Systems and methods for medical imaging
The optical adapter enhances medical imaging by integrating with endoscopes to provide real-time visualization of anatomical and physiological features, addressing the limitations of conventional systems and ICG-based tests, thereby reducing surgical risks and costs.
Patent Information
- Application Number
- JP2024184874
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2019-12-23
- Filing Date
- 2024-10-21
- Publication Date
- 2025-01-28
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
Conventional medical imaging systems, such as endoscopy, often fail to provide real-time visualization of complex anatomical structures or physiological characteristics like blood perfusion, leading to potential surgical complications and injuries due to incomplete or incorrect analysis of target sites, and additional diagnostic tools like ICG-based tests are costly, time-consuming, and limited in accuracy.
An optical adapter with an image sensor and optical assembly that integrates with an endoscope, allowing simultaneous capture of laser spectral patterns and video images without the need for dyes, providing real-time visualization of anatomical and physiological features.
Enables real-time visualization of anatomical structures and physiological characteristics, reducing surgical complications by enhancing existing imaging systems without the need for additional hardware or dyes, and allowing for immediate detection of perfusion changes.
Smart Images

Figure 2025013899000001_ABST
Abstract
Description
[Background technology]
[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 62 / 830,934, filed April 8, 2019, which application is incorporated herein by reference in its entirety for all purposes, and U.S. Provisional Patent Application No. 62 / 952,892, filed December 23, 2019.
[0002] (background) Medical imaging technology (e.g., a speculum assembly such as an endoscope) can be used to capture images or video data of internal anatomical or physiological features of a subject or patient during a medical or surgical procedure. The captured image or video data can be processed and manipulated to provide a medical professional (e.g., a surgeon, medical operator, technician, etc.) with visualization of internal structures or processes within the patient or subject.
[0003] Endoscopic image or video data of internal anatomical or physiological features is limited and often fails to provide complex anatomical or critical structures beneath the tissue surface. Image or video data may not show non-visible features of the target site in real time, such as blood perfusion, cardiac output, liver function, etc. As a result, incomplete or inaccurate analysis of the target site may be dangerous and lead to unintended tissue damage during the surgical procedure. In some cases, at least 2% of hysterectomies may result in surgical complications and unintended injuries, which may result in at least $1 billion in medical costs per year in the United States.
[0004] Additional diagnostic tools, such as fluorescent dye-based angiography (e.g., indocyanine green (ICG) angiography), may be used in conjunction to provide visualization of some complex anatomical or critical structures. However, ICG angiography may be costly in resources and time (e.g., the ICG dye may require several minutes to 24 hours to reach the target site), may be limited in accuracy (e.g., the dye may dissipate to extra-target sites during the surgical procedure), may induce allergic reactions in some patients, and / or may lack real-time visualization capabilities. In addition, the use of separate imaging tools for endoscopy and angiography may lead to additional surgical complications, such as long surgical times or the chance of contamination. Summary of the Invention [Means for solving the problem]
[0005] (summary) The present disclosure addresses at least the aforementioned shortcomings of conventional medical imaging systems. In one aspect, the present disclosure provides an optical adapter that is compatible with one or more medical imaging technologies (e.g., a speculum assembly). In some cases, the optical adapter may allow visualization of additional or multiple features of a target site without the need for the use of dyes.
[0006] One aspect of the disclosure provides an optical adapter comprising: a housing having (1) a first end configured to releasably couple to a speculum; and (2) a second end configured to releasably couple to a camera; an image sensor within the housing; and an optics assembly disposed within the housing, the optics assembly configured to (i) receive an optical signal reflected from a target site within a subject's body and transmitted through the speculum, and (ii) reflect a first portion of the optical signal onto one of the image sensor or the camera while allowing a second portion of the optical signal to pass through to the other of the image sensor or the camera.
[0007] In some embodiments, the image sensor is releasably coupled to the housing.
[0008] In some embodiments, the image sensor is configured to generate a first set of imaging data from a first portion of the optical signal and the camera is configured to generate a second set of imaging data from a second portion of the optical signal, hi some embodiments, the first set of imaging data comprises a laser speckle pattern and the second set of imaging data comprises a photographic or video image.
[0009] In some embodiments, the image sensor is used for laser speckle imaging.
[0010] In some embodiments, the optical assembly comprises a beam splitter, hi some embodiments, the beam splitter comprises a dichroic mirror.
[0011] In some embodiments, the optical assembly is configured to reflect a first portion of the optical signal onto the image sensor while allowing a second portion of the optical signal to pass through to the camera, hi some embodiments, the optical assembly comprises a short-pass dichroic mirror.
[0012] In some embodiments, the optical assembly is configured to reflect a first portion of the optical signal onto the camera while allowing a second portion of the optical signal to pass through to the image sensor, hi some embodiments, the optical assembly comprises a long-pass dichroic mirror.
[0013] In some embodiments, the first portion of the optical signal comprises backscattered light generated when the target site is illuminated with coherent laser light transmitted through the speculum. In some embodiments, the coherent laser light is provided from a single laser source having a substantially single wavelength. In some embodiments, the coherent laser light is provided from multiple laser sources having multiple different wavelengths.
[0014] In some embodiments, the second portion of the optical signal comprises reflected light generated when the target site is illuminated with white light transmitted through the speculum. In some embodiments, the single wavelength is in the invisible spectrum. In some embodiments, the multiple different wavelengths are in the invisible spectrum. In some embodiments, the reflected light is in the visible spectrum.
[0015] In some embodiments, the first end of the housing is configured to releasably couple to the speculum using a quick release mechanism. In some embodiments, the quick release mechanism is configured to releasably couple the optical adapter to various types of speculums having different sizes. In some embodiments, the quick release mechanism is configured to allow a user to releasably couple the first end of the housing to the speculum without the use of tools. In some embodiments, the quick release mechanism is configured to allow a user to releasably couple the first end of the housing to the speculum in less than 30 seconds.
[0016] In some embodiments, the second end of the housing is configured to releasably couple to the camera using a quick release mechanism. In some embodiments, the quick release mechanism is configured to releasably couple the optical adapter to various types of cameras having different sizes. In some embodiments, the quick release mechanism is configured to allow a user to releasably couple the second end of the housing to the camera without the use of tools. In some embodiments, the quick release mechanism is configured to allow a user to releasably couple the second end of the housing to the camera in less than 30 seconds.
[0017] In some embodiments, the optical system assembly further comprises a focusing device for the image sensor.
[0018] In some embodiments, the optical system assembly further comprises (i) a first focusing device for the image sensor and (ii) a second focusing device for the camera. In some embodiments, the first focusing device and the second focusing device are operatively coupled to each other such that focusing for the image sensor and the camera can be performed in parallel. In some embodiments, the first focusing device and the second focusing device are operatively coupled to each other via a gear transmission mechanism. In some embodiments, the first focusing device and the second focusing device are provided separately and configured to be used independently of each other.
[0019] In some embodiments, the speculum is configured to (1) receive a combined light beam from an illumination source and (2) direct the combined light beam onto a target site within the subject's body.
[0020] In some embodiments, the first end and the second end share a common longitudinal axis. In some embodiments, the first end and the second end are provided on opposite sides of the housing.
[0021] In some embodiments, the first end and the second end do not share a common longitudinal axis, hi some embodiments, the first end and the second end are provided on substantially orthogonal sides of the housing.
[0022] In some embodiments, the image sensor and the camera have different optical axes.
[0023] In some embodiments, the optical axis of the image sensor is orthogonal to the optical axis of the camera.
[0024] In some embodiments, the image sensor is configured to releasably couple to a surface of the housing, the surface being substantially orthogonal to the first end or the second end of the housing. In some embodiments, the image sensor comprises a casing configured to releasably couple to the surface of the housing.
[0025] In some embodiments, the image sensor is disposable and configured for a single use in a medical imaging procedure.
[0026] In some embodiments, the image sensor is configured to be reusable for multiple medical imaging procedures.
[0027] Another aspect of the present disclosure provides an imaging kit comprising any one of the subject optical adapters disclosed herein and an illumination source configured to transmit a combined light beam to a speculum for directing the combined light beam onto a target site within a subject's body.
[0028] Another aspect of the disclosure provides a method including: (a) combining white light with coherent laser light to generate a combined light beam; (b) providing the combined light beam to a speculum; (c) using the speculum to direct the combined light beam onto a target site within a subject's body; (d) receiving, via the speculum, an optical signal reflected from the target site; and (e) reflecting a first portion of the optical signal onto one of (i) an image sensor or (ii) a camera in an optical adapter while allowing a second portion of the optical signal to pass through to the other of (i) the image sensor or (ii) the camera, wherein the optical adapter is configured to releasably couple to both the speculum and the camera.
[0029] In some embodiments, a first portion of the light signal is reflected onto an image sensor, while a second portion of the light signal is allowed to pass through to the camera.
[0030] In some embodiments, a first portion of the light signal is reflected onto the camera, while a second portion of the light signal is allowed to pass through to the image sensor.
[0031] In some embodiments, the optical adapter is disposed between the speculum and the camera when releasably coupled thereto.
[0032] In some embodiments, the speculum and camera are releasably coupled to orthogonal sides of the optical adapter.
[0033] Another aspect of the disclosure provides a method including: (a) providing an optical adapter comprising a housing, the image sensor within the housing; (b) releasably coupling a first end of the housing to a speculum; (c) releasably coupling a second end of the housing to a camera; (d) providing a combined light beam to the speculum, the combined light beam comprising white light combined with coherent laser light; (e) using the speculum, directing the combined light beam onto a target site within a body of a subject; (f) receiving, via the speculum, an optical signal reflected from the target site; (g) reflecting a first portion of the optical signal onto one of the image sensor or the camera while allowing a second portion of the optical signal to pass through to the other of the image sensor or the camera; and (h) using the image sensor to generate a first set of imaging data from the first portion of the optical signal and using the camera to generate a second set of imaging data from the second portion of the optical signal.
[0034] In some embodiments, a first portion of the light signal is reflected onto an image sensor, while a second portion of the light signal is allowed to pass through to the camera.
[0035] In some embodiments, a first portion of the light signal is reflected onto the camera, while a second portion of the light signal is allowed to pass through to the image sensor.
[0036] In some embodiments, the first set of imaging data comprises a laser speckle pattern.
[0037] In some embodiments, the second set of imaging data comprises photographs or video images.
[0038] Another aspect of the disclosure provides a non-transitory computer-readable medium comprising machine-executable code that, upon execution by one or more computer processors, implements any of the methods described above or elsewhere herein.
[0039] Another aspect of the present disclosure provides a system comprising one or more computer processors and a computer memory coupled thereto, the computer memory comprising machine executable code that, when executed by the one or more computer processors, implements any of the methods described above or elsewhere herein.
