diagnostic algorithms). The device may also include software for measuring the imaging target and calculating the quantity of various items found in the imaging target. For example, if the target is a wound, the device may include software configured to calculate wound size, wound depth, wound circumference, wound area, wound volume, identify various types of tissue (collagen, elastic, vascular) within the wound, and the percentage of each type of tissue within the wound. Furthermore, the device can determine the amount or quantity of bacteria in the wound, bacterial load, distinguish various types of bacteria within the load, and identify relative percentages. For example, examples of suitable software and methods are described in U.S. Provisional Patent Application No. 62 / 625,611 entitled “Wound Imaging and Analysis”, filed February 2, 2019, and in International Patent Application No. PCT / CA2019 / 000002 entitled “Wound Imaging and Analysis”, filed January 15, 2019, the entire contents of each of which are incorporated herein by reference.

[0121] This device can be configured to co-register white light images, fluorescence images, thermal images, and other images of the target. It can be configured to create a 3D map of the target. It can be configured to enhance color differentiation between different tissue types identified in the images. It can be configured to determine the tissue classification of the target based on different colors or image features captured in the fluorescence image. It can be configured to delineate boundaries between diseased and healthy tissue, providing a map for users to selectively remove diseased tissue while preserving surrounding healthy tissue in a targeted manner.

[0122] Various types of filters, power supplies, light sources, excitation sources, image sensors, and charging configurations may be present in the currently disclosed devices. Examples of such components are described in U.S. Patent No. 9,042,967, national phase application filed internationally on May 20, 2009, PCT / CA2009 / 000680, which claims the benefit of U.S. Provisional Application No. 61 / 054,780, filed May 20, 2008, the entire contents of each of which are incorporated herein by reference. Additional components are disclosed in U.S. Provisional Application No. 62 / 625,983, filed February 3, 2018, entitled “Devices, Systems, and Methods for Tumor Visualization and Removal,” and U.S. Provisional Application No. 62 / 625,967, filed February 2, 2018, entitled “Devices, Systems, and Methods for Tumor Visualization and Removal,” the entire contents of each of which are incorporated herein by reference. Additional information is disclosed in U.S. Provisional Patent Application No. 62 / 793,764, filed January 17, 2019, entitled “Multimodal System for Visualization of Disease,” and U.S. Provisional Patent Application No. 62 / 857,155, filed June 4, 2019, entitled “DEVICES, SYSTEMS, AND METHODS FORTUMOR VISUALIZATION,” the entire contents of which are incorporated herein by reference.

[0123] The imaging systems and methods disclosed herein may rely on tissue autofluorescence and bacterial autofluorescence, as well as the autofluorescence of other target materials. Additionally or alternatively, the use of exogenous contrast agents is considered, which may be applied topically, ingested, or otherwise applied. Examples of such agents are disclosed in U.S. Patent No. 9,042,967, national phase application PCT / CA2009 / 000680, filed internationally on May 20, 2009, which claims the benefit of U.S. Provisional Application No. 61 / 054,780, filed May 20, 2008, the entire contents of which are incorporated herein by reference. Additional details are disclosed in U.S. Provisional Application No. 62 / 625,983, filed February 3, 2018, entitled "Devices, Systems, and Methods for Tumor Visualization and Removal," and U.S. Provisional Application No. 62 / 625,967, filed February 2, 2018, the entire contents of each of which are incorporated herein by reference. Additional details are also disclosed in U.S. Provisional Patent Application No. 62 / 793,764, filed January 17, 2019, entitled "Multimodal System for Visualization of Disease," and U.S. Provisional Patent Application No. 62 / 857,155, filed June 4, 2019, entitled "DEVICES, SYSTEMS, AND METHODS FORTUMOR VISUALIZATION," the entire contents of each of which are incorporated herein by reference.

[0124] The device interface port can support wired (e.g., USB) or wireless (e.g., Bluetooth, WiFi, and similar modes) data transfer to various external devices or third-party add-on modules, such as: head-mounted displays, external printers, tablets, laptops, personal desktop computers, wireless devices that allow image data to be transferred to remote sites / other devices, global positioning system (GPS) devices, devices that allow the use of additional memory, and microphones.

[0125] This device can be used to guide wound cleaning and identify bacterial types to help determine the appropriate treatment / medication / antibiotic.

