Patent Description:
Surgical scopes are used in endoscopic and laparoscopic procedures in which small incisions are employed to pass scopes and instruments, such as scissors, dissectors and graspers, into a cavity of the body at the surgical site. Surgery is performed while observing the site captured by a scope and displaying a live image feed on a video monitor for observation by the surgeon. As such, learning laparoscopic surgery is very difficult, as the surgeon does not observe the organs and tissues directly with the naked eye. Visual information is obtained indirectly via a monitor displaying a two-dimensional image. The loss of information when presenting a three-dimensional environment via a two-dimensional image is significant. In particular, depth perception is reduced when viewing a two-dimensional image as a guide for manipulating instruments in three dimensions. Furthermore, trocars are inserted through small incisions and rest against the abdominal wall. As a result, the manipulation of instruments/scopes is restricted by the abdominal wall, which has a fulcrum effect on the instrument/scope. Hence, hand-eye coordination skills are necessary and must be practiced in order to correlate hand motion with tool tip motion. The surgeon must also develop a set of core haptic skills because tactile sensation is diminished, as the surgeon cannot palpate the tissue directly by hand. The acquisition of all of these skills and more is a challenge in laparoscopic training and there is a need for scopes that are suitable for use in a training environment. An example of a known compact image sensor for use in a surgical camera scope comprising a lens mount having a pocket for the image sensor and a sensor mount is disclosed in US patent number <CIT>.

A surgical simulation camera scope is provided as recited in Claim <NUM>.

Many of the attendant features of the present invention will be more readily appreciated as the same becomes better understood by reference to the following description when considered in connection with the accompanying drawings, in which like reference symbols designate like parts throughout.

Generally, a simulation surgical camera scope is provided to assist in laparoscopic surgical skill training and simulation. The environment for training laparoscopic surgical skills can include a box trainer that is intended to simulate the human abdominal area. The trainer includes a penetrable cover that simulates an abdominal wall through which surgical instruments and scopes are inserted to access the simulated body cavity that houses artificial organs or skills training models upon which mock surgical procedures are practiced. Real surgical or surgical-grade scopes may be employed in a training environment. Surgical-grade scopes are high quality, calibrated, precision instruments, have very limited optical distortion, and provide enough light to completely illuminate the cavity. Surgical-grade scopes however are also very expensive costing thousands of dollars. Because surgical-grade scopes are expensive and can be easily mishandled, damaged, and scratched by less experience users, there is a need for training scopes for use in a training environment. In addition, less expensive scopes and scopes that are more portable are needed, not only in a training environment, but also, in a marketing environment to showcase instruments and demonstrate new procedures on the go. Scopes of the same caliber as surgical-grade scopes are not needed in a training or marketing environment and may be too cumbersome and expensive to port. In addition, because budgets for surgical training and simulation centers are limited, there is a need for inexpensive yet effective scopes designed with training purposes in mind.

The optical performance of a simulation surgical scope should be similar to surgical-grade scopes with respect to certain characteristics. These characteristics include, but are not limited to, working distance, depth-of-field, field-of-view, image color and/or image quality. Some of these characteristics are schematically depicted in <FIG> for readability of the description and not a suggestion of prior art or admission of such. Image quality can include the sharpness of the video images in terms of pixel count resolution and the corresponding frames per second (fps) of the video feed. The simulation surgical scope in accordance with various embodiments provides an image quality that is approximately 640x480 to 720x1024 at approximately <NUM>-<NUM> fps. With respect to image color, the simulation surgical scope in accordance with various embodiments provides an approximate to the actual colors of an object when observed with the naked eye. Hence, the lighting employed at the tip of the training scope should not distort the colors of the organ models so that the realism of the simulation is not compromised. The working distance, which is the distance from the lens to the optimal focal plane is shown in <FIG>, which is the plane of best focus. Still referencing <FIG>, the depth-of-field is defined as the distance away from the optimal focal plane in both directions in which the image is still in focus. The depth-of-field should be as wide as possible. The field-of-view is defined as the area in the displayed image at the working distance. These and other characteristics work together to make for an image that is suitable for a simulation surgical scope in accordance with various embodiments of the present invention. Also, these parameters can provide the image, size, magnification, and/or other similar characteristics that correspond to a surgical-grade scope so that the trainee is not surprised when switching from the simulation surgical scope to using a surgical-grade scope.

With reference to <FIG>, the scope <NUM> in accordance with various embodiments includes a handle <NUM> connected to an elongated shaft <NUM>. A sensor assembly <NUM> and lens assembly <NUM> are located inside the scope <NUM> and connected to the elongated shaft <NUM>. The sensor assembly <NUM> is connected to a controller printed circuit board assembly (PCBA) <NUM> located inside the handle <NUM>. The scope <NUM> is connectable to a computer or video monitor wirelessly or via a cable <NUM>, such as a USB cable, and configured to display the captured video image.

