Medical Equipment

Abstract

The imaging head of the medical scope comprises a capsule that encapsulates an image sensor and electronics associated with the image sensor. The imaging head further comprises a light guide within or attached to the capsule that transmits illumination to the field of view of the image sensor. The imaging head can be disassembled by breaking or cutting the capsule to separate the image sensor and electronics from the light guide. The imaging head is manufactured by encapsulating the image sensor and electronics, and optionally also the light guide, in the capsule. In a first overmolding step, the light guide may be overmolded to embed the light guide in the overmolded body. The image sensor and electronics can then be positioned beside or against the overmolded body and overmolded in a second overmolding step to complete the capsule.

Description

[Technical field]

[0001] The present invention relates to medical instruments, exemplified herein by a medical scope, such as an endoscope or otoscope, used in the examination and treatment of the ear. [Background technology]

[0002] Instruments such as endoscopes and otoscopes can be used to examine and operate on the ear. Some such instruments can be held against the surgeon's eye to view and magnify the object, while other such instruments have a camera that allows the object to be viewed on a video display, such as a computer monitor.

[0003] Effective access and visualization are key to a safe surgical procedure. In this regard, traditional ear surgery using microscopic visualization suffers from a limited field of view looking down the ear canal. As a result, visualization of middle ear disease in difficult to access areas, such as the tympanic sinus and facial recess, may be poor. Transcanal surgery can be performed through a speculum by using a microscope and specialized surgical instruments, but this also suffers from a limited field of view.

[0004] Therefore, to improve visibility, it is often necessary to expose the middle ear and epitympanic region by performing a mastoidectomy. However, because the ear is surrounded by dense bone, a mastoidectomy is associated with increased operative time, potentially significant complications, longer hospital stays, and longer recovery.

[0005] Another drawback of microscopic visualization in ear surgery is the substantial size of the surgical microscope, which impairs the surgeon's dexterity, limits the space available for the surgical intervention, and can have negative ergonomic consequences for the surgeon when using the microscope.

[0006] Endoscopic ear surgery has become an increasingly clinical speciality, especially due to the shortcomings of microscopic visualization. Compared to surgical microscopes, endoscopes offer improved visibility and allow for minimally invasive surgery. However, the ear presents particular challenges to the use of endoscopes, with the requirement that the image-sensing portion of the endoscope be as small as possible while maintaining image quality and allowing multiple viewing angles. Another challenge relates to cleaning, especially keeping the lens of the endoscope clean during use, and more generally to cleaning or reconditioning an endoscope for reuse.

[0007] During use, tissue or other contaminants adhering to the lens of the endoscope can obscure the view. As a result, the endoscope may have to be repeatedly removed from the subject's ear canal during surgery for cleaning. This interrupts and prolongs the surgical procedure, increasing the risk of errors or inadvertent injury to the patient.

[0008] In connection with reuse, there is a risk that the endoscope may be contaminated with prions that may be present in the ear canal. Contamination with the wrong type of prion may endanger the patient's life. Even the cleaning and sterilization processes used in industry cannot remove some types of contamination, such as prions, and in this respect, prions cannot be killed because they are not living organisms. Therefore, the World Health Organization now recommends that all instruments used in surgery are discarded after the operation and therefore disposable as much as possible.

[0009] In light of this and other risks, single-use endoscopes for ear surgery have appeared on the market. Indeed, there is currently a strong trend for hospitals and manufacturers to move away from a model of reuse and maintenance of endoscopic equipment towards single-use endoscopes. This trend is driven, in part, by the inability of in-house sterilization to completely sterilize the equipment, thus reducing the reliability of the system. Summary of the Invention [Problem to be solved by the invention]

[0010] Unlike simple disposable hospital devices such as scalpel blades and syringes, disposable endoscopes are large and generate large amounts of medical waste, which is typically incinerated, rendering the materials unrecoverable. In the case of devices containing electronics, this may include precious or rare earth metals. As a result, valuable resources are wasted and may have a negative impact on the environment.

[0011] At first glance, the transition from a disposable system to a circular economy system can be considered as a solution to this problem. For manufacturers of disposable instruments, the transition to a circular economy system first involves collecting used instruments from hospitals in a reverse logistics operation. This collection step is followed by disassembling the instrument, identifying reusable components and cleaning them, discarding non-reusable components and replacing them with new components, assembling a new instrument from the reused and new components, and packaging and sterilizing the new instrument ready for distribution. However, this process is not feasible as a replacement for disposable endoscopes without incorporating special design features into the endoscope and the process used in the circular economy system. [Means for solving the problem]

[0012] The present invention addresses how surgical instruments can be designed for integration into a circular economy or reverse logistics system, where at least a substantial portion of the surgical instrument can be safely and cost-effectively reused with minimal waste. The inventive concept also includes methods by which surgical instruments can be reconditioned for reuse under a circular economy or reverse logistics system.

[0013] More generally, the present invention also improves upon prior solutions to provide a panoramic endoscope for ear surgery that is small, reliable, easy to keep clean between uses, and provides highly effective visualization.

[0014] An embodiment of the invention describes how an endoscopic camera can be incorporated into a rotating head to meet the requirement of allowing multiple viewing angles. Ideally, the rotating head can rotate 360°. This allows convenient cleaning of the camera lens by rotating the head, and therefore the lens, beyond the useful viewing angle, and onto a wiper blade that removes debris from the lens. Elegantly, this allows one simple mechanism to solve two of the major challenges of endoscopic ear surgery.

[0015] To enable the endoscope to operate in this manner, the camera unit of the rotating head is an integrated module incorporating a lens, an image sensor, and data transmission means. Data may be transmitted wirelessly from the rotating head to the endoscope's supporting probe structure or to a control unit outside the endoscope. A wireless solution has the advantage of eliminating wired data connections, which may otherwise limit the rotation of the head.

[0016] Power must also be delivered to the rotating head to power any other electrical systems, such as the camera module and illumination LEDs, which are commonly found with on-chip image sensors in endoscope designs. Again, this should ideally be done in a way that does not restrict the rotation of the head.

[0017] One solution for powering a rotating head involves using rotating or sliding contacts on or around a rotating shaft where the head is joined to the supporting probe of the endoscope. This requires a robust sealing arrangement to insulate the current carrying contacts from moisture in the ear, which is conductive, and from the saline solution used in surgery. Another solution is to supply power wirelessly or electromagnetically, for example in a manner similar to an inductive charging unit. However, implementing either of these solutions remains challenging due to the compactness required for endoscopes for ear surgery.

[0018] The narrowness of the ear canal dictates that optimally the outer diameter of the probe and rotating head should be 3.2 mm or less. Wireless power supply requires a coil within the rotating head, which in this situation can severely limit the space available for other components within the head, especially the camera module itself.

[0019] The same size constraints also have a significant impact on image quality, as they require that the camera's image sensor must be small in area, typically smaller than 2 mm x 2 mm. This means that the pixel size is small, and the higher the resolution, the smaller the pixel size. Problems arise because small sensor pixels are less sensitive to light than larger pixels. This results in a dimmer, lower quality image than would be delivered by a larger sensor, all other things being equal. To counter this, a larger optical aperture or lens can be used to capture more light, but this has the knock-on effect of reducing the depth of field. In fact, with a sufficiently compact optical system, the depth of field can be so limited that it cannot be used for surgery.

[0020] Ultimately, what is needed to offset the small size of the system is better illumination, which may require providing larger and more powerful LEDs, or using remote light sources and fiber optics or other light transmission features.

[0021] Against this background, the present invention resides in a medical scope comprising an imaging head, the imaging head comprising a capsule enclosing an image sensor and electronics associated with the image sensor, and a light guide arranged to convey illumination to the field of view of the image sensor, the light guide being within the capsule or attached to the capsule.

[0022] The imaging head may further include a breakaway interface at which the encapsulated image sensor and electronics are preferentially separable from the light guide. For example, the breakaway interface may comprise at least one weak point or line of weakness in or on the imaging head or capsule. Such a feature may be aligned with a joint of the imaging head disposed between the light guide and the image sensor and electronics. The breakaway interface may further comprise a protective barrier embedded within the capsule.

[0023] The probe of the scope may include a mount to which the imaging head is movably attached to the probe. The imaging head may be cantilevered from the mount. In an refinement, the capsule or light guide may include a structure configured to movably engage with the mount. The light guide is preferably disposed between the mount and the image sensor in a direction parallel to an axis of rotation about which the imaging head can rotate relative to the mount.

[0024] The imaging head is suitably located at the distal end of the probe. The handle may be detachably attached to the proximal end of the probe. The handle may comprise a drive for moving the imaging head relative to the probe, a light source for transmitting illumination along the probe to the light guide of the imaging head, and power and / or data connections for transmitting power and / or data along the probe to and / or from the imaging head. Thus, the drive interface, the light interface, and the power and / or data interface are suitably located between the handle and the probe. The probe may also support a protective oversheath that can be pulled over the handle.

[0025] The inventive concept encompasses a corresponding method of disassembling the imaging head of a medical scope. The method then includes breaking or cutting the imaging head capsule that encloses the image sensor and associated electronics, and separating the image sensor and electronics from the imaging head's light guide, which is positioned to transmit illumination to the image sensor's field of view. In a preliminary step, the capsule is preferably checked for seal integrity before being broken, cut, or otherwise penetrated.

[0026] The light guide may be separated from the capsule, for example, by being removed from within the capsule or by being removed from outside the capsule. A force may be applied to a line or point of weakness in the imaging head or capsule to separate the image sensor and electronics from the light guide.

[0027] After use, the scope may be placed in the container, which is then sealed around the scope. Advantageously, the scope may be removed from the same container in a sterile manner prior to use. Before sealing, water may be added to the container to activate the cleaning agent within the container. The sealed container may then be placed in a storage location, or when full or nearly full, may be transported to a disassembly unit.

[0028] Once the container is received at the disassembly unit, whether directly or via a storage location, the scope may be unpacked from the container and then disassembled into parts. Unpacking and / or disassembly is preferably performed by a robot. During disassembly, a partial vacuum may be applied to the scope or a gas flow may be applied across the scope. This prevents contaminant particles from migrating from the disassembled exterior to the internal components during disassembly. The parts may be sorted into parts for recycling, parts for reuse, which may include an image sensor, waste for destruction, and / or biodegradable materials. The parts for reuse may then be transported to a remanufacturing facility.

[0029] The inventive concepts also extend to a method of manufacturing an imaging head of a medical scope of the invention, the method further comprising encapsulating an image sensor and associated electronics of the imaging head, the imaging head comprising a light guide positioned to convey illumination to a field of view of the image sensor.

[0030] The light guide may also be encapsulated. For example, the light guide may be overmolded in a first overmolding step, embedding the light guide in the overmolded body. The image sensor and electronics may then be positioned against or beside the overmolded body before being overmolded in a second overmolding step to complete the encapsulation. An induction coil may also be embedded in the overmolded body.

[0031] The imaging head may be formed with an overmolded body on a mount that is movable relative to the probe of the scope. For example, the mount may be configured to allow the imaging head to rotate relative to the probe.

[0032] Thus, in the present invention, an imaging head of a medical scope comprises a capsule that encapsulates an image sensor and electronics associated with the image sensor. The imaging head further comprises a light guide within or attached to the capsule that transmits illumination to the field of view of the image sensor. The imaging head can be disassembled by breaking or cutting the capsule to separate the image sensor and electronics from the light guide.

[0033] The imaging head is manufactured by encapsulating the image sensor and electronics, and optionally also the light guide. In a first overmolding step, the light guide may be overmolded to embed the light guide in the overmolded body. The image sensor and electronics may then be positioned beside or against the overmolded body and overmolded in a second overmolding step to complete the encapsulation.

[0034] In another aspect of the invention, a medical scope includes an elongate body or probe, an imaging head supported by and movable relative to a mount on the body, the imaging head including a light emitter for illuminating a field of view of the imaging head, and an optical path extending from the body through the imaging head to the light emitter, the optical path including an optical entrance of the imaging head opposite an optical exit of the body. The imaging head is preferably cantilevered from the mount.

[0035] Conveniently, the light inlet and light outlet may be opposite each other across a mounting interface, such as a pivot joint, to which the imaging head is movably attached to the mount.

[0036] If the imaging head includes an image sensor, the imaging head may further comprise a photovoltaic device arranged such that impingement of light generates power for the image sensor. The imaging head may further comprise a data transmitter powered by the photovoltaic device for transmitting image data from the image sensor to a receiver external to the imaging head.

[0037] The imaging head may also include a light guide in the light path configured to direct a portion of the light received from the body to the photovoltaic device and another portion of the light received from the body to the light emitter. The light guide may include, for example, a filter configured to split the light received from the body into portions directed onto the photovoltaic device and toward the light emitter.

[0038] The light inlet and light outlet may be disposed on an axis of rotation about which the imaging head can rotate relative to the mount, and the light guide may be disposed between the mount and the image sensor in a direction parallel to the axis. The light emitter may also be disposed between the mount and the image sensor in a direction parallel to the axis of rotation at a location radially spaced from the axis of rotation.

