Systems and methods for connecting a medical imaging device to a medical imaging controller

Abstract

A cable for connecting a medical imaging device to a medical imaging controller, comprising: a first connector located at the distal end of the cable for connecting to the imaging device; a second connector located at the proximal end for connecting to the medical imaging controller; a circuit board including at least one memory that stores at least authentication information associated with the cable. The circuit board is communicatively connected to the second connector via a communication bus on the circuit board to enable the medical imaging controller to access the authentication information. One or more imaging communication lines extend between the first connector and the second connector for transmitting imaging data from the medical imaging device to the medical imaging controller. The one or more imaging communication lines bypass the communication bus on the circuit board.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 791,828, filed on Jan. 13, 2019, the entire contents of which are hereby incorporated by reference herein. Technical Field

[0003] The present invention generally relates to medical imaging and, more particularly, to connecting a medical imaging device to a medical imaging controller. Background Art

[0004] Medical systems, instruments, or tools are used for various purposes before, during, or after surgery. Some of these medical tools can be used in procedures commonly referred to as endoscopic procedures or open - field procedures. For example, endoscopic examination in the medical field allows viewing of internal features of a patient's body without using traditional fully invasive surgery. Endoscopic imaging systems combine an endoscope that enables a surgeon to view the surgical site, and endoscopic tools that enable minimally invasive surgery at that site. For example, such a tool can be a razor - type device for mechanically cutting bone and hard tissue, or a radio - frequency (RF) probe for removing or coagulating tissue via ablation to minimize bleeding at the surgical site.

[0005] In endoscopic surgery, the endoscope is placed at a location in the body where a surgical procedure is to be performed. Other surgical instruments (such as the endoscopic tools mentioned above) are also placed at the surgical site in the body. The surgeon views the surgical site through the endoscope in order to manipulate the tools to perform the desired surgical procedure. For the purpose of processing the images received by the endoscope, some endoscopes can be used with a camera. An endoscopic camera system typically includes a camera connected to a camera control unit (CCU) via a cable. The CCU processes the input image data received from the camera's image sensor via the cable and then outputs the image data for display. The resolution and frame rate of endoscopic camera systems are constantly increasing, and each component of the system must be designed accordingly.

[0006] Another type of medical imager that can include a camera connected to a CCU via a cable is an open - field imager. Open - field imagers can be used to image an open surgical field, such as visualizing blood flow in blood vessels and related tissue perfusion during plastic, microsurgical, reconstructive, and gastrointestinal procedures.

[0007] The cameras of endoscope imaging systems, open field imaging systems, and other types of medical imaging systems can be specialized, with different forms and functions for various medical specialties and / or procedures. The CCU can process imaging data in different ways depending on the type of camera. Thus, it is desirable for the CCU to be able to identify and have information about the camera. This information can be used for a variety of different purposes to achieve optimal accuracy and the display desired by the user. SUMMARY OF THE INVENTION

[0008] According to some embodiments, a cable for connecting a camera to a CCU includes: a printed circuit board integrated into the cable for enabling the connected CCU to authenticate the cable. The printed circuit board can include an authentication component that allows secure storage of authentication information (such as encryption keys) and performs operations required for encrypted communication with the CCU to enable a secure confirmation that the correct cable is being used, which can help ensure optimal performance of the imaging system. In some embodiments, the circuit board includes: one or more components that store information about the camera and the cable itself. The authentication ability in the cable ensures that the camera and cable information can be trusted.

[0009] According to some embodiments, a cable for connecting a medical imaging device to a medical imaging controller includes: a first connector located at the distal end of the cable for connecting the cable to the medical imaging device; and a second connector located at the proximal end of the cable for connecting the cable to the medical imaging controller. The cable includes: a circuit board that includes at least one memory, wherein the at least one memory stores at least authentication information associated with the cable, and the circuit board is communicatively connected to the second connector via a communication bus on the circuit board for enabling the medical imaging controller connected to the second connector to access the authentication information. The cable includes: one or more imaging communication lines extending between the first connector and the second connector for transmitting imaging data from the medical imaging device connected to the first connector to the medical imaging controller connected to the second connector, wherein the one or more imaging communication lines bypass the communication bus on the circuit board.

[0010] In any of these embodiments, the at least one memory can further store identification information for identifying the medical imaging device associated with the cable.

[0011] In any of these embodiments, the at least one memory can include a plurality of memories.

[0012] In any of these embodiments, the authentication information can be stored in a memory on the circuit board, such as the memory of an authentication chip, and the identification information can be stored in a separate memory on the circuit board.

[0013] In any of these embodiments, the circuit board may include: one or more processors for facilitating communication between the medical imaging controller and at least a portion of the at least one memory.

[0014] In any of these embodiments, the one or more processors may be configured to facilitate communication of one or more medical imaging device calibration parameters stored in at least a portion of the at least one memory to the medical imaging controller.

[0015] In any of these embodiments, the cable may further include: at least one auxiliary communication line extending between the first connector and the circuit board for transmitting at least non-imaging data from the medical imaging device to or through the circuit board.

[0016] In any of these embodiments, the communication bus may be communicatively coupled to the second connector, and at least one auxiliary communication line may be connected to the communication bus.

[0017] In any of these embodiments, at least a portion of the at least one memory may be directly connected to the communication bus.

[0018] In any of these embodiments, the circuit board may be located at the proximal end of the cable.

[0019] In any of these embodiments, the circuit board may be integrally formed as part of the cable.

[0020] In any of these embodiments, the circuit board may be overmolded to protect the circuit board during cable disinfection.

[0021] In any of these embodiments, the cable may further include a second circuit board located near the first connector.

[0022] In any of these embodiments, the at least one memory may store at least one of medical imaging device runtime, medical imaging device type, medical imaging device usage count, medical imaging device button operation count, cable identification information, cable type, medical imaging device identification information, medical imaging device calibration information, and medical imaging device pixel compensation information.

[0023] In any of these embodiments, the one or more imaging control lines may extend between the first connector and the second connector for transmitting imaging control signals from a medical imaging controller connected to the second connector to a medical imaging device connected to the first connector, wherein the one or more imaging control lines bypass the communication bus of the circuit board.

[0024] In any of these embodiments, the first connector may be configured to connect to at least one of an endoscopic camera, a medical microscope camera, and an open field medical camera.

[0025] In any of these embodiments, the one or more imaging communication lines may be configured to transmit at least one of pixel data and voxel data.

[0026] According to some embodiments, a device includes: a medical imaging device connected to a cable, the cable including: a first connector located at the distal end of the cable for connecting the cable to the medical imaging device; a second connector located at the proximal end of the cable for connecting the cable to a medical imaging controller, the circuit board including at least one memory, wherein the at least one memory stores at least authentication information associated with the cable, and the circuit board is communicatively connected to the second connector via a communication bus on the circuit board for enabling a medical imaging controller connected to the second connector to access the authentication information; and one or more imaging communication lines extending between the first connector and the second connector for transmitting imaging data from the medical imaging device connected to the first connector to the medical imaging controller connected to the second connector, wherein the one or more imaging communication lines bypass the communication bus on the circuit board.

[0027] In any of these embodiments, the at least one memory may further store identification information of the medical imaging device.

[0028] In any of these embodiments, the at least one memory may include a plurality of memories.

[0029] In any of these embodiments, the authentication information may be stored in the memory of an authentication chip on the circuit board, and the identification information may be stored in a separate memory on the circuit board.

[0030] In any of these embodiments, the circuit board may include: one or more processors for facilitating communication between the medical imaging controller and at least a portion of the at least one memory.

[0031] In any of these embodiments, the one or more processors may be configured to facilitate communication of one or more medical imaging device calibration parameters stored in at least a portion of the at least one memory.

[0032] In any of these embodiments, the device may further include: at least one auxiliary communication line extending between the first connector and the circuit board for transmitting at least non-imaging data from the medical imaging device to the circuit board.

[0033] In any of these embodiments, a communication bus may be communicatively coupled to a second connector, and the at least one auxiliary communication line may be connected to the communication bus.

[0034] In any of these embodiments, at least a portion of the at least one memory may be directly connected to the communication bus.

[0035] In any of these embodiments, the circuit board may be located proximal to the cable.

[0036] In any of these embodiments, the circuit board may be integrally formed as part of the cable.

[0037] In any of these embodiments, the circuit board may be overmolded to protect the circuit board during cable disinfection.

[0038] In any of these embodiments, the cable may include a second circuit board located near the first connector.

[0039] In any of these embodiments, the at least one memory may store at least one of a medical imaging device runtime, a medical imaging device type, a medical imaging device usage count, a medical imaging device button operation count, a cable identification information, a cable type, a medical imaging device identification information, a medical imaging device calibration information, and a medical imaging device pixel compensation information.

[0040] In any of these embodiments, the cable may further include: one or more imaging control lines extending between the first connector and the second connector for transmitting imaging control signals from a medical imaging controller connected to the second connector to a medical imaging device connected to the first connector, wherein the one or more imaging control lines bypass the communication bus of the circuit board.

[0041] In any of these embodiments, the medical imaging device may be an endoscope camera, a medical microscope camera, or an open field medical camera.

[0042] In any of these embodiments, the one or more imaging communication lines may be configured to transmit at least one of pixel data and voxel data.

[0043] According to some embodiments, a medical imaging system includes: a medical imaging device, a medical imaging controller, and a cable connecting the medical imaging device to the medical imaging controller. The medical imaging controller includes one or more processors, a memory, and one or more programs stored in the memory for execution by the one or more processors. The one or more programs include instructions for: accessing cable authentication information stored in at least one memory of a circuit board of the cable, and authenticating the cable based on the cable authentication information stored in the at least one memory.

[0044] In any of these embodiments, the cable may include: a first connector located at a distal end of the cable and connecting the cable to the medical imaging device; a second connector located at a proximal end of the cable and connecting the cable to the medical imaging controller; and one or more imaging communication lines extending between the first connector and the second connector for transmitting imaging data from the medical imaging device to the medical imaging controller. The circuit board is communicatively connected to the second connector via a communication bus on the circuit board to enable the medical imaging controller connected to the second connector to access the authentication information, and the one or more imaging communication lines bypass the communication bus on the circuit board.

[0045] In any of these embodiments, the circuit board may be integrally formed as a part of the cable.

[0046] In any of these embodiments, the one or more programs may include instructions for providing an unauthenticated cable warning based on an unsuccessful authentication of the cable.

[0047] In any of these embodiments, the one or more programs may include instructions for accessing medical imaging device identification information stored in at least one memory and controlling the medical imaging device based on the medical imaging device identification information.

[0048] In any of these embodiments, the one or more programs may include instructions for communicating with one or more processors of the circuit board to retrieve one or more medical imaging device calibration parameters stored in the at least one memory.

[0049] In any of these embodiments, the one or more programs may include instructions for communicating with one or more non-imaging components in the medical imaging device via a communication bus on the circuit board.

[0050] In any of these embodiments, the one or more programs may include instructions for receiving imaging data from the medical imaging device via one or more imaging communication lines in the cable, where the imaging communication line bypasses the circuit board.