[0126] The device can also be attached to a mounting mechanism (e.g., a tripod or stand) to function as a relatively stationary optical imaging device for white light, fluorescence, and reflection imaging of objects, materials, and surfaces (e.g., a body). This may allow the device to be used on a desk or table, or for “assembly line” imaging of objects, materials, and surfaces. In some embodiments, the mounting mechanism may be movable.

[0127] Other features of the device may include digital image and video recording capabilities, audio and document methods (e.g., image storage and analysis software), and wired or wireless data transmission for telemedicine / e-healthcare needs.

[0128] In addition to detecting bacterial strains, this device can also be used to distinguish the presence and / or location of different bacterial strains (e.g., Staphylococcus aureus or Pseudomonas aeruginosa), such as in wounds and surrounding tissues. This may be based on the different autofluorescence emission characteristics of different bacterial strains, including autofluorescence emission characteristics in the 490-550 nm and 610-640 nm emission bands when excited by violet / blue light (e.g., light around 405 nm). Other combinations of wavelengths can be used to distinguish other species on the image. This information can be used to select appropriate treatment methods, such as antibiotic selection.

[0129] The device can scan over any wound (e.g., on a body surface) so that excitation light can illuminate the wound area. The device can then be used to examine the wound, allowing an operator to view it in real time, for example, via a viewer on the imaging device or via an external display device (e.g., a heads-up display, television display, computer monitor, LCD projector, or head-mounted display). Images acquired from the device can also be transmitted in real time (e.g., via wireless communication) to a remote viewing site, for example, for telemedicine purposes, or directly to a printer or computer memory. Imaging can be performed during routine clinical evaluation of patients with wounds.

[0130] Prior to imaging, reference markers can be placed on the skin surface near or around the wound edge (e.g., using an indelible fluorescent ink pen). For example, four dots can be placed near the wound edge or boundary on a surface close to normal skin, each from a different fluorescent ink color of a separate indelible fluorescent ink pen, which can be provided as a kit to the clinical operator. These colors can then be imaged by the device using excitation light and a multispectral band filter that matches the emission wavelengths of the four ink dots. Image analysis can then be performed by co-registering the reference markers for alignment between images. Therefore, the user may not need to align the imaging device between different imaging sessions. This technique can facilitate longitudinal (i.e., over time) imaging of the wound, thus enabling the clinical operator to image the wound over time without needing to align the imaging device during each image acquisition.

[0131] Furthermore, to aid in intensity calibration of fluorescence images, a disposable, simple fluorescence standard “strip” can be placed in the field of view during wound imaging (e.g., by temporarily attaching the strip to the skin using a mild adhesive). This strip can be impregnated with one or more different concentrations of fluorescent dye that produces a predetermined and calibrated fluorescence intensity when irradiated by an excitation source, which can have a single (e.g., 405 nm) or multiple fluorescence emission wavelengths or wavelength bands for image intensity calibration. The disposable strip can also have four dots as described above (e.g., each with a different diameter or size, each with a different fluorescent ink color, next to which is a unique black dot), drawn from a separate, non-erasable fluorescent ink pen. By placing the strip near the edge or boundary of the wound on a normal skin surface, the device can be used to capture both white light and fluorescence images. This strip can provide a convenient way to capture multiple images of a given wound over time and then align the images using image analysis. Additionally, the fluorescence “intensity calibration” strip can also incorporate additional linear measuring devices, such as a fixed-length ruler, to help measure the spatial distance of the wound. Such a bar can be an example of a calibration target that can be used with the device to help calibrate or measure image parameters (e.g., wound size, fluorescence intensity, etc.), and other similar calibration targets can be used.

[0132] It may be desirable to increase the consistency of imaging results and reproduce the distance between the device and the wound, because tissue fluorescence intensity may vary slightly if the distance changes during multiple imaging sessions. Therefore, in an embodiment, the device may have a rangefinder to determine a fixed or variable distance between the device and the wound surface.