[0039] The imaging head may comprise an encapsulation around the image sensor. The encapsulation may include a tear-away interface at which the image sensor is preferentially separable from the light emitter. The tear-away interface may, for example, comprise at least one weak point within the encapsulation. The tear-away interface may also or instead comprise a protective strip embedded along the cut line within the encapsulation.

[0040] The concepts of the present invention also encompass a corresponding method of illuminating a field of view of an imaging head of a medical scope, the head being movable relative to a support of the scope, the method including transmitting light along an optical path from an optical outlet of the body to an optical inlet of the imaging head, then through the imaging head for emission from the imaging head.

[0041] As a refinement, and as described above, the image sensor of the imaging head may be powered using electricity generated within the imaging head from at least a portion of the light transmitted along the optical path.

[0042] Light traveling along an optical path within the imaging head may be filtered to separate the light into power generation and illumination components, at least one of which may be altered, for example in intensity, relative to another of the light components to allow independent adjustment of power generation and / or illumination.

[0043] An embodiment of the present invention delivers light longitudinally through a support structure to a rotating endoscope head, which is used as a mechanism for power delivery to a tip-on-tip endoscope for ear surgery.

[0044] In some embodiments, hermetic capsules are used to protect components designed for disassembly in a circular economy system. Daisy chain connections for the transmission of light, power or data between capsules may be provided.

[0045] In another aspect of the invention, a medical scope includes an imaging head supported by and movable relative to a body such as a probe, the imaging head including an image sensor and an optical emitter for illuminating a field of view of the image sensor; an optical path extending from the body to the optical emitter, the optical path including an optical inlet of the imaging head opposing an optical outlet of the body across a wireless interface between the imaging head and the body; and an optical transmitter in the imaging head coupled to the optical path to transmit image data from the image sensor to the body via the interface.

[0046] In a refinement, the light inlet and the light outlet may face each other across a mount on which the imaging head is movably attached to the body. For example, the light inlet and the light outlet may be arranged on an axis of rotation about which the imaging head can rotate relative to the body. In a compact configuration, the light emitter may be arranged between the interface and the image sensor in a direction parallel to the axis of rotation at a position radially spaced from the axis of rotation.

[0047] The interface may further comprise a wireless power transfer coupling providing for transfer of power from the body to the image sensor. The power transfer coupling may, for example, comprise opposing coils, a first of which surrounds an optical inlet of the imaging head and a second of which surrounds an optical outlet of the body. In an alternative approach, the imaging head may include a photovoltaic device for powering the image sensor from light transmitted through the interface.

[0048] The imaging head may further include a filter in the optical path configured to block reflected light from the light emitter and pass light transmitted from the optical transmitter.

[0049] A light source external to the imaging head may be coupled to the light path to provide illumination light to the light emitter, where the light source and image sensor may be synchronized such that the light source is on when the image sensor is capturing an image frame and is off between image frames while the light transmitter transmits imaging data from the image sensor.

[0050] An image sensor controller external to the imaging head may be configured to communicate control signals from the image sensor controller through the interface to the image sensor. The control signals may include a clock signal multiplexed with the write signal.

[0051] The image sensor controller may, for example, be connected to a wireless power transmission coupling of the interface and communicate control signals to the image sensor via the coupling. The image sensor controller may in turn drive an LED to communicate the control signals to the image sensor as light control signals. An optical transmitter in the imaging head may then be responsive to the light control signals.

[0052] The inventive concept encompasses a corresponding method of operating a scope with an imaging head movable relative to a support, the method including illuminating a field of view of the imaging head by transmitting light along an optical path from the body to the imaging head across a wireless interface, and optically transmitting image data along the optical path from the imaging head to the body via the interface. [Brief description of the drawings]

[0053] [Figure 1] FIG. 2 is a perspective view of the distal end portion of the endoscope of the present invention; [Diagram 2] FIG. 2 is a side view in longitudinal section of the endoscope of FIG. [Diagram 3] 3 corresponds to FIG. 2, but shows the endoscope from a direction about the longitudinal axis perpendicular to the direction shown in FIG. 2. [Figure 4] A modified version of the endoscope is shown, but otherwise corresponds to FIG. [Diagram 5]FIG. 5 is a block diagram of an endoscope system including a modified example of FIG. 4. [Figure 6] 2, which illustrates how an endoscope of the present invention can be designed to facilitate remanufacturing in a circular economy system. [Figure 7] FIG. 1 is a series of schematic diagrams illustrating how the present invention can be applied in a circular economy system. [Figure 8] FIG. 8 is a perspective view of a tray for use in the method shown in FIG. 7. [Figure 9] FIG. 8 is an enlarged detailed view of a robot cell used in one of the method steps shown in FIG. 7. [Figure 10a] FIG. 13 is a longitudinal cross-sectional side view of a modified camera module for use in an endoscope of the present invention. [Figure 10b] FIG. 13 is a longitudinal cross-sectional side view of a modified camera module for use in an endoscope of the present invention. [Figure 10c] FIG. 13 is a longitudinal cross-sectional side view of a modified camera module for use in an endoscope of the present invention. [Figure 10d] FIG. 13 is a longitudinal cross-sectional side view of a modified camera module for use in an endoscope of the present invention. [Figure 11] 2 is a schematic side view of a drive mechanism for rotating the head of the endoscope of the present invention. FIG. [Figure 12a] 12 is a simplified version of FIG. 11 showing how the drive mechanism works. [Figure 12b] 12 is a simplified version of FIG. 11 showing how the drive mechanism works. [Figure 12c] 12 is a simplified version of FIG. 11 showing how the drive mechanism works. [Figure 12d] 12 is a simplified version of FIG. 11 showing how the drive mechanism works. [Figure 12e] 12 is a simplified version of FIG. 11 showing how the drive mechanism works. [Figure 12f] 12 is a simplified version of FIG. 11 showing how the drive mechanism works. [Figure 12g]12 is a simplified version of FIG. 11 showing how the drive mechanism works. [Figure 13] 11A-11D are side views of further embodiments of the present invention, all in longitudinal section; [Figure 14] 11A-11D are side views of further embodiments of the present invention, all in longitudinal section; [Figure 15] 11A-11D are side views of further embodiments of the present invention, all in longitudinal section; [Figure 16] 11A-11D are side views of further embodiments of the present invention, all in longitudinal section; [Figure 17] 11A-11D are side views of further embodiments of the present invention, all in longitudinal section; [Figure 18] 11A-11D are side views of further embodiments of the present invention, all in longitudinal section; [Figure 19] FIG. 13 is a longitudinal cross-sectional side view of a distal portion of the probe showing optical paths and components for data and power transmission. [Figure 20] FIG. 20 is a block diagram of an endoscope system including the modified example of FIG. 19. [Figure 21] FIG. 13 is a longitudinal cross-sectional side view of a distal portion of a probe in which data is transferred optically and power is transferred non-optically as well as wirelessly. [Figure 22a] 22A-22C are detailed perspective views of the probe of FIG. 21 in assembled and disassembled configurations. [Figure 22b] 22A-22C are detailed perspective views of the probe of FIG. 21 in assembled and disassembled configurations. [Diagram 23] FIG. 22 is an exploded perspective view of a rotating head assembly for the probe of FIGS. 21, 22a and 22b. [Figure 24] FIG. 24 is an enlarged perspective view of the camera module of the rotating head assembly shown in FIG. 23. [Diagram 25] FIG. 22 is a block diagram of an endoscope system including the modified example of FIG. 21. [Figure 26] FIG. 1 is a block diagram of an endoscopic system that supports bidirectional data transmission. [Figure 27] 1 is a diagram illustrating data multiplexing. [Figure 28a] FIG. 1 is a perspective view of an endoscopic system of the present invention comprising a probe assembly, a handle assembly, and a camera control unit. [Figure 28b] FIG. 1 is a perspective view of an endoscopic system of the present invention comprising a probe assembly, a handle assembly, and a camera control unit. [Figure 29] FIG. 28c is a cross-sectional perspective view of the proximal end of the probe assembly shown in FIGS. 28a and 28b. [Figure 30a] 1 is a series of perspective views illustrating some of the steps involved in manufacturing an endoscope. [Figure 30b] 1 is a series of perspective views illustrating some of the steps involved in manufacturing an endoscope. [Figure 30c] 1 is a series of perspective views illustrating some of the steps involved in manufacturing an endoscope. [Figure 30d] 1 is a series of perspective views illustrating some of the steps involved in manufacturing an endoscope. [Figure 30e] 1 is a series of perspective views illustrating some of the steps involved in manufacturing an endoscope. [Fig. 30f] 1 is a series of perspective views illustrating some of the steps involved in manufacturing an endoscope. [Diagram 31] 1 is a schematic diagram in longitudinal section showing the mechanism for driving and managing the movement of the drive cable. FIG. [Diagram 32] 1 is a schematic diagram in longitudinal section showing the mechanism for driving and managing the movement of the drive cable. FIG. [Diagram 33] FIG. 13 is a perspective view showing a worm gear mechanism for transmitting torque along the probe shaft to the head of the endoscope. [Diagram 34] FIG. 13 is a perspective view showing a worm gear mechanism for transmitting torque along the probe shaft to the head of the endoscope. [Diagram 35] FIG. 13 is a perspective view showing a hybrid shaft and belt drive mechanism for transmitting torque along the probe shaft to the head of the endoscope. [Diagram 36] FIG. 2 is a schematic diagram of a longitudinal cross section showing an optical multiplexer configuration. [Figure 37] FIG. 2 is a schematic diagram of a longitudinal cross section showing an optical multiplexer configuration. [Figure 38] 1 shows visualization of body structures during surgery. [Figure 39] FIG. 39 is a schematic diagram of a longitudinal cross section of an optical multiplexer configuration suitable for use with the visualization technique shown in FIG. 38. [Diagram 40] 1 is a schematic diagram of a light guide in the head of an endoscope having optical multiplexer / demultiplexer functionality. [Diagram 41] FIG. 2 is a block diagram of another endoscope system of the present invention. [Diagram 42] FIG. 42 is a detailed block diagram of a portion of the system shown in FIG. 41. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0054] So that the invention may be more readily understood, reference is now made, by way of example, to the accompanying drawings, in which: Referring initially to Figures 1 to 3 of the drawings, a distal end portion of an endoscope 10 comprises a body in the form of an elongated stem, shaft or probe 12 which supports a rotating imaging head 14. Head 14 houses an integrated camera module 16 and a light emitter 18 disposed alongside the camera module 16 to illuminate the field of view.

[0055] The probe 12 extends along a longitudinal axis 20. The head 14 rotates relative to the probe 12 about an axis of rotation 22 that extends perpendicular to the longitudinal axis 20. The camera module 16 has a field of view that extends radially relative to the axis of rotation 22. Thus, the camera module 16 can be oriented across multiple viewing angles by rotating the probe 12 about its longitudinal axis 20 and rotating the head 14 about its axis of rotation 22. In FIG. 1, the camera module 16 and adjacent light emitter 18 are shown at a 45° angle relative to the longitudinal axis 20.

[0056] The head 14 is generally cylindrical and extends along and is rotationally symmetric about an axis of rotation 22. The head 14 is supported for rotation by a mount in the form of a cantilever arm 24 that extends distally of the probe 12, offset laterally from the longitudinal axis 20. The cantilever arm 24 supports the head 14 at only one end or side of the head 14. This advantageously maximizes the size of the head 14 within the constrained diameter of the endoscope 10, facilitating assembly and disassembly, providing greater freedom for positioning the internal components of the head 14, and leaving a free end or side of the head 14 available for additional lateral imaging, if desired.

[0057] In this example, rotation of the head 14 is driven by a continuous drive cable 26 that extends from a drive mechanism (not shown) within the probe 12 and wraps around the head 14. The drive cable 26 is held in a pulley groove 28 that surrounds the axis of rotation 22 adjacent the end of the head 14 adjacent the cantilever arm 24. Rotation of the head 14 relative to the probe 12 about the axis of rotation 22 is unconstrained and therefore can exceed 360° in this example.

[0058] The probe 12 supports a distally facing, resilient wiper blade 30 having an elongated free edge that extends parallel to the axis of rotation 22. The wiper blade 30 abuts the proximal side of the head 14. As the head 14 rotates past the wiper blade 30, the wiper blade 30 clears debris from the head 14 to prevent the debris from obscuring the field of view of the camera module 16 or blocking the illumination from the light emitter 18.

[0059] Although not shown here, the outer lens of the camera module 16 may be positioned slightly raised from the outer surface around the periphery of the head 14 so that as the head 14 rotates, the wiper blade 30 strikes only the outer lens and is not dragged around the remainder of the circumference of the head 14. Thus, there may be a small radial gap between the wiper blade 30 and the head 14, except where the protruding outer lens of the camera module 16 fills the gap as it encounters the wiper blade 30.

[0060] In this embodiment, as will be described, the light emitter 18 is the distal end of an illumination conductor or optical path that conveys light from a remote light source along the probe 12 to the head 14. This solution is advantageous in view of size constraints within the head 14 and because the light spectrum can be more easily varied, for example, through the use of different light sources, which may be useful for tissue identification and otherwise.