[0051] According to some embodiments, a method for authenticating a cable via a medical imaging controller connected to a medical imaging device via a cable, the medical imaging controller including one or more processors, a memory, and one or more programs stored in the memory for execution by the one or more processors, the method including: accessing cable authentication information stored in at least one memory of a circuit board of the cable; and authenticating the cable based on the cable authentication information stored in the at least one memory.

[0052] In any of these embodiments, the cable can include: a first connector located at a distal end of the cable and connecting the cable to the medical imaging device; a second connector located at a proximal end of the cable and connecting the cable to the medical imaging controller; and one or more imaging communication lines extending between the first connector and the second connector for transmitting imaging data from the medical imaging device to the medical imaging controller, wherein the circuit board is communicatively connected to the second connector via a communication bus on the circuit board to enable the medical imaging controller connected to the second connector to access the authentication information, and the one or more imaging communication lines bypass the communication bus on the circuit board.

[0053] In any of these embodiments, the circuit board can be integrally formed as part of the cable.

[0054] In any of these embodiments, the method can further include: providing an unauthenticated cable warning based on an unsuccessful authentication of the cable.

[0055] In any of these embodiments, the one or more programs include: instructions for accessing medical imaging device identification information stored in the at least one memory and controlling the medical imaging device based on the medical imaging device identification information.

[0056] In any of these embodiments, the method can further include: communicating with one or more processors of the circuit board to retrieve one or more medical imaging device calibration parameters stored in the at least one memory.

[0057] In any of these embodiments, the method can further include: communicating with one or more non-imaging components in the medical imaging device via a communication bus on the circuit board.

[0058] In any of these embodiments, the method can further include: receiving imaging data from the medical imaging device via one or more imaging communication lines in the cable, wherein the imaging communication lines bypass the circuit board.

[0059] According to some embodiments, a non-transitory tangible computer-readable medium has computer-executable program code embedded thereon for implementing any of the above methods.

[0060] According to some embodiments, a computer program product includes computer-executable instructions that, when implemented by a programmable computer, cause the computer to perform any of the above methods.

[0061] According to some embodiments, a method of imaging tissue of a subject includes: authenticating a cable via a medical imaging controller connected to a medical imaging device via a cable, the medical imaging controller including one or more processors, a memory, and one or more programs stored in the memory for execution by the one or more processors, the one or more programs including instructions for: accessing cable authentication information stored in at least one memory of a circuit board integrally formed as part of the cable, and authenticating the cable based on the cable authentication information stored in the at least one memory; and generating a time series of images of the subject's tissue using the medical imaging device and the authenticated cable.

[0062] In any of these embodiments, generating a time series of images of the subject's tissue may include generating a time series of fluorescence images of the subject's tissue.

[0063] In any of these embodiments, the method may further include: administering a fluorescence imaging agent to the subject before generating the time series of fluorescence images of the subject's tissue.

[0064] According to some embodiments, a kit for processing a time series of images of a subject's tissue includes any of the above cables, any of the above devices, any of the above systems, or the above non-transitory tangible computer-readable medium.

[0065] In any of these embodiments, the imaging agent may be a fluorescence imaging agent. The fluorescence imaging agent may be or may include tricarbocyanine dyes, ICG, methylene blue, fluorescein isothiocyanate, rhodamine, phycoerythrin, phycocyanin, allophycocyanin, o-phthalaldehyde, fluorescamine, rose bengal, trypan blue, fluorogold, or a combination thereof. In some embodiments, analogs or derivatives of the fluorescence imaging agent may be used.

[0066] According to some embodiments, the fluorescence imaging agent is used in any of the above systems, any of the above methods, or any of the above kits for imaging tissue.

[0067] In any of these embodiments, imaging the tissue may include: imaging the tissue during blood flow imaging, tissue perfusion imaging, lymphatic imaging, or a combination thereof.

[0068] In any of these embodiments, blood flow imaging, tissue perfusion imaging, and / or lymphatic imaging may include: blood flow imaging, tissue perfusion imaging, and / or lymphatic imaging performed during an invasive medical procedure, a minimally invasive medical procedure, or a non-invasive medical procedure.

[0069] In any of these embodiments, an invasive medical procedure may include: a cardiac-related medical procedure or a reconstructive medical procedure.

[0070] In any of these embodiments, a cardiac-related medical procedure may include a coronary artery bypass graft (CABG) procedure.

[0071] In any of these embodiments, the CABG procedure may be on-pump or off-pump.

[0072] In any of these embodiments, a non-invasive medical procedure may include a wound care procedure.

[0073] In any of these embodiments, lymphatic imaging may include: identification of lymph nodes, lymph node drainage, lymphatic mapping, or a combination thereof.

[0074] In any of these embodiments, lymphatic imaging may be related to the female reproductive system.

[0075] According to some embodiments, any one of the above-mentioned cables, any one of the above-mentioned devices, any one of the above-mentioned systems, any one of the above-mentioned methods, any one of the above-mentioned kits, or any one of the above-mentioned fluorescent agents is used for lymphatic imaging.

[0076] According to some embodiments, any one of the above-mentioned cables, any one of the above-mentioned devices, any one of the above-mentioned systems, any one of the above-mentioned methods, any one of the above-mentioned kits, or any one of the above-mentioned fluorescent agents is used for blood flow imaging, tissue perfusion imaging, or a combination thereof. BRIEF DESCRIPTION OF THE DRAWINGS

[0077] The present invention will now be described by way of example only with reference to the accompanying drawings, in which:

[0078] Figure 1A An endoscopic camera system according to one embodiment is shown;

[0079] Figure 1B An open field camera system according to one embodiment is shown;

[0080] Figure 2A and 2B An imaging system according to one embodiment is illustrated, which includes an imaging device connected to an imaging controller via a cable;

[0081] Figure 3 is a block diagram of a printed circuit board for a connection cable from an imaging device to an imaging controller according to one embodiment;

[0082] Figure 4 is a block diagram of an imaging system according to one embodiment, showing the paths of light and signals in the overall system;

[0083] Figure 5 is a block diagram of a method for authenticating a cable connecting an imaging device to an imaging controller according to one embodiment;

[0084] Figure 6 is an illustrative depiction of an exemplary fluorescence imaging system according to some embodiments;

[0085] Figure 7 is an illustrative depiction of an exemplary illumination module of a fluorescence imaging system according to some embodiments; and

[0086] Figure 8 is an exemplary camera module of a fluorescence imaging system according to some embodiments. DETAILED DESCRIPTION

[0087] Implementations and embodiments of various aspects and variations of the systems and methods described herein will now be described in detail. Although several exemplary variations of the systems and methods are described herein, other variations of the systems and methods may include aspects of the systems and methods described herein combined in any suitable manner having all or some of the described aspects in combination. Devices, systems, and methods are described herein for connecting an imaging device to an imaging controller using an authenticable cable that can store information about the cable and / or the imaging device. Since conventional imaging devices typically include: electronics for image sensing and user interface components, a known method for storing information about the imaging device is to incorporate memory into the existing electronics and provide a communication channel through which the imaging controller can access these memory elements. However, this method ignores the importance of the cable in system performance. The cables described herein according to various exemplary embodiments provide the ability to authenticate the cable to prevent the use of potentially low-quality substitutes. Additionally, according to various embodiments, information about the imaging device can be stored on the cable rather than in the imaging device, which allows for the storage of information about the cable itself and reduces the complexity of the imaging device.

[0088] According to some embodiments, a cable for connecting an imaging device to an imaging controller includes: a printed circuit board assembly integrated into the cable. The printed circuit board may include: a memory for storing information about an image sensor in a camera, a camera assembly, and the cable itself. The circuit board includes an authentication component that allows for secure storage of encryption keys and performs operations required for encrypted communication with a camera control unit to allow for secure confirmation that the correct cable is being used. The circuit board may also include a microcontroller that is capable of communicating with and controlling one or more of the other components on the circuit board.

[0089] According to some embodiments, at least one of the authentication component, the microcontroller, and the memory element is connected to the same communication bus to facilitate minimizing the number of wires in the cable. The same communication bus may continue to the imaging device for use by one or more components in the imaging device. The microcontroller is capable of routing the communication path in such a way that its own firmware can be updated if new or different functionality of the circuit board is needed.

[0090] Several types of information may be stored in the electronic components on the circuit board. Calibration information of an image sensor, life usage information of a camera and a cable, logs of various types of events, camera identification information, cable identification information, and cable authentication information are some examples of information that may be stored in the circuit board. Previously, this information was typically not stored at all or was stored inside the camera. The larger the storage capacity required in the camera, the more complex the design of the camera becomes. The storage in the camera is actually only useful for the camera information itself and not for the cable information, because cables tend to get damaged over time and are then replaced by a third party on site. The camera and the camera control unit have no way of knowing whether such a replacement has occurred, and thus may track incorrect information in many cases. Moving the storage to the cable and adding authentication forces qualified personnel to use compliant replacement cables and services, which means the information will be correctly transferred and transferred to the replacement unit.

[0091] Collecting all of the above information and ensuring its accuracy has multiple benefits. It allows the camera system to indicate when periodic maintenance may be needed based on actual usage data. It also allows many systems to aggregate usage data over the life of the platform, and then all of the usage data can be analyzed to better understand use cases, test requirements, and quality issues of future products. Additionally, the more information each unit collects, the easier it becomes during development and testing, and even during troubleshooting on site. The authentication capability further ensures a high-quality experience for the end user by increasing the likelihood that only cables designed, verified, and validated to work with the camera system will be used.

[0092] In the following description of various embodiments, reference is made to the accompanying drawings, which show by way of illustration specific embodiments in which the disclosure may be practiced. It is to be understood that other embodiments and examples may be practiced and changes may be made without departing from the scope of the disclosure.

[0093] In addition, it is to be understood that the singular forms "a", "an", and "the" as used in the following description are also intended to include the plural forms, unless the context clearly dictates otherwise. It is also to be understood that the term "and / or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items. It is further to be understood that the terms "comprises", "comprising", "has", and / or "having" when used herein specify the presence of the stated features, integers, steps, operations, elements, components, and / or units, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, units, and / or groups thereof.

[0094] Certain aspects of the disclosure include process steps and instructions described herein in algorithmic form. It should be noted that the process steps and instructions of the disclosure may be embodied in software, firmware, or hardware, and when embodied in software, may be downloaded to reside on and run from different platforms used by a variety of operating systems. Unless specifically stated otherwise clearly from the following discussion, it is to be appreciated that throughout this description, the discussion utilizes terms such as "processing", "computing", "calculating", "determining", "displaying", "generating", etc. to refer to actions and processes of a computer system or similar electronic computing device that manipulates and transforms data represented as physical (electronic) quantities in the computer system memory or registers or other such information storage, transmission, or display devices.

