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

Abstract

To provide an authentication method at the time of connecting a medical imaging device to a medical imaging controller.SOLUTION: A cable for connecting a medical imaging device to a medical imaging controller includes a first connector located at a distal end of the cable for connecting to the medical imaging device, a second connector located at a proximal end for connecting to the medical imaging controller, and a circuit board comprising at least one memory that stores at least authentication information associated with the cable. The circuit board is communicatively connected via a communication bus on the circuit board to the second connector for enabling access to the authentication information by the medical imaging controller. One or more imaging communication lines extend between the first connector and the second connector for communicating 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.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates generally to medical imaging, and more particularly to connecting a medical imaging device to a medical imaging controller. [Background technology]

[0002] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Application No. 62 / 791,828, filed January 13, 2019, the entire contents of which are incorporated herein by reference.

[0003] Medical systems, instruments or tools are utilized before, during or after surgery for various purposes. Some of these medical tools may be used in what are commonly referred to as endoscopic or open field procedures. For example, endoscopy in the medical field allows the surgeon to view the internal features of the patient's body without using traditional fully invasive surgery. Endoscopic imaging systems incorporate endoscopes to allow the surgeon to view the surgical site, and endoscopic tools allow minimally invasive surgery at the site. Such tools may be, for example, shaver-type devices that mechanically cut bone and hard tissue, or radio frequency (RF) probes that are used to remove tissue by ablation or to coagulate tissue to minimize bleeding at the surgical site.

[0004] In endoscopic surgery, an endoscope is placed inside the body at a location where a surgical procedure needs to be performed. Other surgical instruments, such as the endoscopic tools mentioned above, are also placed inside the body at the surgical site. The surgeon views the surgical site through the endoscope and manipulates the tools to perform the desired surgical procedure. Some endoscopes are available with a camera head for the purpose of processing images received by the endoscope. An endoscopic camera system typically includes a camera head connected by a cable to a camera control unit (CCU). The CCU processes input image data received from the camera's imaging sensor via the cable and then outputs image data for display. The resolution and frame rate of endoscopic camera systems continue to increase, and each component of the system must be designed accordingly.

[0005] Another type of medical imaging device, which may include a camera head connected to the CCU by a cable, is an open-field imaging device, which may be used to image an open surgical field, such as to visualize blood flow within blood vessels and associated tissue perfusion during plastic, microsurgical, reconstructive, and gastrointestinal procedures.

[0006] The camera heads of endoscopic imaging systems, open field imaging systems, and other types of medical imaging systems may be specialized, with different forms and functions for various medical specialties and / or procedures. The CCU may process the imaging data differently depending on the type of camera head. It is therefore desirable for the CCU to be able to identify the camera head and have information about the camera head. This information can be used for a variety of different purposes to achieve the best accuracy and desired view for the user. Summary of the Invention

[0007] According to some embodiments, a cable for connecting a camera head to a CCU includes a printed circuit board integrated into the cable to allow a connected CCU to authenticate the cable. The printed circuit board may include an authentication component that allows secure storage of authentication information, such as encryption keys, and performs the operations necessary for encrypted communication with the CCU to allow secure verification that the proper 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 head and the cable itself. The authentication capabilities in the cable ensure that this camera head and cable information can be trusted.

[0008] According to some embodiments, a cable connecting a medical imaging device to a medical imaging controller includes a first connector disposed at a distal end of the cable for connecting the cable to a medical imaging device and a second connector disposed at a proximal end of the cable for connecting the cable to a medical imaging controller. The cable includes a circuit board having at least one memory that stores at least authentication information associated with the cable, the circuit board communicatively connected to the second connector via a communication bus on the circuit board to enable access to the authentication information by a medical imaging controller connected to the second connector. The cable includes one or more imaging communication lines extending between the first connector and the second connector for communicating imaging data from a medical imaging device connected to the first connector to a medical imaging controller connected to the second connector, the one or more imaging communication lines bypassing the communication bus on the circuit board.

[0009] In any of these embodiments, the at least one memory may further store identification information for identifying a medical imaging device associated with the cable.

[0010] In any of these embodiments, the at least one memory may include a plurality of memories.

[0011] In any of these embodiments, the authentication information may be stored in a memory on the circuit board, such as the memory of an authentication chip, and the identification information may be stored in another memory on the circuit board.

[0012] In any of these embodiments, the circuit board may include one or more processors to facilitate communication between the medical imaging controller and at least a portion of the at least one memory.

[0013] In any of these embodiments, the one or more processors may be configured to facilitate communication of calibration parameters of one or more medical imaging devices stored in at least a portion of the at least one memory to the medical imaging controller.

[0014] In any of these embodiments, the medical imaging device may further include at least one auxiliary communication line extending between the first connector and the circuit board for communicating at least non-imaging data from the medical imaging device to the circuit board or from the medical imaging device via the circuit board.

[0015] In any of these embodiments, the communication bus may be communicatively coupled to the second connector, and the at least one auxiliary communication line may be connected to the communication bus.

[0016] In any of these embodiments, at least a portion of the at least one memory may be directly connected to the communications bus.

[0017] In any of these embodiments, the circuit board may be disposed at the proximal end of the cable.

[0018] In any of these embodiments, the circuit board may be integrally formed as part of the cable.

[0019] In any of these embodiments, the circuit board may be overmolded to protect the circuit board during sterilization of the cable.

[0020] In any of these embodiments, the cable may further include a second circuit board disposed proximate to the first connector.

[0021] 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.

[0022] In any of these embodiments, one or more imaging control lines may extend between the first connector and the second connector for communicating imaging control signals from a medical imaging controller connected to the second connector to a medical imaging device connected to the first connector, the one or more imaging control lines bypassing the communication bus of the circuit board.

[0023] In any of these embodiments, the first connector may be connected to at least one of an endoscopic camera head, a medical microscope camera head, and an open field medical camera head.

[0024] In any of these embodiments, the one or more imaging communication lines may be configured to communicate pixel data and / or voxel data.

[0025] According to some embodiments, an apparatus includes a medical imaging device connected to a cable, the cable including a first connector disposed at a distal end of the cable for connecting the cable to a medical imaging device, and a second connector disposed at a proximal end of the cable for connecting the cable to a medical imaging controller, a circuit board having at least one memory, the at least one memory storing at least authentication information associated with the cable, the circuit board communicatively connected to the second connector via a communication bus on the circuit board to enable access to the authentication information by a 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 communicating imaging data from a medical imaging device connected to the first connector to a medical imaging controller connected to the second connector, the one or more imaging communication lines bypassing the communication bus on the circuit board.

[0026] In any of these embodiments, the at least one memory may further store identification information for the medical imaging device.

[0027] In any of these embodiments, the at least one memory may include a plurality of memories.

[0028] In any of these embodiments, the authentication information may be stored in a memory of an authentication chip on the circuit board, and the identification information may be stored in another memory on the circuit board.

[0029] In any of these embodiments, the circuit board may include one or more processors to facilitate communication between the medical imaging controller and at least a portion of the at least one memory.

[0030] In any of these embodiments, the one or more processors may be configured to facilitate communication of calibration parameters of one or more medical imaging devices stored in the at least a portion of the at least one memory.

[0031] In any of these embodiments, the medical imaging device may further include at least one auxiliary communication line extending between the first connector and the circuit board for communicating at least non-imaging data from the medical imaging device to the circuit board.

[0032] In any of these embodiments, the communication bus may be communicatively coupled to the second connector, and the at least one auxiliary communication line may be connected to the communication bus.

[0033] In any of these embodiments, at least a portion of the at least one memory may be directly connected to the communications bus.

[0034] In any of these embodiments, the circuit board may be disposed at the proximal end of the cable.

[0035] In any of these embodiments, the circuit board may be integrally formed as part of the cable.

[0036] In any of these embodiments, the circuit board may be overmolded to protect the circuit board during sterilization of the cable.

[0037] In any of these embodiments, the cable may include a second circuit board located proximate to the first connector.

[0038] 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.

[0039] 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 communicating imaging control signals from a medical imaging controller connected to the second connector to a medical imaging device connected to the first connector, the one or more imaging control lines bypassing the communication bus of the circuit board.

[0040] In any of these embodiments, the medical imaging device may be an endoscopic camera head, a medical microscope camera head, or an open field medical camera head.

[0041] In any of these embodiments, the one or more imaging communication lines may be configured to communicate pixel data and / or voxel data.

[0042] 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 having 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 of the cable and authenticating the cable based on the cable authentication information stored in the at least one memory.

[0043] In any of these embodiments, the cable may include a first connector located at a distal end of the cable connecting the cable to the medical imaging device, a second connector located at a proximal end of the cable 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 communicating 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 authentication 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.

[0044] In any of these embodiments, the circuit board may be integrally formed as part of the cable.

[0045] In any of these embodiments, the one or more programs may include instructions for providing an unauthenticated cable warning in response to failing to authenticate the cable.

[0046] In any of these embodiments, the one or more programs may include instructions for accessing identification information of a medical imaging device stored in the at least one memory and controlling the medical imaging device based on the identification information of the medical imaging device.

[0047] In any of these embodiments, the one or more programs may include instructions to communicate with one or more processors of the circuit board to obtain calibration parameters of one or more medical imaging devices stored in the at least one memory.

[0048] In any of these embodiments, the one or more programs may include instructions to communicate with one or more non-imaging components of the medical imaging device via a communications bus on the circuit board.

[0049] 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 of the cable, the imaging communication lines bypassing the circuit board.

[0050] According to some embodiments, a method of authenticating a cable by a medical imaging controller connected to a medical imaging device via the cable, the medical imaging controller having one or more processors, a memory, and one or more programs stored in the memory for execution by the one or more processors, includes 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.

[0051] In any of these embodiments, the cable may include a first connector located at a distal end of the cable connecting the cable to the medical imaging device, a second connector located at a proximal end of the cable 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 communicating 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 authentication 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.

[0052] In any of these embodiments, the circuit board may be integrally formed as part of the cable.

[0053] In any of these embodiments, the method may include providing an unauthenticated cable warning in response to failing to authenticate the cable.

[0054] In any of these embodiments, the one or more programs include instructions for accessing identification information of a medical imaging device stored in the at least one memory and controlling the medical imaging device based on the identification information of the medical imaging device.

