Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. Provisional Application No. 61/302,811 filed on Feb. 9, 2010, which is titled IMAGING SENSOR WITH THERMAL PAD FOR USE IN A SURGICAL APPLICATION. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not Applicable. 
       BACKGROUND 
       [0003]    The disclosure relates generally to imaging devices used during surgical procedures to visualize a surgical area, and more particularly, but not necessarily entirely, to an imaging device and imaging sensor comprising a thermal pad used to dissipate and direct heat from the imaging sensor. 
         [0004]    Endoscopic surgery is experiencing rapid growth in the medical field. Endoscopy is a minimally invasive surgical procedure that is used to analyze the interior of a body cavity or interior surfaces of an organ by inserting a tubular member into the body cavity through a minor or minimal incision. A conventional endoscope is generally an instrument with a light source and an image sensor or device for visualizing the interior a body cavity. A wide range of applications have been developed for the general field of endoscopes including, but not necessarily limited to: arthroscope, angioscope, bronchoscope, choledochoscope, colonoscope, cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope (gastroscope), laparoscope, laryngoscope, nasopharyngo-neproscope, sigmoidoscope, thoracoscope, and utererscope (hereinafter referred to generally as “endoscope”). The advantages of endoscopy include smaller surgical incisions and less soft tissue damage. As a result, there is significantly less discomfort and pain for the patient as well as a decrease in recovery time. 
         [0005]    The advantages of minimally invasive surgery performed with the help of an endoscope are well known and understood in the medical field. As a result, there have been a growing number of devices for use with endoscopes for delivering, for example, diagnostic, monitoring, treatment, operating instruments, tools, and accessories (collectively, “tools”) into the observation field and working space of the physician&#39;s endoscope. 
         [0006]    As part of forming an image of the surgical site, the endoscope includes a light source and an image sensor. Endoscopes may also incorporate more than one tubular member for observation or operation within the body, such as a working channel for passing diagnostic, monitoring, treatment, or surgical tools through the endoscope. Endoscopes include glass lenses and an adjustable ocular or eye piece, a lateral connection for a light conductor, an adaptor that allows focusing, and a camera head. This configuration is also called a video endoscope. 
         [0007]    Additionally, imaging devices are subject to governmental regulations, for example the FDA in the United States, to protect patients and surgeons from potential burns and electric shock that may result in injury. These devices may be made in accordance and consistent with International Electrotechnical Commission (“IEC”) standard 60601-1. The disclosure is directed to an apparatus, assembly and method for removing heat from a medical device, specifically an imaging device such as a camera head, while isolating the patient from the heat source. 
         [0008]    It is axiomatic that strict sterilization of the operating room and surgical equipment is required during any surgery. The strict hygiene and sterilization conditions required in a “surgical theater,” i.e., operating or treatment room, necessitate the highest possible sterility of all medical devices and equipment. Part of that sterilization process is the need to sterilize anything that comes in contact with the patient or penetrates the sterile field, including the endoscope and its attachments and components. It will be appreciated that the sterile field may be considered a specified area, such as within a tray or on a sterile towel, that is considered free of microorganisms; or the sterile field may be considered an area immediately around a patient that has been prepared for a surgical procedure. The sterile field may include the scrubbed team members, who are properly attired, and all furniture and fixtures in the area. 
         [0009]    In recent years there has been a trend of providing a single use endoscope and components as a packaged, sterilized product, similar to a package containing a surgical implant, such as a knee or hip implant. In terms of endoscopy, instead of using endoscopes that have been reconditioned for each new surgery through traditional sterilization procedures, it means using a single use endoscope and components that are delivered to the hospital in a sterilized package. Due to this trend, it has become increasingly difficult to ensure that each endoscope and its components are properly cared for, used and sterilized for single use and not simply re-sterilized using traditional sterilization procedures. 
         [0010]    Traditional drawbacks or problems of video endoscopes include a lack of image quality, the need for sterilization and high manufacturing cost as well as high processing cost. To address these and potentially other problems, the disclosure utilizes unique imaging devices or sensors in addition to a unique method, system and process for providing and reclaiming single use imaging devices. 
         [0011]    The features and advantages of the disclosure will be set forth in the description that follows, and in part will be apparent from the description, or may be learned by the practice of the disclosure without undue experimentation. The features and advantages of the disclosure may be realized and obtained by means of the instruments and combinations particularly pointed out herein. 
       SUMMARY OF THE DISCLOSURE 
       [0012]    An embodiment may comprise a single use camera used for general purpose surgical procedures including, but not limited to: arthroscopic, laparoscopic, gynecologic, and urologic. An embodiment may comprise an imaging device that is a sterile and designed to ensure single use. An embodiment may be an imaging device that comprises a single imaging sensor, either CCD (charge coupled device) or CMOS (complementary metal oxide semiconductor), encased in a molded plastic housing. The imaging device may further comprise the means to be attached to an optical coupling device, using C-Mount and CS-Mount threads or another proprietary or unique connection method. It is within the disclosure to include integrated optical systems, such that no specific coupling means is required. The imaging device may further comprise a cable or wireless method to transmit data to and from a camera control unit. An embodiment may further comprise a thermal energy dissipation means such as a heat sink or cooling mechanism. 
         [0013]    An embodiment may comprise a thermal pad that may be substantially rigid or may be deformable. An embodiment may comprise a thermal pad that may be configured to cover substantially all of the surface contact area between the heat sink and any heat generating circuitry. An embodiment may comprise a thermal pad that may be configured to cover a portion of the surface contact area between the heat sink and any heat generating circuitry. An embodiment may comprise a thermal pad that may be configured to cover a plurality of surface contact areas. An embodiment may comprise a thermal pad that may comprise a plurality of thermal pads working on a single surface contact area. An embodiment may comprise a plurality of thermal pads working on a plurality of surface contact areas. An embodiment may comprise a thermal pad having areas of varying thickness configured to accommodate the structure and geometry of surrounding components. An embodiment may comprise a thermal pad comprising a plurality of materials. An embodiment may comprise a thermal pad comprising fold lines. 
         [0014]    In an embodiment, information will be recorded in the memory of the imaging device each time it is used in a procedure or quality control (QC) checked at the manufacturer. This information may be used to evaluate usage time, expiration date, etc. An embodiment may comprise features to ensure that the imaging device is only used once and that the imaging device is safe for use. 
         [0015]    In an embodiment, the imaging device may be fully covered in plastic having a sensor heat sink to ensure the camera head meets cardiac floating (CF) and body floating (BF) ISO standards. An embodiment may comprise an imaging device that may be stamped with the current time when plugged into a console in the field after a quality control check has been performed. This time may be used as a baseline for usage. If the imaging device is powered off for a predetermined period of time, which may be equivalent to a sterilization cycle, then the imaging device will not function. The imaging device may display an onscreen message telling the user that the camera has already been used and will not allow current operation. These features ensure the imaging device will not be used more than one time per sterilization cycle and further ensures that proper sterilization is performed by the manufacturer or other authorized source. This function is to protect the patient and the doctor from an invalid or unsafe use. 
         [0016]    In an embodiment an active imaging device may be attached to a control unit. The control unit will check the last sterilization date and ensure that the imaging device is no older than a predetermined safety date. If the imaging device is older than the required date, an onscreen warning will tell the user that the imaging device has expired and is unsafe for use. These features will protect the patient and the doctor from using a non-sterile imaging device. 