With particular reference to <FIG>, the handle <NUM> is a two-piece, clamshell design that defines an interior and houses the controller PCBA <NUM>. The PCBA is connected to the sensor assembly <NUM> and to an output cable <NUM> that is in turn connected to a computer or video monitor in order to display a video image captured by a sensor and processed by a microcontroller on the controller PCBA. The elongated shaft <NUM> is connected to the distal end of the handle <NUM>. In various embodiments, the handle <NUM> is provided with one or more buttons connected to a microcontroller on the PCBA to control the power and lighting of the scope <NUM>. The lumen of the elongated shaft <NUM> opens to the interior of the handle <NUM> in order to connect the sensor assembly <NUM> to the PCBA <NUM>.

The elongated shaft <NUM> includes a sidewall having a cylindrical shape defining a lumen. The shaft <NUM> includes a proximal end and a distal end. The proximal end of the shaft <NUM> is connected to the handle <NUM> and includes a proximal opening such that the lumen of the shaft <NUM> opens to the interior of the handle <NUM>. The distal end of the shaft <NUM> includes a distal opening. The diameter of the shaft <NUM> is approximately between <NUM> to <NUM>. The outside diameter is sized to fit inside a correspondingly sized trocar. For example, if the outside diameter of the shaft <NUM> is <NUM>, the inside diameter of the trocar is greater than <NUM>. The inner diameter of a <NUM> shaft <NUM> is approximately <NUM>. Hence, in such a variation, the diameter of the sensor is less than <NUM> so that it fits inside the shaft. Not only is the outer diameter sized to fit inside a corresponding trocar, but also, the inner diameter of the shaft <NUM> is sized to receive a sensor inside the shaft <NUM>. In one variation, the inner diameter of the shaft <NUM> has a larger inner diameter at the distal end relative to the proximal end of the shaft <NUM> in order to house a larger sensor. For example, a shaft <NUM> with an inner diameter of approximately <NUM> is machined to be larger, approximately <NUM> at the distal end of the shaft <NUM> in order to fit a <NUM> sensor. Hence, the inner diameter of the shaft is stepped to a larger diameter at the distal end relative to the inner diameter at the proximal end as can be seen in <FIG>. The length of the shaft <NUM> is approximately <NUM>-<NUM>. The length from the handle <NUM> to the distal end of the shaft <NUM> is approximately <NUM>.

With additional reference to <FIG>, the sensor assembly <NUM> will now be described in greater detail. The sensor assembly <NUM> includes a sensor <NUM> and lights <NUM> mounted on an electrical connector <NUM>. The sensor assembly <NUM> further includes a sensor mount <NUM>. The sensor mount <NUM> is connected to the elongated shaft <NUM> via an indexing, mounting pin <NUM>.

With continued reference to <FIG>, the sensor mount <NUM> will now be described in greater detail. The sensor mount <NUM> is sized and configured to provide a backing and support for the sensor <NUM> and connector <NUM>. The sensor mount <NUM> is partially cylindrical in shape and is sized to fit closely within the lumen of the elongated shaft <NUM>. The sensor mount <NUM> has a proximal end and a distal end interconnected by a sidewall. Two pin holes <NUM> are provided extending parallel to the longitudinal axis of the shaft <NUM>. The pin holes <NUM> extend between the proximal end and the distal end and are sized and configured to receive a pin <NUM>' or dowel <NUM> in each pin hole <NUM>. Each pin hole <NUM> includes a beveled entry <NUM> at the distal end of the pin hole <NUM> as can be seen in <FIG>. The beveled entry <NUM> is a ramped or tapered entryway to facilitate insertion of a pin <NUM>' or dowel <NUM> into the pin hole <NUM>. In various embodiments, the distal end of the pin hole <NUM> includes a length <NUM> of the pin hole <NUM> having a diameter that is slightly larger than the diameter of the pin hole <NUM> at the proximal end as can be seen in <FIG>.

In various embodiments, the dowel to pin hole interface is a slip fit arrangement, e.g., the diameter of the hole <NUM> is larger than dowel <NUM>. This locates the sensor mount <NUM> and a lens mount <NUM> to each other in the radial directions, but allows movement in the axial direction. When the assembly is ready, glue is placed on the dowel and hole interface on the backside of the sensor mount to prevent the sensor mount from separating from the lens mount. It should be noted that care is taken before the application of the adhesive to ensure that the sensor mount <NUM> and lens mount <NUM> are aligned both radially and axially before permanently affixed together. It has been found that affixing the alignment of the sensor and lens mount in one direction, e.g., radial, first and then adjusting the sensor and lens mount in another direction, e.g., axial, ensures optimal alignment of the sensor and lens mount. It has also been found that allowing movement or adjustment of the sensor and lens mounts axially provides a precise placement of the sensor relative to the lens to ensure the sensor <NUM> is within the depth of focus of the lens. Placement of the sensor <NUM> outside of this range degrades image quality or inoperability of the scope. Likewise, any radial and skewed placement of the senor <NUM> also degrades image quality. Additionally, the relaxed or slip fit arrangement allows the coupling of the sensor and lens mount to be precise by avoiding friction and in particular friction that can cause sudden axial movement as the sensor and lens mounts are coupled together. Sudden axial movement or imprecise axial coupling of the sensor and lens mounts together can cause damage to the sensor and thus cause the scope to be inoperable.