[0055] In any of these embodiments, the method may further include communicating with one or more processors of the circuit board to obtain calibration parameters of the one or more medical imaging devices stored in the at least one memory.

[0056] In any of these embodiments, the method may further include communicating with one or more non-imaging components of the medical imaging device via a communications bus on the circuit board.

[0057] In any of these embodiments, the method may further include receiving imaging data from the medical imaging device via one or more imaging communication lines of the cable, the imaging communication lines bypassing the circuit board.

[0058] According to some embodiments, a non-transitory tangible computer readable medium has computer executable program code embedded therein for performing any of the methods described above.

[0059] According to some embodiments, a computer program product comprises computer implementable instructions that, when implemented by a programmable computer, cause the computer to perform any of the methods described above.

[0060] According to some embodiments, a method of imaging tissue of a subject includes authenticating a cable by a medical imaging controller connected to a medical imaging device, the medical imaging controller having 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 time-series images of the subject's tissue using the medical imaging device and the authenticated cable.

[0061] In any of these embodiments, generating the time series of images of the tissue of the subject may include generating time series of fluorescence images of the tissue of the subject.

[0062] In any of these embodiments, the method may further include administering a fluorescent imaging agent to the subject prior to generating the time series of fluorescent images of the tissue of the subject.

[0063] According to some embodiments, a kit for processing time series images of a subject's tissue includes any of the cables described above, any of the devices described above, any of the systems described above, or any of the non-transitory tangible computer readable medium described above.

[0064] In any of these embodiments, the imaging agent may be or may include a tricarbocyanine dye, ICG, methylene blue, fluorescein isothiocyanate, rhodamine, phycoerythrin, phycocyanin, allophycocyanin, o-phthalaldehyde, fluorescamine, rose bengal, trypan blue, fluorogold, or combinations thereof. In some embodiments, analogs or derivatives of fluorescent imaging agents may be used.

[0065] According to some embodiments, the fluorescent imaging agent is for use in imaging tissue in any of the above-mentioned systems, any of the above-mentioned methods, or any of the above-mentioned kits.

[0066] In any of these embodiments, imaging of tissue may include imaging of said tissue in blood flow imaging, tissue perfusion imaging, lymphatic imaging, or a combination thereof.

[0067] In any of these embodiments, the blood flow imaging, tissue perfusion imaging, and / or lymphatic imaging may include blood flow imaging, tissue perfusion imaging, and / or lymphatic imaging in an invasive, minimally invasive, or non-invasive medical procedure.

[0068] In any of these embodiments, the invasive medical procedure may include a cardiac-related or reconstructive medical procedure.

[0069] In any of these embodiments, the heart-related medical procedure may include a coronary artery bypass graft (CABG) procedure.

[0070] In any of these embodiments, the CABG procedure can be on-pump or off-pump.

[0071] In any of these embodiments, the non-invasive medical procedure may include a wound care procedure.

[0072] In any of these embodiments, the lymphatic imaging may include identification of lymph nodes, lymphatic drainage, lymphatic mapping, or a combination thereof.

[0073] In any of these embodiments, the lymphatic imaging may relate to the female reproductive system.

[0074] According to some embodiments, any of the above-mentioned cables, any of the above-mentioned devices, any of the above-mentioned systems, any of the above-mentioned methods, any of the above-mentioned kits, or any of the above-mentioned fluorescent contrast agents are used for lymphatic imaging.

[0075] According to some embodiments, any of the above-mentioned cables, any of the above-mentioned devices, any of the above-mentioned systems, any of the above-mentioned methods, any of the above-mentioned kits, or any of the above-mentioned fluorescent contrast agents are used for blood flow imaging, tissue perfusion imaging, or a combination thereof. [Brief description of the drawings]

[0076] The invention will now be described, by way of example only, with reference to the accompanying drawings in which: [Figure 1A] FIG. 1A illustrates an endoscopic camera system according to one embodiment. [Figure 1B] FIG. 1B illustrates an open field camera system according to one embodiment. [Figure 2A] , [Figure 2B] 2A and 2B are diagrams illustrating an imaging system including an imaging device connected by a cable to an imaging controller, according to one embodiment. [Diagram 3] FIG. 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. [Figure 4] FIG. 4 is a block diagram of an imaging system showing the light and signal paths throughout the system according to one embodiment. [Diagram 5] FIG. 5 is a block diagram of a method for authenticating a cable connecting an imaging device to an imaging controller according to one embodiment. [Figure 6] FIG. 6 is an exemplary depiction of an exemplary fluorescence imaging system, according to some embodiments. [Figure 7] FIG. 7 is an exemplary depiction of an exemplary illumination module of a fluorescence imaging system, according to some embodiments. [Figure 8] FIG. 8 is an exemplary camera module of a fluorescence imaging system according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0077] 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 combinations of all or some of the described aspects. Described herein are devices, systems, and methods for connecting an imaging device to an imaging controller using an authentication cable that can store information about the cable and / or imaging device. Because conventional imaging devices typically include imaging electronics and user interface components, a known approach to store information about the imaging device is to incorporate memory into the existing electronics and provide a communication channel to the imaging controller to access these memory elements. However, this approach ignores the importance of the cable in the system performance. The cables described herein according to various exemplary embodiments provide the ability to authenticate the cable to protect against the use of potentially inferior substitutes. Furthermore, according to various embodiments, information about the imaging device can be stored on the cable rather than within the imaging device, thereby allowing information about the cable itself to be stored, reducing the complexity of the imaging device.

[0078] According to some embodiments, a cable for connecting an image capture device to an image capture controller includes a printed circuit board assembly integrated into the cable. The printed circuit board may include memory for storing information about the image capture device in the camera head, the camera head assembly, and the cable itself. The circuit board includes an authentication component that allows secure storage of an encryption key and performs the operations necessary for encrypted communication with the camera control unit to allow secure verification that the proper cable is being used. The circuit board may also include a microcontroller that can communicate with and control one or more other components on the circuit board.

[0079] According to some embodiments, to minimize the number of wires in the cable, at least the authentication component, the microcontroller, and one of the memory elements are connected to the same communication bus. This same communication bus can be continued to the imaging device for use by one or more components in the imaging device. The microcontroller can route the communication paths such that it can update its firmware if new or different features of the circuit board are required.

[0080] The electronics on the circuit board can store several types of information. Calibration information for the imaging sensor, camera head and cable life usage information, logs of various types of events, camera head identification information, cable identification information, and cable authentication information are some examples of information that can be stored on the circuit board. Previously, this information was typically not stored at all or was stored inside the camera head. The more storage capacity required in the camera head, the more complex the camera head design becomes. Also, since cables often become damaged over time and can be replaced in the field by a third party, the storage in the camera head is only really useful for the camera head information itself, not the cable information. The camera head and camera control unit often track incorrect information because they have no way of knowing if such a replacement has occurred. Moving the storage to the cable and adding authentication ensures the use of compliant replacement cables and service by qualified personnel, which means that the information is properly transferred and translated to the replacement unit.

[0081] Collecting all of the above information and ensuring its accuracy has multiple benefits. Based on actual usage data, the camera system can indicate when routine maintenance is required. Many systems also aggregate usage data over the life of the platform and analyze it in its entirety to better understand future product use cases, testing requirements, and quality concerns. Furthermore, the more information collected per unit, the easier it is to troubleshoot failures during development and testing, and even in the field. Certification also ensures a quality experience for the end user by increasing the likelihood that only cables designed, verified, and certified for the camera system are used.

[0082] In the following description of various embodiments, reference is made to the accompanying drawings in which is shown, by way of illustration, specific embodiments which 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 present disclosure.

[0083] It should further be understood that the singular forms "a," "an," and "the" used in the following description are intended to include the plural forms unless the context clearly dictates otherwise. It should also be understood that the term "and / or" as used herein means and encompasses one or more and all combinations of the associated listed items. It should also be understood that the terms "includes," "including," "comprises," and / or "comprising," as used herein, specify the presence of referenced features, integers, steps, operations, elements, components, and / or units, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, units, and / or groups thereof.

[0084] Certain aspects of the present disclosure include the process steps and instructions described herein in the form of an algorithm. It should be noted that the process steps and instructions of the present disclosure can be implemented in software, firmware, or hardware, and when implemented in software, can reside on and be downloaded to be operated from different platforms used by various operating systems. As will become apparent from the following description, unless otherwise indicated, descriptions using words such as "processing," "computing," "calculating," "determining," "displaying," "generating," and the like throughout this specification are understood to refer to the operation and processing of a computer system or similar electronic computing device that manipulates and transforms data represented as physical (electronic) quantities in computer system memory or registers, or other such information storage, transmission, or display devices.

[0085] The present disclosure in some embodiments also relates to an apparatus for performing the operations described herein. Such an apparatus may be specially constructed for the required purposes or may include a general-purpose computer selectively activated or reconfigured by a computer program stored in the computer. Such a computer program may be stored on a non-transitory computer-readable recording medium, such as, but not limited to, a floppy disk, a USB flash drive, an external hard drive, an optical disk, a CD-ROM, a magneto-optical disk, a read-only memory (ROM), a random access memory (RAM), an EPROM, an EEPROM, a magnetic or optical card, any type of disk including an application specific integrated circuit (ASIC), or any type of medium suitable for storing electronic instructions, each connected to a computer system bus. Furthermore, the computers referred to herein may include a single processor or may be architectures employing multiple processors to increase computing power.

[0086] The methods, apparatus, and systems described herein are not inherently related to any particular computer or other apparatus. In addition, various general-purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct more specialized apparatus to perform the required method steps. The required structure for a variety of these systems will appear from the description below. In addition, the present invention is not described with reference to any particular programming language. It will be understood that a variety of programming languages ​​may be used to implement the teachings of the present invention as described herein.