         [0017]    In an embodiment a security code or some other means of identifying, and validating for use, an imaging device by a control unit maybe provided in order to verify that the imaging device is authorized for use. A validating security code or procedure of validation may be distributed to control units from a central database over the internet, by direct transfer from portable storage device such as USB device containing memory, another computer, or other storage device. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]    The features and advantages of the disclosure will become apparent from a consideration of the subsequent detailed description presented in connection with the accompanying drawings in which: 
           [0019]      FIG. 1  is an illustration of an embodiment of the features of the disclosure and made in accordance with the teachings and principles of the disclosure; 
           [0020]      FIG. 2  is an illustration of an embodiment of an imaging system made in accordance with the teachings and principles of the disclosure; 
           [0021]      FIG. 3  is an illustration of an imaging system having wireless features made in accordance with the teachings and principles of the disclosure; 
           [0022]      FIG. 4  is an illustration of an embodiment of a control unit disconnected from an imaging device, but illustrated as remaining connected to complementary apparatuses, and made in accordance with the teachings and principles of the disclosure; 
           [0023]      FIG. 5  is an illustration of an embodiment of a control unit display made in accordance with the teachings and principles of the disclosure; 
           [0024]      FIG. 6  is an illustration of an embodiment of a retractable display of a control unit in a retracted or closed position and made in accordance with the teachings and principles of the disclosure; 
           [0025]      FIG. 6A  is an illustration of an embodiment of a retractable display of a control unit in an open position and made in accordance with the teachings and principles of the disclosure; 
           [0026]      FIG. 7  is a cross-sectional view of an embodiment of an imaging device head made in accordance with the teachings and principles of the disclosure; 
           [0027]      FIG. 8  is a cross-sectional view of an embodiment of an imaging device head made in accordance with the teachings and principles of the disclosure; 
           [0028]      FIG. 9  is a cross-sectional view of an embodiment of an imaging device head made in accordance with the teachings and principles of the disclosure; 
           [0029]      FIG. 10  is a cross-sectional view of an embodiment of an imaging device head having a ball joint made in accordance with the teachings and principles of the disclosure; 
           [0030]      FIG. 11  is a cross-sectional view of an embodiment of an imaging device head made in accordance with the teachings and principles of the disclosure; 
           [0031]      FIG. 12  is a layout view of an embodiment of an imaging system made in accordance with the teachings and principles of the disclosure; 
           [0032]      FIG. 13  is a schematic diagram of a memory of an embodiment of an imaging system made in accordance with the teachings and principles of the disclosure; 
           [0033]      FIG. 14  illustrates an embodiment of a method in accordance with the teachings and principles of the disclosure; 
           [0034]      FIG. 15  illustrates an embodiment of a method in accordance with the teachings and principles of the disclosure; 
           [0035]      FIG. 16  illustrates an embodiment of a method in accordance with the teachings and principles of the disclosure; 
           [0036]      FIG. 17  illustrates an embodiment of a method of use according to the teachings and principles of the disclosure; 
           [0037]      FIG. 18  illustrates an embodiment of a method of reclaiming an imaging device after use according to the teachings and principles of the disclosure; 
           [0038]      FIG. 19  illustrates an embodiment of a method of making an imaging device for use in a sterilized environment according to the teachings and principles of the disclosure; 
           [0039]      FIG. 20  illustrates an embodiment of a method for updating an imaging device system; 
           [0040]      FIG. 21  illustrates an embodiment of a system for providing updates to an imaging system; 
           [0041]      FIG. 22  is a cross-sectional view of an embodiment of an imaging device head in accordance with the teachings and principles of the disclosure; 
           [0042]      FIG. 23  is a cross-sectional view of an embodiment of an imaging device head made in accordance with the teachings and principles of the disclosure; 
           [0043]      FIG. 24  illustrates a detailed view of an embodiment of a thermal pad with corresponding heat sink as assembled in thermal communication with surrounding heat generating components; 
           [0044]      FIG. 25  illustrates a detailed view of an embodiment of a corresponding printed circuit board; 
           [0045]      FIG. 26  illustrates a detailed view of an embodiment of a corresponding image sensor; 
           [0046]      FIG. 27  illustrates a detailed view of an embodiment of a corresponding image sensor; 
           [0047]      FIG. 28  illustrates a detailed view of an embodiment of a corresponding image sensor; and 
           [0048]      FIG. 29  illustrates an embodiment of a method for control thermal properties and isolation of electrical components of an imaging device. 
       
    
    
     DETAILED DESCRIPTION 
       [0049]    For the purposes of promoting an understanding of the principles in accordance with the disclosure, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended. Any alterations and further modifications of the inventive features illustrated herein, and any additional applications of the principles of the disclosure as illustrated herein, which would normally occur to one skilled in the relevant art and having possession of this disclosure, are to be considered within the scope of the disclosure claimed. 
         [0050]    Before the devices, systems, methods and processes for providing and reclaiming single use imaging devices are disclosed and described, it is to be understood that this disclosure is not limited to the particular embodiments, configurations, or process steps disclosed herein as such embodiments, configurations, or process steps may vary somewhat. It is also to be understood that the terminology employed herein is used for the purpose of describing particular embodiments only and is not intended to be limiting since the scope of the disclosure will be limited only by the appended claims, if any, and equivalents thereof. 
         [0051]    In describing and claiming the subject matter of the disclosure, the following terminology will be used in accordance with the definitions set out below. 
         [0052]    It must be noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. 
         [0053]    As used herein, the phrase “optic mount” contemplates a structure to which optics, such as an endoscope, may be mounted or coupled thereto and a structure that may accept other optic mounting or coupling systems, such as changeable mounting systems as commonly seen in the industry. 
         [0054]    As used herein the phrase “electrically isolate,” and any derivative thereof, contemplates electric shielding sufficient to comply with regulations in the fields of art, and must not be construed as requiring absolute isolation. For example, the phrase “electrically isolate,” when used in the medical, electrical equipment field, contemplates electric shielding sufficient to comply with International Electrotechnical Commission Standard 60601-1, including Editions 1, 2 and 3. 
         [0055]    As used herein, the terms “comprising,” “including,” “containing,” “characterized by,” and grammatical equivalents thereof are inclusive or open-ended terms that do not exclude additional, unrecited elements or method steps. 
         [0056]    As used herein, the phrase “consisting of” and grammatical equivalents thereof exclude any element, step, or ingredient not specified in the claim. 
         [0057]    As used herein, the phrase “consisting essentially of” and grammatical equivalents thereof limit the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic or characteristics of the claimed disclosure. 
         [0058]    With reference primarily to  FIG. 1 , an embodiment of the features of the disclosure will be discussed generally.  FIG. 1  illustrates a system  100  for providing a digital image using a remote imaging device  110  that may be tethered electronically and physically to a control unit  120 . The control unit  120  may be configured to exchange data with imaging device  110  in order to provide single use functionality and safety in a sterile environment, such as an operating room, a doctor&#39;s office or dental office. Additionally, the control unit  120  may be electrically connected to a computer  130  or external monitor  140  for increased functionality. 
         [0059]    Referring now to  FIG. 2  where the imaging system  100  will be discussed in greater detail. As is illustrated in  FIG. 2 , the imaging device  110  can be connected or disconnected from the control unit  120  by way of an electronic connector  114  on the imaging device  110  that is configured to electronically and physically interact with a corresponding electronic connector  126  on the control unit  120 . The ability to disconnect the imaging device  110  from the control unit  120  provides the ability to easily replace a used imaging device  110  for a sterilized, renewed imaging device  110 . The imaging device  110  may have a head portion  112  generally positioned remotely from the electronic connector  114 , thereby allowing greater mobility of the head portion  112  during use. 
         [0060]    Also illustrated in  FIG. 2  is an embodiment of the control unit  120  having an electronic connector  126  therein for receiving the corresponding electronic connector  114  of the imaging device  110 . The control unit  120  may also have a display  128  for conveying information during a procedure to an operator or user. The display  128  may also comprise interactive functionality allowing an operator to enter commands or change what information is being displayed. Such functionality may be provided by a touch screen system as is commonly known. The control unit may also have video inputs  122  and video outputs  124  for transferring image data to other apparatuses for increased functionality. As illustrated in  FIG. 1 , common apparatuses may be a computer  130  or an external monitor  140 . 