[0061] Unlike the transmission of electricity, the transmission of light from the probe 12 to the head 14 does not require complicated contact or sealing arrangements. However, the problem of powering the camera module 16 in the head 14 remains. In this embodiment, the solution is to generate the necessary electricity in the head 14 from a portion of the incoming light. In this way, a single efficient mechanism avoids the problem of sealing electrical contacts and better addresses the challenge of providing a lighting solution in a limited space than the alternative of an integrated LED in the head. The mechanism shown also facilitates the rotation and cleaning solutions mentioned above.

[0062] The cross-sectional views of FIGS. 2 and 3 show the internal features that define the light transmission paths within endoscope 10.

[0063] 2 is a view perpendicular to both the longitudinal axis 20 and the rotational axis 22. It shows that light from an external light source (not shown) travels distally through an optical medium 32 within the probe 12 in a direction generally parallel to the longitudinal axis 20. Upon reaching the distal end portion of the probe 12, the light strikes a mirror or preferably a prism 34 attached to the cantilever arm 24. This causes the light to be directed in a direction generally parallel to the rotational axis 22 through the optical medium 36 and into the head 14 via a sliding interface or gap at the junction between the cantilever arm 24 and the head 14. The optical medium 36 thus functions as a light outlet through which light is transmitted or transmitted across the interface or gap to strike the head 14.

[0064] 2 also shows that the cantilever arm 24 includes a spigot 38 that engages in a complementary socket in the head 14 to support the head 14 for rotation relative to the cantilever arm 24. The optical medium 36 extends within the spigot 38 along the axis of rotation 22 to the interface between the cantilever arm 24 and the head 14, thereby emitting light through that interface into the head 14. In this example, the spigot 38 is substantially flush with an exterior groove 28 of the head 14 that houses the drive cable 26.

[0065] As can be seen in Figure 2, the head 14 further comprises a light guide 40 behind the light emitter 18. Advantageously, a pulley component 42 which defines the pulley groove 28 which receives the drive cable 26 and a socket which engages the spigot 38 of the cantilever arm 24 is integrated with the light guide 40, for example as part of the same component or with internal features encapsulated within an external structure.

[0066] The light guide 40 is disposed between the camera module 16 and the cantilever arm 24. In other words, the cantilever arm 24, the light guide 40, and the camera module 16 are disposed successively along the axis of rotation 22. The light guide 40 thus defines a portion of the interface between the head 14 and the cantilever arm 24, and receives light from the optical medium 36 in the spigot 38 of the cantilever arm 24. The light guide 40 thus functions as an optical inlet of the head 14 that receives light transmitted or transmitted from the optical outlet of the cantilever arm 24 across the interface or gap at the junction between the cantilever arm 24 and the head 14.

[0067] Upon entering head 14, the incoming light is split into two portions by light guide 40. The first portion of the light enters a mirror, or preferably a prism 44, of light guide 40 and is thereby redirected radially away from axis of rotation 22. The first portion of the light thus redirected is then transmitted through the optical medium of light guide 40 to light emitter 18, where it exits head 14 and illuminates the field of view of camera module 16.

[0068] A second portion of the light is directed through light guide 40 to be incident on photocell 46, which generates power for the electronics of camera module 16. In this example, photocell 46 is conveniently integrated into camera module 16, although in principle photocell 46 could be separate from camera module 16.

[0069] Reference is now also made to Figure 3, which shows a longitudinal cross-section of the camera module 16, viewed perpendicular to the longitudinal axis 20 and along the axis of rotation 22. This illustrates that the camera module 16 preferably has a stacked structure. Specifically, the camera module 16 suitably comprises a commercially available image sensor 48 having a lens barrel 50 and a lens 52 attached thereto. The image sensor 48 has a BGA (ball grid array) connection electrically connected to a power IC (integrated circuit) 54 for transferring power to and image data from the image sensor 48. The image sensor 48 may include image processing circuitry, in which case fewer connections may be required to transfer image data to the power IC 54.

[0070] The power IC 54 preferably includes the photovoltaic cell 46, power control circuitry that provides power to the image sensor 48, and wireless data transmission circuitry implemented on the data IC 56. The power IC 54 also passes data from the image sensor 48 to the data IC 56. The data IC 56 preferably includes an antenna and circuitry for transmitting data in packets as required by the wireless transmission protocol.

[0071] To minimize the power required for wireless data transmission, the data IC 56 of the camera module 16 conveniently transmits the data over a very short range from the image sensor 48 to a wireless receiver 58 located within the probe 12, in this example near the distal end of the probe 12.

[0072] Reference is now made to FIG. 4, which shows a variation of the embodiment shown in FIGS. 1-3, with like features being labeled with like references. This variation differs by the addition of a filter or filter layer 60 applied to the prism 44 in the light guide 40 of the head 14. In this variation, the camera module 16 is powered by light that is tuned or filtered to a particular wavelength or spectrum, preferably outside the visible light spectrum. The filter layer 60 allows that particular light to pass to the photocell 46 of the camera module 16, while deflecting the remaining light to provide illumination via the light emitter 18. This allows independent control of the power delivered to the camera module 16 and the visible light used to illuminate the target area, for example by varying the intensity or other parameters of one component of the light provided relative to the other components of that light. More generally, the filtering of the light can be done internally or externally to the head 14 or probe 12.

[0073] Figure 5 is a block diagram of an endoscope system 11 comprising the endoscope 10 shown in Figure 4, where power is transmitted optically from the probe 12 to the head 14 and data is transmitted wirelessly from the head 14 to the probe 12 using RF. As also shown in Figures 27(a) and 27(b), the endoscope system 11 comprises a handle 13 removably attachable to the probe 12, and a camera control system 15 removably coupled to the handle 13 by an electrical cable 17 for powering and controlling the handle 13 and the endoscope 10. To this end, the camera control system 15 comprises an embedded computer 19.

[0074] The handle 13 includes a stepper motor 21 that actuates a drive mechanism in the probe 12 to drive the rotation of the head 14 about the axis of rotation 22 shown in FIG. 4. The handle 13 further includes a wireless receiver in the form of a receiving antenna 58 that provides a signal to an RF demodulator 23, which in turn returns the signal to the embedded computer 19 of the camera control system 15 via a cable 17. The cable 17 also provides power to a near infrared source 25 and an LED 27 that emits white light. The output of the light source 25 and the LED 27 are combined by a fiber optic coupler 29 and passed through the probe 12 via the aforementioned optical medium acting as a light guide 40 and then through a prism 34 to the head 14. In the head 14, a spectral split is performed by a filter layer 60, whereby the white light is directed to the light emitter 18 and the near infrared wavelengths are directed through a prism 44 to the photocell 46 of the camera module 16.

[0075] In this example, a photovoltaic cell 46 of the camera module 16 powers an application specific integrated circuit (ASIC) 31 that combines the functions of the power IC 54 and data IC 56 described above. The ASIC 31 comprises a power regulator 33, a control unit 35 with clock functions, and an RF modulator 37 that receives signals from an image sensor 48 and provides signals to a transmit antenna 39.

[0076] Figure 6 shows how the embodiment of Figures 1-3 can have features to facilitate reuse of key components in a circular economy system. Like features are given like numbers. Similar construction principles can be applied to other embodiments such as that shown in Figure 4.

[0077] In view of the aforementioned problem of prion contamination, any structure defining the exterior or other surfaces of the endoscope 10 that may come into contact with organic materials cannot be reused and must be removed from the device while maintaining the integrity of the uncontaminated internal components. To this end, the internal components are encapsulated. This ensures that once the endoscope 10 is successfully disassembled and the encapsulation removed, the reused internal components will not contaminate other components during reassembly or if the device fails and those components become exposed during surgery.

[0078] 6, the main active components of head 14, including integrated camera module 16 and internal features of light guide 40, such as prism 44, are encapsulated to form an airtight seal around those internal components. Specifically, camera module 16 is encapsulated by shroud 62, and, as described above, light guide 40 is integral with or tightly encapsulated within the components that also define pulley groove 28 and spigot 38.

[0079] The shroud 62 joins with the light guide 40 at a planar joint 64 to assemble the head 14 as a unitary capsule. A seal between the light guide 40 and the shroud 62 is formed by overmolding, or optionally by gluing, welding or compression. The components within the light guide 40 and the shroud 62 are similarly overmolded, or optionally glued, welded or otherwise encapsulated using a compression fit.

[0080] A groove 66 surrounding the head 14 aligned with the joint 64 forms a line of weakness at which the capsule can be broken to separate the light guide 40 and the shroud 62 in a controlled manner to remove the protected components therein. More generally, the groove 66 illustrates a disassembly interface at which the camera module 16 is preferentially separable from other portions of the head 14, such as the light guide 40 and / or the light emitter 18. Although the groove 66 is external to the head 14 in this example, optionally a line of weakness or point of weakness can be defined within the head 14. Optionally, the groove 66 can be formed to provide a hinge for controlled opening of the capsule, for example if the groove 66 does not extend the entire circumference of the head 14.

[0081] 6 also shows an optional strip or band 68 of harder material embedded within head 14 below the cut line, e.g., located below groove 66 as shown. This allows a laser or knife to cut into head 14 while protecting the internal components of head 14 during the cutting process. For example, a laser may cut through the plastic capsule of head 14, opening or weakening it, while being prevented from penetrating into the inside of the capsule by metal band 68 located below the cut site.

[0082] Advantageously, the capsule of head 14 may be opened by applying a bending or twisting force to its exterior surface to tear, crack or break the capsule. Optionally, this action may be directed to a predetermined line or point of weakness as described above and / or may be followed by the application of cut or scribe marks to the capsule as a preliminary step. Ideally, the required force is applied to the exterior surface of the capsule in a controlled and repeatable manner, for example by using a robotic arm.

[0083] Ensuring that the capsule of the head 14 has maintained its integrity during use is important to determine whether the components within that capsule can be used again. During disassembly, this check can be done visually, and optionally by applying a strain or color die, or by scanning frequencies to visualize cracks or check for resonance. Alternatively, or in addition, a liquid or gas pressure can be applied to the exterior surface of the capsule. If the capsule breaks, any voids or pockets within the pressurized capsule will fill with fluid. Optionally, the test can be in the form of a bubble leak test, performed with a pressure differential. This can be detected by visual or pressure monitoring.

[0084] The manufacture of endoscope 10 with its encapsulated components is described below with reference to Figures 30a-30f of the drawings.

[0085] Figure 7 illustrates how the present invention can be applied to a circular economy system. In this regard, it is important to protect the integrity of critical components after use and return them. Therefore, robust reverse logistics and supply chain management, as well as focused product design and disassembly / reassembly processes are required.

[0086] Figure 7 shows an endoscope of the present invention removed from a sterile reusable tray (1), connected to a monitor or camera control unit (2), and being used in ear surgery (3). After use, the endoscope is returned to its original tray (4), although the tray in which the endoscope is supplied or returned may alternatively be disposable.

[0087] An example of a reusable tray 70 is shown in Figure 8. In step (5) of Figure 7, the user pulls the protective backing from return seal 72 and then expediently uses the original cover film to reseal the tray 70 around the endoscope 10 and close the open top of the tray 70. Advantageously, the user can first fill the tray 70 with water, thus activating the water-soluble detergent capsules 74 within the tray 70. The detergent initiates the cleaning process, liberating visible biological material and debris from the endoscope 10.

[0088] Returning to Figure 7, the trays 70 are then placed in storage vaults (6) located at each individual hospital. The vaults can provide geographic location and inventory data. When the vault is full or nearly full, an alert is generated (7) and the vault is transported (8) to a dedicated disassembly unit (9). This removes the burden of cleaning and waste management from the hospital and eliminates the risk of inadequate sterilization.

[0089] The Global Product Identification System allows for individual serialization and secure tracking of products and components, as well as verification of their authenticity as part of the return process. This allows for a robust implementation of a Smart Kanban (Lean Scheduling) system, which can be used by local distributors to transport endoscopes to disassembly units.

[0090] Advantageously, the disassembly units may be robotic cells sized to facilitate transportation. A set number of such cells may fit into a standard shipping container, or the cells may be packaged within a shipping container. Such cells may be deployed regionally or nationally as an integral part of a reverse logistics system.

[0091] Thus, used endoscopes delivered directly from hospitals, classified as medical waste, may be fed into a robotic cell that serves as a disassembly unit. The initial disassembly of the endoscope is automated using a pick-and-place robot to protect staff. The robotic arm unpacks and disassembles the endoscope (10), sorting the parts into parts for recycling (11), parts for reuse in a circular economy system (12), waste for incineration, and biodegradable materials.

[0092] Parts for reuse in a circular economy system are no longer classified as medical waste and can be shipped internationally (13) to circular production facilities where the endoscopes are remanufactured (14). This solution avoids many of the regulatory challenges that would have to be overcome if the parts were shipped internationally while remaining classified as medical waste.

[0093] Each endoscope undergoes rigorous testing to ensure it meets the same safety and sterility standards as the original and is packaged ready for resale (15).