[0087] FIG. 1A illustrates an exemplary medical imaging system 10 that may utilize an authenticable data cable to connect a medical imaging device to a medical imaging controller according to principles described herein. As used herein, medical imaging includes, but is not limited to, pre-operative, intra-operative, post-operative, and diagnostic imaging sessions and procedures. The system 10 includes a scope assembly 11 that may be utilized in an endoscopic procedure. The scope assembly 11 incorporates an endoscope or scope 12 that is coupled to an endoscopic camera head 13 by a coupler 14 disposed at a distal end of the camera head 13. Light is provided to the scope by a light source 14A via a light guide 15, such as a fiber optic cable. The camera head 13 is connected to a camera control unit (CCU) 17 by an electrical cable 18. The operation of the camera 13 is controlled in part by the CCU 17. The cable 18 transmits still and / or video image data from the camera head 13 to the CCU 17 and transmits various control signals bidirectionally between the camera head 13 and the CCU 17. In one embodiment, the image data output by camera head 13 is digital. Cable 18 may also include a memory device for storing authentication data for authenticating cable 18, as described below.

[0088] A control or switch arrangement 20 may be provided on the camera head 13 to allow a user to manually control various functions of the system 10. These and other functions may be controlled by voice commands using a voice control unit 23 connected to the CCU 17. Optionally, voice commands are input to a microphone 24 attached to a headset worn by the surgeon and coupled to the voice control unit 23. A handheld control device 26, such as a tablet or PDA having a touch screen user interface, may be connected to the voice control unit 23 as a further control interface. In the illustrated embodiment, a recorder 27 and a printer 28 are also connected to the CCU 17. Additional devices, such as image capture and archiving devices, may be included in the system 10 and connected to the CCU 17. Video image data acquired by the camera head 13 and processed by the CCU 17 may be displayed on a monitor 29, recorded by the recorder 27, and / or converted to images that may be used to generate still images, hard copies of which may be generated by the printer 28.

[0089] FIG. 1B illustrates an open field imaging device 60, which is another example of a type of imaging device that can be connected to an imaging controller via an authenticable cable as described herein. The open field imaging device 60 can be used as part of an imaging system, such as the system 10 of FIG. 1B, for a variety of purposes, including visualization of blood flow in blood vessels and associated tissue perfusion during plastic, ultrastructural, reconstructive, and gastrointestinal procedures. As seen in FIG. 1B, 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 a light guiding cable 15 that provides light to the imaging field via a port in the window frame 64. The open field imaging device 60 can be connected to a CCU 17 via an authenticable data cable 18 that can transmit power, image data, and any other type of data according to the principles described herein.

[0090] Control surface 62 includes focus buttons 63a (to decrease working distance) and 63b (to increase working distance) that control linkage 40. Other buttons on control surface 62 may be programmable and may be used for various other functions, such as excitation laser power on / off, display mode selection, white light imaging white balance, screenshot saving, etc. In some embodiments, the functions of the control surface may be communicated to CCU 17 via non-imaging data communication lines in cable 18, as described further below.

[0091] 2A and 2B show an imaging system 200 including an imaging device 201, such as the endoscopic camera head 13 of FIG. 1A or the open field imaging device 60 of FIG. 1B, a cable 202, and an imaging controller 203, such as the CCU 17 of FIG. 1A. The cable 202 is configured to communicatively connect the imaging device 201 to the imaging controller 203 to enable the imaging controller 203 to receive imaging data from the imaging device 201 for processing and / or display and to control one or more imaging and / or non-imaging functions of the imaging device 201. The imaging device may be a medical imaging device or a non-medical imaging device. The imaging device may be a surgical imaging device. The imaging device may be one of an endoscopic camera head, a surgical microscope camera head, or an open field medical camera head.

[0092] 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. A cable body 207 extends between the ends 204, 206 and houses multiple communication lines. As used herein, a communication line is a single signal line that may be formed of solid or stranded conductive wire.

[0093] The distal connector 205 and the proximal connector 208 may each be any suitable connector and may include any suitable number of contacts (e.g., pins and receptacles) for connecting communication wires. A suitable connector may include one or more locking mechanisms to prevent or inhibit an end user from disconnecting the connector. Examples of suitable locking mechanisms are a locking lever, a locking screw, a locking toggle, a locking nut, or a locking bayonet. In some embodiments, the locking mechanism is configured to require a tool for unlocking. A suitable connector may also be a disconnectable connector, allowing an end user to disconnect the connector in the field.

[0094] In some embodiments, the distal connector 205 configured to connect the cable to the imaging device 201 may be configured to be permanently or at least semi-permanently attached to the imaging device 201 to prevent (or inhibit) an end user from removing the distal connector 205 from the imaging device 201. The distal connector 205 may include one or more locking mechanisms to prevent removal of the distal connector 205 from the imaging device without a tool. In some embodiments, the imaging device 201 and the distal connector 205 may be permanently or semi-permanently connected at a manufacturing facility and shipped to an end user as an assembled set. In some embodiments, the distal connector 205 includes a sealing mechanism, such as an O-ring or grommet, to seal the connection to the imaging device 201. This may protect the imaging device 201 and / or electronics within the cable 202 during sterilization.

[0095] In some embodiments, the proximal connector 208 is configured for severable attachment to the imaging controller 203. In this manner, a user may be able to repeatedly disconnect the proximal connector 208, such as by hand. Once disconnected, the imaging device 201 and attached cable 202 can be cleaned, sterilized, stored, used in a different imaging controller, repaired, or disposed of separately from the imaging controller 203.

[0096] The cable 202 includes one or more imaging communication lines 214 for communicating image data (e.g., pixel and / or voxel data) from the imaging device 201 to the imaging controller 203. The imaging communication lines 214 may be configured for high speed transmission of imaging data, such as video data, from an imaging sensor in the imaging device to an imaging data processor in the imaging controller. The cable 202 may include one or more imaging control communication lines 216 that enable control communications 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, may be any suitable number of any suitable data communication lines.

[0097] The cable 202 includes a printed circuit board (PCB) 210 that includes at least one memory 212 that stores information for retrieval by the imaging device controller via a communication bus 211 on the PCB 210. The at least one memory 212 may store authentication data that allows the connected imaging controller 203 to authenticate the cable such that upon connection of the cable 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 authentic cable. This functionality can help ensure the use of functional and quality cables for connection to the imaging controller of the imaging device. By providing the ability to authenticate the cable, the system can prevent end users or third party service providers from substituting inferior or unauthorized third party cables, improving the performance of the imaging system.

[0098] At least one memory 212 may store other information in addition to authentication information for access by the imaging controller 203. The stored data may include cable-related information such as cable type, cable identity, and number of times the cable has been used, and / or may include device information including imager type, imager identity, number of times the imager has been used, imager settings, imager calibration parameters, imager pixel compensation information, imager runtime, imager button press counts, or any other useful information. The ability to authenticate the cable allows the imaging system to trust other information stored on the PCB.

[0099] 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 portion of the cable 200, such as within the distal end 202 or between the proximal and distal ends. In the illustrated embodiment, the PCB 210 is communicatively connected to the proximal end connector 208, such as through one or more wires 213 that are connected to pins or receptacles 215 of the proximal end connector 208. The PCB 210 may be a single PCB or multiple PCBs.

[0100] The PCB 210 may be integrally formed into one or more of the ends of the cable. For example, the PCB may be connected to the proximal end connector 208 and any non-communication wiring and then overmolded. Integrating the PCB 210 in this manner can ensure that the PCB is hermetically sealed within the cable, which is important for cables that require sterilization and can help prevent an end user or third party from removing the PCB 210 and attaching a third party cable to the PCB 210 in an attempt to bypass the security features provided by the cable.

[0101] In some embodiments, the cable 202 includes one or more auxiliary communication lines 218 for communicating at least non-imaging data between the imaging controller 203 and the imaging device 201. The imaging device 201 may include one or more non-imaging components, such as the switch array 20 of the system 10, and the auxiliary communication lines 218 may 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 controllers for controlling the non-imaging components. In some embodiments, imaging and / or imaging control data is transmitted over one or more of the auxiliary communication lines 218.

[0102] In some embodiments, the one or more auxiliary communication lines 218 are connected to the PCB 210 such that communications on the auxiliary communication lines 218 pass through the PCB 210. In other embodiments, the one or more auxiliary communication lines 218 bypass the PCB 210 and extend directly to the proximal connector 208. In some embodiments, some of the auxiliary communication lines connect to the PCB 210 and some of the auxiliary communication lines bypass 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 connect through the PCB 210. In some embodiments, at least one of the imaging communication lines 214 connects through the PCB 210 but bypasses the communication bus 211 of the PCB 210.

[0103] 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 the embodiment illustrated in Figures 2A and 2B, all of the imaging and imaging control communication lines 214, 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 connect through the PCB 210 but bypass the communication bus 211 of the PCB 210.

[0104] According to some embodiments, the PCB 210 is communicatively connected to the proximal connector 208 to enable access to authentication information by an imaging controller connected to the proximal connector 208, and one or more imaging communication lines 214 extend from the distal connector 205 to the proximal connector 208 to communicate imaging data from an imaging device connected to the distal connector 205 to an imaging controller connected to the proximal connector 208, the one or more imaging communication lines 214 bypassing the PCB 210. In some of these embodiments, the imaging control communication lines 216 also bypass the PCB 210.

[0105] 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 for authentication of the cable. The authentication chip may include one or more processors and one or more memories to facilitate authentication of the cable by the imaging controller. The memory 212 may include multiple separate memories, including multiple types of memory, which may include separate memory components on the PCB 210 and / or separate memory units embedded in separate components on the PCB 210. For example, the memory 212 may include any suitable number and / or combination of flash memory, ROM, PROM, EEPROM, and RAM.

[0106] In some embodiments, PCB 210 may include an additional PCB 250 that may be located at an end of the cable, such as distal end 204, for interacting with one or more components of a connected imaging device. For example, 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 for bonding the signal ground of the imaging device and the shield ground of the cable.

[0107] 3 is a block diagram of one embodiment of a PCB 300 for incorporation into a cable as described 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 that is connectable to one or more pins (or receptacles) of a proximal connector, such as the proximal connector 208 of FIGS. 2A and 2B, via one or more connections 312. In some embodiments, the communication bus 310 includes clock and signal lines. 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, and the flash memory is connected only to the microcontroller 306.

[0108] In some embodiments, the communication bus 310 can be connected to one or more auxiliary communication lines, such as auxiliary communication lines 218 of Figures 2A and 2B, via one or more connections 314. The imaging controller can communicate with non-imaging components of the imaging device using the same communication lines that it uses to communicate with components on the PCB 300. This can reduce the amount of wiring and connections (e.g., pins and / or receptacles), which can be beneficial in reducing failure points, reducing costs, and / or reducing sterilization complexity.