[0095] In some embodiments, the disclosure also relates to an apparatus for performing the operations herein. The apparatus may be specially constructed for the desired purposes or it may comprise a general-purpose computer selectively activated or reconfigured by a computer program stored in a computer. Such a computer program may be stored in a non-transitory computer-readable storage medium, such as but not limited to any type of disk, including floppy disks, USB flash drives, external hard disk drives, optical disks, CD-ROMs, magneto-optical disks, read-only memory (ROM), random access memory (RAM), EPROM, EEPROM, magnetic or optical cards, application specific integrated circuits (ASICs), or any type of medium suitable for storing electronic instructions, and all are connected to the computer system bus. Additionally, the computers mentioned in the specification may include a single processor or may be an architecture employing a multi-processor design to increase computing power.

[0096] The methods, devices, and systems described herein have no inherent relationship with any particular computer or other device. A variety of general-purpose systems may also be used with programs in accordance with the teachings herein, or it may prove convenient to construct more specialized devices to perform the required method steps. The structure required for various such systems will become apparent from the following description. In addition, the present invention has not been described with reference to any particular programming language. It should be appreciated that a variety of programming languages may be used to implement the teachings of the present invention as described herein.

[0097] Figure 1A An exemplary medical imaging system 10 in accordance with the principles described herein is shown, which may utilize an authenticated data cable to connect a medical imaging device to a medical imaging controller. As used herein, medical imaging includes, but is not limited to, pre-operative, intra-operative, post-operative, and diagnostic imaging sessions and procedures. System 10 includes a scope assembly 11 that may be used in endoscopic surgery. Scope assembly 11 incorporates an endoscope or viewer 12 that is coupled to an endoscope camera 13 via a coupler 14 located at the distal end of the camera 13. Light is provided to the viewer by a light source 14A via an optical waveguide 15, such as an optical fiber cable. Camera 13 is connected to a camera control unit (CCU) 17 via a cable 18. The operation of camera 13 is controlled in part by CCU 17. Cable 18 transfers still and / or video image data from camera 13 to CCU 17 and transfers various control signals bidirectionally between camera 13 and CCU 17. In one embodiment, the image data output by camera 13 is digital. As discussed further below, cable 18 may include a memory device for storing authentication data for authenticating cable 18.

[0098] A control or switch arrangement 20 may be provided on camera 13 and allows a user to manually control various functions of system 10. These and other functions may also be controlled by voice commands using a voice control unit 23 connected to CCU 17. Optionally, voice commands are input into a microphone 24 that is mounted on a headset 25 worn by a surgeon and coupled to voice control unit 23. A hand-held control device 26, such as a tablet computer or PDA having a touch-screen user interface, may be connected to voice control unit 23 as an additional control interface. In the illustrated embodiment, a recorder 27 and a printer 28 are also connected to CCU 17. Additional devices, such as image capture and archival devices, may be included in system 10 and connected to CCU 17. The video image data acquired by camera 13 and processed by CCU 17 is converted into an image that may be displayed on a monitor 29, recorded by recorder 27, and / or used to generate a static image, a hard copy of which may be produced by printer 28.

[0099] Figure 1B Illustrated is an open field imaging device 60, as discussed herein, which is another example of a type of imaging device that can be connected to an imaging controller via an authenticated cable. The open field imaging device 60 can be used as part of an imaging system, such as Figure 1B system 10, for various purposes, including visualizing blood flow in blood vessels and associated tissue perfusion during plastic, microsurgical, reconstructive, and gastrointestinal procedures. As Figure 1B can be seen, the open field imaging device 60 includes a control surface 62, a window frame 64, and a nosepiece 66. The open field imaging device 60 can be connected to a light source 14A via an optical fiber cable 15, through which light is provided to the imaging field via a port in the window frame 64. According to the principles described herein, the open field imaging device 60 can be connected to a CCU 17 via an authenticated data cable 18, which can transmit power, imaging data, and any other type of data.

[0100] The control surface 62 includes focusing buttons 63a (decrease working distance) and 63b (increase working distance) that control linkage 40. Other buttons on the control surface 62 can be programmable and can be used for various other functions, such as firing laser power on / off, display mode selection, white light imaging white balance, saving screenshots, and so on. In some embodiments, control surface functions can be transmitted to the CCU 17 via a non-imaging data communication line in cable 18, as discussed further below.

[0101] Figure 2A and 2B Illustrated is an imaging system 200, which includes: an imaging device 201 (such as Figure 1A endoscope camera 13 or Figure 1B open field imaging device 60), a cable 202, and an imaging controller 203 (such as Figure 1A CCU 17). The cable 202 is configured to communicatively connect the imaging device 201 to the imaging controller 203 such that the imaging controller 203 can receive imaging data from the imaging device 201 for processing and / or display and control one or more imaging and / or non-imaging functions of the imaging device 201. The imaging device can be a medical imaging device or a non-medical imaging device. The imaging device can be a surgical imaging device. The imaging device can be any one of an endoscope camera, a surgical microscope camera, or an open field medical camera.

[0102] The cable 202 includes a distal end 204 that includes a distal connector 205 for connecting the cable 202 to the imaging device 201. The proximal end 206 of the cable 200 includes a proximal connector 208 for connecting the cable 202 to the imaging controller 203. The cable body 207 extends between the two ends 204, 206 and houses a plurality of communication lines. As used herein, a communication line is a single signal line that can be formed by solid or stranded conductive wires.

[0103] Both the distal connector 205 and the proximal connector 208 can be any suitable connectors and can include any suitable number of contacts (e.g., pins and sockets) for connecting communication lines. Suitable connectors can include one or more locking features for preventing or deterring the end user from disconnecting the connectors. Examples of suitable locking features are locking levers, locking screws, locking elbows, locking nuts, or locking bayonets. In some embodiments, the locking feature is configured to require a tool for unlocking. Suitable connectors can also be disconnectable connectors that enable the end user to disconnect the connector in the field.

[0104] In some embodiments, the distal connector 205 configured to connect the cable to the imaging device 201 can be configured for permanent or at least semi-permanent attachment to the imaging device 201 to prevent (or deter) the end user from detaching the distal connector 205 from the imaging device 201. The distal connector 205 can include one or more locking features that prevent tool-free detachment of the distal connector 205 from the imaging device. In some embodiments, the imaging device 201 and the distal connector 205 can be permanently or semi-permanently connected at the manufacturing facility and shipped to the end user as an assembled set. In some embodiments, the distal connector 205 includes a sealing feature, such as an O-ring or grommet, for sealing the connection to the imaging device 201. This can protect the imaging device 201 and / or the electronics within the cable 202 during disinfection.

[0105] In some embodiments, the proximal connector 208 is configured for disconnectable attachment to the imaging controller 203. Accordingly, the user can be able to repeatedly disconnect the proximal connector 208, such as by hand. Once disconnected, the imaging device 201 and the attached cable 202 can be cleaned, disinfected, stored, used with a different imaging controller, repaired, or otherwise deployed separately from the imaging controller 203.

[0106] The cable 202 includes one or more imaging communication lines 214 for transferring imaging data (e.g., pixel and / or voxel data) from the imaging device 201 to the imaging controller 203. The imaging communication lines 214 can be configured to transfer imaging data (such as video data) at high speed from an imaging sensor in the imaging device to an imaging data processor in the imaging controller. The cable 202 can include: one or more imaging control communication lines 216 that enable control communication to be exchanged between the imaging device 201 and the imaging controller 203. The communication lines including the imaging communication lines 214 and the imaging control lines 216 can be any suitable number of any suitable data communication lines.

[0107] The cable 202 includes: a printed circuit board (PCB) 210 that includes at least one memory 212 which stores information retrievable by an imaging device controller via a communication bus 211 on the PCB 210. The at least one memory 212 can store authentication data for enabling the connected imaging controller 203 to authenticate the cable such that when the cable is connected to the imaging controller 203, the imaging controller 203 can access the information on the at least one memory 212 and verify that the cable is an authenticated cable. This capability can help ensure the use of a cable with the capabilities and quality intended for connecting an imaging device to an imaging controller. By providing the ability to authenticate the cable, the system can prevent an end user or a third-party service provider from replacing the cable with an inferior or unauthenticated third-party cable, which can improve the performance of the imaging system.

[0108] In addition to the authentication information for access by the imaging controller 203, the at least one memory 212 can also store other information. The stored data can include cable-related information such as cable type, cable identity, and cable usage count, and / or can include device information including imaging device type, imaging device identity, imaging device usage count, imaging device settings, imager calibration parameters, imager pixel compensation information, imaging device runtime, imaging device button operation count, or any other useful information. The ability to authenticate the cable can enable the imaging system to trust the other information stored in the PCB.

[0109] In the illustrated embodiment, the PCB 210 is located at the proximal end 206 of the cable 200. In other embodiments, the PCB 210 is located in another part of the cable 200, such as at the distal end 202 or between the proximal and distal ends. In the illustrated embodiment, the PCB 210 is communicatively connected to the proximal connector 208, such as by one or more wires 213 connecting to pins or sockets 215 of the proximal connector 208. The PCB 210 can be a single PCB or multiple PCBs.

[0110] The PCB 210 can be integrally formed in one or more ends of the cable. For example, the PCB can be connected to the proximal connector 208 and any non - communication wiring and then overmolded. Integrating the PCB 210 in this way can ensure that the PCB is sealed within the cable, which is important for cables that require disinfection, and can help prevent an end - user or third - party from removing the PCB 210 and installing the PCB 210 in a third - party cable in an attempt to bypass the security features provided by the cable.

[0111] In some embodiments, the cable 202 includes one or more auxiliary communication lines 218 for transmitting at least non - imaging data between the imaging controller 203 and the imaging device 201. The imaging device 201 can include one or more non - imaging components, such as the switch arrangement 20 of the system 10, and the auxiliary communication lines 218 can communicatively connect the non - imaging components to the imaging controller 203. Examples of non - imaging components include memory, user interface components (such as buttons and switches), sensors (such as accelerometers and gyroscopes), displays, and a controller for controlling the non - imaging components. In some embodiments, imaging and / or imaging control data is transmitted via one or more auxiliary communication lines 218.

[0112] In some embodiments, the one or more auxiliary communication lines 218 are connected to the PCB 210 such that communication on the auxiliary communication lines 218 passes through the PCB 210. In other embodiments, the one or more auxiliary communication lines 218 extend directly to the proximal connector 208, bypassing the PCB 210. In some embodiments, a portion of the auxiliary communication lines is connected to the PCB 210 and a portion of the auxiliary communication lines bypasses the PCB 210. In some embodiments, at least one of the imaging communication lines 214 and / or at least one of the auxiliary communication lines 218 are connected through the PCB 210. In some embodiments, at least one of the imaging communication lines 214 is connected through the PCB 210 but bypasses the communication bus 211 of the PCB 210.

[0113] In some embodiments, at least one of the imaging communication lines 214 bypasses the PCB 210. In some embodiments, at least one of the imaging control communication lines 216 bypasses the PCB 210. In Figure 2A and 2B the illustrated embodiment, all of the imaging communication lines 214 and imaging control communication lines 216 bypass the PCB 210. In some embodiments, at least one of the imaging communication lines 214 and / or at least one of the imaging control communication lines 216 are connected through the PCB 210 but bypass the communication bus 211 of the PCB 210.