[0133] This device can be used to take white-light images of the entire wound with normal surrounding tissue using a measuring device (e.g., a ruler) placed within the imaging field of view. This may allow for visual assessment of the wound and the calculation / determination of quantitative parameters such as wound area, perimeter, diameter, and topographic profile. Wound healing can be assessed by planar measurements of the wound area at multiple time points (e.g., at clinical presentation) until the wound heals. The time progression of wound healing can be compared to the expected healing time calculated using the wound radius reduction from multiple time-point measurements using the equation R = √A / π (R, radius; A, planar wound area; π, constant 3.14). This quantitative information about the wound can be used to track and monitor changes in wound appearance over time to assess and determine the extent of wound healing caused by natural means or any therapeutic intervention. This data may be stored electronically in the patient's health record for future reference. White-light imaging can be performed during the operator's initial clinical assessment of the patient.

[0134] This device can be designed to detect all or most tissue autofluorescence (AF). For example, using a multispectral band filter, the device can image tissue autofluorescence and blood-related optical absorption from tissue biomolecules, such as: collagen (types I, II, III, IV, V, and others) exhibiting green color under 405 nm excitation; elastin exhibiting green-yellow-orange color; reduced nicotinamide adenine dinucleotide (NADH); flavin adenine dinucleotide (FAD) emitting a blue-green autofluorescence signal; and bacteria / microorganisms, most of which appear to have broad (e.g., green and red) autofluorescence emission.

[0135] Image analysis can include calculating the ratio of red to green aberrations (AF) in an image. Intensity calculations can be obtained from regions of interest within a wound image. A pseudo-color image can be mapped onto a white-light image of the wound.

[0136] This device maps the biodistribution of bacteria at the wound site and surrounding skin, thus aiding in microbial testing of specific tissue areas requiring swabs or biopsies. Furthermore, this imaging device allows monitoring of the response of bacterially infected tissue to various drug treatments, including antibiotics and other therapies such as photodynamic therapy (PDT), hyperbaric oxygen therapy (HOT), low-level phototherapy, or anti-matrix metalloproteinase (MMP) treatments. The device can be used to observe bacterial biodistribution on the wound surface and within tissue depth, as well as to observe surrounding normal tissue. Therefore, this device can be used to indicate the spatial distribution of infection.

[0137] Typically, the device can be used to image and / or monitor targets such as skin targets, tumor targets, wound targets, confined anatomical spaces or cavities, oral targets, ear, nose and throat targets, eye targets, genital targets, anal targets, and any other suitable targets on the subject.

[0138] Image analysis algorithms can provide one or more of the following features:

[0139] Patient digital image management

[0140] Integration of multiple image acquisition devices

[0141] Record all imaging parameters, including all exogenous fluorescent contrast agents.

[0142] • Multiple scale and calibration settings

[0143] • Built-in spectral image unmixing and calculation algorithm for quantitative determination of tissue / bacterial autofluorescence and exogenous reagent fluorescence signals.

[0144] • Convenient annotation tools

[0145] Digital archives

[0146] Online publishing

[0147] Basic Image Processing and Analysis

[0148] • Complete image processing and quantitative analysis functions

[0149] Image stitching algorithms will allow a series of panoramic or partially overlapping wound images to be stitched into a single image in automatic or manual mode.

[0150] • Easy-to-use measuring tools

[0151] • Intuitive settings for processing parameters

[0152] Convenient manual editor

[0153] Report generation

[0154] A powerful image report generator with professional templates that can be integrated into existing clinical reporting infrastructure or telemedicine / e-healthcare patient data infrastructure. For example, reports can be exported as PDF, Word, or Excel.

[0155] Large-scale automation solutions library

[0156] • Customized automated solutions for all areas of wound assessment, including quantitative image analysis.

[0157] Although image analysis algorithms, techniques, or software have been described, this description also extends to the computing devices, systems, and methods used to perform the image analysis.

[0158] Image guidance

[0159] This device can also be used to provide fluorescence imaging guidance, for example, in surgical procedures, even without the use of dyes or markers. When observed using an imaging device, or under certain excitation light conditions, some tissues and / or organs may exhibit different fluorescence spectra (e.g., endogenous fluorescence).