Another pin hole <NUM> that is traverse to the longitudinal axis of the elongated shaft <NUM> is provided in the sensor mount <NUM> and extends through the sensor mount <NUM> between the sidewall. As can be seen in <FIG>, the traverse pin hole <NUM> also includes an enlarged diameter portion <NUM> to facilitate insertion of a pin <NUM> as well as alignment and setting of the sensor mount <NUM> with respect to the elongated shaft <NUM>. The pin <NUM> is longer than the dowel <NUM> or pin <NUM>' employed in pin holes <NUM>.

The proximal end of the sensor mount <NUM> includes a channel-like groove <NUM> sized and configured to receive an instrument such as a flat-head screwdriver. The groove <NUM> assists in the installation of the sensor mount <NUM> within the elongated shaft <NUM>. During assembly, an instrument can be inserted into the groove <NUM> in order to help hold and move the sensor mount <NUM> into the lumen of the elongated shaft <NUM>, hold the sensor mount <NUM> in position inside the elongated shaft <NUM>, rotate the sensor mount <NUM> with respect to the elongated shaft <NUM>, align the sensor mount <NUM> with respect to corresponding pin holes formed in the elongated shaft <NUM>, and/or generally hold the sensor mount <NUM> stationary with respect to elongated shaft <NUM>. The proximal end of the sensor mount <NUM> is substantially parallel to the distal end of the sensor mount <NUM>. The proximal end of the sensor mount <NUM> also includes an angled surface <NUM> interconnected with a flat portion <NUM> of the sidewall. The angled surface <NUM> together with the flat portion <NUM> provide a landing and pathway for the connector <NUM> extending proximally inside the elongated shaft <NUM> to the PCBA <NUM> located in the handle <NUM>. The distal end of the sensor mount <NUM> includes a bevel <NUM> at the intersection of the distal end with the flat portion <NUM> of the sidewall. The bevel <NUM> helps to provide a smooth bend in the connector <NUM> to prevent a sharp bend and associated stress concentrations in the connector <NUM>.

In various embodiments, the distal end of the sensor mount also includes raised surfaces <NUM> disposed on either side of a middle, flat cavity or surface <NUM>. The sensor and connector <NUM> are positioned on the middle, flat surface <NUM> of the sensor mount <NUM>. It has been found that due to the limitations in size and dimensions of the distal end of the scope and the need for the precise placement of the sensor relative to the lens, the sensor is often crushed or damaged between the sensor and lens mounts. As such, raised surfaces <NUM> act as a hard stop to prevent crushing of the sensor between the sensor mount and lens mount. Thus, the dimensions and tolerance of the raised surfaces relative to the middle surface are such that when the sensor mount and lens mount are coupled or connected together with the sensor and connector between them, the sensor is not crushed. Additionally, there is a gap of <NUM> (<NUM> inch) or less between the flexboard assembly and the sensor mount and in various embodiments that is also accommodated by the raised surfaces. Accordingly, in accordance with various embodiments, the sensor and/or lens mount are configured to ensure that the spacing between the lens and sensor mounts is greater than the thickness of the sensor and the flexible printed circuit board and yet smaller than or no greater than the depth of focus range of the lens thereby ensuring the sensor is always located within the depth of focus, ensuring image quality is maintained and the sensor is not damaged. As such, in various embodiments, the height of the raised surface relative to the middle surface of the sensor mount is not greater than the depth of focus range of the lens.

In accordance with other various embodiments, the light sensing portion of the senor is indexed to the lens mount to keep the crucial distance between the sensor and lens consistent. When assembling, the sensor mount without raised surfaces and the lens mount are brought together with less pressure than would crush the sensor. Force or pressure gauges or other similar force or pressure limiting components would be utilized to ensure that the threshold crush pressure of the sensor is not exceeded. Once in place, i.e., the sensor is located within the depth of focus of the lens, the mounts are affixed together, e.g., glued to the pins, preventing axial movement of the mounts relative to the sensor. In various other embodiments, the raised surfaces extends further from the middle surface, i.e., have a greater height or are larger in the axial direction, resulting in a bigger gap or spacing between lens and sensor mounts when assembled. To index the sensor to the lens mount, a mechanical spring or a material with spring like attributes, like silicone, is placed in the gap or spacing that is created by the raised surfaces, thus taking up the resulting gap of having the raised surfaces further from the middle, flat surface. In various embodiments, the sensor can be indexed, with a set screw coming from the proximal end of the sensor mount or similarly through the use of shim stock, to push the sensor against the lens mount.

The connector <NUM> is a flexible circuit board or flexboard <NUM>. The flexboard <NUM>, in one embodiment, is approximately <NUM> (<NUM> inches) long, approximately <NUM> (<NUM> inches) wide and approximately <NUM> (<NUM> inches) thick. The flexboard <NUM> is a connective device that provides an electrical connection between electrical components. The flexboard <NUM> is connected to the sensor <NUM> and lights <NUM>, extends along the length of the shaft <NUM> and connects to the PCBA <NUM> inside the handle <NUM>. The flexboard <NUM> reduces wiring errors during assembly, reduces assembly time and costs, eliminates mechanical connectors and provides design flexibility including highly complex configurations and provides a support for surface mounted devices. The flexboard <NUM> can be made to conform to a desired shape and flex during use and installation. The flexboard <NUM> is substantially planar and is connected at its proximal end to the PCBA <NUM> inside the handle <NUM>. The flexboard <NUM> extends distally inside the shaft <NUM> as can be seen in <FIG>. The flexboard <NUM> will twist approximately <NUM> degrees within the shaft <NUM> to facilitate connection with the sensor assembly <NUM> at the distal end and the PCBA <NUM> at the proximal end.