[0114] According to some embodiments, the PCB 210 may be communicatively coupled to the proximal connector 208 such that an imaging controller coupled to the proximal connector 208 can access authentication information, and one or more imaging communication lines 214 extend from the distal connector 205 to the proximal connector 208 for transmitting imaging data from an imaging device coupled to the distal connector 205 to an imaging controller coupled to the proximal connector 208, and the one or more imaging communication lines 214 bypass the PCB 210. In some of these embodiments, the imaging control communication line 216 also bypasses the PCB 210.

[0115] The PCB 210 may include one or more components 220 in addition to the memory 212. Examples of additional components include additional memory, one or more processors, one or more microcontrollers, and one or more integrated circuits. In some embodiments, the memory 212 is a component of an authentication chip configured to communicate with the imaging controller 203 to authenticate the cable. The authentication chip may include one or more processors and one or more memories for facilitating authentication of the cable by the imaging controller. The memory 212 may include multiple discrete memories, including multiple types of memories, which may include separate memory components on the PCB 210 and / or separate memory cells incorporated into separate components on the PCB 210. For example, the memory 212 may include any suitable number of flash memories, ROMs, PROMs, EEPROMs, and RAMs and / or any combination thereof.

[0116] In some embodiments, the PCB 210 may include an additional PCB 250, which may be located at one end of the cable, such as the distal end 204, for engaging one or more components of the connected imaging device. For example, the PCB 250 may be configured to mount connectors for one or more control boards of the imaging device and to provide a large ground pad to connect the cable shield ground to the signal ground of the imaging device.

[0117] Figure 3 is a block diagram of a PCB 300 for integration into a cable as discussed above. The PCB 300 includes: an authentication chip 302, an EEPROM 304, a microcontroller 306, and a flash memory 308. The PCB 300 includes: a communication bus 310, which may be connected via one or more connections 312 to one or more pins (or sockets) of the proximal connector, such as Figure 2A and Figure 2BThe proximal connector 208. In some embodiments, the communication bus 310 includes: a clock line and a signal line. One or more components on the PCB 300 may be connected to the communication bus 310. In the illustrated embodiment, the authentication chip 302, the EEPROM 304, and the microcontroller 306 are directly connected to the communication bus 310, while the flash memory is only connected to the microcontroller 306.

[0118] In some embodiments, the communication bus 310 may be connected to one or more auxiliary communication lines, such as Figure 2A and Figure 2B the auxiliary communication line 218. The imaging controller may use the same communication lines it uses to communicate with the components on the PCB 300 to communicate with non-imaging components on the imaging device. This allows for a reduction in the number of wirings and connections (e.g., pins and / or sockets), which is beneficial for reducing failure points, reducing costs, and / or reducing disinfection complexity.

[0119] The authentication chip 302 is configured to store authentication information and communicate with the imaging controller to authenticate the authentication chip 302 by the imaging controller and thereby authenticate the cable. The authentication chip 302 allows for the secure storage of encryption keys and performs operations required for encrypted communication with the imaging controller in order to allow for a secure confirmation that the correct cable is being used.

[0120] The EEPROM 304 may be used to store information about the cable and / or information about the imaging device. Exemplary information includes: cable and imaging device serial numbers, cable and imaging device types, cable and imaging device usage statistics (e.g., number of uses, usage time), imaging device component usage (e.g., number of button presses). In some embodiments, the cable and the imaging device are assembled at the manufacturer and provided to the end user as a matching group. Imaging device data (such as any of the above information) may be pre-loaded onto the EEPROM 304 before being delivered to the end user. Thus, these types of information may be stored in the cable rather than (or in addition to) stored in the camera. In some embodiments, the information stored in the EEPROM 304 may be updated by the connected imaging controller. For example, each time the imaging device is used, the imaging controller may increment the usage count of the cable and the imaging device. Additionally, the usage of non-imaging components (such as data indicating button presses) may be transmitted to the imaging controller, such as via the PCB 300 or via a communication line bypassing the PCB 300, and the imaging controller may update the data in the EEPROM 304 accordingly. In some embodiments, the imaging device may write directly to the EEPROM 304 (or other memory on the PCB 300) without the involvement of the imaging controller.

[0121] According to some embodiments, the microcontroller 306 can control one or more components on the PCB 300. The microcontroller 306 can control read / write access to one or more components via the communication bus 310. For example, commands for the microcontroller can be received from the imaging controller to enable one or more components on the PCB 300 to communicate with the imaging controller, and the microcontroller can respond accordingly. The microcontroller can also be capable of routing communication paths in such a way that if new or different functionality of the PCB 300 is required, its own firmware can be updated.

[0122] In some embodiments, the microcontroller 306 serves as a converter for communication of one or more components (such as the flash memory 308) that are not directly connected to the communication bus 310. This can be beneficial, for example, when the shared communication bus 310 is not compatible with the one or more components, such as when the one or more components require more communication lines than the communication bus 310 provides. The microcontroller can transform the communication received on the communication bus 310 into commands sent on one or more communication lines to the one or more components. This can reduce the number of communication lines that need to be connected to the imaging controller, thereby reducing complexity and cost. For example, the communication bus 310 can be a two-wire bus, and the flash memory can be configured for four-wire communication. The microcontroller can convert from two-line commands to four-line commands so that not all four-line commands need to be provided to the proximal connector.

[0123] According to some embodiments, the flash memory 308 can be used to store imaging-related information of the imaging device, such as imager calibration parameters and imager pixel compensation information.

[0124] Figure 4 Depicts the paths of light and signals of the camera system 10 according to some embodiments Figure 1A In operation, light is projected from the light source 14A through the light guide 15 to the viewer 12. The light can come from the visible light source 118 or from a light source 120 in the invisible spectrum. The light source 14A also includes a serial communication port 122 to allow communication with the CCU 17 via the non-imaging control signal line 134. The CCU 17 communicates with the light source 14A to adjust the light source and the emitted light 124 as needed.

[0125] The emitted light 124 from the light source 14A passes through the light guide 15, reaches and passes through the viewer 12, and reaches the target site. Further, the incoming image or light 126 travels through the viewer 12, enters and passes through the relay lens assembly 68 in the coupler 14, and enters the camera sensor unit 70. The relay lens 68 can be controlled by a lens driver 88 (if applicable), which sends a control signal 128 from the camera 13 to the relay lens 68.

[0126] The use of the camera can be controlled by the control / switch arrangement 20 in combination with the button board 94, which communicates with the lens driver 88 and the accelerometer / gyroscope 120. The sensor unit 70 communicates with the CCU 17 via one or more imaging control communication lines 130. High-speed digital video is transmitted from the sensor unit 70 to the CCU 17 via one or more imaging communication lines 132. The imaging communication line 132 and the imaging control communication line 130 extend to the CCU 17 through the cable 18.

[0127] Various components of the camera 13 can communicate with the printed circuit board 108 in the cable 18 and communicate with the CCU 17 through the circuit board 108. As discussed above, the circuit board can include multiple components, including but not limited to the microcontroller 110, flash memory 112, authentication chip 113, and EEPROM 116. Communication to or from camera components such as the lens driver 88 and the button board 94 is transmitted in the cable 18 via one or more auxiliary communication lines 134.

[0128] Once the high-speed digital video 132 reaches the CCU 17, the CCU 17 can process the video as needed and forward the processed video to the display via the high-speed digital video signal 132.

[0129] Such a system having a printed circuit board (including memory) in the camera cable 18 provides a much more useful and much safer system, which can, among other things, authenticate the cable and identify the type of attached camera, enabling the CCU to perform various functions and run various algorithms as needed.

[0130] Figure 5 Illustrated is an authentication according to some embodiments such as Figure 2A and Figure 2BMethod 500 for a cable such as cable 202. Method 500 can be implemented by an imaging controller (such as imaging controller 203) connected to an imaging device (such as imaging device 201) via a cable. The imaging controller can include one or more processors, a memory, and one or more programs stored in the memory for execution by the one or more processors and including instructions for performing the steps detailed below. In some embodiments, the imaging device is a medical imaging device, such as a surgical endoscope camera, a surgical microscope camera, or an open field hand-held imager.

[0131] At step 502, the imaging controller accesses cable authentication information stored in at least one memory of the circuit board of the cable. After connecting the cable to the imaging controller, the imaging controller can power the circuit board and can initiate communication with, for example, an authentication chip (such as Figure 3 authentication chip 302) to exchange authentication information (e.g., one or more cryptographic keys) according to well-known methods.

[0132] At step 504, the cable is authenticated based on the cable authentication information stored in at least one memory of the cable. The imaging controller verifies the authentication information in the memory.

[0133] In some embodiments, at step 506, the imaging controller can provide an unauthenticated cable warning based on an unsuccessful authentication of the cable. The warning can be provided as a display on a display of the imaging controller and / or a display connected to the display of the imaging controller. The warning can additionally or alternatively be provided as an audible warning, such as a buzzer or an alarm or an automated audible message. In some embodiments, the imaging controller can disable one or more normal operation functions, e.g., to prevent the use of the unauthenticated cable. In some embodiments, the imaging controller can disable operation completely.

[0134] In some embodiments, the imaging controller can access information associated with the imaging device stored in at least one memory and can control the imaging device and / or process imaging data from the imaging device based on the imaging device identification information. For example, the imaging controller can control the frame rate, shutter parameters, gain, lens positioning, or any other suitable parameter of the imaging device according to the imaging device information. The imaging controller can crop and / or scale the imaging data or otherwise process the imaging data received from the imaging device based on, for example, the imaging device type or imaging device parameters (calibration parameters, pixel compensation parameters, etc.).

[0135] In some embodiments, the imaging controller may communicate with one or more processors of the circuit board to retrieve one or more imaging device calibration parameters stored in at least one memory. For example, the imaging controller may communicate with a microcontroller to obtain pixel compensation data stored in the memory, as discussed above with respect to microcontroller 306 and flash memory 308. According to well-known methods, the imaging controller may process imaging data received from the imaging device based on the calibration and / or pixel compensation data.

[0136] In some embodiments, the imaging controller may write information to one or more memories of the circuit board. For example, the imaging controller may update a cable usage counter in the memory, update an imaging device usage counter in the memory, may update an imaging device runtime counter in the memory, or may update an imaging device button operation count. In some embodiments, a cable associated with the imaging device may be replaced, and information related to the imaging device stored in the circuit board may be transferred to the replacement cable. This allows tracking of information about the imaging device and its associated cable across their respective lifetimes, which is an improvement over known systems that completely ignore the importance of the cable to the imaging system.

[0137] In some embodiments, the imaging controller may communicate with one or more non-imaging components in the imaging device via a communication bus on the circuit board. For example, the imaging controller may send commands to a lens assembly controller in the imaging device for controlling focus and / or zoom, or may receive button press indications from a button control board in the imaging device, and / or sensor signals from the imaging device via the communication bus of the circuit board. In some embodiments, the imaging controller may write information to one or more components on the circuit board based on information received from one or more components on the imaging device. For example, whenever an associated button on the imaging device is actuated, the imaging controller may increment a button press counter in the memory on the circuit board.