[0160] Food Applications

[0161] This imaging device can also be used to monitor contamination in food (e.g., meat products). This can be useful, for example, in the preparation of food / animal products in the meat, poultry, dairy, fish, and agricultural industries. The device can be used as part of a comprehensive multidisciplinary approach in the sector's analytical laboratory services, providing capabilities including image-based contamination detection and guidance on obtaining samples for testing. The device can be used to detect, identify, and monitor levels of bacterial and other microbial contamination / adulteration in meat in real time. It can be used for bacterial contamination tracking in food processing plant environments, thus providing an image-based approach to determine food safety and quality. In handheld, compact, and portable embodiments, the imaging device can be used in food preparation areas to determine food safety and prevent bacterial / microbial contamination. During processing and in finished food products, the device can also be used for relatively rapid detection and analysis of bacteria / microorganisms in collected or sampled meat samples (and preparation surfaces), for example, as part of food safety and quality regulatory inspection processes. The device can be used in the meat, horticulture, and aquaculture industries to implement food safety inspection / testing procedures that meet food safety and quality requirements. The device can be used to detect food contaminants, such as those found in the meat, poultry, dairy, and fish industries. This technology can be used in fecal contaminant detection systems because fecal bacteria produce porphyrins, which can be easily detected by the device.

[0162] Detecting and accurately identifying foodborne pathogens, such as Listeria monocytogenes (LM), in food samples and processing lines is crucial for ensuring food quality assurance and tracking bacterial outbreaks in the food supply. Current detection methods used in food production and processing facilities typically rely on multiple random surface samplings of equipment (e.g., swabs) followed by molecular-based diagnostic analyses (e.g., real-time polymerase chain reaction, RT-PCR), which usually provide quantitative confirmation of LM presence within 24–72 hours. However, due to time and cost constraints, pathogen contamination testing is often performed only on randomly selected areas of a given food production facility at a time. The significant potential for undersampling during the equipment's "first-pass" surface swabbing process could result in undetected pathogens with catastrophic health and economic consequences. Furthermore, there are limitations such as i) the inability to quickly sample all surface areas during the “first pass” swabbing process to identify areas with a high probability of infection, ii) the inability to visually document the initial screening process (e.g., no imaging method is available to date), iii) delays in obtaining laboratory results, iv) high costs associated with current methods, and v) more importantly, the lack of potential infection by deadly pathogens, prompting efforts to improve the cost-effectiveness of early and accurate detection of foodborne pathogens.

[0163] This device can be used to provide a relatively rapid and accurate method for detecting such pathogens. It can be used in conjunction with the analysis of multicolor fluorescent probe "mixtures" (e.g., combinations of two or more contrast agents) that can definitively identify (and make visible) surviving Listeria monocytogenes from other Listeria species using highly specific gene probe technology. This could allow for real-time, specific detection of live LMs, potentially minimizing the need for standard, time-consuming enrichment methods. This approach can also be extended to include the detection of other pathogens of interest, including *Cronobacter sakazakii*, *Campylobacter* (*Escherichia coli*, *Escherichia jejuni*, and *Lariobacter*), *Escherichia coli* and *Escherichia coli* (including lactose and indole-negative *Escherichia coli*), *Salmonella*, all bacteria belonging to the *Staphylococcus* genus and all bacteria belonging to the *Staphylococcus* genus, and *Pseudomonas aeruginosa*. Other bacteria can be detected by selecting appropriate probes or combinations of probes. For example, combinations of two or more contrast agents can be designed to be specific to a particular bacterium and can result in unique detectable fluorescent features when imaged using an imaging device.

[0164] This imaging device can be used (e.g., when combined with an applied exogenous bacteria-specific contrast agent, including multi-targeting probes or combinations of probes) for relatively rapid “first-pass” screening of food preparation and processing surfaces for targeted swab and microbial testing. The device allows for relatively rapid image-based monitoring of any surface of equipment and food, and can capture the fluorescent signatures of foodborne bacteria / pathogens in real time. As mentioned above, the device can be used in conjunction with analyses, such as multicolor fluorescent probe “mixtures” (and combinations thereof), which can definitively identify (and make visible) only surviving Listeria monocytogenes from other Listeria species using highly specific gene probe technology. Such probe “mixtures” can be designed to specifically target certain pathogens based on specific combinations of probes known to be sensitive to such pathogens and known to produce characteristic fluorescent responses. In addition to detecting these pathogens, the device also allows for the differentiation of the presence and / or location of different strains based on their distinct characteristic fluorescent responses.

[0165] Surface contamination

[0166] This imaging device can be used to detect surface contamination, such as "surface bacterial contamination" in healthcare environments. It can be used to detect and image the presence of bacteria / microorganisms and other pathogens on various surfaces / materials / instruments (especially surgical-related surfaces / materials / instruments) in hospitals, chronic care facilities, and nursing homes, where contamination is a primary source of infection. The device can be used in conjunction with standard detection, identification, and counting strategies for indicating organisms and pathogens.