With particular reference to <FIG> and <FIG>, the flexboard <NUM> makes contact with the angled surface <NUM> of the sensor mount <NUM>. The flexboard <NUM> is directed to pass over the flat portion <NUM> of the sidewall. The flat portion <NUM> advantageously reduces the diametrical distance of the sensor mount <NUM> to accommodate the thickness of the flexboard <NUM> as can be seen in <FIG> and in the <FIG>. The flexboard <NUM> may be adhered with adhesive to the flat portion <NUM>. From the flat portion <NUM>, the flexboard <NUM> turns to extend along the distal end of the sensor mount <NUM>. The flexboard <NUM> in one embodiment may be adhered to the distal end of the sensor mount <NUM>. The distal end and proximal end of the sensor mount <NUM> are perpendicular to the longitudinal axis of the shaft <NUM>. The flexboard <NUM> is also substantially perpendicular to the longitudinal axis of the shaft <NUM> along the distal end of the sensor mount. This perpendicular and flat portion of the flexboard <NUM> along the distal end of the sensor mount <NUM> is called a sensor location <NUM>. It is at this location that the sensor <NUM> is connected to the flexboard <NUM> as can be seen in <FIG>. The sensor location <NUM> has an enlarged flat area compared to the flexboard <NUM> that is proximal to the sensor location. After the distal end of the sensor mount <NUM>, the flexboard <NUM> makes an approximately <NUM> degree bend and extends distally before bending approximately <NUM> degrees to form a lighting or LED location <NUM> that is also approximately perpendicular to the longitudinal axis of the shaft <NUM>. The lighting or LED location <NUM> of the flexboard <NUM> is where the lights/LEDs <NUM> are connected to the flexboard <NUM>. The LED location <NUM> is flat and includes a central opening <NUM> as can be seen in <FIG> and <FIG>. The central opening <NUM> permits unobstructed and illuminated viewing via the lens assembly <NUM>. In one variation, the lights <NUM> are a plurality of LEDs connected to the flexboard <NUM> with electrically conductive solder or adhesive and arranged in a circle around the central opening <NUM> and around the lens prior to assembly with the rest of the scope components. The flexboard <NUM> forms an S-shaped pathway as can be seen in <FIG>.

The flexboard <NUM> includes electrical contacts for the LEDs <NUM> and image sensor <NUM> and traces that allow power and data to be transmitted to the controller PCBA <NUM>. The flexboard <NUM> also locates the LEDs <NUM> and image sensor <NUM> for assembly with the rest of the components in the shaft <NUM>. The flexboard <NUM> eliminates the use of wires, is flat and smaller than an equivalent wire bundle it is replacing and can be designed and configured to meet the confines of the shaft dimension and assembly components. Furthermore, due to the sensor <NUM> being placed at the distal end of the scope and the controller PCBA <NUM> being positioned at the proximal end of the scope and the speed and/or amount of data being transmitted, the signal integrity between the components can degrade. However, the flexboard <NUM>, in various embodiments, being a single monolithic component ensures that signal integrity of data transfer from the image sensor <NUM> is not compromised. In various embodiments, the flexboard includes, integrated or attached, a metallic layer, e.g., a copper only layer, to ensure signal integrity is maintained. The metallic layer is sized and dimensioned in various embodiments to shield the flexboard from outside electrical noise that can interfere with the signals transmitted through the traces on the flexboard, especially the high speed data lines. The flexboard <NUM> is sufficiently flexible to navigate the S-shaped pathway making multiple approximately <NUM>-degree bends to meet the design of the sensor assembly <NUM> and lens assembly <NUM>.

A ring of LEDs <NUM> are employed in the sensor assembly <NUM> and arrayed around the lens assembly as can be seen in <FIG>. The LEDs <NUM> serve to illuminate the target object and surgical field. Approximately, <NUM>-<NUM> white LEDs <NUM> are used depending on the brightness required for a particular application or to allow use in all conditions including confined procedures such as transanal minimally invasive surgery (TAMIS) which may require more lighting. The LEDs may be selected to have an appropriate color temperature, or tinted, e.g., via tinted glass <NUM>, to optimize color matching.

The sensor <NUM>, in one embodiment, is a CMOS image sensor such as one produced by OmniVision Technologies, Inc. It is a ¼ sensor sized to fit within a <NUM> shaft <NUM>. The sensor <NUM> supports video quality maximums of <NUM> pixels at <NUM> fps and has a resolution of 640x480 characteristic of the VGA hardware at <NUM> fps. The sensor <NUM> supports a video output format of YUV422 and has inter-integrated circuit communications to communicate with a microprocessor and has a camera serial interface <NUM> (CSI-<NUM>) mobile industry processor interface (MIPI) for the video communications. Sensors that would be small enough to fit within a <NUM> tube do not have the associated microprocessor, electronics and demosaicing algorithm to output in YUV422. Therefore, a separate circuit board would be needed to support a microprocessor and associated algorithm external to the sensor. The sensor <NUM> in various embodiments has a smaller active image area <NUM> comprising the array of photo sites. The sensor <NUM>, which is not limited to a CMOS type sensor, is adhered with solder or electrically conductive adhesive to the flat sensor location <NUM> on the flexboard <NUM>.