[0138] In some embodiments, the imaging controller may receive imaging data from the imaging device via one or more imaging communication lines in the cable, where the one or more imaging communication lines bypass at least the communication bus of the circuit board (or bypass the circuit board entirely). Since imaging data may be data-intensive, bypassing the circuit board can reduce latency and signal-to-noise ratio of the imaging data, and additionally improve imaging data transmission performance.

[0139] Example system for use in generating imaging data

[0140] A system for collecting medical imaging data (such as Figure 1AThe system 10) may include one or more imaging systems for acquiring a time series of tissue images (e.g., a time series of fluorescence images, a time series of white light images, etc.). In some embodiments, the imaging system is a fluorescence imaging system. Figure 6 FIG. Figure 6 is a schematic example of a fluorescence imaging system 610 according to one embodiment. The fluorescence imaging system 610 includes: a light source 612 for irradiating the tissue of a subject to induce fluorescence emission from a fluorescence imaging agent 614 in the tissue of the subject (e.g., in blood, urine, lymphatic fluid, cerebrospinal fluid, or other body fluids or tissues); an image acquisition assembly 616 arranged to generate a time series of fluorescence images and / or a subject time series from the fluorescence emission; and a processor assembly 618 arranged to process the generated time series of fluorescence images / subject time series. The processor assembly 618 may include a memory 668 having instructions thereon, a processor module 662 arranged to execute the instructions on the memory 668 to process the time series of fluorescence images and / or the subject time series, and a data storage module 664 for storing the unprocessed and / or processed time series of fluorescence images and / or the subject time series. In some variations, the memory 668 and the data storage module 664 may be embodied in the same storage medium, while in other variations, the memory 668 and the data storage module 664 may be embodied in different storage media. The system 610 may further include a communication module 666 for transmitting images and other data (such as some or all of the time series of fluorescence images / subject time series, or other input data, spatial maps, subject spatial maps, and / or tissue numerical (quantifiers)) to an imaging data processing center.

[0141] In some variations, the light source 612 includes, for example, an illumination module 620. The illumination module 620 may include a fluorescence excitation source arranged to generate excitation light having a suitable intensity and a suitable wavelength for exciting the fluorescence imaging agent 614. As Figure 7 shown, the illumination module 620 may include a laser diode 622 (e.g., which may include, for example, one or more fiber-coupled diode lasers) arranged to provide excitation light to excite a fluorescence imaging agent (not shown) in the tissue of the subject. Examples of other excitation light sources that may be used in various embodiments include: one or more LEDs, arc lamps, or other illumination techniques having sufficient intensity and appropriate wavelength to excite a fluorescence imaging agent in tissue. For example, the excitation of a fluorescence imaging agent in blood (where the fluorescence imaging agent is a fluorescent dye having near-infrared excitation and emission characteristics) may use one or more 793 nm conduction-cooled single-fiber-coupled laser diode modules from DILAS Diode Laser GmbH, Germany.

[0142] In some variations, the light output from the light source 612 can be projected through one or more optical elements to shape and direct the output for illuminating the tissue region of interest. The optical elements can include one or more lenses, light guides, and / or diffractive elements to facilitate ensuring a flat field of view across substantially the entire field of view of the image acquisition assembly 616. The fluorescence excitation source can be selected to emit at a wavelength close to the absorption maximum of the fluorescence imaging agent 614 (e.g., indocyanine green (ICG), etc.). For example, as Figure 7 shown, the output 624 from the laser diode 622 can pass through one or more focusing lenses 626 and then through a homogenizing light pipe 628, such as a light pipe commonly available from Newport Corporation, USA. Finally, the light can pass through an optical diffractive element 632 (i.e., one or more optical diffusers), such as a ground glass diffractive element also available from Newport Corporation, USA. The power for the laser diode 622 can be provided by, for example, a high-current laser driver, such as those available from Lumina Power, Inc., USA. During the image acquisition process, the laser can optionally operate in a pulsed mode. An optical sensor, such as a solid-state photodiode 630, can be incorporated into the illumination module 620 and can sample the illumination intensity generated by the illumination module 620 via scattered or diffuse reflection from the various optical elements. In some variations, an additional illumination source can be used to provide guidance when the module is aligned and positioned over the region of interest.

[0143] Referring again to Figure 6 , in some variations, the image acquisition assembly 616 can be a component of the fluorescence imaging system 610, which is configured to acquire a time series of fluorescence images and / or a time series of the subject from the fluorescence emission of the fluorescence imaging agent 614. The image acquisition assembly 616 can include a camera module 640, which can include an imaging device, such as Figure 1A the endoscopic camera 13 of Figure 1B the open field imaging device 60 of Figure 2A and 2B the imaging device 201 of Figure 8As shown, the camera module 640 can collect fluorescence emissions and focus them onto the image sensor assembly 644 by using imaging optics (e.g., 646a, 646b, 648, and 650) to acquire an image of the fluorescence emission 642 from a fluorescent imaging agent in tissue. The image sensor assembly 644 can include at least one 2D solid-state image sensor. The solid-state image sensor can be a charge-coupled device (CCD), a CMOS sensor, a CID, or similar 2D sensor technology. The charge generated by the light signal converted by the image sensor assembly 644 is converted into a video signal, including both digital and analog video signals, by appropriate readout and amplification electronics in the camera module 640.

[0144] According to an exemplary variant of the fluorescence imaging system, the light source can provide an excitation wavelength of approximately 800 nm + / - 10 nm, and the image acquisition assembly uses an emission wavelength > 820 nm and NIR-compatible optics for, e.g., ICG fluorescence imaging. In an exemplary embodiment, the NIR-compatible optics can include a CCD monochromatic image sensor with a GigE standard interface and a lens compatible with the sensor in terms of optical format and mounting format (e.g., C / CS mount).

[0145] In some variants, the processor module 662 includes any computer or computing component, such as, for example, a tablet computer, a laptop computer, a desktop computer, a networked computer, or a dedicated stand-alone microprocessor. For example, the processor module 662 can include one or more central processing units (CPUs). In an exemplary embodiment, the processor module 662 is a quad-core 2.5 GHz processor with four CPUs, where each CPU is a microprocessor, such as a 64-bit microprocessor (e.g., sold as an INTEL Core i3, i5, or i7, or sold in the AMD Core FX series). However, in other embodiments, the processor module 662 can be any suitable processor with any suitable number of CPUs and / or any suitable clock speed.

[0146] The input to the processor module 662 can be taken from, for example Figure 8 the image sensor 644 of the camera module 640 as shown, from Figure 7 the solid-state photodiode 630 in the illumination module 620 in, and / or from any external control hardware, such as a footswitch or a remote control. The output is provided to the laser diode driver and the optical alignment aid. As Figure 6As shown, in some variations, the processor assembly 618 may have a data storage module 664 having the ability to save a time series of images / subject time series, or a data representation thereof, or other input data to a tangible non-transitory computer-readable medium, such as, for example, internal memory (e.g., a hard disk or flash memory), to facilitate recording and processing of the acquired data. In some variations, the processor module 662 may have an internal clock to enable control of various elements and ensure proper timing of illumination and sensor shutters. In some variations, the processor module 662 may also provide a graphical display for user input and output. The fluorescence imaging system may optionally be configured with a communication unit 666, such as a wired or wireless network connection or a video output connection, for transmitting the time series of fluorescence images when they are acquired or played back after recording. The communication unit 666 may additionally or alternatively transmit processed data, such as spatial maps, subject spatial maps, and / or tissue values.

[0147] In Figures 6 - 8 the operation of the exemplary system described, the subject is positioned relative to the fluorescence imaging system 610 such that the region of interest (e.g., the target tissue region) is located below the light source 612 and the image acquisition assembly 616, such that the illumination module 620 of the light source 612 produces a substantially uniform illumination field across substantially the entire region of interest. In some variations, an image of the region of interest may be acquired for background subtraction purposes prior to administration of the fluorescence imaging agent 614 to the subject. To acquire fluorescence images / subject fluorescence images, an operator of the fluorescence imaging system 610 may initiate acquisition of the time series of fluorescence images / subject time series by pressing a remote switch or foot control, or via a keyboard (not shown) connected to the processor assembly 618. As a result, the light source 612 is turned on, and the processor assembly 618 begins recording fluorescence image data / subject fluorescence image data provided by the image acquisition assembly 616. When operating in the pulse mode of this embodiment, the image sensor 644 in the camera module 640 is synchronized to collect fluorescence emission after the laser pulse generated by the diode laser 622 in the illumination module 620. In this way, the maximum fluorescence emission intensity is recorded, and the signal-to-noise ratio is optimized. In this embodiment, the fluorescence imaging agent 614 is administered to the subject and delivered via arterial flow to the region of interest. For example, acquisition of the time series of fluorescence images is initiated shortly after administration of the fluorescence imaging agent 614, and a time series of fluorescence images from substantially the entire region of interest is acquired during the entire entry of the fluorescence imaging agent 614. Fluorescence emission from the region of interest is collected by the collection optics of the camera module 640. The remaining ambient light and reflected excitation light are removed by subsequent optical elements (e.g., Figure 8The optical element 650 therein (which can be a filter) attenuates such that fluorescence emission can be collected by the image sensor assembly 644 with minimal interference from light from other sources.

[0148] In some variations, after the acquisition or generation of the time series of fluorescence images / subject time series, the processor assembly 618 (e.g., the processor module 662 or other processor) can then be activated to execute instructions stored on the memory 668 and process the imaging data before transmitting the imaging data to the imaging data processing system. The system 610 can transmit the spatial map / subject spatial map, and / or any clinical relevance or diagnosis derived therefrom, or both, via the connection 666 for display to the user in a composite display feed, such as as a grayscale or false color image, and / or be stored for subsequent use.

[0149] A tangible non-transitory computer-readable medium having computer-executable (readable) program code embedded thereon can provide instructions for causing one or more processors to perform one or more of the methods described herein when executing the instructions. The program code can be written in any suitable programming language and delivered to the processor in many forms, including for example but not limited to information permanently stored on a non-writable storage medium (e.g., a read-only memory device such as a ROM, a CD-ROM disk, etc.), information changeably stored on a writable storage medium (e.g., a hard disk drive, etc.), information transmitted to the processor via a communication medium (such as a local area network, a public network such as the Internet), or any type of medium suitable for storing electronic instructions. Such a computer-readable medium represents examples of various embodiments when carrying computer-readable instructions implementing the various embodiments of the methods described herein. In various embodiments, the tangible non-transitory computer-readable medium includes all computer-readable media, and the scope of the present invention is limited to computer-readable media that are both tangible and non-transitory.

[0150] The kit may include any part of the systems described herein and a fluorescence imaging agent, such as, for example, a fluorescent dye (such as ICG) or any suitable fluorescence imaging agent. In additional aspects, the kit may include a tangible non-transitory computer-readable medium having computer-executable (readable) program code embedded thereon, the program code providing instructions for causing one or more processors, when executing the instructions, to perform one or more of the methods for characterizing the tissue and / or predicting clinical data described herein. The kit may include instructions for using at least some of its components (e.g., for using the fluorescence imaging agent, for installing the computer-executable (readable) program code having instructions embedded thereon, etc.). In still additional aspects, a fluorescence imaging agent, such as, for example, a fluorescent dye, is provided for use in the methods and systems described herein. In additional variations, the kit may include any part or the entire system of the systems described herein and a fluorophore, such as, for example, a fluorescent dye (such as ICG), or any other suitable fluorophore, or a combination of fluorophores.