[0094] FIG. 9 shows a robotic cell 76 of a disassembly unit that can be used in step (10) of FIG. 7. In this example, air is drawn from cell 76 through port 78 to apply a partial vacuum to endoscope 10 during disassembly of endoscope 10 by robotic arm 80. This is to inhibit migration of particles such as prions from the exterior surface of endoscope 10 to its interior protected components. The vacuum may be localized or temporary, or the entire disassembly process may take place in a low pressure environment. Alternatively, a laminar or other air flow may be applied to endoscope 10 in robotic cell 76 for the same purpose.

[0095] 10a-10d, these figures show variations of camera modules 16 each having at least two lens elements 82, at least one of which is attached to and movable by a micro-electro-mechanical system (MEMS) actuator 84. This allows the lens elements 82 to be moved independently of one another or in an accordion fashion. Optionally, the illustrated arrangement of MEMS actuators 84 may be replicated on all lens elements 82. The MEMS actuator 84 may act on the lens aperture 86 of the camera module 16 as well.

[0096] A lens array 88 of three longitudinally spaced lens elements 82 is shown in Figures 10a and 10b. Longitudinally acting peripherally disposed MEMS actuators 84L act on each lens element 82 to vary the longitudinal spacing between the lens elements 82. This effect is apparent from a comparison of Figures 10a and 10b, where the former shows the lens array 88 in a longitudinally extended state and the latter shows the lens array 88 in a longitudinally contracted state. In this example, the lens elements 82 move relative to each other in an accordion-like manner, and thus the longitudinal positions of the lens elements 82 are interdependent.

[0097] 10a and 10b also show that at least one lens element 82 may have a further MEMS actuator 84R acting radially to keep that lens element 82, or more generally the lens array 88, in alignment. In principle, a similar MEMS actuator 84R could also act on the lens aperture 86.

[0098] 10a and 10b, the lens elements 82 remain parallel and mutually aligned on a common longitudinal optical axis 90 as they move longitudinally. Conversely, the variation shown in FIG. 10c illustrates how the MEMS actuators 84 on either side of a lens element 82 can be controlled independently, for example, by extending the MEMS actuator 84L on one side and retracting the MEMS actuator 84L on the other side. This causes at least one lens element 82 to tilt relative to the optical axis 90 and at least one other lens element 82. Similarly, extending the MEMS actuator 84R on one side and retracting the MEMS actuator 84R on the other side causes at least one lens element 82 to move laterally relative to the optical axis 90 and at least one other lens element 82.

[0099] These pivotal and translational motions can be used to steer or manipulate lens array 88, which includes complex asymmetric lenses, allowing refocusing in ways not possible with simple lenses. For example, a lateral shift of lens element 82 can result in a different optical shape on the optical axis, thus refocusing the optical system.

[0100] In the variation shown in Figure 10d, lens array 88 comprises two lens elements 82. Lens elements 82 are independently suspended via MEMS actuators 84L and are therefore independently movable relative to the surrounding barrel structure. Lens aperture 86 may be mounted in a similar manner. Again, means for pivoting and / or translational movement may be provided as described above.

[0101] 11 and 12a-12g, these figures show an orientation or drive mechanism 92 for rotating the head 14, and thus the camera module 16 and light emitters 18, relative to the probe 12 of the endoscope 10. The drive mechanism 92 is located near the distal end of the probe 12 and employs a sliding finger or pawl that may be powered using, for example, a MEMS actuator.

[0102] Specifically, the drive mechanism 92 has a ratchet and pawl arrangement that includes a ratchet wheel 94 coupled to the head 14, for example, coaxially for direct drive or via the drive cable 26 of the previous embodiment. The drive mechanism 92 further includes a pair of opposed pawls 96 that are movable as part of a series of movements or sequences to engage and apply torque to the ratchet wheel 94, thereby driving and controlling the angular incremental movement of the ratchet wheel 94.

[0103] To this end, each pawl 96 is movable by a respective actuation rod 98 and linkage 100 to engage and disengage the ratchet wheel 94 and apply a torque to the ratchet wheel 94 when so engaged. A connecting arm 102 extending from each linkage 100 is driven by the movement of its linkage 100 and acts on the linkage 100 of the opposing pawl 96. In this manner, extending one pawl 96 to advance the ratchet wheel 94 in a particular angular direction disengages the other pawl 96 from the ratchet wheel 94, freeing the ratchet wheel 94 for its own movement.

[0104] Figure 11 shows the complete drive mechanism 92 required to rotate the ratchet wheel 94 in the opposite angular direction. However, for ease of understanding, Figures 12a-12g omit the actuation rod 98, linkage 100, and one of the arms 102 to show the unidirectional angular motion of the ratchet wheel 94. Nonetheless, it will be apparent how these features omitted from Figures 12a-12g but shown in Figure 11 can be used to rotate the ratchet wheel 94 in the opposite direction.

[0105] The sequence of operation shown in Figures 12a to 12g is as follows: Firstly, in the rest position shown in Figure 12a and corresponding to Figure 11, both pawls 96 engage the ratchet wheel 94 preventing angular movement of the head 14 relative to the probe 12.

[0106] 12b shows the actuation rod 98 of one of the pawls 96 being driven longitudinally toward the ratchet wheel 94 along a tangential axis that is laterally offset from the center of the ratchet wheel 94. Initially, this motion causes a linkage 100 to pivot relative to the actuation rod 98 and pawl 96. This pivoting motion of the linkage 100 moves an arm 102 attached to the linkage 100 toward and relative to the opposing pawl 96. This movement of the arm 102 disengages the opposing pawl 96 from the ratchet wheel 94, allowing the ratchet wheel 94 to move freely.

[0107] Clockwise movement of the ratchet wheel 94 is then driven by further longitudinal movement of the pawl 96 which is coupled to the actuation rod 98 via a linkage 100, as shown in Figures 12c and 12d.

[0108] Next, the actuating rod 98 reaches the end of its longitudinal stroke and begins to return in the opposite longitudinal direction, as shown in FIG. 12e. Initially, this return motion pivots the linkage 100 in the opposite direction, pulling the arm 102 away from the opposing pawl 96. This allows the opposing pawl 96 to reengage with the ratchet wheel 94, thus preventing angular motion of the ratchet wheel 94. FIG. 12f then shows the actuating rod 98 retracting further, thus disengaging the pawl 96 coupled to the linkage 100 from the ratchet wheel 94. Further retraction of the actuating rod 98 pulls the pawl 96 counterclockwise, sliding over at least one tooth of the ratchet wheel 94 to reengage the ratchet wheel 94 in a relatively counterclockwise position, as shown in FIG. 12g.

[0109] If the ratchet wheel 94 is further rotated in a clockwise direction, the actuation rod 98 is now ready to repeat its longitudinal stroke. Alternatively, the actuation rod 98 may remain stationary if the ratchet wheel 94 is held in a fixed angular position, or driven in a counterclockwise direction by corresponding movement of the actuation rod 98, a linkage 100, and an arm 102 associated with the opposing pawl 96, as shown in FIG.

[0110] 13 illustrates another embodiment of the invention, where like numbers are used for like features. In this embodiment, the head 14 is not cantilevered from the probe 12, but instead is supported for rotation about the axis of rotation 22 by and between a pair of laterally spaced parallel arms 104 that extend distally from the probe 12.

[0111] Again, head 14 houses and encloses camera module 16 and supports at least one light emitter 18 positioned to illuminate the field of view of camera module 16. In this example, there are at least two light emitters 18, one on each side of camera module 16.

[0112] Optionally, as shown in this example, light is introduced to the head 14 from parallel longitudinal optical paths 106 that extend along the probe 12. The light is redirected from these optical paths 106 towards the head 14 by mirrors, light pipes or prisms 34 in respective arms 104 that are aligned with the axis of rotation 22 on opposite sides around the head 14. Thus, the light enters the head 14 from both sides along the axis of rotation 22. From there, light guides 108, such as optical fibers, in the head 104 convey the light to the respective light emitters 18.

[0113] In this example, the camera module 16 may be powered by conventional means such as sliding contacts or electromagnetic induction. However, it will be apparent that the camera module 16 shown in Figure 13 may instead be powered by a photovoltaic device using a portion of the light entering the head 14, for example using one or more light guides inserted between the camera module 16 and at least one of the arms 104 as in the embodiment of Figures 1-3.

[0114] Again, mechanisms such as weakened lines that allow head 14 to be cut or disassembled to access the recyclable or reusable components encapsulated therein can be provided to facilitate robotic disassembly of head 14 in a circular economy system.

[0115] Turning now to Figures 14, 15 and 16, these show an embodiment of the present invention in the form of an endoscope similar to a conventional Hopkins® scope.

[0116] In the endoscope 10 of Figure 14, a tubular capsule 110 has an end closed with a lens or transparent end cap 112 to enclose a rod lens assembly 114. The rod lens assembly 114 includes a longitudinal array of rod lenses 116 within a tubular housing 118, which may be made of stainless steel, for example. Note that the metal housing 118 of the rod lens assembly 114 provides rigidity to the longitudinal shaft of the endoscope 108, and that the capsule 110 is a disposable component that may be molded of a polymer.

[0117] The lateral extension of capsule 110 also houses and supports, but does not enclose, an optical fiber 120 that extends parallel to rod lens assembly 114. Optical fiber 120 terminates at the distal end of endoscope 10 within a light emitter adjacent distal cap 112 of capsule 110. Distal cap 112 functions as the distal lens of endoscope 10.

[0118] The capsule 110 is surrounded near its proximal end by a groove 122 that defines a line of weakness for controlled disassembly, whereby the proximal end cap 112 may be removed or hinged from the capsule 110. This allows the rod lens assembly 114 to be removed from the capsule 110 and reused. For example, the distal end cap 112 may be pushed proximally into the capsule 110 to push the rod lens assembly 114 proximally out of the capsule 110. If the proximal end cap 112 has not already been removed or opened, that telescoping action may also break or otherwise open the proximal end cap 112. Preferably, the end cap 112 is longitudinally spaced from the rod lens assembly 114 to ensure that the rod lens assembly 114 is not damaged during removal from the capsule 110.

[0119] Capsule 110 is supported by a structural support 124 that surrounds and covers the proximal end of capsule 110. Groove 122 is located within support 124 and thus protects the weakened proximal end of capsule 110 by groove 122. Thus, capsule 110 must be removed from support 124 when access to rod lens assembly 114 is required. Capsule 110 is then held such that a uniform force is applied across rod lens assembly 114 before a force is applied to the proximal side of groove 122 to tear capsule 110.

[0120] The support 124 also holds a proximal lens 126 aligned with the rod lens assembly 114 and defines a connector 128 for coupling the light source to the optical fiber 120. The support 124 is preferably made from a biomaterial. Optionally, the optical fiber and proximal lens can be encapsulated similarly to the rod lens assembly 114.

[0121] The endoscopes 10 shown in Figures 15 and 16 also resemble conventional Hopkins® scopes with fiber optic light guide illumination, but in this case they each have an encapsulated camera module 16 integrated into the distal end to provide a chip-on-chip solution.

[0122] Preferably, as shown, camera module 16 includes a variable focus lens that is controllable from the proximal end of endoscope 10. For example, an objective lens 130 in front of the image sensor of camera module 16 allows for focusing of camera module 16 by varying the distance between them.

[0123] A separate encapsulated control module 132 near the proximal end of each endoscope 10 controls the focus of the camera module 16 and receives image data from the camera module 16. In Figure 15, the control module 132 receives the data wirelessly from the camera module 16, receiving the data from an antenna 134 located near the camera module 16. Conversely, the control module 132 has a wired data connection to the camera module 16 in Figure 16.

[0124] The focus of the camera module 16 may be conveniently controlled by a proximal knob 136 that acts on the control module 132. In these examples, the knob 136 interacts with the control module 132 without physical contact between them. To this end, the knob 136 has a fiducial marker 138 by which a sensor 140 on the control module 132 can monitor the movement of the knob 136.

[0125] In the endoscope 10 of Figures 15 and 16, a tubular shaft or probe 12 functions as a structural element and a light guide. Light is transmitted along the probe 12 by internal reflection as shown, and emerges from the distal tip of the probe 12 around the camera module 16. In the embodiment of Figure 15, a portion of that light can power the camera module 16 via a photocell. In the embodiment of Figure 16, the camera module 16 may be powered directly by a wired connection to the control module 132.

[0126] Power and data connections to the control module are made via a cable 142 that couples to a connector 144 on the endoscope 10 of Figures 15 and 16. In Figure 15, the cable 142 also includes an optical fiber 146 for delivering light from a remote light source (not shown) via the connector 144 to the light guide of the probe 12. Conversely, in Figure 16, the cable 142 provides power to an on-board light source within the endoscope 10, here exemplified by an LED 148 that delivers light to the light guide of the probe 12.

[0127] 17, the endoscope 10 of this embodiment has a flexible tubular probe 12 surrounding an optical fiber 150, a wireless communication module 152, and steering wires 154 configured to bend the flexible probe 12 along its length. The probe 12 also contains a working channel that terminates in an exit opening 156 in a head component 158 ​​at the distal tip of the probe 12.

[0128] In addition to defining an exit opening 158 for the working channel of the probe 12, the head component 158 ​​encloses the camera module 16, directs illumination from the optical fiber 150, and provides a protective anchor for a plug 160 at the distal end of the steering wire 154. A portion of the optical fiber 150 is oriented to illuminate a photocell that provides power to the camera module 16. The head component 158, along with the probe 12 and handle structure 162, also maintains protection for the internal components of the endoscope 10 against the ingress of contaminants.