         [0061]    Referring now to  FIG. 3  an imaging system  300  will be discussed having wireless capability and features. As is illustrated in  FIG. 3 , the imaging device  310  may communicate with a control unit  320  by way of wireless transmissions such as Wifi, infrared, bluetooth etc. Other forms of wireless non-tethered connectivity may also be used for providing communication between the imaging device  310  and control unit  320 , including but not limited to, radio frequency from any available spectrum, infrared of all configurations, ultrasonic, and optical. The imaging device  310  may comprise a head portion  312  that houses an imaging sensor, memory and associated circuitry, which will be discussed in greater detail below. The head portion  312  may further comprise a wireless transceiver  314  for communicating with a corresponding wireless transceiver  322  housed in the control unit  320 . The ability to separate the head portion  312  from the control unit  320  via wireless transmissions may provide for the easy replacement of used imaging devices for sterilized and renewed imaging devices. In other words, the wireless communication may be enabled by an electronic communication circuit that is a wireless communication transceiver configured to communicate wirelessly with a corresponding transceiver on said control unit using any of the above noted wireless technologies. The wireless functionality also allows for greater mobility of the head portion  312  during use. It will be appreciated that the wireless features and functionality may be incorporated into any of the embodiments disclosed herein or embodiments that fall within the scope of this disclosure. 
         [0062]    Also illustrated in  FIG. 3  is an embodiment of the control unit  320  having wireless capabilities and features. A transceiver  322  may be provided in or as part of the control unit  320  for receiving and transmitting wireless data to the imaging device  310 . The control unit  320  may also have a display  328  for conveying information during a procedure to an operator or user. The display  328  may also comprise interactive functionality allowing an operator to enter commands or change what information is being displayed. Such functionality may be provided by a touch screen system as is commonly known. The control unit  320  may also have video inputs  321  and video outputs  324  for transferring image data to other apparatuses for increased functionality. As illustrated in  FIG. 1  common apparatuses may be a computer  130  or an external monitor  140 . It is within the scope of this disclosure to include an imaging system comprising both wired and wireless communication capabilities. 
         [0063]    Illustrated in  FIG. 4  is an embodiment of the control unit  420  disconnected from an imaging device that is illustrated as being connected to complementary apparatuses. A connector  426  may be provided therein for transferring data to and from an imaging device. The ability to separate the imaging device may provide for the easy replacement of used imaging devices with sterilized and renewed imaging devices. The control unit  420  may also have a display  428  for conveying to an operator information during a procedure. The display  428  may also comprise interactive functionality allowing an operator to enter commands or change what information is being displayed. Such functionality may be provided by a touch screen system as is commonly known. The control unit may also have video inputs  421  and video outputs  424  for transferring image data to other apparatuses for increased functionality. Common apparatuses may be a computer  430  or an external monitor  440  there by increasing the technical functionality of the system  400 . A computer  430  may be used for storing the digital output from the imaging system or may be used to enhance and provide further adjustment within the system. An external monitor  440  may be used to show real time digital images to aid an operator in the use of the system, or later review and study the recorded digital imagery. 
         [0064]    Referring now to  FIG. 5  an embodiment of a control unit display  428  that may be part of a control unit  420  will be discussed in greater detail. The display  428  may be a digital display of liquid crystal design (LCD), or the display may be some other technology beside LCD, and may have touch screen functionality and capability for an operator or user to input commands into the system  400 . The embodiment discussed herein may have input portions  428   a  and  428   b  whereby an operator or user may input commands into the system  400 . The embodiment may further comprise a status portion  428   c  informing a user about the operational status of the components of the system  400 . For example, display portion  428   c  may display an error message related to the condition of an attached imaging device  410  if the imaging device  410  has already been used or has been deemed unfit for a procedure. The display  428  may also have a dedicated message portion  428   d  providing instructions and further information to an operator or user. The configuration of the display  428  may change during use to accommodate further functionality. A plurality of displays  428  is contemplated by, and falls within the scope of, this disclosure and may be used alternatively or in conjunction with this embodiment. An embodiment may comprise a key pad or a button pad for control purposes within a control unit. 
         [0065]    Illustrated in  FIGS. 6 and 6A  is an embodiment of a retractable display  428  of a control unit  420 . The display  428  may have a first or retracted position within the control unit  420  (illustrated best in  FIG. 6 ) that may be used to protect the display  428  when it is not being used. The display  428 ′ of  FIG. 6A  illustrates how the display may be deployed into a more user readable position, as it has been extended and rotated outward. As illustrated in  FIGS. 6 and 6A , the display may be slid in and out of a passage and rotated about an axis to orient the display  428  in a wide range of positions. 
         [0066]    Illustrated in  FIG. 7  is a cross-sectional view of an embodiment of an imaging device head  712 . The imaging device head  712  may comprise a housing  710  made of a suitably rigid material, such as plastic or metal. The housing  710  may be sealed against fluids and gases so as to protect the internal circuitry and provide a suitable surface for sterilization and renewal. The imaging device head  712  may further comprise a user input panel  720  having buttons  721  and  722  for operation of the imaging device head  712 . Additional, buttons may be provided and the functionality of the buttons can be customized for a given procedure or a given operator. The control panel  720  may be internally connected to other circuitry of the imaging device head  712  by an electrical connector  726 . 
         [0067]    As illustrated further in  FIG. 7 , imaging device head  712  may comprise an optical mount system  750 , such as a C-mount system for receiving threaded accessories, for example one inch threaded accessories. A window  755  may also be incorporated into the embodiment for facilitating the transmission of light from an optical accessory to an image sensor  775 . The image sensor  775  may be mounted to a supporting printed circuit board or supportive substrate  770 . An electronic connector  778  may be incorporated to electronically connect the image sensor  775  to a main circuit or main printed circuit board  760 . A main wiring harness  782  may be incorporated into a wired tether  780  thereby electrically connecting the components of the imaging device head  712  to a control unit. 
         [0068]    The imaging device head  712  may further comprise a memory  788  or memory circuit allowing the storage of data within the imaging device head  712 . It will be appreciated that memory may be any data storage device that is capable of recording (storing) information (data). Data that may be stored or written into memory  788  may include an identifying serial number that uniquely identifies an imaging device. Other data that maybe stored or written into memory  788  may include data such as the amount of the time the imaging device has been used, i.e., the hours of operation, or the amount of time the imaging device has been powered on. Data that may be written into memory  788  may include sterilization data or renewal data, representing the working condition of the imaging device. Data that may be stored or written into memory  788  may include data such as manufacturing date, date of last verification or quality control check, location of manufacture, i.e., may include name, city, state, street address and so forth, last control unit that the imaging device head was attached to, imaging device head diagnostic information, specific procedural settings for the imaging device head, or preferred settings for an operator or user, such as a surgeon. Data representing the above characteristics, or other indicia, of the imaging device may be recorded into memory within the imaging device. 
         [0069]    The memory  788  may be encryption protected so as to avoid tampering or unintended use and foreseeable misuse. It should be noted that a memory  788  may be placed anywhere in the imaging device and not just the imaging device head without departing from the scope of the disclosure. The memory  788  may comprise a permanent or semi-permanent portion allowing varying degrees of data durability. 
         [0070]    Illustrated in  FIG. 8  is a cross-sectional view of an embodiment of an imaging device head  812 . The imaging device head  812  may comprise a housing  810  made of a suitably rigid material such as plastic or metal. The housing  810  may be sealed against fluids and gases so as to protect the internal circuitry and provide a suitable surface for sterilization and renewal. The imaging device head  812  may further comprise a user input panel  820  having buttons  821  and  822 . Additional, buttons may be provided and the functionality of the buttons can be customized for a given procedure and or a given operator. The control panel  820  maybe internally connected to other circuitry of the imaging device head  812  by an electrical connector  826 . 
         [0071]    As illustrated further in the embodiment of  FIG. 8 , the imaging device head  812  may comprise an optical mount system  850 , such as a C-mount system for receiving threaded accessories, for example one inch threaded accessories. A window  855  may also be incorporated into the embodiment for facilitating the transmission of light from an optical accessory to an image sensor  875 . The image sensor  875  may be mounted to a supporting printed circuit board or supportive substrate  870 . An electronic connector  878  maybe incorporated to electronically connect the image sensor  875  to a main circuit or main printed circuit board  860 . In order to provide heat dissipation from the image sensor  875  and other circuitry, a heat sink  861  may be provided. The heat sink  861  may be physically connected to the image sensor  875  and it may also be connected to the housing  810 , such that heat energy can be conducted or transferred to the external portion of the imaging device head  812 . The heat sink  861  may be a neutral sensor heat sink exposed externally to ensure the camera head meets cardiac floating (CF) and body floating (BF) ISO standards. An embodiment of the heat sink  861  may be made of aluminum and have fins for added heat transfer surface area. A main wiring harness  882  may be incorporated into a wired tether  880  thereby electrically connecting the components of the imaging device head  812  to a control unit. 