[0151] Example imaging agents for use in generating imaging data

[0152] According to some embodiments, in fluorescence medical imaging applications, the imaging agent is a fluorescence imaging agent, such as, for example, ICG dye. The fluorescence imaging agent (such as ICG) may be pre-administered to a subject prior to performing measurements of the signal intensity generated from the fluorescence imaging agent. ICG binds to blood proteins when administered to the subject and circulates in the tissue with the blood. The fluorescence imaging agent (e.g., ICG) may be administered to the subject as a bolus injection (e.g., injected into a vein or artery) at a concentration suitable for imaging such that the bolus circulates in the vasculature and passes through the microvasculature. In other embodiments where multiple fluorescence imaging agents are used, such agents may be administered simultaneously (e.g., as a single bolus) or sequentially in the form of separate boluses. The fluorescence imaging agent may be pre-administered to the subject prior to performing measurements of the signal intensity generated from the fluorescence imaging agent. In some embodiments, the fluorescence imaging agent may be administered via a catheter. In certain embodiments, the fluorescence imaging agent may be administered less than one hour prior to performing measurements of the signal intensity generated from the fluorescence imaging agent. For example, the fluorescence imaging agent may be administered to the subject less than 30 minutes prior to the measurement. In still other embodiments, the fluorescence imaging agent may be administered at least 30 seconds prior to performing the measurement. In yet other embodiments, the fluorescence imaging agent may be administered while performing the measurement.

[0153] According to some embodiments, a fluorescent imaging agent can be administered at various concentrations to achieve a desired circulating concentration in the blood. For example, in embodiments where the fluorescent imaging agent is ICG, it can be administered at a concentration of about 2.5 mg / mL to achieve a circulating concentration in the blood of about 5 μM to about 10 μM. In various embodiments, the upper limit of the concentration of the administered fluorescent imaging agent is the concentration at which the fluorescent imaging agent becomes clinically toxic in the circulating blood, and the lower limit of the concentration is the instrumental limitation for detecting the fluorescent imaging agent for collecting signal intensity data generated by the imaging agent circulating in the blood. In various other embodiments, the upper limit of the concentration of the administered fluorescent imaging agent is the concentration at which the fluorescent imaging agent becomes self-quenched. For example, the circulating concentration range of ICG can range from about 2 μM to about 10 mM. Thus, in one aspect, the method includes the steps of administering an imaging agent (e.g., a fluorescent imaging agent) to a subject and collecting signal intensity data (e.g., video) prior to processing the signal intensity data according to various embodiments. In another aspect, the method does not include any steps of administering an imaging agent to a subject.

[0154] According to some embodiments, a suitable fluorescent imaging agent for use in fluorescence imaging applications to generate fluorescence image data is an imaging agent that can circulate with the blood (e.g., a fluorescent dye that can circulate with components of the blood such as lipoproteins or serum plasma in the blood) and the transport vasculature of tissues (i.e., large blood vessels and the microvasculature), and that generates a signal intensity when the imaging agent is exposed to appropriate light energy (e.g., excitation light energy, or absorbed light energy). In various embodiments, the fluorescent imaging agent includes: fluorescent dyes, analogs thereof, derivatives thereof, or combinations of these. Fluorescent dyes include: any non-toxic fluorescent dye. In certain embodiments, the fluorescent dye optimally emits fluorescence in the near-infrared spectrum. In certain embodiments, the fluorescent dye is or includes a tricarbocyanine dye. In certain embodiments, the fluorescent dye is or includes ICG, methylene blue, or a combination thereof. In other embodiments, the fluorescent dye is or includes fluorescein isothiocyanate, rhodamine, phycoerythrin, phycocyanin, allophycocyanin, o-phthalaldehyde, fluorescamine, rose bengal, trypan blue, fluorogold, or a combination thereof, and can be excited using an excitation light wavelength suitable for each dye. In some embodiments, analogs or derivatives of the fluorescent dye can be used. For example, fluorescent dye analogs or derivatives include: fluorescent dyes that have been chemically modified but still retain their ability to fluoresce when exposed to light energy of an appropriate wavelength.

[0155] In various embodiments, the fluorescent imaging agent can be provided as a lyophilized powder, solid, or liquid. In certain embodiments, the fluorescent imaging agent can be provided in a vial (e.g., a sterile vial) which can be reconstituted to a suitable concentration by administering a sterile fluid with a sterile syringe. Any suitable carrier or diluent can be used for reconstitution. For example, the fluorescent imaging agent can be reconstituted immediately prior to administration with an aqueous diluent. In various embodiments, any diluent or carrier that maintains the fluorescent imaging agent in solution can be used. As an example, ICG can be reconstituted with water. In some embodiments, once the fluorescent imaging agent is reconstituted, it can be mixed with additional diluents and carriers. In some embodiments, the fluorescent imaging agent can be conjugated to another molecule, such as a protein, peptide, amino acid, synthetic polymer, or sugar, for example to enhance solubility, stability, imaging properties, or a combination thereof. Additional buffers can optionally be added, including Tris, HCl, NaOH, phosphate buffer, and / or HEPES.

[0156] Those skilled in the art will appreciate that although the fluorescent imaging agent has been described in detail above, depending on the optical imaging modality, other imaging agents can be used in combination with the systems, methods, and techniques described herein. Such fluorescent agents can be administered to body fluids (e.g., lymphatic fluid, cerebrospinal fluid) or body tissues.

[0157] In some variations, the fluorescent imaging agent used in combination with the methods, systems, and kits described herein can be used for blood flow imaging, tissue perfusion imaging, lymphatic imaging, or a combination thereof, and such imaging can be performed before, during, or after an invasive surgical procedure, minimally invasive surgical procedure, non-invasive surgical procedure, or a combination thereof. The methods of blood flow imaging, tissue perfusion imaging, lymphatic imaging, or a combination thereof can themselves exclude any invasive surgical steps. Examples of invasive surgical procedures that may involve blood flow and tissue perfusion include: surgical procedures related to the heart (e.g., on-pump or off-pump CABG) or reconstructive surgical procedures. Examples of non-invasive or minimally invasive procedures include: wound (e.g., chronic wounds such as pressure ulcers) treatment and / or management. In this regard, for example, changes in a wound over time (such as changes in wound size (e.g., diameter, area), or changes in tissue perfusion in and / or around the wound) can be tracked over time in the context of applying the methods and systems. Examples of lymphatic imaging include: identification of one or more lymph nodes, lymph node drainage, lymphatic mapping, or a combination thereof. In some variations, such lymphatic imaging may be related to the female reproductive system (e.g., uterus, cervix, vulva).

[0158] In a variant related to cardiac applications, (one or more) imaging agents (e.g., ICG alone or in combination with another imaging agent) can be intravenously injected, for example, through a central venous line, a bypass pump, and / or a cardioplegia line to flow and / or perfuse the coronary vasculature, the microvasculature, and / or the graft. ICG can be administered along the graft vessel as a diluted ICG / blood / salt solution such that the final concentration of ICG in the coronary artery is approximately the same as or lower than the concentration obtained by injecting approximately 2.5 mg (i.e., 1 ml of 2.5 mg / ml) into the central line or the bypass pump. ICG can be prepared by dissolving, for example, 25 mg of solid in 10 ml of sterile aqueous solvent, which can be provided by the manufacturer along with the ICG. One milliliter of the ICG solution can be mixed with 500 ml of sterile saline (e.g., by injecting 1 ml of the ICG into a 500 ml saline bag). Thirty milliliters of the diluted ICG / salt solution can be added to 10 ml of the subject's blood, which can be obtained in a sterile manner from the central arterial line or the bypass pump. The ICG in the blood binds to plasma proteins and helps prevent leakage out of the blood vessels. The mixing of ICG with the blood can be performed using standard aseptic techniques within a sterile surgical area. Ten milliliters of the ICG / saline / blood mixture can be administered for each graft. Instead of injecting ICG by using a needle through the wall of the graft, ICG can be administered by means of a syringe attached to the proximal (open) end of the graft. When the graft is harvested, the surgeon routinely attaches an adapter to the proximal end of the graft such that they can attach a saline-filled syringe, seal the distal end of the graft, and inject saline down the graft, pressurize the graft, and thus evaluate the integrity of the conduit (regarding leaks, side branches, etc.) prior to performing the first anastomosis. In other variants, methods, doses, or combinations thereof as described herein in connection with cardiac imaging can be used in any vascular and / or tissue perfusion imaging application.

[0159] Lymphatic mapping is an important part of the effective surgical staging of cancers that spread through the lymphatic system (e.g., breast cancer, gastric cancer, gynecologic cancers). Excision of multiple lymph nodes from a specific lymph node basin can lead to serious complications, including acute or chronic lymphedema, paresthesia, and / or seroma formation. In fact, if sentinel lymph node metastases are negative, the surrounding lymph nodes are also likely to be negative. For example, the identification of tumor-draining lymph nodes (LNs) has become an important step in staging cancers that spread through the lymphatic system, such as in breast cancer surgery. LN mapping involves the use of dyes and / or radioactive tracers to identify the LNs for biopsy or excision, and subsequent pathologic evaluation of metastases. The purpose of lymph node resection at the time of surgical staging is to identify and remove LNs at high risk for local cancer spread. Sentinel lymph node (SLN) mapping has become an effective surgical strategy for treating breast cancer. It is generally based on the concept that if metastases (cancer spread to axillary LNs) are present, they should be located in the SLN, which is defined in the art as the first LN or group of LNs to which cancer cells are most likely to spread from the primary tumor. If SLN metastases are negative, the surrounding secondary and tertiary LNs should also be negative. The primary benefit of SLN mapping is to reduce the number of subjects undergoing traditional partial or complete lymph node resection, and thus reduce the number of subjects with associated morbidities such as lymphedema and lymphocele.

[0160] The current standard of care for SLN mapping involves injection of a tracer, which identifies the lymphatic drainage pathway from the primary tumor. The tracer used can be a radioisotope (e.g., technetium-99 or Tc-99m) for intraoperative localization using a gamma probe. Radioactive tracer technology (known as scintigraphy) is limited to hospitals with access to the radioisotope, requires the involvement of a nuclear medicine physician, and does not provide real-time visual guidance. A colored dye, isosulfan blue, has also been used; however, this dye cannot be seen through skin and adipose tissue. In addition, blue staining can result in breast tattooing that lasts for months, skin necrosis can occur with subcutaneous injection, and allergic reactions as well as rare anaphylactic reactions have been reported. Severe allergic reactions (approx. 2% of patients) have occurred after injection of isosulfan blue. Manifestations include respiratory distress, shock, angioedema, urticaria, and pruritus. Subjects with a history of bronchial asthma, or those allergic to triphenylmethane dyes or having drug reactions are more likely to have a reaction. It is well known that isosulfan blue interferes with pulse oximetry for measuring oxygen saturation and gas analyzers for measuring methemoglobin. Use of isosulfan blue can result in temporary or long-term (tattoo) blue discoloration.