[0129] Handle 162 includes a control element 164 for manipulating steering wire 154 without direct physical interaction between control element 164 and an internal mechanism 166 enclosed within handle 162. To this end, a sensor 168 in mechanism 166 monitors the movement of a fiducial marker 170 on control element 164 and causes mechanism 166 to respond to such movement by pushing or pulling steering wire 154 to a desired extent. Optionally, mechanism 166 is assisted or powered by a motor. A weakness 172 may be provided for controlled disassembly of handle 162 to extract enclosed mechanism 166 for reuse.

[0130] In the variation of Figure 18, the sensor 168 and fiducial marker 170 of Figure 17 have been omitted. Instead, the control element 164 interacts with the internal mechanism 166 via a flexible membrane 173, which provides a sterile barrier between the internal mechanism 166 and the exterior of the endoscope 10.

[0131] Turning now to FIGS. 19-27, these figures illustrate various alternative wireless configurations for powering the components of head 14 and receiving data from head 14.

[0132] In a variation shown in longitudinal section in Figure 19 and block diagram in Figure 20, power and data are transferred optically to and from head 14. For this purpose, a data transmitting LED 174 is shown in Figure 18 which emits a data signal as light to prism 44 in head 14 which redirects the light to prism 34 in probe 12 and from there to light guide 32.

[0133] The layout and components shown in the block diagram of Figure 20 are similar to those in the block diagram of Figure 5, and like numbers are used for like features. For brevity, the following description will focus on the main differences relative to Figure 5.

[0134] In the camera module 16 of FIG. 20, the RF modulator 37 and transmit antenna 39 of FIG. 5 are replaced by an optical modulator driver 176 within the ASIC 31 which provides a data signal to a transmit LED 174 .

[0135] In this example, the near infrared source 25, the white LED 27, and the fiber optic coupler 29 are implemented in the camera control unit 15. Here, the coupler 29 is thus coupled to the light guide 32 in the probe 12 via an optical cable 178 that extends through the handle 13 to the probe 12. The optical cable 178 not only transmits light towards the head 14, but also receives light from the LED 174 in the head 14 via the light guide 32, e.g., via the coupler 29 as shown. The optical cable 41 transmits the received light to an optical receiver 180 in the camera control unit 15. The wavelength used for the optical data transmission from the LED 174 is different from the wavelength of the white light transmission, and therefore can be identified and detected by the optical receiver 180. The optical receiver 180 provides the resulting signal to the embedded computer 19 in the camera control unit 15.

[0136] The optical receiver 180, near-infrared source 25, white LED 27, and fiber optic coupler 29 are implemented within the camera control unit 15 in this example, but any or all of them could alternatively be implemented elsewhere outside the head 14, such as within the handle 13 or within the probe 14.

[0137] In the variant shown in Figures 21 to 27, data is transferred optically from the head 14 as in the previous embodiment, but power is transferred wirelessly to the head 14 by non-optical means such as RF or near-field inductive coupling. The latter possibility is shown in Figure 21, where power is transferred inductively between mutually opposing coils 182 surrounding the spigot 38 of the probe 12 about which the head 14 rotates. One coil 182 is on the probe 12 and the opposite coil 182 is on the head 14.

[0138] The coil 182 of the probe 12 is connected to a power cable 17 that runs along the probe 12 parallel to the light guide 32. The light guide 32 conveys illumination light on a forward path 184 to the light emitters 18 in the head 14. The light guide 32 also conveys light carrying data signals from the data transmission LEDs 174 in the head 14 on a return path 186.

[0139] 21, 22a and 22b also show a removable cover insert 188 that is retained on the probe 12 by engagement of a spigot 190 on the insert 188 in a complementary socket 192 on the probe 12. The insert 188 retains a cleaning module, such as a wiper blade 30, in a receptacle 194 integral with the probe 12. The insert 188 also has a concave hub bearing arrangement 196 that engages a complementary convex shoulder arrangement 198 centered on the axis of rotation 22 on the outside of the head 14 opposite the spigot 38. The insert 188 thus allows for assembly of the wiper blade 30 onto the probe 12 and removal of the head 14 from the probe 12. The insert 188 also supports the wiper blade 30 and head 12 in the assembled probe 12. Conversely, the insert 188 facilitates disassembly for circular manufacturing.

[0140] 22a and 22b show how the drive cable 26 may be wrapped around the head 14 within the pulley groove 28. In this example, the drive cable 26 rotates through approximately 540°, including one full 360° loop around the head 14, plus approximately a half rotation between the point where the tangential leg of the drive cable 26 extends proximally from the pulley groove 28 into the probe 12, thus a nominal 180° rotation. Thus, the drive cable 26 wraps around the head 14 once for a 180° rotation and then twice for a 360° rotation.

[0141] In another example, there may not be a complete loop of drive cable 26 around head 14, in which case drive cable 26 simply wraps or rotates once around head 14 by about a half revolution of about 180°. In other examples, drive cable 26 can wrap around head 14 more than once in a capstan fashion. For example, there may be two complete loops of 360° each or 720° total, meaning that drive cable 26 rotates a total of about 900°. Again, this includes about a half revolution of about 180° to allow for convergence and divergence of drive cable 26 into and out of pulley groove 28.

[0142] 23 illustrates an exemplary assembly of the components of head 14. In this example, pulley housing 200 and camera housing 202 surround and sandwich camera module 16 and light guide 40, as well as an axis structure 204 that cooperates with light guide 40 to position camera module 16 within camera housing 202. The assembly further includes a slot 206 in camera housing 202 that receives a window 208 for admitting light to camera module 16.

[0143] In a preferred sequence, the camera module 16 is first assembled with the window 208, light guide 40, and axle structure 204, each of which are preferably designed to grip or place the camera module 16 between them. The pulley housing 200 is then added to the assembly, followed by the camera housing 202. The pulley housing 200 is placed around a cylindrical protrusion 210 of the light guide 40, which engages with a slot 212 in the pulley housing 200. This engagement locks the pulley housing 200 against angular movement relative to the remainder of the assembly.

[0144] Alternatively, the pulley housing 200 and camera housing 202 may be formed over the other components of the assembly by an overmolding process, or by low pressure injection molding of an adhesive, as described with reference to Figures 30a-30f.

[0145] The camera module 16 is shown in more detail in FIG. 24, which shows the lens 52, the image sensor 48, the ASIC 31 and its power conditioner 33, the data transmission LED 174, and the power flex cable 214 with the coil 182 of the head 14. The power flex cable 214 is shown in FIGS. 23 and 24 in an initial position where it is bent to place the coil 182 at 90° to its final position after assembly. In its final position, the power flex cable 214 is bent downwards, as shown by the dashed arrow in FIG. 24, so that the coil 182 sits parallel to the plane of the circumferential groove 28 in the pulley housing 200 and above the cylindrical protrusion 210 of the light guide 40.

[0146] The layout and components shown in the block diagram of Figure 25 are similar to those in the block diagram of Figure 20 and like numbers are used for like features. The main difference from Figure 20 is the provision of a coil 182 which provides power transfer from the probe 12 to the head 14. The coil 182 of the probe 12 is now shown connected to a power cable 17 which also supplies power to the stepper motor 21. Conversely, the coil 182 of the head 14 is shown connected to a power regulator 33 of the ASIC 31.

[0147] The near infrared source 25 of Figure 20 is omitted since the only light provided to the head 14 is for illumination purposes and power is now supplied to the head 14 by other means. However, the light emitted from the data transmitting LED 174 still undergoes spectral splitting or filtering at 60. This is to reduce reflections of light back along the light guide 32 from the light emitter 18 that could otherwise interfere with the ability of the optical receiver 180 to distinguish between the reflected light and the data signal from the LED 174.

[0148] Another difference in the block diagram of FIG. 25 versus FIG. 20 is that the optical receiver 180, LED 27, and fiber optic coupler 29 have been moved from the camera control unit 15 back to the handle 13.

[0149] Furthermore, to help the optical receiver 180 distinguish data signals from light that may be reflected along the light guide 32 from the probe 12 or head 14, the illumination of the LED 27 emitting white light may be synchronized with the frame rate of the image sensor 48. In particular, the illumination of the LED 27 may be on only when the image sensor 48 takes a frame image, and therefore off in the intervals between frames. The interval periods during which the illumination of the LED 27 is off may be used to transmit optical data without signal overlap, thus making signal processing easier. Similar measures may be taken in any configuration in which data is optically transmitted, including the configurations shown in Figures 21 to 25 as well as the configurations of Figures 19 and 20.

[0150] More generally, techniques used in modern electronic devices dictate that one-way data transmission from the image sensor 48 to the camera control unit 15 is not necessarily an option, and therefore elements of bidirectional data communication may be required. In this regard, FIG. 26 develops the configuration of FIG. 25 to address bidirectional data transmission. Here, data is transmitted back to the camera control unit 15 using the light guide 32 as previously described, but the wireless power transmission circuitry has the dual purpose of transmitting data to the image sensor 48 as well as transmitting power. This data 48 is in the form of a clock signal and a serial peripheral interface (SPI) control signal, i.e., an SPI write signal. The ASIC 31 of the camera module 16 includes a filter 216 that distinguishes between the clock signal at 218 and the SPI control signal at 220.

[0151] Because the power delivery circuitry provides only one channel, signal multiplexing is used. Specifically, to transmit the clock signal and the SPI write data, the channel must transmit at least three different signal amplitude levels, such as 0%, 50%, and 100%. The clock signal is represented by a 0% amplitude for the low portion of its signal and a 50% amplitude for the high portion of its signal. During the brief period of the SPI write data transfer, the 100% amplitude level is used to encode a "high clock with a high SPI write data signal" and the 50% amplitude level encodes a "high clock with a low SPI write data signal". This is equivalent to amplitude modulation of the clock signal by the SPI write data signal.

[0152] The multiplexing principle is illustrated in Figure 27, where a clock signal 218 and an SPI control signal 220 are combined into a multiplexed signal 222. Since one bit of the SPI write data signal lasts for four clock cycles, the modulation is simple.

[0153] Inductive coupling is proposed for power transmission, where a pair of coupling coils 182 are used to electromagnetically transfer power together with a clock signal 218 and / or other signals. Power may be harvested by an energy harvester chip and then conditioned using a power conditioner to drive the camera module 16 on the disposable side of the endoscope 10. A double-sided flexible PCB planar coil 218 may be used for transmission and reception of power signals. The number of turns of the coil 218 may be, for example, 4 to 8 turns per side. The receiver coil 182 may also have one or more windings on the cylindrical protrusion 210 of the light guide 40 to improve inductive reception of power and related signals.

[0154] Returning to Figure 26, this figure further details the functionality of the camera control unit 15 in this context. An image signal processing chip 224, responsive to an embedded computer 226, drives an SPI controller 228 implemented on the image sensor companion chip 230. The SPI controller 228 provides SPI write data to the electrical cable 17 which provides power to the coil 182 of the probe 14. The image sensor companion chip 230 also implements a clock 232, whose signal is also provided to the cable 17 and multiplexed with the SPI write data generated by the SPI controller 228.

[0155] In a further variation, the LED 174 can operate in two directions, both transmitting and receiving optical data, allowing the SPI control signals 220 to be optically transmitted to the rotating head.

[0156] The computer 226 also drives the LED controller 234, which in turn controls the LED 27 to generate the illumination white light. Conversely, the optical demodulator 236 receives and demodulates the signal from the optical receiver 180 and provides its output to the image signal processing chip 224 via an analog-to-digital converter 238 and a parallel mobile industrial processor interface 240 (parallel).

[0157] 28a and 28b, which illustrate an endoscopic system 11 of the present invention comprising three main components: a probe assembly 12 including a rotating head 14 at the distal end of a shaft 242, a handle assembly 13, and a camera control unit 15 connected to the handle assembly 13 by a cable 17. In this example, the handle assembly 13 and the camera control unit 15 are reusable, whereas the probe assembly 12 is disposable or manufactured in a reusable manner so that it is provided in a sterile condition for each surgical procedure.

[0158] The probe assembly 12 has a cylindrical body 244 that supports and is surrounded by an oversheath 246. The oversheath 246 is secured to the body 244 by a series of O-rings 248 that surround both the oversheath 246 and the body 244. The oversheath 246 can be slipped over the handle assembly 13 to provide a sterile barrier around the handle assembly 13, as shown in FIG.

[0159] The handle assembly 13 includes the necessary cables and connectors to interface with the probe assembly 12 and the camera control unit 15. Optionally, the handle assembly 13 includes controls 250 for adjusting the head 14 and initiating cleaning or wiping of the camera module 16. The handle assembly 13 may also include the aforementioned stepper motor 21 that acts on the mechanism that rotates the head 14, along with electrical contacts, an optical receiver 180, an LED, and a PCB.