[0040] Additional aspects and advantages of the present disclosure will become readily apparent to those skilled in the art from the following detailed description, in which only illustrative embodiments of the disclosure are shown and described. As will be realized, the present disclosure is capable of other and different embodiments, and its several details are capable of modification in various obvious respects, all without departing from the present disclosure. Thus, the drawings and description are to be regarded as illustrative in nature, and not as restrictive. The present invention provides, for example, the following: (Item 1) An optical adapter, comprising: a housing having (1) a first end configured to releasably couple to a speculum; and (2) a second end configured to releasably couple to a camera; an image sensor within the housing; an optical assembly disposed within the housing; Equipped with an optical adapter, the optical system assembly configured to (i) receive an optical signal reflected from a target site within a subject's body and transmitted through the speculum, and (ii) reflect a first portion of the optical signal onto one of the image sensor or the camera while allowing a second portion of the optical signal to pass through to the other of the image sensor or the camera. (Item 2) Item 2. The optical adapter of item 1, wherein the image sensor is releasably coupled to the housing. (Item 3) 2. The optical adapter of claim 1, wherein the image sensor is configured to generate a first set of imaging data from a first portion of the optical signal, and the camera is configured to generate a second set of imaging data from a second portion of the optical signal. (Item 4) Item 3. The optical adapter of item 2, wherein the first set of imaging data comprises a laser speckle pattern and the second set of imaging data comprises photographic or video images. (Item 5) 2. The optical adapter of item 1, wherein the image sensor is used for laser speckle imaging. (Item 6) Item 2. The optical adapter of item 1, wherein the optical assembly comprises a beam splitter. (Item 7) 7. The optical adapter of claim 6, wherein the beam splitter comprises a dichroic mirror. (Item 8) 2. The optical adapter of claim 1, wherein the optical system assembly is configured to reflect the first portion of the optical signal onto the image sensor while allowing the second portion of the optical signal to pass through to the camera. (Item 9) Item 9. The optical adapter of item 8, wherein the optical assembly comprises a short-pass dichroic mirror. (Item 10) 2. The optical adapter of claim 1, wherein the optical system assembly is configured to reflect the first portion of the optical signal onto the camera while allowing the second portion of the optical signal to pass through to the image sensor. (Item 11) Item 11. The optical adapter of item 10, wherein the optical assembly comprises a long-pass dichroic mirror. (Item 12) 2. The optical adapter of claim 1, wherein the first portion of the optical signal comprises backscattered light generated when the target site is illuminated with coherent laser light transmitted through the speculum. (Item 13) Item 13. The optical adapter of item 12, wherein the coherent laser light is provided from a single laser source having a substantially single wavelength. (Item 14) Item 13. The optical adapter of item 12, wherein the coherent laser light is provided from a plurality of laser sources having a plurality of different wavelengths. (Item 15) 2. The optical adapter of claim 1, wherein the second portion of the optical signal comprises reflected light generated when the target site is illuminated with white light transmitted through the speculum. (Item 16) Item 14. The optical adapter of item 13, wherein the single wavelength is located in the invisible spectrum. (Item 17) Item 15. The optical adapter of item 14, wherein the plurality of different wavelengths are located in the non-visible spectrum. (Item 18) Item 16. The optical adapter of item 15, wherein the reflected light is in the visible spectrum. (Item 19) Item 2. The optical adapter of item 1, wherein the first end of the housing is configured to releasably couple to the speculum using a quick release mechanism. (Item 20) 20. The optical adapter of claim 19, wherein the quick release mechanism is configured to releasably couple the optical adapter to various types of specula having different sizes. (Item 21) 20. The optical adapter of claim 19, wherein the quick release mechanism is configured to allow a user to releasably couple the first end of the housing to the speculum without the use of tools. (Item 22) 20. The optical adapter of claim 19, wherein the quick release mechanism is configured to allow a user to releasably couple the first end of the housing to the speculum in less than 30 seconds. (Item 23) 2. The optical adapter of claim 1, wherein the second end of the housing is configured to releasably couple to the camera using a quick release mechanism. (Item 24) Item 24. The optical adapter of item 23, wherein the quick release mechanism is configured to releasably couple the optical adapter to various types of cameras having different sizes. (Item 25) 24. The optical adapter of claim 23, wherein the quick release mechanism is configured to allow a user to releasably couple the second end of the housing to the camera without the use of tools. (Item 26) 24. The optical adapter of claim 23, wherein the quick release mechanism is configured to allow a user to releasably couple the second end of the housing to the camera in less than 30 seconds. (Item 27) Item 2. The optical adapter of item 1, wherein the optical system assembly further comprises a focusing device for the image sensor. (Item 28) 2. The optical adapter of claim 1, wherein the optical system assembly further comprises: (i) a first focusing device for the image sensor; and (ii) a second focusing device for the camera. (Item 29) 30. The optical adapter of item 28, wherein the first focusing device and the second focusing device are operably coupled to each other such that focusing for the image sensor and the camera can be performed in parallel. (Item 30) 30. The optical adapter of claim 28, wherein the first focusing device and the second focusing device are operably coupled to each other via a gear transmission mechanism. (Item 31) Item 30. The optical adapter of item 28, wherein the first focusing device and the second focusing device are provided separately and configured to be used independently of each other. (Item 32) Item 1, wherein the speculum is configured to: (1) receive a combined light beam from an illumination source; and (2) direct the combined light beam onto the target site within the subject's body. (Item 33) Item 2. The optical adapter of item 1, wherein the first end and the second end share a common longitudinal axis. (Item 34) Item 34. The optical adapter of item 33, wherein the first end and the second end are provided on opposite sides of the housing. (Item 35) Item 2. The optical adapter of item 1, wherein the first end and the second end do not share a common longitudinal axis. (Item 36) Item 36. The optical adapter of item 35, wherein the first end and the second end are provided on substantially perpendicular sides of the housing. (Item 37) Item 2. The optical adapter of item 1, wherein the image sensor and the camera have different optical axes. (Item 38) 2. The optical adapter of item 1, wherein an optical axis of the image sensor is perpendicular to an optical axis of the camera. (Item 39) 2. The optical adapter of claim 1, wherein the image sensor is configured to releasably couple to a surface of the housing, the surface being substantially perpendicular to the first end or the second end of the housing. (Item 40) 40. The optical adapter of claim 39, wherein the image sensor comprises a casing configured to releasably couple to the surface of the housing. (Item 41) Item 14. The optical adapter of item 1, wherein the image sensor is disposable and configured for a single use in a medical imaging procedure. (Item 42) Item 14. The optical adapter of item 1, wherein the image sensor is configured to be reusable for multiple medical imaging procedures. (Item 43) An imaging kit, comprising: The optical adapter according to item 1, Illumination source and Equipped with The illumination source is configured to transmit the combined light beam to the speculum for directing the combined light beam onto the target site within the subject's body. (Item 44) 1. A method, comprising: combining the white light with the coherent laser light to generate a combined light beam; providing the combined light beam to a microscope; using the speculum to direct the combined light beams onto a target site within a subject's body; receiving, via the speculum, a light signal reflected from the target site; reflecting a first portion of the optical signal onto one of (i) an image sensor in an optical adapter or (ii) a camera while allowing a second portion of the optical signal to pass through to the other of (i) the image sensor or (ii) the camera; Including, The method of claim 1, wherein the optical adapter is configured to releasably couple to both the speculum and the camera. (Item 45) Item 45. The method of item 44, wherein the first portion of the light signal is reflected onto the image sensor while the second portion of the light signal is allowed to pass through to the camera. (Item 46) Item 45. The method of item 44, wherein the first portion of the light signal is reflected onto the camera while the second portion of the light signal is allowed to pass through to the image sensor. (Item 47) Item 45. The method of item 44, wherein the optical adapter is disposed between the speculum and the camera when the optical adapter is releasably coupled to the speculum and the camera. (Item 48) Item 45. The method of item 44, wherein the speculum and the camera are releasably coupled to orthogonal sides of the optical adapter. (Item 49) 1. A method, comprising: An optical adapter comprising a housing, an image sensor within the housing; releasably coupling a first end of the housing to a speculum; releasably coupling a second end of the housing to a camera; providing a combined light beam to the speculum, the combined light beam comprising white light combined with coherent laser light; using the speculum to direct the combined light beams onto a target site within a subject's body; receiving, via the speculum, a light signal reflected from the target site; reflecting a first portion of the optical signal onto one of the image sensor or the camera while allowing a second portion of the optical signal to pass through to the other of the image sensor or the camera; using the image sensor to generate a first set of imaging data from the first portion of the optical signal, and using the camera to generate a second set of imaging data from the second portion of the optical signal. A method comprising: (Item 50) 50. The method of claim 49, wherein the first portion of the light signal is reflected onto the image sensor while the second portion of the light signal is allowed to pass through to the camera. (Item 51) 50. The method of claim 49, wherein the first portion of the light signal is reflected onto the camera while the second portion of the light signal is allowed to pass through to the image sensor. (Item 52) Item 50. The method of item 49, wherein the first set of imaging data comprises a laser speckle pattern. (Item 53) 50. The method of claim 49, wherein the second set of imaging data comprises photographs or video images.
[0041] (Incorporated by reference) All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent that the publications and patents or patent applications incorporated by reference conflict with the disclosure contained herein, the specification is intended to supersede and / or precede any such conflicting material. [Brief description of the drawings]
[0042] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings (also referred to herein as "Figure" and "FIG.") in which:
[0043] [Figure 1A] FIG. 1A diagrammatically illustrates a system for medical imaging, according to some embodiments.
[0044] [Figure 1B] FIG. 1B diagrammatically illustrates a speculum assembly, according to some embodiments.
[0045] [Figure 2A] 2A, 2B, 2C, and 2D diagrammatically illustrate examples of an optical adapter operatively coupled to a speculum assembly, according to some embodiments. [Figure 2B]2A, 2B, 2C, and 2D diagrammatically illustrate examples of an optical adapter operatively coupled to a speculum assembly, according to some embodiments. [Figure 2C] 2A, 2B, 2C, and 2D diagrammatically illustrate examples of an optical adapter operatively coupled to a speculum assembly, according to some embodiments. [Figure 2D] 2A, 2B, 2C, and 2D diagrammatically illustrate examples of an optical adapter operatively coupled to a speculum assembly, according to some embodiments.
[0046] [Figure 3A] 3A, 3B, and 3C diagrammatically illustrate an exemplary ecosystem of the subject optical adapter and speculum device. [Figure 3B] 3A, 3B, and 3C diagrammatically illustrate an exemplary ecosystem of the subject optical adapter and speculum device. [Figure 3C] 3A, 3B, and 3C diagrammatically illustrate an exemplary ecosystem of the subject optical adapter and speculum device.
[0047] [Figure 4] FIG. 4 diagrammatically illustrates an exemplary flow chart of a method for medical imaging, according to some embodiments.
[0048] [Diagram 5] FIG. 5 diagrammatically illustrates different exemplary flow charts of methods for medical imaging, according to some embodiments.
[0049] [Figure 6] FIG. 6 diagrammatically illustrates another different exemplary flow chart of a method for medical imaging, according to some embodiments.
[0050] [Figure 7]7A, 7B, 7C, and 7D illustrate comparative images of tissue sites acquired by the subject systems for medical imaging and existing dye-based angiography devices, according to some embodiments.
[0051] [Figure 8] 8A, 8B, 8C, and 8D illustrate comparative methods based on existing surgical procedures and the subject systems for medical imaging, according to some embodiments.
[0052] [Figure 9] 9 and 10 diagrammatically illustrate machine learning algorithms operatively coupled to the subject systems for medical imaging, according to some embodiments. [Figure 10] 1 and 2 diagrammatically illustrate machine learning algorithms operatively coupled to the subject systems for medical imaging, according to some embodiments.
[0053] [Figure 11] FIG. 11 diagrammatically illustrates a computer system programmed or otherwise configured to implement the methods provided herein.
[0054] [Figure 12] FIG. 12 illustrates an example imaging system in accordance with one or more embodiments.
[0055] [Figure 13] FIG. 13 illustrates a simplified block diagram of the imaging system of FIG. 12, according to some embodiments.
[0056] [Figure 14] 14A, 14B, and 14C illustrate screenshots of an exemplary standard RGB surgical image, a laser speckle contrast image, and a laser speckle contrast image overlaid on the standard image, according to some embodiments.
[0057] [Figure 15] FIG. 15 illustrates a simplified block diagram of an exemplary camera for depth and laser speckle imaging, according to some embodiments.
[0058] [Figure 16] FIG. 16 illustrates a simplified block diagram of an exemplary camera for hyperspectral, depth, and laser speckle imaging, according to some embodiments.
[0059] [Figure 17] FIG. 17 illustrates a simplified block diagram of an exemplary computer node that may be used in connection with the medical imaging systems disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0060] (Detailed Description) While various embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the invention. It is understood that various alternatives to the embodiments of the invention described herein may be employed.
[0061] Whenever the terms "at least," "greater than," or "greater than or equal to" precede a first number in a series of two or more numerical values, the terms "at least," "greater than," or "greater than or equal to" apply to each and every number in the series. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.
[0062] Whenever the term "less than", "below", or "less than or equal to" precedes a first number in a series of two or more numbers, the term "less than", "below", or "less than or equal to" applies to each and every number in the series. For example, less than or equal to 3, less than or equal to 2, or less than or equal to 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.
[0063] As used herein, the term "perfusion" generally refers to the movement of fluid to an organ or tissue through the circulatory or lymphatic system. In some instances, perfusion may refer to the delivery of blood at the arterial or capillary level, where an exchange of oxygen and / or nutrients between blood and tissue occurs. In some cases, perfusion may comprise the flow rate of fluid, the volume of fluid present or traversing the target tissue site, the pattern of fluid flow channels at the target tissue site, or a combination thereof. In some cases, the perfusion of a liquid of interest may increase, decrease, or remain substantially the same during one or more imaging processes. In some cases, any change in the flow rate or volume of perfusion fluid may indicate (i) one or more biological events or (ii) one or more surgical events that occur upstream, downstream, or substantially at the target tissue site. When quantified, perfusion may be measured in cubic meters (m) per second per kilogram. 3 Perfusion may be measured as the rate at which blood is delivered to a tissue or the volume of blood (blood flow) per unit time per unit tissue mass, in units of millimeters per second per kg (mL / sec / kg) or millimeters per gram per minute (mL / min / g). The degree of perfusion may be indicative of one or more health conditions, e.g., cardiovascular disease, such as coronary artery disease, cerebrovascular disease, peripheral artery disease, etc.
[0064] The term "real time" or "real-time," as used interchangeably herein, generally refers to an event (e.g., an operation, process, method, technique, calculation, computation, analysis, visualization, optimization, etc.) that is performed using recently obtained (e.g., collected or received) data. In some cases, a real-time event may be performed nearly instantly or within a sufficiently short period of time, such as within at least 0.0001 milliseconds (ms), 0.0005 ms, 0.001 ms, 0.005 ms, 0.01 ms, 0.05 ms, 0.1 ms, 0.5 ms, 1 ms, 5 ms, 0.01 s, 0.05 s, 0.1 s, 0.5 s, 1 s, or more. In some cases, a real-time event may be performed nearly instantly or within a sufficiently short period of time, such as within up to 1 second, 0.5 seconds, 0.1 seconds, 0.05 seconds, 0.01 seconds, 5 ms, 1 ms, 0.5 ms, 0.1 ms, 0.05 ms, 0.01 ms, 0.005 ms, 0.001 ms, 0.0005 ms, 0.0001 ms, or less.
[0065] Various limitations of currently available medical imaging systems are now recognized. Conventional medical imaging systems (e.g., speculum such as endoscopes) may use a single light signal (e.g., white light) to visualize a target site (e.g., an internal portion) within a subject. Such visualization may be limited to a two-dimensional representation of the surface of the target site (e.g., tissue of interest). In some cases, conventional medical procedures may utilize additional imaging techniques or settings to visualize additional features of the target site, such as internal processes such as perfusion (e.g., blood flow). In one example, one or more dyes (e.g., ICG dyes) may be used in conjunction with endoscopy to visualize blood flow. In another example, a separate laser speckle imaging setting may be used to visualize additional features of the target site, such as blood flow. However, the additional imaging techniques or settings may (i) limit the time frame in which an operator may visualize changes in the additional features, and / or (ii) require additional personnel (e.g., technicians or medical personnel) on-site to manage components and processes.
[0066] The optical adapter of the present disclosure may enable visualization of structures or features (e.g., blood flow) within, near, and / or beneath the surface of the target site that would normally be invisible to the human eye or other speculum assemblies. The optical adapter of the present disclosure may enable visualization of one or more anatomical structures and / or physiological features or functions. The optical adapter of the present disclosure may be used for physiological, pathological, morphological, and / or anatomical visualization of various structures, features, and / or functions within a subject's body. The optical adapter of the present disclosure may make the invisible visible. The optical adapter of the present disclosure may help make the invisible visible. The optical adapter as a single setup with an existing speculum assembly (e.g., an endoscope with an off-the-shelf camera) may enable multiple different imaging modalities. For example, the optical adapter may provide speckle imaging capabilities as well as photographic images and / or video in a single setup. In such cases, the optical adapter may allow the user to switch between different visualization modes, for example: (i) white light-based video only, (ii) laser speckle imaging only, and (iii) both white light-based video and laser speckle imaging.
[0067] The optical adapters of the present disclosure may enable visualization of perfusion (e.g., blood perfusion) at a tissue site of interest in substantially real-time, as compared to delayed visualization of perfusion data from dye-based angiography. In one example, a real-time event may include visualization of blood perfusion at a tissue site, where a data set (e.g., one or more optical signals) indicative of blood perfusion is captured by a tool (e.g., an image sensor) and the data is transmitted to a display for visualization to a user. In another example, a real-time event may include combining two different data sets indicative of different features of a target site for simultaneous visualization on a display.