[0109] The authentication chip 302 stores authentication information and is configured to communicate with the imaging controller in order for the imaging controller to authenticate the authentication chip 302 and thereby authenticate the cable. The authentication chip 302 allows for secure storage of encryption keys and performs the operations necessary for encrypted communication with the imaging controller to ensure that the proper cable is being used.

[0110] The EEPROM 304 may be used to store information about the cable and / or about the imaging device. Exemplary information includes serial numbers of the cable and imaging device, types of cable and imaging device, usage statistics of the cable and imaging device (e.g., number of uses, time of use), and usage of components of the imaging device (e.g., number of button presses). In some embodiments, the cable and imaging device are assembled at the manufacturer and provided to the end user as a matched set. Imaging device data, such as any of the above information, may be preloaded into the EEPROM 304 before being provided to the end user. Thus, these types of information may be stored in the cable rather than (or in addition to) in the camera head. In some embodiments, the information stored in the EEPROM 304 may be updated by a connected imaging controller. For example, usage counts of the cable and imaging device may be incremented by the imaging controller each time the imaging device is used. Additionally, usage of non-imaging components, such as data indicating button presses, may be sent to the imaging controller, such as via the PCB 300 or via communication lines bypassing the PCB 300, and the imaging controller may update the data in the EEPROM 304 accordingly. In some embodiments, the imager can write directly to the EEPROM 304 (or other memory on the PCB 300) without the involvement of the imaging controller.

[0111] According to some embodiments, the microcontroller 306 can control one or more of the components on the PCB 300. The microcontroller 306 may control read / write access to one or more components via a communication bus 310. For example, the microcontroller may receive commands from the imaging controller for the microcontroller to enable one or more components on the PCB 300 to communicate with the imaging controller, and the microcontroller may respond accordingly. The microcontroller may also be capable of routing communication paths so that it can update its own firmware if new or different functionality of the PCB 300 is required.

[0112] In some embodiments, the microcontroller 306 acts as a translator for communications of one or more components not directly connected to the communication bus 310, such as the flash memory 308. This can be beneficial when the shared communication bus 310 is incompatible with one or more components, for example, when one or more components require more communication lines than are provided by the communication bus 310. The microcontroller can translate communications received on the communication bus 310 into commands that are sent to one or more components on one or more communication lines. This can reduce the number of communication lines that need to be connected to the imaging controller, reducing complexity and cost. For example, the communication bus 310 may be a two-wire bus and the flash memory may be configured for four-wire communication. The microcontroller can translate from two-wire commands to four-wire commands, eliminating the need to provide all four wires to the proximal connector.

[0113] According to some embodiments, the flash memory 308 can be used to store imaging related information for the imaging device, such as image sensor calibration parameters and image sensor pixel compensation information.

[0114] FIG 4 illustrates the light and signal paths throughout the camera system 10 of FIG IA, according to some embodiments. In operation, light is projected from light source 14A through light guide 15 onto scope 12. The light may be from a visible light source 118 or from a light source 120 in the invisible spectrum. Light source 14A also includes a serial communications port 122 that allows communication with CCU 17 via non-imaging control signal lines 134. CCU 17 communicates with light source 14A to adjust the light source and output light 124 as needed.

[0115] Emitted light 124 from light source 14A travels through light guide 15 to scope 12 and passes through it to the target site. Incoming image or light 126 then travels through scope 12 to relay lens assembly 68 in coupler 14 and through it to camera sensor unit 70. Relay lens 68 may be controlled by lens driver 88 (if applicable), which sends control signal 128 from camera head 13 to relay lens 68.

[0116] Use of the camera can be controlled by a control / switch array 20 in conjunction with a button board 94 which is in communication with a lens driver 88 and an 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 communicated from the sensor unit 70 to the CCU 17 via one or more imaging communication lines 132. The imaging and imaging control communication lines 130, 132 extend through cable 18 to the CCU 17.

[0117] The various components of the camera head 13 communicate with a printed circuit board 108 within cable 18 and may communicate with the CCU 17 via the circuit board 108. As mentioned above, the circuit board may include multiple components including, but not limited to, a microcontroller 110, flash memory 112, an authentication chip 113, and an EEPROM 116. Communications to and from camera head components, such as the lens driver 88 and button board 94, are carried within cable 18 by one or more auxiliary communication lines 134.

[0118] Once the high speed digital video 132 reaches the CCU 17, the CCU 17 can process the video as necessary and forward the processed video to a display via high speed digital video signal 132.

[0119] Such a system having a printed circuit board containing memory within the camera cable 18 provides a much more useful and secure system that can, among other things, authenticate the cable and identify the type of camera head attached so that the CCU can perform various functions and run various algorithms as required.

[0120] 5 illustrates a method 500 for authenticating a cable, such as cable 202 of FIGS. 2A and 2B, according to some embodiments. Method 500 may be performed by an imaging controller, such as imaging controller 203, connected by a cable to an imaging device, such as imaging device 201. The imaging controller may include one or more processors, a memory, and one or more programs stored in the memory for execution by the one or more processors, the programs including instructions for performing the steps detailed below. In some embodiments, the imaging device is a medical imaging device, such as a surgical endoscopic camera, a surgical microscope camera, or an open field handheld imager.

[0121] In step 502, the imaging controller accesses cable authentication information stored in at least one memory of a circuit board of the cable. When the cable is connected to the imaging controller, the imaging controller may provide power to the circuit board and initiate communication with, for example, an authentication chip (such as authentication chip 302 of FIG. 3) to exchange authentication information (e.g., one or more encryption keys) according to well-known methods.

[0122] At step 504, the cable is authenticated based on cable authentication information stored in at least one memory of the cable. The imaging controller verifies the authentication information in the memory.

[0123] In some embodiments, at step 506, the imaging controller may provide a warning of an unauthorized cable in response to failing to authenticate the cable. The warning may be provided as a display on the imaging controller's display and / or a display connected to the imaging controller's display. The warning may additionally or alternatively be provided as an audible warning, such as a buzzer or siren, or an automated audible message. In some embodiments, the imaging controller may disable one or more normal operational features, e.g., to prevent use of an unauthorized cable. In some embodiments, the imaging controller may disable operation entirely.

[0124] In some embodiments, the imaging controller may access information related to the imaging device stored in at least one memory, control the imaging device, and / or process imaging data from the imaging device based on the identification information of the imaging device. For example, the imaging controller may control the frame rate, shutter parameters, gain, lens position, or any other suitable parameters of the imaging device according to the imaging device information. The imaging controller may crop and / or zoom the imaging data or process imaging data received from the imaging device based on, for example, the type of imaging device and imaging device parameters (calibration parameters, pixel compensation parameters, etc.).

[0125] In some embodiments, the imaging controller may communicate with one or more processors on the circuit board to obtain one or more imager 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 described above with respect to the microcontroller 306 and flash memory 308. The imaging controller may process imaging data received from the imager in accordance with the calibration and / or pixel compensation data, according to known methods.

[0126] In some embodiments, the imaging controller may write information to one or more memories on the circuit board. For example, the imaging controller may update a cable usage counter in the memory, may update an imager usage counter in the memory, may update an imager runtime counter in the memory, or may update an imager button press count. In some embodiments, a cable associated with an imager may be replaced and the information associated with the imager stored on the circuit board may be transferred to the replacement cable. This allows information about the imager and its associated cable to be tracked over the life of the imager and cable, respectively, which is an improvement over known systems that completely ignore the importance of the cable to the imaging system.

[0127] 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 to control focus and / or zoom, and 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 on 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 of the imaging device. For example, the imaging controller may increment a button press counter in a memory on the circuit board each time an associated button on the imaging device is actuated.

[0128] In some embodiments, the imaging controller may receive imaging data from the imaging device via one or more imaging communication lines in the cable that bypass at least the communication bus of the circuit board (or bypass the circuit board altogether). Because imaging data can be data intensive, bypassing the circuit board can reduce latency and signal-to-noise ratio of the imaging data and otherwise improve imaging data transmission performance.

[0129] Examples of contrast agents used to generate imaging data A system for collecting, enhancing, and displaying medical imaging data, such as the system 10 of FIG. 1A, may include one or more imaging systems for acquiring a time series of images of tissue (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. FIG. 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 that illuminates a tissue of a subject to induce fluorescence emission from a fluorescent contrast agent 614 in the tissue of the subject (e.g., in blood, urine, lymph, cerebrospinal fluid, or other body fluid or tissue), an image acquisition assembly 616 configured to generate a time series and / or subject time series of fluorescence images from the fluorescence emission, and a processor assembly 618 configured to process the generated time series / subject time series of fluorescence images. The processor assembly 618 may include a memory 668 having instructions thereon, a processor module 662 configured to execute the instructions on the memory 668 to process the time series and / or subject time series fluorescence images, and a data storage module 664 for storing the raw and / or processed time series and / or subject time series fluorescence images. In some variations, the memory 668 and the data storage module 664 may be embodied in the same recording medium, while in other variations, the memory 668 and the data storage module 664 may be embodied in different recording media. The system 610 may further include a communications module 666 for transmitting image and other data, such as some or all of the time series / subject time series fluorescence images or other input data, spatial maps, subject spatial maps, and / or tissue quantifiers, to the imaging data processing hub.

[0130] In some variations, the light source 612 includes, for example, an illumination module 620. The illumination module 620 may include a fluorescent excitation source configured to generate excitation light having an appropriate intensity and an appropriate wavelength for exciting the fluorescent imaging agent 614. As shown in FIG. 7, the illumination module 620 may include a laser diode 622 (which may include, for example, one or more fiber-coupled diode lasers) configured to provide excitation light for exciting the fluorescent imaging agent (not shown) in the subject's tissue. Examples of other sources of excitation light that may be used in various embodiments include one or more LEDs, arc lamps, or other illumination technologies having sufficient intensity and appropriate wavelengths to excite the fluorescent imaging agent in the tissue. For example, excitation of the fluorescent imaging agent in blood (where the fluorescent imaging agent is a fluorescent dye with near-infrared excitation and emission characteristics) may be performed using one or more 793 nm, conductively cooled, single bar, fiber-coupled laser diode modules from DILAS Diode Laser Co. of Germany.