[0160] The probe assembly 12 includes conduits for transmitting power, data, illumination and mechanical motion to and / or from the rotating head 14. Referring to the proximal end view of the probe assembly 12 in Fig. 29, this shows the features that interface with the handle assembly 13, namely a socket 252 for receiving the distal end of the handle assembly, a mechanical rotation interface 254 or dog clutch for receiving drive from the stepper motor 21, electrical contacts 256, and an optical interface 258. Fig. 29 also shows that the shaft 242 of the probe 12 is a multi-lumen structure and is supported by an internal structural wire 260.

[0161] 30a-30f, these figures show a method for addressing the challenges of manufacturing an endoscope of the present invention. In this regard, the extreme miniaturization of head 14 in particular means that novel approaches are beneficial during manufacture and assembly.

[0162] 30a-30f show a sequence of steps in deploying overmolding technology in a clean room assembly line for building subassemblies of endoscope 10. FIG.

[0163] Overmolding can be done using micro-injection molding or low pressure adhesive injection molding techniques.

[0164] Figure 30a shows the distal structure of the probe 12 with the power flex cable 262 in place, with the coil 182 of the power flex cable 262 surrounding the spigot 38 that defines the axis of rotation 22. This assembly is placed into a mold for overmolding. Figure 30b then shows the power flex cable 214 of the camera module 16 and light guide component 40, which are also assembled into the mold.

[0165] Figure 30c shows the pulley housing 200 overmolded onto the previously placed components described above. Next, referring to Figure 30d, the resulting assembly is placed into a second mold for overmolding again, before the camera module 16, axis structure 204, and window 208 components are positioned. This step also allows electrical connections to be made between the camera module 16 and its power flex cable 214.

[0166] Figure 30e shows the assembly ready for a second overmolding process and Figure 30f shows the assembly with the resulting camera housing overmolding 264 in place. This defines the head 14 assembled onto the distal structure of the probe 12, the head 14 being rotatable on the spigot 38 of the distal structure. The hermetic nature of the assembly prevents fluid ingress beyond the interface of the spigot 38 and the pulley housing 200.

[0167] Importantly, camera module 16, which contains the most expensive components such as electronic components containing rare metals, is fully encapsulated in this process, which is advantageous because it protects camera module 16 from contamination with prions or other contaminants that are difficult or impossible to remove, thus allowing for disassembly and reuse of camera module 16 in a circular manufacturing process.

[0168] Turning to Figures 31 and 32, these figures show an optional mechanism for driving and managing the movement of the drive wire, belt or cable 26. With reference to Figures 28b and 29, the mechanism shown in Figures 31 and 32 is housed within a cylindrical body 244 at the proximal end of the shaft 242 of the probe assembly 12. Portions of the drive cable 26 run parallel to one another along the shaft 242 to rotate the head 14 of the probe at the distal end of the shaft 242.

[0169] As previously mentioned, the proximal socket 252 of the body 244 receives and mates with a distal end arrangement of the handle assembly 13, not shown in these drawings. In either case, the mechanism is powered by a drive arrangement comprising the previously mentioned stepper motor 21 in the handle 13, via a dog clutch 254.

[0170] The mechanism shown in FIG. 31 comprises a pair of spools 266 which counter-rotate on respective parallel longitudinal axes 268 by means of a meshing gear 270. One of the spools 266 is driven directly by the dog clutch 254 and the other spool 266 is driven indirectly via the meshing gear 270. One spool 266, shown here on the left, winds up an end of the drive cable 26 such that the other spool 266, shown here on the right, pays out the opposite end of the drive cable 26. Each portion of the drive cable 26 passes through a set of guides 272 on its way to and from the shaft 242. It will be apparent that when the drive to the dog clutch 254 is reversed, the action of the spool 266 will also be reversed, reversing the motion of the drive cable 26 and therefore the rotation of the head 14.

[0171] Each spool 266 has a splined spindle or spigot 274 at its proximal end and a threaded spindle or spigot 276 at its distal end, with both spigots 274, 276 extending longitudinally and coaxial with the axis 268 of the spool 266. The splined spigot 274 is received within a complementary splined socket 278 that is integral with or otherwise rotates with the gear 270. The spigot 274 and socket 278 are in a fixed angular relationship by virtue of their splined or keyed profile, but the spigot 274 can slide longitudinally in and out of the socket 278.

[0172] Conversely, the male threaded spigot 276 is received in a complementary female threaded socket 280 that is fixed relative to the body 244. By virtue of their mating threads, rotation of the spigot 276 within the socket 280 causes the spigot 276, and thus the remainder of the spool 266, to move longitudinally along the axis 268 relative to the socket 280 and body 244. This drives the aforementioned longitudinal movement of the splined spigot 274 within the splined socket 278.

[0173] It will be apparent that the threads on the spigot 276 and socket 280 associated with both spools 266 have the same windings, but because the spools 266 counter-rotate, the rotating spools 266 move in opposite longitudinal directions as shown. This longitudinal movement prevents the drive cable 26 from being wound into overlapping coils, thus facilitating smooth and reliable winding and unwinding of the drive cable 26 onto and from the spools 266. Optionally, the spools 266 may have an external helical groove configuration, similar to a screw thread, to guide the coils of the drive cable 26 during winding and unwinding.

[0174] The opposing longitudinal movements of the spool 266 also maintain a consistent gap between the set of guides 272 and the intersection of the drive cable 26 and the spool 266. This helps to maintain consistent tension in the drive cable 26, allowing the drive cable 26 to reliably and faithfully drive the rotation of the head 14 without slipping or jumping. Optionally, as shown, a biasing mechanism 282 biases the shaft 242 distally away from the body 244 of the probe assembly 12, which also has the effect of maintaining tension in the drive cable 26.

[0175] Both ends of drive cable 26 are secured to tie holes 284 in respective spools 266. In this manner, drive cable 26 can be open ended and therefore simplifies manufacture since it does not need to be a continuous loop.

[0176] The mechanism shown in Fig. 31 drives the head 14 of the probe assembly 12 to rotate a set amount in each direction depending on the diameter of the spool 266 relative to the pulley groove 28 of the head 14, the number of coils of the drive cable 26 carried by the spool 266, and the thread pitch of the spigot 276 and socket 280. The mechanism can be set in a variety of ways, using combinations of right and left hand threads, as well as rollers, belts, or additional gears, to achieve a similar effect. Optionally, the position or orientation of the spool 266 or set of guides 272 relative to the surrounding body 244 can be adjusted in a manner now described with reference to Fig. 32, where like numerals are used for like features.

[0177] 32, a single spool 266, directly driven through dog clutch 254 about longitudinal axis 268, carries a series of coils of drive cable 26 looped continuously. Drive cable 26 is wound onto one end of spool 266 and unwound from the other end of spool 266. The coil of drive cable 26 is slid along spool 266 to make room for additional coils to be wound onto spool 266. Lubrication may be provided to assist the sliding motion.

[0178] Optionally, as shown, spool 266 is shaped to assist drive cable 26 in sliding along spool 266 and to provide additional tension at the arrival and departure points where drive cable 26 is wound onto and unwound from spool 266 via a set of guides 272. This allows the coil of drive cable 26 to slide more easily along spool 266 while maintaining tension in drive cable 26. In this example, spool 266 has a concave, hourglass shape that is relatively narrow between the arrival and departure points of drive cable 26.

[0179] 32 illustrates another optional feature, namely, a means for adjusting the position or orientation of the spool 266 and / or the set of guides 272 relative to the surrounding body 244, as described above. Specifically, the spool 266 has distal and proximal spindles 286 surrounded by respective bearing blocks 288. The bearing blocks 288 may be moved transverse to the axis 268 relative to the body 244 and the set of guides 272 by screws 290. Increasing the spacing between the spool 266 and the set of guides 272 increases the tension in the looped drive cable 26.

[0180] In this example, the bearing blocks 288 are able to move independently, thus tilting the shaft 268 relative to the body 244. This allows for different adjustments of tension in the respective portions of the drive cable 26 upstream and downstream of the spool 266.

[0181] Another tension adjustment means shown in FIG. 32 is a guide mount 292 that can be moved relative to the body 244 to move at least some of the sets of guides 272 toward and away from the spool 266. In this example, the guide mount 292 is movable longitudinally, generally parallel to the axis 268 by a screw 290. However, the guide mount 292 can also be moved transversely relative to the axis 268. A bias, such as a spring load, can also or alternatively be applied to the adjustment point exemplified by the screw 290. Additionally, although not shown in FIG. 32, a means such as the biasing mechanism 282 of FIG. 31 can bias the shaft 242 distally away from the body 244 to increase tension in the drive cable 26.

[0182] The limited space available within the narrow shaft 242 of the probe 12 due to miniaturization places constraints on a drive system capable of generating sufficient torque to rotate the head 14 about an axis perpendicular to the shaft 242. It is also difficult to minimize errors caused by any mismatch between the inputs and outputs at the proximal and distal ends, respectively, of the endoscope 10. In other words, for a given input from the proximal drive mechanism, the change in angular position of the head 14 must be reasonably calculable and predictable based on the position or movement of the drive mechanism.

[0183] To address this issue, belt or cable drive systems may require the drive cable 26 to be looped multiple times around a pulley or spool at either end, like a capstan, to prevent slippage under high loads, even though some potential for slippage of the drive cable 26 relative to the driving or driven pulley or spool may still exist.

[0184] In miniaturized systems, space constraints impose a trade-off between the thickness of the drive cable 26 and the number of times the drive cable 26 can be looped, wrapped, or turned around a pulley. Reducing the thickness of the drive cable 26 to increase the number of loops, wraps, or turns that can be accommodated reduces its stiffness, which increases the risk and / or impact of mismatch between input and output. Also, as discussed above, manufacturing a suitable closed-loop drive cable 26 can present a design challenge.

[0185] To address these various challenges, Figures 33 and 34 show a worm gear mechanism that provides for torque to be directly transmitted to the head 14 within the shaft 242 of the probe 12 while also providing a significant mechanical advantage. In this regard, the worm gear mechanism comprises a helical worm arrangement 294 at the distal end of a thin rod 296 that extends within and is generally parallel to the shaft 242. The rod 296 functions as a transmission shaft for transmitting torque from a drive device, such as the aforementioned stepper motor 21, located proximally relative to the shaft 242.

[0186] The worm gear mechanism further comprises a worm gear 298 integral with or attached to the head 14 at the distal end of the shaft 242. The worm gear 298 comprises a series of partial helical grooves 300 spaced circumferentially about the axis of rotation 22 of the head 14 and angled at an acute angle relative to the axis of rotation 22 of the head 14. The worm arrangement 294 rotates about an axis that is generally tangential to the worm gear 298 and meshes with the grooves 300 to rotate the worm gear 298 and head 14 in response to rotation of the rod 296.

[0187] The positive mechanical engagement through meshing between the worm arrangement 294 and the worm gear 298 reduces the possibility of slippage, thus improving control over the angular position of the head 14. Also, the rotational drive is advantageously transmitted along the length of the shaft 242 about an axis of rotation that extends along the shaft 242. This minimizes losses, backlash and the effects of tolerances.

[0188] To facilitate compactness, Figures 33 and 34 show two modifications to conventional worm gear designs. Worm arrangement 294 comprises an elongated wire that is coiled or helically formed at the distal end of rod 296, rather than being machined into the shaft. Worm arrangement 294 may be integrally formed with rod 296 or may be attached to rod 296. Conversely, worm gear 298 is formed with a pattern of notched grooves 300 complementary to the helical shape of worm arrangement 294 to allow smooth transmission of rotational drive from rod 296.

[0189] The axis of rotation of the worm arrangement 294 cannot be coaxial with the central axis of the shaft 242, which presents a challenge to compactness. There are also constraints on the helical shape of the worm arrangement 294 that contacts the worm gear 298. Therefore, the rod 296 may be reinforced to increase its structural integrity.

[0190] FIG. 35 shows that a system combining belt and gear drive principles may provide a solution for transmitting torque while minimizing strain on different parts of the system. Here, a rod 296 serves as a transmission shaft that can be located along the central axis of the probe shaft 242 and can be rotated about its axis to transmit torque towards the distal end of the shaft 242. Near the distal end of the shaft 242, a meshed bevel gear 302 rotates the axis of rotation by 90°. A pulley 304 rotating with the second bevel gear 302 is aligned with the pulley groove 28 of the head 14 and transmits the drive force to the head 14 via a short continuous loop drive cable 26. It is noted that in this configuration, the cleaning module or wiper blade 30 is located between the pulley 304 and the rotating head 14.

[0191] The configuration of FIG. 35 does not benefit from the same mechanical advantages as the worm gear design shown in FIGS. 33 and 34. However, locating the rod 296 on the central axis of the probe shaft 242 allows the rod 296 to be thicker and stiffer, thus potentially reducing strain resulting from twisting of the rod 296. Also, the short span between the pulley 304 and the pulley groove 28 reduces strain on the drive cable 26, thus reducing mismatch between the input and output. This short span also makes it easier to manufacture a suitable closed loop drive cable 26.

[0192] 36, an endoscope 10, as shown diagrammatically herein, requires that white light illumination be transmitted from a high intensity light source 27, for example contained in a handle 13 at the proximal end of the endoscope 10, along a light guide 32 to the distal tip of the probe 12 and from there to the head 14. At the same time, data carried by optical signals is transmitted between electronic components in the form of optical transceivers within the handle 13 and head 14. Due to space constraints in the miniaturized endoscope 10, these signals are transmitted in the same light guide 32 that extends along the probe 12 and proximally into the body 244 of the probe 12.