[0068] By enhancing the flexibility and usability of existing medical imaging equipment, the optical adapter of the present disclosure may not require or incur expensive capital equipment upgrades in healthcare environments. By replacing existing dye-based imaging systems, the optical adapter of the present disclosure may reduce the footprint of an operating room.
[0069] The optical adapter of the present disclosure may be usable for a number of medical applications, such as general surgery, neurosurgical procedures, orthopedic procedures, and spinal procedures. The optical adapter of the present disclosure may be applicable to a wide variety of endoscope-based procedures, including, but not limited to, cholecystectomy (e.g., 1,200,000 procedures per year), hysterectomy (e.g., 575,000 procedures per year), thyroidectomy (e.g., 150,500 procedures per year), and gastrectomy (e.g., 225,000 procedures per year).
[0070] In one aspect, the present disclosure provides an optical adapter for medical imaging. The optical adapter may be configured to be operatively coupled to a speculum assembly for medical imaging. The optical adapter may enhance one or more functions (e.g., imaging functions) of the speculum assembly. The optical adapter may introduce one or more additional functions (e.g., imaging functions) to the speculum assembly. The optical adapter may enable a user (e.g., a medical professional such as a physician, field nurse, nurse, imaging specialist, etc.) to visualize and / or analyze a target site of interest, such as a patient's internal tissue, in one or more ways that any conventional speculum assembly alone cannot.
[0071] The optical adapter (or at least a portion of the optical adapter) may be reusable and interchangeable with different speculum assemblies. In some cases, the optical adapter may enable a speculum from a first speculum assembly to be operatively coupled to a camera of a different speculum assembly, thereby further diversifying the imaging modalities of an existing speculum assembly.
[0072] The speculum assembly may be configured to visualize the external and / or internal surfaces of tissue of a subject (e.g., skin or internal organs). The speculum assembly may be used to (i) inspect (e.g., visually inspect) tissue of a subject, (ii) diagnose and / or assist in medical intervention (e.g., treatment such as surgery). In some cases, the speculum assembly may be an endoscope. Examples of endoscopes may include, but are not limited to, cystoscopes (bladder), nephroscopes (kidneys), bronchoscopes (bronchi), arthroscopes (joints), and colonoscopes (colon), and laparoscopes (abdomen or pelvis).
[0073] The optical adapter may be configured to be operatively coupled to at least one, two, three, four, five, or more speculum assemblies. The optical adapter may be configured to be operatively coupled to up to five, four, three, two, or one speculum assemblies. The optical adapter may be disposable and configured for a single use in a medical imaging procedure. Alternatively, the optical adapter may be configured to be reusable for multiple medical imaging procedures. The multiple medical imaging procedures may be for the same subject (e.g., the same patient) or for multiple different subjects. The optical adapter may be reusable for at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, 1,000, or more medical imaging procedures. The optical adapter may be reusable for up to 1,000, 500, 400, 300, 200, 100, 90, 80, 70, 60, 50, 40, 30, 20, 10, 9, 8, 7, 6, 5, 4, 3, or 2 medical imaging procedures. In some cases, the optical adapter may be autoclavable for sterile subsequent use.
[0074] The optical adapter may be configured to receive one or more optical signals from a target site of a subject. The optical adapter may be configured to receive at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more optical signals from the target site. The optical adapter may be configured to receive up to 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 optical signals from the target site. The one or more optical signals may be reflected or emitted from the target site upon exposure or illumination of the target site to the optical beam. In some examples, the native tissue of the target site or one or more dyes introduced into the target site may be involved in reflecting or emitting the one or more optical signals. Alternatively, or in addition, the one or more optical signals may be emitted by the target site without exposure to the optical beam. In some examples, the target site may emit at least a portion of the electromagnetic spectrum, such as infrared radiation.
[0075] Infrared radiation emitted by the target site may range from about 1 millimeter (mm) from the red edge of the visible spectrum at wavelengths of about 700 nanometers (nm), which roughly equates to frequencies of about 430 terahertz (THz) to about 300 gigahertz (GHz). Regions within the infrared spectrum may include, for example, near infrared (NIR), short wavelength infrared (SWIR), mid-wavelength infrared (MWIR), intermediate infrared (IIR), long wavelength infrared (LWIR), and far infrared (FIR). Near infrared signals may range from about 0.7 micrometers (μm) to about 1.4 μm, which roughly equates to frequencies of about 214 THz to about 400 THz. Long wavelength infrared may range from about 8 μm to about 15 μm, which roughly equates to frequencies of about 20 THz to about 37 THz.
[0076] The optical beam may comprise a single light beam from a single light source. Alternatively, the optical beam may be a combined light beam comprising multiple light beams. In some cases, the multiple light beams may be directed to the target site from the same direction. Alternatively, the multiple light beams may be directed to the target site from different directions. In some cases, the multiple light beams may comprise (i) white light and (ii) one or more laser beams. The multiple light beams may be directed from a single optical source or multiple optical sources. The one or more laser beams may include at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more laser beams. The one or more laser beams may include up to 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 laser beams.
[0077] Laser beams of various wavelengths may be selected based on a desired penetration depth of the tissue site. Alternatively, or in addition, laser beams of various wavelengths may be selected based on compositions of interest (e.g., one or more molecules, compounds, or chemicals) present or expected to be present at the tissue site. In an example, a first laser beam having a first wavelength may be selected to detect oxygenated blood, while a second laser beam having a second wavelength may be selected to detect deoxygenated blood. A user of the subject systems and methods provided herein may be able to select one or more laser wavelengths of interest depending on such parameters of the tissue site.
[0078] The speculum assembly may include a speculum and a camera. The speculum and camera may be operatively coupled to one another, for example, electronically or mechanically. The speculum and camera may be releasably coupled to one another. The speculum may be configured to (1) receive a light beam from an illumination source and (2) direct the light beam onto a target site in the subject's body. In some cases, the speculum may be configured to (1) receive a combined light beam from an illumination source and (2) direct the combined light beam onto a target site in the subject's body.
[0079] The optical adapter may include a housing having a first end and a second end, the first end may be configured to couple to a speculum of the speculum assembly, and the second end may be configured to couple to a camera of the speculum assembly. Any one of the couplings of the subject matter of this disclosure may utilize one or more coupling mechanisms such as, for example, magnets (e.g., electromagnets or permanent magnets), mechanical tethers (e.g., string or thread tethers), adhesives (e.g., solid, semi-solid, gel, viscous liquid, etc.), male-female fasteners (e.g., interlocking or interlocking fasteners, hook and hole, hook and loop such as Velcro®, a female nut that threads onto a male bolt, a male protrusion that inserts into a female recess in a LEGO block, a male threaded pipe that fits into a female threaded elbow in plumbing, a male Universal Serial Bus (USB) plug that inserts into a female USB socket, etc.), threaded couplings (e.g., with or without coaxial connectors), elastic couplings, gear couplings, hydrodynamic couplings, and other gripping mechanisms such as a robotic arm that operatively holds two or more components relative to one another. In some cases, (i) the coupling between the first end of the housing and the speculum, and / or (ii) the coupling between the second end of the housing and the camera may be reversible or irreversible. In some examples, the coupling may be a releasable coupling.
[0080] In some cases, the first end of the housing may be configured to releasably couple to the speculum using a quick release mechanism (e.g., a snap fit, a latch, etc.). The quick release mechanism may be configured to releasably couple the optical adapter to various types of speculums having different sizes. In one example, the first end may include different sections with varied dimensions (e.g., different radial dimensions) configured to releasably couple to different speculums having different sizes. In another example, the first end may include an adjustable opening mechanism with an adjustable opening diameter to accommodate different speculums having different sizes. The quick release mechanism may be configured to rapidly move between a locked position (i.e., a coupled position) and a released position (i.e., a non-coupled position) in response to one or more movements of the quick release mechanism, such as a single non-repeatable movement (e.g., lateral or rotation) of the quick release mechanism. The quick release mechanism may be configured to rapidly move between a locked position and a released position in response to a user command via a switch, e.g., a mechanical switch disposed on the optical adapter or the speculum.
[0081] The quick release mechanism may be configured to allow a user to releasably couple the first end of the housing to the speculum without the use of a tool. Alternatively, the quick release mechanism may be configured to allow a user to releasably couple the first end of the housing to the speculum with one or more tools, e.g., one or more keys for operatively coupling to the quick release mechanism to activate the release of the quick release mechanism. The quick release mechanism may be configured to allow a user to releasably couple the first end of the housing to the speculum in less than 60 seconds. The quick release mechanism may be configured to allow a user to releasably couple the first end of the housing to the speculum in less than 60, 55, 50, 45, 40, 35, 30, 25, 20, 15, 10, 5, or fewer seconds.
[0082] In some cases, the coupling between the first end of the housing and the speculum may not utilize a quick release mechanism. In some cases, the speculum may be threaded onto the first end of the housing, thereby preventing quick release of the speculum from the first end of the housing. In some instances, the coupling surface of the first end of the housing may substantially mimic the structure of the coupling surface of a camera, which is originally configured to couple to the speculum.
[0083] In some cases, the second end of the housing may be configured to releasably couple to a camera of the speculum assembly using a quick release mechanism (e.g., a snap fit, a latch, etc.). The quick release mechanism may be configured to releasably couple the optical adapter to various types of cameras having different sizes. In one example, the second end may include different sections with varied dimensions (e.g., different radial dimensions) configured to be releasably coupled to different cameras having different sizes. In another example, the second end may include an adjustable opening mechanism with an adjustable opening diameter to accommodate different cameras having different sizes. The quick release mechanism may be configured to move rapidly between a locked position (i.e., a coupled position) and a released position (i.e., an uncoupled position) in response to one or more movements of the quick release mechanism, such as a single non-repeatable movement (e.g., lateral or rotation) of the quick release mechanism. The quick release mechanism may be configured to move rapidly between a locked position and a released position in response to a user command via a switch, e.g., a mechanical switch disposed on the optical adapter or the camera.
[0084] The quick release mechanism may allow for precision coupling of two components, such as (i) a first end of the housing and a speculum, or (ii) a second end of the housing and a camera. The precision coupling may provide an optimal optical path between the two components. The precision coupling may be achieved within an accuracy of less than about 20 μm. In some cases, the precision coupling may be achieved within an accuracy of up to about 100 μm, 90 μm, 80 μm, 70 μm, 60 μm, 50 μm, 40 μm, 30 μm, 20 μm, 10 μm, 9 μm, 8 μm, 7 μm, 6 μm, 5 μm, 4 μm, 3 μm, 2 μm, 1 μm, 900 nm, 800 nm, 700 nm, 600 nm, 500 nm, 400 nm, 300 nm, 200 nm, 100 nm, 50 nm, or less.
[0085] The quick release mechanism may be configured to allow a user to releasably couple the second end of the housing to the camera without the use of tools. Alternatively, the quick release mechanism may be configured to allow a user to releasably couple the second end of the housing to the camera with one or more tools, e.g., one or more keys for operatively coupling to the quick release mechanism to activate the release of the quick release mechanism. The quick release mechanism may be configured to allow a user to releasably couple the second end of the housing to the camera in less than 60 seconds. The quick release mechanism may be configured to allow a user to releasably couple the second end of the housing to the camera in less than 60, 55, 50, 45, 40, 35, 30, 25, 20, 15, 10, 5, or fewer seconds.
[0086] In some cases, the coupling between the second end of the housing and the camera may not utilize a quick release mechanism. In some cases, the camera may be threaded onto the second end of the housing, thereby preventing quick release of the camera from the second end of the housing. In some instances, the coupling surface of the second end of the housing may substantially mimic the structure of the coupling surface of the speculum, which is originally configured to couple to the camera.
[0087] The housing may include one or more biologically acceptable and / or compatible materials suitable for medical applications, depending on the particular application and / or the preferences of the medical practitioner. For example, the components of the housing may be made of polyvinyl chloride, polyvinylidene chloride, low density polyethylene, linear low density polyethylene, polyisobutene, poly(ethylene-vinyl acetate) copolymer, lightweight aluminum foil, and combinations thereof, stainless steel alloys, commercially pure titanium, titanium alloys, silver alloys, copper alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, stainless steel alloys, superelastic metal alloys (e.g., superelastic plastic metals such as Nitinol, GUM METAL® manufactured by Toyota Material Incorporated, Japan), ceramics such as calcium phosphate and composites thereof (e.g., SKELITE manufactured by Biologix Inc., and the like). TM The material may include or be made from materials such as thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK), and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaS04 polymeric rubber, polyethylene terephthalate (PET), textiles, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubber, polyolefin rubber, hydrogels, semi-rigid and rigid materials, elastomers, rubber, thermoplastic elastomers, thermoset elastomers, elastomer composites, polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, rigid polymers including epoxies, glass, and combinations thereof.
[0088] At least a portion of the housing can be opaque, translucent, or transparent. In some cases, the housing can be opaque and configured to block any external light from (i) entering through the housing and into one or more components within the housing, and (ii) interfering with one or more optical signals from a target site of interest that are received by the optical adapter.
[0089] The pressure inside the housing of the optical adapter may be approximately the same as the ambient pressure (e.g., atmospheric pressure). Alternatively, the pressure inside the housing may be controlled (or adjusted, e.g., manually or automatically) such that the pressure inside the housing is lower or higher than the ambient pressure. The temperature inside the housing of the optical adapter may be approximately the same as the ambient temperature (e.g., room temperature). Alternatively, the temperature inside the housing may be controlled (or adjusted, e.g., manually or automatically) such that the temperature inside the housing is lower or higher than the ambient temperature. The humidity inside the housing of the optical adapter may be approximately the same as the ambient humidity. Alternatively, the humidity inside the housing may be controlled (or adjusted, e.g., manually or automatically) such that the humidity inside the housing is lower or higher than the ambient humidity. In some examples, the pressure, temperature, and / or humidity of the optical adapter may be adjusted for optimal functioning of the optical adapter.