[0131] In some variations, the light output from the light source 612 may be projected through one or more optical elements to shape and direct the output used to illuminate the tissue region of interest. The optical elements may include one or more lenses, light guides, and / or diffractive elements to ensure a flat field across substantially the entire field of view of the image acquisition assembly 616. The fluorescent excitation source may be selected to emit at a wavelength close to the absorption maximum of the fluorescent contrast agent 614 (e.g., indocyanine green (ICG) or the like). For example, as shown in FIG. 7, the output 624 from the laser diode 622 may 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 may pass through an optical diffractive element 632 (i.e., one or more light diffusers), such as a ground glass diffractive element available from Newport Corporation, USA. Power to the laser diode 622 may be provided by a high current laser driver, such as one available from Lumina Power Inc., USA. The laser may optionally be operated in a pulsed mode during the image acquisition process. An optical sensor, such as a solid-state photodiode 630, may be incorporated into the illumination module 620 and may sample the illumination intensity generated by the illumination module 620 via scattered or diffuse reflection from various optical elements. In some variations, an additional illumination source may be used to provide guidance in aligning and positioning the module over the region of interest.

[0132] Referring again to FIG. 6, in some variations, the image acquisition assembly 616 may be a component of a fluorescence imaging system 610 configured to acquire time-series and / or subject-time-series fluorescence images from the fluorescence emission from the fluorescent imaging agent 614. The image acquisition assembly 616 may include a camera module 640, which may include an endoscopic camera 13 of FIG. 1A, an open field imaging device of FIG. 1B, and an imaging device 201 of FIGS. 2A and 2B connected to an imaging controller, such as imaging controller 203, via an authenticable cable having memory, such as cable 202. As shown in FIG. 8, the camera module 640 may acquire images of the fluorescence emission 642 from the fluorescent imaging agent in the tissue by collecting and focusing the fluorescence emission onto an image sensor assembly 644 using a system of imaging optics (e.g., 646a, 646b, 648, and 650). The imaging sensor assembly 644 may include at least one 2D solid-state image sensor. The solid-state image sensor may be a charge-coupled device (CCD), a CMOS sensor, a CID, or similar 2D sensor technology. The charge resulting from the optical signals converted by the imaging sensor assembly 644 is converted by suitable readout and amplification electronics in the camera module 640 into electrical video signals, including both digital and analog video signals.

[0133] According to an exemplary variation of the fluorescence imaging system, the light source may provide an excitation wavelength of about 800 nm + / - 10 nm, and the image acquisition assembly uses an emission wavelength of more than 820 nm with NIR compatible optics, e.g., for ICG fluorescence imaging. In an exemplary embodiment, the NIR compatible optics may include a CCD monochrome imaging sensor with a GigE standard interface and a lens compatible with the sensor in terms of optical format and mount format (e.g., C / CS mount).

[0134] In some variations, the processor module 662 includes any computer or computing means, such as a tablet, laptop, desktop, network computer, or dedicated stand-alone microprocessor. For example, the processor module 662 may include one or more central processing units (CPUs). In an exemplary embodiment, the processor module 662 is a quad-core 2.5 GHz processor having four CPUs, each CPU being a microprocessor such as a 64-bit microprocessor (e.g., available as an INTEL Core i3, i5, or i7, or in the AMD Core FX series). However, in other embodiments, the processor module 662 may be any suitable processor having any suitable number of CPUs and / or other suitable clock speeds.

[0135] Input for the processor module 662 may be obtained, for example, from the imaging sensor 644 of the camera module 640 shown in FIG. 8, from the solid-state photodiode 630 of the illumination module 620 of FIG. 7, and / or from any external control hardware such as a foot switch or remote control. Output is provided to a laser diode driver and optical alignment aid. As shown in FIG. 6, in some variations, the processor assembly 618 may have a data storage module 664 capable of storing the time series / subject time series images, or data indicative thereof, or other input data, in a tangible, non-transitory computer readable medium, such as an internal memory (e.g., hard disk or flash memory), to enable recording and processing of acquired data. In some variations, the processor module 662 may have an internal clock to enable control of various elements and ensure precise timing of illumination and sensor shutters. In some variations, the processor module 662 may also provide user input and graphic displays. The fluorescence imaging system may optionally be configured with a communications unit 666, such as a wired or wireless network connection or a video output connection, for transmitting the time series of fluorescence images as they are being acquired or for playback after recording. The communications unit 666 may additionally or alternatively transmit processed data such as the spatial map, the subject spatial map, and / or tissue values.

[0136] In operation of the exemplary system described in FIGS. 6-8, the subject is positioned relative to the fluorescence imaging system 610 such that the region of interest (e.g., a target tissue region) is located beneath the light source 612 and acquisition assembly 616, and such that the illumination module 620 of the light source 612 produces a substantially uniform field of illumination across substantially the entire region of interest. In some variations, an image of the region of interest may be acquired for background deduction purposes prior to administration of the fluorescent contrast agent 614 to the subject. To acquire the fluorescence image / subject fluorescence image, an operator of the fluorescence imaging system 610 may initiate acquisition of the time series / subject time series of fluorescence images 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 the fluorescence image data / subject fluorescence image data provided by the image acquisition assembly 616. When operating in the pulsed mode of this embodiment, the imaging sensor 644 in the camera module 640 is synchronized to collect the fluorescence emission following 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 fluorescent imaging agent 614 is administered to the subject and delivered to the region of interest via the arterial flow. The acquisition of the time series / non-analyte time series of fluorescence images is started, for example, immediately after the administration of the fluorescent imaging agent 614, and the time series of fluorescence images from substantially the entire region of interest are acquired during the infiltration of the fluorescent imaging agent 614. The fluorescence emission from the region of interest is collected by the collection optics of the camera module 640. The residual ambient light and the reflected excitation light are attenuated by the subsequent optical elements of the camera module 640 (e.g., the optical element 650 in FIG. 8, which may be a filter), so that the fluorescence emission can be acquired by the imaging sensor assembly 644 with minimal interference from light from other light sources.

[0137] In some variations, following acquisition or generation of the time-series / subject-time-series fluorescence images, the processor assembly 618 (e.g., processor module 662 or other processor) may then be initiated to execute instructions stored in memory 668 to process the imaging data prior to transmission to the imaging data processing system. System 610 may transmit via connection 666 the spatial / subject-space maps and / or any clinical correlations or diagnoses derived therefrom for display to a user in a composite display feed, for example as grayscale or colorized images, and / or for storage for subsequent use.

[0138] A tangible, non-transitory computer-readable medium having computer-executable (readable) program code embedded therein can provide instructions to one or more processors for performing one or more methods described herein when the instructions are executed. The program code can be written in any suitable programming language and delivered to the processor in many forms, including, but not limited to, information persistently stored on a non-writable storage medium (e.g., a read-only memory device such as a ROM or CD-ROM disk), information mutably stored on a writable storage medium (e.g., a hard drive), information communicated 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. When carrying computer-readable instructions that implement various embodiments of the methods described herein, such computer-readable media represent examples of various embodiments. In various embodiments, a tangible, non-transitory computer-readable medium includes all computer-readable media, and the scope of the present invention is limited to computer-readable media, where the medium is both tangible and non-transitory.

[0139] The kit may include any part of the system described herein and a fluorescent imaging agent, such as a fluorescent dye, e.g., ICG, or any suitable fluorescent imaging agent. In a further aspect, the kit may include a tangible, non-transitory computer readable medium having computer executable (readable) program code embedded therein, which upon execution of the instructions can provide instructions to one or more processors for performing one or more methods for tissue characterization and / or clinical data prediction described herein. The kit may include instructions for using at least some of its components (e.g., for using the fluorescent imaging agent, for installing computer executable (readable) program code having the embedded instructions, etc.). In yet another aspect, a fluorescent imaging agent, e.g., a fluorescent dye, for use in the methods and systems described herein is provided. In a further variation, the kit may include any part or all of the system described herein and a fluorescent agent, e.g., a fluorescent dye, e.g., ICG, or any other suitable fluorescent agent, or combination of fluorescent agents.

[0140] Examples of contrast agents used to generate imaging data According to some embodiments, in fluorescent medical imaging applications, the imaging agent is a fluorescent imaging agent, such as an ICG dye. The fluorescent imaging agent, such as ICG, may be pre-administered to the subject prior to making measurements of signal intensity resulting from the fluorescent imaging agent. When administered to the subject, ICG binds to blood proteins and circulates with the blood through tissues. The fluorescent imaging agent (e.g., ICG) may be administered to the subject as a bolus injection (e.g., injection into a vein or artery) in a concentration suitable for imaging, such that the bolus circulates through the vasculature and passes through the microvasculature. In other embodiments in which multiple fluorescent imaging agents are used, such agents may be administered simultaneously, for example, in a single bolus, or sequentially in separate boluses. The fluorescent imaging agent may be pre-administered to the subject prior to making measurements of signal intensity resulting from the fluorescent imaging agent. In some embodiments, the fluorescent imaging agent may be administered by a catheter. In certain embodiments, the fluorescent imaging agent may be administered less than one hour prior to making measurements of signal intensity resulting from the fluorescent imaging agent. For example, the fluorescent imaging agent may be administered to the subject less than 30 minutes prior to making the measurements. In yet other embodiments, the fluorescent imaging agent may be administered at least 30 seconds prior to taking the measurement, hi yet other embodiments, the fluorescent imaging agent may be administered simultaneously with taking the measurement.

[0141] According to some embodiments, the fluorescent imaging agent may be administered at various concentrations to achieve a desired circulating concentration in the blood. For example, in an embodiment where the fluorescent imaging agent is ICG, it may 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 concentration limit for administration of the fluorescent imaging agent is the concentration at which the fluorescent imaging agent becomes clinically toxic in the circulating blood, and the lower concentration limit is the instrument limit for acquiring signal intensity data resulting from the fluorescent imaging agent circulating with the blood to detect the fluorescent imaging agent. In various other embodiments, the upper concentration limit for administration of the fluorescent imaging agent is the concentration at which the fluorescent imaging agent self-quenches. For example, the circulating concentration of ICG may range from about 2 μM to about 10 mM. Thus, in one aspect, the method includes administering a contrast agent (e.g., a fluorescent imaging agent) to a subject and acquiring signal intensity data (e.g., an image) prior to processing the signal intensity data according to various embodiments. In another aspect, the method excludes any step of administering an imaging agent to the subject.