[0167] The systems and methods disclosed herein can form systems as described below and can perform processes as described below:

[0168] A method / system / apparatus for illuminating an object with light of calibrated intensity and for capturing a close-up fluorescent digital image, comprising:

[0169] - Optical rangefinder

[0170] - Digital camera sensor with optical fluorescence filter

[0171] - One or more narrow-band optical emitters

[0172] - Computing processor with memory

[0173] -User Display

[0174] -User Input Control

[0175] thus:

[0176] - The light emitter is activated.

[0177] - Present a preview of the camera image to the user via the display screen.

[0178] - Display the rangefinder value to the user via the screen.

[0179] - Users can activate the camera to capture images.

[0180] This user can:

[0181] Based on the rangefinder readings on the screen, the light intensity on the object is set by adjusting the height of the device above the object, and an image is captured.

[0182] A method / system / apparatus for capturing close-up digital images with consistent magnification and perspective, comprising:

[0183] - Optical rangefinder

[0184] - One or more similar digital camera sensors

[0185] - Computing processor with memory

[0186] -User Display

[0187] -User Input Control

[0188] thus:

[0189] - Present a preview of the camera image to the user via the display screen.

[0190] - Display the rangefinder value to the user via the screen.

[0191] Users can activate one or another camera to capture images.

[0192] This user can:

[0193] Based on the rangefinder value on the screen, the view of the object is set by adjusting the height of the device above the object, and an image is captured.

[0194] A method / system / apparatus for capturing a measurement-ready close-up digital image of an object, comprising:

[0195] - Optical rangefinder

[0196] -Digital camera sensor

[0197] - Computing processor with memory

[0198] -User Display

[0199] -User Input Control

[0200] Image processing software

[0201] thus:

[0202] - The object comes with two visible wound stickers.

[0203] - Present a preview of the camera image to the user via the display screen.

[0204] - Display the rangefinder value to the user via the screen.

[0205] - If the positions of two stickers are detected using image processing, they will be continuously displayed to the user via the screen.

[0206] When a sticker is detected, the user can activate the camera to capture an image.

[0207] This user can:

[0208] -Based on the rangefinder readings on the screen, adjust the height of the device relative to the object to set the view of the object.

[0209] - Set the view of the object by adjusting the position of the device relative to the object in order to detect the sticker, and

[0210] - Capture the image.

[0211] Those skilled in the art who will benefit from this disclosure will understand that it provides various exemplary apparatuses, systems, and methods for surgical and / or in vitro visualization of tumors and / or residual cancer cells at surgical margins. In light of this description, further modifications and alternative embodiments of various aspects of this disclosure will be apparent to those skilled in the art.

[0212] Furthermore, the apparatus and methods may include additional components or steps omitted from the drawings for clarity of illustration and / or operation. Therefore, this description should be construed as illustrative only and is intended to teach those skilled in the art the general manner of implementing this disclosure. It should be understood that the various embodiments shown and described herein will be considered exemplary. It will be apparent to those skilled in the art, upon benefiting from the description herein, that elements and materials, and arrangements of such elements and materials, may be substituted for those illustrated and described herein, that components and processes may be reversed, and that certain features of this disclosure may be utilized independently. Changes may be made to the elements described herein without departing from the spirit and scope of this disclosure and the appended claims, including their equivalents.

[0213] It should be understood that the specific examples and implementation methods described herein are non-limiting and modifications may be made to the structure, dimensions, materials and methods without departing from the scope of this disclosure.

[0214] Furthermore, the terminology used in this specification is not intended to limit this disclosure. For example, spatially relative terms—such as “below,” “down,” “below,” “above,” “over,” “bottom,” “right,” “left,” “proximal,” “farthest,” “front,” etc.—may be used to describe the relationship of one element or feature to another element or feature shown in the figures. In addition to the positions and orientations shown in the figures, these spatially relative terms are intended to cover different positions (i.e., locations) and orientations (i.e., rotational placement) of the device in use or operation.