         [0072]    The imaging device head  812  may further comprise a memory  888  or memory circuit allowing the storage of data within the imaging device head  812 . Data that may be stored or written into memory  888  may include an identifying serial number that uniquely identifies an imaging device. Other data that may be stored or written into memory  888  may include data such as the amount of the time the imaging device has been used, i.e., the hours of operation, or the amount of time the imaging device has been powered on. Data that may be written into memory  888  may include sterilization data or renewal data, representing the working condition of the imaging device. Data that may be stored or written into memory  888  may include data such as manufacturing date, date of last verification or quality control check, location of manufacture, i.e., may include name, city, state, street address and so forth, last control unit that the imaging device head was attached to, imaging device head diagnostic information, specific procedural settings for the imaging device head, or preferred settings for an operator or user, such as a surgeon. Data representing the above characteristics, or other indicia, of the imaging device may be recorded into memory within the imaging device. 
         [0073]    The memory  888  may be encryption protected so as to avoid tampering or unintended use and foreseeable misuse. It should be noted that a memory may be placed anywhere in the imaging device and not just the imaging device head without departing from the scope of the disclosure. The memory  888  may comprise a permanent or semi-permanent portion allowing varying degrees of data durability. 
         [0074]    Illustrated in  FIG. 9  is a cross-sectional view of an embodiment of an imaging device head  912 . The imaging device head  912  may comprise a housing  910  made of a suitably rigid material such as plastic or metal. The housing  910  may be sealed against fluids and gases so as to protect the internal circuitry and provide a suitable surface for sterilization and renewal. The imaging device head  912  may further comprise a user input panel  920  having buttons  921  and  922 . Additional, buttons maybe provided and the functionality of the buttons can be customized for a given procedure and or a given operator. The control panel  920  maybe internally connected to other circuitry of the imaging device head  912  by an electrical connector  926 . 
         [0075]    As illustrated further in the embodiment of  FIG. 9 , the imaging device head  912  may comprise an optical mount system  950 , such as a C-mount system for receiving threaded accessories, for example one inch threaded accessories. A window  955  may also be incorporated into the embodiment for facilitating the transmission of light from an optical accessory to an image sensor  975 . The image sensor  975  may be mounted to a supporting printed circuit board or supportive substrate  970 . An electronic connector  978  may be incorporated to electronically connect the image sensor  975  to a main circuit or main printed circuit board  960 . In order to provide heat dissipation from the image sensor  975  and other circuitry, a heat sink may be provided, similar to the heat sink provided in  FIG. 8 . The heat sink may be physically connected to the image sensor  975  and it may also be connected to the housing  910 , such that heat energy can be conducted or transferred to the external portion of the imaging device head  912 . A main wiring harness  982  may be incorporated into a wired tether  980  thereby electrically connecting the components of the imaging device head  912  to a control unit. 
         [0076]    The imaging device head  912  may further comprise a memory  988  or memory circuit allowing the storage of data within the imaging device head  912 . Data that may be stored or written into memory  988  may include an identifying serial number that uniquely identifies an imaging device. Other data that may be stored or written into memory  988  may include data such as the amount of the time the imaging device has been used, i.e., the hours of operation, or the amount of time the imaging device has been powered on. Data that may be stored or written into memory  988  may include data such as manufacturing date, date of last verification or quality control check, location of manufacture, i.e., may include name, city, state, street address and so forth, last control unit that the imaging device head was attached to, imaging device head diagnostic information, specific procedural settings for the imaging device head, or preferred settings for an operator or user, such as a surgeon. Data representing the above characteristics, or other indicia, of the imaging device may be recorded into memory within the imaging device. 
         [0077]    The memory  988  may be encryption protected so as to avoid tampering or unintended use and foreseeable misuse. It should be noted that a memory may be placed anywhere in the imaging device and not just the imaging device head without departing from the scope of the disclosure. The memory  988  may comprise a permanent or semi-permanent portion allowing varying degrees of data durability. 
         [0078]    The imaging device head  912  may comprise a ball joint  990  with a corresponding seal and socket, thereby providing increased mobility between the housing  910  and the tether  980  during articulation of the imaging device by an operator or user. 
         [0079]    With reference primarily to  FIG. 10 , an embodiment of an imaging device ball joint  990  will be discussed in further detail.  FIG. 10  is illustrative of a cross-sectional view of a ball joint  990 , which provides greater freedom of articulation for an operator when moving the imaging device head  912  relative to the wiring tether  980 . The ball joint  990  may comprise a substantially spherical rotatable portion or ball  991 . The ball  991  may be configured to mechanically operate in communication with a corresponding socket  992 , such that the ball  991  may substantially freely rotate while being retained within the socket  992 . A seal may be provided withing the ball joint  990  by the inclusion of a seal ring  993 . The seal ring  993  may also provide mechanical resistance within the ball joint  990 . The ball  991  may further include an opening  994  therethrough allowing wiring  995  to pass through the ball joint  990 . 
         [0080]    With reference to  FIG. 11 , an embodiment of an imaging device  1100  comprising wireless transmission functionality will be discussed. A cross-sectional view of an embodiment of an imaging device head  1112  is shown in  FIG. 11 . The imaging device head  1112  may comprise a housing  1110  made of a suitably rigid material such as plastic or metal. The housing  1110  may be sealed against fluids and gases so as to protect the internal circuitry and provide a suitable surface for sterilization and renewal. The imaging device head  1112  may further comprise a user input panel  1120  having buttons  1121  and  1122 . Additional, buttons may be provided and the functionality of the buttons can be customized for a given procedure and or a given operator. The control panel  1120  may be internally connected to other circuitry of the imaging device head  1112  by an electrical connector  1126 . The imaging device head  1112  may communicate with a control unit by way of wireless transmissions such as Wifi, infrared, bluetooth etc. Other forms of wireless non-tethered connectivity may also be used for providing communication between the imaging device head  1112  and the control unit, including but not limited to, radio frequency from any available spectrum, infrared of any configuration, ultrasonic, and optical. As illustrated further in the embodiment of  FIG. 11 , the imaging device head  1112  may comprise an optical mount system  1150 , such as a C-mount system for receiving threaded accessories, for example one inch threaded accessories. A window  1155  may also be incorporated into the embodiment for facilitating the transmission of light from an optical accessory to an image sensor  1175 . The image sensor  1175  may be mounted to a supporting printed circuit board or supportive substrate  1170 . An electronic connector  1178  may be incorporated to electronically connect the image sensor  1175  to a main circuit or main printed circuit board  1160 . The circuitry of the imaging device head  1112  may electrically be connected to a wireless transceiver  1111  for transmitting and receiving data from a wirelessly configured control unit as illustrated in  FIG. 3 . 
         [0081]    The imaging device head  1112  may further comprise a memory  1188  or memory circuit allowing the storage of data within the imaging device head  1112 . Data that may be stored or written into memory  1188  may include an identifying serial number that uniquely identifies an imaging device. Other data that may be stored or written into memory  1188  may include data such as the amount of the time the imaging device has been used, i.e., the hours of operation, or the amount of time the imaging device has been powered on. Data that may be stored or written into memory  1188  may include data such as manufacturing date, date of last verification or quality control check, location of manufacture, i.e., may include name, city, state, street address and so forth, last control unit that the imaging device head was attached to, imaging device head diagnostic information, specific procedural settings for the imaging device head, or preferred settings for an operator or user, such as a surgeon. Data representing the above characteristics, or other indicia, of the imaging device may be recorded into memory within the imaging device. 
         [0082]    The memory  1188  may be encryption protected so as to avoid tampering or unintended use and foreseeable misuse. It should be noted that a memory may be placed anywhere in the imaging device and not just the imaging device head without departing from the scope of the disclosure. The memory  1188  may comprise a permanent or semi-permanent portion allowing a varying degrees of data durability. 