[0193] The configuration shown in Figure 36 combines these two optical signals, illumination and data, within the handle 13 so that the light can be efficiently transmitted across the interface 306 between the handle 13 and the body 244 to the head 14. The solution shown in Figure 36 also separates the data signal returning from the head 14 to the handle 13 so that it can be further processed electronically. Because this configuration combines and separates optical signals, it can be described as an optical multiplexer. Figure 36 shows one possible design of such an optical multiplexer.

[0194] The configuration of Figure 36 includes an optical multiplexer element 308 disposed within the handle 13 of the endoscope 10. The handle 13 is a reusable component of the system and is intended to connect directly to the body 244 of the probe 12, which is a disposable or partially recyclable component of the system.

[0195] The element 308 is disposed within the handle 13 such that, when the handle 13 is engaged with the body 244, the distal end of the element 308 faces and is in optical communication with the proximal end of the light guide 32 within the body 244. Thus, the mechanical configuration of the handle 13 is such that, when mated with the body 244 of the probe 12, the element 308 is longitudinally and laterally aligned with the light guide 32 to minimize insertion loss across the interface 306.

[0196] Element 308 is made of a transparent material such as glass or a suitable polymer with high transmission properties at visible and near infrared wavelengths. At its proximal end, element 308 has a 45° chamfer or bevel 310 that is coated with a short-pass dichroic coating. The coating of bevel 310 is transparent to light having wavelengths below a cutoff level, which in this case may be defined as the boundary between visible and near infrared light. Wavelengths above the cutoff level, and therefore near infrared light, are reflected by the coating of bevel 310.

[0197] 36 , light in the visible wavelength range from illumination source 27 passes through the coating of bevel 310 and is therefore guided through element 308 and into light guide 32. Meanwhile, light in the near infrared range emitted by transceiver 312 is reflected by the coating of bevel 310 and is therefore also guided through element 308 and into light guide 32. Similarly, data signals returning along light guide 32 from head 14 of endoscope 10 are reflected off the coated surface of bevel 310 and directed towards transceiver 312.

[0198] FIG. 36 shows an optional lens 314 that may be used to optimize the coupling of light into element 308 and, in the case of a data signal, optimize the collection of emitted light that is focused onto a transceiver 312.

[0199] 37, the illumination source 27, light source and transceiver 312 are still located within the handle 13. However, the multiplexer is not a separate element forming part of the handle 13, but instead is a chamfered or beveled proximal end of the light guide 32 itself. In this variation, the insertion loss across the interface 306 is eliminated.

[0200] In this example, the proximal end portion of light guide 32 that defines the multiplexer protrudes proximally from body 244 and is protected by an outer housing 316 of body 244. The 45° bevel 310 at the proximal end of light guide 32 is again coated with a short-pass dichroic coating and has the same function as described above in connection with FIG.

[0201] When the handle 13 is engaged with the body 244, the housing 316 is received in a complementary socket 318 of the handle 13 as a male / female mechanical coupling. The socket 318 supports the lens 314, and the housing 316 has a window or opening that is aligned with or faces the lens 314 for the light guide 32 to optically communicate with the illumination source 27 and the transceiver 312 via the beveled surface 310.

[0202] In another variant, also applicable to Fig. 36, the dichroic coating of the bevel 310 may be replaced by a polarizing beam splitter. In that case, the illumination and data optical signals are linearly polarized orthogonally to each other. One polarization state associated with the data is reflected by the splitter to or from the transceiver 312, while the other polarization state associated with the illumination passes straight through the splitter from the illumination source 27.

[0203] The source of white light serving as illumination source 27 may be a light emitting diode (LED), an RGB laser, a laser-pumped phosphor source, or other equivalent broadband, visible light emitting source.

[0204] Turning now to FIG. 38, visualization of certain structures during surgery (e.g., between blood vessels and parenchymal tissue) can be difficult due to low contrast under standard white light illumination. Visualization can be improved by illuminating the tissue with wavelengths of light that take advantage of the optical properties of endogenous pigments in the body and allow greater contrast to be observed. For example, shorter visible wavelengths in the blue or green range are absorbed more strongly by hemoglobin in blood than red. As a result, illuminating the tissue with such wavelengths allows enhancement of blood-rich features from the background.

[0205] Contrast can also be enhanced by introducing dyes, either topically or intravenously, to provide exogenous contrast enhancement. This can be accomplished passively by flowing, diffusing, or otherwise staining the tissue of interest, or actively using molecular targeting. In one variation, the dye is fluorescent and can emit light of a particular wavelength when a particular excitation wavelength is incident upon it. In another variation, the dye can be a pigment that absorbs light of a particular wavelength or range of wavelengths.

[0206] In this case, the illumination source must be controlled so that the contrast-enhancing signal (e.g., fluorescence emission or absorption signal) is not contaminated or washed out by other overlapping wavelengths used for standard illumination. One method is to temporally separate the signal wavelengths representing the fluorescence excitation light or dye absorption peaks from the standard white-light illumination source by alternately switching them on and off in a strobe fashion, as shown in the top of FIG. 38. If this strobing is done synchronously with the image acquisition, the video feed can be subsequently processed to select frames that show either standard white-light illumination, contrast-enhancing illumination, or a combination of contrast enhancement superimposed on a standard illuminated background, as also shown in FIG. 38. Simulated views under these three scenarios, as seen by the surgeon on the system display, are shown in the bottom of FIG. 38.

[0207] Illumination requires multiple wavelength channels for both intrinsic and extrinsic contrast enhancement. Such channels include channels capable of providing standard white light illumination and, in the case of exogenous contrast agents, channels capable of providing excitation wavelengths. Referring to FIG. 39, a light multiplexer 320 combines these multiple wavelengths into a single light guide 32, which is then guided to the head 14 of the endoscope 10 to illuminate the tissue.

[0208] Conveniently, the multiplexer 320 may be incorporated into the handle 13 of the endoscope 10, as shown in Figure 39. In this example, the multiplexer 320 is a proximal extension of the light guide 32 in a manner similar to the configuration shown in Figure 37, with the extension projecting from the body 244 and housed within a housing 316 that is received within a socket 318 in the handle 13. In other examples, the multiplexer 320 may comprise a separate element in optical communication with the light guide 32 via an interface 306, such as element 308 shown in Figure 36.

[0209] 39 shows an optical transceiver 312 used to communicate optical data to and from the head 14 at the distal end of the endoscope 10. In this case, in addition to the white light source 27 axially mounted at the end of the multiplexer, a further emitter 322 is positioned axially consecutively along the multiplexer 320. The emitter 322 and the white light source 27 emit light at different wavelengths.

[0210] The various light sources, in this example the transceiver 312, the emitter 322, and the white light source 27, communicate with the light guide 32 via respective lenses 314. As previously mentioned, the lenses 314 optimize the coupling of light into the light guide 32 and, in the case of data signals, optimize the collection of the emitted light that is focused onto the transceiver 312.

[0211] The transceivers 312 and emitters 322 are axially aligned with respective shortpass dichroic filters 324 in the light guide 32, each at a 45° angle to the longitudinal axis of the light guide 32. Thus, in this variation, the input ports of the multiplexer 320 are formed by stacking multiple waveguiding elements separated by filters 324. The light sources are arranged in order of increasing wavelength from the white light source 27 through the emitters 322 to the transceivers 312, either top to bottom as shown, or distally consecutively. The filters 324 are designed to have a cutoff wavelength between the wavelength ranges of each of these light sources.

[0212] Additional light sources may be used by simply stacking dichroic filters 324 in addition to those shown in Figure 39. As previously mentioned, the light sources used may be light emitting diodes (LEDs), lasers or the like.

[0213] Figure 40 shows a possible arrangement of light guides 40 in the head 14 featured in the previous embodiment. In summary, illumination and optical data signals, combined using an optical multiplexer / demultiplexer in the handle 13, travel down the light guide 32 of the probe 12 until reflected into the head 14 by a 90° prism 34, as in the configurations shown in Figures 36, 37 and 39. The prism 34 directs the light along the axis of rotation 22 of the head 14 into the light guide 40 shown in Figure 40.

[0214] The light guide 40 functions as an optical demultiplexer by separating the illumination from the optical data signals and directing the illumination to the light emitters 18 and the optical data signals to an optical transceiver implemented by a transceiver LED 174 coupled to the electronics of the camera module 16. Conversely, the light guide 40 also functions as an optical multiplexer to receive the optical data signals emitted by the LEDs 174 and couple them back into the light guide 32 for transmission via an optical multiplexer / demultiplexer in the handle 13 to the optical transceiver 312.

[0215] In the variation shown in Figure 40, two dichroic filters 326, 328 are orthogonal to each other in an "X" configuration centered about the axis of rotation 22 of the head 14, with each filter 326, 328 oriented at 45° to the light entering and exiting the light guide 40. Filter 326, shown in dashed lines, is a short pass filter that is transmissive to visible light and reflective to near infrared light, while filter 328, shown in solid lines, is a long pass filter that is transmissive to near infrared light and reflective to visible light. This configuration achieves the required separation of the input illumination, shown in solid lines, from the input and output data signals, shown in dashed lines.

[0216] Detail A of Figure 40 shows how the crossed dichroic filters 326, 328 can be assembled from four separate optical elements 330, 332. A pair of elements 330 aligned with each other and with the light emitter 18 and LED 174 each have tapered tips defined by facets 334 that converge at 90° to each other. The other pair of elements 332, oriented at 90° to element 330, has similarly tapered tips that laterally engage element 330 to complete the light guide 40.

[0217] While elements 332 are uncoated, facets 334 of each element 330 are coated to define the desired characteristics of filters 326, 328. Specifically, one facet 334 of each element 330, represented here by a dashed line, is coated to define the shortpass characteristics of filter 326. The other facet 334 of each element 330, represented here by a solid line, is coated to define the longpass characteristics of filter 328.

[0218] When elements 330 are gathered tip-to-tip, their facets 334 combine to define filters 326, 328. In this regard, it should be noted that the short-pass coated facets 334 and the long-pass coated facets 334 of elements 330 are diagonally opposed around the abutting tips of the elements 330.

[0219] In another variation, the light guide 40 shown in Figure 40 can be used to separate wavelength bands other than visible and near infrared. Any two wavelength bands may be selected for the design of the illumination and data channels, and the selection is implemented in the optical properties of the dichroic filters 326, 328. These coatings may be long or short pass with cut on / off wavelengths at various locations, or may have a band pass structure that selectively transmits or reflects narrow or wide wavelength ranges and multiple discontinuous bands.

[0220] In a further variation, as described above in relation to Figures 36 and 37, the dichroic filters may be replaced by polarising beam splitters operating on the orthogonal polarisations used for the data and illumination channels.

[0221] Finally, referring to Figures 41 and 42, free 360° rotation of head 14 requires that the circuitry be electrically isolated, and therefore data and power be transmitted wirelessly. The requirement for wireless power transmission in such a confined space presents challenges when the data includes video signals that are susceptible to distortion. Thus, a solution is needed that can mitigate power and data loss while still allowing 360° rotation of head 14.

[0222] Figure 41 is a block diagram outlining this solution as a system overview, while Figure 42 shows the details of the system shown in Figure 41. The system shown in Figures 41 and 42 is split into two parts, a disposable part and a reusable part. The probe 12 and head 14 are in the disposable part of the system, and the handle 13 and camera control system or CCU 15 are in the reusable part of the system.

[0223] In this solution, the clock signal and power are transmitted together on a single channel using a superimposed signal as shown in Figure 27. In the reusable part of the system, a high frequency clock signal is generated that is used as the power transmission clock. This signal requires a phase lock condition with the signal provided by the image sensor companion chip 230, such as 24 MHz.

[0224] On the receiver side, at the head 14 of the disposable part of the system, a digital divider is needed to recover the clock signal at the correct frequency of 24 MHz. If the frequency of the power clock signal is an integer multiple of the 24 MHz clock, a simple frequency divider can be used. The frequency divider is simpler if the multiplier is a power of 2, for example 2, 4 or 8. For simplicity, the solutions shown in Figures 41 and 42 use 4 as the multiplier.

[0225] For reliable data signal transfer, the reconstructed 24 MHz clock signal within head 14 must have an equal phase relationship with the clock signal generated externally to head 14. To solve this problem, the system provides phase adjustment.

[0226] In this example, the image sensor 48 of the head 14 uses a 24 MHz clock signal generated in the image sensor companion chip 230. Power transfer can be performed by inductive coupling. The power circuit may employ, for example, a sinusoidal ("sine") signal having a frequency of 96 MHz (which is four times the 24 MHz clock frequency in this example) to enable the use of a small, compact planar coil 182 for power transfer. As previously mentioned, such a coil 182 can be fabricated using a two-layer flex board.

[0227] Due to the high frequency of the power signals, the SPI data transfer method described in the previous embodiment may not be suitable. For this purpose, the optical channel video data signal path is reused in the reverse direction for the SPI control signals.