[0161] In contrast, fluorescence imaging according to various embodiments for use in SLN visualization and mapping facilitates direct real-time visual identification of LNs and / or afferent lymphatic channels during surgery, facilitating real-time high-resolution optical guidance through skin and adipose tissue, visualization of blood flow, tissue perfusion, or a combination thereof.

[0162] In some variants, visualization, classification, or both of lymph nodes during fluorescence imaging can be based on the imaging of one or more imaging agents, which can further be based on visualization and / or classification using a gamma probe (e.g., technetium Tc-99m is a clear, colorless aqueous solution and is typically injected into the periareolar region according to standard of care), another commonly used colored imaging agent (isosulfan blue), and / or other assessments such as, for example, histology. The subject's breast can be injected, for example, twice with approximately 1% isosulfan blue (for comparison purposes) and twice with an ICG solution at a concentration of approximately 2.5 mg / ml. The injection of isosulfan blue can precede the ICG injection, or vice versa. For example, using a TB syringe and a 30 G needle, the subject under anesthesia can be injected with 0.4 ml (0.2 ml at each site) of isosulfan blue in the periareolar region of the breast. For the right breast, the subject can be injected at the 12 o'clock position and the 9 o'clock position, while for the left breast, at the 12 o'clock position and the 3 o'clock position. The total dose of isosulfan blue injected intradermally into each breast can be approximately 4.0 mg (1% solution of 0.4 ml: 10 mg / ml). In another exemplary variant, the subject can first receive an ICG injection, followed by isosulfan blue (for comparison). A vial of 25 mg of ICG can be reconstituted with 10 ml of sterile water for injection to produce a 2.5 mg / ml solution immediately before ICG administration. For example, using a TB syringe and a 30G needle, the subject can be injected with approximately 0.1 ml of ICG (0.05 ml at each site) in the periareolar region of the breast (for the right breast, the injection can be performed at the 12 o'clock position and the 9 o'clock position, and for the left breast at the 12 o'clock position and the 3 o'clock position). The total dose of ICG injected intradermally into each breast can be approximately 0.25 mg per breast (0.1 ml of 2.5 mg / ml solution). For example, ICG can be injected at a rate of 5 to 10 seconds per injection. When injected intradermally, the protein-binding properties of ICG cause it to be rapidly absorbed by the lymph and move to the LN through conducting vessels. In some variants, ICG can be provided in the form of a sterile lyophilized powder containing 25 mg of ICG, with no more than 5% sodium iodide. ICG can be packaged with an aqueous solvent consisting of sterile water for injection, which is used to reconstitute ICG. In some variants, depending on the administration route, the ICG dose (mg) in breast cancer sentinel lymph mapping can range from approximately 0.5 mg to approximately 10 mg. In some variants, the ICG dose can be from approximately 0.6 mg to approximately 0.75 mg, from approximately 0.75 mg to approximately 5 mg, from approximately 5 mg to approximately 10 mg.The route of administration can be, for example, subcutaneous, intradermal (e.g., into the periareolar region), subareolar, over the skin covering the tumor, intradermal in the areola closest to the tumor, subcutaneous into the areola, intradermal over the tumor, periareolar over the entire breast, or a combination thereof. The injection can be before visualization and / or classification. NIR fluorescent positive LNs (e.g., using ICG) can be represented as, for example, (one or more) black and white NIR fluorescent images and / or full-color or partial-color (white light) images, fully or partially desaturated white light images, enhanced color images, overlays (e.g., fluorescence with any other image), synthetic images (e.g., fluorescence merged into another image), which can have various colors, various degrees of desaturation, or various color ranges to highlight / visualize certain features of interest. Further processing of the images can be performed for further visualization and / or other analysis (e.g., quantification). Lymph nodes and lymphatic vessels can be visualized (e.g., during surgery, in real time) as follows: using solely the fluorescence imaging system and method according to various embodiments for ICG and SLN, or using the fluorescence imaging system and method in combination with a gamma probe (Tc-99m) according to the American Society of Breast Surgeons (ASBrS) practice guidelines for SLN biopsy in breast cancer patients. Fluorescence imaging of LNs can start from the injection site by tracking the lymphatic channels leading to the LNs in the axilla. Once the visual image of the LN is identified, LN mapping and identification of the LN can be completed through the incised skin, and LN mapping can be performed until the ICG-visualized lymph node is identified. The LN mapping method itself can exclude any surgical steps. For comparison, mapping using isosulfan blue can be performed until the "blue" lymph node is identified. LNs identified solely using ICG or in combination with another imaging technique (e.g., isosulfan blue and / or Tc-99m) can be marked for excision. The subject may have breast cancer at different stages (e.g., IA, IB, IIA).

[0163] In some variations, such as, for example, in gynecological cancers (e.g., uterine cancer, endometrial cancer, vulvar cancer, and cervical cancer), ICG can be administered interstitially for visualization of lymph nodes, lymphatic channels, or a combination thereof. Upon interstitial injection, the protein-binding properties of ICG cause it to be rapidly absorbed by the lymph and move via conducting vessels to the SLN. ICG can be provided for injection in the form of a sterile lyophilized powder that contains 25 mg of ICG (e.g., 25 mg / vial), with no more than 5.0% sodium iodide. Then, the ICG can be reconstituted with commercially available water for injection (sterile) prior to use. According to an embodiment, a vial containing 25 mg of ICG can be reconstituted with 20 ml of water for injection to yield a 1.25 mg / ml solution. For a total ICG dose of 5 mg per subject, a total of 4 ml of this 1.25 mg / ml solution is injected into the subject (4 x 1 ml injections). For a total dose of 40 mg, the cervix can also be injected four (4) times with a 1 ml solution of 1% isosulfan blue 10 mg / ml (for comparison). The injection can be performed while the subject is anesthetized in the operating room. In some variations, depending on the route of administration, the ICG dose (mg) in sentinel lymph node detection and / or mapping in gynecological cancers can range from about 0.1 mg to about 5 mg. In some variations, the ICG dose can be about 0.1 mg to about 0.75 mg, about 0.75 mg to about 1.5 mg, about 1.5 mg to about 2.5 mg, about 2.5 mg to about 5 mg. The route of administration can be, for example, cervical injection, peritumoral vulvar injection, hysteroscopic endometrial injection, or a combination thereof. To minimize interference of spillage of isosulfan blue or ICG during LN resection on the mapping procedure, the mapping can be performed on the hemipelvis, and the mapping can be performed using isosulfan blue and ICG prior to resection of any LNs. Sentinel lymph node mapping for clinical stage I endometrial cancer can be performed according to the NCCN uterine tumor guidelines, the sentinel lymph node algorithm for surgical staging of endometrial cancer; and sentinel lymph node mapping for clinical stage I cervical cancer can be performed according to the NCCN cervical tumor guidelines, the surgical / sentinel lymph node mapping algorithm for early cervical cancer. Thus, the identification of LNs can be based solely on ICG fluorescence imaging, or on a combination or co-administration of ICG fluorescence imaging with a colorimetric dye (isosulfan blue) and / or a radioactive tracer.

[0164] The visualization of lymph nodes can be qualitative and / or quantitative. Such visualization can include, for example, lymph node detection, detection rate, and the anatomical distribution of lymph nodes. The lymph node visualization according to various embodiments can be used alone or in combination with other variables (e.g., vital signs, height, weight, demographics, surgical predictors, relevant medical history and underlying conditions, histological visualization and / or assessment, Tc-99m visualization and / or assessment, concomitant medications). Follow-up visits can occur on the discharge date and subsequent dates (e.g., one month).

[0165] Lymph fluid contains a large amount of protein, so ICG can bind to endogenous proteins when entering the lymphatic system. When used according to the methods and systems described herein, fluorescence imaging for lymphatic mapping (e.g., ICG imaging) provides the following exemplary advantages: a high signal-to-background ratio (or tumor-to-background ratio) because NIR does not generate significant autofluorescence, real-time visualization characteristics for lymphatic mapping, tissue definition (i.e., structural visualization), rapid excretion and elimination after entering the vascular system, and avoidance of non-ionizing radiation. In addition, the tissue penetration of NIR imaging (approx. 5 to 10 mm of tissue) is superior to that of visible light (1 to 3 mm of tissue). For example, the use of ICG also facilitates visualization through the peritoneum covering para-aortic lymph nodes. Although tissue fluorescence can be observed with NIR light for a long time, it cannot be seen with visible light and thus does not affect the pathological evaluation or treatment of LNs. Moreover, intraoperative detection of fluorescence is easier compared to the blue staining of lymph nodes (isosulfan blue). In other variants, methods, doses, or combinations thereof described herein in combination with lymphatic imaging can be used in any vascular and / or tissue perfusion imaging application.

[0166] Tissue perfusion involves the microcirculatory flow of blood per unit tissue volume, where oxygen and nutrients are supplied to the capillary bed of the perfused tissue and wastes are removed from the capillary bed of the perfused tissue. Tissue perfusion is a phenomenon related to but distinct from blood flow in blood vessels. The quantified blood flow through a blood vessel can be expressed in terms of defining flow (i.e., volume / time) or defining velocity (i.e., distance / time). Tissue blood perfusion defines the movement of blood through the microvascular system (such as arterioles, capillaries, or venules) within the tissue volume. Quantified tissue blood perfusion can be expressed as the blood flow through the tissue volume, i.e., blood volume / time / tissue volume (or tissue mass). Perfusion is associated with nutritive blood vessels (e.g., the microvessels known as capillaries), which include the vessels associated with metabolite exchange between blood and tissue, rather than larger-diameter non-nutritive blood vessels. In some embodiments, quantification of the target tissue can include calculating or determining parameters or quantities related to the target tissue, such as rate, size volume, time, distance / time, and / or volume / time, and / or quantities of changes related to any one or more of the foregoing parameters or quantities. However, compared to the movement of blood through larger-diameter blood vessels, the movement of blood through individual capillaries can be highly erratic, mainly due to vasomotion, where spontaneous oscillations in vascular tone manifest as pulsations in the movement of red blood cells. In some embodiments, the blood flow and tissue perfusion imaging described herein in connection with the systems and methods can be used to image tumor tissue and distinguish such tissue from other tissues.

[0167] For illustrative purposes, the foregoing description has been made with reference to specific embodiments. However, the above illustrative discussion is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Given the above teachings, many modifications and variations are possible. The embodiments were chosen and described in order to best explain the principles of these techniques and their practical applications. Thereby enabling others skilled in the art to best utilize the techniques and various embodiments with various modifications suitable for the particular uses contemplated. For purposes of clear and concise description, features are described herein as part of the same or separate embodiments, however, it should be appreciated that the scope of the invention may include embodiments having combinations of all or some of the described features.