[0215] For the purposes of this specification and the appended claims, unless otherwise stated, all figures representing quantities, percentages, or proportions, as well as other numerical values, used in the specification and claims, shall in all cases be understood to be modified by the term "about" (if not already modified). Therefore, unless indicated to the contrary, the numerical parameters set forth in the specification and the appended claims are approximations that may vary according to the desired properties sought to be obtained in this disclosure. At least, and without attempting to limit the application of the doctrine of equivalence to the scope of the claims, each numerical parameter shall be interpreted at least according to the number of significant figures reported and by applying ordinary rounding techniques.

[0216] Although the numerical ranges and parameters used to illustrate the broad scope of this disclosure are approximate, the numerical values ​​described in the specific examples are reported as precisely as possible. However, any numerical value inherently contains some errors, which are necessarily caused by the standard deviations found in their respective test measurements. Furthermore, all ranges disclosed herein should be understood to encompass any and all subranges contained herein.

[0217] It should be noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the,” and any singular use of any word, include plural references unless expressly and unambiguously limited to one reference. As used herein, the term “comprising” and its grammatical variations are intended to be non-restrictive, such that the listing of items does not exclude other similar items that may replace or be added to the listed items.

[0218] It should be understood that although this disclosure has been described in detail with respect to various exemplary embodiments thereof, it should not be considered as limited thereto, as various modifications may be made without departing from the broad scope of the appended claims, which include their equivalents.

Claims

1. A portable handheld imaging system, comprising: At least one excitation source is configured to emit excitation light during fluorescence imaging; A first image sensor is configured to detect fluorescence wavelengths when the imaging system is in fluorescence imaging mode; A first filter is configured to allow an optical signal having a wavelength corresponding to one or more of bacterial fluorescence, bacterial autofluorescence, tissue fluorescence, and tissue autofluorescence to pass through in response to irradiation of the target surface with the excitation light, the first filter being fixed to the first image sensor. The white light source is configured to emit white light during white light imaging; Second image sensor; A second filter is configured to allow optical signals with wavelengths in the visible light range to pass through in response to illumination of the target surface with white light. The second filter is fixed to a second image sensor, which, when the imaging system is in white light imaging mode, images the optical signals with wavelengths in the visible light range that pass through the second filter in response to illumination of the target surface with white light. Third image sensor; A third filter is configured to allow optical signals having wavelengths within the visible light range to pass through in response to illumination of the target surface with white light. The third filter is fixed to the third image sensor, which, when the imaging system is in white light imaging mode, images the optical signals having wavelengths within the visible light range that pass through the third filter in response to illumination of the target surface with white light. A thermal sensor is configured to detect thermal information about the target surface; as well as The processor is configured to receive detected fluorescent and white light optical signals and output a representation of the target surface to a display based on the detected fluorescent and white light optical signals, wherein the processor is further configured to receive image data from the second image sensor and the third image sensor and output a stereoscopic image or a three-dimensional image.

2. The system according to claim 1, wherein, The at least one excitation source is configured to emit excitation light having wavelengths of 350 nm to 400 nm, 400 nm to 450 nm, 450 nm to 500 nm, 500 nm to 550 nm, 550 nm to 600 nm, 600 nm to 650 nm, 650 nm to 700 nm, 700 nm to 750 nm, 750 nm to 800 nm, 800 nm to 850 nm, 850 nm to 900 nm and / or combinations thereof.

3. The system according to claim 1 or claim 2, wherein, The at least one excitation source is configured to emit excitation light with a wavelength of 400 nm to 450 nm.

4. The system according to claim 1 or 2, wherein, The at least one excitation source is configured to emit excitation light with a wavelength of 405 nm ± 10 nm.

5. The system according to claim 1 or 2, wherein, The at least one excitation light source is coupled to the housing of the portable handheld imaging system.

6. The system according to claim 1 or 2, wherein, The first filter is further configured to block the passage of optical signals with a wavelength of 405nm ± 10nm.

7. The system according to claim 1 or 2, wherein, The first filter is configured to allow optical signals with wavelengths between 500 nm and 550 nm and / or optical signals with wavelengths between 600 nm and 660 nm to pass through the first filter to the first image sensor.

8. The system according to claim 1 or 2, wherein, The at least one excitation light source includes first and second violet / blue LEDs, each LED being configured to emit light with a wavelength of 405nm ± 10nm.

9. The system according to claim 1 or 2 further includes a housing having a display on the front side of the housing.

10. The system according to claim 9, wherein, The at least one excitation light source is located on the rear side of the housing.

Images