[0228] 26 embodiment, an image signal processing chip 224 responsive to an embedded computer 226 drives an SPI controller 228 implemented on the image sensor companion chip 230. In this case, however, the SPI controller 228 provides SPI write data to the optical transceiver 312.

[0229] The image sensor companion chip 230 also implements a clock generator 232 which generates a 24 MHz signal which is multiplied by 4 in frequency multiplier 336 to 96 MHz and fed to a power and clock sine wave filter driver 338 which then wirelessly transmits the power and clock signals through the interface between the probe 12 and head 14 via the inductive link at 182 to the head 14.

[0230] In the head 14, a power harvester chip 340 receives power from the inductive link at 182 and provides the power to a power regulator 33. The power regulator 33 regulates the power to drive the image sensor 48 and supporting circuitry. A filter 216 filters the clock signal from the power signal. The clock signal is then divided by 4 in a digital divider 218 to control the image sensor 48, thus returning it to a frequency of 24 MHz.

[0231] In the optical channel video data signal path, a sync separator 342 receives the SPI data from the optical transceiver 312. A clock phase alignment detector 344 receives inputs from the sync separator 342 and the clock generator 232 of the companion chip 230 to apply phase control to the frequency multiplier 336.

[0232] As shown in FIG. 26, the optical demodulator 236 receives and demodulates the signal from the optical transceiver 312 and provides its output to the image signal processing chip 224 via an analog-to-digital converter 238 and a parallel mobile industrial processor interface 240 .

[0233] Many other variations are possible within the concept of the invention. For example, data communication and power transmission between parts of the surgical instrument could in principle be achieved by wireless techniques other than those described, such as magnetic resonance communication. However, electrical contacts on the external surfaces of adjacent capsules, modules or components or conductors between them could potentially be used for this purpose.

[0234] Data communication and power transmission in the instrument may be accomplished by daisy-chain connections between successive capsules, modules, or encapsulated components of the instrument. Thus, each capsule, module, or component in a daisy-chain configuration has a means for receiving data or power from an external source, and / or a means for transmitting or conveying data or power to an external receiver. Such daisy-chain functionality is exemplified herein by a means for receiving light in the head to power the camera module, and a means for transmitting data from the camera module to an external receiver. In the case of RF communication, daisy-chain connections are advantageous because short transmission distances mean that power can be kept low, making it easier to provide sufficient electrical energy and ensuring that RF radiation does not penetrate too deeply into the patient's body.

[0235] In some embodiments of the invention, the outer element of the endoscope may be made from a biodegradable material, further reducing waste that would otherwise be sent for recycling or incineration. This is most appropriate for structural parts such as handles. The biodegradable portion may form part of the capsule and may degrade as described above. Alternatively, the second inner layer may form an airtight seal. In that case, the second inner layer may be of a non-structural nature and may be supported and protected by the outer biodegradable layer.

Claims

1. A medical scope, With a long, slender body, an imaging head supported by a mount on the body and movable relative to the mount, the imaging head including a light emitter for illuminating a field of view of the imaging head; an optical path extending from the body through the imaging head to the light emitter, the optical path including an optical inlet of the imaging head opposed to an optical outlet of the body; A scope.

2. The scope of claim 1 , wherein the optical inlet and the optical outlet are opposed to each other across a mounting interface to which the imaging head is movably attached to the mount.

3. The imaging head includes: An image sensor; 3. The scope of claim 1 or 2, further comprising: a photovoltaic device arranged to impinge light from the body to generate power for the image sensor.

4. 4. The scope of claim 3, further comprising a data transmitter powered by the photovoltaic device for transmitting image data from the image sensor to a receiver external to the imaging head.

5. 5. The scope of claim 3 or 4, wherein the imaging head further comprises a light guide in the optical path configured to direct a portion of the light received from the body to the photovoltaic device and to direct another portion of the light received from the body to the light emitter.

6. 6. The scope of claim 5, wherein the light inlet and the light outlet are disposed on an axis of rotation about which the imaging head can rotate relative to the mount, and the light guide is disposed between the mount and the image sensor in a direction parallel to the axis.

7. 7. The scope of claim 6, wherein the light emitter is also disposed between the mount and the image sensor in a direction parallel to the axis of rotation at a location radially spaced from the axis of rotation.

8. 8. The scope of claim 5, wherein the light guide comprises a filter configured to split the light received from the body into the portions directed onto the photovoltaic device and towards the light emitter.

9. 9. The scope of claim 3, wherein the imaging head comprises an encapsulation around the image sensor, the encapsulation comprising a disassembly interface by which the image sensor is preferentially separable from the light emitter.

10. The scope of claim 9 , wherein the disassembly interface comprises at least one point of weakness in the enclosure.

11. The scope of claim 1 , wherein the imaging head is cantilevered from the mount.

12. 1. A method of illuminating a field of view of an imaging head of a medical scope, comprising: the imaging head is movable relative to a support of the scope; The method includes transmitting light along an optical path from an optical outlet of the body to an optical inlet of the imaging head, and then transmitting the light through the imaging head to be emitted from the imaging head.

13. The method of claim 12 , comprising powering an image sensor of the imaging head with power generated within the imaging head from at least a portion of the light transmitted along the optical path.

14. 14. The method of claim 13, comprising filtering light traveling along the optical path within the imaging head to separate the light into respective components for power generation and illumination.

15. 15. The method of claim 14, comprising varying at least one of the components of the light relative to another of the components of the light for independent regulation of power generation and / or illumination.

16. A medical scope, an imaging head supported by and movable relative to a body, the imaging head including an image sensor and a light emitter for illuminating a field of view of the image sensor; an optical path extending from the body to the light emitter, the optical path including an optical inlet of the imaging head facing an optical outlet of the body across a wireless interface between the imaging head and the body; an optical transmitter in the imaging head, the optical transmitter being coupled to the optical path to transmit image data from the image sensor to the body via the wireless interface; and A scope.

17. The scope of claim 16 , wherein the light inlet and the light outlet face each other across a mount to which the imaging head is movably attached to the body.

18. 18. The scope of claim 16 or 17, wherein the light inlet and the light outlet are arranged on a rotation axis on which the imaging head can rotate relative to the body.

19. 20. The scope of claim 18, wherein the light emitter is disposed between the wireless interface and the image sensor in a direction parallel to the axis of rotation at a location radially spaced from the axis of rotation.

20. 20. The scope of any one of claims 16 to 19, wherein the wireless interface further comprises a wireless power transfer coupling providing transfer of power from the body to the image sensor.

21. 21. The scope of claim 20, wherein the power transfer coupling comprises opposing coils, a first of the coils surrounding the optical entrance of the imaging head and a second of the coils surrounding the optical exit of the body.

22. 20. The scope of claim 16, wherein the imaging head further comprises a photovoltaic device for powering the image sensor from light transmitted over the wireless interface.

23. 23. The scope of any one of claims 16 to 22, wherein the imaging head further comprises a filter in the optical path configured to block reflected light from the light emitter and pass light transmitted from the optical transmitter.

24. 24. The scope of any one of claims 16 to 23, further comprising a light source external to the imaging head and coupled to the light path to provide illumination light to the light emitter, the light source and the image sensor being synchronized such that the light source is on when the image sensor is capturing an image frame and the light source is off between image frames while the optical transmitter is transmitting imaging data from the image sensor.

25. 25. The scope of claim 16, further comprising an image sensor controller disposed outside the imaging head, the image sensor controller configured to communicate control signals from the image sensor controller to the image sensor via the wireless interface.

26. 26. The scope of claim 25, wherein the control signals include a clock signal multiplexed with a write signal.

27. 27. A scope according to claim 25 or 26, wherein the image sensor controller is connected to a radio power transfer coupling of the wireless interface and communicates the control signals to the image sensor via the power transfer coupling.

28. 28. The scope of any one of claims 25 to 27, wherein the image sensor controller drives an LED to communicate the control signal to the image sensor as a light control signal.

29. 30. The scope of claim 28, wherein the optical transmitter in the imaging head is responsive to the optical control signal.

30. 1. A method of operating a scope having an imaging head movable relative to a support, the method comprising: transmitting light from the body to the imaging head along an optical path that traverses a wireless interface to illuminate a field of view of the imaging head; optically transmitting image data from the imaging head to the body along the optical path via the wireless interface; A method comprising:

31. A medical scope including an imaging head, the imaging head comprising: an capsule encapsulating an image sensor and electronics associated with said image sensor; a light guide positioned to transmit illumination to a field of view of the image sensor; A scope.

32. 32. The scope of claim 31, wherein the light guide is within the capsule.

33. 32. The scope of claim 31 , wherein the light guide is attached to the capsule.

34. 34. The scope of any one of claims 31 to 33, wherein the imaging head further comprises a breakaway interface through which the encapsulated image sensor and electronics are preferentially separable from the light guide.

35. 35. The scope of claim 34, wherein the disassembly interface comprises at least one point or line of weakness in or on the imaging head.

36. 36. The scope of claim 35, wherein the weak point or line of weakness is aligned with a joint of the imaging head disposed between the image sensor and electronics and the light guide.

37. 37. The scope of any one of claims 34 to 36, wherein the disintegration interface comprises a protective barrier embedded within the encapsulation.

38. 38. A scope according to any one of claims 31 to 37, wherein the probe of the scope comprises a mount to which the imaging head is movably attached to the probe.

39. 40. The scope of claim 38, wherein the capsule or the light guide includes a formation configured to movably engage the mount.

40. 40. A scope as claimed in claim 38 or 39, wherein the imaging head is cantilevered from the mount.

41. 41. The scope of any one of claims 38 to 40, wherein the light guide is disposed between the mount and the image sensor in a direction parallel to an axis of rotation about which the imaging head can rotate relative to the mount.

42. 42. The scope of any one of claims 38 to 41, wherein the imaging head is disposed at a distal end of the probe and a handle is detachably attached to a proximal end of the probe.

43. 43. The scope of claim 42, wherein the handle comprises a drive for moving the imaging head relative to the probe, a light source for transmitting illumination along the probe to the light guide of the imaging head, and power and / or data connections for transmitting power and / or data along the probe to or from the imaging head.

44. 44. A scope according to claim 43, comprising a drive interface, an optical interface, and a power and / or data interface between the handle and the probe.

45. 45. A scope according to any one of claims 42 to 44, wherein the probe supports and is surrounded by an oversheath that can be placed over the handle.

46. 1. A method for disassembling an imaging head of a medical scope, the method comprising: breaking or severing an encapsulation of the imaging head that encapsulates an image sensor and associated electronics; and separating the image sensor and the electronics from a light guide of the imaging head, the light guide having illumination positioned to transmit to a field of view of the image sensor.

47. 47. The method of claim 46, comprising separating the light guide from the encapsulation.

48. 48. The method of claim 46 or 47, comprising removing the light guide from within the capsule.

49. 49. The method of any one of claims 46 to 48, comprising applying a force to a line or point of weakness in the imaging head to separate the image sensor and electronics from the light guide.

50. 50. The method of any one of claims 46 to 49, further comprising the preliminary step of inspecting the capsule for seal integrity prior to breaking or cutting the capsule.

51. 51. The method of any one of claims 46 to 50, further comprising the preliminary step of placing the scope in a container after use.

52. 52. The method of claim 51, comprising the further preliminary step of removing the scope from the container in a sterile manner prior to use.

53. 53. The method of claim 51 or 52, comprising adding water to the container to activate the cleaning agent therein.

54. 54. The method of any one of claims 51 to 53, comprising placing the container in a repository.

55. 55. The method of claim 54, including transporting the archive to a remote decomposition unit.

56. 56. The method of claim 55, comprising, in response to an alert regarding remaining capacity of the vault, transporting the vault to the decomposition unit.

57. 54. The method of any one of claims 51 to 53, comprising transporting the container to a remote decomposition unit.

58. 58. The method of any one of claims 55 to 57, comprising, in the disassembly unit, robotically unpacking and disassembling the scope into parts and sorting the parts into parts for recycling, parts for reuse, waste for destruction, and / or biodegradable materials.

59. 60. The method of claim 58, wherein the part for reuse includes the image sensor.

60. 60. The method of claim 58 or 59, comprising applying a partial vacuum to the scope and / or applying a flow of gas across the scope during disassembly.

61. 61. The method of any one of claims 58 to 60, comprising transporting the part to a remanufacturing facility for reuse.

62. 1. A method of manufacturing an imaging head for a medical scope, the method including encapsulating an image sensor and associated electronics of the imaging head, the imaging head further comprising a light guide positioned to transmit illumination to a field of view of the image sensor.

63. 63. The method of claim 62, further comprising encapsulating the light guide within the encapsulant.

64. in a first overmolding step, overmolding the light guide to embed the light guide within an overmolded body; positioning the image sensor and the electronics next to or opposite the overmolded body; 64. The method of claim 63, including overmolding the image sensor and the electronics in a second overmolding step to complete the encapsulation.

65. 65. The method of claim 64, further comprising embedding an induction coil within the overmolded body.

66. 66. The method of claim 64 or 65, comprising forming the overmolded body on a mount where the imaging head is moveable relative to a probe of the scope.

67. 67. The method of claim 66, wherein the mount is configured to allow the imaging head to be rotated relative to the probe.

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