[0142] According to some embodiments, a fluorescent contrast agent suitable for use in a fluorescent imaging application to generate fluorescent image data is an imaging agent that circulates with blood (e.g., a fluorescent dye capable of circulating with blood components such as lipoproteins or serum plasma in blood), can pass through the vasculature of a tissue (i.e., macrovasculature and microvasculature), and generates a signal intensity when the imaging agent is exposed to appropriate light energy (e.g., excitation light energy or absorption light energy). In various embodiments, the fluorescent contrast agent includes a fluorescent dye, an analog thereof, a derivative thereof, or a combination thereof. The fluorescent dye includes 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 dyes are or include fluorescein isothiocyanate, rhodamine, phycoerythrin, phycocyanin, allophycocyanin, o-phthalaldehyde, fluorescamine, rose bengal, trypan blue, fluorogold, or combinations thereof, excitable using wavelengths of excitation light appropriate for each dye. In some embodiments, analogs or derivatives of fluorescent dyes may be used. For example, fluorescent dye analogs or derivatives include fluorescent dyes that have been chemically modified but retain the ability to fluoresce when exposed to light energy of the appropriate wavelength.

[0143] In various embodiments, the fluorescent imaging agent may be provided as a lyophilized powder, solid, or liquid. In certain embodiments, the fluorescent imaging agent may be provided in a vial (e.g., a sterile vial) that can be reconstituted to the appropriate concentration by administering a sterile fluid with a sterile syringe. Reconstitution can be performed using any suitable carrier or diluent. For example, the fluorescent imaging agent may be reconstituted with an aqueous diluent immediately prior to administration. In various embodiments, any diluent or carrier that maintains the fluorescent imaging agent in solution can be used. As an example, ICG may be reconstituted with water. In some embodiments, once the fluorescent imaging agent is reconstituted, it may be mixed with additional diluents and carriers. In certain embodiments, the fluorescent imaging agent may 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, including Tris, HCl, NaOH, phosphate buffer, and / or HEPES, may be optionally added.

[0144] Although fluorescent contrast agents are described in detail above, those skilled in the art will appreciate that other contrast agents may be used in connection with the systems, methods, and techniques described herein, depending on the optical imaging modality. Such fluorescent agents may be administered to bodily fluids (e.g., lymphatic fluid, spinal fluid) or bodily tissues.

[0145] In some variations, the fluorescent imaging agents used in combination with the methods, systems and kits described herein may be used for blood flow imaging, tissue perfusion imaging, lymphatic imaging, or a combination thereof, which may be performed before, during, or after an invasive, minimally invasive, or non-invasive surgical procedure, or a combination thereof. The blood flow imaging, tissue perfusion imaging, lymphatic imaging, or a combination thereof method may itself exclude an invasive surgical step. Examples of invasive surgical procedures involving blood flow and tissue perfusion include cardiac-related surgical procedures (e.g., on-pump and off-pump CABG) and reconstructive surgical procedures. Examples of non-invasive or minimally invasive procedures include the treatment and / or management of wounds (e.g., chronic wounds such as pressure sores). In this regard, changes in a wound over time, such as changes in wound dimensions (e.g., diameter, area), or changes in the wound and / or tissue perfusion surrounding the wound, may be tracked over time by application of the methods and systems. Examples of lymphatic imaging include identification of one or more lymph nodes, lymphatic drainage, lymphatic mapping, or a combination thereof. In some variations, such lymphatic imaging may relate to the female reproductive system (e.g., uterus, cervix, vulva).

[0146] In a variation for cardiac application, the contrast agent (e.g., ICG alone or in combination with other contrast agents) may be injected intravenously, for example, through a central venous circuit, a bypass pump, and / or a cardioplegic circuit, to flow and / or perfuse the coronary vasculature, microvasculature, and / or graft. ICG may be administered below the grafted vessel as diluted ICG / blood / saline such that the final concentration of ICG in the coronary arteries is approximately the same as or less than if about 2.5 mg (i.e., 1 ml of 2.5 mg / ml) was injected into the central circuit or bypass pump. ICG may be prepared, for example, by dissolving 25 mg of solid in 10 ml of sterile aqueous solvent, which may be provided with ICG by the manufacturer. 1 ml of ICG solution may be mixed with 500 ml of sterile saline (e.g., inject 1 ml of ICG into a 500 ml saline bag). Thirty milliliters of the diluted ICG / saline may be added to 10 ml of the subject's blood obtained aseptically from the central arterial circuit or bypass pump. ICG in the blood binds to plasma proteins and acts to prevent leakage outside the blood vessels. Mixing of ICG and blood can be performed in a sterile surgical field using standard aseptic techniques. For each graft, 10 ml of ICG / saline / blood mixture can be administered. ICG can be administered using a syringe attached to the (open) proximal end of the graft, rather than by injection through the wall of the graft using a needle. Surgeons routinely attach an adapter to the proximal end of the graft when the graft is harvested so that a syringe filled with saline can be attached, the distal end of the graft can be sealed, and saline can be injected underneath the graft to pressurize the graft and assess the integrity of the conduit (for leaks, side branches, etc.) before performing the first anastomosis. In other variations, the methods, dosages, or combinations thereof described herein in connection with cardiac imaging can be used in any vascular and / or tissue perfusion imaging application.

[0147] Lymphatic mapping is an important part of effective surgical staging for cancers that spread via the lymphatic system (e.g., breast, gastric, and gynecologic cancers). Although removal of multiple nodes from a particular nodal basin can result in serious complications, including acute or chronic lymphedema, paresthesia, and / or seroma formation, in practice, if sentinel lymph nodes are negative for metastasis, the surrounding lymph nodes are most likely negative as well. For example, in breast cancer surgery, identification of tumor-draining lymph nodes (LNs) has become a critical step in staging cancers that spread via the lymphatic system. LN mapping involves the use of dyes and / or radioactive tracers for the identification of LNs for either biopsy or resection, followed by pathologic evaluation of metastases. The goal of lymphadenectomy during surgical staging is to identify and remove LNs that are at high risk for local spread of cancer. Sentinel lymph node (SLN) mapping has emerged as an effective surgical strategy in the treatment of breast cancer. It is generally based on the concept that if metastasis (spread of cancer to the axillary LNs) is observed, it should be located in the SLNs, which are defined in the art as the group of nodes to which cancer cells are most likely to spread from the first LN or primary tumor. If the SLNs are negative for metastasis, the surrounding secondary and tertiary LNs should also be negative. The main advantage of SLN mapping is that it reduces the number of subjects who undergo conventional partial or complete lymphadenectomy and, as a result, suffer from associated morbidities such as lymphedema and lymphocysts.

[0148] The current standard of care for SLN mapping involves the injection of a tracer that identifies lymphatic drainage pathways from the primary tumor. The tracer used may be a radioisotope (e.g., technetium-99 or Tc-99m) for intraoperative localization using a gamma probe. Radioactive tracer techniques (known as scintigraphy) are limited to hospitals with access to radioisotopes, require the involvement of a nuclear medicine physician, and do not provide real-time visual guidance. The colored dye isosulfan blue has also been used, but this dye cannot be seen through skin and fatty tissue. Also, blue staining can result in breast tattooing that can last for months, subcutaneous injections can cause skin necrosis, and rare allergic reactions with anaphylaxis have been reported. Severe anaphylactic reactions have occurred after injection of isosulfan blue (in approximately 2% of patients). Symptoms include dyspnea, shock, angioedema, urticaria, and pruritus. Reactions are more likely in subjects with a history of bronchial asthma or allergic or drug reactions to triphenylmethane dyes. Isosulfan blue is known to interfere with measurements of oxygen saturation by pulse oximetry and methemoglobin by gas analyzers. Use of isosulfan blue may result in transient or long-lasting (tattoo-like) blue staining.

[0149] In contrast, fluorescence imaging according to various embodiments for use in visualizing and mapping SLNs facilitates direct, real-time visual identification of LNs and / or afferent lymphatic vessels during surgery and facilitates real-time, high-resolution optical navigation through skin and adipose tissue, organization of blood flow, tissue perfusion, or a combination thereof.

[0150] In some variations, visualization, classification, or both of lymph nodes during fluorescence imaging may be based on imaging of one or more contrast agents, which may further be based on visualization and / or classification using a gamma probe (e.g., Technetium Tc-99m, a clear, colorless aqueous solution typically injected into the periareolar region as standard care), another conventionally used colored contrast agent (isosulfan blue), and / or other evaluations, such as histology. The subject's breast may be, for example, injected twice with about 1% isosulfan blue (for comparison) and injected twice with an ICG solution having a concentration of about 2.5 mg / ml. The injection of isosulfan blue may precede the injection of ICG, or vice versa. For example, an anesthetized subject may be injected with 0.4 ml (0.2 ml at each site) of isosulfan blue into the periareolar region of the breast using a TB syringe and a 30G needle. The subject may be injected at the 12 o'clock and 9 o'clock positions for the right breast and at the 12 o'clock and 3 o'clock positions for the left breast. The total dose of intradermal injection of isosulfan blue into each breast may be about 4.0 mg (0.4 ml of 1% solution: 10 mg / ml). In another exemplary variation, the subject may receive an ICG injection first, followed by isosulfan blue (for comparison). One 25 mg vial of ICG may be reconstituted with 10 ml of sterile water for injection to obtain a 2.5 mg / ml solution immediately prior to ICG administration. Using a TB syringe and a 30G needle, for example, the subject may be injected with about 0.1 ml of ICG (0.05 ml per site) into the periareolar region of the breast (injections may be performed at the 12 o'clock and 9 o'clock positions for the right breast and at the 12 o'clock and 3 o'clock positions for the left breast). The total dose of intradermal injection of isosulfan blue into each breast may be about 0.25 mg (0.1 ml of 2.5 mg / ml solution) per breast. ICG may be injected at a rate of, for example, 5-10 seconds per injection. When ICG is injected intradermally, the protein-binding properties of ICG allow it to be rapidly taken up by the lymph and travel through the ducts to the LN. In some variations, ICG may be provided in the form of a sterile, lyophilized powder containing 5% or less sodium iodide and 25 mg of ICG.ICG may be packaged with an aqueous solvent consisting of sterile water for injection, which is used to reconstitute ICG. In some variations, the ICG dosage (mg) in breast cancer sentinel lymphatic mapping may range from about 0.5 mg to about 10 mg, depending on the route of administration. In some variations, the ICG dosage may be about 0.6 mg to about 0.75 mg, about 0.75 mg to about 5 mg, about 5 mg to about 10 mg. The route of administration may be, for example, subcutaneous, intradermal (e.g., periareolar), subareolar, skin overlying the tumor, intradermal into the areola closest to the tumor, subcutaneous into the areola, intradermal over the tumor, periareolar throughout the breast, or a combination thereof. Injection may occur prior to visualization and / or classification. NIR fluorescence positive LNs (e.g., using ICG) may be represented, for example, as black and white NIR fluorescence images, and / or full or partial color (white light) images, full or partially desaturated white light images, enhanced color images, overlays (e.g., fluorescence with any other images), composite images (e.g., fluorescence incorporated into other images) that may have different colors, different desaturation levels, or different ranges of colors to highlight / visualize specific features of interest. Further processing of the images may be performed for further visualization and / or other analysis (e.g., quantification). Lymph nodes and lymphatic vessels may be visualized (e.g., intraoperatively, in real time) using the fluorescence imaging systems and methods according to various embodiments, with ICG and SLNs alone or in combination with a gamma probe (Tc-99m), in accordance with the American Society of Breast Surgeons (ASBrS) clinical practice guidelines for SLN biopsy in breast cancer patients. Fluorescence imaging of the LNs may begin from the injection site by following the lymphatic vessels to the LNs in the axilla. Once a visual image of the LN is identified, the skin is incised and LN mapping and identification of the LN may be performed until an ICG visualized node is identified. The method of LN mapping may itself eliminate any surgical steps. For comparison, mapping with isosulfan blue may be performed until a "blue" node is identified.Identified LNs may be labeled for resection using ICG alone or in combination with another imaging technique (e.g., isosulfan blue, and / or Tc-99m). Subjects may have various stages of breast cancer (e.g., IA, IB, IIA).