With reference to <FIG> and <FIG>, the lens assembly <NUM> will now be described. The lens assembly <NUM> in accordance with various embodiments includes a lens <NUM>, a lens housing <NUM>, a lens mount <NUM>, a tinted glass <NUM>, a cover glass <NUM> and/or combinations thereof. The lens <NUM> in various embodiments may include one or more lenses and optical elements. In various embodiments, the lens <NUM> includes an optical train having four lenses and an infrared filter. The lens <NUM> has a <NUM> focal length and is aspheric and achromatic. This configuration provides a working distance of approximately <NUM>-<NUM>, a depth-of-field of approximately <NUM>-<NUM> and a field-of-view of <NUM>-<NUM> degrees. Also, this configuration minimizes optical distortion while keeping costs down. The optical distortion is limited to the edges of the optical image. Since the diagonal dimension of the image area <NUM> of the sensor <NUM> is smaller than the diagonal of the focused optical image hitting the sensor, the distorted edges are not picked up by the sensor giving a clean non-distorted image on the monitor. The lens <NUM> is connected to and located inside the lens housing <NUM>. The lens housing <NUM> is cylindrical in shape and includes an outer surface that is threaded. The threads are configured for threaded engagement with the lens mount <NUM>. Although threads are employed, other types of fasteners are within the scope of the present invention so long as the lens is axially movable along the longitudinal axis with respect to the lens mount <NUM>. The lens housing <NUM> further includes one or more notch, socket or the like <NUM> configured for receiving a distal end of a correspondingly shaped instrument. The instrument is inserted into the notch/socket <NUM> of the lens housing <NUM> in order to rotate the lens housing <NUM> with respect to the lens mount <NUM> for optically tuning the lens assembly.

With particular reference to <FIG>, there is shown the lens mount <NUM>. The lens mount <NUM> includes a proximal end and a distal end interconnected by a sidewall. The lens mount <NUM> includes a central lumen <NUM> extending between an opening at the proximal end and an opening at the distal end. The lens mount <NUM> is partially cylindrical and is sized to fit closely within the lumen of the elongated shaft <NUM>. The central lumen <NUM> includes a threaded inner surface for engaging the threads on the outer surface of the lens housing <NUM> such that, when threaded into the lens mount <NUM>, the lens <NUM> moves along the longitudinal axis. The lens mount <NUM> includes two pin holes <NUM> that extend between the proximal end and the distal end. The pin holes <NUM> are sized and configured to receive a dowel <NUM> or pin <NUM>' in each pin hole <NUM>. Each pin hole <NUM> includes a beveled entry <NUM> at the proximal end of the pin hole <NUM> as can be seen in <FIG> and <FIG>. The beveled entry <NUM> is a ramped or tapered entryway of greater diameter to facilitate insertion of a dowel <NUM> or pin <NUM>' into the pin hole <NUM>. A portion <NUM> of the length of the pin hole <NUM> has a larger diameter relative to the remaining length of the pin hole <NUM> that is distal to the larger diameter portion <NUM> as can be seen in <FIG>. The beveled entry <NUM> has a diameter larger than the diameter of portion <NUM>, which has a diameter larger than the rest of the pin hole <NUM>. The enlarged diameter portion <NUM> allows the dowel <NUM> or pin <NUM>' to be located within the enlarged diameter portion <NUM> before deeper insertion into the pin hole <NUM> allowing for the lens mount <NUM> to be located and set in position within the elongated shaft <NUM>. The sidewall of the lens mount <NUM> includes a flat portion <NUM>. The flat portion <NUM> transitions to a bevel <NUM> at the intersection of the flat portion <NUM> with the distal end. Together, the flat portion <NUM> and bevel <NUM> provide room and a smooth transition for the flexboard <NUM> as it bends approximately <NUM> degrees and extends in juxtaposition to the flat portion <NUM>. The proximal end of the lens mount <NUM> includes a recess <NUM> that is also called a pocket. The recess <NUM> is a surface that is a planar notched depression into the proximal end in the shape of the sensor <NUM> and sized slightly larger than the sensor <NUM> in order to form a receiving location for the sensor <NUM>. The recess <NUM> encompasses the proximal opening of the central lumen <NUM>. The recess <NUM> is slightly offset and not coaxial with the proximal opening of the central lumen <NUM> in order to align the active image area <NUM> of the sensor <NUM> with the axis of the optical train of the lens <NUM>. The shape of the recess <NUM> matches the shape of the sensor <NUM>. The recess <NUM> is a square, rectangle, parallelogram or other shape. The recess <NUM> includes radiused corners <NUM> with radii on the exterior of the corner as shown in <FIG>. Not all of the corners are radiused as at least one corner is outside the sidewall perimeter. The radiused corners <NUM> allow the sensor to closely fit within the recess <NUM> such that at least a portion of the perimeter edges of the sensor <NUM> is in juxtaposition with the four sides of the recess <NUM>. In one variation shown in the figures, not all of the four sides of the recess <NUM> are straight. At least two sides of the recess <NUM> are curved sharing the curvature of the lumen opening at the proximal end as can be seen in <FIG>. The depth of the recess <NUM> or pocket depth is approximately <NUM> (<NUM> inches). When a sensor <NUM> is located inside the recess <NUM> translation of the sensor <NUM> laterally with respect to the longitudinal axis is prevented.