[0090] The first end of the housing and the speculum may be directly coupled to one another. Alternatively, the first end of the housing and the speculum may be operatively coupled to one another via one or more couplers. The second end of the housing and the camera may be directly coupled to one another. Alternatively, the second end of the housing and the camera may be operatively coupled to one another via one or more couplers (e.g., coupling rings). In some cases, the first end of the coupler may be configured to couple (e.g., releasably couple) to the speculum and the second end of the coupler may be configured to couple (e.g., releasably couple) to the first end of the housing. In some cases, the first end of the coupler may be configured to couple (e.g., releasably couple) to the camera and the second end of the coupler may be configured to couple (e.g., releasably couple) to the second end of the housing.
[0091] The first and second ends of the housing may share a common longitudinal axis. In some cases, the first and second ends may be provided on opposing sides of the housing. In such cases, when the optical adapter is operatively coupled to the speculum assembly, the speculum and camera of the speculum assembly may be disposed on opposing sides of the housing of the optical adapter. Alternatively, the first and second ends of the housing may not share a common longitudinal axis. In such cases, the first and second ends may be provided on orthogonal sides of the housing.
[0092] The optical adapter may include one or more sensors. The optical adapter may include at least one, two, three, four, five, or more sensors. The optical sensor may include up to five, four, three, two, or one sensor. Examples of the one or more sensors may include, but are not limited to, a pressure sensor, a temperature sensor, an optical sensor (e.g., an image sensor), a gas composition sensor, a membrane or diaphragm sensor, a thin film sensor, a resistive or capacitive sensor, or other types of sensing devices. The one or more sensors may be permanently coupled to the optical adapter or, alternatively, may be removable from the optical adapter.
[0093] In some cases, the optical adapter may include an image sensor. The image sensor may be part of the optical adapter. The image sensor may be permanently coupled to the optical adapter or, alternatively, may be removable from the optical adapter. In some examples, the image sensor may be configured to releasably couple to a housing of the optical adapter. The image sensor may be configured to releasably couple to a surface of the housing, where the surface may be substantially orthogonal to the first end and / or the second end of the housing. In such cases, the image sensor may include a casing configured to releasably couple to a surface of the housing. Alternatively, the surface may not be substantially orthogonal to the first end and / or the second end of the housing. The image sensor may be coupled (e.g., releasably coupled) to the housing using one or more of the coupling mechanisms discussed above.
[0094] The image sensor may be disposable and configured for a single use in a medical imaging procedure. Alternatively, the image sensor may be configured to be reusable for multiple medical imaging procedures. The multiple medical imaging procedures may be for the same subject (e.g., the same patient) or for multiple different subjects. The image sensor may be reusable for at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, 1,000, or more medical imaging procedures. The image sensor may be reusable for up to 1,000, 500, 400, 300, 200, 100, 90, 80, 70, 60, 50, 40, 30, 20, 10, 9, 8, 7, 6, 5, 4, 3, or 2 medical imaging procedures. In some cases, the image sensor may be autoclavable for sterile subsequent use.
[0095] The image sensor may be configured to receive optical signals from a target site of the subject for analysis and / or visualization of the target site of the subject. Such optical signals may be reflected or emitted from the target site. The image sensor may be configured to detect optical signals from the target site, convert the detected optical signals, and generate an image indicative of the target tissue. The generated image may be one-dimensional or multi-dimensional (e.g., two-dimensional, three-dimensional, etc.). Alternatively, the image sensor may be operatively coupled to a processor. In such a case, the image sensor may be configured to detect optical signals from the target site and convert the detected optical signals into digital signals. The image sensor may be further configured to transmit the digital signals to the processor, which is capable of generating an image indicative of the target tissue.
[0096] Examples of image sensors may include, but are not limited to, charge-coupled devices (CCDs), metal-oxide semiconductors (MOSs) (e.g., complementary MOS, or CMOS), modifications thereof, functional variations thereof, and modifications thereof. The optical adapter may include at least one, two, three, four, five, or more image sensors. The optical adapter may include up to five, four, three, two, or one image sensors.
[0097] The casing of the image sensor may include one or more biologically acceptable and / or compatible materials suitable for medical applications, depending on the particular application and / or the preferences of the medical practitioner. For example, the casing components may be made of polyvinyl chloride, polyvinylidene chloride, low density polyethylene, linear low density polyethylene, polyisobutene, poly(ethylene-vinyl acetate) copolymer, lightweight aluminum foil, and combinations thereof, stainless steel alloys, commercially pure titanium, titanium alloys, silver alloys, copper alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, stainless steel alloys, superelastic metal alloys (e.g., superelastic plastic metals such as Nitinol, GUM METAL® manufactured by Toyota Material Incorporated, Japan), ceramics such as calcium phosphate and composites thereof (e.g., SKELITE manufactured by Biologix Inc., and the like). TMThe optical adapter housing and the image sensor casing may include or be made of materials such as thermoplastics such as polyaryletherketone (PAEK), polyetheretherketone (PEEK), polyetherketoneketone (PEKK), and polyaryletherketone (PAEK), including polyetherketone (PEK), carbon-PEEK composites, PEEK-BaS04 polymeric rubber, polyethylene terephthalate (PET), fabrics, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubber, polyolefin rubber, hydrogels, semi-rigid and rigid materials, elastomers, rubber, thermoplastic elastomers, thermoset elastomers, elastomer composites, polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, rigid polymers including epoxies, glass, and combinations thereof. The optical adapter housing and the image sensor casing may be made of the same or different materials.
[0098] At least a portion of the casing can be opaque, translucent, or transparent. In some cases, the casing can be opaque and configured to block any external light from (i) entering through the casing and into one or more components within the casing (e.g., the imaging sensing mechanism of an image sensor such as a CCD or CMOS) and (ii) interfering with one or more optical signals directed from a target site of the subject toward the image sensor.
[0099] The image sensor and the camera may have different optical axes. The image sensor optical axis and the camera optical axis may intersect at an angle of at least 1 degree, 2 degrees, 3 degrees, 4 degrees, 5 degrees, 6 degrees, 7 degrees, 8 degrees, 9 degrees, 10 degrees, 20 degrees, 30 degrees, 40 degrees, 50 degrees, 60 degrees, 70 degrees, 80 degrees, 90 degrees, or more. The image sensor optical axis and the camera optical axis may intersect at an angle of up to 90 degrees, 80 degrees, 70 degrees, 60 degrees, 50 degrees, 40 degrees, 30 degrees, 20 degrees, 10 degrees, 9 degrees, 8 degrees, 7 degrees, 6 degrees, 5 degrees, 4 degrees, 3 degrees, 2 degrees, 1 degree, or less. In some examples, the image sensor optical axis may be orthogonal to the camera optical axis. Alternatively, the image sensor and the camera may have parallel but different longitudinal optical axes.
[0100] The optical adapter may include an optical system assembly disposed within the housing. The optical system assembly may be configured to receive an optical signal transmitted through the speculum from the target site. In an example, the optical signal may be reflected from the target site within the subject's body. The optical system assembly may be further configured to reflect a first portion of the optical signal onto one of the image sensor and the camera while allowing a second portion of the optical signal to pass through to the other of the image sensor and the camera. In an example, the optical system assembly (e.g., including a short-pass dichroic mirror) may be configured to reflect the first portion of the optical signal onto the image sensor while allowing a second portion of the optical signal to pass through to the camera. In another example, the optical system assembly (e.g., including a long-pass dichroic mirror) may be configured to reflect the first portion of the optical signal onto the camera while allowing a second portion of the optical signal to pass through to the image sensor.
[0101] The first portion of the optical signal may comprise polarized light (e.g., backscattered light) generated when the target site is illuminated with laser light (e.g., coherent laser light). In some cases, the coherent laser light may be transmitted toward the target site through a speculum of the speculum assembly. The coherent laser light may be provided from a single laser source configured to emit coherent laser light having a single wavelength. Non-limiting examples of a single laser source may include a single mode laser, a laser diode with a volume holographic grating (VHG), or a laser with a laser clean-up filter (e.g., for narrow band pass). The coherent laser light may be provided from multiple laser sources having multiple different wavelengths. The multiple different wavelengths may be located within the invisible spectrum. The invisible spectrum may comprise wavelengths (i) above about 700 nm and / or (ii) below about 400 nm. In some cases, the invisible spectrum may comprise wavelengths (i) above about 770 nm and / or (ii) below about 390 nm. The second portion of the optical signal may comprise reflected light generated when the target site is illuminated with a different light (e.g., white light). In some cases, the different light may be white light comprising multiple wavelengths in the visible spectrum comprising wavelengths from about 400 nm to about 700 nm. In some cases, the white light may be transmitted towards the target site via the speculum. In some examples, the speculum may comprise multiple optical paths for directing the coherent laser light and the white light separately from one another. In some examples, the speculum may comprise a single optical path for directing a combined light comprising both the coherent laser light and the white light.
[0102] In some cases, the optical system assembly may include a beam splitter. The beam splitter may be configured to receive an optical signal from the target site, (i) reflect a first portion of the optical signal within a first range of the electromagnetic spectrum toward an image sensor, and (ii) allow a second portion of the optical signal within a second range of the electromagnetic spectrum to pass toward a camera of the speculum assembly. Alternatively, the beam splitter may be configured to receive an optical signal from the target site, (i) reflect a second portion of the optical signal within a second range of the electromagnetic spectrum toward a camera of the speculum assembly, and (ii) allow a first portion of the optical signal within the first range of the electromagnetic spectrum to pass toward the image sensor. Examples of beam splitters may include, but are not limited to, a half mirror, a dichroic beam splitter (e.g., a short-pass or long-pass dichroic mirror), or a multi-band beam splitter. In some examples, the beam splitter may be a cube with two prisms (e.g., two triangular glass prisms) positioned adjacent to each other.
[0103] The first and second electromagnetic spectrum ranges may be different. In some cases, the first portion of the optical signal may comprise one or more wavelengths from the invisible electromagnetic spectrum. The invisible electromagnetic spectrum may comprise one or more wavelengths from about 700 nm (or 0.7 μm) to about 1 mm (or 1,000 μm). Alternatively, or in addition, the invisible electromagnetic spectrum may comprise one or more wavelengths below 400 nm. In some cases, the second portion of the optical signal may comprise one or more wavelengths from the visible electromagnetic spectrum, ranging from about 400 nm (or 0.4 μm) to about 700 nm (or 0.7 μm).
[0104] The first portion of the optical signal may comprise one or more wavelengths from about 0.7 μm to about 1,000 μm. The first portion of the optical signal may comprise one or more wavelengths from at least about 0.7 μm. The first portion of the optical signal may comprise one or more wavelengths from up to about 1,000 μm. The first portion of the optical signal may be from about 0.7 μm to about 1 μm, from about 0.7 μm to about 5 μm, from about 0.7 μm to about 10 μm, from about 0.7 μm to about 50 μm, from about 0.7 μm to about 100 μm, from about 0.7 μm to about 500 μm, from about 0.7 μm to about 1,000 μm, from about 1 μm to about 5 μm, from about 1 μm to about 10 μm, from about 1 μm to about 50 μm, from about 1 μm to about 100 μm, from about 1 μm to about 500 μm, from about 1 μm to about 1,000 μm, from about 5 μm to about 10 μm, from about 5 μm to about 50 μm , about 5 μm to about 100 μm, about 5 μm to about 500 μm, about 5 μm to about 1,000 μm, about 10 μm to about 50 μm, about 10 μm to about 100 μm, about 10 μm to about 500 μm, about 10 μm to about 1,000 μm, about 50 μm to about 100 μm, about 50 μm to about 500 μm, about 50 μm to about 1,000 μm, about 100 μm to about 500 μm, about 100 μm to about 1,000 μm, or about 500 μm to about 1,000 μm. The first portion of the optical signal may comprise one or more wavelengths from about 0.7 μm, about 1 μm, about 5 μm, about 10 μm, about 50 μm, about 100 μm, about 500 μm, or about 1,000 μm.
[0105] The second portion of the optical signal may comprise one or more wavelengths from about 400 nm to about 700 nm. The second portion of the optical signal may comprise one or more wavelengths from at least about 400 nm. The second portion of the optical signal may comprise one or more wavelengths from up to about 700 nm. The second portion of the optical signal may comprise one or more wavelengths from about 400 nm to about 450 nm, about 400 nm to about 500 nm, about 400 nm to about 550 nm, about 400 nm to about 600 nm, about 400 nm to about 650 nm, about 400 nm to about 700 nm, about 450 nm to about 500 nm, about 450 nm to about 550 nm, about 450 nm to about 600 nm, about 450 nm to about 650 nm, about 450 nm to about 70 The second portion of the optical signal may comprise one or more wavelengths from about 400 nm, about 450 nm, about 500 nm, about 550 nm, about 600 nm, about 650 nm, about 500 nm to about 700 nm, about 550 nm to about 600 nm, about 550 nm to about 650 nm, about 550 nm to about 700 nm, about 600 nm to about 650 nm, about 600 nm to about 700 nm, or about 650 nm to about 700 nm.
[0106] In some cases, the beam splitter may be a polarizing beam splitter, e.g., a Wollaston prism, that may be configured to receive an optical signal from a target site and (i) reflect a first portion of the optical signal in a first polarization toward an image sensor and (ii) allow a second portion of the optical signal in a second polarization to pass toward a camera of the examination assembly.
[0107] The optical system assembly may not include any focusing device (e.g., an optical aperture such as an objective lens) in front of the beam splitter (e.g., before the optical signal reaches the beam splitter). Alternatively, the optical system assembly may include one or more focusing devices in front of the beam splitter. The optical system assembly may include at least one, two, three, four, five, or more focusing devices positioned in front of the beam splitter. The optical system assembly may include up to five, four, three, two, or one focusing devices positioned in front of the beam splitter.
[0108] In some cases, the image sensor may be configured to generate a first set of imaging data from a first portion of the optical signal, and the camera may be configured to generate a second set of imaging data from a second portion of the optical signal. The first set of imaging data and the second set of imaging data may be the same. In some examples, the first set of imaging data and the second set of imaging data may be the same to verify the validity of the collected data. Alternatively, the first set of imaging data and the second set of imaging data may be different, e.g., representing different characteristics of the target site. The first set of imaging data may complement the second set of imaging data. In some examples, the image sensor of the optical adapter may be used for laser speckle imaging. In such cases, the first set of imaging data may comprise one or more laser speckle patterns, and the second set of imaging data may comprise one or more photographic and / or video images. The first set of imaging data may comprise at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more laser speckle patterns. The first set of imaging data may comprise up to 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 laser speckle patterns.