[0151] In some variations, for example in gynecological cancers (e.g., uterine, endometrial, vulvar and cervical malignancies), ICG may be administered intercellularly for visualization of lymph nodes, lymphatic vessels, or a combination thereof. Upon injection intercellularly, the protein-binding properties of ICG allow it to be rapidly taken up by lymphatic fluid and migrate through the ducts to the SLN. ICG may be provided for injection in the form of a sterile, lyophilized powder containing 25 mg of ICG (e.g., 25 mg / vial) and 5.0% or less sodium iodide. The ICG may then be reconstituted with commercially available water for injection (sterile) prior to use. According to one embodiment, a vial containing 25 mg of ICG may be reconstituted with 20 ml of water for injection, resulting in a 1.25 mg / ml solution. A total of 4 ml of this 1.25 mg / ml solution may be injected into the subject (4 x 1 ml injections), resulting in a total dose of 5 mg of ICG per subject. Also, 1 ml of a 1% isosulfan blue 10 mg / ml solution (for comparison purposes) may be injected into the cervix four times for a total dose of 40 mg. The injections may be performed while the subject is under anesthesia in an operating room. In some variations, the dose (mg) of ICG in the detection and / or mapping of sentinel lymph nodes in gynecologic cancer may range from about 0.1 mg to about 5 mg depending on the route of administration. In some variations, the ICG may be from about 0.1 mg to about 0.75 mg, from about 0.75 mg to about 1.5 mg, from about 1.5 mg to about 2.5 mg, from about 2.5 mg to about 5 mg. The route of administration may be, for example, cervical injection, perivulval injection, hysteroscopic endometrial injection, or a combination thereof. To minimize spillage of isosulfan blue or ICG that may interfere with the mapping procedure when resecting LNs, mapping may be performed on a hemipelvis, and mapping with both isosulfan blue and ICG may be performed prior to resection of any LNs.LN mapping for clinical stage I endometrial cancer may be performed according to the NCCN Guidelines for Uterine Neoplasms, SLN Algorithm for Surgical Staging of Endometrial Cancer, and SLN mapping for clinical stage I cervical cancer may be performed according to the NCCN Guidelines for Cervical Neoplasms, Surgical / SLN Mapping Algorithm for Early Stage Cervical Cancer. Thus, LN identification may be based on ICG fluorescence imaging alone or in combination or coadministration with colorimetric dyes (isosulfan blue) and / or radiotracers.

[0152] Lymph node visualization may be qualitative and / or quantitative. Such visualization may include, for example, lymph node detection, detection rate, and anatomical distribution of lymph nodes. Lymph node visualization according to various embodiments may 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 evaluation, Tc-99m visualization and / or evaluation, concomitant medications). Follow-up visits may occur on the date of discharge and thereafter (e.g., one month).

[0153] Because lymph contains high levels of proteins, ICG may bind to endogenous proteins upon entering the lymphatic system. When used in accordance with the methods and systems described herein, fluorescence imaging (e.g., ICG imaging) for lymphatic mapping offers the following exemplary advantages: high signal-to-background ratio (or tumor-to-background ratio), real-time visualization features for lymphatic mapping, tissue definition (i.e., structural visualization), rapid excretion and clearance after entering the vasculature, and avoidance of non-ionizing radiation, since NIR does not produce significant autofluorescence. In addition, NIR imaging has better tissue penetration (approximately 5-10 mm of tissue) than visible light (1-3 mm of tissue). Also, the use of ICG, for example, facilitates visualization through the peritoneum covering the para-aortic nodes. Tissue fluorescence can be observed for extended periods with NIR light, but not with visible light, and consequently does not affect pathological evaluation or processing of LNs. Also, fluorescence is easier to detect intraoperatively than blue staining of lymph nodes (isosulfan blue). In other variations, the methods, dosages, or combinations thereof described herein in connection with lymphatic imaging may be used in any vascular and / or tissue perfusion imaging application.

[0154] Tissue perfusion is related to the microcirculatory flow of blood per unit tissue volume, which supplies oxygen and nutrients and removes waste products from the capillary bed of the perfused tissue. Tissue perfusion is related to, but distinct from, blood flow in blood vessels. Quantified blood flow through blood vessels can be expressed in terms that define flow (i.e., volume / time) or in terms that define velocity (i.e., distance / time). Tissue blood perfusion defines the movement of blood through microvasculature, such as arterioles, capillaries, or venules, within a tissue volume. Quantified tissue blood perfusion can be expressed as blood flow through a tissue volume, i.e., blood volume / time / tissue volume (or tissue mass). Perfusion is related to nutrient vessels (e.g., microvessels known as capillaries), which include vessels involved in the exchange of metabolites between blood and tissue, but not to larger diameter non-nutrient vessels. In some embodiments, quantifying the tissue of interest may include calculating or determining a parameter or quantity associated with the tissue of interest, such as velocity, size, volume, time, distance / time, and / or volume / time, and / or a change associated with any one or more of the aforementioned parameters or quantities. However, compared to the movement of blood through larger diameter vessels, the movement of blood through individual capillaries is highly irregular, mainly due to vasomotion, and spontaneous oscillations in vascular tone are manifested as pulsations in the movement of red blood cells. In some embodiments, blood flow and tissue perfusion imaging as described herein in connection with the systems and methods may be used to image tumor tissue and distinguish such tissue from other tissues.

[0155] The foregoing disclosure has been disclosed with reference to specific embodiments for purposes of illustration. However, the above exemplary discussion is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of the above teachings. The embodiments have been chosen and disclosed in order to best explain the principles of the technology and their practical application. This will enable those skilled in the art to best utilize the technology and various embodiments with various modifications suited to the particular use envisaged. Although features are described herein as part of the same or separate embodiments for clarity and conciseness, it will be understood that the scope of the present invention may include embodiments having all or a partial combination of the described features.

[0156] Although the present disclosure and examples have been fully described with reference to the accompanying drawings, it should be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications should be understood as being included within the scope of the disclosure and examples as defined by the claims. Finally, the entire disclosures of the patents and publications referenced in this application are incorporated herein by reference.

Claims

1. 1. A cable for connecting a medical imaging device to a medical imaging controller, comprising: a first connector disposed at a distal end of the cable for connecting the cable to a medical imaging device; a second connector disposed at a proximal end of the cable for connecting the cable to a medical imaging controller; a circuit board having at least one memory that stores at least authentication information associated with the cable, the circuit board being communicatively connected to the second connector via a communication bus on the circuit board to enable access to the authentication information by a medical imaging controller connected to the second connector; one or more imaging communication lines extending between the first connector and the second connector for communicating imaging data from a medical imaging device connected to the first connector to a medical imaging controller connected to the second connector, the one or more imaging communication lines bypassing the communication bus on the circuit board; A cable comprising:

2. 10. The cable of claim 1, wherein the at least one memory further stores identification information for identifying a medical imaging device associated with the cable.

3. 3. The cable of claim 1 or 2, wherein the at least one memory comprises a plurality of memories.

4. the authentication information is stored in a memory of an authentication chip on the circuit board; The identification information is stored in a separate memory on the circuit board.

4. The cable according to claim 3.

5. 5. The cable of claim 1, 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.

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

7. 7. The cable of claim 1, further comprising at least one auxiliary communication line extending between the first connector and the circuit board for communicating at least non-imaging data from the medical imaging device to the circuit board or from the medical imaging device via the circuit board.

8. the communication bus is communicatively coupled to the second connector; The at least one auxiliary communication line is connected to the communication bus.

8. The cable according to claim 7.

9. 9. The cable of claim 8, wherein at least a portion of said at least one memory is directly connected to said communication bus.

10. 10. The cable of claim 1, wherein the circuit board is disposed at the proximal end of the cable.

11. 11. A cable according to any preceding claim, wherein the circuit board is integrally formed as part of the cable.

12. 12. The cable of claim 11, wherein the circuit board is overmolded to protect the circuit board during sterilization of the cable.

13. 13. The cable of claim 1, further comprising a second circuit board disposed adjacent to the first connector.

14. 14. The cable of claim 1, wherein the at least one memory stores 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 press count, a cable identification, a cable type, a medical imaging device identification, medical imaging device calibration information, and a medical imaging device pixel compensation information.