         [0083]    It will be appreciated that the ball joint illustrated in  FIGS. 9 and 10  may be used by any embodiment of the disclosure without departing from the spirit or scope of the disclosure. Thus, for example, the ball joint  990  may be used with imaging device head  712 ,  812 ,  912 , or  1112 . Similarly, it will be appreciated that the heat sink  861  (illustrated in  FIG. 8 ) may be used by any embodiment of the disclosure without departing from the scope of the disclosure. 
         [0084]    Referring now to  FIG. 12  an embodiment of a system for acquiring imagery in a sterilized environment will be discussed. The system may comprise an imaging device  1201  having a memory  1202 , an image sensor  1204 , and supporting circuitry  1206 . The system may further comprise and control unit  1220  having a processor  1221 , time circuit or realtime clock  1222 , a counting or incrementing circuit  1224  and a control unit memory  1226 . The components will generally be provided in a housing, but are shown hear in block diagram form for simplicity and discussion purposes. It is contemplated that any of the above circuits can operate from either a control unit or an imaging device. 
         [0085]    As can be seen in  FIG. 13  the memory  1202  of the imaging device  1201  may comprise the following arrays of data storage: 
         [0086]    a. Hours of camera head operation; 
         [0087]    b. Number of times camera has been used; 
         [0088]    c. Unique identification i.e. serial number, id, etc.; 
         [0089]    d. Manufacture date; 
         [0090]    e. Date of last verification/quality check; 
         [0091]    f. Location of manufacture i.e. (Address, state, city etc.); 
         [0092]    g. Last console that the camera head was connected to; 
         [0093]    h. Camera console diagnostic information; 
         [0094]    i. Procedural specific camera head settings (i.e. video settings, button settings, etc.); 
         [0095]    j. Last Sterilization date (used to ensure safety to product); and 
         [0096]    k. Surgeon or user settings. 
         [0000]    Additional data may be stored within the memory  1202  that would enhance the imaging device and is considered to be within the scope of the disclosure. 
         [0097]    With reference to  FIG. 14 , a method of using an imaging system consistent with the embodiments disclosed herein will be discussed. In use, a sterilized single use imaging device  1201  will be provided that may comprise memory  1202  at  1410 . At  1420  a user may connect the single use imaging device  1201  to a complementary control unit  1220  both electronically and physically. At  1430  the control unit  1220  may initiate a process of reading memory  1202  and registers the serial number of the imaging device  1201 . At  1440  the system causes a value to be recorded into memory  1202  indicating that the imaging device  1201  has been used. At  1450  the system records into memory  1202  the date and time the imaging device  1201  is connected to the control unit  1220 . At  1460  a timing process is initiated by the control unit from the base line time recorded at  1450  and tracks or times the duration that the imaging device  1201  is used and the duration is recorded into memory  1202  at  1470 . After use, the imaging device  1201  is disconnected from the control unit  1220  at  1480  and then discarded for renewal or reclamation. 
         [0098]    Referring now to  FIG. 15 , a method of renewing and reclaiming a single use imaging device  1201  will be discussed. At  1510  the imaging device  1201  may be connected to a testing control unit or a master control unit. At  1520  the testing control unit or master control unit causes the data stored in memory  1202  to be recorded into storage on the testing control unit or master control unit as stored, in order for the specific imaging device  1201  to be renewed. At  1525  a value is placed in memory  1202  indicating that the imaging device has been renewed and is ready for use such that when connected to another control unit for use it will operate. The location and date of the renewal may then be recorded into memory  1202  at  1530 . At  1540  the imaging device  1201  can be sterilized and (at  1550 ) placed in a protective sterilized package. 
         [0099]    With reference to  FIG. 16  an alternative embodiment of a method of use will be discussed illustrating safety settings of the embodiment. At  1610  the memory imaging device head may be stamped with time of manufacture when it is plugged into the master control unit or master console after assembly in the field, i.e., in an operating room, and after a quality control check has been performed. At  1620  a check may be made to determine if the imaging device has been powered off for a predetermined number of minutes, such as a time frame that is close to what a typical sterilization cycle would last. At  1630 , if the imaging device has been powered off the predetermined amount of time the control unit will display an onscreen message telling the user the imaging device has already been used, and will not allow further operation, such that no image will be produced through video feed. This feature will ensure the imaging device, i.e., the camera, will not be used more than one time per sterilization cycle. This feature also protects the patient and the doctor from an invalid or unsafe use and foreseeable misuse. 
         [0100]    Referring to  FIG. 17  an embodiment of a method of use will be discussed. During use, an imaging device may be connected to a control unit. Upon connection, an electronic communication connection is formed between the imaging device and the control unit. At  1702  the imaging device may be powered on by power supplied by the control unit. At  1704  a processor in the control unit may cause data regarding imaging device identification that may be stored in a memory within the imaging device to be read. At  1706  a processor in the control unit may cause data regarding the manufacturing date of the imaging device to be read from memory within the imaging device. The processor in the control unit may then compare the data to a predetermined data value range. At  1707  an error message may be displayed if the read data is outside the predetermined data value range and the imaging device will be stopped from operating. At  1708  a processor in the control unit may cause data regarding the reclamation of the imaging device to be read from memory within the imaging device. The data regarding reclamation of the imaging device may include data representing whether or not the imaging device has been previously used. The processor may then compare the data to a predetermined data value range. At  1709  an error massage may be displayed if the read data is outside the predetermined data value range and the imaging device will be stopped from operating. At  1710  a processor in the control unit may cause data regarding the reclamation date of the imaging device to be read from memory within the imaging device. The processor may then compare the data to a predetermined data value range. At  1711  an error massage may be displayed if the read data is outside the predetermined data value range and the imaging device will be stopped from operating. At  1712  a processor in the control unit may cause usage information of the current procedure to be monitored to note whether imaging device has been unpowered for a predetermined period of time and then re-powered. If this condition occurs it is possible that the imaging device has been tampered with or that an attempt has been made to sterilize the imaging device and use it a second time. The predetermined period of time may correspond to the amount of time a typical sterilization process would normally take. The processor then compares the data to a predetermined data value range. At  17013  an error massage may be displayed if the data read is outside the predetermined data value range and the imaging device will be stopped from operating. At  1714  a processor in the control unit may cause a value to be placed in memory in the imaging device indicating that the imaging device has been used. At  1716  a processor in the control unit may cause the date and time of use to be recorded in memory in the imaging device. Additional information may be recorded into the memory of the imaging device such as, for example, duration of use, procedure settings, and user settings and any other data suitable for recording to memory. The imaging device may be disconnected from the control unit and thereby powered off at  1718 . 
         [0101]    Referring now to  FIG. 18  a method of reclaiming an image device after use will be discussed. It should be noted that a single use imaging device may comprise the durability to be used a plurality of times, however sterilization requirements may prevent an imaging device from being used more than once without a process for reclaiming the imaging device, thereby returning it to a sterilized condition. A method of reclamation for an imaging device may comprise the process of powering on the imaging device at  1802 , when the imaging device is electrically connected to a control unit. At  1804  a processor in the control unit may cause data representing identification information for the imaging device to be stored in storage in the control unit. A control unit maybe a master control unit configured for reclaiming the imaging devices. The master control unit may track a plurality of imaging devices thereby keeping a catalog of associated information such as use and condition of the device or devices. At  1806  a processor in the control unit may cause that data representing a manufacturing date to be read and compared to a predetermined value or range of values. If the read data is out of the predetermined range value, an error report may be issued at  1807 . At  1808  a processor in the control unit may cause data representing use data written in memory of the imaging device to be read and recorded into storage in the control unit. At  1810  a processor may cause data representing a date and time of reclamation to be recorded into memory in the imaging device. At  1812  a processor in the control unit may cause that data representing the number of uses of the imaging device to be read and recorded into storage in the control unit. The processor may compare the read data to a predetermined value or range of values to determine whether the imaging device is fit for continued use. If the predetermined value is exceeded an error message may be displayed (at  1813 ) and the imaging device may be retired. At  1814  a processor in the control unit may initiate a test or quality control check of all the circuitry in the imaging device to ensure that the device is functional. At  1815  it may be determined that the imaging device failed the quality control check and an error massage may be displayed. At  1816  the imaging device can be reset for use. The resetting process may comprise writing data to the memory of the imaging device indicating that the imaging device has been reclaimed and sterilized. At  1816  the device may be disconnected from the control unit and physically sterilized and repackaged. 