[0109] Examples of features of the target site that may be detected by the image sensor and recorded in the first set of imaging data may include, but are not limited to, temperature, surface depth (i.e., tomography), blood flow, oxygen concentration (e.g., in blood), calcium potential, electrical potential, magnetic field, the presence of one or more markers of interest (e.g., immunological staining), etc.
[0110] A focusing device as used herein in this disclosure may comprise any lens (e.g., fisheye, elliptical, conical, etc.), reflector, optical system, concentrator, or other device capable of reflecting or focusing light. In an example, the focusing device may be a relay lens. The optical system assembly may comprise at least one focusing device (e.g., at least one, two, three, four, five, or more focusing devices) for the image sensor. The at least one focusing device may be disposed between the beam splitter and the image sensor. The optical system assembly may comprise at least one focusing device (e.g., at least one, two, three, four, five, or more focusing devices) for the camera. The at least one focusing device may be disposed between the beam splitter and the camera. In some cases, the optical system assembly may comprise at least one focusing device (e.g., at least one, two, three, four, five, or more focusing devices) disposed in the optical path between the speculum and the beam splitter.
[0111] In some cases, the optical system assembly may include (i) a first focusing device for the image sensor and (ii) a second focusing device for the camera. The first focusing device may be operatively coupled to a first focusing knob for adjusting the focusing degree of the first focusing device. The first focusing knob may be operatively coupled (e.g., electronically or mechanically coupled) to the first focusing device. In some examples, the first focusing knob may be mechanically coupled to the first focusing device via a first gear transmission mechanism comprising one or more gears. The first focusing knob may be operable by a user to adjust the focusing of the first focusing device. The second focusing device may be operatively coupled to a second focusing knob for adjusting the focusing degree of the second focusing device. The second focusing knob may be operatively coupled (e.g., electronically or mechanically coupled) to the second focusing device. In one example, the second focusing knob can be mechanically coupled to the second focusing device via a second gear transmission comprising one or more gears, and the second focusing knob can be operable by a user to adjust the focusing of the second focusing device.
[0112] In some cases, the first focusing device and the second focusing device may be operatively coupled to each other (e.g., electronically or mechanically) such that focusing for the image sensor and focusing for the camera can be performed in parallel. In some examples, the first focusing device and the second focusing device may be coupled to each other via a gear transmission comprising one or more gears. The first focusing device and the second focusing device may be coupled to a common focusing knob that is operable by a user. Alternatively, the first focusing device may be operatively coupled to the first focusing knob, the second focusing device may be operatively coupled to the second focusing knob, and the first and second focusing knobs may be operatively coupled to each other. In such a case, (i) operating the first focusing knob may adjust the focusing of both the first focusing device and the second focusing device, and (ii) operating the second focusing knob may adjust the focusing of both the first focusing device and the second focusing device.
[0113] In some cases, the first focusing device and the second focusing device may not be operably coupled to one another. The first focusing device and the second focusing device may be provided separately and configured to be used independently of one another.
[0114] At least one focusing device may be manually adjusted for focusing. In some cases, one or both of the first focusing device and the second focusing device may be manually adjusted for focusing. Alternatively, at least one focusing device may be automatically adjusted for focusing. In some cases, the optical system assembly may be capable of auto-focusing at least one focusing device. In some cases, one or both of the first focusing device and the second focusing device may be automatically adjusted for focusing. In some examples, focusing the first focusing device (e.g., manually or automatically) may result in auto-focusing the second focusing device, or vice versa. In another example, the first focusing device and the second focusing device may be auto-focused simultaneously.
[0115] In some cases, the optical system assembly of the housing may include at least one focusing device for the image sensor and may not include any focusing device for the camera. In such cases, the camera may have its own focusing device. The at least one focusing device of the optical system assembly and the focusing device of the camera may or may not be operatively coupled to each other.
[0116] In some cases, a processor (or computer) may be operatively coupled to the image sensor and the camera. The processor may be configured to direct the image sensor to capture a first set of imaging data and direct the camera to capture a second set of imaging data. The processor may be configured to compare the first and second sets of imaging data. Based at least in part on the comparison, the processor may be configured to direct one or more focusing devices operatively coupled to the image sensor and / or the camera to adjust an alignment of the image sensor relative to the camera. Such calibration of the image sensor and / or the camera may improve alignment between an image of the first set of imaging data and another image of the second set of imaging data. The calibration may be performed by the processor (e.g., in response to a user command or automatically) (i) prior to use of the optical adapter to image the target site and / or (ii) in real time during imaging of the target site.
[0117] In some cases, the viewpoint (i.e., field of view) of the image sensor and the viewpoint (i.e., field of view) of the camera may be aligned with respect to one another. The processor may be configured to direct the image sensor to capture a first set of imaging data (e.g., based on infrared or laser light reflected from the target site) and direct the camera to capture a second set of imaging data (e.g., based on white light reflected from the target site). The processor may be further configured to spatially (and / or temporally) align the first and second sets of imaging data. In some examples, the processor may perform digital image processing on one or both of the first and second sets of imaging data (e.g., affine transformation of one or more pixels of the first and second sets of imaging data) such that the viewpoints of the image sensor and the camera are aligned (or collocated) and spatially correspond to one another. Such alignment of the two imaging units may be useful when creating an overlay of the first and second sets of imaging data, for example, when generating an overlay of blood flow and perfusion (e.g., from an image sensor) on a standard white light surgical view (e.g., from a camera). In another example, the processor may be configured to perform image registration. The processor may be configured to find one or more matching features in the first and second sets of imaging data and then calculate a transformation of one or both of the first and second sets of imaging data for their alignment. Non-limiting examples of such features include corners, lines, speed-up robust features (SURF), and scale-invariant feature transform (SIFT) features.
[0118] FIG. 1A diagrammatically illustrates an exemplary ecosystem for medical imaging. The ecosystem may include a target site 100 of a subject (e.g., a tissue site of interest of a patient). The ecosystem may include a speculum assembly 200. The ecosystem may include an illumination source 230 in optical communication with the speculum assembly 200. The illumination source 230 may be configured to provide one or more light beams (e.g., combined light beams) toward the target site 100 via the speculum assembly 20. The target site 100 may be in optical communication with the speculum assembly 200 such that (i) the target site 100 may be illuminated by one or more light beams from the speculum assembly 200, and (ii) the speculum assembly 200 may detect one or more light signals reflected or emitted by the target site 100 upon such illumination. The speculum assembly 200 may be configured to capture at least one image or video of the target site based at least in part on the one or more light signals from the target site 100. The ecosystem may include an optical adapter 300 operatively coupled to one or more components of the speculum assembly 200. The optical adapter 300 may be in optical communication with the speculum assembly 200 such that (i) the optical adapter 300 may receive one or more optical signals from the speculum assembly 200 and (ii) the speculum assembly 200 may receive one or more optical signals from the optical adapter 300. The optical adapter 300 may be configured to generate data (e.g., images, videos, laser speckle imaging, etc.) based on at least an additional portion of the one or more optical signals from the target site 100. The generated data may encode characteristics of the target site that are distinct from that of at least one image or video captured by the speculum assembly 200. The speculum assembly 200 and the optical adapter 300 may be operatively coupled to an imaging processor 340. The imaging processor 340 may be configured to analyze or combine data, images, or videos generated by the speculum assembly 200 and the optical adapter 300.
[0119] FIG. 1B diagrammatically illustrates an exemplary ecosystem of the speculum assembly 200 without the optical adapter 300. The speculum assembly 200 comprises a speculum 210 and a camera 220 operatively coupled to one another. The speculum 210 and the camera 220 may be in mechanical and optical communication with one another. The speculum 210 may be in optical communication with an illumination source 230 via an optical signal path 235 (e.g., optical fiber). The illumination source 230 may direct one or more light beams to the speculum 210 via the optical signal path 235, and the speculum 210 may direct one or more light beams towards the target site 100. The speculum 210 may also serve as an optical signal path for any light signals reflected or emitted by the target site 100 towards the camera 220. The camera 220 may be operatively coupled to an imaging processor 340 via a signal line 225 (e.g., an electrical wire such as a copper wire, an optical fiber, etc.). In some cases, a focusing coupler may be placed between the speculum 210 and the camera 220. The focusing coupler may be permanently attached to the camera 220. The focusing coupler may include a focusing knob.
[0120] 2A and 2B diagrammatically illustrate an embodiment of the ecosystem shown in FIG. 1A in which an optical adapter 300 is operatively coupled to a speculum assembly 200. FIG. 2A diagrammatically illustrates a side view of the optical adapter 300, while FIG. 2B diagrammatically illustrates a cross-sectional view of the optical adapter 300. The optical adapter 300 may comprise a housing 305. The housing 305 may comprise a first end 350 configured to releasably couple to the speculum 210. The housing 305 may comprise a second end 360 configured to releasably couple to the camera 220. The housing 305 may comprise an image sensor 310 within a casing 315. The image sensor 310 (e.g., the casing 315 comprising the image sensor 310) may be configured to releasably couple to the housing 305.
[0121] 2B, the housing 305 may include an optical system assembly 330 disposed therein. The optical system assembly 330 may be configured to (1) receive an optical signal reflected from the target site 100 within the subject's body and transmitted through the speculum 210, and (2) reflect a first portion of the optical signal onto the image sensor 310 while allowing a second portion of the optical signal to pass therethrough to the camera 220. The optical system assembly 330 may include a beam splitter, such as, for example, a dichroic mirror. The housing 305 may include a first focusing device (e.g., a lens) disposed between the optical system assembly 330 and the image sensor 310, the first focusing device configured to focus a first portion of the optical signal traveling from the optical system assembly 330 toward the image sensor 310. The housing 305 may further include a first focusing knob 320 configured to adjust the focusing of the first focusing device. The housing 305 may include a second focusing device (e.g., a lens) disposed between the optical assembly 330 and the camera 220, the second focusing device configured to focus a second portion of the optical signal traveling from the optical assembly 330 toward the camera 220. The housing 305 may further include a second focusing knob 325 configured to adjust the focusing degree of the second focusing device. The first focusing knob 320 and the second focusing knob 325 are operatively coupled to each other and thus may operate in conjunction with each other. In an example, operating the first focusing knob 320 to focus the first focusing device may automatically instruct the second focusing knob 325 to focus the second focusing device. In another example, operating the first focusing knob 320 to unfocus the first focusing device may automatically instruct the second focusing knob 325 to unfocus the second focusing device. Alternatively, operating the first focusing knob 320 to focus the first focusing device may automatically instruct the second focusing knob 325 to unfocus the second focusing device, or vice versa. In some cases, the first focusing knob 320 and the second focusing knob 325 may operate independently of one another.
[0122] 2C and 2D diagrammatically illustrate an example of the ecosystem shown in FIGS. 2A and 2B. The first end 350 of the housing 305 and the speculum 210 may be operatively coupled to one another via a coupler 340. The coupler 340 may be configured to releasably couple to the speculum 210 and the first end 350 of the housing 305. The coupler 340 may be in optical communication with the speculum 210 and the first end 350 of the housing 305.
[0123] 3A-3B diagrammatically illustrate an embodiment of an ecosystem for medical imaging. The ecosystem may include a speculum assembly 200, which includes a speculum 210 and a camera 220. The ecosystem further includes an optical adapter 300 of the presently disclosed subject matter. For example, releasably coupled to the speculum assembly 200, the optical adapter 300 may include an image sensor and an optical system assembly. The optical system assembly may be configured to (1) receive an optical signal reflected from a tissue site within a subject's body and transmitted through the speculum 210, and (2) reflect a first portion of the optical signal onto the image sensor while allowing a second portion of the optical signal to pass through to the camera 220.
[0124] With reference to FIG. 3A, the speculum assembly 200 may be operatively coupled to a base module 250. The base module 250 may include a processor configured to analyze data acquired by the camera 220, a light source for providing light to the speculum assembly 200, and a display (e.g., a liquid crystal display (LCD) or light emitting diode (LED) screen) for visualizing data acquired by the camera. In some cases, the optical adapter 300 may also be operatively coupled to the base module 250. The base module 250 may be configured to provide combined light (e.g., white light and one or more laser beams) through the speculum 210 to the tissue site. The processor of the base module 250 may be configured to analyze and visualize a first data set from the image sensor and a second data set from the camera 220. Alternatively, the optical adapter 300 may be operatively coupled to an additional imaging module 370 that includes a light source configured to provide combined light through the speculum 210 toward the tissue site. Such a light source may be optically coupled to the light source of the base module 250 (e.g., for white light) and one or more additional light sources configured to provide one or more laser beams. A processor of the additional imaging module 370 may be configured to analyze and visualize a first data set from the image sensor. In addition, the processor of the additional imaging module 370 may be operatively coupled to the processor of the base module 250 to generate a combined analysis and visualization of the first data and a second data set from the camera 220.
[0125] As shown in FIG. 3B, the additional imaging module 370 may include one or more of the following features: (i) one or more processors for imaging and / or video processing, (ii) a database for local image / video storage, (iii) a connection (e.g., wired or wireless) to a medical database network, (iv) a connection (e.g., wired or wireless) to the base module 250 of the speculum 210, and (v) one or more light sources (e.g., high-speed laser light source, hyperspectral light source, etc.).
[0126] FIG. 3C diagrammatically illustrates multiple imaging modalities accomplished by the optical adapter of the subject matter of this disclosure. The base module 250 and / or additional imaging module 370 may provide combined light (e.g., a combination of white light and multiple laser beams) to the tissue site through the speculum 210. Upon exposure to the combined light, the tissue site may reflect or emit an optical signal toward the optical adapter 300. The optical system assembly of the optical adapter 300 may then be configured to receive the optical signal transmitted through the speculum and reflect at least a portion of the optical signal onto the image sensor of the optical adapter. Examples of at least a portion of the optical signals that may be detected and recorded by the image sensor may include, but are not limited to, (i) hyperspectral data 380 as a unique fingerprint of the tissue site for identification of tissue type, (ii) a primary measure of reflection of the laser light beam 382 regarding perfusion (e.g., blood flow) beneath the tissue site, and (iii) reflection of NIR light 384 that may be indicative of structures at the tissue site that would otherwise be invisible to white light based imaging. In some cases, NIR light originally directed at a tissue site may be able to penetrate deeper into the tissue site than white light, and thus reflections of such NIR light may reveal previously invisible structures of the tissue site.