[0168] Although the present disclosure and examples have been described in sufficient detail with reference to the accompanying drawings, it should be noted that various changes and modifications should become apparent to those skilled in the art. Such changes and modifications are to be understood as being included within the scope of the disclosure and examples defined by the claims. Finally, the entire disclosures of the patents and publications mentioned in this application are hereby incorporated by reference herein.

Claims

1. A cable for connecting a medical imaging device to a medical imaging controller, the cable comprising: A first connector located at the distal end of the cable for connecting the cable to the medical imaging device; A second connector located at the proximal end of the cable for connecting the cable to the medical imaging controller; A circuit board including at least one memory, wherein the at least one memory stores at least authentication information associated with the cable and identification information for identifying the medical imaging device associated with the cable, and wherein the circuit board is communicatively connected to the second connector via a communication bus on the circuit board for enabling access to the authentication information and the identification information by the medical imaging controller connected to the second connector; and One or more imaging communication lines extending between the first connector and the second connector for transmitting imaging data from the medical imaging device connected to the first connector to the medical imaging controller connected to the second connector, wherein the one or more imaging communication lines bypass the communication bus on the circuit board.

2. The cable according to claim 1, wherein, The at least one memory includes a plurality of memories.

3. The cable according to claim 2, wherein, The authentication information is stored in the memory of an authentication chip on the circuit board, and the identification information is stored on a separate memory on the circuit board.

4. The cable according to any one of claims 1 to 3, wherein The circuit board includes one or more processors for facilitating communication between the medical imaging controller and at least a portion of the at least one memory.

5. The cable according to claim 4, wherein, The one or more processors are configured to facilitate transmission of one or more medical imaging device calibration parameters stored in at least a portion of the at least one memory to the medical imaging controller.

6. The cable according to any one of claims 1 to 3, further comprising: At least one auxiliary communication line extending between the first connector and the circuit board for transmitting at least non-imaging data from the medical imaging device to or through the circuit board.

7. The cable according to claim 6, wherein, The communication bus is communicatively coupled to the second connector, and the at least one auxiliary communication line is connected to the communication bus.

8. The cable according to claim 7, wherein, At least a portion of the at least one memory is directly connected to the communication bus.

9. The cable according to any one of claims 1 to 3, wherein, The circuit board is located at the proximal end of the cable.

10. The cable according to any one of claims 1 to 3, wherein, The circuit board is integrally formed as a part of the cable.

11. The cable according to claim 10, wherein, The circuit board is overmolded to protect the circuit board during disinfection of the cable.

12. The cable according to any one of claims 1 to 3, further comprising: A second circuit board located near the first connector.

13. The cable according to any one of claims 1 to 3, wherein, The at least one memory stores at least one of medical imaging device runtime, medical imaging device type, medical imaging device usage count, medical imaging device button operation count, cable identification information, cable type, medical imaging device identification information, medical imaging device calibration information, and medical imaging device pixel compensation information.

14. The cable according to claim 13, further comprising: One or more imaging control lines extending between the first connector and the second connector for transmitting imaging control signals from the medical imaging controller connected to the second connector to the medical imaging device connected to the first connector, wherein the one or more imaging control lines bypass the communication bus of the circuit board.

15. The cable according to any one of claims 1 to 3, wherein, The first connector is configured to connect to at least one of an endoscopic camera, a medical microscope camera, and an open field medical camera.

16. The cable according to any one of claims 1 to 3, wherein, The one or more imaging communication lines are configured to transmit at least one of pixel data and voxel data.

17. An apparatus including a medical imaging device connected to a cable, the cable including: A first connector located at a distal end of the cable and connecting the cable to the medical imaging device; A second connector located at a proximal end of the cable for connecting the cable to a medical imaging controller; A circuit board including at least one memory, wherein the at least one memory stores at least authentication information associated with the cable and identification information for identifying the medical imaging device associated with the cable, and wherein the circuit board is communicatively connected to the second connector via a communication bus on the circuit board to enable access to the authentication information and the identification information by the medical imaging controller connected to the second connector; and One or more imaging communication lines extending between the first connector and the second connector for transmitting imaging data from the medical imaging device connected to the first connector to the medical imaging controller connected to the second connector, wherein the one or more imaging communication lines bypass the communication bus on the circuit board.

18. The apparatus according to claim 17, wherein, The at least one memory includes a plurality of memories.

19. The apparatus according to claim 18, wherein, The authentication information is stored in a memory of an authentication chip on the circuit board, and the identification information is stored on a separate memory on the circuit board.

20. The apparatus according to any one of claims 17 to 19, wherein, The circuit board includes one or more processors for facilitating communication between the medical imaging controller and at least a portion of the at least one memory.

21. The apparatus according to claim 20, wherein, The one or more processors are configured to facilitate communication of one or more medical imaging device calibration parameters stored in at least a portion of the at least one memory.

22. The apparatus according to any one of claims 17 to 19, further comprising: At least one auxiliary communication line extending between the first connector and the circuit board for transmitting at least non-imaging data from the medical imaging device to the circuit board.

23. The device according to claim 22, wherein, The communication bus is communicatively coupled to the second connector, and the at least one auxiliary communication line is connected to the communication bus.

24. The apparatus according to claim 23, wherein, At least a portion of the at least one memory is directly connected to the communication bus.

25. The device according to any one of claims 17 to 19, wherein The circuit board is located at the proximal end of the cable.

26. The device according to any one of claims 17 to 19, wherein The circuit board is integrally formed as part of the cable.

27. The apparatus according to claim 26, wherein, The circuit board is overmolded to protect the circuit board during disinfection of the cable.

28. The apparatus according to any one of claims 17 to 19, wherein, The cable includes: a second circuit board located near the first connector.

29. The apparatus according to any one of claims 17 to 19, wherein The at least one memory stores at least one of medical imaging device run time, medical imaging device type, medical imaging device usage count, medical imaging device button operation count, cable identification information, cable type, medical imaging device identification information, medical imaging device calibration information, and medical imaging device pixel compensation information.

30. The apparatus according to claim 29, wherein, The cable further includes: one or more imaging control lines extending between the first connector and the second connector for transmitting an imaging control signal from a medical imaging controller connected to the second connector to a medical imaging device connected to the first connector, wherein the one or more imaging control lines bypass the communication bus of the circuit board.

31. The device according to any one of claims 17 to 19, wherein, The medical imaging device is an endoscopic camera, a medical microscope camera, or an open field medical camera.

32. The apparatus according to any one of claims 17 to 19, wherein The one or more imaging communication lines are configured to transmit at least one of pixel data and voxel data.

33. A medical imaging system, comprising: A medical imaging device, a medical imaging controller, and a cable connecting the medical imaging device to the medical imaging controller, wherein the medical imaging controller includes one or more processors, a memory, and one or more programs stored in the memory for execution by the one or more processors, the one or more programs including instructions for: Accessing cable authentication information and medical imaging device identification information stored in at least one memory of the circuit board of the cable; Authenticating the cable based on the cable authentication information stored in the at least one memory; and Controlling the medical imaging device based on the medical imaging device identification information, wherein the cable includes: A first connector located at the distal end of the cable and connecting the cable to the medical imaging device; A second connector located at the proximal end of the cable and connecting the cable to the medical imaging controller; and One or more imaging communication lines extending between the first connector and the second connector for transmitting imaging data from the medical imaging device to the medical imaging controller, wherein the circuit board is communicatively connected to the second connector via a communication bus on the circuit board to enable access to the cable authentication information and the medical imaging device identification information by the medical imaging controller connected to the second connector, and the one or more imaging communication lines bypass the communication bus on the circuit board.

34. The system according to claim 33, wherein, The circuit board is integrally formed as part of the cable.

35. The system according to any one of claims 33 to 34, wherein, The one or more programs include instructions for providing an unauthenticated cable warning based on an unsuccessful authentication of the cable.

36. The system according to any one of claims 33 to 34, wherein The one or more programs include instructions for communicating with one or more processors of the circuit board to retrieve one or more medical imaging device calibration parameters stored in the at least one memory.

37. The system according to any one of claims 33 to 34, wherein, The one or more programs include instructions for communicating with one or more non-imaging components in the medical imaging device via the communication bus on the circuit board.

38. The system according to any one of claims 33 to 34, wherein, The one or more programs include instructions for receiving imaging data from the medical imaging device via one or more imaging communication lines in the cable, wherein the imaging communication lines bypass the circuit board.

39. A method for authenticating a cable by a medical imaging controller connected to a medical imaging device via the cable, the medical imaging controller including one or more processors, a memory, and one or more programs stored in the memory for execution by the one or more processors, the method including: Access the cable authentication information and the medical imaging device identification information in at least one memory of a circuit board to which the cable is connected; Authenticate the cable based on the cable authentication information stored in the at least one memory; And Control the medical imaging device based on the medical imaging device identification information, wherein the cable includes: A first connector located at a distal end of the cable and connecting the cable to the medical imaging device; A second connector located at a proximal end of the cable and connecting the cable to the medical imaging controller; and One or more imaging communication lines extending between the first connector and the second connector for transmitting imaging data from the medical imaging device to the medical imaging controller, wherein the circuit board is communicatively connected to the second connector via a communication bus on the circuit board to enable access to the cable authentication information and the medical imaging device identification information by the medical imaging controller connected to the second connector, and the one or more imaging communication lines bypass the communication bus on the circuit board.

40. The method according to claim 39, wherein, The circuit board is integrally formed as a part of the cable.

41. The method according to any one of claims 39 to 40, further comprising: Provide an unauthenticated cable warning based on an unsuccessful authentication of the cable.

42. The method according to any one of claims 39 to 40, further comprising: Communicate with one or more processors of the circuit board to retrieve one or more medical imaging device calibration parameters stored in the at least one memory.

43. The method according to any one of claims 39 to 40, further comprising: Communicate with one or more non-imaging components in the medical imaging device via the communication bus on the circuit board.

44. The method according to any one of claims 39 to 40, further comprising: Receive imaging data from the medical imaging device via one or more imaging communication lines in the cable, wherein the imaging communication lines bypass the circuit board.

45. A non-transitory tangible computer-readable medium having computer-executable program code embedded thereon to implement the method according to any one of claims 39 to 44.

46. A computer program product including computer-implementable instructions that, when implemented by a programmable computer, cause the computer to implement the method according to any one of claims 39 to 44.

47. A kit for processing a time series of images of a subject's tissue, the kit including the cable according to any one of claims 1 to 16, the device according to any one of claims 17 to 32, the system according to any one of claims 33 to 38, or the non-transitory tangible computer-readable medium according to claim 45, and a contrast agent.

48. The kit according to claim 47, wherein The contrast agent is a fluorescence contrast agent.

49. The cable according to any one of claims 1 to 16, the device according to any one of claims 17 to 32, the system according to any one of claims 33 to 38, or the kit according to claim 47 or claim 48, for lymphatic imaging.

50. The cable according to any one of claims 1 to 16, the device according to any one of claims 17 to 32, the system according to any one of claims 33 to 38, or the kit according to claim 47 or claim 48, for blood flow imaging, tissue perfusion imaging, or a combination thereof.

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