Still referencing <FIG>, the lens assembly <NUM> includes a cover glass <NUM>. The cover glass <NUM> is a glass disc that covers the distal opening of the elongated shaft <NUM>. The cover glass can be made of sapphire crystal to prevent scratching, Gorilla Glass, alkali-aluminosilicate sheet glass, to prevent impact and coated borosilicate to reduce reflections depending on which properties of the glass are more important. For example, sapphire crystal protects against accidental scratching but it is more brittle and can break on impact. Gorilla Glass resists impacts but can be scratched. Coated borosilicate can mitigate reflections of the LEDs into the sensor. The cover glass <NUM> prevents damage to the internal components of the elongated shaft <NUM> especially the lens since it can scratch easily and is located at the distal tip. The cover glass <NUM> also prevents particulate matter from migrating into the elongated shaft <NUM> and obscuring the lens.

To assemble the scope <NUM>, two pins <NUM> or dowels <NUM>' are inserted into the two pin holes <NUM> in the lens mount <NUM>. In various embodiments, only the tapered portion <NUM> of pins <NUM> are inserted into the larger diameter portion <NUM> of each pin hole <NUM>. The sensor mount <NUM> is aligned to bring the opposite ends of the pins <NUM> into the enlarged portion <NUM> of pin holes <NUM> formed in the distal end of the sensor mount <NUM>. A pin alignment fixture, in various embodiments, that holds the sensor mount <NUM> and the lens mount <NUM> in position is used. The pins <NUM> that are partially inserted in their respective pin holes <NUM>, <NUM> keep the sensor mount <NUM> and the lens mount <NUM> spaced apart for further assembly and alignment. The sensor <NUM> is soldered to electrically connect the sensor <NUM> to the flexboard <NUM>. A portion of the flexboard <NUM> with the attached sensor <NUM> is then positioned between the sensor mount <NUM> and the lens mount <NUM> while the sensor mount <NUM> and lens mount <NUM> are held in a spaced-apart position by the alignment fixture. The sensor <NUM> is aligned and placed inside the recess <NUM> formed in the proximal end of the lens mount <NUM>. The sensor mount <NUM> and lens mount <NUM> are coupled together with the distal end of the sensor <NUM> located in the pocket <NUM> and facing the lens <NUM> while the proximal end of the sensor <NUM> is attached to the sensor location <NUM> of the flexboard <NUM>. The sensor location <NUM> is planar and substantially perpendicular to the longitudinal axis of the elongated shaft <NUM>. The proximal end of the sensor location <NUM> of the flexboard <NUM> is supported by the distal end of the sensor mount <NUM>. The flexboard <NUM> is then bent around the flat portion <NUM> of the sidewall and bevel <NUM> of the sensor mount <NUM>. Distally, the flexboard <NUM> is bent under the flat portion <NUM> and around the bevel <NUM> of the lens mount <NUM>.

In various embodiments, an optical system, e.g., the sensor mount <NUM> and lens mount <NUM> together with flexboard <NUM>, sensor <NUM> and pins <NUM> are inserted into the elongated shaft <NUM>. A long screwdriver or the like is used to engage the groove <NUM> at the proximal end of the sensor mount <NUM>. The traverse pin hole <NUM> is aligned with an opening in the shaft <NUM> and a pin <NUM> is inserted into the pin hole <NUM> to lock the sensor mount <NUM> and associated lens mount <NUM> in position. The indexing pin <NUM> not only prevents longitudinal translation of the assembly, but also, prevents rotation of the assembly around the longitudinal axis of the shaft <NUM>.

In accordance with various embodiments, the elongated shaft <NUM> is connected to one side of the handle <NUM>. A receiving slot on the elongated shaft <NUM> is aligned with a tab formed on the inside of the handle <NUM>. A clamp is positioned over the shaft <NUM> and tightened to permit movement of the shaft <NUM> with respect to the handle <NUM>. The shaft <NUM> is permitted to rotate in order to ensure that the horizon line of an image captured by the scope <NUM> is level, horizontal with respect to a vertical orientation of the handle <NUM>. The flexboard <NUM> and other wiring are connected to the PCBA <NUM> to create a functioning scope. To electrically connect the flexboard <NUM> to the PCBA <NUM>, the flexboard <NUM> is attached by a <NUM>-pin connector to the controller PCBA. The controller PCBA <NUM> has a CX3 microcontroller that supports YUV422 image format, provides I<NUM>C communications and supports MIPI Camera Serial Interface <NUM>. The controller PCBA <NUM> also provides USB communication out to a monitor, regulates five voltage levels, and provides three different clock speeds for the microcontroller and image sensor. Firmware was written to provide the USB communication and to set the settings for the image sensor to meet the image requirements referred to previously. The scope <NUM> is then fitted with a USB cable that outputs the image to a video display, laparoscopic trainer or monitor.