         [0102]    With reference primarily to  FIG. 19  an embodiment of a method for making an imaging device having memory therein for use in a sterilized environment will be discussed. At  1902  an imaging device may be powered on upon being connected to a control unit. The control unit may be a master control unit configured for the manufacturing process. At  1904  a processor in the control unit may cause that data representing an identification serial number for the imaging device to be written into memory of the imaging device. At  1906  a processor in the control unit may cause that data representing the location of manufacture be recorded to memory in the imaging device. At  1908  a processor may cause that data representing the date of manufacture may be recorded into memory on the imaging device. At  1910  a processor in the control unit may initiate a test or quality control check of all the circuitry in the imaging device to ensure that the device is functional. At  1912  the imaging device may be unplugged from the control and sterilized for packaging. 
         [0103]    Referring to an embodiment illustrated in  FIG. 20 , a system having a security code or some other means of identifying, and validating for use, an imaging device by a control unit, in order to verify that the imaging device is authorized for use will now be described. A validating security code or procedure of validation may be distributed to control units from a central database over the internet, by direct transfer from portable storage device such as USB device containing memory, another computer, or other storage device. With reference to  FIG. 20  an embodiment of a method for providing updates with in a medical imaging system will be discussed. At  2002  a control unit may be powered on to receive a security update. At  2004  security update data may provided comprising validation codes that correspond to imaging devices to be connected to the control unit. Such validation codes may enable the system to insure that users of the system may be prevented from using imaging devices that have been selected for non-use by a manufacturer or distributor. Selection criteria for non-use may include safety considerations, recall considerations, anti counterfeit measures, and sales and contract considerations. At  2006  the data may be transferred into storage or memory of the control unit in order to provide that data for later comparison to security codes provided by imaging devices. It is within the scope of this disclosure to include all means for transferring data, including but not limited to, transmission over a network, transfer via on site transmission from a storage medium that is portable, such as a disk, memory drive, or short distance wireless transmission. At  2008  the system may be powered off. 
         [0104]    With reference primarily to  FIG. 21  an embodiment of an imaging system have the feature of updating data will be discussed. An imaging system  2100  may comprise a control unit  2102  and a data server  2104 . The control unit  2106  may be electronically in communication with the data server  2104  over a network such as the internet  2106 . The control unit  1202  may receive update data over the internet  2106  from data server  2104 . The control unit  2102  may also receive update data directly from a memory transfer device  2108  such as a memory stick, thumb drive, jump drive, hard drive, optical disk to name a few. The control unit  2102  may also receive update data from another computer or portable device  2110  such as a PDA or laptop that is presented to the control unit  2102  on site. Data transfer may be made with a physical connection and or by a wireless transfer of data. 
         [0105]    With reference to  FIG. 22 , an embodiment of an imaging device  2200  comprising a heat sink  2277  having a thermal pad  2278  will be discussed. A cross-sectional view of an embodiment of an imaging device head  2212  is shown in  FIG. 22 . The imaging device head  2212  may comprise a housing  2210  made of a suitably rigid material such as a plastic or metal. The housing  2210  may be sealed against fluids and gases so as to protect the internal circuitry and provide a suitable surface for sterilization and renewal. The imaging device head  2212  may further comprise a user input panel  2220  having buttons  2221  and  2222 . Additional, buttons may be provided and the functionality of the buttons can be customized for a given procedure and/or a given operator. The control panel  2220  may be internally connected to other circuitry of the imaging device head  2212  by an electrical connector  2226 . The imaging device head  2212  may communicate with a control unit by way of wireless transmissions such as Wifi, infrared, bluetooth etc. Other forms of wired and wireless non-tethered connectivity may also be used for providing communication between the imaging device head  2212  and the control unit, including but not limited to, hard wired, radio frequency from any available spectrum, infrared of any configuration, ultrasonic, and optical. 
         [0106]    As illustrated further in the embodiment of  FIG. 22 , the imaging device head  2212  may comprise an optical mount system  2250 , such as a C-mount system for receiving threaded accessories, for example one inch threaded accessories. A window  2255  may also be incorporated into the embodiment for facilitating the transmission of light from an optical accessory to an image sensor  2275 . The image sensor  2275  may be mounted to a supporting printed circuit board or supportive substrate  2270 . An electronic connector  2278  may be incorporated to electronically connect the image sensor  2275  to a main circuit or main printed circuit board  2260 . The circuitry of the imaging device head  2212  may electrically be connected to a wireless transceiver  2211  for transmitting and receiving data from a wirelessly configured control unit as illustrated in  FIG. 3 . 
         [0107]    The imaging device head  2212  may further comprise a memory  2288  or memory circuit allowing the storage of data within the imaging device head  2212 . Data that may be stored or written into memory  2288  may include an identifying serial number that uniquely identifies an imaging device. Other data that may be stored or written into memory  2288  may include data such as the amount of the time the imaging device has been used, i.e., the hours of operation, or the amount of time the imaging device has been powered on. Data that may be stored or written into memory  2288  may include data such as manufacturing date, date of last verification or quality control check, location of manufacture, i.e., may include name, city, state, street address and so forth, last control unit that the imaging device head was attached to, imaging device head diagnostic information, specific procedural settings for the imaging device head, or preferred settings for an operator or user, such as a surgeon. Data representing the above characteristics, or other indicia, of the imaging device may be recorded into memory within the imaging device. 
         [0108]    The memory  2288  may be encryption protected so as to avoid tampering or unintended use and foreseeable misuse. It should be noted that a memory may be placed anywhere in the imaging device and not just the imaging device head without departing from the scope of the disclosure. The memory  2288  may comprise a permanent or semi-permanent portion allowing varying degrees of data durability. 
         [0109]    In order to provide protection to a user against electrical contact an embodiment may be electrically sealed or electrically insulated from a user. It will be appreciated that a user may be a surgeon, a surgical assistant, a technician, a patient, or any other person who may come in contact with the device. Such insulation may provide for heat transfer while at the same time electrically insulating the user from the electronics of the camera head  2200 . Illustrated in  FIG. 22  is a heat sink  2277  having a thermal pad  2278 . The thermal pad  2278  maybe configured to allow the transfer of thermal energy from circuit board  2270  and image sensor  2275  to the heat sink  2277 , while electrically insulating the components from the heat sink  2277 , thereby dissipating heat generated by the circuitry without risk of electrical contact with the user. The thermal pad  2278  may be substantially rigid or may be deformable. The thermal pad  2278  may be configured to cover substantially all of the surface contact area between the heat sink  2277  and any heat generating circuitry. The thermal pad may be configured to cover a portion of the surface contact area between the heat sink  2277  and any heat generating circuitry. The thermal pad  2278  may be configured to cover a plurality of surface contact areas. An embodiment may comprise a plurality of thermal pads  2278  working on a single surface contact area. An embodiment may comprise a plurality of thermal pads  2278  working on a plurality of surface contact areas. An embodiment may comprise a thermal pad  2278  having areas of varying thickness configured to accommodate the structure and geometry of surrounding components. An embodiment may comprise a thermal pad  2278  comprising a plurality of materials. An embodiment may comprise a thermal pad  2278  comprising fold lines. 
         [0110]    As illustrated further in the embodiment of  FIG. 23 , the imaging device head  2312  may comprise an optical mount system  2350 , such as a C-mount system for receiving threaded accessories, for example one inch threaded accessories. A window  2355  may also be incorporated into the embodiment for facilitating the transmission of light from an optical accessory to an image sensor  2375 . The image sensor  2375  may be mounted to a supporting printed circuit board or supportive substrate  2370 . An electronic connector  2378  may be incorporated to electronically connect the image sensor  2375  to a main circuit or main printed circuit board  2360 . 