[0127] Any of the subject optical adapters of the present disclosure can be incorporated as part of an imaging kit. In one aspect, the present disclosure provides an imaging kit comprising any of the subject optical adapters of the present disclosure and one or more illumination sources. The one or more illumination sources can be configured to transmit one or more light beams to a speculum of a speculum assembly to direct the one or more light beams through the speculum onto a target site of a subject's body. The kit can comprise at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more illumination sources. The kit can comprise up to 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 illumination sources. In some cases, a single illumination source can be configured to transmit at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more light beams to a speculum. A single illumination source may be configured to transmit up to 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 laser beams to the speculum. In some cases, multiple illumination sources may be configured to transmit at least 2, 3, 4, 5, 6, 7, 8, 9, 10, or more light beams to the speculum. Multiple illumination sources may be configured to transmit up to 10, 9, 8, 7, 6, 5, 4, 3, or 2 light beams to the speculum. In some examples, the illumination sources may be configured to transmit a combined light beam to the speculum to direct the combined light beam onto a target site within the subject's body.
[0128] The optical adapter of any of the subject matter of the present disclosure can be used for medical imaging of a target site of a subject. In an aspect, the present disclosure provides a method of using an optical adapter for medical imaging. FIG. 4 shows an exemplary flow chart of a method of using an optical adapter for medical imaging. The method may include providing a speculum assembly comprising (i) an optical adapter, and (ii) a speculum and a camera. The method may include combining a first light with a second light to generate a combined light beam. In some cases, the method may include combining a white light with a coherent laser light to generate a combined light beam (process 410). The method may further include providing the combined light beam to a speculum (process 420). The method may further include using a speculum to direct the combined light beam onto a target site within the subject's body (process 430). The method may further include receiving an optical signal reflected or emitted from the target site via the speculum (process 440). Alternatively, the method may include receiving an optical signal reflected or emitted from the target site via an additional optical path. The method further includes reflecting a first portion of the optical signal onto an image sensor in an optical adapter while allowing a second portion of the optical signal to pass through to a camera, where the optical adapter may be configured to operatively couple (e.g., releasably couple) to both the speculum and the camera (process 450). In some cases, the optical adapter may be disposed between the speculum and the camera when releasably coupled thereto. The speculum, optical adapter, and camera may share a common longitudinal axis.
[0129] FIG. 5 shows an additional exemplary flow chart of a method of using an optical adapter for medical imaging. The method may include providing an optical adapter comprising a housing, where an image sensor of the optical adapter may be operatively coupled to the housing (Process 510). The image sensor may be permanently or releasably coupled to the housing. The method may further include providing a speculum assembly comprising a speculum and a camera. The method may further include operatively coupling (e.g., releasably coupling) a first end of the housing to the speculum (Process 520). The method may further include operatively coupling (e.g., releasably coupling) a second end of the housing to the camera (Process 520). The method may further include providing a combined light beam to the speculum, where the combined light beam may comprise a first light and a second light. In some cases, the method may include providing a combined light beam to the speculum, where the combined light beam may comprise a white light combined with a coherent laser light (Process 530). The method may further include using a speculum to direct the combined light beams onto a target site within the subject's body (process 540). The method may further include receiving a light signal reflected or emitted from the target site via the speculum (process 550). Alternatively, the method may further include receiving a light signal reflected or emitted from the target site via an additional optical path. The method may further include reflecting a first portion of the light signal onto an image sensor while allowing a second portion of the light signal to pass through to a camera (process 560). The method may further include using an image sensor to generate a first set of imaging data from the first portion of the light signal and using a camera to generate a second set of imaging data from the second portion of the light signal (process 570). In some cases, the first set of imaging data comprises a laser speckle pattern. In some cases, the second set of imaging data comprises a photograph or video image. Alternatively, the image sensor may not or need not be releasably coupled to an optical adapter as illustrated in FIG. 6. In such cases, the optical adapter may include an image sensor, which may be integrated within the adapter.
[0130] In some embodiments, the optical adapter of the present disclosure may enable a user (e.g., a medical professional) to visualize both (i) an image or video of the target tissue site (e.g., captured by the camera of an existing speculum) and (ii) the perfusion of a fluid of interest (e.g., blood perfusion) beneath or within the target tissue site. In some cases, the optical adapter may enable a user to visualize (i) an image or video of the target tissue site and (ii) the blood perfusion in substantially real-time. In some cases, changes in blood perfusion at the target tissue site may indicate the onset of one or more surgical complications (e.g., accidentally damaging a blood vessel) or potential surgical complications (e.g., stroke, seizure, allergic reaction of a subject, etc.). Thus, the optical adapter of the present disclosure may enable a user (e.g., a surgeon in an operating room) to (1) detect one or more procedural or patient-related problems earlier compared to only existing speculum devices, and (2) make an informed decision as to whether to continue or abort the remainder of the surgical procedure.
[0131] 7A-7D illustrate comparative images of a tissue site of interest (e.g., a porcine small intestine) acquired by the optical adapter of the present disclosure or an existing ICG-based angiography. With reference to FIGS. 7A and 7B, a portion of a blood vessel in the mesentery was devascularized using electrocautery, and the tissue site was imaged in real time by an ICG angiography (FIG. 7A) or an optical adapter operatively coupled to an endoscope (FIG. 7B). In FIG. 7A, the dark region 710 does not indicate any blood perfusion, while the light region 715 indicates the presence of blood perfusion (e.g., complete perfusion). In FIG. 7B, the red region 720 does not indicate any blood perfusion, while the blue region 725 indicates the presence of blood perfusion. Both the ICG angiography and the optical adapter can compare and accurately distinguish the ablation regions (710 and 720, respectively) within the tissue site.
[0132] With reference to Figures 7C and 7D, the vascular ablation was further expanded at the target site shown in Figures 7A and 7B, and the tissue site was imaged in real time by ICG angiography (Figure 7C) or an optical adapter operatively coupled to the endoscope (Figure 7D). As shown in Figure 7C, no significant change in color of the expanded ablation site 730 is evident by ICG angiography. Rather, the expanded ablation site 730 appears to have blood perfusion (i.e., a false positive) due to the ICG dye previously injected and still present within the tissue site. In contrast, as shown in Figure 7D, the expanded ablation site 740 is clearly captured as a red area, confirming that there is no blood perfusion at such site. Thus, the optical adapter can more accurately portray blood perfusion data than ICG angiography.
[0133] 8A-8D illustrate advantages of the optical adapter of the present disclosure over existing systems and methods for medical imaging. As shown in FIG. 8A, it may be necessary to obtain a survey (e.g., a pre-operative two-dimensional (2D) computed tomography (CT) scan) of the tissue site prior to surgery (e.g., 2-6 weeks prior to surgery). In contrast, as shown in FIG. 8B, the optical adapter of the present disclosure, when operatively coupled to any existing endoscopic system, may enable real-time visualization of one or more features 810 of the tissue site that would not be captured or distinguished by the existing endoscopic system alone. In addition, as shown in FIG. 8C, surgeons may often rely on a physical ruler to measure one or more dimensions (e.g., length, area, etc.) of the tissue site or its features. In contrast, as shown in FIG. 8D, the optical adapter of the present disclosure may enable accurate measurement of such dimensions in real time without the need for a physical ruler.
[0134] The optical adapter of the present disclosure may provide one or more advantages over existing ICG dye-based systems for medical imaging. ICG dye-based systems are traditionally used for blood perfusion data. In some cases, ICG dye-based systems may require different hardware equipment for different applications. In addition, one ICG dye-based system may not be compatible with all endoscopes. Thus, the ICG dye-based system may be hardware dependent. In some cases, instantaneous updates of the hardware or software of the ICG dye-based system may not be possible. In some cases, since the ICG dye-based system relies on injection of dye into a subject (e.g., a patient), the ICG dye may be for single use only and may not be reused even for the same subject. In addition, the ICG dye (or any other dye for dye angiography) may induce allergic reactions in some subjects and thus may not be applicable to all patients. In some cases, the ICG dye may require time (e.g., minutes to hours) to reach the target site. In addition, depending on reaching the target site, the dye may not remain at the target site for long. Alternatively, the dye may remain at the target site too long and provide false positive or false negative imaging data. Therefore, ICG dye-based systems may not be a reliable method for real-time imaging of tissue sites. In contrast, the optical adapter of the present disclosure (i) may be hardware independent, (ii) may receive instant software updates, (iii) may be reused for the same subject or multiple subjects if needed, (iv) may not induce allergic reactions, (v) may be used with all patients, (vi) may provide 100% real-time data, and (vii) may provide blood perfusion data that is invisible to conventional endoscopy systems without any dye-based angiography.
[0135] The optical adapter of the present disclosure may provide additional advantages over existing dye-based systems for medical imaging: the optical adapter may exhibit the following features more than any of the existing dye-based systems for medical imaging: (i) minimally invasive imaging capabilities, (ii) visualization of perfusion at tissue sites, (iii) optimized mucosal views, (iv) tissue identification, (v) quantified multi-dimensional (e.g., three-dimensional) reconstruction and sensing, (vi) dye-free imaging, and (vii) data-rich overlay of images acquired by the optical adapter onto images acquired by a conventional endoscopic camera.
[0136] In some embodiments, the optical adapter of the present disclosure may be operatively coupled to a processor (e.g., a computer) configured to analyze an optical signal dataset (e.g., optical spectrum, image, or video) captured by the optical adapter and identify a tissue type of the tissue site or one or more features thereof. In an example, the optical adapter may use hyperspectral imaging to identify the tissue type. The processor may be capable of employing one or more machine learning algorithms to analyze a database comprising a plurality of known datasets or previously collected datasets (e.g., optical spectrum, image, or video) associated with a plurality of tissue sites or features thereof. The one or more machine learning algorithms may be capable of analyzing an optical signal dataset from an image sensor of the optical adapter or an additional optical signal dataset from an endoscopic camera. The one or more machine learning algorithms may comprise an artificial neural network. The artificial neural network may involve a network of simple processing elements (i.e., artificial neurons) that may exhibit complex global behavior determined by connections between the processing elements and element parameters. With or without a training set (e.g., a database of previously identified tissue sites and their features along with their respective optical signal datasets), the artificial neural network may enhance the analytical capabilities of the machine learning algorithm. As shown in Figure 9, the one or more machine learning algorithms of the present disclosure may comprise (i) an input 910 comprising image / video data collected from at least an optical adapter of the present disclosure, (ii) a machine learning module 920 for analysis of the input 910, and (iii) an output 930. As shown in Figure 10, the artificial neural network of the one or more machine learning algorithms may comprise an input layer 1010, one or more hidden layers (e.g., at least two hidden layers 1020 and 1025), and an output layer 1030. The one or more hidden layers may take input signals (e.g., optical signal data), analyze them, and convert them into an output (e.g., identified tissue type). In some cases, the optical signal data input may comprise at least wavelengths (e.g., more than three wavelengths, up to 1,000 wavelengths, etc.).In some cases, the output layer 1030 may comprise one or more of the following: (i) tissue identification utilizing spectral fingerprint and / or perfusion data, (ii) spatial location (e.g., X, Y, Z Cartesian coordinates) of the tissue site or its features, (iii) quantified perfusion (e.g., blood flow), (iv) surgical decision support (e.g., continue vs. discontinue), and (v) geofencing of critical structures within the tissue site of interest.
[0137] In some cases, the optical adapters of the present disclosure may collect surgical data that is orders of magnitude denser or more detailed than data collected from existing imaging systems (e.g., endoscopes or dye-based imaging systems). In some examples, stereometry may not be capable of generating a three-dimensional (3D) reconstruction of a tissue site, while the optical adapters of the present disclosure may be capable of generating a quantitative depth map of a tissue site (e.g., with a depth error of 0.5 millimeters or less).
[0138] Any one of the optical adapters of the subject matter of the present disclosure can be used to visualize the anatomy, morphology, one or more physiological features, and / or one or more pathological features of a target site within a subject's body. Examples of physiological and / or pathological features can include, but are not limited to, oxygenation, deoxygenation, arterial-venous (AV) classification, flow rate and / or flow volume of bodily fluids (e.g., blood, lymph, tissue fluid, milk, saliva, semen, bile, etc.) such as blood perfusion or infarction, angiogenesis, cell density, inflammation, tissue swelling (e.g., brain swelling), tissue death, tissue dimensions (e.g., diameter, area, volume), viral infection, bacterial infection, tumor dimensions (e.g., diameter, area, volume), tumor borders after tumor resection, metastatic growth, etc.
[0139] Examples of target sites within a subject's body include, but are not limited to, the thyroid gland, adrenal glands, breast glands, prostate, testicles, trachea, superior vena cava, inferior vena cava, lungs, liver, gallbladder, kidneys, ureters, appendix, bladder, urethra, heart, esophagus, diaphragm, aorta, spleen, stomach, pancreas, small intestine, large intestine, rectum, vagina, ovaries, bone, thymus, skin, fat, eye, brain, fetus, arteries, veins, nerves, ureters, bile ducts, healthy tissue, and diseased tissue.