15. one or more imaging control lines extending between the first connector and the second connector for communicating imaging control signals from a medical imaging controller connected to the second connector to a medical imaging device connected to the first connector; The one or more imaging control lines bypass the communication bus of the circuit board.

15. The cable of claim 14.

16. 16. The cable of claim 1, wherein the first connector is configured to connect to at least one of an endoscopic camera head, a medical microscope camera head, and an open field medical camera head.

17. 17. The cable of any preceding claim, wherein the one or more imaging communication lines are configured to communicate pixel data and / or voxel data.

18. 1. An apparatus having a medical imaging device connected to a cable, comprising: The cable includes: a first connector disposed at a distal end of the cable for connecting the cable to the medical imaging device; a second connector disposed at a proximal end of the cable for connecting the cable to a medical imaging controller; a circuit board having at least one memory that stores at least authentication information associated with the cable, the circuit board being communicatively connected to the second connector via a communication bus on the circuit board to enable access to the authentication information by a medical imaging controller connected to the second connector; one or more imaging communication lines extending between the first connector and the second connector for communicating imaging data from a medical imaging device connected to the first connector to a medical imaging controller connected to the second connector, the one or more imaging communication lines bypassing the communication bus on the circuit board; An apparatus comprising:

19. 20. The apparatus of claim 18, wherein the at least one memory further stores identification information for the medical imaging device.

20. 20. Apparatus according to claim 18 or 19, characterized in that said at least one memory comprises a plurality of memories.

21. the authentication information is stored in a memory of an authentication chip on the circuit board; The identification information is stored in a separate memory on the circuit board.

21. The apparatus of claim 20.

22. 22. The apparatus of any one of claims 18 to 21, 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.

23. 23. The apparatus of claim 22, wherein the one or more processors are configured to facilitate communication of calibration parameters of one or more medical imaging devices stored in the at least a portion of the at least one memory.

24. 24. The apparatus of claim 18, further comprising at least one auxiliary communication line extending between the first connector and the circuit board for communicating at least non-imaging data from the medical imaging device to the circuit board.

25. the communication bus is communicatively coupled to the second connector; The at least one auxiliary communication line is connected to the communication bus.

25. The apparatus of claim 24.

26. 26. The apparatus of claim 25, wherein at least a portion of said at least one memory is directly connected to said communications bus.

27. 27. The apparatus of any one of claims 18 to 26, wherein the circuit board is disposed at the proximal end of the cable.

28. 28. Apparatus according to any one of claims 18 to 27, wherein the circuit board is integrally formed as part of the cable.

29. 30. The apparatus of claim 28, wherein the circuit board is overmolded to protect the circuit board during sterilization of the cable.

30. 30. The apparatus of any one of claims 18 to 29, wherein the cable includes a second circuit board located adjacent the first connector.

31. 31. The apparatus of claim 18, wherein the at least one memory stores 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, a cable type, a medical imaging device identification, medical imaging device calibration information, and a medical imaging device pixel compensation information.

32. the cable further comprising one or more imaging control lines extending between the first connector and the second connector for communicating imaging control signals from a medical imaging controller connected to the second connector to a medical imaging device connected to the first connector; The one or more imaging control lines bypass the communication bus of the circuit board.

32. The apparatus of claim 31 .

33. 33. The apparatus of any one of claims 18 to 32, wherein the medical imaging device is an endoscopic camera head, a medical microscope camera head, or an open field medical camera head.

34. 34. The apparatus of any one of claims 18 to 33, wherein the one or more imaging communication lines are configured to communicate at least one of pixel data and voxel data.

35. 1. 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, the medical imaging controller having 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 are accessing cable authentication information stored in at least one memory of a circuit board of the cable; authenticating the cable based on the cable authentication information stored in the at least one memory.

16. A system comprising:

36. The cable includes: a first connector disposed at a distal end of the cable for connecting the cable to the medical imaging device; a second connector disposed at a proximal end of the cable for connecting the cable to the medical imaging controller; one or more imaging communication lines extending between the first connector and the second connector for communicating imaging data from the medical imaging device to the medical imaging controller; having 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 by the medical imaging controller connected to the second connector; The one or more imaging communication lines bypass the communication bus on the circuit board.

36. The system of claim 35.

37. 37. The system of claim 35 or 36, wherein the circuit board is integrally formed as part of the cable.

38. 38. The system of any one of claims 35 to 37, wherein the one or more programs include instructions for providing an unauthenticated cable warning in response to failing to authenticate the cable.

39. The one or more programs are accessing identification information of the medical imaging device stored in the at least one memory; Controlling the medical imaging device based on identification information of the medical imaging device 39. A system according to any one of claims 35 to 38, comprising instructions.

40. 40. The system of any one of claims 35 to 39, wherein the one or more programs include instructions to communicate with one or more processors on the circuit board to obtain calibration parameters of one or more medical imaging devices stored in the at least one memory.

41. 41. The system of any one of claims 35 to 40, wherein the one or more programs include instructions for communicating with one or more non-imaging components of the medical imaging device via a communications bus on the circuit board.

42. the one or more programs include instructions for receiving imaging data from the medical imaging device via one or more imaging communication lines of the cable; The imaging communication line bypasses the circuit board.

42. A system according to any one of claims 35 to 41.

43. 1. A method of authenticating a cable by a medical imaging controller connected to a medical imaging device via the cable, comprising: the medical imaging controller having 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 comprises: accessing cable authentication information stored in at least one memory of a circuit board of the cable; authenticating the cable based on the cable authentication information stored in the at least one memory. The method according to claim 1, further comprising:

44. The cable includes: a first connector disposed at a distal end of the cable for connecting the cable to the medical imaging device; a second connector disposed at a proximal end of the cable for connecting the cable to the medical imaging controller; one or more imaging communication lines extending between the first connector and the second connector for communicating imaging data from the medical imaging device to the medical imaging controller; having 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 by the medical imaging controller connected to the second connector; The one or more imaging communication lines bypass the communication bus on the circuit board.

44. The method of claim 43.

45. 45. The method of claim 43 or 44, wherein the circuit board is integrally formed as part of the cable.

46. 46. ​​The method of any one of claims 43 to 45, further comprising providing an unauthenticated cable warning in response to failing to authenticate the cable.

47. accessing identification information of the medical imaging device stored in the at least one memory; Controlling the medical imaging device based on identification information of the medical imaging device 47. The method of any one of claims 43 to 46, further comprising:

48. 48. The method of any one of claims 43 to 47, further comprising communicating with one or more processors on the circuit board to obtain calibration parameters of one or more medical imaging devices stored in the at least one memory.

49. 49. The method of any one of claims 43 to 48, further comprising communicating with one or more non-imaging components of the medical imaging device via a communications bus on the circuit board.

50. receiving imaging data from the medical imaging device via one or more imaging communication lines of the cable; The imaging communication line bypasses the circuit board.

50. The method of any one of claims 43 to 49.

51. 51. A non-transitory tangible computer readable medium having computer executable program code embedded therein for performing the method of any one of claims 43 to 50.

52. 51. A computer program product comprising computer implementable instructions which, when implemented by a programmable computer, cause the computer to carry out the method of any one of claims 43 to 50.

53. 1. A method of imaging tissue in a subject, comprising:

1. A process for authenticating a cable by a medical imaging controller connected to a medical imaging device via the cable, the medical imaging controller having 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 comprising: accessing cable authentication information stored in at least one memory of a circuit board integrally formed as part of the cable; authenticating the cable based on the cable authentication information stored in the at least one memory. a step including instructions; generating time series images of tissue of a subject using said medical imaging device and said authenticated cable; The method according to claim 1, further comprising:

54. 54. The method of claim 53, wherein generating the time series of images of the tissue of the subject comprises generating a time series of fluorescence images of the tissue of the subject.

55. 55. The method of claim 54, further comprising administering a fluorescent imaging agent to the subject prior to generating the time series of fluorescent images of the tissue of the subject.

56. 1. A kit for processing time series images of tissue of a subject, comprising: A cable according to any one of claims 1 to 17, a device according to any one of claims 18 to 34, a system according to any one of claims 35 to 42, or a non-transitory tangible computer readable medium according to claim 51; A contrast agent; A kit comprising:

57. 57. The kit of claim 56, wherein the imaging agent is a fluorescent imaging agent.

58. 57. A fluorescent contrast agent for use in imaging tissue in a system according to any one of claims 35 to 42, a method according to any one of claims 43 to 50 and 52 to 54, or a kit according to claim 55 or 56.

59. 60. The fluorescent imaging agent of claim 58, wherein imaging of tissue comprises imaging of said tissue for blood flow imaging, tissue perfusion imaging, lymphatic imaging, or a combination thereof.

60. 60. The fluorescent imaging agent of claim 59, wherein the blood flow imaging, tissue perfusion imaging, and / or lymphatic imaging includes blood flow imaging, tissue perfusion imaging, and / or lymphatic imaging in an invasive, minimally invasive, or non-invasive medical procedure.

61. 61. The fluorescent imaging agent of claim 60, wherein the invasive medical procedure comprises a cardiac-related or reconstructive medical procedure.

62. 62. The fluorescent imaging agent of claim 61, wherein the cardiac-related medical procedure comprises a cardiac coronary artery bypass graft (CABG) procedure.

63. 63. The fluorescent contrast agent of claim 62, wherein the CABG procedure is on-pump or off-pump.

64. 61. The fluorescent imaging agent of claim 60, wherein the non-invasive medical procedure comprises a wound care procedure.

65. 65. The method of claim 59, wherein the lymphatic imaging includes identification of lymph nodes, lymphatic drainage, lymphatic mapping, or a combination thereof.

66. 66. The fluorescent imaging agent of any one of claims 59 to 65, wherein said lymphatic imaging relates to the female reproductive system.

67. Use of a cable according to any one of claims 1 to 17, a device according to any one of claims 18 to 34, a system according to any one of claims 35 to 42, a method according to any one of claims 43 to 50 and 53 to 55, or a kit according to claim 56 or 57 for lymphatic imaging.

68. Use of a cable as claimed in any one of claims 1 to 17, an apparatus as claimed in any one of claims 18 to 34, a system as claimed in any one of claims 35 to 42, a method as claimed in any one of claims 43 to 50 and 53 to 55, or a kit as claimed in claim 56 or 57, for blood flow imaging, tissue perfusion imaging, or a combination thereof.

Images