         [0111]    The imaging device head  2312  may further comprise a memory  2388  or memory circuit allowing the storage of data within the imaging device head  2312 . Data that may be stored or written into memory  2388  may include an identifying serial number that uniquely identifies an imaging device. Other data that may be stored or written into memory  2388  may include data such as the amount of the time the imaging device has been used, i.e., the hours of operation, or the amount of time the imaging device has been powered on. Data that may be stored or written into memory  2388  may include data such as manufacturing date, date of last verification or quality control check, location of manufacture, i.e., may include name, city, state, street address and so forth, last control unit that the imaging device head was attached to, imaging device head diagnostic information, specific procedural settings for the imaging device head, or preferred settings for an operator or user, such as a surgeon. Data representing the above characteristics, or other indicia, of the imaging device may be recorded into memory within the imaging device. 
         [0112]    The memory  2388  may be encryption protected so as to avoid tampering or unintended use and foreseeable misuse. It should be noted that a memory may be placed anywhere in the imaging device and not just the imaging device head without departing from the scope of the disclosure. The memory  2388  may comprise a permanent or semi-permanent portion allowing a varying degrees of data durability. 
         [0113]    In order to provide protection to a user against electrical contact an embodiment may be electrically sealed or electrically insulated from a user. Such insulation may provide for heat transfer while at the same time electrically insulating the user from the electronics of the camera head  2300  and camera control unit (CCU). Illustrated in  FIG. 23  is a heat sink  2377  having a thermal pad  2378 . The thermal pad  2378  may be configured to allow the transfer of thermal energy from circuit board  2370  and image sensor  2375  to the heat sink  2377  while electrically insulating the components from the heat sink  2377 , thereby dissipating heat generated by the circuitry without risk of electrical contact with the user. The thermal pad  2378  may be substantially rigid or may be deformable. The thermal pad  2378  may be configured to cover substantially all of the surface contact area between the heat sink  2377  and any heat generating circuitry. The thermal pad may be configured to cover a portion of the surface contact area between the heat sink  2377  and any heat generating circuitry. The thermal pad  2378  may be configured to cover a plurality of surface contact areas. An embodiment may comprise a plurality of thermal pads  2378  working on a single surface contact area. An embodiment may comprise a plurality of thermal pads  2378  working on a plurality of surface contact areas. An embodiment may comprise a thermal pad  2378  having areas of varying thickness configured to accommodate the structure and geometry of surrounding components. An embodiment may comprise a thermal pad  2378  comprising a plurality of materials. An embodiment may comprise a thermal pad  2378  comprising fold lines. 
         [0114]    Illustrated in  FIG. 24  is a detailed view of an embodiment of a thermal pad  2440  with corresponding heat sink  2430  as assembled in thermal communication with surrounding heat generating components. The assembly  2400  may comprise an imaging sensor or chip  2410 , a printed circuit board  2420 , a heat sink  2430  and a thermal pad  2440 . Referring to  FIGS. 24 and 25 , the printed circuit board  2420  may comprise an opening  2422  for receiving the heat sink  2430  and may comprise a plurality of electrical contacts  2424  for contacting corresponding sensor contacts  2414  on the imaging sensor  2410 . 
         [0115]    Referring to  FIGS. 24 and 26 , the imaging sensor  2410  comprises a thermal pad  2415  used to dissipate and direct heat from the imaging sensor  2410 . The thermal interface material  2440  illustrated in  FIG. 24  is located between the heat sink  2430  and the thermal pad  2415 . The thermal interface  2440  is a material that is thermally conductive, but electrically non-conductive or insulating. The insulating properties of the material  2440  prevent electrical current from flowing from the electronics in the imaging device or camera head to the heat sink  2430 , which may be in contact with the patient or user of the device or both. It will be appreciated that thermal energy may be dissipated from the imaging sensor  2410  through the thermal pad  2415  and through the thermal pad  2440  to the heat sink  2430  where the heat is quickly dissipated without the flow of electricity. The heat sink  2430  may be any heat sink known in the art and may be made of a thermally conductive material to quickly distribute and dissipate the heat from the sensor  2410 . The thermal pad  2440  may be substantially rigid or may be deformable. The thermal pad  2440  may be configured to cover substantially all of the surface contact area between the heat sink  2430  and any heat generating circuitry. The thermal pad may be configured to cover a portion of the surface contact area between the heat sink  2430  and any heat generating circuitry. The thermal pad  2440  may be configured to cover a plurality of surface contact areas. An embodiment may comprise a plurality of thermal pads  2440  working on a single surface contact area. An embodiment may comprise a plurality of thermal pads  2440  working on a plurality of surface contact areas. An embodiment may comprise a thermal pad  2440  having areas of varying thickness configured to accommodate the structure and geometry of surrounding components. An embodiment may comprise a thermal pad  2440  comprising a plurality of materials. An embodiment may comprise a thermal pad  2440  comprising fold lines. 
         [0116]    Illustrated in  FIG. 27  is a cross-sectional view of an embodiment of an imaging device head  2712 . The imaging device head  2712  may comprise a housing  2710  made of a suitably rigid material, such as plastic or metal. The housing  2710  may be sealed against fluids and gases so as to protect the internal circuitry and provide a suitable surface for sterilization and renewal. The imaging device head  2712  may further comprise a user input panel  2720  having buttons  2721  and  2722  or electrical communication mechanisms for operation of the imaging device head  2712 . Additional buttons or electrical communication mechanisms may be provided and the functionality of the buttons or electrical communication mechanisms can be customized for a given procedure or a given operator. The control panel  2720  may be internally connected to other circuitry of the imaging device head  2712  by an electrical connector  2726 . 
         [0117]    As illustrated further in  FIG. 27 , imaging device head  2712  may comprise an optical mount system  2750 , such as a C-mount system for receiving threaded accessories, for example one inch threaded accessories. A window  2755  may also be incorporated into the embodiment for facilitating the transmission of light from an optical accessory to an image sensor  2775 . The image sensor  2775  may be mounted to a supporting printed circuit board or supportive substrate  2770 . An electronic connector  2778  may be incorporated to electronically connect the image sensor  2775  to a main circuit or main printed circuit board  2760 . A main wiring harness  2782  may be incorporated into a wired tether  2780  thereby electrically connecting the components of the imaging device head  2712  to a control unit. 
         [0118]    The imaging device head  2712  may further comprise a memory  2788  or memory circuit allowing the storage of data within the imaging device head  2712 . It will be appreciated that memory may be any data storage device that is capable of recording (storing) information (data). Data that may be stored or written into memory  2788  may include an identifying serial number that uniquely identifies an imaging device. Other data that may be stored or written into memory  2788  may include data such as the amount of the time the imaging device has been used, i.e., the hours of operation, or the amount of time the imaging device has been powered on. Data that may be written into memory  2788  may include sterilization data or renewal data, representing the working condition of the imaging device. Data that may be stored or written into memory  2788  may include data such as manufacturing date, date of last verification or quality control check, location of manufacture, i.e., may include name, city, state, street address and so forth, last control unit that the imaging device head was attached to, imaging device head diagnostic information, specific procedural settings for the imaging device head, or preferred settings for an operator or user, such as a surgeon. Data representing the above characteristics, or other indicia, of the imaging device may be recorded into memory within the imaging device. 
         [0119]    The memory  2788  may be encryption protected so as to avoid tampering or unintended use and foreseeable misuse. It should be noted that a memory  2788  may be placed anywhere in the imaging device and not just the imaging device head without departing from the scope of the disclosure. The memory  2788  may comprise a permanent or semi-permanent portion allowing varying degrees of data durability. An embodiment may further comprise a heat sink  2777  for transferring heat away from circuitry and said image sensor  2775 , and a thermal pad  2778  configured to be in physical contact with said image sensor  2775  and said circuitry and said heat sink  2777 . The thermal pad  2778  may be configured to electronically isolate the image sensor  2775  from the patient and operator while enhancing the dissipation of heat generated by the image sensor  2775 . As can be seen in the figure, the thermal pad  2778  may be disposed between the image sensor  2775 , or the non-light sensing portion of the image sensor  2775 , and the heat sink  2777 . As illustrated, the thermal pad  2778  may contact the image sensor  2775  or the heat sink  2777  at a plurality of points. It is within the scope of this disclosure to contemplate a multi piece thermal pad that may be place under the plurality of contact areas between the heat sink  2777  and the image sensor  2775 . The thermal pad  2778  may also contact the image sensor  2775  at less than the entirety of the surface area of the image sensor. The thermal pad  2778  may be larger than the area of either the heat sink  2777  or the area of the image sensor  2775 . 