[0140] In some cases, affected tissues include acanthoma, acinic cell tumor, acoustic neuroma, acral lentigo melanoma, acrohidrotic adenoma, acute eosinophilic leukemia, acute lymphoblastic leukemia, acute megakaryoblastic leukemia, acute monocytic leukemia, acute myeloblastic leukemia with maturation, acute myeloid dendritic cell leukemia, acute myeloid leukemia, acute promyelocytic leukemia, adamantinoma, adenocarcinoma, adenoid cystic carcinoma, adenoma, adenoid odontogenic tumor, adrenocortical carcinoma, adult T-cell leukemia, aggressive NK-cell leukemia, AIDS-related cancer, AIDS-related lymphoma, alveolar soft part sarcoma, ameloblastoma, anal carcinoma, anaplastic large cell lymphoma, thyroid anaplastic lymphoma, thyroid cancer ... Cancer, angioimmunoblastic T-cell lymphoma, angiomyolipoma, angiosarcoma, appendix cancer, astrocytoma, atypical teratoid rhabdoid tumor, basal cell carcinoma, basal-like carcinoma, B-cell leukemia, B-cell lymphoma, Bellini duct carcinoma, biliary tract cancer, bladder cancer, blastoma, bone cancer, bone tumor, brain stem glioma, brain tumor, breast cancer, Brenner tumor, bronchial tumor, bronchoalveolar carcinoma, brown tumor, Burkitt lymphoma, cancer of unknown primary site, carcinoid tumor, carcinoma, carcinoma in situ, carcinoma of the penis, carcinoma of unknown primary site, carcinosarcoma, Castremann's disease, central nervous system embryonal tumor, cerebellar astrocytoma, cerebral astrocytoma, cervical cancer, cholangiocarcinoma, chondroma, Chondrosarcoma, chordoma, choriocarcinoma, choroid plexus papilloma, chronic lymphocytic leukemia, chronic monocytic leukemia, chronic myelogenous leukemia, chronic myeloproliferative disorder, chronic neutrophilic leukemia, clear cell tumor, colon cancer, colorectal cancer, craniopharyngioma, cutaneous T-cell lymphoma, Dego's disease, dermatofibrosarcoma protuberans, dermoid cyst, desmoplastic small round cell tumor, diffuse large B-cell lymphoma, dysembryoplastic neuroepithelial tumor, embryonal carcinoma, endodermal sinus tumor, endometrial cancer, endometrial carcinoma, endometrioid tumor, enteropathy-associated T-cell lymphoma, ependymoblastoma, ependymoma, epithelioid sarcoma, erythroleukemia, esophageal cancer, nasal neuroblastoma, Ewing's tumor Family, Ewing's sarcoma family, Ewing's sarcoma, extracranial germ cell tumor, extragonadal germ cell tumor, extrahepatic bile duct carcinoma, extramammary Paget's disease, fallopian tube carcinoma, inclusion fetal malformation, fibroma, fibrosarcoma, follicular lymphoma, follicular thyroid carcinoma, gallbladder cancer, gallbladder cancer, ganglioglioma, ganglioneuroma, gastric cancer, gastric lymphoma, gastrointestinal carcinoid tumor, gastrointestinal stromal tumor, gastrointestinal stromal tumor, germ cell tumor, germ cell tumor, gestational choriocarcinoma, gestational trophoblastic tumor, giant cell tumor of bone, glioblastoma multiforme, glioma, gliomatosis cerebri, glomus tumor, glucagonoma, gonadoblastoma, granulosa cell tumor, hairy cell leukemia,Hairy cell leukemia, Head and neck cancer, Head and neck cancer, Cardiac cancer, Hemangioblastoma, Hemangiopericytoma, Hemangiosarcoma, Hematologic malignancies, Hepatocellular carcinoma, Hepatosplenic T-cell lymphoma, Hereditary breast and ovarian cancer syndrome, Hodgkin's lymphoma, Hodgkin's lymphoma, Hypopharyngeal cancer, Hypothalamic glioma, Inflammatory breast cancer, Intraocular melanoma, Islet cell carcinoma, Islet cell tumor, Juvenile myelomonocytic leukemia, Kaposi's sarcoma, Kaposi's sarcoma, Kidney cancer, Klatskin tumor, Krukenberg tumor, Laryngeal cancer, Laryngeal cancer, Laryngeal lentigo maligna melanoma, Leukemia, Leukemia, Lip and oral cancer, Liposarcoma, Lung cancer, Lung luteinoma, Lymphangioma, Lymphangiosarcoma, Lymphoepithelioma, Lymphoid leukemia , lymphoma, macroglobulinemia, malignant fibrous histiocytoma, malignant fibrous histiocytoma, malignant fibrous histiocytoma of bone, malignant glioma, malignant mesothelioma, malignant peripheral nerve sheath tumor, malignant rhabdoid tumor, malignant triton tumor, MALT lymphoma, mantle cell lymphoma, mast cell leukemia, mediastinal germ cell tumor, mediastinal tumor, medullary thyroid carcinoma, medulloblastoma, medulloepithelioma, melanoma, melanoma, meningioma, Merkel cell carcinoma, mesothelioma, mesothelioma, metastatic squamous cell neck carcinoma of unknown primary, metastatic urothelial carcinoma, Mullerian mixed tumor, monocytic leukemia, oral cancer, mucinous tumor, multiple endocrine neoplasia syndrome, multiple bone myeloma, multiple myeloma, mycosis fungoides, myelodysplastic disease, myelodysplastic syndrome, myeloid leukemia, myelosarcoma, myeloproliferative disease, myxoma, nasal cavity cancer, nasopharyngeal cancer, nasopharyngeal carcinoma, neoplasm, schwannoma, neuroblastoma, neuroblastoma, neurofibroma, neuroma, nodular melanoma, non-Hodgkin's lymphoma, non-melanoma skin cancer, non-small cell lung cancer, eye tumor, oligoastrocytoma, oligodendroglioma, oncocytoma, optic nerve sheath meningioma, oral cavity cancer, oral cancer, oropharyngeal cancer, osteosarcoma, osteosarcoma, ovarian cancer, ovarian cancer, ovarian epithelial cancer, ovarian germ cell tumor, ovarian low malignant grade tumor, Paget's disease of the breast, pancose tumors, pancreatic cancer, pancreatic cancer, papillary thyroid cancer, papillomatosis, paraganglioma, paranasal sinus cancer, parathyroid cancer, penile cancer, perivascular epithelioid cell tumor, pharyngeal cancer, pheochromocytoma, moderately differentiated pineal tumor, pineoblastoma, pyramidal cell tumor, pituitary cell tumor, pituitary adenoma, pituitary tumor, plasma cell tumor, pleuropulmonary blastoma, polygerminoma, precursor T lymphoblastic lymphoma, primary central nervous system lymphoma, primary effusion lymphoma, primary hepatocellular carcinoma, primary liver cancer, primary peritoneal carcinoma, primitive neuroectodermal tumor, prostate cancer, pseudomyxoma peritonei, rectal cancer, renal cell carcinoma, respiratory tract carcinoma involving the NUT gene on chromosome 15, retinoblastoma,Rhabdomyoma, rhabdomyosarcoma, Richter transformation, sacrococcygeal teratoma, salivary gland carcinoma, sarcoma, schwannomatosis, sebaceous gland carcinoma, secondary neoplasm, seminoma, serous tumor, Sertoli-Leydig cell tumor, genital cord stromal tumor, Sezary syndrome, signet ring cell carcinoma, skin cancer, small blue round cell tumor, small cell carcinoma, small cell lung cancer, small cell lymphoma, small intestine cancer, soft tissue sarcoma, somatostatinoma, sooty wart, spinal cord tumor, spinal tumor, splenic marginal zone lymphoma, squamous cell carcinoma, gastric cancer, superficial spreading melanoma, supratentorial primitive neuroectodermal tumor, superficial epithelial stromal tumor, synovial sarcoma, T-cell acute lymphoid tumor The tumor or cancer may be selected from the group consisting of leukemia, T-cell large granular lymphocytic leukemia, T-cell leukemia, T-cell lymphoma, T-cell prolymphocytic leukemia, teratoma, end-stage lymphoid cancer, testicular cancer, theca cell tumor, pharyngeal cancer, thymic cancer, thymoma, thyroid cancer, renal pelvis and ureter transitional cell carcinoma, transitional cell carcinoma, urachal cancer, urethral cancer, genitourinary neoplasm, uterine sarcoma, uveal melanoma, vaginal cancer, Werner-Morrison syndrome, verrucous carcinoma, optic pathway glioma, vulvar cancer, Waldenstrom's hypergammaglobulinemia, Warthin's tumor, Wilms' tumor, and combinations thereof.
[0141] (Computer Systems) In an aspect, the present disclosure provides a computer system programmed or otherwise configured to implement the methods of the present disclosure, for example, any of the subject methods for medical imaging. FIG. 11 shows a computer system 1701 programmed or otherwise configured to implement a method for medical imaging. The computer system 1701 may be configured, for example, to (i) direct an illumination source to combine white light with coherent laser light and generate a combined light beam, (ii) direct the illumination source to provide the combined light beam to a speculum of a speculum assembly, and (iii) direct an image sensor of an optical adapter to receive at least a portion of an optical signal reflected or emitted by a target site of an object upon illumination with the combined light beam. The computer system 1701 may be a user's electronic device or a computer system located remotely relative to the electronic device. The electronic device may be a mobile electronic device.
[0142] The computer system 1701 may include a central processing unit (CPU, also referred to herein as "processor" and "computer processor") 1705, which may be a single-core or multi-core processor, or multiple processors for parallel processing. The computer system 1701 also includes memory or memory locations 1710 (e.g., random access memory, read-only memory, flash memory), an electronic storage unit 1715 (e.g., hard disk), a communication interface 1720 (e.g., network adapter) for communicating with one or more other systems, and peripheral devices 1725, such as cache, other memory, data storage devices, and / or electronic display adapters. The memory 1710, the storage unit 1715, the interface 1720, and the peripheral devices 1725 communicate with the CPU 1705 through a communication bus (solid lines) such as a motherboard. The storage unit 1715 may be a data storage unit (or data repository) for storing data. The computer system 1701 may be operatively coupled to a computer network ("network") 1730 using the communication interface 1720. The network 1730 may be the Internet, an intranet, and / or an extranet, or an intranet and / or an extranet in communication with the Internet. The network 1730 may be a telecommunications and / or data network in some cases. The network 1730 may include one or more computer servers, which may enable distributed computing such as cloud computing. The network 1730 may implement a peer-to-peer network in some cases, using the computer system 1701, which may enable devices coupled to the computer system 1701 to behave as clients or servers.
[0143] The CPU 1705 can execute sequences of machine-readable instructions, which may be embodied in a program or software. The instructions may be stored in a memory location, such as the memory 1710. The instructions may be directed to the CPU 1705, which may then program or otherwise configure the CPU 1705 to implement the methods of the present disclosure. Examples of operations performed by the CPU 1705 may include fetch, decode, execute, and writeback.
[0144] The CPU 1705 may be part of a circuit, such as an integrated circuit. One or more of the other components of the system 1701 may be included in the circuit. In some cases, the circuit is an application specific integrated circuit (ASIC).
[0145] The storage unit 1715 can store files such as drivers, libraries, and saved programs. The storage unit 1715 can store user data, such as user preferences and user programs. The computer system 1701 can include one or more additional data storage units in some cases located outside the computer system 1701 (e.g., on a remote server in communication with the computer system 1701 through an intranet or the Internet).
[0146] Computer system 1701 can communicate with one or more remote computer systems through network 1730. For example, computer system 1701 can communicate with a remote computer system of a user (e.g., a subject, an end user, a consumer, a health care provider, an imaging technician, etc.). Examples of remote computer systems include a personal computer (e.g., a portable PC), a slate or tablet PC (e.g., Apple® iPad®, Samsung® Galaxy Tab), a phone, a smartphone (e.g., Apple® iPhone®, Android-enabled devices, Blackberry®), or a personal digital assistant. A user can access computer system 1701 through network 1730.
[0147] Methods as described herein can be implemented using machine (e.g., computer processor) executable code stored on electronic storage locations of the computer system 1701, such as, for example, on memory 1710 or electronic storage unit 1715. The machine executable or machine readable code can be provided in the form of software. In use, the code can be executed by the processor 1705. In some cases, the code can be read from the storage unit 1715 and stored on the memory 1710 for quick access by the processor 1705. In some circumstances, the electronic storage unit 1715 can be omitted and the machine executable instructions are stored on the memory 1710.
[0148] The code can be pre-compiled and configured for use with a machine having a processor adapted to execute the code, or can be compiled during run-time. The code can be provided in a programming language that can be selected to allow the code to be executed in a pre-compiled or as-compiled manner.
[0149] Aspects of the systems and methods provided herein, such as computer system 1701, can be embodied in programming. Various aspects of the technology can be considered as a "product" or "article of manufacture" in the form of machine (or processor) executable code and / or associated data typically carried on or embodied in some type of machine-readable medium. The machine executable code can be stored on an electronic storage unit, such as a memory (e.g., read-only memory, random access memory, flash memory) or hard disk. A "storage" type medium can include any or all of the tangible memory of a computer, processor, etc., or its associated modules, such as various semiconductor memories, tape drives, disk drives, etc., that can provide non-transitory storage at any time for software programming. All or a portion of the software can be communicated from time to time over the Internet or various other telecommunications networks. Such communication can, for example, enable loading of the software from one computer or processor to another (e.g., from a management server or host computer to a computer platform of an application server). Thus, other types of media that may carry software elements include optical, electrical, and electromagnetic waves, such as those used across physical interfaces between local devices, through wired and optical fixed networks, and via various air links. The physical elements that carry such waves, such as wired or wireless links, optical links, etc., may also be considered media that carry the software. As used herein, unless limited to non-transitory tangible "storage" media, terms such as computer or machine "readable medium" refer to any medium that participates in providing instructions to a processor for execution.
[0150] Thus, a machine-readable medium such as a computer executable code may take many forms, including, but not limited to, a tangible storage medium, a carrier wave medium, or a physical transmission medium. For example, non-volatile storage media, including optical or magnetic disks, or any storage device within any computer or the like, may be used to implement the databases, etc., shown in the figures. Volatile storage media include dynamic memory, such as the main memory of such a computer platform. Tangible transmission media include coaxial cables, copper wire and optical fibers, including the wires that make up a bus within a computer system. Carrier wave transmission media may take the form of electric or electromagnetic signals, or acoustic or light waves, such as those generated during radio frequency (RF) and infrared (IR) data communications. Common forms of computer readable media thus include, for example, a floppy disk, a flexible disk, a hard disk, a magnetic tape, any other magnetic medium, a CD-ROM, a DVD or DVD-ROM, any other optical medium, punch cards, paper tape, any other physical storage medium with a pattern of holes, RAM, ROM, PROM and EPROM, FLASH-EPROM, any other memory chip or cartridge, a carrier wave that transmits data or instructions, a cable or link that transmits such a carrier wave, or any other medium from which a computer may read programming code and / or data. Many of these forms of computer readable media may be involved in carrying one or more sequences of one or more instructions to a processor for execution.