In accordance with various embodiments, the shaft <NUM> and one side of the handle <NUM> is placed into an optical alignment fixture. The fixture, in various embodiments, has two towers and a toggle clamp. A target is illuminated and the scope <NUM> is connected to a computer monitor in order to observe an image of the target. The shaft <NUM> is rotated with respect to the handle <NUM> until the horizon becomes level, horizontal and then the toggle clamp is used to fix the position of the shaft <NUM>. The handle <NUM> is then adjusted, rotated with respect to the shaft <NUM> until the handle <NUM> is vertical. The tube clamp is then tightened completely.

In various embodiments, after the assembly of the handle <NUM> is completed, the handle <NUM> and shaft <NUM> are placed into a press fixture. The other side of the handle clamshell is aligned in the fixture and the two halves of the handle <NUM> are pressed together to complete the handle and shaft assembly.

In accordance with various embodiments, the scope <NUM> is optically tuned by placing the scope into an optical alignment fixture. An optical target is provided and mounted into a slider movable along a rail in front of the distal end of scope <NUM> along the longitudinal axis of the shaft <NUM>. The target is illuminated. The target is moved and aligned with the working distance of the lens. Then, an instrument is used to engage the socket <NUM> at the distal end of the lens housing <NUM> in order to rotate the lens housing <NUM> with the lens <NUM> inside. As the lens housing <NUM> is rotated, it is threadingly moved proximally or distally along the longitudinal axis with respect to the lens mount <NUM> to bring the image into focus. The position of the lens housing <NUM> with respect to the lens mount <NUM> is adjusted along the longitudinal axis until a middle "<NUM>" target is in acceptable focus. Focus should be acceptable through a depth-of-field range of approximately <NUM> with approximately <NUM>/<NUM> of that distance in front of the optimal focal plane and approximately <NUM>/<NUM> of that distance in back of the optimal focal plane. With the target image in focus, rotation of the lens housing <NUM> and tuning is finished.

After the scope <NUM> is optically tuned, in accordance with various embodiments, the cover glass <NUM> is attached to the shaft <NUM>. The cover glass <NUM> is placed against the ring of LEDs connected to the flexboard <NUM>. The cover glass <NUM> is then glued at four equally spaced locations to the shaft <NUM>. Ultraviolet light is used to partially cure the adhesive. The position of the cover glass <NUM> is checked and, if the position is correct, the adhesive is exposed to more ultraviolet light to finish curing the adhesive. If the cover glass <NUM> is not in a correct position, it is readjusted while the adhesive remains partially cured.

In accordance with various embodiments, the lens mount <NUM> includes a recessed pocket <NUM>, also referred to as a recess, having a known depth. When the sensor <NUM> is placed in the pocket <NUM>, it is located radially with respect to the shaft <NUM>. Also, the depth of the pocket <NUM> within the lens mount <NUM> has a predetermined distance to the front of the lens mount <NUM>. This distance effectively meets all magnification, working distance and depth-of-field requirements. Any tolerances found in the sensor or its electronics are accommodated by the varying distance between the lens mount <NUM> and sensor mount <NUM> as they sandwich the image sensor <NUM> and electronics. This simplifies assembly as the components fit with respect to each other in only one way with the sensor <NUM> always at a known distance from the end of the lens mount <NUM>. Because of this, the adjustment of the lens housing <NUM> to optically tune the system is made easier. Otherwise, the need to tune the optics can vary from assembly to assembly because individual components have associated tolerances. When placed in relation to other components these tolerances can stack-up making tuning more difficult and leading to out-of-focus images. Tuning is also necessary as the distance from the backside of the lens to the image sensor affects magnification, working distance and the depth-of-field. The scope <NUM>, in accordance with various embodiments, mitigates the tolerance stack-up issue. For example, as schematically illustrated in <FIG>, the sensor <NUM> and lens <NUM> are shown relative to the longitudinal axis <NUM> and the tolerance <NUM> between the components is enhanced or otherwise maximized. In accordance with various embodiments, the thickness <NUM> of sensor <NUM> doesn't affect the tolerance stack-up as the top of the sensor remains in the same or fixed spot relative to the threaded side of the lens mount and the thickness <NUM> between the sensor and lens mount also doesn't affect the stack-up. In accordance with various embodiments, the sensor and/or lens mounts are configured to ensure the location of the sensor is within the depth of focus of the lens is maintained while not damaging the sensor. The sensor mount in various embodiments is configured to remove the unpredictability, difficulties and/or complexity in the coupling of the lens mount with the sensor mount with the sensor and connector there between.