         [0120]    An embodiment of a single use imaging device for use with and communicating with a control unit may comprise a housing, an image sensor, an opening proximate to an optic mount that has been configured to facilitate the transmission of light from any attached optics to said image sensor. The imaging device may further comprise a memory for storing data representing any characteristics of the imaging device. In order to manage the heat created by the electronics in the imaging device, the embodiment may further comprise a heat sink for transferring heat away from circuitry and said image sensor, and a thermal pad configured to be in physical contact with said image sensor and said circuitry and said heat sink. Wherein said thermal pad is further configured to electrically isolate said image sensor and said circuitry from said heat sink, and is further configured to thermally conduct heat generated by said circuitry and said image sensor. The thermal pad may be disposed between said image sensor and said heat sink, such that the image sensor is electrically isolated from said heat sink. The thermal pad may also be in substantial contact with said image sensor across substantially all of the surface area defined by the image sensor. In other configurations the thermal pad may be in substantial contact with said image sensor at a portion that is less than the surface area defined by the imaging sensor. 
         [0121]    Illustrated in  FIG. 28  is a cross-sectional view of an embodiment of an imaging device head  2812 . The imaging device head  2812  may comprise a housing  2810  made of a suitably rigid material, such as plastic or metal. The housing  2810  may be sealed against fluids and gases so as to protect the internal circuitry and provide a suitable surface for sterilization and renewal. The imaging device head  2812  may further comprise a user input panel  2820  having buttons  2821  and  2822  for operation of the imaging device head  2812 . Additional, buttons may be provided and the functionality of the buttons can be customized for a given procedure or a given operator. The control panel  2820  may be internally connected to other circuitry of the imaging device head  2812  by an electrical connector  2826 . 
         [0122]    As illustrated further in  FIG. 28 , imaging device head  2812  may comprise an optical mount system  2850 , such as a C-mount system for receiving threaded accessories, for example one inch threaded accessories. A window  2855  may also be incorporated into the embodiment for facilitating the transmission of light from an optical accessory to an image sensor  2875 . The image sensor  2875  may be mounted to a supporting printed circuit board or supportive substrate  2870 . An electronic connector  2878  may be incorporated to electronically connect the image sensor  2875  to a main circuit or main printed circuit board  2860 . A main wiring harness  2882  may be incorporated into a wired tether  2880  thereby electrically connecting the components of the imaging device head  2812  to a control unit. 
         [0123]    The imaging device head  2812  may further comprise a memory  2888  or memory circuit allowing the storage of data within the imaging device head  2812 . It will be appreciated that memory may be any data storage device that is capable of recording (storing) information (data). Data that may be stored or written into memory  2888  may include an identifying serial number that uniquely identifies an imaging device. Other data that may be stored or written into memory  2888  may include data such as the amount of the time the imaging device has been used, i.e., the hours of operation, or the amount of time the imaging device has been powered on. Data that may be written into memory  2888  may include sterilization data or renewal data, representing the working condition of the imaging device. Data that may be stored or written into memory  2888  may include data such as manufacturing date, date of last verification or quality control check, location of manufacture, i.e., may include name, city, state, street address and so forth, last control unit that the imaging device head was attached to, imaging device head diagnostic information, specific procedural settings for the imaging device head, or preferred settings for an operator or user, such as a surgeon. Data representing the above characteristics, or other indicia, of the imaging device may be recorded into memory within the imaging device. 
         [0124]    The memory  2888  may be encryption protected so as to avoid tampering or unintended use and foreseeable misuse. It should be noted that a memory  2888  may be placed anywhere in the imaging device and not just the imaging device head without departing from the scope of the disclosure. The memory  2888  may comprise a permanent or semi-permanent portion allowing varying degrees of data durability. An embodiment may further comprise a heat sink  2877  for transferring heat away from circuitry and said image sensor  2875 , and a thermal pad  2878  configured to be in physical contact with said image sensor  2875  and said circuitry and said heat sink  2877 . The thermal pad  2878  may be configured to electronically isolate the image sensor  2875  from the patient and operator while enhancing the dissipation of heat generated by the image sensor  2875 . As can be seen in the figure, the thermal pad  2878  may be disposed between the image sensor  2875  and may conform or be conformed to contact many surfaces of the heat sink  2877  or the image sensor  2875 . The thermal pad  2878  may cover substantially all of the facing surfaces between the heat sink  2877  and image sensor  2875 . It is within the scope of this disclosure to contemplate a multi piece thermal pad that may be place under the plurality of contact areas between the heat sink  2877  and the image sensor  2875 . The thermal pad  2878  may also contact the image sensor  2875  at less than the entirety of the surface area of the image sensor. The thermal pad  2878  may be larger than the area of either the heat sink  2877  or the area of the image sensor  2875 . 
         [0125]    An embodiment of a single use imaging device for use with and communicating with a control unit may comprise a housing, an image sensor, an opening proximate to an optic mount that has been configured to facilitate the transmission of light from any attached optics to said image sensor. The imaging device may further comprise a memory for storing data representing any characteristics of the imaging device. In order to manage the heat created by the electronics in the imaging device the embodiment may further comprise a heat sink for transferring heat away from circuitry and said image sensor, and a thermal pad configured to be in physical contact with said image sensor and said circuitry and said heat sink. Wherein said thermal pad is further configured to electrically isolate said image sensor and said circuitry from said heat sink, and is further configured to thermally conduct heat generated by said circuitry and said image sensor. The thermal pad may be disposed between said image sensor and said heat sink such that image sensor is electrically isolated from said heat sink. A thermal pad may be configured to be in substantial contact with a single surface of said heat sink or maybe in substantial contact with a plurality of surfaces of said heat sink. In an embodiment the thermal pad may be in substantial contact with said heat sink across substantially all of a surface area defined by the heat sink surfaces facing said thermal pad, or at a portion that is less than the surface area defined by the heat sink surfaces facing said thermal pad. The thermal pad have a plurality of portions that are less than the surface area defined by the heat sink surfaces facing said thermal pad. The thermal pad may be of rigid configuration or may be flexible to conform to the surfaces of the image sensor and/or the heat sink 
         [0126]    With primary reference to  FIG. 29  a method for electrically isolating an image sensor within an imaging device while concurrently dissipating heat generated by the circuits therein. At  2900  the imaging device and system may be powered on for use. This may include the imaging device and system being initialized rather than actually being powered on. During operation electronic components, primarily the imaging sensor, will produce heat that may be dissipated. At  2910  heat is transferred from the imaging sensor to a heat sink via a thermal pad that may be optimized for transferring heat while insulating against electricity transmission. At  2920  the connection or contact of the imaging sensor and heat sink via a thermal pad is maintained. At  2930  the thermal condition of the imaging sensor and system may be monitored. Monitoring may be automatic with internal sensors and a control system, or monitoring may comprise observation by a user. At  2940  the system may be powered off if the monitoring returns a condition out side of predetermined range of parameters. The range of parameters may be electronic values or may comprise operational considerations such as resistance, inductance, perceived heat and the like. At  2950  the imaging device continues use until the procedure is finished. The imaging device may be powered down or place in a non-use state. Communication may be initiated with a control unit, wherein the data of the communication may comprise thermal related data. At  2960  any thermal related data my be recorded into memory on the imaging device. Such thermal data may be used to ensure quality control and operational fitness of the imaging device by preventing an over heated unit from continued use. 
         [0127]    In the foregoing Detailed Description, various features of the disclosure are grouped together in a single embodiment for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, as the disclosure reflects, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. 
         [0128]    It is to be understood that the above-described arrangements are only illustrative of the application of the principles of the disclosure. Numerous modifications and alternative arrangements may be devised by those skilled in the art without departing from the spirit and scope of the disclosure and the disclosure is intended to cover such modifications and arrangements. Thus, while the disclosure has been shown in the drawings and described above with particularity and detail, it will be apparent to those of ordinary skill in the art that numerous modifications, including, but not limited to, variations in size, materials, shape, form, function and manner of operation, assembly and use may be made without departing from the principles and concepts set forth herein.

Technology Category: 1