[0151] The computer system 1701 may include or communicate with an electronic display 1735 with a user interface (UI) 1740 to provide a portal for, for example, a healthcare provider or imaging technician to monitor or track one or more features of the optical adapter (e.g., coupling to a speculum, coupling to a camera, image sensor, optics assembly, etc.). The portal may be provided through an application programming interface (API). A user or entity may also interact with various elements within the portal via the UI. Examples of UIs include, but are not limited to, graphical user interfaces (GUIs) and web-based user interfaces.
[0152] The methods and systems of the present disclosure may be implemented using one or more algorithms. The algorithms may be implemented using software when executed by the central processing unit 1705.
[0153] In another aspect, the present disclosure provides a medical imaging method and system that can be used with an endoscopic device to overlay a laser speckle contrast image on a standard RGB image of a surgical site. The endoscopic device can be coupled to an RGB video camera to provide a surgeon with high quality images of anatomical structures or physiological features at a surgical site within a patient's body. Laser speckle contrast imaging can also be used to instantly visualize microcirculatory tissue blood perfusion within a patient's body.
[0154] The present disclosure provides methods and systems that can be used with commercially available endoscopic devices to display laser speckle contrast images in addition to standard images of the surgical site. The images can be displayed individually or together. For example, the laser speckle contrast image can be overlaid on a standard image of the surgical site.
[0155] 12 illustrates an exemplary imaging system according to one or more embodiments that may be used with any conventional endoscopic imaging system to display laser speckle contrast images in addition to standard images of the surgical site. A conventional endoscopic imaging system may include an endoscope 2100 (e.g., a laparoscope or stereoscope) that may be directly coupled to an RGB video camera 2102. An image processing system 2104 coupled to the camera 2102 may display standard RGB surgical images on a display 2106.
[0156] In some cases, the imaging system may include an adapter device 2108 that may be attached between the endoscope 2100 and the video camera 2102. The imaging system may further include a light source and an image processing system 2110.
[0157] 13 is a simplified block diagram of an exemplary imaging system, in accordance with one or more embodiments. The light source and image processing system 2110 may be configured to combine laser light and white light provided to an optical input port 2112 of the endoscope 2100. The dichroic beam splitter 2114 may be configured to combine laser light from an IR laser diode 2116, controlled by an IR laser controller 2118, with white light from a white light LED 2120, controlled by a white light controller 2122.
[0158] Light from the light source may be directed through the distal end of the endoscope 2100 and may be incident on the surgical site. Light returned or reflected from the surgical site may be transmitted through the endoscope to the adapter device 2108. A dichroic beam splitter 2124 in the adapter device 2108 may pass light having wavelengths greater than 800 nanometers (nm) to a monochrome near-infrared (NIR) camera 2126. Light having wavelengths below 800 nm may proceed to the RGB color camera 2102. The NIR camera 2126 may generate a sensor signal that is processed by the image processing system 2128. The RGB color camera 2102 may generate a sensor signal that is processed by the camera video processor 2104, which may use the processed sensor signal to generate a standard RGB video stream. The RGB video stream may be provided to the image processing system 2128.
[0159] The image processing system 2128 may be configured to perform laser speckle contrast imaging from the sensor signal received from the NIR camera 2126. The image processing system 2128 may be configured to combine the laser speckle contrast imaging with the standard RGB video stream output by the video processor 2104 to generate a video output that may be displayed on the display 2106.
[0160] The laser speckle contrast image and the standard RGB image of the surgical site may be displayed individually or together. For example, the laser speckle contrast image may be overlaid on the standard image of the surgical site. FIG. 14A is an example screenshot from a standard RGB surgical video shown on the display 2106. FIG. 14B shows the corresponding laser speckle contrast image shown on the display 2106. In this example, the highlighted portion of FIG. 14B may indicate one or more areas in the scene where blood flow is present. FIG. 14C shows the laser speckle contrast image of FIG. 14B overlaid on the standard image of FIG. 14A. The user may switch between each of the types of images displayed as desired.
[0161] 15 is a simplified block diagram illustrating a camera 2130 for performing both depth and laser speckle imaging, according to one or more embodiments. The camera 2130 may utilize a depth imaging processor 2128 to generate stereo depth data from two or more sensors 2132. Laser speckle contrast imaging may be performed using data from a third sensor 2134. An image processor 2138 may be configured to process data from one or more sensors for video output.
[0162] FIG. 16 illustrates a simplified block diagram of an alternative camera 2140 for performing hyperspectral, depth, and laser speckle imaging. Stereo depth imaging may be processed using a field programmable gate array (FPGA) 2142. The stereo depth imaging may be frame synchronized before being processed by the FPGA. In one or more embodiments, the device may acquire alternating white light and hyperspectral light for every other frame (for an effective 30 frames per second (FPS) video) at one or more sensors 2144. 60 frames per second (FPS) video may be used when the hyperspectral mode is not enabled. Laser speckle data may be acquired simultaneously using a third sensor 2146.
[0163] 17, a schematic diagram of an exemplary computing node that may be used with the medical imaging system described herein is shown. The computing node 3010 is merely one example of a suitable computing node and is not intended to suggest any limitation on the scope of use or functionality of the embodiments described herein. Nevertheless, the computing node 3010 may be capable of implementing and / or performing any of the functionality described herein above.
[0164] There may be computer systems / servers 3012 operating in numerous other general purpose or special purpose computing system environments or configurations present in computing node 3010. Examples of well-known computing systems, environments, and / or configurations that may be suitable for use with computer systems / servers 3012 include, but are not limited to, personal computer systems, server computer systems, thin clients, thick clients, handheld or laptop devices, multiprocessor systems, microprocessor-based systems, set-top boxes, programmable consumer electronics, network PCs, minicomputer systems, mainframe computer systems, distributed cloud computing environments that include any of the above systems or devices, and the like.
[0165] The computer system / server 3012 may be described in the general context of computer system executable instructions, such as program modules, executed by a computer system. Generally, program modules may include routines, programs, objects, components, logic, data structures, etc. that perform particular tasks or implement particular abstract data types. The computer system / server 3012 may be practiced in a distributed cloud computing environment where tasks are performed by remote processing devices that are linked through a communications network. In a distributed cloud computing environment, program modules may be located in both local and remote computer system storage media, including memory storage devices.
[0166] 17, a computer system / server 3012 in a computing node 3010 is shown in the form of a general-purpose computing device. Components of the computer system / server 3012 may include, but are not limited to, one or more processors or processing units 3016, a system memory 3028, and a bus 3018 that couples various system components including the system memory 3028 to the processor 3016.
[0167] The bus 3018 may comprise any one or more of several types of bus structures including a memory bus or memory controller, a peripheral bus, a high-speed graphics port, and a processor or local bus using any of a variety of bus architectures. By way of example, and without limitation, such architectures include Industry Standard Architecture (ISA) bus, MicroChannel Architecture (MCA) bus, Enhanced ISA (EISA) bus, Video Electronics Standards Association (VESA) local bus, and Peripheral Component Interconnect (PCI) bus.
[0168] The computer system / server 3012 may include a variety of computer system readable media. Such media may be any available media that is accessible by the computer system / server 3012 and may include both volatile and nonvolatile media, removable and non-removable media.
[0169] The system memory 3028 may include computer system readable media in the form of volatile memory, such as random access memory (RAM) 3030 and / or cache memory 3032. The computer system / server 3012 may further include other removable / non-removable, volatile / non-volatile computer system storage media. By way of example only, a storage system 3034 may be provided for reading from and writing to a non-removable non-volatile magnetic medium (not shown, typically referred to as a "hard drive"). Although not shown, a magnetic disk drive for reading from and writing to a removable non-volatile magnetic disk (e.g., a "floppy disk") and an optical disk drive for reading from or writing to a removable non-volatile optical disk, such as a CD-ROM, DVD-ROM, or other optical media, may be provided. In such instances, each may be connected to the bus 3018 by one or more data media interfaces. As will be further depicted and explained below, the memory 3028 may include at least one program product having a set of program modules (e.g., at least one of which) configured to perform functions of embodiments of the present disclosure.
[0170] By way of example, and not limitation, a program / utility 3040 having a set of program modules 3042 (at least one of which) may be stored in memory 3028, in addition to an operating system, one or more application programs, other program modules, and program data. Each of the operating system, one or more application programs, other program modules, and program data, or some combination thereof, may include an implementation of a networking environment. The program modules 3042 generally perform the functions and / or methodologies of the embodiments described herein.
[0171] The computer system / server 3012 may also communicate with one or more external devices 3014, such as a keyboard, pointing device, display 3024, one or more devices that allow a user to interact with the computer system / server 3012, and / or any device (e.g., network card, modem, etc.) that allows the computer system / server 3012 to communicate with one or more other computing devices. Such communication may occur via an input / output (I / O) interface 3022. Furthermore, the computer system / server 3012 may communicate with one or more networks, such as a local area network (LAN), a general wide area network (WAN), and / or a public network (e.g., the Internet), via a network adapter 3020. As depicted, the network adapter 3020 communicates with other components of the computer system / server 3012 via a bus 3018. It should be understood that other hardware and / or software components, not shown, may also be used in conjunction with the computer system / server 3012. Examples include, but are not limited to, microcode, device drivers, redundant processing units, external disk drive arrays, RAID systems, tape drives, and data archive storage systems.
[0172] The present disclosure provides systems, methods, and / or computer program products that may include a computer-readable storage medium (or media) having computer-readable program instructions thereon for causing a processor to perform aspects of the present disclosure.
[0173] A computer-readable storage medium may be a tangible device that can hold and store instructions for use by an instruction execution device. A computer-readable storage medium may be, for example, but not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the above. A non-exhaustive list of more specific examples of computer-readable storage media includes: portable computer diskettes, hard disks, random access memories (RAMs), read-only memories (ROMs), erasable programmable read-only memories (EPROMs or flash memories), static random access memories (SRAMs), portable compact disk read-only memories (CD-ROMs), digital versatile disks (DVDs), memory sticks, floppy disks, punch cards or mechanically encoded devices such as raised structures in grooves with instructions recorded thereon, and any suitable combination of the above. A computer-readable storage medium as used herein is not to be construed as being a transitory signal per se, such as electric waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through a waveguide or other transmission medium (e.g., light pulses passing through a fiber optic cable), or electrical signals transmitted through wires.
[0174] The computer-readable program instructions described herein can be downloaded from a computer-readable storage medium to each computing / processing device or to an external computer or storage device via a network, such as the Internet, a local area network, a wide area network, and / or a wireless network. The network may comprise copper transmission cables, optical transmission fiber, wireless transmission, routers, firewalls, switches, gateway computers, and / or edge servers. A network adapter card or network interface in each computing / processing device receives the computer-readable program instructions from the network and forwards the computer-readable program instructions for storage in a computer-readable storage medium in the respective computing / processing device.
[0175] The computer readable program instructions for carrying out the operations of the present disclosure may be either source or object code written in any combination of one or more programming languages, including assembler instructions, instruction set architecture (ISA) instructions, machine instructions, machine dependent instructions, microcode, firmware instructions, state setting data, or conventional procedural programming languages, such as object oriented programming languages, such as Smalltalk, C++, and the like, and the "C" programming language or similar programming languages. The computer readable program instructions may be executed entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or wide area network (WAN), or the connection may be made to an external computer (e.g., through the Internet using an Internet Service Provider). In various embodiments, electronic circuitry including, for example, a programmable logic circuit, a field programmable gate array (FPGA), or a programmable logic array (PLA) may execute computer readable program instructions by utilizing state information of the computer readable program instructions to personalize the electronic circuitry to implement aspects of the present disclosure.
[0176] Aspects of the present disclosure are described herein with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the present disclosure. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer-readable program instructions.
[0177] These computer readable program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to generate a machine such that the instructions executed via the processor of the computer or other programmable data processing apparatus create means for implementing the function / acts specified in the block or blocks of the flowcharts and / or block diagrams. These computer readable program instructions may also be stored within a computer readable storage medium that may instruct a computer, programmable data processing apparatus, and / or other device to function in a particular manner such that the computer readable storage medium having instructions stored therein constitutes an article of manufacture including instructions that implement an aspect of the function / acts specified in the block or blocks of the flowcharts and / or block diagrams.
[0178] The computer readable program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other device to cause a series of operational steps to be performed on the computer, other programmable apparatus, or other device, generating a computer-implemented process such that the instructions executing on the computer, other programmable apparatus, or other device implement the function / acts specified in a block or blocks of the flowcharts and / or block diagrams.
[0179] The flowcharts and block diagrams in the figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present disclosure. In this regard, each block in the flowcharts or block diagrams may represent a module, segment, or part of instructions constituting one or more executable instructions for implementing a specified logical function. In various alternative implementations, the functions described in the blocks may be performed out of the order described in the figures. For example, two blocks shown in succession may in fact be executed substantially in parallel, or the blocks may sometimes be executed in reverse order, depending on the functionality involved. It should also be noted that each block of the block diagrams and / or flowchart diagrams, and combinations of blocks in the block diagrams and / or flowchart diagrams, may be implemented by a dedicated hardware-based system that performs the specified functions or acts, or executes a combination of dedicated hardware and computer instructions.
[0180] The description of various embodiments of the present disclosure is presented for illustrative purposes and is not intended to be exhaustive or limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used in this specification is selected to most clearly explain the principles of the embodiments, practical applications, or technical improvements over the technology found in the market, or to enable those skilled in the art to understand the embodiments disclosed in this specification.
[0181] While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. The present invention is not intended to be limited by the specific examples provided herein. Although the present invention has been described with reference to the above specification, the description and illustration of the embodiments herein are not meant to be construed in a limiting sense. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the present invention. Furthermore, it should be understood that all aspects of the present invention are not limited to the specific depictions, configurations, or relative proportions described herein which depend upon a variety of conditions and variables. It should be understood that various alternatives to the embodiments of the present invention described herein may be employed in practicing the present invention. It is therefore contemplated that the present invention also covers any such alternatives, modifications, variations, or equivalents. The following claims define the scope of the present invention, and it is intended that methods and structures within the scope of these claims and their equivalents be covered thereby.
Claims
[Claim 1] The invention described in this specification.