In <FIG>, there is shown a pin <NUM>, <NUM>' according to various embodiments of the present invention. In various embodiments, the pin <NUM>' replaces the dowel <NUM>. The pin <NUM>, <NUM>' is a spring pin that is rolled about itself and made of sufficiently flexible material to have a variable diameter. When compressed, the spring pin <NUM>, <NUM>', also called a roll pin, has a smaller diameter relative to when the spring pin <NUM>' is relaxed. This variation in diameter assists insertion of the pin <NUM>, <NUM>' into pin holes <NUM> and <NUM>, <NUM>, respectively. When in a small diameter, compressed configuration, the pin <NUM>, <NUM>' can be easily inserted into the pin holes <NUM>, <NUM> and when relaxed the relatively enlarged diameter assists in fixing the pin <NUM>, <NUM>' in place. The distal ends of the each pin <NUM>, <NUM>' include a slight taper <NUM>.

In various embodiments, the scope has an elongated shaft that is connected to a handle at the proximal end. The shaft is long enough so that the distal end of the scope, which is the image acquisition end, is disposed inside the body cavity while the handle resides outside the patient. A scope includes an image sensor located behind a lens. The image sensor is connected to a controller printed circuit board assembly (PCBA) that includes a microcontroller configured to process data acquired by the image sensor, which is displayed on the monitor. The PCBA may be connected to the monitor or other device wirelessly or with a wire, cable or the like. Lights, such as LEDs or a fiber optic light source that transmits light through one or more fiber optic cables to the distal end of the scope, are included and connected to the scope and flexboard and/or controller PCBA to illuminate the surgical field. The lights are typically arranged in a circular fashion around the image acquisition end of the scope. One or more lenses are included in the optical assembly to focus the light reflected off the surgical site.

In order for the simulation surgical scopes in accordance with various embodiments of the present invention to be suitable or effective for training or simulation purposes, the scopes should meet one or more certain criteria. For example, the ergonomics of the scope should be similar to surgical-grade scopes. The size and shape of the handle, the length of the shaft as well as the weight of the scope should approximate a surgical-grade scope. Also, the simulation surgical scope should be capable of being manipulated by one hand. The scope should also be able to withstand accidental bumps and drops without breaking or losing functionality. Also, in order for users to learn and get comfortable with medical device trocars and the like, a simulation surgical scope should be sized and configured to be compatible with and fit inside medical device trocars that are used in surgery. Typically, there are two sizes of trocars, <NUM> and <NUM>, that are used as a port for passing a scope to the surgical site. Therefore, a simulation surgical scope should be at least be compatible with either a <NUM> and/or <NUM> trocar.

The simulation surgical scope in accordance with various embodiments does not need to be made to withstand repeated sterilization, cleaning and autoclave cycles. As such, the scope can be less expensive. While lighting on the scope can be required for certain procedure simulations, the light source at the tip of the scope in some instances can be supplemented by other light sources installed inside the cavity of the box trainer. Therefore, the lighting demands for a surgical simulation scope is reduced which may further lower manufacturing costs of the scope. Also, with respect to the optical performance, the simulation surgical scope in accordance with various embodiments may sacrifice some image quality and include some distortion at the edges of the image by using less expensive components and a simpler lens assembly design. Overall, the image quality should be sufficient enough to provide an appropriate amount of detail in order to distinguish the subtle differences in simulated anatomy. Since the requirements for image quality and lighting at the tip for a surgical simulation scope are not as stringent as that for a surgical-grade scope and there is no requirement for sterility, it is possible to keep the cost lower than that of surgical-grade scopes. A simulation surgical scope, in accordance with various embodiments, should have the balance of a quality image, working distance and depth-of-field, low cost, and/or robustness to last for a multitude of uses. These desired attributes can be connected and optimally designing a scope for one of these attributes may make meeting another attribute more difficult.

The surgical simulation scope in accordance with various embodiments is suitable for use with laparoscopic trainers to educate and train medical professionals and medical students. The surgical simulation scope in accordance with various embodiments provides significant improvements that may also be employed in surgical-grade scopes.

Claim 1:
A simulation surgical camera scope (<NUM>) comprising:
a handle (<NUM>);
an elongate shaft (<NUM>) having a proximal end coupled to the handle (<NUM>) and a distal end comprising a sensor mount (<NUM>) and a lens mount (<NUM>), the lens mount (<NUM>) having a proximal portion having a pocket (<NUM>) therein and at least one pin hole (<NUM>) positioned next to the pocket (<NUM>);
a lens (<NUM>) disposed within the lens mount (<NUM>); and
an image sensor (<NUM>) disposed within the pocket (<NUM>) of the lens mount (<NUM>) and between the lens mount (<NUM>) and the sensor mount (<NUM>), the image sensor (<NUM>) having a distal face facing the distal end of the elongate shaft (<NUM>), the sensor mount (<NUM>) having a first pin hole (<NUM>) corresponding to the at least one pin hole (<NUM>) of the lens mount (<NUM>) with the at least one pin hole (<NUM>) of the lens mount (<NUM>) being aligned by a first pin (<NUM>') with the first pin hole (<NUM>) of the sensor mount (<NUM>), and the sensor mount having a second pin hole (<NUM>) transverse to the longitudinal axis of the elongate shaft (<NUM>) and aligned with an opening in the elongate shaft (<NUM>) by a second pin (<NUM>) inserted into the second pin hole (<NUM>) to prevent rotation of the sensor mount (<NUM>) within the elongate shaft.